• Medical - Instruments & Supplies
  • Healthcare
Becton, Dickinson and Company logo
Becton, Dickinson and Company
BDX · US · NYSE
241.87
USD
+5.86
(2.42%)
Executives
Name Title Pay
Mr. Thomas E. Polen Jr. President, Chief Executive Officer & Chairman 3.46M
Mr. Michael Garrison Executive Vice President & President of Medical segment 1.73M
Mr. Thomas J. Spoerel Senior Vice President, Controller & Chief Accounting Officer --
Ms. Elizabeth McCombs Executive Vice President & Chief Technology Officer --
Mr. Greg Rodetis Head of Investor Relations --
Ms. Michelle Quinn Executive Vice President & General Counsel --
Ms. Shana Carol Neal Executive Vice President & Chief People Officer 1.79M
Mr. Christopher J. DelOrefice Executive Vice President & Chief Financial Officer 1.6M
Dr. Joseph M. Smith F.A.C.C, M.D., Ph.D. Senior Vice President, Chief Scientific Officer & Co-Chair of Scientific Advisory Board --
Ms. Denise Russell Fleming Executive Vice President of Technology & Global Services and Chief Information Officer --
Insider Transactions
Date Name Title Acquisition Or Disposition Stock / Options # of Shares Price
2024-07-31 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 124 0
2024-07-31 Byington Carrie L director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 124 0
2024-02-05 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock UnderBD Deferred Compensation Plan 230 0
2024-07-01 Spoerel Thomas J SVPController & Chief Acct Off D - F-InKind Common Stock 48 0
2024-06-10 Spoerel Thomas J SVP,Controller&Chief Acct Off D - S-Sale Common Stock 300 239.31
2024-05-15 Goette Roland EVP and President EMEA D - S-Sale Common Stock 800 235.29
2024-05-15 Goette Roland EVP and President EMEA D - S-Sale Common Stock 1400 236.99
2024-05-15 Goette Roland EVP and President EMEA D - S-Sale Common Stock 1100 237.46
2024-05-13 Goette Roland EVP and President EMEA D - S-Sale Common Stock 1700 236.28
2024-05-13 Goette Roland EVP and President EMEA D - S-Sale Common Stock 1572 237.14
2024-05-13 Goette Roland EVP and President EMEA D - S-Sale Common Stock 28 237.9
2024-05-03 Byington Carrie L director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 129 0
2024-05-03 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 129 0
2024-04-30 Garrison Michael David EVP & President Medical D - S-Sale Common Stock 1715 232.81
2024-04-04 Neal Shana Carol EVP and Chief People Officer D - F-InKind Common Stock 1921 0
2024-03-14 Spoerel Thomas J SVP,Controller&Chief Acct Off D - S-Sale Common Stock 282 238.29
2024-03-01 Garrison Michael David EVP & President Medical D - F-InKind Common Stock 178 0
2024-03-01 Spoerel Thomas J SVP,Controller&Chief Acct Off D - F-InKind Common Stock 36 0
2024-03-01 Ezell Antoine C EVP, President NA & CMO D - F-InKind Common Stock 282 0
2024-02-05 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 126 0
2024-02-05 Byington Carrie L director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 126 0
2024-01-23 Waldstreicher Joanne director A - A-Award Common Stock 900 0
2024-01-23 SCOTT BERTRAM L director A - A-Award Common Stock 900 0
2024-01-23 RING TIMOTHY M director A - A-Award Common Stock 900 0
2024-01-23 Jones Christopher Ian Montague director A - A-Award Common Stock 900 0
2024-01-23 Henderson Jeffrey William director A - A-Award Common Stock 900 0
2024-01-23 Fraser Claire director A - A-Award Common Stock 900 0
2024-01-23 ECKERT R ANDREW director A - A-Award Common Stock 900 0
2024-01-23 Byington Carrie L director A - A-Award Common Stock 900 0
2024-01-23 Brown William M director A - A-Award Common Stock 900 0
2024-01-23 BURZIK CATHERINE M director A - A-Award Common Stock 900 0
2019-01-22 BURZIK CATHERINE M director A - A-Award Common Stock 923 0
2023-11-16 Goette Roland EVP and President, EMEA D - D-Return Common Stock 2233 235.07
2024-01-03 Shan David EVP and Chief ISC Officer D - F-InKind Common Stock 44 0
2017-12-29 RING TIMOTHY M director D - Common Stock 0 0
2023-01-24 Jones Christopher Ian Montague director A - A-Award Common Stock 848 0
2023-12-11 Garrison Michael David EVP & President Medical D - S-Sale Common Stock 1239 232.46
2023-11-28 Byrd Richard EVP & President Interventional D - S-Sale Common Stock 2156 238.47
2023-11-26 Spoerel Thomas J SVPController & Chief Acct Off A - A-Award Common Stock 757 0
2023-11-26 Spoerel Thomas J SVPController & Chief Acct Off A - A-Award Stock Appreciation Rights 2764 238.89
2023-11-26 Spoerel Thomas J SVPController & Chief Acct Off D - F-InKind Common Stock 365 0
2023-11-26 Spoerel Thomas J SVPController & Chief Acct Off A - A-Award Common Stock 375 0
2023-11-26 Hickey David EVP & President, Life Sciences A - A-Award Rights to Common Stock Under Deferred Compensation Plan 3024 238.89
2023-11-26 Hickey David EVP & President, Life Sciences A - A-Award Stock Appreciation Rights 9213 238.89
2023-11-26 Hickey David EVP & President, Life Sciences A - A-Award Common Stock 1663 0
2023-11-26 Byrd Richard EVP & President Interventional A - A-Award Stock Appreciation Rights 8061 238.89
2023-11-26 Byrd Richard EVP & President Interventional A - A-Award Common Stock 2886 0
2023-11-26 Byrd Richard EVP & President Interventional D - F-InKind Common Stock 1509 0
2023-11-26 Byrd Richard EVP & President Interventional A - A-Award Common Stock 1455 0
2023-11-26 DelOrefice Christopher EVP & Chief Financial Officer A - A-Award Stock Appreciation Rights 18425 238.89
2023-11-26 DelOrefice Christopher EVP & Chief Financial Officer A - A-Award Common Stock 3325 0
2023-11-26 DelOrefice Christopher EVP & Chief Financial Officer D - F-InKind Common Stock 812 0
2023-11-26 Garrison Michael David EVP & President Medical A - A-Award Stock Appreciation Rights 10364 238.89
2023-11-26 Garrison Michael David EVP & President Medical A - A-Award Common Stock 3131 0
2023-11-26 Garrison Michael David EVP & President Medical D - F-InKind Common Stock 1646 0
2023-11-26 Garrison Michael David EVP & President Medical A - A-Award Common Stock 1871 0
2023-11-26 Mocherla Pavan Kumar EVP & President Greater Asia A - A-Award Stock Appreciation Rights 2764 238.89
2023-11-26 Mocherla Pavan Kumar EVP & President Greater Asia A - A-Award Common Stock 252 0
2023-11-26 Mocherla Pavan Kumar EVP & President Greater Asia D - F-InKind Common Stock 64 0
2023-11-26 Mocherla Pavan Kumar EVP & President Greater Asia A - A-Award Common Stock 499 0
2023-11-26 Neal Shana Carol EVP and Chief People Officer A - A-Award Common Stock 1659 0
2023-11-26 Neal Shana Carol EVP and Chief People Officer D - F-InKind Common Stock 258 0
2023-11-26 Neal Shana Carol EVP and Chief People Officer A - A-Award Stock Appreciation Rights 9190 238.89
2023-11-26 Quinn Michelle EVP and General Counsel A - A-Award Stock Appreciation Rights 6679 238.89
2023-11-26 Quinn Michelle EVP and General Counsel A - A-Award Common Stock 909 0
2023-11-26 Quinn Michelle EVP and General Counsel D - F-InKind Common Stock 440 0
2023-11-26 Quinn Michelle EVP and General Counsel A - A-Award Common Stock 1206 0
2023-11-26 Shan David EVP and Chief ISC Officer A - A-Award Common Stock 1576 0
2023-11-26 Shan David EVP and Chief ISC Officer D - F-InKind Common Stock 149 0
2023-11-26 Shan David EVP and Chief ISC Officer A - A-Award Stock Appreciation Rights 4607 238.89
2023-11-26 Shan David EVP and Chief ISC Officer A - A-Award Common Stock 832 0
2022-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Common Stock 32296 0
2022-11-26 Polen Thomas E Jr Chairman, CEO and President D - F-InKind Common Stock 19574 0
2023-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Rights to Common Stock Under Deferred Compensation Plan 7520 238.89
2023-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Stock Appreciation Rights 63335 238.89
2022-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Common Stock 11429 0
2023-11-26 Ezell Antoine C EVP, President NA & CMO A - A-Award Common Stock 3113 0
2023-11-26 Ezell Antoine C EVP, President NA & CMO D - F-InKind Common Stock 1654 0
2023-11-26 Ezell Antoine C EVP, President NA & CMO A - A-Award Common Stock 956 0
2023-11-26 Ezell Antoine C EVP, President NA & CMO A - A-Award Stock Appreciation Rights 5298 238.89
2023-11-26 Goette Roland EVP and President EMEA A - A-Award Common Stock 2608 0
2023-11-26 Goette Roland EVP and President EMEA D - F-InKind Common Stock 213 0
2023-11-26 Goette Roland EVP and President EMEA A - A-Award Common Stock 582 0
2023-11-26 Goette Roland EVP and President EMEA A - A-Award Stock Appreciation Rights 3225 238.89
2023-11-16 Goette Roland EVP and President, EMEA A - M-Exempt Common Stock 3544 107.12
2023-11-16 Goette Roland EVP and President, EMEA D - D-Return Common Stock 1751 235.07
2023-11-16 Goette Roland EVP and President, EMEA D - M-Exempt Stock Appreciation Rights 3544 107.12
2023-11-03 Byington Carrie L director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 118 0
2023-11-03 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 118 0
2023-09-07 DelOrefice Christopher EVP & Chief Financial Officer D - F-InKind Common Stock 601 0
2023-09-05 Byrd Richard EVP & President Interventional D - S-Sale Common Stock 459 274.48
2023-09-01 Byrd Richard EVP & President Interventional D - F-InKind Common Stock 216 0
2023-09-01 DelOrefice Christopher EVP & Chief Financial Officer D - F-InKind Common Stock 353 0
2023-08-28 Fraser Claire director D - S-Sale Common Stock 848 281.66
2023-08-11 Hickey David EVP & President, Life Sciences A - M-Exempt Common Stock 3883 132.54
2023-08-11 Hickey David EVP & President, Life Sciences D - D-Return Common Stock 1857 277.85
2023-08-11 Hickey David EVP & President, Life Sciences D - S-Sale Common Stock 2974 277.85
2023-08-11 Hickey David EVP & President, Life Sciences D - M-Exempt Stock Appreciation Rights 3883 132.54
2023-08-08 Garrison Michael David EVP & President Medical D - S-Sale Common Stock 1300 277.13
2023-08-02 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 108 0
2023-08-02 Byington Carrie L director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 108 0
2023-07-24 Waldstreicher Joanne director A - A-Award Common Stock 419 0
2023-07-24 Waldstreicher Joanne director D - No securities are beneficially owned 0 0
2023-07-01 Spoerel Thomas J VP Controller & Chief Acct Off D - A-Award Common Stock 47 0
2023-05-05 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 118 0
2023-05-05 Byington Carrie L director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 118 0
2023-05-01 Quinn Michelle EVP and General Counsel D - F-InKind Common Stock 99 0
2023-04-04 Neal Shana Carol Chief Human Resources Officer A - A-Award Common Stock 8229 0
2023-04-04 Neal Shana Carol Chief Human Resources Officer D - F-InKind Common Stock 731 0
2023-03-02 Ezell Antoine C EVP, President NA & CMO D - F-InKind Common Stock 650 0
2023-03-01 Spoerel Thomas J SVP,Controller&Chief Acct Off D - F-InKind Common Stock 35 0
2023-03-01 Garrison Michael David EVP & President Medical D - F-InKind Common Stock 193 0
2023-03-01 Ezell Antoine C EVP, President NA & CMO D - F-InKind Common Stock 418 0
2023-02-03 Quinn Michelle EVP and Acting General Counsel D - Common Stock 0 0
2021-11-26 Quinn Michelle EVP and Acting General Counsel D - Stock Appreciation Rights 2828 223.77
2020-11-26 Quinn Michelle EVP and Acting General Counsel D - Stock Appreciation Rights 2804 251.06
2022-11-26 Quinn Michelle EVP and Acting General Counsel D - Stock Appreciation Rights 2903 241.1
2023-11-26 Quinn Michelle EVP and Acting General Counsel D - Stock Appreciation Rights 4116 238.06
2023-02-03 Byrd Richard EVP & President Interventional D - S-Sale Common Stock 1421 248.6
2023-02-02 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 205 0
2023-02-02 Byington Carrie L director A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 106 0
2023-01-23 Shan David EVP, Integrated Supply Chain D - Common Stock 0 0
2019-11-26 Shan David EVP, Integrated Supply Chain D - Stock Appreciation Rights 700 238.16
2020-11-26 Shan David EVP, Integrated Supply Chain D - Stock Appreciation Rights 1605 251.06
2021-11-26 Shan David EVP, Integrated Supply Chain D - Stock Appreciation Rights 4250 223.77
2022-11-26 Shan David EVP, Integrated Supply Chain D - Stock Appreciation Rights 3871 241.1
2023-11-26 Shan David EVP, Integrated Supply Chain D - Stock Apprciation Rights 5305 238.06
2023-01-24 SCOTT BERTRAM L director A - A-Award Common Stock 848 0
2023-01-24 RING TIMOTHY M director A - A-Award Common Stock 848 0
2023-01-24 LARSEN MARSHALL O director A - A-Award Common Stock 848 0
2023-01-24 Jones Christopher Ian Montague director A - A-Award Common Stock 848 0
2023-01-24 Henderson Jeffrey William director A - A-Award Common Stock 848 0
2023-01-26 Fraser Claire director A - A-Award Common Stock 848 0
2023-01-24 ECKERT R ANDREW director A - A-Award Common Stock 848 0
2023-01-24 BURZIK CATHERINE M director A - A-Award Common Stock 848 0
2023-01-24 Byington Carrie L director A - A-Award Common Stock 848 0
2023-01-24 Brown William M director A - A-Award Common Stock 848 0
2022-12-21 Khichi Samrat S. EVP and General Counsel D - G-Gift Common Stock 19 0
2022-12-13 Khichi Samrat S. EVP and General Counsel D - G-Gift Common Stock 40 0
2022-11-26 Khichi Samrat S. EVP & General Counsel A - A-Award Stock Appreciation Rights 12484 0
2022-11-26 Khichi Samrat S. EVP & General Counsel A - A-Award Common Stock 1956 0
2022-11-26 Khichi Samrat S. EVP & General Counsel D - F-InKind Common Stock 1908 0
2022-11-26 Khichi Samrat S. EVP & General Counsel A - A-Award Common Stock 3334 0
2022-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Stock Appreciation Rights 69966 0
2022-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Common Stock 17678 0
2022-11-26 Polen Thomas E Jr Chairman, CEO and President D - F-InKind Common Stock 10473 0
2022-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Common Stock 11577 0
2022-11-26 Polen Thomas E Jr Chairman, CEO and President A - A-Award Rights to Common Stock Under Deferred Compensation Plan 1927 0
2022-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Stock Appreciation Rights 3019 0
2022-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 294 0
2022-11-26 Spoerel Thomas J VP Controller & Chief Acct Off D - F-InKind Common Stock 232 0
2022-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 375 0
2022-11-26 Hickey David EVP & President, Life Sciences A - A-Award Rights to Common Stock Under Deferred Compensation Plan 1125 0
2022-11-26 Hickey David EVP & President, Life Sciences A - A-Award Stock Appreciation Rights 10975 0
2022-11-26 Hickey David EVP & President, Life Sciences A - A-Award Common Stock 1816 0
2022-11-26 Mocherla Pavan Kumar EVP & President Greater Asia A - A-Award Stock Appreciation Rights 2195 0
2022-11-26 Mocherla Pavan Kumar EVP & President Greater Asia A - A-Award Common Stock 98 0
2022-11-26 Mocherla Pavan Kumar EVP & President Greater Asia D - F-InKind Common Stock 46 0
2022-11-26 Mocherla Pavan Kumar EVP & President Greater Asia A - A-Award Common Stock 364 0
2022-11-26 Goette Roland EVP and President EMEA A - A-Award Common Stock 1183 0
2022-11-26 Goette Roland EVP and President EMEA D - F-InKind Common Stock 99 0
2022-11-26 Goette Roland EVP and President EMEA A - A-Award Common Stock 636 0
2022-11-26 Goette Roland EVP and President EMEA A - A-Award Stock Appreciation Rights 3842 0
2022-11-26 Garrison Michael David EVP & President Medical A - A-Award Stock Appreciation Rights 9466 0
2022-11-26 Garrison Michael David EVP & President Medical A - A-Award Common Stock 1223 0
2022-11-26 Garrison Michael David EVP & President Medical D - F-InKind Common Stock 617 0
2022-11-26 Garrison Michael David EVP & President Medical A - A-Award Common Stock 1567 0
2022-11-26 Byrd Richard EVP & President Interventional A - A-Award Stock Appreciation Rights 7409 0
2022-11-26 Byrd Richard EVP & President Interventional A - A-Award Common Stock 1275 0
2022-11-26 Byrd Richard EVP & President Interventional D - F-InKind Common Stock 711 0
2022-11-26 Byrd Richard EVP & President Interventional A - A-Award Common Stock 1226 0
2022-11-26 Neal Shana Carol Chief Human Resources Officer A - A-Award Stock Appreciation Rights 10948 0
2022-11-26 Neal Shana Carol Chief Human Resources Officer A - A-Award Common Stock 1812 0
2022-11-26 Ezell Antoine C EVP, President NA & CMO A - A-Award Common Stock 1045 0
2022-11-26 Ezell Antoine C EVP, President NA & CMO D - F-InKind Common Stock 115 0
2022-11-26 Ezell Antoine C EVP, President NA & CMO A - A-Award Stock Appreciation Rights 6311 0
2022-11-26 DelOrefice Christopher EVP & Chief Financial Officer A - A-Award Stock Appreciation Rights 18658 0
2022-11-26 DelOrefice Christopher EVP & Chief Financial Officer A - A-Award Common Stock 3087 0
2022-11-26 DelOrefice Christopher EVP & Chief Financial Officer D - F-InKind Common Stock 269 0
2022-11-16 Goette Roland EVP and President, EMEA A - M-Exempt Common Stock 4617 74.94
2022-11-16 Goette Roland EVP and President, EMEA D - D-Return Common Stock 2996 222.08
2022-11-16 Goette Roland EVP and President, EMEA D - M-Exempt Stock Appreciation Rights 4617 0
2022-11-11 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 113 235.97
2022-11-11 Byington Carrie L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 113 235.97
2022-09-06 Byrd Richard EVP & President Interventional D - Common Stock 0 0
2022-07-29 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 109 244.31
2022-07-29 Byington Carrie L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 109 244.31
2022-09-07 DelOrefice Christopher EVP & CFO D - F-InKind Common Stock 506 0
2022-09-06 Byrd Richard EVP & President Interventional D - Common Stock 0 0
2018-11-26 Byrd Richard EVP & President Interventional D - Stock Appreciation Rights 9058 222.6
2021-11-26 Byrd Richard EVP & President Interventional D - Stock Appreciation Rights 11865 223.77
2019-11-26 Byrd Richard EVP & President Interventional D - Stock Appreciation Rights 6003 238.16
2022-11-26 Byrd Richard EVP & President Interventional D - Stock Apprciation Rights 7966 241.1
2020-11-26 Byrd Richard EVP & President Interventional D - Stock Appreciation Rights 8365 251.06
2022-09-06 Garrison Michael David EVP and President Medical D - Common Stock 0 0
2022-09-06 Garrison Michael David EVP and President Medical D - Rights to Common Stock Under BD Deferred Compensation Plan 2997 0
2016-11-26 Garrison Michael David EVP and President Medical D - Stock Appreciation Rights 6360 147.68
2017-11-26 Garrison Michael David EVP and President Medical D - Stock Appreciation Rights 3054 167.91
2018-11-26 Garrison Michael David EVP and President Medical D - Stock Appreciation Rights 3252 222.6
2021-11-26 Garrison Michael David EVP and President Medical D - Stock Appreciation 10934 223.77
2019-11-26 Garrison Michael David EVP and President Medical D - Stock Appreciation Rights 2801 238.16
2022-11-26 Garrison Michael David EVP and President Medical D - Stock Appreciation 7966 241.1
2020-11-26 Garrison Michael David EVP and President Medical D - Stock Appreciation Rights 8023 251.06
2022-09-01 DelOrefice Christopher EVP & CFO A - A-Award Common Stock 2674 0
2022-08-15 Hickey David EVP & President, Life Sciences D - S-Sale Common Stock 475 265
2022-08-15 Polen Thomas E Jr Chairman, CEO and President A - M-Exempt Common Stock 15000 167.91
2022-08-15 Polen Thomas E Jr Chairman, CEO and President D - D-Return Common Stock 5500 265.13
2022-08-15 Polen Thomas E Jr Chairman, CEO and President D - S-Sale Common Stock 9500 265.13
2022-08-15 Polen Thomas E Jr Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 15000 167.91
2022-08-09 Khichi Samrat S. EVP and General Counsel D - D-Return Common Stock 5194 260.44
2022-08-09 Khichi Samrat S. EVP and General Counsel D - S-Sale Common Stock 7295 260.44
2022-08-09 Khichi Samrat S. EVP and General Counsel A - M-Exempt Stock Appreciation Rights 12489 0
2022-08-09 Polen Thomas E Jr Executive Vice President A - M-Exempt Common Stock 3825 147.68
2022-08-09 Polen Thomas E Jr Executive Vice President D - D-Return Common Stock 2173 260
2022-08-09 Polen Thomas E Jr Executive Vice President D - S-Sale Common Stock 1652 260
2022-08-09 Polen Thomas E Jr Executive Vice President D - M-Exempt Stock Appreciation Rights 3825 147.68
2022-07-08 Grover Rishi EVP and Chief ISC Officer A - A-Award Common Stock 9340 0
2022-07-07 Grover Rishi EVP and Chief ISC Officer D - Common Stock 0 0
2022-07-01 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 414 0
2022-07-01 Mocherla Pavan Kumar EVP and President Greater Asia D - Common Stock 0 0
2018-11-26 Mocherla Pavan Kumar EVP and President Greater Asia D - Stock Appreciation Rights 1941 222.6
2021-11-26 Mocherla Pavan Kumar EVP and President Greater Asia D - Stock Appreciation Rights 1243 223.77
2019-11-26 Mocherla Pavan Kumar EVP and President Greater Asia D - Stock Appreciation Rights 594 238.16
2022-11-26 Mocherla Pavan Kumar EVP and President Greater Asia D - Stock Appreciation Rights 628 241.1
2020-11-26 Mocherla Pavan Kumar EVP and President Greater Asia D - Stock Appreciation Rights 635 251.06
2022-07-01 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 420 0
2022-06-17 Lim James C Executive Vice President A - A-Award Common Stock 3280 0
2022-06-07 Spoerel Thomas J VP Controller & Chief Acct Off D - D-Return Common Stock 583 260
2022-06-07 Spoerel Thomas J VP Controller & Chief Acct Off D - S-Sale Common Stock 443 260
2022-06-07 Spoerel Thomas J VP Controller & Chief Acct Off D - M-Exempt Stock Appreciation Rights 1026 0
2022-05-06 Byington Carrie L A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 107 255
2022-05-06 Hickey David EVP & President, Life Sciences D - S-Sale Common Stock 475 256
2022-05-06 Jones Christopher Ian Montague A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 107 255
2022-05-06 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 107 0
2022-04-06 Neal Shana Carol Chief Human Resources Officer A - A-Award Common Stock 7525 0
2022-04-06 Neal Shana Carol Chief People Officer D - Common Stock 0 0
2022-04-06 Neal Shana Carol Chief People Officer D - Deferred Shares of BD stock 631 0
2022-03-01 Ezell Antoine C EVP, President, NA & CMO D - F-InKind Common Stock 276 0
2022-03-02 Ezell Antoine C EVP, President, NA & CMO D - F-InKind Common Stock 610 0
2022-03-01 Spoerel Thomas J VP Controller & Chief Acct Off D - F-InKind Common Stock 35 0
2022-02-28 Brown William M director A - A-Award Common Stock 714 0
2022-02-28 Brown William M director D - No securities are beneficially owned 0 0
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 10245 217.84
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 9377 143.07
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 7076 121.49
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 6789 242.1
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 3684 227.47
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 4630 255.22
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 4935 271.9
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 3162 271.9
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 3684 227.47
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 3613 110.04
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 1463 271.9
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 8209 271.9
2022-02-25 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 1244 227.47
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 6045 271.9
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 3083 271.9
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 4346 271.9
2022-02-25 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 1041 271.9
2022-02-25 Larson Betty D EVP HR & CHRO D - S-Sale Common Stock 601 271.9
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 4630 255.22
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 1244 227.47
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 6789 242.1
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 7076 121.49
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 10245 217.84
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 9377 143.07
2022-02-25 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 3613 110.04
2022-02-11 Campion Simon D EVP and Segment President D - G-Gift Common Stock 50 0
2022-02-08 Khichi Samrat S. EVP and General Counsel D - G-Gift Common Stock 375 0
2022-02-08 Fraser Claire director D - S-Sale Common Stock 841 271.7
2022-02-03 Conroy Alexandre EVP of Integrated Supply Chain A - M-Exempt Common Stock 12787 134.73
2022-02-03 Conroy Alexandre EVP of Integrated Supply Chain D - D-Return Common Stock 6377 270.16
2022-02-03 Conroy Alexandre EVP of Integrated Supply Chain D - S-Sale Common Stock 6410 270.16
2022-02-03 Conroy Alexandre EVP of Integrated Supply Chain D - M-Exempt Stock Appreciation Rights 12787 134.73
2022-02-02 Byington Carrie L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 105 0
2022-02-02 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 203 0
2022-01-27 Campion Simon D EVP and Segment President D - F-InKind Common Stock 190 0
2022-01-25 RING TIMOTHY M director A - A-Award Common Stock 820 0
2022-01-25 Melcher David F director A - A-Award Common Stock 820 0
2022-01-25 LARSEN MARSHALL O director A - A-Award Common Stock 820 0
2022-01-25 BURZIK CATHERINE M director A - A-Award Common Stock 820 0
2022-01-25 Fraser Claire director A - A-Award Common Stock 820 0
2022-01-25 Jones Christopher Ian Montague director A - A-Award Common Stock 820 0
2022-01-25 SCOTT BERTRAM L director A - A-Award Common Stock 820 0
2022-01-25 Pomeroy Claire director A - A-Award Common Stock 820 0
2022-01-25 Henderson Jeffrey William director A - A-Award Common Stock 820 0
2022-01-25 ECKERT R ANDREW director A - A-Award Common Stock 820 0
2022-01-25 Byington Carrie L director A - A-Award Common Stock 820 0
2021-12-16 Larson Betty D EVP HR & CHRO A - M-Exempt Common Stock 893 97.14
2021-12-16 Larson Betty D EVP HR & CHRO D - D-Return Common Stock 341 255
2021-12-16 Larson Betty D EVP HR & CHRO D - S-Sale Common Stock 552 255
2021-12-16 Larson Betty D EVP HR & CHRO D - S-Sale Common Stock 2789 255
2021-12-16 Larson Betty D EVP HR & CHRO D - M-Exempt Stock Appreciation Rights 893 97.14
2021-12-07 Spoerel Thomas J VP Controller & Chief Acct Off D - S-Sale Common Stock 233 250
2021-11-26 Polen Thomas E Jr Executive Vice President A - A-Award Stock Appreciation Rights 75632 245.09
2021-11-26 Polen Thomas E Jr Executive Vice President A - A-Award Common Stock 10583 0
2021-11-26 Polen Thomas E Jr Executive Vice President A - A-Award Common Stock 2786 0
2021-11-26 Polen Thomas E Jr Executive Vice President D - F-InKind Common Stock 1913 0
2021-11-26 Campion Simon D EVP and Segment President A - A-Award Stock Appreciation Rights 12487 245.09
2021-11-26 Campion Simon D EVP and Segment President A - A-Award Common Stock 1748 0
2021-11-26 Campion Simon D EVP and Segment President A - A-Award Common Stock 1027 0
2021-11-26 Campion Simon D EVP and Segment President D - F-InKind Common Stock 650 0
2021-11-26 Goette Roland EVP and President, EMEA A - A-Award Common Stock 625 0
2021-11-26 Goette Roland EVP and President, EMEA A - A-Award Common Stock 312 0
2021-11-26 Goette Roland EVP and President, EMEA D - F-InKind Common Stock 31 0
2021-11-26 Goette Roland EVP and President, EMEA A - A-Award Stock Appreciation Rights 4464 245.09
2021-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Common Stock 1325 0
2021-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Common Stock 1210 0
2021-11-26 Conroy Alexandre EVP of Integrated Supply Chain D - F-InKind Common Stock 863 0
2021-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Stock Appreciation Rights 9469 245.09
2021-11-26 Khichi Samrat S. EVP and General Counsel A - A-Award Stock Appreciation Rights 13678 245.09
2021-11-26 Khichi Samrat S. EVP and General Counsel A - A-Award Common Stock 1914 0
2021-11-26 Khichi Samrat S. EVP and General Counsel A - A-Award Common Stock 990 0
2021-11-26 Khichi Samrat S. EVP and General Counsel D - F-InKind Common Stock 681 0
2021-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Stock Appreciation Rights 15121 245.09
2021-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Common Stock 2116 0
2021-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Common Stock 1686 0
2021-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences D - F-InKind Common Stock 798 0
2021-11-26 Larson Betty D EVP HR & CHRO A - A-Award Stock Appreciation Rights 12956 245.09
2021-11-26 Larson Betty D EVP HR & CHRO A - A-Award Common Stock 1813 0
2021-11-26 Larson Betty D EVP HR & CHRO A - A-Award Common Stock 843 0
2021-11-26 Larson Betty D EVP HR & CHRO D - F-InKind Common Stock 580 0
2021-11-26 Reidy Christopher R CFO and EVP of Administration A - A-Award Common Stock 2945 0
2021-11-26 Reidy Christopher R CFO and EVP of Administration A - A-Award Common Stock 2053 0
2021-11-26 Reidy Christopher R CFO and EVP of Administration D - F-InKind Common Stock 1132 0
2021-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Stock Appreciation Rights 2726 245.09
2021-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 287 0
2021-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 202 0
2021-11-26 Spoerel Thomas J VP Controller & Chief Acct Off D - F-InKind Common Stock 195 0
2021-11-26 Hickey David EVP & President, Life Sciences A - A-Award Stock Appreciation Rights 10522 245.09
2021-11-26 Hickey David EVP & President, Life Sciences A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 1511 0
2021-11-26 Hickey David EVP & President, Life Sciences A - A-Award Common Stock 1473 0
2021-11-26 Ezell Antoine C EVP, President, NA & CMO A - A-Award Common Stock 758 0
2021-11-26 Ezell Antoine C EVP, President, NA & CMO A - A-Award Stock Appreciation Rights 5411 245.09
2021-11-26 DelOrefice Christopher EVP & CFO A - A-Award Stock Appreciation Rights 18638 245.09
2021-11-26 DelOrefice Christopher EVP & CFO A - A-Award Common Stock 2608 0
2021-11-26 Lim James C Executive Vice President A - A-Award Common Stock 893 0
2021-11-16 Goette Roland EVP and President, EMEA A - M-Exempt Common Stock 3055 72.12
2021-11-16 Goette Roland EVP and President, EMEA D - F-InKind Common Stock 1914 244.11
2021-11-16 Goette Roland EVP and President, EMEA D - M-Exempt Stock Appreciation Rights 3055 72.12
2021-11-02 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 112 0
2021-10-21 Byington Carrie L director A - A-Award Common Stock 221 0
2021-10-21 Byington Carrie L director D - No securities are beneficially owned 0 0
2021-09-08 Spoerel Thomas J VP Controller & Chief Acct Off D - S-Sale Common Stock 267 260
2021-09-08 Hickey David EVP & President, Life Sciences D - S-Sale Common Stock 500 260
2021-09-07 DelOrefice Christopher EVP & CFO A - A-Award Common Stock 4359 0
2021-09-08 RIMEL REBECCA W director D - S-Sale Common Stock 500 260
2021-09-04 Hickey David EVP & President, Life Sciences D - F-InKind Common Stock 268 0
2021-09-03 Lim James C Executive Vice President A - M-Exempt Common Stock 14584 134.73
2021-09-03 Lim James C Executive Vice President D - D-Return Common Stock 7628 257.44
2021-09-03 Lim James C Executive Vice President D - S-Sale Common Stock 6956 257.44
2021-09-03 Lim James C Executive Vice President D - M-Exempt Stock Appreciation Rights 14584 134.73
2021-09-06 DelOrefice Christopher EVP & CFO D - No securities are beneficially owned 0 0
2021-09-03 RIMEL REBECCA W director D - S-Sale Common Stock 500 257.1
2021-09-02 RIMEL REBECCA W director D - S-Sale Common Stock 244 254
2021-08-30 RIMEL REBECCA W director D - S-Sale Common Stock 207 252
2021-08-18 Fraser Claire director D - S-Sale Common Stock 387 251.58
2021-08-17 RIMEL REBECCA W director D - S-Sale Common Stock 207 252
2021-08-06 Spoerel Thomas J VP Controller & Chief Acct Off D - S-Sale Common Stock 266 242.3
2021-08-03 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 104 0
2021-05-28 Lim James C Executive Vice President D - S-Sale Common Stock 3429 241.68
2021-05-27 Fraser Claire director D - S-Sale Common Stock 390 241.36
2021-05-03 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 107 0
2021-03-01 Ezell Antoine C EVP, President, NA & CMO A - A-Award Common Stock 2817 0
2021-03-01 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 302 0
2021-03-02 Ezell Antoine C EVP, President, NA & CMO D - F-InKind Common Stock 505 0
2021-02-08 Larson Betty D EVP HR & CHRO D - F-InKind Common Stock 760 0
2021-02-08 Khichi Samrat S. EVP and General Counsel D - F-InKind Common Stock 1616 0
2021-02-08 Campion Simon D EVP and Segment President D - F-InKind Common Stock 747 0
2021-02-02 SCOTT BERTRAM L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 198 0
2021-02-02 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 198 0
2021-01-27 Campion Simon D EVP and Segment President D - F-InKind Common Stock 198 0
2021-01-26 SCOTT BERTRAM L director A - A-Award Common Stock 829 0
2021-01-26 RING TIMOTHY M director A - A-Award Common Stock 829 0
2021-01-26 RIMEL REBECCA W director A - A-Award Common Stock 829 0
2021-01-26 Pomeroy Claire director A - A-Award Common Stock 829 0
2021-01-26 Melcher David F director A - A-Award Common Stock 829 0
2021-01-26 LARSEN MARSHALL O director A - A-Award Common Stock 829 0
2021-01-26 Jones Christopher Ian Montague director A - A-Award Common Stock 829 0
2021-01-26 Henderson Jeffrey William director A - A-Award Common Stock 829 0
2021-01-26 Fraser Claire director A - A-Award Common Stock 829 0
2021-01-26 ECKERT R ANDREW director A - A-Award Common Stock 829 0
2021-01-26 BURZIK CATHERINE M director A - A-Award Common Stock 829 0
2021-01-01 Hickey David EVP & President, Life Sciences D - Common Stock 0 0
2021-01-01 Hickey David EVP & President, Life Sciences D - Rights to Common Stock Under BD Deferred Compensation Plan 3816 0
2021-11-26 Hickey David EVP & President, Life Sciences D - Stock Appreciation Rights 9273 227.47
2020-11-26 Hickey David EVP & President, Life Sciences D - Stock Appreciation Rights 7261 255.22
2019-11-26 Hickey David EVP & President, Life Sciences D - Stock Appreciation Rights 7381 242.1
2018-11-26 Hickey David EVP & President, Life Sciences D - Stock Appreciation Rights 8911 226.28
2017-11-26 Hickey David EVP & President, Life Sciences D - Stock Appreciation Rights 5939 170.69
2016-11-26 Hickey David EVP & President, Life Sciences D - Stock Appreciation Rights 5854 150.12
2015-11-25 Hickey David EVP & President, Life Sciences D - Stock Appreciation Rights 3820 134.73
2021-01-02 Khichi Samrat S. EVP and General Counsel D - A-Award Common Stock 1295 0
2021-01-02 Khichi Samrat S. EVP and General Counsel D - F-InKind Common Stock 669 0
2021-01-02 Larson Betty D EVP HR & CHRO D - A-Award Common Stock 851 0
2021-01-02 Larson Betty D EVP HR & CHRO D - F-InKind Common Stock 679 0
2021-01-02 Campion Simon D EVP and Segment President D - A-Award Common Stock 370 0
2021-01-02 Campion Simon D EVP and Segment President D - F-InKind Common Stock 195 0
2020-12-15 FORLENZA VINCENT A Chairman of the Board D - G-Gift Common Stock 268 0
2020-12-10 Campion Simon D EVP and Segment President D - G-Gift Common Stock 50 0
2020-12-14 Campion Simon D EVP and Segment President D - F-InKind Common Stock 205 0
2020-11-26 Campion Simon D EVP and Segment President A - A-Award Stock Appreciation Rights 16023 227.47
2020-11-26 Campion Simon D EVP and Segment President D - F-InKind Common Stock 184 0
2020-11-26 Campion Simon D EVP and Segment President A - A-Award Stock Appreciation Rights 3154 227.47
2020-11-26 Goette Roland EVP and President, EMEA A - A-Award Common Stock 266 0
2020-11-26 Goette Roland EVP and President, EMEA D - F-InKind Common Stock 36 0
2020-11-26 Goette Roland EVP and President, EMEA A - A-Award Stock Appreciation Rights 6044 227.47
2020-11-26 Goette Roland EVP and President, EMEA A - A-Award Stock Appreciation Rights 1279 227.47
2020-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Common Stock 1253 0
2020-11-26 Conroy Alexandre EVP of Integrated Supply Chain D - F-InKind Common Stock 1125 0
2020-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Stock Appreciation Rights 15067 227.47
2020-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Stock Appreciation Rights 5422 227.47
2020-11-26 Larson Betty D EVP HR & CHRO A - A-Award Stock Appreciation Rights 14736 227.47
2020-11-26 Larson Betty D EVP HR & CHRO D - F-InKind Common Stock 164 0
2020-11-26 Larson Betty D EVP HR & CHRO A - A-Award Stock Appreciation Rights 3734 227.47
2020-11-26 Khichi Samrat S. EVP and General Counsel A - A-Award Stock Appreciation Rights 14984 227.47
2020-11-26 Khichi Samrat S. EVP and General Counsel D - F-InKind Common Stock 192 0
2020-11-26 Khichi Samrat S. EVP and General Counsel A - A-Award Stock Appreciation Rights 5001 227.47
2020-11-26 Lim James C Executive Vice President A - A-Award Common Stock 802 0
2020-11-26 Lim James C Executive Vice President A - A-Award Stock Appreciation Rights 10919 227.47
2020-11-26 Lim James C Executive Vice President A - A-Award Stock Appreciation Rights 3745 227.47
2020-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Stock Appreciation Rights 21694 227.47
2020-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Common Stock 949 0
2020-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences D - F-InKind Common Stock 672 0
2020-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Stock Appreciation Rights 5893 227.47
2020-11-26 Reidy Christopher R CFO and EVP of Administration A - A-Award Stock Appreciation Rights 29912 227.47
2020-11-26 Reidy Christopher R CFO and EVP of Administration A - A-Award Common Stock 2372 0
2020-11-26 Reidy Christopher R CFO and EVP of Administration D - F-InKind Common Stock 1924 0
2020-11-26 Reidy Christopher R CFO and EVP of Administration A - A-Award Stock Appreciation Rights 9716 227.47
2020-11-26 Ezell Antoine C EVP, President, NA & CMO A - A-Award Stock Appreciation Rights 7215 227.47
2020-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Stock Appreciation Rights 2319 227.47
2020-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 238 0
2020-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 257 0
2020-11-26 Spoerel Thomas J VP Controller & Chief Acct Off D - F-InKind Common Stock 222 0
2020-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Stock Appreciation Rights 1004 227.47
2020-11-26 Polen Thomas E Jr Executive Vice President A - A-Award Stock Appreciation Rights 92298 227.47
2020-11-26 Polen Thomas E Jr Executive Vice President A - A-Award Common Stock 2657 0
2020-11-26 Polen Thomas E Jr Executive Vice President D - F-InKind Common Stock 2352 0
2020-11-26 Kaltenbach Patrick EVP & Pres Life Sciences A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 621 0
2020-11-26 FORLENZA VINCENT A Chairman of the Board A - A-Award Common Stock 7969 0
2020-11-26 FORLENZA VINCENT A Chairman of the Board D - F-InKind Common Stock 7080 0
2020-11-10 FORLENZA VINCENT A Chairman of the Board A - G-Gift Common Stock 7507 0
2020-11-12 FORLENZA VINCENT A Chairman of the Board D - G-Gift Common Stock 104 0
2020-11-18 FORLENZA VINCENT A Chairman of the Board D - G-Gift Common Stock 462 0
2020-11-23 Goette Roland EVP and President, EMEA A - M-Exempt Common Stock 3485 76.64
2020-11-23 Goette Roland EVP and President, EMEA D - D-Return Common Stock 1161 230.1
2020-11-23 Goette Roland EVP and President, EMEA D - S-Sale Common Stock 930 230.1
2020-11-23 Goette Roland EVP and President, EMEA D - M-Exempt Stock Appreciation Rights 3485 76.64
2020-11-04 SCOTT BERTRAM L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 115 0
2020-11-04 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 115 0
2020-10-01 Ezell Antoine C EVP, President, NA & CMO D - Common Stock 0 0
2020-05-13 FORLENZA VINCENT A Chairman of the Board A - G-Gift Common Stock 10474 0
2020-06-30 FORLENZA VINCENT A Chairman of the Board D - G-Gift Common Stock 21192 0
2020-07-10 FORLENZA VINCENT A Chairman of the Board D - G-Gift Common Stock 11660 0
2020-09-01 Spoerel Thomas J VP Controller & Chief Acct Off D - F-InKind Common Stock 59 0
2020-08-13 SCOTT BERTRAM L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 57 0
2020-08-13 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 57 0
2020-07-14 Kaltenbach Patrick EVP & Pres Life Sciences A - A-Award Rights to Common Stock Under BD Deferred Compensation Plan 620 0
2020-07-09 Kaltenbach Patrick EVP & Pres Life Sciences D - S-Sale Common Stock 1272 260
2020-06-03 Kaltenbach Patrick EVP & Pres Life Sciences D - F-InKind Common Stock 2027 0
2020-06-05 Kaltenbach Patrick EVP & Pres Life Sciences D - S-Sale Common Stock 1049 243.2
2020-06-01 Kaltenbach Patrick EVP & Pres Life Sciences D - F-InKind Common Stock 400 0
2020-06-02 Kaltenbach Patrick EVP & Pres Life Sciences D - S-Sale Common Stock 222 244.83
2020-05-27 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 106 0
2020-05-27 SCOTT BERTRAM L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 106 0
2020-05-08 Fraser Claire director D - S-Sale Common Stock 771 256.56
2020-03-30 Banerjee Ranjeet President, US Region & Canada D - Common Stock 0 0
2020-03-30 Banerjee Ranjeet President, US Region & Canada I - Common Stock 0 0
2020-03-30 Banerjee Ranjeet President, US Region & Canada D - Rights to Common Stock under Deferred Compensation Plan 79 0
2015-11-25 Banerjee Ranjeet President, US Region & Canada D - Stock Appreciation Rights 10021 134.73
2016-11-26 Banerjee Ranjeet President, US Region & Canada D - Stock Appreciation Rights 13762 150.12
2017-11-26 Banerjee Ranjeet President, US Region & Canada D - Stock Appreciation Rights 9977 170.69
2018-11-26 Banerjee Ranjeet President, US Region & Canada D - Stock Appreciation Rights 9596 226.28
2019-11-26 Banerjee Ranjeet President, US Region & Canada D - Stock Appreciation Rights 7381 242.1
2020-11-26 Banerjee Ranjeet President, US Region & Canada D - Stock Appreciation Rights 8586 255.22
2020-02-19 Khichi Samrat S. EVP and General Counsel D - G-Gift Common Stock 195 0
2020-03-16 Khichi Samrat S. EVP and General Counsel D - S-Sale Common Stock 4349 224.53
2020-02-14 SCOTT BERTRAM L director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 188 0
2020-02-14 Jones Christopher Ian Montague director A - A-Award Rights to Common Stock Under 1996 Directors Deferral Plan 188 0
2020-02-10 Khichi Samrat S. EVP and General Counsel D - F-InKind Common Stock 2338 0
2020-02-10 Campion Simon D EVP and Segment President D - F-InKind Common Stock 1130 0
2020-02-10 Larson Betty D EVP HR & CHRO D - F-InKind Common Stock 968 0
2020-02-11 Fraser Claire director D - S-Sale Common Stock 800 258.73
2020-02-11 Fraser Claire director D - S-Sale Common Stock 700 258.7
2020-02-04 Campion Simon D EVP and Segment President A - M-Exempt Common Stock 4783 121.49
2020-02-04 Campion Simon D EVP and Segment President A - M-Exempt Common Stock 3089 110.04
2020-02-04 Campion Simon D EVP and Segment President A - M-Exempt Common Stock 2891 143.07
2020-02-04 Campion Simon D EVP and Segment President D - D-Return Common Stock 2039 285.09
2020-02-04 Campion Simon D EVP and Segment President A - M-Exempt Common Stock 2326 88.87
2020-02-04 Campion Simon D EVP and Segment President D - D-Return Common Stock 1193 285.09
2020-02-04 Campion Simon D EVP and Segment President D - D-Return Common Stock 726 285.09
2020-02-04 Campion Simon D EVP and Segment President D - D-Return Common Stock 1452 285.09
2020-02-04 Campion Simon D EVP and Segment President A - M-Exempt Common Stock 523 63.66
2020-02-04 Campion Simon D EVP and Segment President D - D-Return Common Stock 117 285.09
2020-02-04 Campion Simon D EVP and Segment President D - S-Sale Common Stock 1439 285.09
2020-02-04 Campion Simon D EVP and Segment President D - M-Exempt Stock Appreciation Rights 2891 143.07
2020-02-04 Campion Simon D EVP and Segment President D - M-Exempt Stock Appreciation Rights 523 63.66
2020-02-04 Campion Simon D EVP and Segment President D - M-Exempt Stock Appreciation Rights 2326 88.87
2020-02-04 Campion Simon D EVP and Segment President D - M-Exempt Stock Appreciation Rights 3089 110.04
2020-02-04 Campion Simon D EVP and Segment President D - M-Exempt Stock Appreciation Rights 4783 121.49
2020-02-04 Mas Ribo Alberto EVP and Pres, Life Sciences D - S-Sale Common Stock 1430 285
2020-01-28 ECKERT R ANDREW director A - A-Award Common Stock 765 0
2020-01-28 SCOTT BERTRAM L director A - A-Award Common Stock 765 0
2020-01-28 RING TIMOTHY M director A - A-Award Common Stock 765 0
2020-01-28 RIMEL REBECCA W director A - A-Award Common Stock 765 0
2020-01-28 Pomeroy Claire director A - A-Award Common Stock 765 0
2020-01-28 Melcher David F director A - A-Award Common Stock 765 0
2020-01-28 LARSEN MARSHALL O director A - A-Award Common Stock 765 0
2020-01-28 Jones Christopher Ian Montague director A - A-Award Common Stock 765 0
2020-01-28 Henderson Jeffrey William director A - A-Award Common Stock 765 0
2020-01-28 BURZIK CATHERINE M director A - A-Award Common Stock 765 0
2020-01-28 Fraser Claire director A - A-Award Common Stock 765 0
2020-01-27 Campion Simon D EVP and Segment President A - A-Award Common Stock 1876 0
2020-01-27 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Common Stock 2345 0
2020-01-28 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 38362 72.12
2020-01-28 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 9848 280.96
2020-01-28 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 28514 280.96
2020-01-28 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 38362 72.12
2020-01-27 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 34406 72.12
2020-01-27 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 8860 280.09
2020-01-24 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 9666 72.12
2020-01-23 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 8464 72.12
2020-01-24 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 2489 280.13
2020-01-23 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 2180 280.06
2020-01-27 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 25546 280.09
2020-01-23 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 6284 280.06
2020-01-24 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 7177 280.13
2020-01-23 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 8464 72.12
2020-01-24 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 9666 72.12
2020-01-27 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 34406 72.12
2020-01-10 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 26665 72.12
2020-01-10 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 6990 275.15
2020-01-08 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 18783 72.12
2020-01-08 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 4923 275.19
2020-01-08 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 13860 275.19
2020-01-10 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 19675 275.15
2020-01-08 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 18783 72.12
2020-01-10 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 26665 72.12
2020-01-02 Larson Betty D EVP HR & CHRO D - F-InKind Common Stock 374 0
2020-01-02 Campion Simon D EVP and Segment President D - F-InKind Common Stock 58 0
2020-01-02 Khichi Samrat S. EVP and General Counsel D - F-InKind Common Stock 213 0
2020-01-01 RING TIMOTHY M director D - F-InKind Common Stock 7027 0
2020-01-02 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 45448 72.12
2020-01-02 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 12083 271.28
2020-01-02 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 33365 271.28
2020-01-02 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 45448 72.12
2019-12-19 FORLENZA VINCENT A Chairman, CEO and President D - G-Gift Common Stock 186 0
2019-12-16 Mas Ribo Alberto EVP and Pres, Life Sciences A - M-Exempt Common Stock 12153 134.73
2019-12-16 Mas Ribo Alberto EVP and Pres, Life Sciences D - D-Return Common Stock 6068 269.51
2019-12-16 Mas Ribo Alberto EVP and Pres, Life Sciences D - S-Sale Common Stock 11860 269.51
2019-12-16 Mas Ribo Alberto EVP and Pres, Life Sciences D - M-Exempt Stock Appreciation Rights 12153 134.73
2019-12-16 Polen Thomas E Jr Executive Vice President A - M-Exempt Common Stock 10000 150.12
2019-12-16 Polen Thomas E Jr Executive Vice President D - D-Return Common Stock 5568 269.63
2019-12-16 Polen Thomas E Jr Executive Vice President A - M-Exempt Common Stock 3907 134.73
2019-12-16 Polen Thomas E Jr Executive Vice President D - D-Return Common Stock 1953 269.63
2019-12-16 Polen Thomas E Jr Executive Vice President D - S-Sale Common Stock 4432 269.63
2019-12-16 Polen Thomas E Jr Executive Vice President D - M-Exempt Stock Appreciation Rights 10000 150.12
2019-12-16 Polen Thomas E Jr Executive Vice President D - M-Exempt Stock Appreciation Rights 3907 134.73
2019-12-14 Campion Simon D EVP and Segment President D - F-InKind Common Stock 133 0
2019-12-12 Kaltenbach Patrick EVP & Pres Life Sciences A - M-Exempt Common Stock 4236 242.1
2019-12-12 Kaltenbach Patrick EVP & Pres Life Sciences D - D-Return Common Stock 3897 263.23
2019-12-12 Kaltenbach Patrick EVP & Pres Life Sciences D - S-Sale Common Stock 339 263.23
2019-12-12 Kaltenbach Patrick EVP & Pres Life Sciences D - M-Exempt Stock Appreciation Rights 4236 242.1
2019-12-12 FORLENZA VINCENT A Chairman, CEO and President A - M-Exempt Common Stock 16343 76.64
2019-12-12 FORLENZA VINCENT A Chairman, CEO and President D - D-Return Common Stock 4717 265.57
2019-12-12 FORLENZA VINCENT A Chairman, CEO and President D - S-Sale Common Stock 11626 265.57
2019-12-12 FORLENZA VINCENT A Chairman, CEO and President D - M-Exempt Stock Appreciation Rights 16343 76.64
2019-12-13 Spoerel Thomas J VP Controller & Chief Acct Off D - S-Sale Common Stock 506 267.95
2019-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 596 0
2019-12-09 Campion Simon D EVP and Segment President D - F-InKind Common Stock 147 0
2019-12-06 Kaltenbach Patrick EVP & Pres Life Sciences D - S-Sale Common Stock 312 261.51
2019-12-02 Campion Simon D EVP and Segment President D - G-Gift Common Stock 50 0
2019-11-26 Larson Betty D EVP HR & CHRO A - A-Award Stock Appreciation Rights 9260 255.22
2019-11-26 Larson Betty D EVP HR & CHRO D - F-InKind Common Stock 164 0
2019-11-26 Khichi Samrat S. EVP and General Counsel A - A-Award Stock Appreciation Rights 12627 255.22
2019-11-26 Khichi Samrat S. EVP and General Counsel D - F-InKind Common Stock 192 0
2019-11-26 Kaltenbach Patrick EVP & Pres Life Sciences A - A-Award Stock Appreciation Rights 18119 255.22
2019-11-26 Kaltenbach Patrick EVP & Pres Life Sciences D - F-InKind Common Stock 308 0
2019-11-26 Campion Simon D EVP and Segment President A - A-Award Stock Appreciation Rights 12963 255.22
2019-11-26 Campion Simon D EVP and Segment President D - F-InKind Common Stock 123 0
2019-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Common Stock 2791 0
2019-11-26 Conroy Alexandre EVP of Integrated Supply Chain D - F-InKind Common Stock 2165 0
2019-11-26 Conroy Alexandre EVP of Integrated Supply Chain A - A-Award Stock Appreciation Rights 12627 255.22
2019-11-26 Goette Roland EVP and President, EMEA A - A-Award Common Stock 931 0
2019-11-26 Goette Roland EVP and President, EMEA D - F-InKind Common Stock 578 0
2019-11-26 Goette Roland EVP and President, EMEA A - A-Award Stock Appreciation Rights 4630 255.22
2019-11-26 Polen Thomas E Jr Executive Vice President A - A-Award Stock Appreciation Rights 76810 255.22
2019-11-26 Polen Thomas E Jr Executive Vice President A - A-Award Common Stock 4430 0
2019-11-26 Polen Thomas E Jr Executive Vice President D - F-InKind Common Stock 3768 0
2019-11-26 Lim James C Executive Vice President A - A-Award Common Stock 1773 0
2019-11-26 Lim James C Executive Vice President A - A-Award Stock Appreciation Rights 10102 255.22
2019-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Stock Appreciation Rights 19361 255.22
2019-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences A - A-Award Common Stock 1507 0
2019-11-26 Mas Ribo Alberto EVP and Pres, Life Sciences D - F-InKind Common Stock 1403 0
2019-11-26 Reidy Christopher R CFO and EVP of Administration A - A-Award Common Stock 4873 0
2019-11-26 Reidy Christopher R CFO and EVP of Administration A - A-Award Stock Appreciation Rights 27778 255.22
2019-11-26 Reidy Christopher R CFO and EVP of Administration D - F-InKind Common Stock 3747 0
2019-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Stock Appreciation Rights 1894 255.22
2019-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 435 0
2019-11-26 Spoerel Thomas J VP Controller & Chief Acct Off A - A-Award Common Stock 185 0
Transcripts
Operator:
Hello and welcome to BD's Third Quarter Fiscal 2024 Earnings Conference Call. At the request of BD, today's call is being recorded and will be available for replay on BD's Investor Relations website at investors.bd.com or by phone at 800-839-2385 for domestic calls and area code +1 402-220-7203 for international calls. For today's call, all parties have been placed in a listen-only mode until the question-and-answer session. I will now turn the call over to Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations. Please go ahead.
Greg Rodetis:
Good morning and welcome to BD's earnings call. I'm Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations. Thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD releases results for the third quarter of fiscal 2024. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Following this morning's prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents
Tom Polen:
Thanks, Greg and good morning, everyone. We continue to make excellent progress advancing our BD 2025 strategy. This quarter demonstrates the durability of our portfolio and strength of new innovations, delivering mid-single-digit organic revenue growth of 5.2%. Growth was broad-based and reflects strong volume and share gains across the portfolio. Our team executed very well through transitory market dynamics in BDB and PS [ph] and macro factors in China. We continue to grow above the market and believe we are extremely well positioned as these markets recover. We have growing momentum from our BD Excellence operating system that enabled us to deliver significant sequential and year-over-year adjusted gross margin increases. This drove strong operating margin expansion contributed to over 18% adjusted earnings per share growth and is allowing us to raise our earnings guidance once again. Our team's excellent execution also drove over 100% year-to-date growth in free cash flow, reaching over 80% free cash flow conversion year-to-date, with margins, earnings and cash flow all ahead of plan. As a reminder, our strategy consists of 3 pillars
Chris DelOrefice:
Thanks, Tom and good morning, everyone. As Tom noted, the quarter's results reflect strong performance across multiple parts of our portfolio, even amid the previously noted transitory market dynamics and macro factors. Importantly, with strong execution of our BD Excellence programs, we exceeded our margin, earnings and cash flow goals. I'll now provide some further insight into our adjusted revenue performance. Q3 revenue grew 5.2% organic, driven by volume growth and share gains. Regionally, over 90% of our revenue which includes our 3 largest geographies, grew 6% plus organic. This strong performance was partially offset by a decrease in China from continued market dynamics. BD Medical growth was led by MMS with exceptional performance in infusion systems, driven by the BD Alaris return to market and higher utilization of infusion sets, partially offset by a tough prior year comparison in dispensing. Broad volume growth and share gains across our MDS consumable portfolio in developed markets also contributed to the segment's growth. Pharm Systems had another quarter of increasing demand with double-digit growth in prefilled devices for biologic drugs, primarily GLP-1s. This growth was offset by transitory market dynamics across the industry, including expected customer inventory destocking. BD Life Sciences performance was led by IDS with high single-digit growth in specimen management which reflects both increased utilization and customer upgrades to higher-value products to provide an enhanced patient experience. The segment's growth was partially offset by transitory market dynamics in biosciences that resulted in lower market demand for instruments. Given our leading portfolio in instruments and reagents, we significantly outperformed the category in the quarter. Strong organic growth in BD Interventional was led by high single-digit growth in UCC with continued momentum in our PureWick franchise, delivering another quarter of double-digit growth. Surgery delivered another strong quarter across all 3 major platforms with double-digit organic growth across advanced repair and reconstruction, infection prevention and biosurgery. We continue to make excellent progress with conversion to our bioresorbable Phasix technology which we see as a durable contributor to future growth. BDI performance was also supported by peripheral intervention with double-digit growth in peripheral vascular disease that was partially offset by a decrease in oncology, driven primarily by market dynamics in China. Now moving to our P&L. We realized strong sequential and year-over-year margin improvement with adjusted gross margin of 54.3% and adjusted operating margin of 25.2%, both above our expectations. The gross margin year-over-year increase of 170 basis points was primarily driven by increased productivity and cost improvement from our BD Excellence initiatives and moderating inflation. Our operating margin increased by 220 basis points year-over-year, driven by the increase in gross margin and healthy operating expense leverage with expenses increasing slightly on a dollar basis year-over-year. As a result of these items, we exceeded our Q3 operating income and adjusted diluted EPS expectations, resulting in adjusted diluted EPS of $3.50 which grew double digits or 18.2% on a reported basis. Regarding our cash and capital allocation, I'm really pleased with our strategic choices and the execution on cash flow. As a result, year-to-date free cash flow increased $1.2 billion year-over-year to $2.2 billion reflecting continued improvement in working capital, including continued inventory optimization, planned phasing certain cash flow items and the ability to leverage our capital expenditures as we benefit from BD Excellence productivity gains. We remain focused on free cash flow conversion and are on track to deliver another double-digit step improvement in fiscal year '24, with our year-to-date free cash flow conversion above 80% and we remain well positioned to achieve our long-term cash goals. Net leverage improved to 2.4x and cash and short-term investments totaled $5.3 billion, inclusive of about $3.4 billion in proceeds from the February debt refinancing and the Critical Care acquisition financing in June. Moving to our updated guidance for fiscal year '24. The detailed assumptions underlying our guidance can be found in our presentation. As we look ahead, we are confident in a strong close to fiscal year '24. We remain focused on driving multiple areas of momentum and share gains across our portfolio, including Alaris. For the full year, even with this broad-based momentum, it is prudent for us to reflect the latest market dynamics which others are also experiencing. As a result, we now expect organic revenue growth to be 5% to 5.25% for the full year. Based on the strength of our margin performance, we were able to absorb the revised organic revenue growth guidance and are raising our adjusted diluted EPS guidance range to $13.05 to $13.15 on a reported basis. This reflects an increase of $0.05 at the midpoint and $0.10 at the bottom of the range. We believe we are well positioned to achieve our updated adjusted operating margin guidance of over 50 basis points improvement which implies full year adjusted operating margins of over 24%. We continue to expect margin acceleration in Q4, driven by our BD Excellence and continuous improvement efforts and continued expense leverage on our expected strong revenue performance, including Alaris. Looking ahead to fiscal year '25. While it's too early to provide guidance as we are in our planning process, I can offer the following thoughts. We are continuing to monitor dynamics in select markets. Even in an environment where these dynamics continue to exist, we are confident in delivering strong performance, particularly our ability to exceed our 25% adjusted operating margin goal and deliver double-digit EPS growth, given the increasing benefit to gross margin from accelerating BD Excellence momentum. We think 10% EPS growth would be a good starting point for fiscal year '25, including Critical Care and the expected impact of Pillar 2. So in summary, based on the durability of our portfolio and momentum in Alaris, we are confident in delivering another year of strong growth. Our team's execution supported overdelivering on our margin expectations. And as a result, as we enter Q4, we are on track to exceed our full year margin improvement goals, deliver another year of double-digit free cash flow growth and once again increase our fiscal year '24 earnings outlook. Our strategy is demonstrating positive momentum and we remain well positioned to continue to deliver on our BD 2025 value creation objectives. With that, let's start the Q&A session. Operator, can you please assemble our queue?
Operator:
[Operator Instructions] Our first question will come from Robbie Marcus with JPMorgan.
Robbie Marcus:
Great, two for me. First, I wanted to ask on guidance, particularly fourth quarter. What's implied there in revenue guidance and the margins, it looks like, by my math, about 6.5% organic growth and still healthy operating margin performance. Maybe just walk us through some of the things that happened in third quarter that led to the touch lower organic growth and the confidence in fiscal fourth quarter, both from a revenue and a margin perspective where you did well in the quarter.
Tom Polen:
Robbie, thanks for the question. This is Tom. I'll start off and then turn it over to Chris. I think as we look at Q3, first off, we're really pleased with strong performance across many areas of almost every area of the company, particularly as we look at compared to market, where we saw strong share gains in a number of areas. We saw a strong volume performance. And even in markets that are undergoing transitory market dynamics, specifically the BDB research market environment and the destocking in Pharm systems. As we look at our performance, I really like our competitive position in those spaces. You're seeing us outperform what's been announced by others to date. And so as those markets ultimately rebound and you heard us talk about some of the new innovations in BDB. Obviously, our position in biologics and the differentiated growth that we're getting there. And the differentiated share gains that we're getting there in terms of our share of new molecules and even biosimilar spaces. We really like our position there long term. So I think that's really -- as we think about Q3, those dynamics in those spaces as well as just the continued play out in China is what we saw. I'll turn it to Chris, just to talk a little bit more about how we think about guidance in Q4. Pretty straightforward.
Chris DelOrefice:
Yes. Thanks, Tom. Thanks, Robbie, for the question. Yes, Q4 is actually pretty straightforward. So to your point on the top line revenue organic it implies upper 6% range, consistent with what you shared, maybe a little north of that. It's really attributed to one key dynamic. It's the continued momentum of Alaris. By the way, we obviously have a much stronger line of sight based on our committed contract position. This is the strongest quarter that we have this year as it relates to line of sight of that because now we're 3 quarters in that. In addition to that, if you recall, last year in Q4, we have a favorable comp in Alaris as well because we had stopped shipping under medical necessity, as we got the approval and we're preparing for launch. So you actually have a favorable comp and you have continued momentum with Alaris which as you saw was very positive in the quarter. The rest of the portfolio, we actually assume similar performance. So we're not making assumptions of significant market recovery or things of that. We're going to continue to outperform in those spaces from a relative standpoint. So I feel good about revenue. Margin, hopefully, everyone had an opportunity to see, Q3 was really strong. We outperformed margin. It led to the outperformance on EPS. The story there is straightforward. Gross margin, it basically just have to repeat Q3 which is already flowing through our cost base, right? We're in our cap and roll period there. So there's not a substantive change in terms of gross margin. On operating margin, the gross margin will flow through. We're actually increasing expenses slightly from an OpEx standpoint where you end up with that, call it, high 6% growth. You get a little bit of a natural leverage there that will flow through and we feel really good about that. I think importantly and we can talk more about this, pretends well for '25 as we think of margins.
Robbie Marcus:
Well, that's a perfect segue to my follow-up question on fiscal '25. You gave color about 10% EPS growth, I want to make sure that's reported, I think I heard. And there's a lot of moving parts, timing of when Critical Care closes, the accretion that could add, China versus Alaris. When you came up with that -- the 10% which I think is about where the Street is, when we factor in the Critical Care accretion. Maybe just some of the components, I heard 25% operating margin you feel good about. Just anything else you could give us up and down the P&L.
Chris DelOrefice:
Yes. Thanks, Robbie. Yes. Look, we're excited about '25. It's setting up nicely to deliver strong performance. First, top line, I'll just reiterate, we're extremely pleased. Our strategy is paying off in terms of strength of portfolio. Continue to focus on driving volume and share gains. And what you're really seeing in this quarter is the ability to deliver strong performance despite these market dynamics, most notably BDB, Pharm Systems and as Tom noted, China. So we're not dependent on one thing. The durability of our portfolio sets us up nicely. And then from a margin standpoint, I shared that on the momentum we have this year, we expect to now exceed 25%. I think importantly, what you'll see different in '25 going forward is the significant majority of that will come from gross margin. And actually, if you look at where we are in the back half of the year, you can kind of think of Q3 as sort of a nice number directionally to think of '25 and carrying that through. So I feel very good about line of sight to margin. As you noted, we're excited about Critical Care. It just gives us another positive catalyst to continue to deliver double-digit earnings growth. We are contemplating headwinds from Pillar 2. So still more to come on that. It's premature to share specifics but we do anticipate that's a headwind that we will absorb as part of that. And so all that collectively sets us up nicely, to your point, I think what I see externally where the Street is, we would see that more in the low end of the range and it would be 10% and that is on a reported basis. So FX at this point, there's a modest headwind into the year but we've contemplated that. The other thing, just we did actually activate formally. We had talked about doing this but partially derisk transactional FX. But we are active with now cash flow hedges that gives us another lever just to help solidify that performance.
Operator:
Our next question will come from Travis Steed with Bank of America.
Travis Steed:
I guess first two questions here. I wanted to focus on the guide change. And so I think China biosciences and pharma were the big reasons why you lowered the revenue guide this quarter. But it sounded like things were all on kind of track over the course of the quarter. So just curious like what changed, what kind of surprised you, when it happened. And I thought you didn't assume those markets to get better. So I was just kind of curious if there's -- are you changing your assumptions on when those things get better kind of going forward?
Tom Polen:
Travis, this is Tom. Thanks for the question. Yes, so as we mentioned before, we feel really good about the performance across the different businesses. Of course, mid-single-digit growth is a strong position, particularly given those dynamics that we see in those spaces. And even at flat essentially in BDB, that's differentiated versus what you're seeing competitively. I think what we're doing is just recognizing that we're not calling that those markets are going to turn in Q4, that we're going to continue to see some transitory dynamics in those spaces. We assume we're going to continue to compete and perform above market in those spaces which we've been doing all year. And so that's what we've built in here. The same dynamic a bit in China. I'd say China has played out as we look at Q3 and into Q4. So MDS, BDB playing out as we projected at the beginning of the year. no real change in that. I'd say in China, the two things are the bioscience dynamic is certainly noted in China. You're seeing that reported across essentially every peer where research spending is down in China, just given the economic macro environment. And so we're projecting that, that would continue. And then also as we see anticorruption in certain markets, one of the things that we see happen and we saw that in Q3 is that distributors, when there's uncertainty, they'll pull back on their inventory until they better understand it, right? So they won't let their inventory levels come down. We saw that play out a bit in Q3. We don't expect Q3 China performance to repeat in Q4. We do think there are some onetime dynamics there. But nevertheless, particularly on the bioscience side, we expect that dynamic to continue through the year. That's really it, Travis.
Travis Steed:
Okay. And then I guess the follow-up question is more into next year, kind of what kind of revenue growth do you need to kind of get to that double-digit reported EPS growth. Before you were kind of talking about BD at 5.5% plus, is that still possible if some of these headwinds that you're seeing this year, linger into next year? Just kind of doing the math this year, kind of ex-Alaris, looks like the growth is close to looking at 3.5% to 4%. I just wanted to see how to think about the next year revenue growth.
Tom Polen:
We're not going to give revenue guidance on this call, Travis. But what I can do is maybe just share some color. Obviously, you're seeing us even in this environment which we do expect, particularly the Pharm Systems is probably easier to predict on recovery timing. Just given it's -- you can't destock forever, right? So that's pretty clear. Some of the life science research spending dynamics. If you think about a lot of pure players in those spaces are projecting recoveries later into -- early into '25. I think we'll hold to see that come up as we will give the next quarter to be able to observe that a little bit more before we give guidance on that space. But across all those spaces, we feel good. And while we're facing those exact transitory market dynamics, of course, you see us continue to deliver mid-single-digit growth this year, this quarter despite that environment. And I think we would expect, particularly those to only improve as we go into FY '25.
Chris DelOrefice:
Travis, just maybe one other -- just 2 things. One, in my prepared remarks, I did say even in an environment where these dynamics continue, we're confident in delivering strong performance. we did that this quarter. This is still quality growth. I think just to put in context your Alaris comment, these transitory market dynamics, just those 2 areas alone are worth more than Alaris benefit, right? You've got high single-digit growth businesses that are nearly $4 billion, Pharm Systems used to be consistent double-digit grower. We're still seeing that strong biologics performance. That's a significant headwind we're absorbing. And to Tom's point, we're well outperforming those markets and so we continue to perform well there. And as those recover, those market trends are definitely long-term durable trends and we feel good about that. So I'd just add to consensus, what that means is -- the rest of our portfolio, look at -- BDI across the board was really strong, MDS performing well, specimen management performing, there is strong growth throughout our portfolio.
Tom Polen:
Yes. Maybe just a couple of other bits of color is, as we look at kind of our core business, the durable portfolio is high-volume products. We're seeing really strong volume growth and share gain in areas like MDS, PAS, kind of the consumable side of MMS and we don't see a slowdown to that momentum; so we feel good on that. Certainly, as we think about our strategy in health care automation and AI informatics, now with Alaris back in our connected medication management portfolio, we're making really good progress. You heard us say we're already back -- Q3, we're back at the $100 million plus per quarter run rate that we had prior to Alaris going on ship hold. That's 3 to 6 months faster than we had expected going into the year. So we feel really good about that. And that momentum, we expect to continue basically from here on out. We're at that $100 million-plus run rate going forward and we've built a nice backlog of orders for Alaris. Remember, we started with zero backlog as we went into the year. We expect to exit this year at, again, a normalized backlog that we had pre-ship hold at least at that level. Other areas of that connected medication -- or the connected care health care automation portfolio we're really excited about for next year as well. Of course, that's our pharmacy automation strategy and our laboratory automation strategy there as well which continues to really resonate very well with customers. Products like PureWick that are targeting new care settings, we've got not only the new PureWick female launch happening but we also have the mobile PureWick launch happening next year which we're really excited about. And then in that chronic disease management space, you heard us talk about -- in Pharm Systems, double-digit biologics growth. We expect that to continue very strongly into '25. And then as destocking on the vaccine and the anti-coag side starts to alleviate, right, that will lift that whole boat. But we certainly don't expect any change in our underlying Biologics momentum there. Biosciences, maybe I can just give a little bit more color on that one, too, is I would say that we're at the point now where we're -- we've seen us be flat. The market has certainly been down. If you look at peers, I think almost every single peer is down in that space. We've been -- a bit of an outlier is being flat. We are seeing -- if we look at quarter-on-quarter instrument purchases, we're seeing them up a bit sequentially quarter-on-quarter. As we think about China in the future, there is discussion around China stimulus that's been widely discussed across the industry. I think the timing of that still needs a bit more clarity, certainly, sometime in '25, it's expected. But again, as we get into guidance and more specifics there on the November call. I would expect there'll probably be a bit more clarity on the timing of stimulus in China, too. But from a bioscience perspective, I think our assumptions now and what we're seeing, it's certainly not getting worse and we're seeing some green shoots of some positivity in some areas. Other signs that we see are people that even in the U.S. from an NIH perspective, folks that maybe were turned down initially for grants we're seeing on the second submissions, those grants starting to get approved and more POs then coming in for those instruments.
Operator:
Our next question will come from David Roman with Goldman Sachs.
David Roman:
I wanted to ask one question on revenue then one on capital allocation. But maybe starting on the revenue side, appreciate some of the perspective around Alaris and the contribution that you expect that to drive this year than the sort of high-level perspective into next year. But how should we think about the growth drivers in that business beyond the bolus of performance you have from Alaris. I think you have a next-generation Pyxis platform launching. You have some of the pharmacy automation products starting to pick up steam. Maybe sort of contextualize the growth in that business beyond just the Alaris boost that we should see for the next 5 quarters?
Tom Polen:
Yes. I'll start off, David, thanks for the question. This is Tom and then I'll turn it to Mike Garrison who we have here with us in the room. Really in MMS, I'd break it into kind of -- we've got 3 or 4 categories. One is the consumables space, let's just start off with that. We see really strong growth in overall procedure volumes driving strong growth in the consumables of IV sets, etcetera, that fit along with Alaris. So as you mentioned, Alaris is not only back to its historical run rate but we believe we took share in the quarter as we look at independent market data and as well as our own. So we feel really good about the position there. And then, of course, that starts pulling through other elements of our connected care portfolio, inclusive of interoperability, health site and other solutions. We do have the next-gen Pyxis launching in the back half of next year which we're excited about long term and Mike can comment on that. And then, of course, we have pharmacy automation, both in the U.S. and Europe and the overall trends there around pharmacy shortages, labor costs and big demands for productivity improvements which we are ideally suited to address and are by far the market leader in each of those spaces when it comes to those customer needs. So maybe, Mike, some more details on what we're seeing there.
Mike Garrison:
Sure. So in addition to the next-gen Pyxis launch for next year, we've got about 10 additional releases across the connected med management portfolio that will come out. What we've implemented is a cadence of innovation. So whether it's in the core pharmacy, the acquisition of MedKeeper which is growing very nicely, some additions to that portfolio. Our MedBank acquisition which is going into long-term care settings and non-acute settings. These are some ways that, that entire market, we're starting to expand and go along with the shift of care into less acute environments or less hospital-based environments. But still, the hospital needing to stay connected from a data perspective, from an understanding of their total inventory perspective. So I think we're really well positioned from an innovation there. Growth in that market is cyclical. So it goes sort of with the book of business as capital would happen. But we do have a very strong service model there. And also, we offer a very flexible set of financing terms around capital and operating leases. So we're -- we have a little bit less cyclical nature than maybe some of the competitors that show a little bit more volatility in that area. Pharmacy automation between Parata and ROA and our RapidRx acquisition, we sort of built a fairly significant -- I think the largest pharmacy automation robotics company in the world. And the customer interest in that is very, very strong. It's been -- there's very high double-digit growth last year. A bit of change in tax incentives in Europe that we've commented on before that we've been watching, caused a little bit of a slowdown in Europe here this year but we've also started to see the order book pick up sequentially quarter-to-quarter, both in the U.S. and in Europe. So we feel good about that. The fundamentals there are very, very strong around labor efficiency, around safety, around the use of both artificial intelligence and robotics to provide additional efficiencies in health care, in the retail sector, in the long-term care sector and as hospitals start to reinvent their pharmacy. So I think in both areas, there are areas that augment and underscore -- while Alaris is obviously coming back very strong, it's just the 1-year anniversary on this call last year is where we announced that we had got clearance and that couldn't be going any better than the expectations than what it's going right now. But the fundamentals across that connected net management strategy are very strong and continue to resonate with the customers.
Tom Polen:
Thanks for the question, David.
David Roman:
Sorry, I assume -- can I ask a follow-up here?
Tom Polen:
Go ahead, David.
David Roman:
Sorry about that. Can you maybe just on the P&L comments for next year, one of the things that would be helpful to put together here is -- as you think about your growth rate, a lot of what you're describing here are macro factors and sort of end market dynamics which logically flow through to you given your high market share. But what can you do to differentially position BD from a performance perspective, especially given what looks to be like flattish operating expenses. So what are the sort of underlying assumptions around discretionary expense spending that are in that kind of 10% type earnings sort of floor that you've put out there for next year? And how should we think about the rest of the P&L below gross margin?
Chris DelOrefice:
Yes. Thanks, David. It's Chris. Yes, I think the exciting pivot is -- and think of Q3 as kind of an indicator of what' '25 would be, full year '25, based on the comments I shared. So we talked about exceeding now 25% operating margin in FY '25. So it implies north of 100 basis points of improvement. The significant majority of that is coming from gross margin. So you're seeing all the benefit of BD Excellence flow through which, to your point, creates an opportunity for us to kind of reshape below gross margin. The intent is to, as part of that 10% starting point, is to drive more investment in R&D and more investment in business building growth, digital capabilities, commercial go-to-market, etcetera. Our principle will always be to sort of get natural leverage from kind of our G&A space and we've also talked about that we're advancing a global business services model there as well. So that will be a minor catalyst in '25. The leverage will be there but it is also a go-forward catalyst. So that's how we think of the formula, more value out of gross margin. To your point, that lends itself nicely to the natural flow-through on sales and then reinvestment to support growth and leverage kind of your core infrastructure base.
Tom Polen:
Yes. David, maybe just one other thing to add to Chris' good points there. And you heard us talk about this in the prepared remarks. BD Excellence which we really launched last year, we couldn't be more pleased with the momentum that we're getting there. So as you heard, we're up to over 500 Kaizen events this year. Of course, BD Excellence is based on Shingijutsu Kaizen which is the idea of the pursuit of excellence through continuous improvement and providing our organization with the tools, the systems, the capabilities to do that as part of their everyday work and then a series of major events like the 500-plus Kaizen that we mentioned where we immersed in that as an organization in specific areas. And we're really seeing that come through in reduced waste and improved line productivity. You're seeing that flow through also in our cash flow performance with exceptionally strong year-to-date as we're able to actually operate the company on a continued basis with less CapEx, just given the productivity improvements that we're seeing from that. At the same time, of course, Project RECODE which we folded up under our excellence initiative now which is the consolidation of over 20% of our manufacturing plants, right? That starts kicking in '25 as well which at a scale level. We got a bit of it in '24 but we really see that ramping up in '25 which further flywheels that margin. And then you also heard me mention that -- of course, as we now are consolidating plants, one of the things that happens as you end up with fewer larger plants. And as you're having fewer even larger plants, we're taking advantage of investing behind our smart factory strategy and those as well. We think -- as we think about technology, around AI, predictive analytics, companion robotics, etcetera, there's no company in med tech that's better positioned to be able to capitalize and get value out of that than BDS given the scale of production that we have. And so we've been digitizing. We have now quite a few areas that are fully paperless. So we're digitizing all the data coming off of our lines which has been allowing us to now start putting predictive analytics against those. As I mentioned, we've done that and with a focus on our top 30 plants where we're seeing accelerated performance from that. And so we're really combining that excellence Kaizen strategy with that smart factory strategy as well which is going to be continuing to drive at GP [ph] strategy of ours, not just in '25 but that's going to be a key theme as we look forward to Investor Day in Q2 of '25. Expect to hear more about that and our [indiscernible] margin focus over the next phase post-BD 2025.
Operator:
Our next question will come from Patrick Wood with Morgan Stanley.
Patrick Wood:
I'll keep it to one, just given the timing. And I appreciate you guys have covered this but I definitely want to dig into China a little bit more because you've had quite a few companies come out across a range of different industries and have a reasonable tough time in the market. So I guess, obviously, the VBP [ph] dynamics, we know there's biosciences on that side, as you said, lots of companies flagging on that. I guess my question is like what are you hearing from some of the customers? Have you seen any MDS vol changes outside of stocking? I'm just trying to dig into underlying in the market. Is there anything that you feel has structurally changed? Or are these genuinely transitory dynamics?
Tom Polen:
Yes. Thanks, Patrick, for the question. So we've got a great team in China. We still view it as a large market with significant unmet needs and we continue to serve that market opportunity across the breadth of our portfolio. We continue to invest in advancing health care practices and access in China. As you mentioned, we see -- VBP [ph] has been playing out in MDS as expected. Just as a note there, our volumes in MDS China are actually up very nicely. So if you look at the -- even the categories where we're seeing VBP [ph], we see price pressure but we're seeing strong volume growth in those categories in MDS that are complementing that. So our plants are very busy in China because of higher volumes in those spaces. The lower research funding, as you mentioned, that's been broadly commented on across the board. And we do think there will be an end in sight to that as the market ultimately recovers and research investment. We don't see that as a long term, that China will be de-investing in research over the long term. We expect that will recover and that's more of a transitory dynamic. And then some of these other factors, they are related. There are economic challenges at a macro level happening in China, where I think that combines with the anticorruption and some of the actions that distributors take when there's uncertainty and they'll pause to pull inventories down a bit, those dynamics, I think, will evolve as just clarity in the economy and those processes end up coming into light. So -- which, again, we would expect to be more transitory in nature. So we continue to invest in the market. We still see it as a long-term attractive space, an important market for us. And we do have areas of the business that are continuing to do really well in China beyond some of those transitory spaces that we see. So maybe that's a high-level overview of what we see and as we look forward.
Operator:
Our next question will come from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Two quick ones for me and I'll ask them both upfront. On Alaris, the $350 million in fiscal '24 sales implies about a $600 million annual run rate using the implied Q4 sales of about $150 million, if I'm doing the math right, is that the right way to think about fiscal '25 Alaris [ph] sales, about $600 million? And just lastly, Chris, the last two years, growth in margins have been very back-end weighted. And obviously, it's caused a lot of investor anxiety, is there any way or do you expect fiscal '25 to look different from a cadence standpoint?
Chris DelOrefice:
Larry, thanks for the question. Yes, on the second question but we're still in our planning stance and we need to continue to monitor market dynamics, all these factors. I think the one thing is for sure that the margin rhythm is going to be much more balanced throughout. I mean last year, we had one a strategic choice on inventory takedown that was all front-end loaded, right? That was a predominant driver. The execution this year played out exactly as we talked about. As a matter of fact, the past few years, I mean we've executed against everything we said from a margin standpoint the past two years. So that's a big change. FX also was another big front-end item that we don't see that same degree. So I think naturally, we're going to end up with a much more balanced phasing and we'll share more when we provide our official guide in November. But I don't think that's an item that should be tough.
Tom Polen:
But the other big thing that we had this year was, of course, Alaris was a ramp in the second half given that we just launched at the very end of Q4. So you're going to have much more ratable performance in Alaris Q1 through Q4 of next year as well. So we would expect much more smooth which we're very much looking forward to being back at that as we look forward. Just on Alaris, we're not certainly going to give guidance by any product line for '24; we're not at that point. I think that's -- I wouldn't take the run rate necessarily from that and take it through '25. But back to my commentary, we're back at, at least the $100 million historical run rate. Cannot [ph] be an opportunity to do better than that as we go into '25 for sure. And we'll give more color on that on the November call.
Operator:
Our next question will come from Rick Wise with Stifel.
Rick Wise:
Maybe back to the fiscal '25 guide. I just want to make sure I'm thinking about it correctly. It's been talked about several times but I just want to hear your language one more time. The 25% EPS growth commentary and the operating margin for over 25% clearly includes Critical Care, if I understand correctly. But to make sure it -- doesn't that sort of imply that everything else on a total basis is not going to grow as fast in fiscal '25 as it has in '24? And if I'm thinking about it remotely correctly, maybe I'm too deep into earnings season, I'm not thinking about it clearly. Are you -- does that imply you're being conservative or careful in this initial commentary? Just to make sure we're thinking about it correctly.
Chris DelOrefice:
Yes. Thanks for the question, Rick. Yes. I mean, look, '25 is -- we think there's a lot to be excited about. Critical Care is part of it, to your point, that's not a substantive contributor just to be clear, the margin we're generating is fully on the BD base business. So we're well positioned there to now exceed the 25% operating margin goal. Again, importantly, the mix shifts significantly in terms of where margin improvement is coming from, it's coming from gross margin. Look, I think external estimates now are sitting actually just under 9%, right? We see that to the low end of our range, 10% reported is a great starting point, above where we are externally. And like we do every year is, our goal is to continue to create opportunity to exceed that as we move throughout the year; so it's early. We just knew it was important to kind of share context and we've been able to do this, by the way, this year, like on the top line, the questions, deliver strong performance despite these market dynamics. So we'll continue to monitor those but feel really good about how we're positioned moving into 2025.
Operator:
Our last question will come from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Just one for me. Some of these issues you have mentioned, right, I think on the pharma side, some of your close peers are talking about a bottoming on destocking. So just maybe from your perspective, like how are you seeing this destocking impact playing out. And when I look at those moving transitory sort of issues, like China, bioscience and pharma destocking, it looks like biosciences should -- certainly headwind should continue. I think most of tools companies have been cautious about first half of '25. How should we think about China? Is that should that get back to growth? Or is this VBP [ph] headwinds, could that last for a while?
Tom Polen:
Yes, it's a great question, Vijay. So let me start with maybe the bioscience and then touch base on Pharm Systems and then touch base on China. So on Pharm Systems -- or on biosciences, I think, as you mentioned, it's been widely commented on across the tools companies. Again, we see ourselves outperforming the market this year. That's pretty straightforward. There's very few that are flat like we are in that space. And you heard us make -- share in our prepared remarks some of the really exciting innovations that we see driving that. And not only are they driving that in this environment, as the market ultimately recovers, those same technologies around FACSDiscover and the continued cadence of new innovations not only with sorters but next year, launching our first analyzer in that segment, continued innovation with dies and other technologies that are allowing more and more multiplexing in that category are all just going to benefit us as that market picks up and people can begin to buy systems in larger volumes. So we feel good about that. And it really comes down to the timing of the recovery which, as you mentioned, we're assuming it's going to continue to be tight through the balance of this year which is how we've updated our guidance. And then we would expect at some point in '25, again, let's watch Q4, we'll update '25 guidance in November on that. I think we'll benefit from that timing to get clarity as with the whole market. On Pharm Systems, look, we continue to see that strong demand on biologics underlying which is also differentiated versus peers, double-digit growth again in biologics within that space. We see no slowdown there. Obviously, GLP-1s are a big component of that and our position that we have on some of the large current market molecules is benefiting us. We also shared we've got a position with a number of new GLP-1s that are moving through the pipeline towards launch are already having our device spec-ed in. And then we also see -- we have over 40 signed agreements for biosimilar GLP-1s, the early molecules of GLP-1s that we start seeing launch as early as the next 12 months there and that will play out over the longer term as those play out. But we really like our position there. Of course, the destocking that's happening that, as you mentioned, everyone is seeing across that the sector, has really been focused on the anticoagulant and vaccine segment for us. And I think broadly for others and that can't continue forever. So we would expect that as we move into FY '25 and again, we'll give more specifics on timing as we go into guidance. But certainly, as we go to the back half of that, we would expect that to be -- start coming, returning to more normalized growth. On China, look, we have China -- we don't have -- as we think about the numbers that we've shared around double-digit EPS growth for next year, we don't have a major assumption of China returning back to high growth next year in that. We've taken a conservative position in our internal monitoring -- modeling on that. And we'll continue to watch that market play out as we go forward but we've taken a conservative stance on our own internal modeling there as we look at and build our plan for the 10% EPS growth number. So we still see -- and again, that will be related to the biopharma research spending that's happening in China will be something we'll continue to watch closely and how that overall macro recovery -- market recovers, we'll continue to watch the China macroeconomic environment overall. We do see MDS. We don't see a change in terms of the timing of VBP [ph] starting to decline. We've seen that play out this year as we expected. We don't expect that to be as significant next year for MDS, just given the scale that happened this year. I think we've said that in the past, we don't expect that to change, i.e., we see less pressure in MDS next year in China from VBP [ph] but more to come on China as we give guidance. But hopefully, that just gives some color on China and what we've built into some of our preliminary thinking as we shared the number on EPS for next year.
Operator:
Thank you. That concludes today's question-and-answer session. At this time, I'd like to turn the floor back over to Tom Polen for any additional or closing remarks.
Tom Polen:
Okay. Thank you, operator and thank you to all of our investors for joining us on our call today. We are pleased to deliver strong, above-market, broad-based growth and are well positioned to achieve our increased FY '24 earnings guidance. As we look ahead to FY '25, we are excited by multiple growth opportunities across our portfolio, momentum in BD Excellence, driving continued strength in gross margins and cash flow and welcoming the Critical Care team to BD. We look forward to connecting with everyone again in November and thank you for your continued support of BD. Thank you, operator.
Operator:
Thank you. This does conclude this audio webcast. On behalf of BD, thank you for joining today. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to BD's Second Fiscal Quarter 2024 Earnings Call. At the request of BD, today's call is being recorded and will be available for replay on BD's Investor Relations website, investors.bd.com or by phone at +1 (800) 723-5792 for domestic calls and area code +1 (402) 220-2664 for international calls.
[Operator Instructions] I will now turn the call over to Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations.
Greg Rodetis:
Good morning, and welcome to BD's earnings call. I'm Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations. Thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the second quarter of fiscal 2024. The press release and presentation can be accessed on the IR website at investors.bd.com.
Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Following this morning's prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Mike Garrison, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Rick Byrd, President of the Interventional segment. Before we get started, I want to remind you that we'll be making forward-looking statements. You can read the disclaimer in our earnings release and the disclosures in our SEC filings available on the Investor Relations website. Unless otherwise specified, all comparisons will be made on a year-over-year basis versus a relevant fiscal period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. Reconciliations between GAAP and non-GAAP measures are included in the appendices of the earnings release and presentation. With that, I am very pleased to turn it over to Tom.
Thomas Polen:
Thanks, Greg. Good morning, everyone, and thank you for joining us. Second quarter revenue growth accelerated significantly as expected, driven by the strength of our portfolio, increasing volumes across our consumables and Alaris. Margin performance drove adjusted EPS ahead of our expectations and consistent with our plan, we delivered very strong cash flow and are on track to deliver another year of double-digit free cash flow growth. These results give us the confidence to once again increase our FY '24 adjusted EPS guidance.
Turning to our BD 2025 strategy. We continue to execute well on the actions we outlined at our Investor Day to drive profitable growth and value creation. This includes advancing our innovation pipeline, which supports our durable 5.5% plus targeted growth profile. One such area is the strong cadence of new innovation across our connected medication management suite, which delivers many unique benefits to our customers. Q2 was the second full quarter since clearance of our new Alaris system and first half Alaris sales have already eclipsed our total FY '23 performance. Our return to market is ramping faster than initially planned, which wouldn't be possible without our manufacturing team who have executed extremely well in scaling Alaris production. Q2 set an all-time record in both the number of BD Alaris pumps manufactured and the number of pumps shipped in a quarter to upgrade our customers to the cleared version of the pump. We have also seen acceleration of committed contracts, inclusive of competitive conversions as health systems value the capability of Alaris and look to standardize their fleet. This offers confidence in the planned second half contribution to growth and will support momentum heading into FY '25. The Alaris 510(k) clearance is just the beginning. As we have shared, we are excited about our innovation roadmap, and we are planning upcoming Alaris 510(k) submissions to further strengthen our capabilities, like best-in-class interoperability with over 800 live sites, introduce a steady flow of new customer innovations and ensure continuous compliance. Examples such as over-the-air technology for efficient software updates and continued advanced cybersecurity are planned in the next submission later this calendar year. Beyond Alaris, we have a market-leading connected medication management portfolio across inventory management, compounding, pharmacy automation, medication dispensing and infusion and are excited about future innovations and development. This includes new medication dispensing and informatics innovation, including the next generation of our Pyxis dispensing platform, which innovates on our hardware design and will advance our cloud connectivity. We continue to scale our BD Health sites informatics platform, now live in over 1,000 sites, and have upcoming launches to integrate hospital medication data from Pyxis with non-acute medication data from our MedBank and MedKeeper platforms, to bring visibility to medication flows across the customers care network. In Q2, we made meaningful progress achieving other key R&D milestones, including several in our peripheral vascular disease platform, which is one of our key growth areas. Longer term, these technologies are each expected to deliver over $50 million in incremental fifth year revenue and will broaden our leadership in the $5 billion PVD category that is growing high single digits. In our venous portfolio, we have now enrolled over 60 patients in our ARCH pivotal IDE for our BD Liverty TIPS Stent Graft. This novel self-expanding covered stent improves the standard of care for portal hypertension. Building on our success in launching venous products that help deliver better clinical outcomes for patients and strengthening our presence in the venous market. In our arterial portfolio, we enrolled the first patient in our AGILITY pivotal IDE study for our low-profile arterial stent graft, a differentiated technology that minimizes access site complications with precise stent placement that could provide an important new treatment option for over 18 million patients with peripheral arterial disease in the U.S. alone. We also filed our SCION SFA pivotal IDE submission with the FDA for our new sirolimus DCB for the treatment of PAD. We see this new alternative drug platform as a key growth catalyst for both SFA and below-the-knee applications. We are also executing well on our simplification strategy to drive margin expansion. We are seeing growing momentum as we scale our BD Excellence operating system and build world-class lean management systems and culture throughout BD. This drove strong Q2 performance in areas such as waste reduction and production efficiency, contributing to our margin goals. Our focus on cash flow also continues to deliver positive results, generating about $1.1 billion in free cash flow in the first half. This strong start to FY '24 positions us to deliver double-digit growth in free cash flow for the full year. It also enables continued execution of our disciplined capital allocation strategy including accretive M&A opportunities in higher-growth categories and opportunistically returning cash to shareholders. Lastly, our teams around the world continue to make advancements on our corporate sustainability strategy. We were recently named among Fortune Magazine's Most Innovative Companies list, a testament to our 70,000 associates who work every day to deliver innovation that meaningfully advances the standard of care around the world. We continue to forge partnerships that expand access to these critical innovations. And most recently, we announced the first-ever option in Singapore for women to self-collect a sample for cervical cancer screening in the privacy of their own home. In summary, we are delivering accelerated revenue growth, are executing ahead of our plan on Alaris and driving strong margin performance with a growing contribution from BD Excellence. We once again raised our adjusted diluted EPS guidance for fiscal 2024 and believe we are well positioned to achieve our BD 2025 goals. I'll now turn it over to Chris to review our financials and outlook.
Christopher DelOrefice:
Thanks, Tom, and good morning, everyone. As Tom noted, we executed well on our performance goals in Q2. As expected, we delivered strong acceleration in our revenue growth, we exceeded both our margin and earnings goals and delivered very strong free cash flow growth.
I'll now provide some insights into our revenue performance in the quarter. Q2 revenue was $5 billion, with organic growth of 5.7%, driven by strong volume. Growth was led by double-digit growth in BD Interventional with low single-digit growth in BD Medical and BD Life Sciences. Total Q2 revenue growth of 4.7% reflects the divestiture of our surgical instruments platform. Regionally, organic growth was driven by the U.S., partially offset by expected market dynamics in China. In BD Medical, growth was led by Medication Management with strong performance in infusion systems driven by the BD Alaris return to market and mid-single-digit growth across our Medication Delivery Solutions portfolio in the U.S. and EMEA. Strong demand in our Pharmaceutical Systems, pre-fill devices for biologic drugs offset transitory market dynamics across the industry, including customer inventory destocking. BD Life Sciences performance was led by Integrated Diagnostic Solutions with high single-digit growth in our microbiology platforms and mid-single-digit growth in specimen management, which offset a comparison to the prior year and transitory market dynamics in select segments in Biosciences. BD Interventional Organic growth was led by continued strong growth in UCC with continued momentum in our PureWick franchise, delivering another quarter of double-digit growth, along with related licensing revenue. Surgery delivered another strong quarter with double-digit organic growth, supported by global adoption of our Phasix resorbable scaffold. Lastly, growth was supported by Peripheral Intervention with double-digit growth in our peripheral vascular disease platform, where we continue to drive market penetration with our Rotarex atherectomy system and our venous portfolio. The quarter's performance reflects the breadth of the BD portfolio that delivers a durable growth profile. Now moving to our P&L. We realized strong sequential margin improvement with adjusted gross margin of 53% and adjusted operating margin of 24.3%, both above our expectations. For adjusted gross margin, our simplification and BD Excellence initiatives are continuing to drive net cost improvement and sequentially, as planned, we saw a reduced impact from prior year inventory reductions that increased cash flow, driven by strong SSG&A, expense reductions and leverage, our adjusted operating margin increased sequentially by 410 basis points and year-over-year by 160 basis points with Q2 being above our fiscal year '23 full year margin. As a result of these items, we exceeded our Q2 operating income and adjusted diluted EPS expectations resulting in adjusted diluted EPS of $3.17, which grew double digits or 10.8% on a reported basis. Regarding our cash and capital allocation. Year-to-date free cash flow increased more than $900 million year-over-year to over $1.1 billion. This reflects continued improvements around working capital, including our actions to optimize inventory levels, continued discipline around capital investments and leveraging our fixed asset base as a result of the benefits from our BD Excellence operating system. We remain focused on free cash flow conversion and are on track to deliver another double-digit step improvement in FY '24 and remain well positioned to achieve our long-term cash goals. With our strong cash flow, year-to-date, we returned over $1 billion in capital to shareholders, including dividends and $500 million in share repurchases. We improved our net debt position ending Q2 with a net leverage ratio of 2.6x. Our cash and short-term investments balance was almost $3.2 billion, inclusive of about $2 billion in proceeds from debt refinancing during the quarter that will be utilized to repay maturing debt over the balance of the calendar year. Collectively, this positions us well to capitalize on accretive value-creating tuck-in M&A. Moving to our updated guidance for fiscal year '24. The detailed assumptions underlying our guidance can be found in our presentation. As we look ahead for the balance of the year, we remain focused on driving areas of momentum, including Alaris and continue to monitor transitory market dynamics. For the full year, we are maintaining our organic revenue growth guidance range of 5.5% to 6.25%. Based on our Q2 margin performance, we are raising our adjusted diluted EPS guidance range to $12.95 to $13.15 on a reported basis, which is an increase of $0.11 at the midpoint. Strong delivery in Q2 positions us well to achieve our second half earnings growth targets. Regarding foreign currency, based on current spot rates, the impact of currency has moved modestly since our last update. And for illustrative purposes, we see an additional headwind of approximately 40 basis points to full year revenue from translational currency impacts.
As you think of the second half of fiscal '24, the following are some considerations:
First, regarding revenue, the midpoint of our guidance reflects about 7.5% second half organic sales growth with nearly 250 basis points contribution from Alaris and just over 5% growth in the remainder of the BD portfolio. We expect Q3 organic growth of at least 6% with Q4 further accelerating, driven in part by Alaris momentum and improving grow-over dynamics in China.
For the full year, our assumptions imply just over 100 basis points revenue contribution from Alaris or at least $300 million in FY '24 revenues. Second, we are well positioned to achieve our updated adjusted operating margin guidance of at least 50 basis points improvement, which implies full year operating margins of at least 24%. We expect Q3 adjusted operating margin will be modestly higher than Q2, given the strong performance in this quarter. We continue to expect margin acceleration in Q4, driven by our BD Excellence and continuous improvement efforts and continued expense leverage on expected strong revenue performance, including Alaris. Lastly, we expect our tax rate to be ratable across Q3 and Q4 at about 15% when considering the midpoint of our updated full year guidance range. In summary, based on the strength of our portfolio and momentum in Alaris, we have clear line of sight to deliver our fiscal year '24 revenue guide and another year of strong growth. Our team's execution supported over-delivering on our margin expectations. And as a result, as we enter the second half, we are on track to achieve our full year margin improvement goals and once again increased our fiscal year '24 earnings outlook. Additionally, we remain well positioned to deliver another year of double-digit free cash flow growth, which increases our capacity to support additional value-creating opportunities, including M&A. Our strategy is demonstrating positive momentum, and we remain well positioned to continue to deliver on our BD 2025 growth objectives. With that, let's start the Q&A session. Operator, can you please assemble our queue?
Operator:
[Operator Instructions] Our first question will come from Travis Steed with Bank of America.
Travis Steed:
Congrats on a good quarter. I wanted to ask about the second half ramp, both from a revenue and margin perspective. So on revenue growth, you need to step up closer to kind of above the full year range in the second half, curious what the underlying drivers there are and how much of that is dependent upon the increased demand you're seeing in Alaris?
And then on the margin side, curious how much of the outperformance in Q2 was onetime versus underlying? And how you're thinking about the second half and how much of that's kind of derisked versus 3 months ago?
Christopher DelOrefice:
Yes. Thanks for the question, Travis. Yes. So first of all, we were pleased with the quarter. To your point on revenue, one, we did see strong acceleration quarter-over-quarter as expected on revenue. We tried to outline the ramp. Clearly, the back half guidance at our midpoint implies about 7.5% growth. But when you unpack that with the momentum that we have in Alaris, we now expect nearly 250 basis points contribution to our second half growth. That would put us at least $300 million for the full year. So if you strip that out, the rest of the BD portfolio has to perform at just over 5%. We feel confident in that. We have strong areas of momentum.
I think one thing that you saw in our core performance this quarter was -- our core consumables that are anchored against the core of health care, performing really well as you see strong utilization in the health care system. We continue to see great momentum in areas like PureWick, driving strong outsized double-digit growth in that platform, momentum in PVD. And so there's a lot of pockets of strength that we'll continue to build on there. From a margin standpoint, so first, the drivers of the margin that we articulated at the start of the year have played out as expected. To your point, we had really strong execution in the quarter. This is driven by our cost improvement initiatives, the momentum on BD Excellence. So we over-delivered 2 quarters in a row, and we're well on track to deliver the full year, which is at least 50 basis points increase year-over-year. We're just over 24%. As you think of the performance in the quarter, it really wasn't one thing. I would just say strong execution throughout and we remain focused on executing in the back half of the year. I think the important thing is in the back half of the year, there were questions about the ramp. Q2 is a strong signal that we're well on track. As a matter of fact, one simple way to think of this is our first half gross margin was about 52%. And we know we had those kind of transient onetime items, the outsized FX and then the decision we made last year to reduce inventory levels, which improved strong cash flow. Those are worth over 200 basis points. Those are completely behind us as we move to the second half. You add that to the 52% and you're basically where we need to be in the back half already. So we just have to continue the strong cost improvement. In addition to that, we lapped the outsized inflation. In the front half of the year, that was almost 150 basis points. We cycled through that and that moderates down very low. So lot of momentum in terms of how we're advancing margin. And then lastly, what I would point to is, obviously, with that Alaris momentum and ramp through Q3 and Q4, you get a bit of what I would call outsized leverage on the revenue that's also worth about 150 basis points in the back half. As a matter of fact, our OpEx expenditures are not reducing. They're about flat or even up slightly. So it's not about cost reductions in OpEx. It's all about the top line leverage, which we feel good about.
Operator:
We'll go next to Robbie Marcus with JPMorgan.
Robert Marcus:
Nice quarter. I'll try and ask one that answers a couple of things. As you look at the balance of the year, you said you just need 5% in the base business. So if we look at second quarter, excluding the Urology payment and Alaris, what did the base business do so we could get that kind of comparison?
And then maybe while you're at it, speak to some of the underlying trends in Pharm Systems and MMS where results came in a little lower, but it sounds like you're very confident for the rest of the year.
Thomas Polen:
Thanks, Rob. So I think as we look at the quarter and as we look forward to the year, we feel really good about the momentum and the diversity of BD's portfolio. And I'd say, as you look at the areas across the company, we see particular strengths in Medical, in Intervention, in the Life Science businesses that are focused in the health care provider space, right, that are benefiting from strong utilization across the board.
You can see our volumes, if you compare volumes this year versus last year, you're seeing strong growth from a volume perspective. And that's, of course, being supplemented by our very strong innovation pipeline as well. That's allowing us -- that strength of our diverse portfolio is allowing us to overcome what we see as transitory market dynamics that you're seeing across companies in the life science research area as well as in the B2B pharm systems marketplace where you're seeing destocking in certain areas. With that said, we're seeing really strong growth continue, right, around double-digit growth in biologics. The biologics are now over 40% of our Pharm Systems business. So we feel really good about that. And that percentage in weighting is only increasing, right, towards $1 billion of biologic sales in that area. And so as we think about -- that's one of the strengths of BD's portfolio is those puts and takes across and being able to deliver in multiple different environments, really strong revenue performance. So Chris, anything to add?
Christopher DelOrefice:
I would just add, I think Q2 is certainly representative of the growth rate that we need. We feel good about that. There's all kinds of puts and takes in the P&L. I mean just -- Alaris was a modest contribution. It wasn't significant. It's really most predominant in the second half, and that will be a strong driver for us. I articulated the second half drivers. Keep in mind, in Q2, you had some of these other negative comps, right?
You mentioned licensing. There was also a licensing headwind that was in our Life Sciences business, and we were cycling through some very large capital installs. That's a space that -- we still feel good about customer interest, have strong momentum, and there were some timing dynamics there with the launch of our technology in BDB and a really strong install result in the quarter. So net-net, there's always lots of puts and takes. The 5% is something that we're confident in as we think of the second half.
Operator:
We'll go next to Vijay Kumar with Evercore.
Vijay Kumar:
I guess my one question here is on Alaris, the $300 million, Tom, can you give us a sense on what the implied exit rate number is in Q4 for Alaris? Because I understand from a growth perspective, it might be a little tricky. I know you have some upgrades going on. What is the dollar revenue number implied for Q4? And I know Alaris was raised from $200 million to $300 million, but the organic for fiscal was maintained. Is that just conservatism?
Thomas Polen:
Yes. Thanks for the question. So first off, we are really happy that we delivered on our #1 priority last year, which is the clearance of the BD Alaris system. And we said our #1 priority for this year became the relaunch of Alaris and remediation and return to it being a contributing growth driver. And we're certainly delivering exactly on that goal like we did last year. Really proud of our manufacturing team. Hopefully, you heard it in our prepared remarks, right? We went from clearance at the end of Q4 to this past quarter, Q2, setting an all-time record in both the production and shipment numbers of Alaris. That's a combination for sale and remediation, but it really reflects that core manufacturing excellence capability that BD has, which we think is best-in-class in the industry, and this is a great example of it.
We continue to get really positive customer feedback. We've got positive contract momentum. And as you heard, we've got plans progressing for our next 510(k) submission later this calendar year, which will begin to continue to build new innovations on the back of the 510(k) that we got cleared in Q4. So as we think about next year, to your question, we don't put out quarterly guidance by product line by any means. But what I would say is, as Chris said, our current guide implies, as you said, over $300 million, actually closer to $350 million for the year. And we've said before that we expect certainly FY '25 to be at least at our historical run rate, right, which you kind of think of as $400 million. Anything beyond that, we'll get into as we get into FY '25 guidance. But clearly, our performance this year is positioning us really well towards that previously stated goal.
Christopher DelOrefice:
The only thing -- just small thing I would add, we did say that for Q3, you should expect total growth inclusive of Alaris of at least 6%. And then you would expect a sequential step up in Q4. So you think of that step up, a portion of that is going to be Alaris. There's also the China grow-over favorable comp that we'll have, but Alaris is a portion of that.
Operator:
We'll go now to Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Congrats on a nice quarter here. Chris, I know it's really early, but love to hear your confidence in the 25% operating margin goal in fiscal 2025. And are there items right now we should be aware of, such as TSAs rolling off or an increase in the tax rate that would make double-digit EPS growth challenging next year?
Christopher DelOrefice:
Yes. Thanks, Larry. Good question. Yes, first of all, to your point, it's a little early to get into 2025. TSA is not material. That's a normal dynamic that happens. As a matter of fact, year-over-year, we're down. So we're actually absorbing that already. And by the time you get through this year, it's not substantive.
The tax dynamics and things like that are evolving. We'll share more at a future date. I think the key thing is we remain committed to our BD 2025 goals. That remains unchanged. Specifically operating margin, I'm glad you mentioned that. I just think what we've delivered through the first half of this year, the momentum we have with BD Excellence through the back half of this year sets us up nicely with the strong exit rate that gives us confidence in delivering 25% by 2025. I think the big thing that you'll see is the progression from that improvement coming from largely gross margin. So we have really great momentum inside on our improving waste, improving yield in our manufacturing lines that will drive continued momentum there. And that will be a catalyst beyond 2025 as we get to the point that we talk about that, too, that will be very positive, help facilitate reinvestment and continue to drive the top line growth as well. Thanks for the question.
Operator:
We'll go now to Matthew Taylor with Jefferies.
Matthew Taylor:
So just because there's a lot of focus on the phasing and the ramp through the second half of the year. I guess, you gave us some math and some confidence in that. I was wondering if you could take the other side of the coin and maybe talk about any risks that you see to that ramp? I mean what would have to go wrong for you not to hit this express progression in revenue acceleration and margin expansion?
Christopher DelOrefice:
Yes. Thanks for the question. I guess -- so 2 things. One on margin. If you think of margin, a lot of the momentum comes from 2 things like I shared, right? One, we just exit those one-timers in the first half. So high confidence that's done. It's behind us. The second thing is, our cost improvement initiatives with -- when you think of a cap and roll period and inventory, we have a strong line of sight to that, and we already know the embedded inflation dynamics that are all locked up. So we have a high degree of confidence in what's flowing through gross margin.
And then that operating margin, again, is you get natural leverage on top of that from the growth expansion in Q2, which we also feel good about. The momentum of Alaris is part of that kind of outsized back half growth. And we have a strong line of sight to that progression. So really with where we sit in the year, we're feeling good about that. Obviously, we continue to monitor the market dynamics that we touched on within the quarter. That's something that's -- we always have -- look for other levers and opportunities to deliver the full year, but that's probably the thing that we'll continue to watch.
Matthew Taylor:
Can I just ask...
Thomas Polen:
Sure, go ahead.
Matthew Taylor:
I just want to ask a follow-up. You mentioned in the presentation some enhancements to Alaris and Pyxis. So I was hoping you could just talk about the importance of those submissions.
Thomas Polen:
Yes, sure. Happy to, Matt. So on Alaris, and we'll only share a certain level of information on those at this time. We want to keep some of that surprise for customers in the market as we actually launch them. But on Alaris, we're really happy to be back at the innovation cadence. I think when we got the clearance, not only are we happy to be back servicing our customers and driving growth and getting after remediation, but we're happy to immediately jump back into innovation cadence. And you can see our team didn't hesitate in doing that.
So the next 510(k) submission on Alaris later this calendar year will include customer benefits, such as over-the-air is planned for that, for software upgrades; advanced cybersecurity features; as well as a number of other components as well as making sure we continue to keep that file updated as part of our compliance strategy. So that's -- really excited about those. And on Pyxis, there hasn't been a new Pyxis instrument. There's been software upgrades, but hasn't been a new Pyxis instrument, certainly since we've owned CareFusion, and I think it's been more than 15 years. And so the new Pyxis looks different. It's got -- so it's a new hardware platform that we'll be building off of. It significantly advances our cloud strategy and connectivity as well as continuing with advanced analytics as well as hardware features built into that. So it's a significant new platform that we'll be launching and investing in to continue to serially innovate upon over the next many, many years. But we're excited about the first launches of that plan for next year. I'd say -- just say the other thing is that we do continue to invest across our connected medication management portfolio, which is obviously highly unique in the industry. And it's one of those -- we get asked the question about connected care and how we think about it because it can often be used as a buzzword. Our approach to connected care has been we look at major health care processes, and we look at how we use data and connected solutions to then transform them and what we've done in Med Management, right, from software in the pharmacy for compounding and inventory management to Pyxis on the floor to Alaris and our health site platform, which brings that site line or visibility to all the data coming from all of our systems to improve processes. It's a great example of how we're doing that. Obviously, we talked about continuing to innovate Alaris, continuing to innovate on Pyxis, but we're also continuing to innovate on other elements of that. And we shared another good example of that earlier today. One of the upcoming launches, how we're taking now not only our Pyxis platform, but 2 of the acquisitions we made over the last couple of years, our MedBank platform, which is basically Pyxis for the non-acute, a benchtop unit and GSL. And we're putting that data now in through health sites so that people will be able to see end-to-end visibility of medications from Pyxis to MedBank to GSL, all integrated. So if you're an IDN, you're trying to manage across the care continuum as you've been acquiring assets there, right? BD is going to be a company that enables you to do that very uniquely as part of our strategy. So yes, thanks for the question, Matt.
Operator:
We'll go next to Matt Miksic with Barclays.
Matthew Miksic:
Yes, I was on mute. Sorry for that. So just one question, and it's kind of a high-level question, Chris and Tom. You talked about the sequential acceleration in growth, which is evident and the improvement in margins, which you had kind of laid out early in the year. I think when folks look at the results, we're seeing really strong margin growth and strength in the quarter. And what I just mentioned and what you described, sequential acceleration but sort of in an environment where volumes have been stronger across a bunch of med tech businesses. Maybe a touch closer to in line even after adjusting for FX.
And so I guess the good news and encouraging news around Alaris is great, some of the other business lines that you've talked about is great. Was there anything that's had a surprise on the downside, something that was -- remained challenging longer or anything you'd call out? And maybe how you see that playing out the rest of the year?
Thomas Polen:
Yes, I'll take that, Matt. So no, we feel good. It fits right in line with what we -- what I described before, which was you're seeing the diversity of our portfolio, which is a real strength for the company. Where again, those -- the Medical products, Intervention, Life Science businesses that are exposed to health care utilization, health care provider space, right, the vacutainers, the diagnostic systems products, et cetera, along with Intervention and all the Medical products used in that. They're benefiting from that strong utilization and our innovation pipeline that are enabling us to offset what our transitory broad dynamics in the -- that people are seeing in the life science research space and the B2B pharma systems with some destocking, particularly in vaccines and anti-coag.
So we feel really good about those businesses as well. As I said, we're seeing strong double-digit growth right around double-digit growth in biologics and Pharm Systems. We've got a great pipeline there with key launches later this year, turning over to customers, Libertas and Evolve, for them to start doing trials on. We see in our B2B space, we're still in a market that's going through a cycle that we certainly see some positive signs on with NIH funding, having higher visibility. Overall, we're seeing the FACSDiscover now -- platform. We just launched the 3 and 4 lasers. So that's adding access to a more cost-effective option for customers to get into that transformational technology. So we're excited by that. And we're still over delivering, I think, versus what you're seeing comps from others in some of those spaces. And so as those markets end up rebounding, again, which we see that forthcoming over time. We think we're really well positioned there as well, which is just going to help our overall growth. And again, in the meanwhile, that diversified portfolio strength is allowing us to do very well, both on revenue and clearly on a margin perspective.
Operator:
And that will conclude today's question-and-answer session. At this time, I'd like to turn the floor back over to Tom Polen for any additional or closing comments.
Thomas Polen:
Okay. Thank you, operator, and thank you, everyone, and thank you for your questions and interest in BD. We look forward to sharing our progress towards delivering our BD 2025 goals and increased outlook for FY '24 on our next call. Have a great rest of the day.
Operator:
Thank you. This does conclude this audio webcast. On behalf of BD, thank you for joining today. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to BD's First Fiscal Quarter 2024 Earnings Call. At the request of BD, today's call is being recorded and will be available for replay on BD's Investor Relations website investors.bd.com or by phone at 800-688-7339 for domestic calls and area code +1 402-220-1347 for international calls. For today's call, all parties have been placed on a listen-only mode until the question-and-answer session. I will now turn the call over to Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations.
Greg Rodetis:
Good morning, and welcome to BD's earnings call. I'm Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the first quarter of fiscal 2024. We also posted an earnings presentation that provides additional details on our business, strategy and performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's calls are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD 2025 strategy. Chris will then provide additional details on our Q1 financial performance and our updated guidance for fiscal 2024. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Mike Garrison, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Rick Byrd, President of the Interventional segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the Investor Relations website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically noted as a calendar period. I would also call your attention to the non-GAAP reconciliations included in the appendices of the press release and earnings presentation. With that, I’m very pleased to turn it over to Tom.
Tom Polen:
Thanks, Greg. Good morning, everyone, and thank you for joining us. Earlier today, we reported our results for the first quarter. Overall, we executed Q1 as expected. Total revenue growth was largely in line with our expectations. And on the bottom line, adjusted EPS was ahead of our expectations due to good execution on our margin goals through our BD Excellence operating system and the timing of discrete tax item. Also consistent with our plan, we delivered very strong growth in cash flow that positions us well to deliver another year of growing free cash flow double-digits. I want to thank our team of over 70,000 associates for the strong execution, agility and unrelenting determination to deliver for our customers, patients and shareholders. These results give us the confidence to increase our FY '24 guidance. Turning to our BD 2025 strategy. During Q1, we continued to execute well against the five actions we outlined at our Investor Day to drive profitable growth and value creation. This includes continuing to advance our innovation pipeline which supports our durable 5.5% plus targeted revenue growth profile. We remain focused on advancing innovation in high growth areas, anchored against three irreversible forces we see reshaping healthcare today and over the next decade, connected care, new care settings and chronic disease. Specifically in Q1, we made meaningful progress achieving several key R&D milestones for technologies that position BD as key enablers of care shift in new settings. In our PureWick portfolio, which is now the market's leading platform for non-invasive urine management in a billion dollar market growing double-digits. We started our randomized clinical trial pilots for PureWick Female to generate evidence to support future at-home reimbursement. Our PureWick program is progressing well and we remain on track to launch our next-generation Female External Catheter later this fiscal year, which will provide a better patient experience in a more dignified way for women to manage their urinary incontinence. In Q1, we received 510(k) clearance for our new BD MiniDraw Capillary Blood Collection System. Based on a recent study, two-thirds of patients prefer MiniDraw's finger-stick collection in a retail setting over a previous experience with the traditional Venous blood draw. Since it does not require a phlebotomist, MiniDraw can expand access to sample collection for several routine blood tests to new settings such as retail clinics and pharmacies. And lastly, in molecular diagnostics, we initiated clinical trial enrollment for the BD Elience Point-of-Care Molecular platform. In our first assay, a rapid CT/GC test for in-office testing and treatment. BD Elience enables BD to enter into the high growth molecular point-of-care market. We continue to see molecular diagnostics as a strong growth catalyst as evidenced by double-digit growth this quarter in our BD COR and BD MAX platforms where we continue to leverage our growing installed base through menu expansion with more than 20 assays currently available on BD MAX. Both NextGen PureWick and BD MiniDraw are on track to launch later this fiscal year and we anticipate our first 510(k) submission for the BD Elience system and our first assay this fiscal year as well. Regarding Alaris, servicing our customers and bringing all Alaris pumps in the field up to the cleared standard remains our priority. Customer response has been very positive with strong momentum, engaging with customers. And while it is still early in the process, I'm pleased with our progress and as we recently shared, we now believe $200 million as the floor on revenue in fiscal '24. We are also executing well on our broad simplification strategy to drive margin expansion and a double-digit base EPS CAGR through FY '25. This includes accelerating adoption of our BD Excellence Operating System, which focuses on the application of lean principles to drive excellence everywhere, every day across our plants and business and is driving productivity gains across our operations. In FY '23, we held 18 week-long Kaizen events. And in Q1 FY '24 alone, we executed as many, a trajectory, which will continue through the rest of FY '24. We've deployed this mindset outside of our factories, driving greater efficiency through the organization at all levels. Our BD Excellence Operating System is an important new capability we're building to drive a world-class culture of continuous improvement and lean management throughout BD. We also progressed our Project Recode initiatives including our network optimization effort to drive plant efficiencies. We have multiple site consolidations either completed or underway to reduce our footprint by approximately 20%. The combination of BD Excellence with our recode network architecture program is supporting our FY '24 goals, contributing to our plan for 25% operating margins in FY '25. And also, now providing visibility for continued margin expansion beyond FY '25. We're also seeing our systematic focus on cash flow continuing to yield results. Through working capital efficiencies and our BD Excellence Operating System, driving more efficient CapEx spend, we delivered over $850 million in operating cash flows in Q1. This strong execution to start the year positions us well to deliver double-digit growth in free cash flows in FY '24 and positions us to capitalize on M&A opportunities in higher growth categories and opportunistically return cash to shareholders. Lastly, our teams around the world continue to make meaningful advancements on our ESG strategy. Just last week, we announced a collaboration with the Kenyan government to advance access to critical cancer diagnostics for women in Kenya through self-sampling, furthering our commitment to expanding health equity and access around the world. We see the power of the cell sampling model is applicable across other underserved markets, as well as in the U.S. In summary, I'm pleased with the progress we made in Q1 and the solid margin execution, which enables us to raise guidance for fiscal 2024. With strong progress of our innovation pipeline and growing momentum from BD Excellence and our simplification programs, we believe we are well positioned to achieve our BD 2025 goals. With that, let me turn it over to Chris to review our financials, guidance and outlook.
Christopher DelOrefice:
Thanks, Tom, and good morning, everyone. As Tom noted, we executed well against our performance goals in Q1. Q1 revenue growth was largely as we expected and I'm pleased to share we exceeded both our margin and earnings goals and delivered strong cash flow that positions us well to support our double-digit free cash flow growth goal. I'll now provide some insight into our revenue performance in the quarter. Additional detail can be found in today’s earnings' announcement and presentation. Q1 revenue was $4.7 billion with organic growth of 2.4% that was driven by high-single digit organic growth in BD Interventional and solid growth in BD Medical with China market dynamics playing out as expected, partially offset by a decline in BD Life Sciences, which was impacted by the comparison to the prior year respiratory season. As expected, China and respiratory were the primary drivers of Q1 revenue growth under indexing our full year goal. The respiratory season alone impacted total company growth by about 150 basis points. Regionally, organic growth was driven by the U.S., EMEA and Latin America, partially offset by the expected decline in China. Total Q1 revenue growth of 1.6% reflects the divestiture of our surgical instruments platform. Turning to the segment performance. BD Medical revenue totaled $2.2 billion in the quarter, growing 2.4%, driven by growth and medication management solutions and pharmaceutical systems, min-single digit growth in MMS was led by strong performance in dispensing, driven by innovations in our BD Pyxis portfolio that are improving nursing workflows and efficiencies. In our infusion business, we are pleased with our strong progress, bringing the BD Alaris Infusion System back to the market and continue to expect Alaris to ramp over the course of the year. Infusion also reflects strong demand for IV sets. Performance in Pharmacy Automation reflects the comparison to an outsized quarter in the prior year and the timing of planned capital installations. Growth of 3.4% in Pharmaceutical Systems was in line with our expectations and was led by strong double-digit growth in pre-filled devices for biologics and as expected, was partially offset by customer inventory dynamics, including a slowdown in demand for anticoagulants. Growth in Medication Delivery Solutions was about flat and slightly ahead of our expectations. Our Vascular Access Management strategy continues to drive strong performance particularly in Catheter Solutions. As expected, MDS growth was impacted by market dynamics in China including volume based procurement, which continues to play out within our expectations. BD Life Sciences revenue of $1.3 billion declined 2.5% which reflects a decline in IDS as a result of a tough comparison in the respiratory season worth nearly 500 basis points. It was partially offset by strong growth in biosciences. Performance in IDS reflects the tough comparison in respiratory testing that was partially offset by high-single digit growth in our Microbiology platforms and double-digit growth in Molecular IVD assays on both our BD MAX and BD COR platforms. Biosciences grew 5.7% as expected despite a strong comparison in the prior year. BDB performance was driven by strong mid-single digit growth in our research and clinical platforms that reflects double-digit growth in research instruments, driven by strong demand for our recently launched BD FACSDiscover S8 Cell Sorter and double-digit growth in Clinical Reagents as we continue to leverage our growing installed base of FACSLyric and FACSDuet solutions. BD Interventional revenues totaled $1.2 billion in the quarter, growing 4.7% and 8.4% organic, which excludes the impact of the surgical instruments divestiture. BDI organic growth was led by surgery and UCC. In surgery, double-digit organic growth was led by continued market adoption of our leading Phasix resorbable hernia products in our advanced repair and reconstruction portfolio and strong demand for our ChloraPrep infection prevention solution. High-single digit growth in urology was led by strong double-digit growth in our PureWick chronic incontinence solutions with continued strong demand in both the acute care and home care settings. Mid-single digit growth in PI was in line with our expectations and reflects growth across the portfolio. It was partially offset by the expected timing of distributor orders. In our peripheral vascular disease platform, we continue to drive market penetration with our Rotarex Atherectomy System and our Venous portfolio. Performance in our oncology business was driven by growth in biopsy, including strong market acceptance of our recently launched BD Trek powered bone biopsy system. Now moving to our P&L. Adjusted gross margin of 51.1% and adjusted operating margin of 20.2% were ahead of our expectations due to good execution on our margin improvement goals across our portfolio of simplification initiatives and strong SSG&A expense leverage. R&D spend was in line with our expectations. In addition, as we previously shared a discrete tax item that was contemplated in our full-year tax rate was realized in Q1. As a result of these items, we exceeded our Q1 operating income and our adjusted diluted EPS expectations, resulting in an EPS of $2.68. Regarding our cash and capital allocation, Q1 cash flows from operations totaled over $850 million. This reflects continued improvements around working capital, including good management of inventory levels, continued discipline around CapEx investments and leveraging our fixed asset base as a result of the benefit from our simplification programs and BD Excellence Operating System. We remain focused on free cash flow conversion and expect another step improvement in FY '24. As we execute against our BD 2025 strategy, we also remain well positioned to achieve our long-term cash conversion target of around 90%. Beyond our investments in growth, we returned $775 million in capital to shareholders, including dividends and $500 million in share repurchases. We ended Q1 with a cash balance of $1.2 billion and a net leverage ratio of 2.7 times. Moving to our updated guidance for fiscal '24. For your convenience, the detailed assumptions underlying our guidance can also be found in our presentation. Based on our Q1 performance, including the strong momentum in many parts of our business and progression of our margin improvement initiatives, we raised the midpoint of our FY '24 organic revenue growth guidance, and raised our adjusted EPS guidance, increasing the midpoint by $0.09. The increase to adjusted EPS reflects Q1 operational outperformance and a small improvement in FX. As a result, we now expect to deliver organic revenue growth of 5.5% to 6.25%, which increases our midpoint to slightly above 5.8%. We now expect adjusted diluted EPS, including the impact of currency to be in a range of $12.82 to $13.06, which reflects about $12.94 at the midpoint. Regarding foreign currency based on current spot rates, for illustrative purposes, currency has improved modestly and for the full year is now estimated to be a headwind of approximately 25 basis points to total company revenues and approximately 360 basis points to adjusted EPS growth on a full year basis. As you think of phasing over the balance of fiscal '24, the following are some considerations. First, we continue to expect organic sales growth to be higher than our full year range in the second half, partially driven by the expected ramp in Alaris along with the easing of prior year comparisons, such as China. Second, our updated guidance reflects an improved margin cadence over the balance of the year. Specific to Q2, adjusted gross margin is in line with our prior expectation and continues to reflect significant sequential improvement given the lessening impacts from inflation, prior year inventory reductions and FX. We now expect Q2 adjusted operating margin to expand by 25 basis points to 50 basis points year-over-year, driven by our continued margin improvement efforts and continued leverage in SSG&A. Third, the discrete tax item realized in Q1 was largely a shift from Q2 and results and revised phasing of our full year effective tax rate. Based on this timing dynamic, we currently expect our Q2 tax rate to be nearly 17%. We expect strong operating performance to offset the tax phasing impact, and as a result, there are no changes to our expectations for Q2 adjusted earnings per share. Lastly, we remain confident in delivering about 50 basis points of adjusted operating margin improvement for the year. As a reminder, the first half inventory impact is transitory and behind us as we exit Q2. And as FX and inflation moderate at a meaningful rate to the back half, coupled with a continuation of the first half margin improvement, we expect to deliver from our strong simplification portfolio, we can naturally achieve our second half margin goals. In summary, based on the strength of our portfolio and new innovation, we have clear line of sight to deliver our FY '24 revenue guide which at the midpoint is above our 5.5% plus target and results in a three year CAGR of nearly 7% growth. I'm pleased with the continued strong execution by our talented organization to start the year, which supported over delivering on our margin and operating income goals and increasing our earnings outlook. With a strong quarter of cash flow, we remain well positioned to deliver another year of double-digit free cash flow growth, which increases our capacity to support additional value creating opportunities including M&A. We remain well positioned to continue to deliver against our BD 2025 strategy and financial targets. With that, let's start the Q&A session. Operator, can you assemble our queue?
Operator:
[Operator Instructions] Thank you. And our first question will come from Rick Wise with Stifel. Please go ahead. Your line is open.
Christopher DelOrefice:
Good morning, Rick.
Rick Wise:
Tom, hi, Chris. You used the word confidence repeatedly, and just picking up on that, heading into the quarter, we know you were very clear about things like currency and the peso divestitures, the flu benefit, if you will, time shift, but the setup and your new guidance clearly says that the rest of the year, we're going to see accelerating organic growth second half, I think your language in the slide, above full year guide. Help us, maybe you could talk in little more detail about the drivers of sales acceleration than the things that are most critical to creating that outlook that you're feeling confident about.
Tom Polen:
Yeah. Thanks for the question, Rick, and good to connect. So, as you said, Q1 played out as expected, total revenue growth was largely in line with our expectations, as you said, there were really two factors that we recognize we're going to be playing out in Q1. One was the flu compare given the large kind of early timing last year that was about 150 basis points that we knew was going to happen and then value-based procurement in China. And those two factors played out actually exactly as we expected in China, in fact that we were watching that and we saw VOBP stay focused within MDS which was just our assumption. We had really strong growth in BDI within the quarter, double-digit, mid-teen growth, high-single digit growth in life sciences and so we saw that play out. China actually did a little bit better than budgeted in Q1 and so we feel good that that's going to continue to play out for the year. I think, as we also think about the back part of the year to your question, something else we are looking at as we started and gave guidance to begin, '24 was, of course, Alaris. We were really pleased to have Alaris back with new improvements. Our new 510(k), it's a big deal to be back servicing our customers fully. It's a great product and highly unique and so, of course, Q1 was really the first quarter with Alaris relaunched and our team backed it proactively upgrading and remediating our base and we wanted to get feedback and engagement. And it's been quite positive, and I think that part also, as we look ahead, that confidence in those early engagements and the progress we're making is what's led us to also comment that we're seeing now $200 million as the floor for the year. In the other aspects, as you think about the growth drivers that we've been talking about and we often call out six specific platforms, we saw a really great growth in PureWick this quarter. Pharm systems, we have signaled very clearly the anticoagulant topic that was going to create a slower compare or slower growth in Q1. We're seeing the underlying business there do really well. Biologics grew double-digits in the quarter. Flow playing out, strong demand for FACSDiscover, Molecular double-digit growth as you heard in the prepared remarks, Peripheral Vascular and Pharmacy Automation, those trends in the marketplace continue with strong outlooks for those businesses. So again, we saw very clearly the two factors that we knew were going to impact us in Q1 and they played out as expected. Chris, any other comments to add.
Christopher DelOrefice:
I mean, just, sometimes, it's easier just play bigger picture right. I'm sure you're looking at our balance to go plans which we are very confident into Tom's point. We've expressed confidence in Alaris and establishing a floor now. I think the Alaris dynamics important. If you look at the balance to go, it's about 7% revenue growth. Last two years, we delivered right around 7%. This year, actually, if you think about it, Alaris is going to cycle over medical necessity. It's not a significant contributor to growth in the first half despite seeing very strong progress, but what that does is it adds about a point to growth more in the second half, right? So, we see really good momentum there. So when you think of sort of Alaris adjusted, you're at six and we cycle over the China compare in Q4, which have declined as well. So, I think plans are intact, the strong underlying fundamentals in kind of these six key areas we keep pointing to, like, Tom mentioned in biologics are well positioned and feel good about the rest of the year.
Tom Polen:
Thanks for the question, Rick.
Rick Wise:
Yeah. And just as a follow-up, I'd ask about the EPS guide, the $0.07, Chris, I think, I'm calculating correctly, you beat operationally EPS. You've raised $0.09 at the midpoint for the full year. Talk about your confidence in that driving that midpoint EPS raise. Again, how margins are -- in more detail, are going to, or mix or volume are going to help you get to those EPS targets? Thank you.
Christopher DelOrefice:
Yeah. Thanks, Rick. Yeah. We were definitely pleased with the margin progression and operating income delivery Q1 and it was strong and exceeded expectations. We basically passed that through to your point. The other thing we did is we actually accelerated margin improvement in Q2 by about 25 basis points to 50 basis points, so de-risks the back half of the year. We did that on a couple of things. Whenever you start the year, you want to ask -- you want to see a couple of things. One, to recall some of these transitory headwinds like China. We knew we had a transitory item in inventory that hit us in the first quarter that was 200 basis points. We have outsized FX in the quarter. All those played out as expected and we have stronger delivery on calling inflation dynamics and more importantly, our margin improvement program. So, we continue to accelerate those. We've had two years now of consistent track record of delivering against our margin expectations, back to pre-pandemic levels 400 basis points over two years. If you look at our margin progression throughout the year, basically, with these transitory items behind you, the level of cost improvement we delivered in Q1 alone with moderating outsized inflation through the back half of the year. It goes from nearly -- in Q1, we said it was almost 2x what we're calling for the full year and outsized inflation 100 basis points. It cuts in half in Q2 and then moderates in the back half. So, we just have to keep executing against our margin improvement portfolio, which is really strong. And that's what gave us confidence with the Q1 performance and our ongoing programs to raise for the year and we're focused on executing against that.
Rick Wise:
Thanks, Chris.
Operator:
We'll take our next question from Travis Steed with Bank of America. Please go ahead. Your line is open.
Travis Steed:
Hi. Thanks for taking my question. I'll take the first question on revenue. Just curious if there's anything to call out in some of non-flu areas, pharm systems MMS. If you think kind of growth outlook, they are still on track with your expectations, and the decision to raise the revenue guidance. Just curious, what's giving you the confidence at this stage to go ahead and raise that revenue guidance at this point.
Tom Polen:
Yeah, Travis. This is Tom. Thanks for the question. Good morning. So, on pharm systems specifically, again, as I mentioned, we saw that play out as expected with the impact of the one customer that we mentioned in anticoagulants and strong underlying growth beyond that, again, double-digit growth in biologics. Our capacity continues to -- those investments that we made continue to play out as expected. We have capacity to meet customer needs, and we're engaged very actively in that space. And as we think about the slight raise on revenue, again, we feel really Alaris the floor of 200, as we see now for the year based on, again, early engagement with customers. We thought that was prudent to do given our outlook in that space. I don't know, Mike, if you have any other comments to add.
Michael Garrison:
Just also commented in addition to the double-digit demand in biologics, we've been pretty successful in terms of entering, the development agreements for future pipeline of molecules in this space, our innovation portfolio around Hypak and Neopak, and also the wearables portfolio with Libertas and above that continues to progress really well and additional developments -- development agreement in this area are occurring. We've described the pharm systems business is a high-single digit grower, going back to Investor Day and we continue to see that in '24. It's our expectation, despite any early part of the year headwinds.
Travis Steed:
Great. And last question, Chris, just on margin in Q1 was a nice kind of core outperformance on margins in Q1, especially without the revenue upside. Just curious kind of go through what got better in Q1 on the margin side and confidence, and what gets better if you think about that 300 basis point step-up in margins from Q1 to Q2, just to give some confidence that that 300 basis point step-up sequentially is achievable?
Christopher DelOrefice:
Yeah. Thanks, Travis. So, first of all, in the quarter, it wasn't one thing. I'd just say execution is kind of the theme here, organization is hyper focused consistent with what we've done is predominantly our cost improvement programs. We had some mix benefit as well which has been part of our strategy on portfolio as well. So, all of that, I would say, the headwinds kind of played out as expected and we over delivered through good focus, execution on our margin improvement initiatives. To your point, the Q1 step-up, the step-up from Q1 to Q2 about 300 basis points that we've signaled. If you think of it this way, again, we had two, what I would call, pretty transitory items in Q1. We have the outsized FX, coupled with the inventory reduction in absorption dynamic. Those two items alone as you head into Q2 are about 30%, so as we're 400 basis points. They're only about 30% of that value in Q2. So, you pick up momentum there, coupled with the fact that the outsized inflation, which was almost 2x, what we call, for the year in Q1. It starts moderating significantly almost in half in Q2 and then it further moderates by the back half of the year. So really, it's just cycling over those kind of one-time items, outsized inflation moderating back and us continuing to deliver what we already delivered in Q1. So, we're confident that that progression continues. With that, you naturally get the sequential step-up that we're driving towards. And again, feel good about our operating margin, which is why we improved our phasing increased Q2 and feel good about the line of sight we have to the back half of the year.
Travis Steed:
Super helpful. Thanks, Chris
Operator:
We'll take our next question from Vijay Kumar with Evercore ISI. Please go ahead. Your line is open.
Vijay Kumar:
Good morning, Tom, and thanks for taking my question. My first one, Tom, if I just look at Q1 organic 2.4 right? A lot of questions on, look utilization is strong. Why is this optically 2.4 well below medtech sort of trends we've seen so-far. Can you help us bridge? I think you mentioned 150 basis points of respiratory, does that include COVID? I think you mentioned China. What was the China impact in Q1? I think you mentioned some timing elements, customer orders. What was that impact? And Alaris, it looks like it was not a contributor to growth, so maybe just help us draw bridge between the 2.4 and what it should have been without some of these underlying one-time items?
Tom Polen:
Yeah. Great question, Vijay. Maybe just those two items that we've referenced, from the start of our guide, flu and China. Those two combined, if you take those out, it's about 5% underlying growth, just excluding those two items. So, those are quite significant. If you look at procedure volumes, etc., you're seeing that flow through in the base business where those two items aren't, so as an example, if you look in Interventional, you'll see that very strong growth in surgery, right, double-digit growth, which is getting the benefit of procedure volume. We're seeing in UCC, 9% growth there as an example, solid in PI, a little bit of inventory timing there, but we're seeing those factors play out. Again I’d concentrate on those two topics, which again played out as we expected. The large flu compare just given the early timing last year in China, underlying was about five. Chris, do you have any comment?
Christopher DelOrefice:
No. Just I mean on Alaris, Alaris played out as expected actually. Again, what we've highlighted is, it was going to be a journey as you think of the natural progression of engaging with customers and the natural kind of life cycle of then placement, revenue recognition, etc. We're actually very pleased with our progress there. And as a matter of fact, right, we declared the $200 million more of a floor that was part of what gave us confidence to increase the low end of the revenue guide. And so we're continuing to focus on executing there and that was as expected on the flip side, what it does is, in the back half of the year, gives you almost basically a full point of growth tailwind that will help, which so, when you look at the back half, think of that or kind of moderate the expectation that you're seeing around feeling like that growth is outsized versus the front half of the year. It's as expected with the ramp we were expecting on Alaris.
Tom Polen:
Yeah. I will turn it to Mike here. I think it's -- obviously, this is the first quarter that we've relaunched Alaris. And so the focus is first on engaging customers, getting agreements in place for remediation and upgrades. And that those are the key metrics that we look at in the first quarter of launch because that's what's indicating how the revenue is going to evolve in the back half of the year and that's what we, right, are feeling good about.
Michael Garrison:
That's right. And just to remind that last year, we had the Certificate of Medical Necessity, how we were shipping, we're not doing that now. So, it becomes more like a step over to get to there, and then growth on top of that, so that's what we're seeing in first quarter. So, it's actually, starting from ground zero in terms of selling process and ramping it up. I actually feel really good about that. I feel really pleased with the way our manufacturing ramp-up has gone and that scale-up is going quite well. So, we're able to supply product to our customers. I think the customer response, yeah, they're recognizing that, Alaris is almost like a different system. It's a different category in a way it's, the power of one with all the infusion modalities as a single system, the most advanced interoperability in the category, 750 live sites, order of magnitude more than anyone else. Yeah, so, it's almost being recognized a little differently that way, so that's good. And we have sort of exceeded, we set certain expectations, we've exceeded those relative to return to market in terms of upgrading the fleet in the field. So, it's early, but I think the way things have progressed, that's what -- those are the sort of the elements that led us to build confidence to say that we think 200 is the floor.
Vijay Kumar:
That's helpful. And Chris, maybe one quick one for you. The margins still imply a 300 basis point step-up in back half versus your 2Q levels. Can you just talk -- I think inflation was part of it, but just maybe a similar bridge on margins from the '23 to '26 and back half?
Christopher DelOrefice:
Yeah. Again, it's basically a continuation of Q2 when you move out of Q2, both FX, the inventory dynamic goes completely away, which is almost 75 basis points still in Q2, so right off the bat, you pick that up as you move through Q2. That's probably the biggest item FX continues to moderate. We have reasonable signals on FX, obviously can continue to move, but that moderates down. The other thing is outsized inflation moves from about 100 basis points, which is our full year average in Q2 that further moderates down significantly. And then again, if you just continue the cost improvement and margin improvement initiatives, we already executed in Q1 throughout the year, it gets you to where we need to be from a margin standpoint.
Vijay Kumar:
Fantastic. Thanks, guys.
Christopher DelOrefice:
Thanks, Vijay for the question.
Operator:
We'll take our next question from Larry Biegelsen with Wells Fargo. Please go ahead. Your line is open.
Lawrence Biegelsen:
Good morning. Thanks, for taking the question. Mike, why would medical growth in fiscal '24 be in line with the corporate average given the tailwinds in MMS and pharm systems, you just said you expect pharm systems to grow high-single digits in 2024, so what are the expectations for MMS and MDS this year. Last year, Medical was 90%, was above the corporate average.
Michael Garrison:
Yeah. So for -- I'll talk first about, MDS. The business is actually showing really good momentum underlying which is masked a little bit by the impact of VOBP in China. So, that VOBP is a headwind for the year. Yeah. It's playing out as we expected, and built into our plan, but we're seeing strong momentum in the U.S., strong momentum, in catheters, and somewhat, driven by some of the new recent product launches that we've had. Site-Rite 9, Nexiva, NearPort, PIVO Pro, yeah these advancements are working out in the field and being very attractive to customers as we advance the One-Stick Hospital Stay vision. We're also watching injection systems and hypodermic. We're aware of some of the recent recalls, agency action in this area and we've ramped our capacity prepared to serve if market needs arise in the U.S. So, that's sort of, MDS. From MMS perspective, the way that I'm sort of seeing it and thinking about it as infusion sort of returning to be a contributor to growth versus maybe flat to a drag with return of Alaris. And then also, we're really excited for, very soon, our upcoming market release of the ex-U.S. infusion system BD neXus. Our dispensing business continues to perform very well. It's got solid growth both in the quarter, in hospital and alternate site. Our MedBank acquisition grew double-digits in the quarter, and continues to expand our presence in non-acute settings. So, I feel good about that. Pharmacy automation that proposition continues to resonate really well for both ROWA and Parata. As we noted previously and in the presentation, this quarter, last year was actually Parata's strong Q4 finish for their fiscal year. So, created a bit of a tough compare. This was expected and our timing ramp of installs is weighted more towards the back half. So, those are sort of the things that, give me confidence around, MDS and MMS.
Lawrence Biegelsen:
That’s helpful. And Tom, China was down 5% in this quarter in Q1. Talk about what you're seeing there and you're confidence. I think in the past, you said you expect China to be flat to up low-single digits this year. Thanks for taking the question.
Tom Polen:
Yeah. Thanks, Larry. That expectation remains unchanged. China played out essentially exactly as we expected in the quarter was a little bit favorable to budget. What we saw and what we expected was VOBP, as Mike described, specifically within MDS which is where it's remained, we didn't see it expand to other areas at all. We're not seeing that it's -- our view is as we had projected. And we also expected to see strong growth in BDI which we've had over the last several years. We saw that play out in the quarter, mid-teens growth in BDI in Q1 and we saw solid growth, high -- very high single-digits on the cusp of double-digit growth in Life Sciences in China. And so that base business in China is continuing to do well. We'll -- we saw VOBP start in the back half of last year. And so again, that's going to become a tailwind for us as we think about compare in China as we go over that, so. Thanks for the question.
Lawrence Biegelsen:
Thank you.
Christopher DelOrefice:
Thank you.
Operator:
We'll take our next question from Robbie Marcus with J.P. Morgan. Please go ahead. Your line is open.
Robbie Marcus:
Great. Thanks for taking the question. I wanted to ask, I know we're in fiscal '24 here, but wanted to look out to '25, and based on operating margin guidance, it implies about 100 basis points expansion next year to get to your long range plan target. So, I'm sure the answer is pretty similar to the '24, but how do we think about the implied about 100 basis points next year and your confidence in that?
Christopher DelOrefice:
Yeah, Robbie. Thanks for the question. Actually, at J.P. Morgan, as you know, we outlined a strong plan outlining all of our margin improvement initiatives. I think gross margin is the next stage of accelerated focus for us and we already have a great pipeline of margin improvement initiatives there through Project Recode, right? We actually already completed our 20% goal SKU rationalization. We're actually going to go further there. The network architecture, Tom, highlighted in our prepared remarks the strong progress there with initiatives underway that reduced our network by 20%. As a matter of fact next year, the network architecture value we get out of that actually doubles going into '25, you're going to really start seeing the benefits of that. BD excellence is another one. We're getting great traction this year. It's part of the momentum we have in this year on margin that will continue into next year. You also have the Alaris dynamic. As that fully ramps up and scales, we'll get margin leverage there. So, all those things coupled with the continued strong growth profile of being able to consistently do 55 plus which we've been well above gives us strong confidence in 2025 and the 100 basis points, as a matter of fact, as we exit this year. Doing everything we did, we really should be well positioned to carry that kind of momentum into next year. It's premature to kind of make a formal commitment and manage all the puts and takes but certainly high confidence in the '25 and great momentum there.
Tom Polen:
And maybe, Robbie and good morning. Just to add to Chris's good comments, I think another way just to think about it is, as we've launched BD 2025 in '22, it was a four-year road-map ahead, right? And so, the end of '24 will be 75% of the way through BD 2025. As you think about the margin number that we've set out as our guide for FY '24, that's 80% of the way through our margin goal, right? So from a timing perspective, 75% of the way through BD 2025, 80% of our margin goal, we are clearly on track, slightly ahead. And we're seeing really good momentum in our programs as evidenced this quarter. I think you've heard us talk about BD excellence. Obviously, as we started BD 2025, our focus was let's get Alaris back. Number one, take those learnings, apply them across the company to make sure we're building capabilities. Second was optimize our portfolio for growth spinning back up. Obviously, we sold the V. Mueller. We drove tuck-in M&A that's driving accretive growth, we rebalanced our R&D into high-growth spaces. And we've built our portfolio simplification programs starting with Recode which are on track and you're seeing those play out. Along the way and starting last year, we began to develop capabilities for BD Excellence, right? And it's our operating model -- operating system to drive a whole new scale of lean capabilities across the company. And last year, we had thousands of associates across the company engaged in BD Excellence. This year, we're really pressing the pedal on that program now as we've made progress on those first three areas that I mentioned. And so, as we said in the prepared remarks, if you think about the Kaizens that we did all of last year through BD Excellence, we did just as many in Q1 of this year just completed and that's going to continue to scale as we go through the year. And so, we see really good momentum there. It's giving us visibility not only on our '25 margin goal, those we also indicated, it's giving us visibility beyond '25 to continue, margin progression as we look ahead. So, thanks for the question, Robbie.
Robbie Marcus:
Great. Really helpful. Just a quick follow-up. China VBP is a headwind you've talked about. How do we think about where that's hitting each of the business units and the size, just so we can, kind of try and back out that headwind in our models? Thanks.
Tom Polen:
Hey, Robbie. It's almost all within MDS specifically. Essentially, it is all within MDS. That's where we see it, so.
Robbie Marcus:
Great. Thank you.
Tom Polen:
Thanks.
Operator:
We'll take our next question from Patrick Wood with Morgan Stanley. Please go ahead. Your line is open.
Patrick Wood:
Amazing. Thank you. Two quick ones. I guess the first is Pharmacy Automation completely get the timing of year end and that side of things, but just curious, how you think things on orders, whether it's like order mix and kind of the outlook for the rest of the year based on, what you're hearing from the customers right now from the order book?
Michael Garrison:
Yeah. I'll take that. So for pharmacy automation, yeah, we feel really good on that, like I mentioned, the tough compare because, they were incentivized Parata and the team there was incentivized to finish their Q4 strong. So, they had already lined up installations last year for their finishing. They had a record for them quarter last year. So, it's a little bit of a tough compare. Order book looks good, especially in the sort of Retail Long-Term Care channels. Yeah. And we continue to leverage our BD Salesforce to talk to our acute-care customers about starting to transform the pharmacy in the acute care with our IDN customers. So, we see that continuing to grow throughout the year. Overall, it's been -- yeah, we've described it as sort of a low double-digit grower, and that's sort of what we have projected and expected for the rest of the year.
Patrick Wood:
Brilliant. And then maybe quickly one either you, Tom or Dave. Elience, Molecular Point-of-Care is obviously a very fast growing but very competitive market. Just curious, how you're seeing that product fit in, the interplay between like high and low plex? Just curious, how you're going to fit into that market? Thanks.
Tom Polen:
I turn that to Dave. Thanks for the question, Patrick.
Dave Hickey:
Thanks, Patrick and for picking up on Elience. Just take a step back. If you look at the molecular dynamics overall, we have said that this is one of the sort of six growth drivers for BD, right? So, we continue and if you look at the divergence of the market, there is real thesis playing out in terms of the way customer evolution will happen, right? So you think about the centralization of high-volume molecular cervical cancer testing, we satisfy that with BD COR. You think about BD MAX in the acute setting, and we're seeing good, as you heard Tom say in the prepared remarks, good double-digit growth there. But clearly, there is decentralization of relevant testing to the point-of-care and these new care settings. And obviously, Elience will be our entry there in this sort of high, you know, single-digit market. If I think about it specifically on Elience, the way to think about it is, what is different about it? Our goal here will be that we would anticipate it to be CLIA-waived giving critical results, within less than 15 minutes but can be used in a wide variety of settings. What is the unmet need that it will actually address and deliberately, we've actually selected CT/GC as our first assay because when you look at all the CDC and NIH reports, there is an increasing burden of STI. So, it will increase access to testing. And I think about it now, if you're one of those unfortunate patients and you're in the clinic, you could get that result diagnosed and a potential treatment administered while you're in a clinic in a decentralized setting. So, deliberately, we think CT/GC is really the right assay to lead with. And then, of course, because of the capabilities and these less than 15 minute results, we see a strong roadmap behind it, you know, focused on respiratory assays, other STI assays, vaginitis, etc.
Tom Polen:
Yeah. That testing treat concept with 15 minutes or less time to [Multiple Speakers] core component.
Patrick Wood:
Love it. Thank you.
Tom Polen:
Thank you.
Operator:
We'll take our next question from Patrick Miksic (ph) with Barclays. Please go ahead. Your line is open.
Tom Polen:
Good morning, Patrick. Sorry, Matthew.
Matthew Miksic:
This is Matt. It's okay. Just a couple of follow-ups on some of the factors that, play through Q1, you talked about last quarter and I have one follow-up. One was, obviously, a lot of detail and questions that came after around the peso and around wages. If you could just sort of -- you know, It sounds like you're most of the way through that and during Q2 and just maybe a quick update on that. And then the anti-coagulation business in China. I think there was something that you were hoping was going to find -- that capacity would find a new home, perhaps in this quarter or next quarter and an update on that. And then just one follow-up if I could.
Christopher DelOrefice:
Yeah. It's Chris. Thanks, Matt, for the question. Appreciate it. Yeah, when we started the year, we talked about kind of the inflationary dynamics and supply-chain. One of the biggest ones that we were still seeing play out through the year was wage dynamics in our supply-chain organization, that continues but it's playing out as expected. So, nothing new there. Regarding FX, good news is moderately favorable. We passed through both the revenue and earnings on that. So, stable at this point and moving in the right direction. We'll continue to watch it, and I think we're happy with the operational performance in passing through both the $0.07 operational beat and the $0.02 of FX.
Matthew Miksic:
And maybe Mike for pharm systems.
Michael Garrison:
Yeah. For pharm systems, that the capacity that's freed up for anti-coagulants, there is, some of it where the teams are, hunting for home for that. And there's been some success there, but I think we also just took a strategic decision to look at the anticoagulant market overall and it returning to more of a post-COVID normalization there and our converting lines over to biologics to help accelerate our ability to have capacity to serve in that area and that's playing out pretty well. So, we've been able to -- there has been some increased demand that's come in for biologics that, we'll be able to recognize later in the year and then, we'll be able to serve that, in part because of these line conversions. So, it's been a little bit of both relative to that anticoagulant dynamic.
Tom Polen:
Thanks for the question, Matt.
Matthew Miksic:
That's super helpful. You bet. And just one follow-up if I could on cash flows and sort of M&A and I remember last quarter, Chris, you emphasized a bunch of times, and part of that impact was, bringing up excess inventory having an impact on margins, you threw that you made nice progress on leverage. Could you talk a little bit about, what that looks like for the rest of the year, drove M&A outlook and the kinds of things, maybe the size of things that you might be -- we might expect in the next, six, 12, 18 months. Thanks.
Christopher DelOrefice:
Yeah. Thanks for the question, Matt. I appreciate you recognize. We've definitely been extremely focused on cash flow performance. I was really pleased with the quarter. There was really strong cash flow, strong double-digits, gives us confidence for the year. It played out in all the areas we've been trying to leverage. One, we're getting more efficient with our CapEx expenditures. Part of this is from a simplification efforts on BD Excellence that we're driving through our plans. In addition, you saw improvement in inventory and you saw improvement in our collection cycle as well. So, all really positive things. We sit basically at our net leverage target and so we're well positioned and consistently will remain disciplined as you think of M&A, but as you can imagine, we always have an active portfolio of things that we look at. We're going to remain disciplined. It's been a nice contributor organically to growth last year, delivered nearly 40 basis points. So, certainly something that we're going to continue to focus on as part of our growth strategy and more to come on that. Tom, I don't know if you want to add?
Tom Polen:
Extremely well said. Remains an active part of our growth strategy and I think as we've shared in the past, we've been focused on accretive growth, accretive margin acquisitions, which has been our track record and we've executed well against those over the last several years. I think we've clearly built a good track record of that. And so, we've got a strong healthy M&A, you know, active pipeline focused again in strategic areas where the market has significant structural or macro tailwinds to drive sustainable growth and where we can bring meaningful additional value either through our channel or global footprint, our manufacturing prowess. And again, we remain very disciplined on strong returns accretive growth. We haven't been doing dilutive deals that remains, right? Our emphasis is we're focused on delivering on our 25% operating margin goals. And but we're going to continue to focus on that and we have a strong pipeline. Thanks for the question.
Operator:
And this time, I'll return the call to Tom for any closing comments.
Tom Polen:
Thank you all for joining our call. As you heard, we had good momentum to start the year and we look forward to sharing our progress towards delivering our BD 2025 goals and increased outlook for FY '24 on our next call in May. Thank you very much and have a great rest of the day.
Operator:
Thank you. This does conclude today's program. On behalf of BD, thank you for joining today. Please disconnect your line at this time and have a wonderful day.
Operator:
Hello, and welcome to BD's Fourth Quarter and Full Year Fiscal 2023 Earnings Call. At the request of BD, today's call is being recorded and will be available for replay on BD's Investor Relations website, investors.bd.com or by phone at (800) 688-7339 for domestic and area code 1-40220-1347 for International. For today's call, all parties have been placed in a listen-only mode until the question-and-answer session. I will now turn the call over to Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations.
Greg Rodetis:
Good morning, and welcome to BD's earnings call. I'm Greg Rodetis, Senior Vice President, Treasurer and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the fourth quarter and full year of fiscal 2023. We also posted an earnings presentation that provides additional details on our business, strategy and performance. The press release and presentation can be accessed on the IR website at investors.bt.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Crystal DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD 2025 strategy. Chris will then provide additional details on our Q4 and FY '23 financial performance and our guidance for fiscal 2024. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Mike Garrison, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Rick Byrd, President of the Interventional segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the Investor Relations website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis, unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically noted as a calendar period. I would also call your attention to the basis of presentation slide, which defines terms such as base revenues and the non-GAAP reconciliations included in the appendix. With that, I am very pleased to turn it over to Tom.
Tom Polen:
Thanks, Greg. Good morning, everyone, and thank you for joining us. Earlier today, we reported our results for the fourth quarter and full year of FY '23, a year characterized by strong differentiated performance driven by our BD 2025 strategy in action, impactful new innovations and our diversified business portfolio designed to help our customers navigate today's challenging environment. The diversification of our portfolio offers both durability through our leading positions and consistent demand for products essential to everyday patient care and strong growth through a purposeful shift into higher growth markets, anchored against three irreversible forces we see shaping health care, connected care, new care settings and chronic disease. Additionally, we have built capabilities and fostered a culture of operational excellence, where we make disciplined and strategic capital allocation choices, proactively address macro headwinds through our simplification programs and execute with speed and agility, all of which have and continue to play a key role in delivering strong consistent performance. This unique profile can be seen in both our current and 2-year performance and where our purposeful shift into higher growth markets has enabled us to drive the plus side of our targeted 5.5% plus revenue growth profile. In FY '23, we delivered 7% base revenue growth with base organic growth of 5.8%. Our team drove significant margin expansion and delivered $12.21 in adjusted EPS, which represents double-digit currency-neutral growth of 11%. Over the past 2 years, we have made excellent progress toward our BD 2025 financial targets, delivering a 7% base organic revenue CAGR and 390 basis points of operating margin expansion. We are now over 70% of the wave 2 and tracking ahead of our 25% adjusted operating margin target by FY '25. As a result, on the bottom line, we delivered an implied base EPS CAGR of 20% currency neutral. We also ended FY '23 with strong execution of our strategic priorities. First, we delivered our number one priority, obtaining FDA clearance for the updated BD Alaris [ph] infusion system. Post clearance, our priority remains remediation, scaling up manufacturing and engaging with customers on the many benefits of the updated system that include advanced cybersecurity, wireless connectivity and other clinical and patient safety upgrades. We are confident in our remediation plan and have begun the process, prioritizing our existing customers. We are making good progress with active contracting and shipments of our first units to customers taking place ahead of schedule at the end of September. We are excited to deliver the benefits of the updated Alaris system to our customers and their patients, including the power of one integrated infusion platform with a centralized user interface for all major types of infusion as well as the value added through interoperability and other innovations that connect data from Alaris, Pyxis and the rest of our medication management offering into the industry's only end-to-end solution for safer, simpler and smarter medication management from the pharmacy to the floor, to the bedside. The clearance of the BD Alaris infusion system gives us further confidence in our ability to achieve our BD 2025 strategy and financial targets. Second, we significantly advanced our innovation pipeline, launching 27 key new products that benefit researchers, providers and patients, integrating AI, robotics and other advanced technologies. Our products are helping researchers gain deeper insights faster, like our fax Discover S8 cell sorter with CellView image technology and facts to at premium sample preparation system, which apply novel technologies like high-speed cell imaging and liquid handling robotics and our BD Horizon real yellow and real blue reagents, which were developed using AI guidance. Our pharmacy automation business continues to grow double digits and it's helping our customers serve patients more efficiently and with fewer errors across various care settings. Our robotic microbiology platform, BD Kiestra, hit record sales this year, and we continue to drive strong double-digit growth in our BD COR and BD MAX molecular platforms, leveraging our growing installed base through menu expansion that includes our new Vaginal Panel and our Onclarity HPV assay for thin prep on BD core and now greater than 20 assays on BD MAX. We continue to enable the care shift in new settings, including at home, through innovations such as our PureWick system franchise for urinary incontinence that we expanded to include solutions for male patients. PureWick Mail has been one of the fastest ramps of a new product in our history and continues to exceed our expectations. Given the strong adoption, we have now designated this as a greater than $50 million incremental growth opportunity. Pharmaceutical Systems, which achieved 13 consecutive quarters of double-digit growth, continues to empower the delivery of new biologics, many administered by patients at home, such as the growing drug class of GLP-1s for diabetes and weight loss and other molecules, which will be delivered through our self-injection solutions. We are playing an increasing role in addressing chronic diseases like peripheral arterial disease and improving outcomes in tissue reconstruction. This year, we expanded the impact of new products such as our Rotarex Atherectomy system, Venous Stent System and then close RF ablation catheter, helping to address an area of high unmet need for the 10 million patients each year who are suffering from venous disease. In surgery, our teams accelerated the growth of Phasix Mesh to allow more patients to benefit from tissue repair performed with our resorbable synthetic biomaterial. And of course, we continue to drive a relentless focus on improving clinician and patient satisfaction with PIVO Pro and BD Nexiva with near Port IV access, a core element of our OneStick hospital stay vision that enables needleless blood draws, which is a major satisfaction for patients. And BD Pyxis ES 1.7.4, which now fully integrates our C2 Safe system into the Pyxis ES platform, enabling security and automated controlled substance management for pharmacists. I'm really pleased with how our R&D team executed in FY '23, again reaching a new record level of on-time milestones and launches. Our enhanced focus on programs with the potential to move the needle in terms of growth has positioned us well to drive our WAMGR expansion. We are on track to both achieve our target of over 100 new product launches by FY '25 and our new product revenue contribution target as outlined at Investor Day, creating a new wave of margin accretive growth for BD. Third, in addition to our investments in R&D, our tuck-in M&A strategy has been very impactful, targeted in higher-growth markets, M&A is complementing the plus side of our 5.5% plus growth profile and also contributing to growth on an organic basis as we anniversary those assets. This includes our acquisition of Parata Systems, which is part of our pharmacy automation business that is growing double digits. At nearly $700 million in revenue, BD Pharmacy Automation is one of the largest robotics and health care process automation businesses in med tech, focused on improving pharmacy labor efficiency and reducing errors. There's never been a greater need for these solutions. Fourth, we continued our simplification initiatives in FY '23 and actively managed our portfolio, divesting our surgical instrumentation business and executing a program of strategic portfolio exits, allowing us to continue to reallocate our resources into more strategic, higher growth areas and further reduce complexity across our company. We also progressed our project Reco network [ph] and SKU rationalization programs, exiting more than 2,300 incremental SKUs in FY '23 and are pleased that we have now streamlined our portfolio by 20% compared to 2019, achieving our goal laid out at Investor Day 2 years early. We are seeing the benefits in our manufacturing plants and in our simplified portfolio with customers. We will continue to advance this initiative as we keep executing BD 2025. In addition, we initiated our operating model simplification initiative to reduce our organizational complexity and increase agility. As a result, we were able to absorb continued outsized inflation during the year as planned and advanced operating margins towards our 25% target. And lastly, we strengthened our balance sheet, inclusive of executing on our planned inventory reductions and maintaining a disciplined and balanced capital deployment framework. This allows us to support organic and inorganic investments in growth while returning capital to shareholders. We just announced our 52nd consecutive year of dividend increases, continuing our long-standing recognition as a member of the S&P 500 Dividend Aristocrats Index, a distinction that reflects the consistency and reliability of our dividend policy. Lastly, I'm also very pleased with how we've advanced our ESG strategy and goals. In July, we published our 2022 ESG report, which provides details about our strategy and progress against our 2030 plus commitments. Highlights include progress in health equity and diversity as well as improving our environmental footprint, which included a reduction of Scope 1 and 2 greenhouse gas emissions by 10% and having generated 34% of our electric power from renewable energy. In FY '23, we submitted our GHG emission reduction targets to the science-based target initiative for verification. I'm quite excited by our innovative circular economy pilots we did this past year. They were the first of their kind in our industry. Recycling medical waste like use syringes and vacutainers and converting these materials back into usable resins. We'll be advancing this work further in FY '24 as we continue to tackle end-of-life GHG emissions and seek to lead circular economy innovation within our industry. We also continue to pioneer products and solutions that address health and equities, like our efforts to detect HPV infections and diagnose cervical cancer through at-home sample collection. We're proud that our progress continues to be recognized externally with BD most recently named among the 100 Best Corporate Citizens by 3BL and among the top 2 in the health care equipment and services industry. Before I turn it over to Chris, I'd like to provide some perspective on the macro environment and BD2025 as we look forward to FY '24. Starting with the macro environment. The complexity facing all companies will likely persist and in some cases, is accelerating. With China responding to economic pressures and elevated levels of geopolitical uncertainty occurring in multiple markets. Inflation has moderated from the peak high levels overall, but remains elevated compared to prepandemic norms, including higher labor rates in transportation and manufacturing, higher cost of energy and certain raw materials. While there continues to be a heightened degree of macro uncertainty as we head into FY '24, consistent with what we have done in the past several years, we have positioned BD to deliver strong performance through this environment. As we move forward, you can expect to see continued execution of VD2025 with a focus on the bold actions that position BD strategically for the future. These include continuing to advance our strong organic portfolio of programs in higher-growth spaces that are transforming health care. This includes launching another 25 key new products, including our Phase 6 ST umbilical product that will provide patients a reliable alternative to permanent mesh, bringing the benefits of our bioresorbable Phasix material into one of the most common abdominal wall hernia procedures. The BD multimodality vacuum-assisted biopsy device, which is expected to be the first VAB system designed to work across all 3 imaging modalities of ultrasound, CT and MRI allows our customers to consolidate capital equipment, standardize consumables and simplify physician and nurse training. Our next-generation PureWick incontinence solution for the hospital and the home will be launching in FY '24. And our FACSDiscover S8 Cell Sorter 3 and 4 laser configuration that will expand our new-to-world cell sorting instrument to the mid-parameter segment to help more researchers drive new discoveries. We're also launching our Libertas 5 ML device that will provide a wearable option for higher viscous drugs that tend to require longer dosing times. And finally, our BD next-generation infusion pump for Europe. These are just a few examples of the 25 key new product launches planned for FY '24. We will also continue to simplify our organization this year to enable operational excellence and agility, fuel investment and deliver on initiatives that will help us achieve our 25% adjusted operating margin goal in FY '25. this includes our Project Recode initiatives where our network optimization efforts will start Generating savings in FY '24 as we drive plant efficiencies and our operating model efforts where we are seeing positive early results from outsourcing certain back-office functions. As we accelerate our focus on BD Excellence, our unique business performance system, we will increase the adoption of lean principles beyond manufacturing with pilots outside of operations this year. I see our BD excellence system as an important new lever we're building as we look ahead and think about our strategic plans beyond BD 2025. And lastly, we expect to continue our balanced approach to capital deployment. This includes ongoing transformation of our portfolio by deploying capital towards larger tuck-in acquisitions and in higher growth categories that we can scale and leverage to support our growth and margin goals. As I said at the top of the call, in fiscal 2023, our teams demonstrated exceptional agility and strong execution, advancing our BD 2025 strategy. We are delivering consistent durable performance in a challenging environment, which we expect to persist for several years to come. Our continued track record, combined with our growing pipeline and shift into higher growth markets is propelling us into a more innovative leader that is making a profound impact on advancing health care globally. We are advancing into FY '24 with clarity, focus and a growth mindset as we seek to do great things for those who rely on us, our customers, patients, associates and shareholders. With that, let me turn it over to Chris to review our financials, guidance and outlook.
Chris DelOrefice:
Thanks, Tom. We delivered strong, consistent results this fiscal year, which reflect the diversity of our portfolio and our BD 2025 strategy in action. Beginning with our revenue performance. We delivered $5.1 billion in revenue in Q4, exceeding our expectations with base organic growth of 7% and total base growth of 6.3%, which reflects the impact from the surgical instrumentation divestiture. For the full fiscal year, we delivered $19.4 billion in revenue with base organic revenue growth of 5.8% that is 100 basis points higher than our initial guidance. Total base revenue growth was 7%, driven by strong performance in BD Medical and BD Interventional. Base revenue growth was strong regionally as well with high single-digit growth in EMEA and Latin America and mid-single-digit growth in the U.S. and Greater Asia despite low single-digit growth in China. Our revenue performance continues to be supported by our durable core portfolio and an increasing contribution from higher-growth spaces that are driving the plus side of our targeted 5.5% plus revenue growth profile. We also continue to benefit from the organic contribution from tuck-in acquisitions we anniversaried, which was about 40 basis points for the full year. Over a 2-year period, we drove a strong base organic revenue CAGR of about 7%, which is well above our long-term target. Let me now provide some high-level insight into each segment's performance in the quarter. Further detail can be found in today's earnings announcement and presentation. BD Medical revenue totaled $2.6 billion in the fourth quarter, growing 6.2% with strong performance in Medication Management Solutions and Pharmaceutical Systems. BD Medical performance reflects a decline in medication delivery systems resulting from softness in China driven by market dynamics, including some impacts from volume-based procurement. This was partially offset by strong performance in catheter solutions in North America and Europe through continued execution of our vascular access management strategy. MMS delivered exceptional growth of 13.7%, driven by double-digit growth in both dispensing and pharmacy automation as customers focus on solutions, which improve workflows and efficiencies and help pharmacies address rising costs and labor shortages. Pharmaceutical Systems delivered another quarter of double-digit growth of 10.6% driven by continued strong demand for prefillable solutions for biologics, partially offset by a slowdown in China exports of anticoagulants. Ed Life Sciences revenue totaled $1.3 billion in the fourth quarter. Excluding COVID-only testing, Life Sciences base revenues grew 3.8%, driven by strong double-digit growth in Biosciences. Life Sciences base business growth reflects IDS base business growth of 0.6%, driven by continued adoption of our BD KIESTRA microbiology lab automation solution and strong IDAST instrument placements and continued growth of our molecular IVD assays, leveraging the BD core system and our expanded BD MAX installed base. Growth was partially offset by the comparison to prior year COVID-related recovery in China and a decline in specimen management that was driven by distributor and customer stocking in the prior year. PDB [ph] grew 11.7%, driven by strong demand for our recently launched BD Fax Discover SH cell sorter that is enabling an entirely new level of biological depth of speed, ease of use and solution integration for researchers across fields like immunology, cancer research and cell biology. BDs performance also reflects strong growth in clinical reagents, leveraging our increasing installed base of FaxleRic [ph] analyzers in facto-ed automation. BD Interventional revenues totaled $1.2 billion in the fourth quarter, growing 9.6% and 12.8% organic. The strong double-digit organic growth was driven by surgery growth of 5% or 15.5% organic, which excludes the impact from the divestiture of the surgical instrumentation platform of 10.5 percentage points. Organic growth reflects strong market adoption of our leading Phasix Hardie products in our advanced repair and reconstruction portfolio and strong demand for our ChloraPrep infection prevention solution. PI grew 11.7%, which reflects strong performance in peripheral vascular disease driven by global penetration of the rotor atherectomy system and our venous portfolio in China. Growth was aided by improved supply and distribution stabilization in EMEA following a new ERP implementation in fiscal '22. Urology grew 11.7%, primarily driven by continued strong demand for our PureWick chronic incontinence solutions in both the acute care and alternative care settings. Now moving to our P&L. Q4 adjusted diluted EPS of $3.42 reflects strong double-digit growth of 24% or 25% on a currency-neutral basis. Gross margin increased 20 basis points to 52.6%, and as anticipated, we delivered very strong margin improvement with adjusted operating margin of 25.4%, up 340 basis points. As expected, margin improvement was driven by leverage on our strong revenue performance, our ability to offset outsized inflation, lower SSG&A driven by our simplification initiatives, moderated R&D expense as a percent of sales due to investment timing and a favorable comparison to last year's COVID profit reinvestment. Full year adjusted diluted EPS of $12.21 grew 7.6% or 11% currency-neutral. This includes delivering an additional $0.14 of currency-neutral earnings versus our original guidance. Additionally, we absorbed almost 400 basis points associated with reduced COVID-only testing, implying base currency-neutral EPS growth of approximately 15%. For the full year, gross margin of 53.5% was flat to the prior year despite absorbing over 200 basis points of outsized inflation and cost of goods sold. Operating margin of 23.5% was up about 90 basis points or 110 basis points when excluding the 20 basis point impact from the accounting treatment of an employee benefit-related item, exceeding our margin goal for the year. The employee benefit item is recorded in G&A and is fully offset in other income with no resulting impact to EPS. While delivering our margin goals, we also maintained investment in R&D at 6% of sales or about $1.2 billion to advance our pipeline of innovation programs that will support our strong growth profile in fiscal year '24 and beyond. As anticipated, we made significant progress towards achieving our pre-pandemic margin improvement goals. Our FY '23 adjusted operating margin is ahead of our 2019 spin adjusted margin, which is particularly significant given it includes overcoming 500 basis points or almost $1 billion of outsized inflation in the past 3 years. Over the next 2 years, we remain well positioned to return to our targeted 25% operating margins. Regarding our cash and capital allocation. Cash flows from operations totaled approximately $3 billion in FY '23. As expected, cash flow accelerated over the back half of the year and was strongest in Q4 due to normalization of working capital, including continued moderation of our inventory balances. We remain focused on free cash flow conversion and as anticipated, delivered a step-up in FY '23 with free cash flow increasing by over $600 million. We are planning another step improvement in FY '24 and expect free cash flow to increase double digits. This will be achieved through further moderation of inventory levels by the end of the year and continued discipline around CapEx investments through focused prioritization and areas of targeted reduction, both of which we expect to more than offset cash investments to support the Alaris remediation. As we execute against our BD 2025 strategy, we remain well positioned to achieve our long-term cash conversion target of around 90%. Beyond our investments in growth, we paid down over $700 million in debt this fiscal year and returned $1.1 billion in capital to shareholders through dividends. We ended the year with a cash balance of $1.4 billion and a net leverage ratio of 2.6 times This is our strongest net leverage position since FY '21, which positions us well to capitalize on opportunities to accelerate our investment in higher-growth categories through our tuck-in M&A strategy. Moving to our guidance for fiscal '24. For your convenience, the detailed assumptions underlying our guidance can also be found in our presentation. As demonstrated by our results over the past 2 years, BD has the ability to deliver strong performance in the most challenging times. Our performance reflects strong execution of our BD 2025 strategy, the benefit of our diversified and durable portfolio or simplification and outsized cost improvement programs and bold, purposeful capital allocation and investment decisions, all further optimized by our ability to execute with agility. As we look to fiscal '24, while the macro landscape has evolved since our last earnings call, I'm pleased to share we remain committed to the revenue growth profile we previously outlined. And at the midpoint of our guidance, we expect to deliver another year of organic growth above our 5.5% plus profile. Let me share some of the key puts and takes contemplated in our guidance. First, we see strong momentum in many parts of our business. We have 6 key areas in our portfolio now totaling over $5 billion or 25% of our sales that we expect to deliver high single to double-digit growth. These include our farm systems pre-fillable syringes, which are benefiting from the strong trends in biologics, our bioscience business, our peripheral vascular disease platform, our medication management systems business, including pharmacy automation and infusion given the recent clear Delaris pump, urinary incontinence supported by our PureWick franchise; and finally, our molecular diagnostic platforms. This allows us to deliver strong results despite some heightened macro dynamics affecting many industries, most notably in China, along with increasing risk and complexity as the result of the war in the Middle East and other geographies. Specific to the health care industry, providers continue to feel the pressure of elevated inflation and labor dynamics. And while they remain very focused on cost and working capital management, our portfolio has proven to be more resilient in this type of environment given BD's essential role in the health care ecosystem and our ability to transform health care processes and drive efficiencies. As it relates to BD, the largest headwind we anticipate from these macro dynamics is in our China business, where we see market softness and increasing levels of volume-based procurement, predominantly impacting our MDS business along with some impact in farm systems from reduced demand as our Chinese pharmaceutical customers export business slow. As a result, we are projecting China to be flat to modest growth in FY '24, which creates nearly a 75 basis point headwind to our revenue growth this year. Taking these factors into account, we expect to deliver base organic growth of about 6% at the midpoint, which is consistent with the view we provided on our last earnings call. We still expect COVID-only testing to step down from the $73 million reported this year and result in a headwind to organic growth of over 25 basis points. This brings the midpoint of our total organic growth to 5.75% within our 5.25% to 6.25% range. To help simplify our reporting, unless there's a significant change in the COVID-only testing market. Effective this year, we will no longer be reporting base organic growth that excludes COVID-only testing. However, it was important to give us context with our initial guidance. As a reminder, while the sale of the surgical instrumentation platform that closed in Q4 FY '23 does not impact our organic growth, we'll have nearly a 75 basis point impact to total revenue growth in FY '24 and is accounted for in our total currency-neutral revenue growth guidance of 4.5% to 5.5%. Moving to margins and earnings. We plan to deliver another year of strong profitable growth, including progressing our adjusted operating margin towards our FY '25 goal of 25%, while generating cash flow improvements to support our strong and reliable growth profile. On gross margin, we expect to be about flat year-over-year on a reported basis, including the impact of currency headwinds of approximately 75 basis points. Excluding the impact of currency, we expect gross margin to improve with our simplification strategy more than offsetting 150 basis points of headwinds from outsized inflation of about 100 basis points and another 50 basis points from inventory reduction efforts that occurred in FY '23 and that we plan to further moderate down by the end of FY '24, which will improve cash flow. The value from our simplification programs continue to be driven by our recode network optimization, SKU rationalization and operating model simplification programs. Additionally, our BD excellence program, which focuses on the application of lean principles is driving productivity gains across our operations. As it pertains to OpEx, we anticipate SG&A expense leverage on strong revenue performance and continued benefit from our operating model simplification programs. After 3 consecutive years of investing in R&D at over 6% on average, in FY '24, we anticipate a consistent year-to-year dollar spend in R&D that is needed to advance our pipeline, which will result in some modest leverage. As a result, we expect adjusted operating margin to improve by around 50 basis points on a reported basis over the 23.5% reported in FY '23, primarily driven by SSG&A leverage. This puts us well on track to achieve our 25% margin goal by FY '25. For tax, assuming no major legislative or regulatory changes, we expect our adjusted effective tax rate to be between 13% and 15%. As a reminder, it would not be unusual for our tax rate to fluctuate on a quarterly basis given the timing of discrete items. Given all these considerations, we expect adjusted EPS growth before the impact of currency of 8.25% to 10.25% or 9.25% at the midpoint. This includes absorbing about a 75 basis point headwind from the divestiture of the surgical instrumentation business, and as a result, implies double-digit earnings growth, excluding the divestiture of 10% at the midpoint and within a range of approximately 9% to 11%. Let me now walk you through the estimated impact from currency. As a reminder, we manage our business and provide guidance on a currency-neutral basis to best represent underlying performance we provide perspective on currency using current spot rates, consistent with what other companies are discussing in their forward outlook, we are accounting for a headwind to our reported results as we translate currency to a stronger U.S. dollar, along with normal FX translation, given our global manufacturing and distribution footprint, we also faced the impact of currency fluctuations in our P&L, including the impact from the sourcing and timing of inventory production and movements throughout our network. Since our last call in August, the U.S. dollar significantly strengthened against most major currencies and the change over this time period accounts for nearly two thirds of the expected FX impact. Additionally, as it relates to sourcing from Mexico, where we have a large manufacturing footprint, the dollar weakened versus the peso by about 10%, taking the average rate over the last 4 months ending in October versus the average over the first 9 months of fiscal year '23, with the peso achieving peak rates that in that time frame had not been seen in well over 5 years. Based on current spot rates for illustrative purposes, currency is estimated to be a headwind with approximately 75 basis points to total company revenues and approximately 375 basis points to adjusted EPS growth on a full year basis. All in, including the estimated impact of currency, we expect revenues to be between approximately $20.1 billion to $20.3 billion and adjusted EPS to be in a range of $12.70 to $13, which represents growth of 4% to 6.5%. As a reminder, currency can fluctuate over time, and it would not be prudent to deviate from our investment profile that is resulting in consistently strong base organic growth, which is delivering an expected 3-year base organic CAGR of about 6.8%, well above our 5.5% plus growth profile. We continue to deliver margin improvement, resulting in earnings growing 1.3x the rate of sales. And with our focus on improved cash conversion, we expect to deliver double-digit free cash flow growth. As you think of fiscal '24 phasing, the following are considerations for Q1 in context on how revenue and margin will index through the remainder of the year. As it relates to Q1, we expect organic revenue growth to under index the full year by over 200 basis points, and we expect a decline in adjusted EPS versus the prior year of about $0.55 to $0.60. There are 3 key items to consider First, sales was driven by the prior year base and COVID-only respiratory testing comparison, along with the market dynamics in China. These impacts are about equally weighted and primarily impact the IDS and MDS business with a modest impact in farm systems associated with China. We also expect Alaris revenues to ramp over the year and be weighted to the second half. Second, we expect operating margin to decline by around 350 basis points on a reported basis in Q1 with 200 basis points driven by inventory-related FX dynamics and another 200 basis points from the negative absorption impact from our planned inventory reductions, which we expect to partially offset through our simplification and cost mitigation initiatives while also overcoming outsized inflation. Lastly, we had a discrete tax item in Q1 of last year that creates a negative comparison. As you think about the remainder of the year, we expect organic sales growth to be higher than our full year range in the second half, partially driven by the ramp-up of Alaris. We expect our Q2 margins to expand significantly on a sequential basis, resulting in year-over-year operating margin being nearly flat on a reported basis or slightly up on a currency-neutral basis. In closing, we are very pleased with our performance this past year, particularly given our ability to navigate another year of significant macro complexity and inflationary pressure. The momentum in our durable and strong portfolio, along with our track record of successfully executing and delivering against our commitments, gives us confidence in our ability to continue this momentum into FY '24 and create long-term value for all of our stakeholders. Let me take a moment to thank our talented employees across BD who through growth mindset and an unwavering commitment to our purpose or core to delivering this performance. With that, let's start the Q&A session. Operator, can you assemble our queue, please?
Operator:
[Operator Instructions] And our first question comes from Robbie Marcus with JPMorgan.
Robbie Marcus:
Okay. good morning. Thanks for taking the questions. I wanted to start on how you think about reported EPS growth because the range of $12.70 to $13 is just slightly higher than the original guidance for fiscal '20 of 12 [ph] I believe, 1,250 to 12.65. So just thinking about how you're managing reported EPS versus underlying organic constant currency EPS and how we should think about your ability to deliver the double-digit reported EPS growth going forward? Thanks.
Tom Polen:
Robbie, thanks for the question. First of all, our guide range obviously reflects - we basically try and match the top line. So if you look at the top line, you've got about 1 point on the range in total. I mean you dollarize that, take the dollar of sales take margin drop-through on that. It basically mirrors kind of the number of earnings that you have on either side. So there's symmetry between the sales, the drop through at some margin level that's between, call it, GP and EPS. So it contemplates both upside on sales and reinvesting back in the business or vice versa on the downside, basically the opposite. So I mean that's the logic for the range. I think it's pretty consistent with - it modifies year-over-year depending on how you actually set those points and what each point is worth I think more importantly, look, our commitments, we can't control currency, first of all. So we always think of things on an FXN basis. If you look at our FY '24 guide this year, I think there's a lot of strong things. The underlying performance of the business is really strong. Let's start with the top line. So if you remember, last quarter, we talked about delivering 6% organic growth. That was excluding the impact of the COVID-only testing, which we expect to step down by about 25 basis points. That would establish a midpoint range of, call it, 5.75%, which is very strong. It's above our 5.5% plus average. Our 2-year average heading into this year, plus this year at the midpoint would imply a CAGR of just under 7% organic growth. When you think about from the time that we mentioned kind of the direction we were heading 3 months ago to where we are now, looking at the top line, the macro environment certainly got more complex. I think for us, China was one of the dynamics that we called out, there's about a 75 basis point headwind that we're contemplating in our guide that's actually absorbed in that growth rate. So it actually implies excluding that organic growth of north of 6%. So really strong to be able to absorb that. I think this shows the resiliency of the BD portfolio, the diversified nature and all the work that we're doing to drive growth in these transformative spaces. We've talked about 6 key areas that as we think of our guide, kicking both, one, they're helping deliver the midpoint there and can create opportunity for upside. So that's farm systems. That's our MMS portfolio, including pharmacy automation on the back of Parada, our Rowa business, infusion, obviously, with the clearance of Alaris now, our bioscience research, peripheral vascular disease, molecular diagnostics and urinary incontinence. From an earnings standpoint, again, on an FXN basis, it's extremely consistent with what we shared last quarter. There's a couple of small puts and takes in here, but basically excluding our divestiture of eMeler [ph] we're anchored right at double-digit growth at the midpoint. At the top end, we're actually 11%, excluding the eMeler divestiture. So even with that divestiture, we have double-digit EPS growth in the top end of our earnings range. Again, there's 2 things that I would say that are different from last time. That includes us again absorbing the China headwind, which actually comes with some pricing dynamics. So really think of stronger underlying earnings to offset and absorb that. Plus, we've been very focused on cash. So with our strong margin profile, we made an intentional decision to continue to drive inventory levels down, especially in an environment where you have cash earning at high interest, it creates an opportunity and you have inflation flowing through inventory, keeping your inventory levels lower, create strong value creation. That creates a 50 basis point headwind through the year on margin, but that's an intentional choice and we're doing that because we have a strong cost to win program, leverage on our top line growth that we've consistently been driving and we can still drive towards our 25% goal by 2025. I think that focus on cash, one thing that even despite the FX, remember, FX, we don't control FX, I think a couple of the dynamics to think about, we literally had a 5% FX movement across our 5 major currencies since the last guide. It's unprecedented that they all go the same way. On top of that, we had a dynamic where some of our core, call it, expense-only sourcing locations, think of Mexico, where we have a huge manufacturing organization. We saw a 10% movement in that currency, where the peso actually strengthened against the dollar. We're not alone in this. Every company has been talking about it in Q4, adjusting their Q4. We're one of the first to report a full fiscal year. Many have signaled that, that will be coming in their results as well. The good news is one of the reasons that we focus on underlying is FX is not a true cash for cash impact. Some of this FX is pure translational. It does not affect our underlying cash. As a matter of fact, when you think of the cash flow for BD that we're thinking of in 2024 because of that strong FXN earnings growth profile on the back of strong top line growth and the continued cash conversion that we want to improve, we're going to drive double-digit cash flow from a free cash flow standpoint. So ultimate value creation happens with cash, and it's one of our core focus areas going forward. So I think FY '24, again, it's actually outsized versus our top line commitments that we've made as part of our Investor Day. We continue to drive margin improvement. We continue to deliver double-digit FX and earnings growth, and we actually have outsized cash flow growth - the FX is unfortunate, it's unprecedented. We don't control that. I think we're focused on continuing to drive long-term value. It would actually be value destructive to take outsized actions and try and cover that. So hopefully, that context all helps.
Robbie Marcus:
Yes. Very helpful. And you talked a lot about operating margins. It came in below - the Street in fourth quarter and just below the fiscal '23 guide. And first quarter is coming in pretty far substantially sequentially down. How do we think about your confidence levels for being able to achieve the stated operating margin guidance in the back half of the year? Thanks a lot.
Chris DelOrefice:
Yes. Great question. So first of all, 23, I mean, look, we delivered exactly against our commitments from the beginning of the year. As a matter of fact, we increased our organic growth by over 100 basis points from our original guide. We increased our earnings $0.14 on an FXN basis, taking out the currency noise, which actually was favorable as that we advanced through the year. Margin, we fully delivered. Remember, there's a small accounting adjustment from employee benefits that actually gets adjusted in another line item. We're actually over our commitment when you think of that. So we're really pleased with what we did on FY '23. I think the last I looked, there's maybe less than a handful of companies, 2 or 3 that are able to drive margin improvement from the start of this outsized inflation. So over the last 3 years, we've absorbed $1 billion of outsized inflation while improving our margin by almost 400 basis points. So really proud of the organization and strong commitment to executing against that. It's a great question on '24. I actually view '24 in some ways, dress. So here's the criteria as you think of '24. So one, we have another 100 basis points of outsized inflation. Most of that is in labor. There's some other input costs, some packaging fuel. We have 50 basis points that we've actually made the choice around this absorption from lowering our inventories to drive outside cash. So that's an intentional choice that's in our plan because we do have such a strong cost improvement program in place to offset those and still achieve our long-term margin goals. And then we have 75 basis points of FX. We're going to more than absorb that with 225 basis points of cost to win price mix in GP. So gross margin for the year will be about flat. And then we have about 50 basis points coming from SG&A leverage and some of the benefits from our operating model simplification plan. So that's kind of the full year dynamic. In the quarter, to your point, we talked about a 350 basis point headwind in the quarter. But you have 2 large onetime items. Almost all of the FX is indexed towards Q1 and almost 100% of that inventory choice is also happening in Q1. Those are about 200 basis points, respectively. The 100 basis points of outsized inflation is over-indexed in Q1 at about 175 basis points. What that implies is we're actually driving underlying about 225 to 250 basis points of cost improvement that are offsetting those items. The other thing to think of is if you look at last year as an analog and for 8 quarters now, we've been very predictive in what our margin would do quarter-over-quarter, and we fully executed against the commitments we've made externally. So one, there's credibility and that gives us confidence. But if you look at last year, we needed a little over 200 basis points on average in the back half. And as everyone knows, it was weighted towards Q4. This year, you'll see a little bit more balanced in the second half, but we do need another year of a little over 200 basis points of margin improvement in the second half. By Q2, we get back to flat. The good news is last year, we were absorbing 200 basis points of outsized inflation. This year, it's only 100 basis points of outsized inflation and a lot of that is happening in the front end, right? So the back end gets easier, and it's half of the challenge that we had last year when you think of outsized inflation. So it's the same amount of margin improvement we need in the back half with half of the outsized inflation in the back half. And given the fact that we're already delivering about 225 to 250 basis points of cost to win, pricing mix benefits in Q1. If that continues throughout the year, which we have strong plans that execute against that, we feel really confident with our margin goals for the year.
Tom Polen:
Ravi, this is Tom. Just to add to Chris's excellent summary there, just to call out, we feel great about the performance in FY '23 as well as our outlook for '24. And just to give a little bit more detail on that inventory number. So in Q3, you saw meaningful improvements in our cash flow, including a $200 million reduction in inventory. In Q4, if you haven't seen yet, it's a $300 million reduction in our inventory in Q4 that we just achieved. Obviously, that - the inventory reduces within that quarter, the variance is then from producing less inventory from manufacturing, caps and rolls into the first half of next year. And so just to put it in perspective the scale that we've been taking inventory down at. And obviously, that has a meaningful benefit to cash flow and why we see such strong cash flow, growing nice double digits next year all in, which is really enables our continued strategy on our tuck-in M&A strategy, investing behind growth, right, continuing to drive the flywheel. Thanks again for the question.
Operator:
Our next question will come from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys. Thanks for taking my question Sorry, there were a lot of numbers being thrown around. But if you can just -- let's start with Q1 on the top line com. Your Q4 performance was pretty impressive. I think for Q1, you said 200 basis points below the annual guide. Your comps don't seem crazy, right? It's pretty easy. So what's changing here? What are you assuming for pricing China headwinds Aleris?
Tom Polen:
Sure. Thanks for the question, Vijay and Chris will take that.
Chris DelOrefice:
Yes. Yes, Vijay, thanks for the question. Yes. On sales, we indicated that our organic growth in Q1 was under-indexed by 200 basis points. There's really 2 factors, maybe 3. The key factors are, one, the respiratory testing dynamics, both in our base and the COVID only, which we're going to now just report as our base business, right? It was still more indexed in Q1 of last year. So as that normalizes year-over-year. The other one is some of the China slowdown that I noted, which is mostly in our medical business, we're still seeing strong performance, in particular, in BDI, which has been a source of strength for us. The good news is we've baked that into our planning by the time that we ramp up to the back of the year that normalizes throughout the year. So those are the 2 small items. The third one I would point to, of course, that we've articulated is the Alaris. As that comes back, we talked about that being a ramp throughout the year. So those are probably the key 3 considerations. To your point, I think especially on the back of absorbing 75 basis points of a China headwind in our growth rate, 5.75 really implies organic growth of 6% north. So it's just -- it's another year of really strong performance. I think it's -- when you think of BD, we're not dependent on one area of growth. I think that offers a source of confidence in complex times like this. And I think the growth is broad-based, right? We talked about the 6 key areas within our portfolio that offer opportunity to deliver that outsized growth of either high single digits to double digits. So we continue to focus on that, transforming our portfolio through organic investments in R&D and the tuck-in work we've done. If you noticed '23, the impact from our tuck-in acquisitions are now contributing 40 basis points to growth after having anniversaried them for 1 year.
Tom Polen:
And Vijay, just to add on. Obviously, with Aleris, we've always said, of course, typically from when we start booking installations, then we get contracts into 3 to 6 months from then that we actually start doing the installations, et cetera. And obviously, we started just a little over 90 days ago, engaging with customers. And so we're really pleased. We're making solid progress with Alaris, very constructive discussions. We started shipping. We've gotten our first contracts in place, but those will just take time to move through and therefore, we see the bigger ramp in the back half of the year. That's natural for that selling cycle. The other thing is, as Chris mentioned, we've made some assumptions for Q1 on respiratory testing and COVID levels being notably lower than last year. Obviously, that's to be determined. That could be an opportunity there depending on how the respiratory season plays out.
Vijay Kumar:
Understood, Tom. And then one on margins here. I think in the Q1 gross margin is 350 basis points below. I just maintain your OpEx dollars, I still end up with an operating margin close to 21.5%. I think your guidance is implying sub-20% for Q1. So is there some investments that's being pulled forward into Q1? And I think you mentioned gross margin flattish year-on-year. Are you planning to exit at 55%? Like what drives the gross margin from 51% to 55% as the year progresses?
Tom Polen:
Yes. You're talking specifically about Q1?
Vijay Kumar:
Q1 op margins, yes and gross margin progression?
Tom Polen:
Yes. So again, I mean, Q1 has - there's really 2 onetime dynamics in there. You have FX that's 200 basis points and you have the inventory take down, right? So the onetime impact of taking on increased absorption in your cost base, it's 400 basis points, all happening in Q1 that basically goes away. The FX becomes much smaller and more normalized throughout the year. The inventory is predominantly done in Q1. That goes away. You also have the outsized inflation that on average through the year is 100 basis points, but Q1 is more elevated because you have a carryover effect from last year. It's about 175 basis points. The good news again is we have really strong underlying cost improvements. I mean, at this point, Recode, which is supposed to deliver about $300 million savings as we enter into FY '20, 25. We're achieving about two thirds to 70% of that savings in this year. So we've made significant progress. We've actually fully completed the SKU rationalization program in terms of simplifying our SKU portfolio. We're not stopping there. We're going to actually increase that goal. There's more opportunity to go. So you have kind of 2 discrete onetime items in Q1, but the underlying and cost improvement are driving. We just need to maintain that throughout the year, and we'll be fine. Similar to what I shared before on Robbie's question was, last year, we had to deliver 200 basis points of margin improvement, a little bit north of that in the back half. We have to do the same thing this year. But last year, there was 200 basis points of outsized inflation. This year, there's half of outsized inflation. So we actually feel really strong. That's what's afforded us the opportunity to actually look at our inventory harder and maybe take some more aggressive goals, driving that down and driving improved cash. Again, FY '24 year that's going to have double-digit free cash flow growth year-over-year.
Vijay Kumar:
So sorry, the OpEx dollars, are you expecting it to be constant sequentially? Or is that stepping up, Chris?
Chris DelOrefice:
I mean there's - we can follow up. But there are timing on. If you remember last year, I mean, there are some timing dynamics you're going to see. R&D, you're going to see is much more normalized this year. That's one area I would point to. So I think you should expect to see OpEx actually down a little bit in the first half of the year, partially because of that when you're looking at pure SSG&A spend and R&D spend, and then that will renormalize in the back half of the year. We were very front-end loaded with R&D this year in '23. And then we moderated it back in the second half due to timing of programs, milestones and things like that. This year is more normalized, and we're going to spend about the same in R&D year-over-year from a dollar base. That's probably the one key thing I would point to.
Vijay Kumar:
Thanks, guys.
Operator:
Our next question will come from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Thanks for taking the question. Just I'd love to focus on China a little bit, 13% decline in Q4. What were the drivers of that? How much was the anticorruption initiative versus VBP? And how are sales going to be flat to up in fiscal '24, given the Q4 decline. And just one follow-up on fiscal '24, Chris. The tax guidance, does that include the Pillar 2 changes? And how should we think about the tax rate going forward? And the FX headwind of 75 bps to sales, how can that be a 375 basis point impact to EPS?
Chris DelOrefice:
Yes. Thanks, Larry. I appreciate the question. Let me take the last 2 first, I guess. First of all, BD, we started our fiscal year before everyone else. So Pillar 2 is not contemplated more applicable to us in fiscal year '24. We continue to assess those dynamics. We expect a lot more information as this year progresses. We'll share more on that at a future date. Obviously, our tax rate, we are planning for a step up in tax that we've absorbed in our guidance. But I think more to come on Pillar 2, we'll see how this plays out for us. So we have time on that one. The FX. So again, you have a combination of - when every currency moves, so quickly in such a short period of time by a high degree. And I'd mentioned these examples of where you have pure sourcing locations, Think of them as basically a cost center. Mexico is a good example where actually the peso strengthened against the dollar, you end up with cost dynamics that are also going to rollway. So literally, every currency went the wrong way and you also have timing of how that FX flows through inventory and started last year. So it does create this disconnect that we have. It does normalize over time within our portfolio. And certainly, by the time we get out of Q1, you'll see a more normal drop-through on FX. I'll turn it over to Tom on China, just one high-level comment because remember last year, we did have a comp from the recovery. So if you look at the 2-year growth it's more normalized closer to that double-digit range. With that said, we have contemplated some of the headwinds we're seeing in terms of the market dynamics playing out there. But I think the Q4 result was also impacted by the comparison to last year.
Tom Polen:
And specifically on China, I'd really focus on 2 key areas. One is VOBP and then the topic related to farm systems, which Chris mentioned, which obviously we overcame at a global level, but you see it acute the topic within China, and we ended up reallocating the supply to other customers that were outside of China. So on the farm systems, one is, as Chris mentioned in the prepared remarks, we're just seeing specifically within China, basically a slowdown in exports of pharmaceutical products, specifically anticoagulants from China and so lower demand as those companies are seeing significant drops in their exports. So that's really one again, that ended up showing up in our - it will show up in our China numbers as a decline, but that same volume that would have gone to them gets reallocated to other customers globally who are - still have that business in their prefilled syringes for anticoagulants. And so we make - we didn't see it at a pharmaceutical systems level. So that's one and was notable within the quarter. I think the other one is really more VP - and again, primarily focused within the MDS business. We continue to see strong high single-digit, double-digit growth -- strong double-digit growth in Interventional and high in life sciences. So really, they continue at our historically expected growth rates, not only in '23, but through as we look ahead towards '24, that's our outlook there as well. It's really acute within specifically the MDS business and then the continuation, annualization of what we're seeing in China anticoagulants and exports So when it comes to anticorruption campaign, that's obviously a macro topic. We feel very strong about our compliance system, et cetera, nothing we're worried about. I think we saw some stabilization in the market on that versus maybe when it first came out in customers' reactions, but I wouldn't overly attribute it to that topic as much as the other 2 that I mentioned.
Operator:
Our next question comes from Travis Steed with Bank of America.
Travis Steed:
I'll ask the Alaris question. Are you still penciling in $200 million for the full year? And any help on maybe what you've expected in kind of Q1 just to help with the ramp for Aleris? And is that -- when you think about margins, is that one of the drivers of the second half margin ramp?
Tom Polen:
Yes. It's - I'll start and then turn it over to Mike, just maybe start with the margin ramp. It's not a part of the margin ramp. It's not accretive to BDX margin. I think we've shared that in the past the capital itself is not. Obviously, the consumables associated with that tend to be, but not the capital itself. As we think about the $200 million, and then I'll turn it to Mike to just share some broader context. Again, at this point, we're a little over 90 days in. We're making solid progress we're at or ahead of our expectations there. But again, as we said, it's typically 3, 6 months - it's a 3-plus month process once you get a purchase order to get the installs, but then it's even - it's more like a 6-month plus sales process, which we started 90 days ago, right? And so some we are getting in earlier. We're getting contracts signed. We've already started shipments. But what we'll do is we'll continue to share our progress on that. We're not changing the 200 number now. And I think that was also -- just keep in mind that was something that we shared to give some color as related to clearance, but for competitive reasons, I wouldn't expect that we'll share a specific revenue number for Aleris going forward, just like we don't for any other product line. But we will make sure that we share color on our progress in terms of where we are relative to that absolute number. So maybe, Mike, other things to add.
Mike Garrison:
Just really pleased that we were able to manufacture and ship product to the first customers ahead of schedule. We have been sort of planning for that more in Q1 of this year, but the team was able to execute to be able to ship products in end of September. And overall, I think that our discussions with the customers are going well, and we're able to start to line up for focusing on our existing customers for remediation out in the field. The other point that I would make is that we continue to sort of make solid progress just working with the customers. And we've mentioned before how important interoperability was during COVID. And certainly, for a lot of our customers, that's a key consideration in the discussions that we're having with them. So that's good for health care. I think that's good for public health. And so we're really happy that that's a key consideration from their perspective. And we're well positioned in that area.
Operator:
Our next question comes from Matt Miksic with Barclays.
Matt Miksic:
Great. So with all the swing in FX and dominating the questions around the guide here. I have one sort of follow-up on that and then a follow-up on your growth and sort of growth priorities and other sort of investment provides you're making during the year, but out FX, the swing obviously is expecting everybody and we're starting to get a sense of that into year-end and early next year. But if you could maybe highlight the way that, that is managed through your P&L, how it at all there's any...
Tom Polen:
Hey, Matt [indiscernible] there are slightly different than other folks in the space decisions that you make or make in terms of managing FX. And as I said, one follow-up.
Matt Miksic:
That’s the first question.
Tom Polen:
Yes. Matt, so a couple of things. I mean, I think no different from anyway. There's many ways that we mitigate currency dynamics, right? One, we netting where you have crossed currencies. Two is we actually try and match sourcing location-wise, to look at our manufacturing footprint. With that -- and there's hedging that we do, of course, in particular, to preserve cash is the way we think of it, right, like anything translational has no impact to underlying economic value of the currency in the local market. It always really becomes a strategy of how do you match sources and uses of cash. And so those become some of our principles when we think of FX. At the end of the day, what we can control is the underlying business, and that's what we presented here was an extremely strong top line growth, again, another year of margin improvement despite FX, by the way, right, 75 basis points of an FX headwind on margin. So we've committed to the at least 50 basis points. So it's really north of 100 when you think of it that way. And then again, we're being super focused on cash, which is the ultimate thing that creates value. And we expect to have double-digit free cash flow year-over-year. What was the -- was there another part of the question?
Matt Miksic:
Yes. And that's kind of actually dovetails nicely into the part 2, which is -- so you're making some choices that are impacting the margins as you talked about inventory takedowns, which are -- have an absorption effect, which I think everyone would agree is those are solid fundamental cash-generative decisions. And just with the questions as I think everyone is seeing there will be some -- there is some pressure here before the open, and it kind of gives the impression of a company that is under some pressure or defensive posture, but your actions obviously are saying the opposite. And I was wondering if you could talk a little bit about some of your continued efforts to either invest inorganically or highlight some of the drivers that you think are going to be significant growth leaders in the early and mid part of the year in 2024.
Chris DelOrefice:
Yes, Matt, and Tom can expand on this, too, maybe on how we're thinking of tuck-in M&A. But to your point, throughout this time frame, in addition to navigating significant complexity, absorbing outsized inflation, we've actually been leaning in and making bold choices that are paying off on growth and creating kind of a virtual cycle of strong growth. Margin improvement. So inventory is an example, it's an intentional added sort of pressure that we're putting on ourselves in terms of absorption because we know it actually creates net positive from a cash flow standpoint and yet we're absorbing that because we know we have a strong portfolio of cost to win programs like recode, et cetera. So we're doing that from a position of strength and actually you should view that as a sign of confidence, especially in a high interest rate environment, right? Cash is worth a lot more. We're also setting ourselves up from a tuck-in M&A, right? We've talked about the ability to execute against larger tuck-in size deals. Our net leverage is down to 2.6 times. We built strong cash throughout this year. So we feel really well positioned from that standpoint, and we'll continue to be disciplined, but strike on opportunities as they become available.
Tom Polen:
And Matt, I think, as Chris said, we just set the inventory piece aside, create awareness in that, but it's really irrelevant at the end of the day in terms of we're delivering right our 6% top line organic growth, and we're delivering double-digit EPS growth organic, and then it's really FX is what gets flowed through, right? We're not going to cut R&D or cut other investments that we're making to drive our strong growth profile, which is a 7% CAGR over the last couple of years. We're not going to cut that to do FX when - particularly when we look at the cash flow, which is what we use to invest behind that growth has 0 impact from FX really that we see. We're continuing to drive actually outsized free cash flow. Think about in FY '23, we grew free cash flow by $600 million in the year, right? That's strong free cash flow growth, and we expect continued strong growth as we look at '24 and beyond. So I think in terms of we are extremely excited by our portfolio and what we have today. And I think you're seeing outsized performance across our different segments. I mean, if you look at BD Interventional, the strong growth in surgery with our bioabsorbable materials really taking off, and you can see there's been several quarters of strong growth there. PI doing well and obviously, PureWick now with the mail product. You heard us in our prepared remarks actually say that's going to be a bigger product than we thought it was going to be. When we originally put out our guide and declared which products were going to be over $50 million, we just increased PureWick mail to be one of those products that's going to be over $50 million, quite clearly. It's on one of the fastest ramps of any product we've ever seen at the company is doing extremely well, and we're adding capacity as fast as we can, really strong adoption by nurses in particular. In our Life Science business, great growth in Biosciences, I think you're seeing us be a standout within maybe peers in that area. The strength of our fax Discover platform, combined with our dies has done really well. You saw that continue through Q4, and we expect continued strong growth. We see strong demand for that platform and our combination with the unique dies to allow really another level of multiplex testing as well as whole new insights into the cells that you can now visually see in addition to fluorescence. Obviously, when it comes to bid Medical that bold investment that we made in capacity right in the middle of COVID, we're seeing pay off with another just very strong performance in farm systems, and we see just the durable trends there, whether or not it's the GLP-1s, other biologics that we're very well positioned from not only a portfolio offering and technology perspective, but from a capacity perspective, because of those bold investments, we're well positioned to continue to capitalize on those. And of course, in MMS, what we've built now with a $700 million pharmacy robotics business. Really, if you look across med tech, it's hard to name many automation or robotics businesses larger than our franchise that we've now built there in the pharmacy. And that's growing strong double digits. We expect that could continue through '24. And obviously, the return of Alaris has been our number one goal here for a couple of years, and we couldn't be more pleased to achieve that goal at the end of '23, and that gives us another talent and confidence in our long-term plan and our confidence in this year. So a lot of really good things happening. As we think about M&A, you did ask that question. As Chris also mentioned, we ended '23 at strong leverage, 2.6 times leverage, strong - strong cash flow, increasingly strong cash flow as we go into '24. And so we have a strong, robust M&A pipeline. We're still focused on larger-sized tuck-in M&A, which is still our priority, as we've shared, and we're not changing from that. We're going to continue to be very disciplined on the targets that we go after as we have been to make sure that they drive accretive growth and profitability for the company, and we see a number of opportunities to do that. And so - and I think you - we're really pleased with how we've executed on the M&A that we've done. We're really pleased with the track record that we've built there. You can see, as Chris shared, 40 basis points of underlying organic growth driven through the acquisitions that we've done over the last couple of years. And that's a lever we're going to continue to pull in a very systematic way. And I think you're seeing all the other actions that we're taking, including optimizing cash flow fit into that growth algorithm. So thank you for the question.
Matt Miksic:
Appreciate the color.
Operator:
Thank you. All right. This does conclude the question-and-answer portion of our call. So I would like to turn the floor back over to the speakers for any closing or additional remarks.
Tom Polen:
Thank you, operator, and thanks, everyone, for your time today. I'd like to take a moment and again, thank our global team of BD Associates who are advancing our strategy and who are making meaningful impacts for our customers and the patients we mutually serve. Our BD 2025 strategy is demonstrating strong momentum. We're exceeding our commitments and have outlined a strong outlook for fiscal 2024. We look forward to connecting with everyone again on our next call, and thank you very much, and have a great rest of the day.
Operator:
Thank you. This does conclude the audio webcast. On behalf of BD, thank you for joining today. Please disconnect your lines at this time, and have a wonderful day.+
Operator:
Hello, and welcome to BD’s Third Fiscal Quarter of 2023 Earnings Call. At the request of BD, today’s call is being recorded. And will be available for replay on BD’s Investor Relations website, investors.bd.com or by phone at 800-695-1564 for domestic calls and area code 402-530-9025 for international calls. Today’s call all parties have been placed in a listen-only mode until the question-and-answer session. I will now turn the call over to Francesca DeMartino, Senior Vice President, Investor Relations. Please go ahead.
Francesca DeMartino:
Good morning, and welcome to BD’s earnings call. I’m Francesca DeMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the third quarter of fiscal 2023. We also posted an earnings presentation that provides additional details on our business, strategy and performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today’s call are Tom Polen, BD’s Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD 2025 strategy. Chris will then provide additional details on our Q3 financial performance and our updated guidance for fiscal 2023. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Mike Garrison, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Rick Byrd, President of the Interventional segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the IR website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis, unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically noted as a calendar period. I would also call your attention to the basis of presentation slide, which defines terms such as base revenues and the non-GAAP reconciliations included in the appendix. With that, I am very pleased to turn it over to Tom.
Tom Polen:
Thanks, Francesca, and good morning, everyone, and thank you for joining us. Earlier today, we reported another consecutive quarter of broad-based strong financial performance and significant progress advancing our innovation pipeline. Before we detail our quarterly performance, I want to highlight the 510(k) clearance we received on July 21 from the FDA for the updated BD Alaris Infusion System. This has been our number one priority since launching BD 2025, and we’re pleased to deliver this important milestone. For more than 20 years, infusion pumps have represented the backbone of hospital operations. Over that time, Alaris was the first product that connected all patient modules into one integrated system and the first platform to introduce medication safety software, which led the way to interoperability with electronic medical records. And later with the launch of BD HealthSight, Alaris again led the way with integration into the full suite of BD end-to-end connected medication management solutions from the pharmacy to the administration of drugs at the patient’s bedside. Today, the Alaris system continues to advance new levels of innovation with enhanced cybersecurity protection, the latest wireless capabilities and new features that enable various aspects of medication management and ultimately help clinicians deliver the best care. In short, we’re proud of the Alaris Power of One that makes medication management safer, simpler and smarter. With this clearance, we address all open recalls with the latest hardware and a new version of software as well as provide important cybersecurity updates. We can now focus on bringing the updated system to the market, ensuring our installed base is upgraded so customers can realize the full benefits of our latest technology. As we return to market, we will start with upgrading or replacing the hardware and software of Alaris system devices in the U.S. market with priority towards our existing customers. Given the breadth of our footprint, this effort will happen over a multiyear period. Just two weeks into clearance, we are well prepared. We immediately took action have contacted nearly all of our customers. We activated a dedicated team with daily stand-ups and have completed product training for our service teams on the cleared Alaris system. As we previously shared, we are prepared for clearance and our return to market. We have invested in and developed plans for operational capacity, and we’ve strengthened our supply chain. We have now activated those plans, which were dependent on clearance and are moving quickly to help ensure we can reliably supply our market-leading BD Alaris system and deliver for our customers. In parallel, we continue to engage with the FDA on how we intend to execute our remediation plans, which includes a combination of upgrades and replacements. We’ll provide more information as we progress. Before I move on, I would like to thank our customers for their loyalty and patience as we work through this challenging period. Our teams are ready and committed to provide the high-quality service and partnership that you’ve come to expect from us. And on behalf of the entire BD leadership team, I want to extend our deep appreciation to the BD associates who work tirelessly to bring the updated BD Alaris system to market for their ongoing commitment to quality and ensuring we achieve this milestone in the right way, in line with our values. We’d also like to thank the FDA for their rigorous review and engagement as we went through the clearance process. Turning to our quarterly financial results. Our strategy and purposeful investments in innovation are driving consistent higher growth and fueling strong results and momentum. Our results are indicative of our leadership position in our durable core and intentional shifts towards higher growth end markets in a highly motivated and talented global team whose focus on execution is helping our customers provide more efficient and effective care. We delivered another quarter of outstanding results with 7.9% base revenue growth or 6.3% base organic and double-digit adjusted earnings growth. Once again, our results reflect our strategy and action and our strong, consistent growth profile, which gives us the confidence to increase our FY 2023 organic growth rate. We also continue to make strong progress improving our on-time milestones and launches to another record level this year. Starting with a few examples of our recent launches. In our Medical segment, we introduced the BD Prevue II System, a first-to-world technology that magnetizes the tip of certain existing BD catheters and allows them to be seen under the preview ultrasound device. The software then guides clinicians to enter the vasculature with first stick success. This novel approach enables BD peripheral IVs to deliver new value to patients and providers. In our Biosciences business, we are seeing a super cycle of innovation this quarter with three key new product launches. In mid-May, we began shipping the BD FACSDiscover S8 cell sorter. Our customers are utilizing this new standard in flow cytometry to unlock life-changing discoveries across immunology, cancer research and cell biology by uncovering more detailed information about cells and how they interact that was previously invisible. The first installations are complete. Customer feedback has been excellent, and we are seeing strong demand. We also launched the BD Rhapsody HT Xpress, which enables access to the fast-growing single-cell multiomics market with a high throughput research solution. The HT Xpress can process up to 320,000 cells per run. Eightfold the throughput of the BD Rhapsody platform, while leveraging Rhapsody’s micro well designed to ensure high-quality results for all cell types. And most recently, we announced the launch of the BD FACSDuet Premium Sample Preparation System, a new robotic system to automate clinical flow cytometry enabling the only walk-away automation for both HIV and leukemia and lymphoma testing. And in our BDI segment, we launched the BD Trek Powered Bone Biopsy System, expanding our presence in oncology beyond the manual biopsy market. The BD Trek system allows for faster sampling with sizes to accommodate a variety of procedural needs. Our differentiated offering enables the ability to collect large intact samples while providing the clinical versatility to biopsy delicate areas that require precise targeting as well as bones that require power. We’ve also achieved several crucial development milestones this quarter. These include 510(k) submission of the Site-Rite 9 Ultrasound System, which is part of our vascular access management strategy. The Site-Rite 9 was developed to be the first integrated system that combines catheter and ultrasound navigation into a single device to simplify workflow, capital management and training for clinicians for the placement of BD Pyxis. In our IDS business, we are expanding the strategy for our BD Onclarity HPV franchise to enable patients to self-collect samples with the aim to promote health care equity by making cervical cancer screening accessible to women who historically haven’t participated or have had limited access to testing. This is already in use across Sweden, Denmark, the Netherlands, Australia and New Zealand. Clinical trials are set to start in India, Africa and the U.S. later this year. We are proud of this work and its ability to advance our efforts to reduce health care and equities around the world. And in our PI business, we submitted and received IDE approval for our TIPS-Venous Stent Graft and are on track to enroll the first patient in Q4. Used in the liver, this novel self-expanding covered stent continues to expand our leadership position and build on our success in launching venous products that help deliver better clinical outcomes for patients. These launches and milestones are good examples of accelerated levels of innovation across our business and how we are strengthening our position in attractive end markets across our portfolio. We continue to simplify our company through programs across our manufacturing network and operating model while actively managing our portfolio. As such, we recently completed the divestiture of our surgical instruments platform. This value-creating transaction supports the achievement of our BD 2025 financial goals and further advances the BDI segment’s focus on high-growth end markets. This divestiture allows us to focus BD surgery strategic investments In Advanced Repair and Reconstruction and surgical complications, which are driving results and helping to address unmet needs in healthcare. Proceeds from the sale strengthened our cash and net leverage position and support our tuck-in acquisition strategy. We also continue to make progress on our other simplification initiatives, including the reduction of 20% of our SKUs by FY 2025. Ongoing network architecture optimization and our operating model initiatives to transition certain BD shared service center activities to a third-party to optimize our back-office processes and services. Looking externally let me share some perspective on the macro environment. Overall, the macro environment is in line with our view that challenges will persist, not escalate. However, uncertainty remains. We continue to monitor various factors, including how health systems, governments, distributors and suppliers are managing inflation, inventory and other supply chain dynamics. Broadly speaking, inflation is moderating, but is still elevated. The supply chain has continued to stabilize, and we’re very pleased with our progress to reduce back orders. We expect to exit the year at pre-pandemic levels, which is enabling us to shift our focus to reducing raw material and some finished goods inventory, which is contributing to our cash flow improvement. While overall procedure volumes are healthy, our portfolio has been more durable and less impacted by significant short-lived fluctuations in procedure volumes. Overall, the capabilities we have built and the durability of our portfolio have positioned us well. Before I turn it over to Chris, I’d like to share an update on our ESG strategy and goals. We recently issued our 15th annual ESG report that details our progress on the four pillars of our ESG strategy, company health, human health, community health and planet health. The FY 2022 report highlights our notable progress in energy and waste reduction, health care access and diversity. Key achievements include a reduction in greenhouse gas emissions of 10% from an FY 2019 baseline, an increase in the number of locations using renewable energy, the establishment of product recycling pilots around the world and completion of our baseline assessment for Scope 3 emissions. The report also highlights our ongoing work in advancing health equity in under-resourced communities and the product solutions and programs we’re investing in, that directly address these in equities. BD has always played a tremendous role in addressing health disparities and access to health care around the world, and we’re proud of our continued focus in this area. We are also proud to receive continued recognition for our commitment to talent and creating an inclusive culture. Most recently, we were recognized as the best place to work for disability inclusion for the fifth consecutive year, achieving a top score on the Disability Equality Index and we were named to U.S. News & World Report’s inaugural Best Companies to Work for list. In summary, we continue to deliver consistent strong results. Our teams are working unwaveringly to achieve key milestones that sets us up for continued growth and consistent performance. And this quarter is another reflection of our focus and determination in achieving our BD 2025 goals. We continue to grow, simplify and empower BD and evolve into an agile, innovative medical technology company with a durable compelling growth profile. With that, let me turn it over to Chris to review our financials, guidance and outlook.
Chris DelOrefice:
Thanks, Tom. Echoing Tom’s comments, our BD 2025 strategy is driving consistent performance in an outsized growth profile. We are advancing our innovation pipeline and delivering against our revenue, margin, and EPS goals. We’re also making progress strengthening our balance sheet with lower inventory and net leverage, consistent with the commitments we made. With strong year-to-date results, we are well on track to achieve our updated FY 2023 guidance. And with the addition of Alaris return to market, we are increasingly confident in achieving our BD 2025 long-term targets of 5.5% plus organic revenue growth and double-digit adjusted EPS growth. Beginning with some color on our revenue performance. We delivered strong Q3 base revenue growth of 7.9% or 6.3% organic. Base organic growth includes growing over prior year respiratory testing sales which negatively impacted base growth by approximately 100 basis points. Additionally, our tuck-in acquisition strategy continues to enable profitable growth with organic growth from acquisitions that have anniversaried contributing about 40 basis points in the quarter and are expected to contribute 50 basis points for the full year. COVID-only testing revenues were $8 million in the quarter, which as expected, declined from $76 million last year. Revenue growth was strong across BD Medical and BD Interventional with growth of 12.2% and 8.1%, respectively. As expected, BD Life Sciences revenues declined due to lower COVID-only testing revenues compared to the prior year. Life Sciences base revenues, which exclude COVID-only testing, were about flat, given the comparison to prior year respiratory testing sales that negatively impacted base growth by about 400 basis points. On an underlying basis, Life Sciences base revenues grew approximately 4%. Total company base revenue growth was strong across all regions with high single-digit growth in the U.S. and internationally, including strong double-digit growth in China. Strong performance in our Medical segment reflects execution of our growth strategies across our key end markets. This includes an MDS where we continue to drive growth in Vascular Access Management with our BD PosiFlush vascular care and PIVC Catheter Solutions. In Medication Management Solutions, our investments in high-growth areas like pharmacy automation are driving strong growth, led by our Parata acquisition and BD ROWA. Our MMS dispensing platform reported double-digit growth, reflecting our continuous innovations in BD Pyxis, including the BD HealthSight portfolio. And in Pharm Systems [ph], in the higher-growth pharma and biotech drug delivery end market, our capacity expansion investments and strong leadership position in pre-fillable solutions with BD Hypak and newer innovations in products such as BD Neopak, BD Effivax and BD Hylok are driving our 13th consecutive quarter of double-digit growth, while supporting the increased demand in high-growth categories like biologics. Life Sciences base business growth was about flat and approximately 4% underlying when adjusting for the respiratory testing sales comparison. This reflects execution of our growth strategies across our key end markets, including microbiology, molecular diagnostics and single-cell analysis. It was partially offset by impact of some U.S. distributors destocking in specimen management. In our IDS business, double-digit growth in microbiology reflects demand for our BD Kiestra lab automation solution, including continued adoption of the IdentifA and Total Modular Track Solutions and strong demand for our blood culture and ID/AST reagents. Continued strong growth in molecular IVD assays reflects leverage of BD COR and the incremental BD MAX installed base. In Biosciences, high single-digit growth was driven by our clinical business with strong double-digit growth in cancer reagents, leveraging the growth in our installed base of FACSLyric analyzers and adoption of FACSDuet automation. Performance in Research Solutions reflects continued strong growth in research reagents enabled by our innovative BD Horizon dyes. Strong performance in our Interventional segment reflects execution of our growth strategies across our key end markets, including Advanced Repair and Reconstruction, PVD and incontinence, where our newer innovations in high-growth areas are continuing to contribute nicely to growth. Our Surgery business unit delivered strong double-digit growth driven by continued market adoption of Phasix’s hernia resorbable scaffold and our PI business unit, double-digit growth in Peripheral Vascular Disease was driven by broad-based strength across the portfolio, including global penetration of Rotarex. In our UCC business unit, high single-digit growth was driven by strength across the portfolio, including strong double-digit growth of our PureWick solutions for addressing chronic incontinence in both the acute and alternate care settings and double-digit growth in Endourology. Further details regarding each segment’s performance in the quarter can be found in today’s earnings announcement and presentation. Now moving to our P&L. We reported Q3 adjusted diluted EPS of $2.96, which included gross margin of 52.6% and operating margin of 23%. Operating margin improved 100 basis points year-over-year and includes an unfavorable 100 basis point impact from the accounting treatment of an employee benefit-related item that gets recorded in G&A and is fully offset in other income with no resulting impact to EPS. Excluding this item, operating [Technical Difficulty] and was ahead of our expectations driven by strong execution against our margin improvement initiatives. Foreign currency was a 50 basis point headwind to both gross margin and operating margin. Gross margin performance reflects leveraging our strong revenue growth and the benefit of our simplification and inflation mitigation initiatives that enabled us to overcome 200 basis points of outsized inflation. Our Q3 margin drivers are aligned with what we have been anticipating throughout the year, which is that most of the full year margin improvement will come from SSG&A expense leverage. Q3 SSG&A expense increased about 4% year-over-year. Excluding the employee benefit-related item, we drove about 150 basis points of leverage in SSG&A, which reflects shipping efficiency and good leverage in selling and G&A expense. As expected, R&D as a percentage of sales of 5.9% and normalized back towards our expected full year average of about 6% in Q3, given our spending was over-indexed in the first half. In summary, we continue to execute well and fully delivered our Q3 operating margin goal with operating improvement, excluding the employee benefit item nicely leveraged by 200 basis points. Below operating margin, the improvement in other income reflects the offset to the employee benefit-related expense recorded in G&A. Our tax rate in Q3 was 15.7% due to benefits realized that were not previously contemplated. Regarding our cash and capital allocation. Cash flows from operations totaled $1.7 billion year-to-date, as expected, operating cash flows improved substantially in Q3, including a reduction in inventory from the prior quarter. We anticipate a continued normalization of working capital in Q4, including further improvements in our inventory balance as we trend toward levels that are closer to the prior year. We ended Q3 with a cash balance of approximately $1 billion. During the quarter, we repaid over $1 billion in debt maturities, utilizing the proceeds from the February debt refinancing. We ended the quarter with a net leverage ratio of 2.9 times. We continue to move towards our net leverage target of 2.5 times. In summary, we executed well against our cash and net leverage improvement goals this quarter. We remain committed to enhancing our cash conversion and net leverage positions and expect more progress in Q4, including benefiting from the net proceeds from the divestiture of our Surgical Instrumentation Platform which will increase our capacity to deploy cash towards tuck-in M&A. Moving to our guidance for fiscal 2023. For your convenience, the detailed assumptions underlying our guidance can also be found in our presentation. Starting with our updated revenue guidance before the divestiture of the Surgical Instrumentation Platform. Given our strong third quarter performance, we are raising the midpoint of our base revenue guidance by 25 basis points to 7% and we now expect base revenues to be between 6.8% and 7.1%. This includes increases in the midpoint of both organic and inorganic revenue growth and reflects strong third quarter organic performance as well as inorganic momentum driven by our Parata Pharmacy Automation Solution, demonstrating our strong execution and M&A integration capabilities. Inorganic revenue is now expected to contribute approximately 135 basis points to full year base revenue growth. For the full year, base organic revenue growth is now expected to be 5.5% to 5.8%, which continues to reflect strong fourth quarter organic revenue growth of about 6%. Our guidance continues to include the impact of strategic portfolio exits, which has moderated slightly from our original assumption. Finally, adjusting for the impact of the recently completed Surgical Instrumentation divestiture adjusts our updated base revenue growth guidance by 20 basis points to a range of 6.6% to 6.9% to reflect net inorganic revenue adjustments to base growth of approximately 115 basis points. Our increased base organic revenue growth guidance of 5.5% to 5.8% is not impacted. Over a two year period, we are driving strong base organic revenue CAGR of about 7%, which is well above our long-term target. Our segment-specific growth assumptions have not changed. For COVID-only testing, our guidance only includes year-to-date revenues of $56 million. All in, we expect reported revenues to be approximately $19.3 billion, which is an increase from our previous guidance of $19.2 billion to $19.3 billion. Regarding the Alaris 510(k) clearance. As previously disclosed, we expect to ramp our return to market in our infusion business over time with our existing customers and remediation taking first priority. As we scale our manufacturing capacity and ensure we are taking the necessary actions to deliver our products in the right way, we are well positioned to engage with customers and execute as quickly as possible. However, we do not expect any material incremental revenue contribution from Alaris for the remainder of FY 2023, and we expect to begin a more regular rhythm of shipment and installation of devices and recognizing revenue as we progress through FY 2024. Within our FY 2023 guidance range, we expect to absorb any initial investments beyond the sales and service organizations we retained to successfully support our return to market. Regarding our assumptions on earnings, we continue to expect operating margins to improve by at least 100 basis points for the full year. We are executing as planned and have line of sight to our targeted margin improvement. Below operating income, our assumption regarding interest other remains unchanged. We have lowered our effective tax rate guidance to be between 13% and 13.5%. The midpoint of our updated tax guidance range is essentially equivalent to our FY 2022 actual effective tax rate of 13.3% and as a result, is not incrementally contributing to FY 2023 EPS growth. Our adjusted EPS guidance range of $12.10 to $12.32 remains unchanged, but reflects absorbing a $0.02 negative impact from the divestiture of our surgical instrumentation platform and a $0.05 negative impact from the latest FX rates. We are raising our base business earnings forecast by $0.07 based on our strong third quarter performance, including consistent execution of our margin goals, offsetting the impact of the divestiture and FX. On a currency-neutral basis, we now expect adjusted EPS growth of about 10% to 11.5% and driven by very strong mid-teens base business growth of approximately 14.5% to 16%, an increase of 50 basis points from our prior expectation. As a result, given our strong growth and execution on a year-to-date basis versus our original guidance in November. We’ve increased our adjusted base business earnings per share by about $0.27, which added 225 basis points to growth, resulting in the 14.5% to 16% growth on our base. This also includes absorbing another year of outsized inflation of about 200 basis points. These strong base business results enabled us to fully absorb an increased earnings headwind associated with the loss of COVID-only revenue as well as lost earnings associated with the recent surgical instrumentation divestiture and still increase our total FXN growth rate by 75 basis points to 10% to 11.5% double-digit earnings growth. As you think about Q4, the following are a few key considerations. We’ve outlined more detail in the accompanying presentation slides. First, our increased organic guidance continues to reflect strong growth of about 6% in Q4. As a reminder, we’ve now anniversaried the acquisitions of Parata and MedKeeper. Second, as you think about margins, as we’ve described throughout the year, most of the full year improvement is expected to come from SSG&A expense leverage with the balance from slight improvement in gross margin, which has been muted year-to-date because of outsized inflation. For operating margin, we continue to expect significant year-over-year margin expansion in Q4. However, versus our last update in May, the amount of expansion needed has been reduced by about 75 basis points, and thus, we de-risked our Q4 delivery. There are several factors driving Q4 operating margin, including expense leverage, on expected strong revenue performance, inflation mitigation actions to offset outsized inflation and cost of goods sold, SSG&A expense reductions driven by the timing of spend and the full quarter impact of our more recent simplification initiatives. Also, R&D as a percentage of revenue will continue to moderate lower to about 5% of sales, resulting in full year spend of about 6%. Finally, there is also a favorable comparison to the prior year reinvestment of COVID-only testing profits. As we look ahead to FY 2024, we remain confident in our ability to deliver against our BD2025 strategic and financial goals. While it is premature to commit to specifics, I can offer the following thoughts as we look ahead. As discussed, we continue to operate in a macro environment that remains uncertain and an inflationary environment that has moderated but remains elevated. We are especially focused on monitoring how various governments such as China respond to economic and other dynamics. With that said, med tech in general has proven to be much more durable during times of uncertainty, including economic downturns. And certainly, BD has a proven strategy and has demonstrated not only the ability to be resilient, but to deliver strong growth in earnings during the most challenging times. Our market-leading portfolio, strong innovation pipeline, continued shift into high-growth end markets and track record of execution gives us confidence in delivering against our 5.5% plus target next year. With respect to Alaris, we are excited to shift our focus and reengage with our customers. The clearance of Alaris offers much needed certainty to our stakeholders. As previously noted, it increases our confidence in executing against our BD2025 targets. Just two weeks after clearance, it would be premature to provide a range of expected revenue in FY 2024. However, consistent with what we’ve shared we expect to ramp revenues back to our pre-ship hold level of approximately $400 million over time. Our focus will be replacing and upgrading pumps for our existing customers. At this juncture, knowing we have some level of Alaris revenue in our FY 2023 base of around $100 million, we would anticipate a modest level of revenue above that, which could result in about a 50 basis point tailwind to growth in FY 2024. As a result, based on current assumptions and the macro environment factors I mentioned we are monitoring, our base growth with Alaris would be approximately 6%. We will share more about other assumptions across our portfolio when we solidify our FY 2024 plans. As a reminder, if you look outside of our base business, in FY 2023, we have realized nearly $16 [ph] million in COVID-only revenue. Based on current dynamics, we would not expect material revenue in FY 2024 and which results in an expected headwind of about 30 basis points that you need to adjust for. Additionally, the sale of the surgical instrumentation platform will have nearly a 75 basis point impact to total growth. This does not impact our organic growth, which should be considered in your total FXN revenue growth. We will true up for currency when we provide FY 2024 guidance in November. Regarding earnings, we remain confident in our double-digit earnings growth profile of about 10% currency-neutral EPS growth. This includes absorbing the reduction to earnings associated with lower COVID-only testing revenue and the divestiture impact. Combined, these items are worth about 125 basis points. We will share more details when we give our guidance, but given we expect to finish FY 2023 at 70% of our 25% operating margin goal by 2025. At this point, we are tracking ahead of our 2025 margin goals. Importantly, this gives us the flexibility to deliver on our margin goals while investing to maximize growth and deliver on our double-digit earnings growth target. As we finalize our plans, we will look at optimizing the ratio of growth versus margin increase that delivers against these goals. In summary, we see our value proposition as differentiated and importantly, have consistently executed against our commitments, which gives us confidence in our ability to continue to deliver against our future goals. In closing, we are consistently delivering multiple periods of outsized financial performance. I would like to thank our associates around the world who are working hard to deliver on our purpose and help us achieve these results. As we look forward and as reflected in our FY 2023 guidance and our progress towards our BD 2025 long-term targets, we are well positioned for continued growth. With that, let’s start the Q&A session. Operator, can you assemble our queue?
Operator:
[Operator Instructions] We’ll go ahead and take our first question from Vijay Kumar with Evercore ISI. Please go ahead.
Vijay Kumar:
Hey guys, thanks for taking my question and congrats on a good execution here. Tom, maybe my first question here on Alaris. I think you mentioned 50 basis points contribution to growth in fiscal 2024. That would imply, I think total Alaris revenues of $200 million. Can you talk about – is there any supply chain constraints in terms of delivering pumps for next year? My understanding, yes, the markets hasn’t undergone a replacement cycle in three years. So why are we assuming a modest Alaris contribution or ramp in fiscal 2024?
Tom Polen:
Hey, Vijay, good morning and thanks for the recognition of a strong quarter by the team. Just as we get into Alaris, I just want to take a moment and just reiterate some comments that I made on the prepared remarks, which was to thank our team for the efforts to get it here. This is obviously a tremendous milestone. It’s been our number one priority since we kicked off BD 2025. I also want to thank our customers for sticking with us through this process. On your question – so first, I think it’s important, let’s keep it in perspective, we’re two weeks post clearance, right? And our teams have been heads down reaching out to our customers, getting our service organization trained on the new pump. We’re pleased that we’ve contacted the vast majority of our customers, and the feedback is positive. At this time, I think the number that we’ve shared is the prudent number. We’ve always said it’s going to be a ramp over time and that we will get back to the $400 million we expect, but that will be ramping over time. And at this point, two weeks into the process, we see that number as appropriate. We have done some pre-buys on materials coming into clearance. We’re obviously continuing to do that. But we are scaling up to an unprecedented level as we think about also splitting componentry between people purchasing as well as remediating pumps. So we keep that in mind. That’s a process and as it continues to evolve, we’ll continue to provide updates. I don’t know if there’s any other feedback to that here in the room.
Mike Garrison:
Thanks, Vijay, for the question. And this is Mike Garrison. And there are no near-term supply chain constraints. We were able to secure componentry. We are scaling up manufacturing, as Tom mentioned, from our current run rate up to what we look to supply the entire market. And that will take a little bit of time. We want to make sure that we train people effectively get all the componentry in place and get the cells working the right way, but there’s no supply chain constraints at this time.
Vijay Kumar:
That’s helpful comment. And then maybe one more on – and I think you mentioned biotech as being a tailwind. How should we think about GLP-1 opportunities within your pharma portfolio? I think some of your tools peers have made cautious comments on biopharma spending. Is that a cause for concern here in Biosciences? Thank you.
Tom Polen:
Yes. Great question. Obviously, so I’ll break that into two questions. On the biopharma side and Dave can comment further. Obviously, you saw very strong growth out of our Biosciences business. I think that the pace of innovation that we’re driving in that business across instrumentation and reagents as well as just the customer base being perhaps more research-focused and large pharma focused then dependent upon the smaller biotech funding that you’re seeing impact from other companies. We’re seeing strong durability in our performance within the Biosciences business. When it comes to specific drug categories, obviously, you saw another phenomenal quarter out of Pharma Systems in Q3. We feel really good about the continued momentum of that business. We don’t – all of our customers there, it’s a confidential relationships between us and our customers, so we don’t comment on any specific molecules or individual customers. But obviously, the capacity that we’ve been adding, and as we’ve said before, we have five to six extra capacity of the nearest competitor in that space. As there’s large molecules coming to market, of course, our capacity position is an advantage, and we have discussions with customers around that. So we can’t comment on any specific one, but we’re certainly in a very good position to serve very large, fast-growing markets. Dave you have comments on Biosciences?
Dave Hickey:
Yes. Just – hey Vijay, specifically on Biosciences and just – I mean, obviously, it was another strong quarter for us 7%, and we’re seeing good continued growth in life science research and clinical, specifically on biotech biopharma. We have the advantage that for our own bioscience business, we’ve got a very broad range of customer segments, right? So academic research, biotech, of course, pharmas, CROs, hospitals. So we’re not necessarily dependent upon just one or two few customer types. And then given where our specific solutions are used in pharma, biopharma primarily used for discovery and translational research and then clinical studies for those new molecules. So it’s very much earlier in the discovery process and those types of companies still need to do that work so that they can identify those molecules for their own future growth. So I think given where we apply, we’re not seeing as much impact.
Vijay Kumar:
Thanks guys.
Tom Polen:
Hey thanks for the question, Vijay.
Operator:
Thank you. We’ll take our next question from Larry Biegelsen with Wells Fargo. Please go ahead.
Larry Biegelsen:
Good morning. Thanks for taking the question and congrats on the clearance of Alaris. I do want to focus on Alaris. And Tom – and team, I’ll ask a multipart question here and just one upfront. So the remediation and replacement plan, Tom, can you talk about the cost and time line there? And is FDA going to allow you? When is FDA going to allow you to commercialize above the $100 million in medical necessity. Is there kind of a gating factor here? And how should we think about the pent-up demand, Tom? Do you think that at some point – I mean it’s about $1 billion in backlog. Do you think at some point, you’ll exceed $400 million per year to exhaust that backlog? And just lastly, when you remove Alaris from the market or put it on ship hold – I’m sorry, you reduced EPS by about $0.70 for two-thirds of the year. So when can investors expect to get back, what they lost in the earnings here? Thank you.
Tom Polen:
Hi Larry, great set of questions. So, I’ll start and I’ll turn it over to Mike. So when it comes to remediation and CMN, so first off, the 510(k) fully replaces the CMN process. So the CMN process essentially ended and the 510(k) clearance replaces that program. As we think about moving forward in terms of remediation, of course, our focus is prioritizing existing customers to update or replace existing devices to the cleared version. That’s our number one priority now with clearance, and that’s the focus of our efforts is within our existing customer base. To your point, there is a lot of pent-up demand as people have aged fleets. And that is also one of that among our existing customers, those with older pumps are our top priority to get those upgraded or replaced to the current cleared version. So that’s how we view that. And then as we think about EPS, of course, we’ve been driving a very strong growth profile. And in our BD 2025 strategy and Chris can add in further here. In our BD 2025 strategy, we had included the relaunch of Alaris in that. That was very clear at the time. As we set bold margin goals to reach and later updated those goals and increase them to 25% operating margin by 2025. We’re obviously very much on track to that goal. And as we think about the EPS and the margin impact, which was about 80 bps, if you recall at the time, right, that’s coming back in and will continue to come back in, in line with the strategy that we’ve put out. So maybe we start with Chris, anything to add there on the margin side? Alaris is a good question. And then, Mike, if anything to add on the remediation pent-up demand.
Chris DelOrefice:
Yes. I think on the margin side, Tom, you covered it well. There was the 80 basis points that we talked about that was historic. Obviously, a lot’s changed since then, including moving into an inflationary environment. And as you’ve seen from our performance, we’ve been taking a lot of actions in our business to drive margin improvement across the board. But that 80 points will certainly come back. It was always part of our 2025 by 2025 [ph] goals. You should really see that more scale as we’re going to be going through kind of think of a ramp period with Alaris. And certainly, even as you think of the front end around margin, right? One, these are dilutive to GP in terms of the BD level, right? So just keep that in mind. And there’s going to be investments that we need to make that are incremental above and beyond the investments that we retain. First of all, you do have some variable items such as shipping, communication materials, marketing, customer service, ramp up, all of that. Additionally, in the short term that there’s going to be added things. What we’re trying to do as we get back. So certainly, it’s going to be a contributor. And I would point to our FY 2024, which is obviously preliminary. We’re looking at all the market factors that are out there and geopolitical dynamics, et cetera, but we wanted to be prudent and provide some perspective on the momentum we have on 2024 and where we’re heading. But you’ll notice we committed to around 10% EPS growth, which includes absorbing the divestiture and the further headwinds in terms of COVID-only revenues dropping. So it actually implies a base earnings growth above 11%. Some of that is, of course, the momentum we have in our base business, the margin Alaris. So, I think collectively, you see us getting to those goals and the Alaris margin is certainly part of that.
Larry Biegelsen:
Thanks you so much guys.
Mike Garrison:
The only thing I’d add, Larry, and thanks for the question. As we are cleared to market BD Alaris system in the United States. It feels really, really good. To say that after three and a half years, and we’re also really thankful to our customers that throughout this whole process and through a pandemic and through all the challenges they face, they’ve demonstrated their preference for the Alaris system. And so that is our focus. And a priority, first and foremost, is to take care of them and make sure that improvements that are in the cleared product get to them first. So that’s going to be the focus there. It is – we do have the largest fleet in the field. So the size and breadth sort of extends the time line. It’s just going to take a fair amount of time to get through everything. But we’re looking to do that as expeditiously as possible and scale up manufacturing to sort of meet that need. And then we also noticed during COVID that interoperability was a real benefit where nursing and nursing staff didn’t have to spend as much time manually programming the pumps at the bed side. They were able to utilize the interoperability to interface with the electronic medical record that has some time line from an implementation standpoint, it takes a little bit longer to implement to get those advantages. We think there’s going to be some increased demand for interoperability from the field, and that may sort of extend implementation times a little bit. So that’s another factor to think about as we’re doing this upgrade and replacement.
Tom Polen:
Maybe just one last one to add on to Mike’s good comment, so it’s great to be back. Obviously, we’re focused on prioritizing our existing customers and replacing existing devices to the cleared version with a big focus on the older systems. But the other big thing that this allows us to do beyond servicing our customers and helping them refresh their fleets and make sure they have the cleared technology, the most modern technology with all the incremental benefits and upgrades that are in this version, which are fantastic is that we can continue now. We have a basis by which to innovate upon. And that’s a big deal, right? We’ve had a great track record of being first in a number of areas in infusion, right? We were the first company with fully integrated system. We still are the only company and will be with one system approach, right? One interface, much easier for clinicians. We led the way with guardrails with interoperability. Now we have the most advanced wireless cybersecurity on the latest pump, the most modern that’s available. And as we think going ahead, we see other innovations that we already have plan to build upon this, which will continue to add value to our customers. And we already have planned a cadence of additional 510(k)s going forward. And that’s a big deal. Of course, we also have and we’re the first company, and they’re the only company who have integrated pumps beyond being stand-alone devices, but making them part of improving the overall medication management ecosystem, right, with Alaris and our software in the pharmacy. And that has been something that customers have significantly valued. It’s one of the reasons that, as Mike mentioned, most Alaris customers have stuck with us over this time because of all the value that I described. We’re going to now be able to continue to add to that and continue to advance our innovation leadership built upon this 510(k). And so our teams are really excited about that and our R&D teams are already on working on what’s next. So thanks for the question, Larry.
Larry Biegelsen:
Thank you.
Operator:
Thank you. We’ll take our next question from Robbie Marcus with JPMorgan.
Robbie Marcus:
Great. Thanks for the questions and congrats on a nice quarter. Maybe a follow-up on Larry’s question. A lot of analysts across the street were thinking about how big of a backlog there could be in the market. You were doing about $400 million in run rate Alaris sales pre recall. There’s been a couple of years where there just hasn’t been enough replacement in the market. I’ve seen estimates anywhere from a few $100 million all the way up to $1 billion. So to help level set people. Is there any number you could put around what you think could have been sold during that time if normal replacement happened, but didn’t? And how to think about how quickly that can come back into extra sales to replace the fleets out there?
Tom Polen:
Robbie, good question, and I appreciate the recognition of the team. Yes. At this point, again, we’re two weeks into clearance. And I think what we’ve shared in the preliminary outlook for 2024 is what we think is a prudent number to share today. As we continue to advance, we’ll continue to update that. I think it’s also important to recognize that there was – the last couple of years have not been normal years by any means, there’s been a global pandemic and a lot going on in the healthcare system. We also had placed quite a large number of pumps during the global pandemic because Alaris is such a trusted and essential part of delivering healthcare, it was needed in much more significant levels than it has ever been needed before. And so a number of customers added into their fleets at that point in time. So we’re going to get a better sense as we continue beyond the two week period, we get in further periods, get into the months and we’ll continue to update as that moves. Maybe Chris, any other comments to add there? Mike?
Chris DelOrefice:
Well, I mean, I think you answered it well. I mean I just – I think what you talked about is there’s the Alaris benefit that gives us a natural glide path to continue to build on momentum we’ve had the past two years, first two years of our BD 2025 strategy. You could see what we put forth in 2024, and we’re talking about base growth of around 6% now, which is I think, an exciting commitment at this juncture. And certainly, it will be a catalyst going forward. And I think beyond to Tom’s point, Alaris in itself, but really capitalizing on the full value proposition of our Medical segment.
Robbie Marcus:
Great. And sorry, but one more Alaris question. In the approval, you talked about that there – some of the pumps out there would have to be replaced and some would have to be remediated. Can you maybe speak to exactly what makes a pump qualify for replacement versus remediation and what percentage needs to be replaced versus remediated and the difference in costs associated with it? Thanks.
Chris DelOrefice:
Yes. Just the remediation process is very multifaceted complex. We’re working with the agency on this. On a case-by-case basis, it needs to match the 510(k), the cleared and so that’s sort of what we’re doing. We’ll be going out, doing walk-throughs at the customers, customers through COVID may have had mixed fleets of different ages of pumps, things like that. So we need to kind of go on a customer-by-customer basis and in some cases, a pump-by-pump basis. So that’s where that stands. We’ve – our commitment is mainly to our – and our priorities for our existing customers that have stuck bias. Something just to go back to the previous question, the run rate at the – in sort of 2018, 2019, that had a fair amount of competitive position gain. So – because our Alaris product was being preferred at that time and we were gaining position in the marketplace. Probably in the near-term here, we’ll be focused on the remediation and the replacement of our existing customers. So that’s something just to think about from a pent-up demand perspective.
Robbie Marcus:
Great. Thanks a lot.
Tom Polen:
Hey Robbie, this is the last thing. I think if you refer to the prepared comments as well. We did make the comment that we do continue to engage with the FDA on how we intend to execute those remediation plans and the combination of upgrades and replacements and that we will provide more information as we progress. So just to bring you back to those prepared remarks as well. So great question.
Operator:
Thank you. We’ll take our next question from Patrick Wood with Morgan Stanley.
Patrick Wood:
Amazing. Thank you so much. I’ll just ask two quick ones upfront if that works. Yes. You touched on the – and I appreciate you’re not guiding for 2024. But the margin expansion. And if you hit your guide for this year, you’ll obviously exit the year with a very strong finish kind of 26% or so. So I guess like how are you thinking about investing to support the launches next year relative to margin gain given it looks like you’re running about a year out of schedule potentially. Any color around there would be great. And then the second one is just a quick one maybe on MMS. I mean, very, very strong underlying growth and given that drops into organic pretty much next quarter onwards. Just curious what you’re hearing from customers, how you think about the durability within, whether it’s the pharmacy side or anything else? Just any details, that would be great. Thanks.
Tom Polen:
Thanks, Patrick, for the great questions. We’ll start with Chris.
Chris DelOrefice:
Yes. Thanks, Patrick. Yes. Regarding margins, to your point, we’ve executed very strong in a very complex environment, right past two years. We’ve had over 400 basis points of outsized inflation despite that. We’ve had nearly 400 basis points of base margin expansion. And so that puts us 70% of the way on track to the 25% goal. So we feel really good about that. If you do sort of the implied kind of math in the next two years, you would need roughly 50 basis points to 75 basis points per year. We don’t want to share specifics at this time as it relates to margin profile. There’s lots to consider within the P&L. It’s obviously early from a guide, but I think what it offers us the way you should think of it is we have a de-risked path to 25% over the next two years. Not only that, it gives us a lot of flexibility to continue to ensure that, to your point, we’re balancing an investment posture against continuing to drive outsized top-line growth while still achieving our margin goals. So those will be the puts and takes that we’ll think about as we move forward. I think the last comment I would make is, we have a strong profile and pipeline of margin improvement initiatives that have already been underway now for years. So these aren’t just numbers that are on a page to get to an outcome. We have detailed plans that get there and detailed plans that are de-risked in a way that we would plan knowing that execution doesn’t always happen or you have other headwinds that may happen and gives us confidence to get to that number, but also some of those efficiency plans can be reinvested back in the business, too. So I think it’s a very good position to be in, and we’ll continue to share more as we get closer to 2024.
Tom Polen:
Great. And obviously, on MMS, a really strong quarter prior to Alaris clearance obviously occurring. And so some really good things happening in the base business there, Mike?
Mike Garrison:
Yes. Thanks for the question, MMS, a couple of things to note. There is a little bit of an easy compare to last year. Last year, if you recall, at this time, there were some COVID shutdowns in China. That had some implications in terms of supply chain delivery. But that was – that’s not the real driver here. The real driver here is pharmacy automation and dispensing and the value proposition that we have around the combination of patient safety and clinician productivity. And those two things are resonating with our customers. And the Parata acquisition, our BD ROWA, both growing double digits and really helping to transform the way healthcare is thinking about the pharmacy and the value that it can provide moving those pharmacists to work at the top of their license instead of counting to five pills at a time into amber bottles day-in, day-out. On the dispensing side, we really changed our approach a few years ago around innovation and started to focus on a cadence of innovation and dispensing making it more connected, making it more focused on controlled substance management, these types of things. And it’s really started to pay off in the marketplace. That’s really resonating. And it’s helping clinicians, especially during labor shortages and nurse shortages and things like that, to better effectively do their jobs in the hospitals. So the dispensing, the organic, I think, for MMS was quite strong, really driven by dispensing. Some other comments there from a capital allocation perspective, I think our flexible models there help for some customers where we can enter into lease agreements and things like that. So that helps for some customers, whereas other customers have the ability and they invest and they partner with us for the long term there.
Patrick Wood:
Thanks for taking the questions.
Chris DelOrefice:
Yes. And I’m sorry, just one other comment on margins that you made, because I know you mentioned the Q4 exit being, remember, there are some – which is important as you think of us delivering and our confidence to deliver in Q4. There are some timing dynamics in there, right? The phasing of R&D, we’ve talked about, there’s some phasing in SSG&A. There’s some comp dynamics in there. Those are worth between 150 basis points and 200 basis points. So that’s not a pure exit rate that you should think of that’s hot. The other nice thing is we actually de-risked our Q4 margin versus last guide. It’s – it’s about 75 bps depending on how you look at it relative to our last planning stand. So we feel really good about this year then as I shared before, the momentum beyond.
Patrick Wood:
Thank you.
Operator:
We’ll take our next question from Matt Taylor with Jefferies.
Tom Polen:
Hey good morning, Matt.
Mike Sarcone:
This is Mike Sarcone on for Matt today. Thanks for taking my questions. Just another one on the Alaris remediation. I’m just curious, are there any gating factors from the customer side, things that might be out of your control? So, we’re seeing pretty robust procedure volume growth across med tech. Does this plus any remaining staffing constraints limit customer ability to take time out to remediate or replace their fleets?
Tom Polen:
Sure. Turn that to Mike.
Mike Garrison:
Sure. I think maybe in like the acute sense at a particular hospital, but there just be – that’s a scheduling issue more than their ability to do it at all. So, I would just think of it that way that there may be – we can’t do it this week or we can’t do it this month. We can do it next month. It’s more that planning piece, but that’s something that we do anyway, whether it’s on the dispensing side, pharmacy automation. We’re constantly flexing to optimize and work with our customers based on how they can accept it. It’s not our belief at this time that the customer side is going to be a significant barrier in the long run. I think it will be more in the phasing of things over time. Does that help?
Mike Sarcone:
That does help. Thank you. And then just one question on Pharm Systems. You’ve been posting some really strong growth there. It looks like you’re on a mid-teens growth trajectory. Do you think you can just discuss kind of key drivers and how you view the sustainability of that – the growth in that business looking out to 2024 and through the 2025 plan?
Mike Garrison:
Sure. So the primary drivers around Pharm Systems are the sort of move towards biologics and the innovation that’s coming out of the pharmaceutical industry towards biologics. I think there’s a question earlier around GLP-1 and the use of GLP-1s moving from Type 2 diabetes to treat a broader population for obesity. That’s 1 driver that’s significant, but there’s also a wealth of clinical data coming out around Alzheimer’s treatment, cancer treatments, things like that. And these are biological molecules that are quite sensitive to the primary container closure device that’s used to house them. Our technology is really well suited for those types of molecules. And so if we think about the end-user population, the obesity, mental decline with age, cancer, these are very broad patient populations. And so the same sort of main driver that pharma is using there, we are able to support that. So we think that there is a fair amount of durability into the long-term demand here. I think there are also some factors. There is some COVID reset that we are also tracking very closely in the marketplace. The drugs that were used to treat during COVID that went into prefilled syringes, for example, those are being reset in the marketplace. And so we’re watching that to get a good feel for that. But long term, we feel really good about our position in this place. We also just welcome the new president for that business. So we’re really happy to have her start, and she’s coming up to speed very quickly.
Tom Polen:
Mike, and maybe just to complement what the good feedback that Mike gave is, we have a nice cadence of innovation in that business that’s supporting those overall trends as well as, of course, the over $1 billion of capacity that we’ve added. And so you’ve got these great kind of the unmet needs and continued demand cycle that’s happening from pharma driven by biologics. We invested ahead of the curve right in the middle of the pandemic, a pretty bold decision to add capacity in that period of time, and you can see that paying off now. And then a series of innovations, not only on our high-pack syringes but also on the self-injection side. These biologics – people are moved. They don’t – it’s moving from sitting in a clinic with IV in your arm or going into a clinician to get injections as these are becoming biologics are addressing chronic disease. The focus is enabling patients to deliver these medications subcutaneously by themselves in the home, not be an infusion or an injection by a clinician. And so our self-injection business is also doing well and has a number of new innovations, wearables, as an example, our Libertas platform. We’re seeing solid demand. Our auto infuser that’s wearable. Our pen, for example, that has quite a number of biosimilar insulins coming to market and a large percentage of those are coming in our pen format. We’re seeing strong demand there in addition to the high pack business. And so all that wraps up what – and supports what Mike said. Thanks for the question.
Mike Sarcone:
Really helpful. Thank you.
Operator:
Thank you. At this time, I would like to turn the floor back over to Tom for any closing remarks.
Tom Polen:
Okay. Well, thank you, operator, and thanks, everyone, for joining our call and for all of your questions. Before we sign off, I want to again thank our global team of BD associates who continue to execute against our BD 2025 strategy and are making meaningful impacts for our customers and their patients. Particularly, I want to thank our team for their efforts related to the clearance of the updated BD Alaris Infusion System. And for all the work ahead as we move forward in working with our customers, to update, replace existing devices [Technical Difficulty]. We are meeting our commitments and delivering strong, consistent performance with an increased outlook and we look forward to connecting with everyone again in November. And operator with that, we will end today’s call.
Operator:
Thank you. This does conclude today’s audio and webcast. On behalf of BD, we thank you for joining today. Please disconnect your line at this time, and have a wonderful day.
Operator:
Good day everyone and welcome to today’s Becton, Dickinson Q2 Fiscal Year 2023 Earnings Call. At the time, all participants are in a listen-only mode. [Operator Instructions] Please note, this call maybe recorded, and that I will be standing by should you need any assistance. It is now my pleasure to turn today’s program over to Francesca DeMartino. Ma’am please begin.
Francesca DeMartino:
Good morning, and welcome to BD's earnings call. I'm Francesca DeMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the second quarter of fiscal 2023. We also posted an earnings presentation that provides additional details on our business, strategy, and performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer, and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD 2025 Strategy. Chris will then provide additional details on our Q2 financial performance and our updated guidance for fiscal 2023. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment Presidents, Mike Garrison, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Rick Byrd, President of the Interventional segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the IR website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically note it as a calendar period. I will also call your attention to the basis of presentation slide, which defines terms such as base revenues and the non-GAAP reconciliations included in the appendix. With that, I am very pleased to turn it over to Tom.
Tom Polen:
Thanks, Francesca. Good morning, everyone. And thank you for joining us. Earlier today, we reported another consecutive quarter of strong financial performance and significant progress advancing our innovation pipeline. The results we have been delivering for multiple periods reflect our strategy in action. We are now about halfway through our BD 2025 plan to accelerate growth and simplify and empower our company, and I'd like to share how our team's strong execution of our strategy is driving our performance and will enable continued momentum through 2025 and beyond. We have made purposeful and strategic investments, which we're seeing contribute to consistent, higher growth, and strong financial performance. We have been and remain very intentional with how we are deploying our capital towards higher growth spaces and are pleased with the significant progress we continue to make increasing our WAMGR. These actions have evolved BD into an agile, innovative, and durable medical technology company with a compelling growth profile. Our innovation mindset is driving higher product development velocity and super cycles of innovation in many of our businesses. Through a focus on the most impactful programs, improved milestone achievement and launch excellence. To highlight a few examples of our strategy and investments, and how they're fueling strong results and momentum. First in Pharm Systems, due to the start of our BD 2025 journey, we made a bold decision to invest $1.2 billion in additional capacity. Today, we're seeing this capacity investment along with several new innovations we've brought to market, paying off as we are ideally positioned to enable delivery of the large wave of biotech drugs coming to market. We've built Pharm Systems into a $2 billion growth platform with 11 consecutive quarters of double-digit growth. With over 70% of the top 100 biopharma companies using BD's portfolio and 6x the capacity of the nearest competitor we are well-positioned to continue delivering strong growth. Second, during COVID, we also made several strategic reinvestments of certain COVID-only testing proceeds, particularly in our BDB business, which is one of the areas with a super cycle of new breakthrough innovations coming to market over this and the next several years. We've already begun to see acceleration from some of the early new launches notably in biopharma for cell therapy and immune oncology research. Looking forward to the upcoming launch of our FACSDiscover S8 Cell Sorter. That was previously featured on the cover of the journal Science. The S8 combines advanced spectral flow cytometry with novel CellView Image Technology. By combining the power of high parameter spectral flow cytometry with an unprecedented picture of a cell and its inner workings. We are defining a new standard in flow cytometry, which will empower scientists to unlock life changing discoveries across fields like immunology, cancer research, and cell biology. We recently shipped our first early access BD FACSDiscover S8 and we remain on track for launch later this quarter. We've also already begun launching a new family of [spectrally] [ph] optimized BD Horizon reagents that together with the FACSDiscover S8 will create a unique spectral solution inclusive of instruments, dyes, and informatics that only BD can offer. Third, as you know, we have been very purposeful in increasing tuck-in M&A to drive scale within high growth adjacent markets. And have built strong M&A capabilities to successfully integrate assets. Our most recent acquisition of Parata’s Pharmacy Automation Solutions continues to exceed our expectations and we're already seeing an early impact from revenue synergies. The Parata acquisition expanded our offering to establish BD as a leader in pharmacy automation and created a new growth platform with revenues in excess of $0.5 billion growing double-digits. This is an attractive growing market that uses automation to address a number of the critical issues faced by our customers, such as wage inflation, labor attrition, pharmacist burn-out, and the need to reallocate pharmacist's valuable time to clinical care. Parata is just one example of the successful tuck-in acquisitions we've made over the last several years. These acquisitions are currently contributing about 30 basis points to our organic growth rate this year. And once Parata annualizes, we expect that contribution will increase to about 50 basis points. Lastly, we continue to build on our strong competency of serially innovating on and expanding the application of new technologies we develop or acquire. This is exemplified in our urology and critical care business, where our acquisition of PureWick continues to provide significant benefits to patients, and is also an impactful growth driver for UCC. We've already launched the home version of PureWick Female, which continues to be very well received and is aligned with our focus on providing solutions and new care settings. And at the end of FY 2022, we launched PureWick Male, the newest product in our planned portfolio expansion for managing incontinence. PureWick Male provides nurses with a non-invasive option for urine management in men, enabling earlier catheter removal and reduced risk of infection. We are receiving exceptional customer feedback and the adoption of PureWick Male is exceeding our expectations. We have multiple additional R&D programs in the pipeline, to continue to expand our solutions in and incontinence. These are just some of the examples of key investment decisions we have executed to strengthen our business, contributing to our performance today and over the long-term. Turning to our quarterly financial results. We are seeing the strength of our BD 2025 strategy in action across all businesses and geographies in our Q2 performance. We delivered another quarter of outstanding results that exceeded our expectations with 8.7% base revenue growth and double-digit currency neutral earnings growth. But we are excited by what we have achieved to date. We have much more to look forward to. Let me provide a few examples of how we progressed our pipeline this quarter. Starting with our recent launches, in our BD Medical segment, we launched our PowerMe midline catheter in China. And by the beginning of March, it was being used in the first patient. PowerMe was designed by our R&D center in China for China and we're excited about the opportunity it creates to develop a new category of vascular access in China. In our Life Sciences segment, we're really excited about how the BD core platform is expanding us into the high throughput, high growth molecular diagnostics market. In Q2, we received 510(k) clearance for our new Vaginal Panel on BD COR. The world's first microbiome based PCR assay that uses a single swab and test to simultaneously detect the three most common causes of vaginitis infections, enabling targeted cost effective treatment. And in our BDI segment, we launched our Highlander 014 PTA Balloon in Q2. Highlander is the first and only non-compliant fiber based balloon designed to treat peripheral artery disease and below the knee anatomy. We are proud to be leading in this space, building on our history of continuous innovation in the higher growth PVD market. We've also hit several crucial milestones this quarter. These include regulatory submissions of the PIVO Pro and BD Nexiva with NearPort IV Access, which are core elements of our One Stick Hospital Stay and Vascular Access Management strategy in our MDS business. In our biosciences business, we completed the early access program for our BD Rhapsody HT Xpress. And in fact, I'm pleased to report that just in the last few days we announced the launch. The HT Xpress is a single cell analysis system that increases the throughput of the BD Rhapsody platform eightfold, while maintaining compatibility with our existing single cell assays and reagents. This new instrument enabled access to the fast growing translational single-cell multiomics market with a high throughput research solution. And in our surgery business, we completed testing for our Phasix ST Umbilical product to support a 510(k) submission later this fiscal year. Phasix ST Umbilical is designed to provide patients reliable, alternative to permanent mesh, bringing the benefits of the category leading bio resorbable Phasix material into one of the most common abdominal wall hernia procedures. Phasix ST Umbilical will be the first fully reservable product customized for open umbilical repairs, which represents the majority of umbilical procedures. This is another example of a technology reacquired and are now expanding and accelerating the growth of. These launches and milestones are good examples of how we are strengthening our position in attractive end markets across our portfolio. While we advance our growth strategy, we also remain focused on our number 1 priority to bring the Alaris pump back to market. We are confident in the resources invested in our submission, the team and leadership task to prioritize this, and that we will get clearance. As we have stated in the past the relaunch of Alaris is included in the BD 2025 strategic plan. And while we cannot predict clearance timelines, we can ensure that we are prepared for the relaunch with the proper operational capacity and functional capabilities so that we can provide our customers with the best experience. As a reminder, we've launched an updated Alaris pump in several international markets and continue to receive very positive feedback from customers. In Q2, we continue to simplify our company with programs across our manufacturing network, our portfolio, and our operating model. We made further progress on our recode portfolio simplification program, which reduces SKUs in order to improve customer service and focus on the most important products needed to deliver care. We remain on track to remove 20% of our total portfolio by 2025, having achieved more than half of these SKU reductions thus far. In addition, we have numerous initiatives underway to consolidate our manufacturing footprint, improve cost and service, while delivering on our ESG goals to address climate change and carbon neutrality. Earlier this year, we expanded our recode initiatives to include our operating model to drive efficiency and effectiveness and simplify our organization to improve Agility. These actions resulted in us reducing our overall headcount by about 2% this year. We also recently made the strategic decision to partner with a leading business process and professional services firm and are transitioning certain BD shared service center business processes. They will be working to optimize our back office processes and services using automation, data, and process excellence that they have implemented very successfully with other large companies. Collectively, our simplification programs are a core part of our strategy to drive efficiency and enable impactful growth. To share some perspective on the macro environment, overall, the environment continues to stabilize and is in-line with our view that challenges will persist not escalate. While we're seeing signs of inflation cooling off, it is still more than twice the historical average. We see continued labor pressure with different market dynamics impacting hiring and increasing wages for certain roles, particularly in our supply chain organization. Across raw materials, some categories such as resins used and finished goods are beginning to show signs of stabilization. But overall, they have not come down universally and remain well above prior cost levels. In terms of supply availability, we have seen significant improvements across materials, supplies and labor, which are driving our back order reduction leading us to recover towards pre-pandemic supply levels. Broadly speaking, we are seeing stabilization and continued overall procedure volume recovery and volume momentum. Specific to China, we delivered strong performance despite some impact from increased COVID cases in the region and reduced hospital capacity that carried into Q2. We experienced a strong recovery in March and remain well-positioned for continued growth in China. Our strategy has proven to enable strong results in some of the most challenging times. And by successfully navigating the macro environment, we are distinguishing BD and remain well positioned to deliver continued strong performance. Before I turn it over to Chris, I'll provide an update on the progress our team is making to advance our ESG strategy and goals. We continue to be proud of our leading focus on reducing the environmental impact of our product portfolio and we recently announced the launch of our new circular economy pilots in several regions, but we are partnering with healthcare facilities and waste management companies to recycle used materials, including BD syringes in the U.S. and BD vacutainers in Denmark. In addition to launching our 2022 cybersecurity annual report in early Q2, we also established the BD Cybersecurity Risk Committee, which serves as the management level governance body for oversight of all Cybersecurity risk across the company. The committee is chaired by the Chief Risk Officer, and its members include cybersecurity leaders across enterprise, manufacturing, and product cybersecurity, as well as key functional leaders. We are also proud to receive continued recognition for our ongoing commitment to talent and culture. Most recently, we renamed the noteworthy company for the fourth straight year in Diversity Inc.’s annual ranking of the top U.S. companies for diversity. We look forward to providing further updates on the commitments, disclosures, and progress on the four pillars of our ESG strategy. Company health, planet health, community health, and human health as we publish our 15th annual ESG report later this year. In summary, I'm proud of our progress and the positive impact our associates are delivering for our customers and patients around the world. Our purposeful and strategic investments in attractive end markets are driving higher growth and creating value. Our innovation mindset is improving our pipeline execution and launch excellence and creating the most exciting product pipeline in the company's history. Our simplification efforts are reducing complexity and driving business process excellence and agility. Our increased guidance for fiscal 2023 reflects our strategy and action, strong execution by our team and a strengthened growth profile. We will continue to increase investments to support profitable growth through 2025 and beyond. With that, let me turn it over to Chris to review our financials, guidance, and outlook.
Chris DelOrefice:
Thanks, Tom. Echoing Tom's comments our BD 2025 strategy is driving consistent performance and demonstrates our strong growth profile. With our year to date performance, we are well on track to achieve our FY 2025 long-term targets. Beginning with some color on our revenue performance, we delivered strong Q2 base revenue growth of 8.7% or 7% organic. This includes growing over prior year flu COVID combination sales, which negatively impact growth by over 200 basis points and an impact from one-time strategic portfolio exits of about 50 basis points. Adjusting for these impacts, organic volume growth was in the strong mid-single digits at nearly 6%. In addition to the inorganic revenue contribution from M&A, we continue to drive organic growth from acquisitions that have anniversaried, which was about 30 basis points in the quarter. COVID-only testing revenues were $16 million in the quarter, which as expected declined from 214 million last year. Total company base business growth was strong across BD Medical, and BD Interventional with growth of 12.2% and 9.3% respectively. Base revenue growth in BD Life Sciences of 2.2% includes a negative impact of about 800 basis points, due to the comparison to higher combination flu COVID testing sales last year attributable to the Omicron wave, coupled with the timing of this year's respiratory season that peaked earlier than normal during fiscal Q1 and then declined. Base revenue growth was strong across all regions with high-single-digit growth in the U.S. and double-digit growth internationally, including 9% growth in China. For the full-year, we expect to deliver high-single-digit growth in China. Our growth continues to reflect consistent performance of our durable core portfolio and our shift into attractive and higher growth end markets. Strong performance in our Medical segment reflects execution of our growth strategies across our key end markets. This includes our durable core where we continue to drive growth in vascular access management with our BD Posiflush and Catheter Solutions. In Medication Management Solutions, our investments in high growth areas like pharmacy automation are driving strong growth led by our Parata acquisition and BD ROWA. In our Dispensing platform, continuous innovations in BD Pyxis, including the recent launch of BD Pyxis ES 1.7 and the BD HealthSight portfolio drove double-digit growth. And in Pharm Systems in the higher growth pharma and biotech drug delivery end market our capacity investments and newer innovations in products such as BD Effivax, BD Hylok, and BD Neopak are driving continued double-digit growth. Strong underlying performance in our Life Sciences segment reflects growth in our durable core in specimen management and execution of our growth strategies across our key end markets, including single cell analysis, microbiology, and molecular diagnostics. In our IDS business, growth in microbiology reflects demand for our BD Kiestra lab automation solution, including adoption of the recently launched IdentifA and Total Modular Track solutions. Double-digit growth in Molecular IVD assays reflects continued leverage of our large install base. In Biosciences, high teens growth was driven by new innovations, in BD Horizon dyes, and our expanded antibody portfolio that drove double-digit growth in research reagents and continued strong demand for our BD FACSymphony, flow cytometry analyzers. Strong performance in our Interventional segment reflects execution of our growth strategies across our key end markets, including advanced repair and reconstruction, PBD, oncology, and incontinence. Our newer innovations in higher growth areas are all contributing nicely to growth. Our surgery business unit delivered strong double-digit growth with continued market adoption of Phasix hernia resorbable scaffold, driving double-digit growth in advanced repair and reconstruction, and double-digit growth in biosurgery that was aided by Arista. In our PI business unit, the relaunch of Venovo and global penetration of Rotarex are driving high single-digit growth. In our UCC business unit, high-single-digit growth continues to be driven by strong double-digit growth of the PureWick franchise that was aided by the recent launch of PureWick Male. Across BDI, procedure volumes were also strong in the quarter contributing to growth, particularly in our surgery business unit. Further details regarding each segment's performance in the quarter can be found in today's earnings announcement and presentation. Now, moving to our P&L. We reported Q2 adjusted diluted EPS of $2.86, which included gross margin of 54.2%, it was slightly ahead of our expectations and operating margin of 22.7% that was in-line with expectations. Our margin performance reflects leveraging our strong revenue growth, the benefit of our simplification and inflation mitigation initiatives, and strategic portfolio exits that enabled our ability to more than overcome nearly 200 basis points of outsized inflation, which was in-line with our expectations. Gross margin also reflects negative FX, which was slightly higher than anticipated. SSG&A expense increased 5% year-over-year. Half of the SSG&A increase was driven by the unfavorable impact of an employee benefit related item that gets recorded in G&A and is offset in other income with no resulting impact to EPS. Excluding the employee benefit-related item, we drove about 50 basis points of leverage in SSG&A with shipping growth in-line with revenues and good leverage in selling expense. As expected, our phasing of R&D continues to be weighted to the first half of the year with R&D as a percent of sales of 6.5% in Q2. Our R&D investments are aligned to our long-term growth strategy and have been a catalyst to increased velocity of product development. In summary, we continue to execute well and fully delivered our Q2 operating margin goal with operating improvement, excluding the employee benefit item nicely leveraged by 80 basis points, including absorbing a 30 basis point headwind from lower COVID-only testing. Our tax rate in Q2 was lower than anticipated, due to the timing of certain discrete items that were contemplated to occur during the year. Regarding our cash and capital allocation. Cash flows from operations totaled $584 million year-to-date. Operating cash flow reflects an elevated inventory balance that has enabled our strong performance and ability to meet peak demands and support our customers' needs while navigating the complexity of the macro environment. We remain focused on reducing our inventory balance and have several initiatives underway to do so. As a result, while we saw peak inventory levels during the quarter, we exited the quarter with positive progress towards reducing inventory. We expect inventory to continue to decline over the balance of the year with the most prominent reduction expected in Q4 to levels similar to the prior year. We're also driving more effective capital expenditures for the full-year and expect expenditures to be similar to the prior year. We ended the quarter with a cash balance of approximately $2 billion, which includes the proceeds from debt refinancing during the quarter that will be utilized to repay maturing debt over the balance of the year. We ended Q2 with a net leverage ratio of 3.1x. We expect to pay down our commercial paper over the balance of the year and move towards our net leverage target of 2.5x. As the year progresses and we build cash, we will increase our capacity to deploy cash towards tuck-in M&A. Moving to our guidance for fiscal 2023. For your convenience, the detailed assumptions underlying our guidance can also be found in our presentation. Given our quarter performance, we are confident in raising the midpoint of our revenue and adjusted EPS guidance ranges. The strength of our base revenue growth and consistent execution of our margin goals is enabling our ability to offset lower COVID-only testing revenues and the latest FX rates, while reinvesting in the business to drive future growth. Starting with revenues, I will provide some insights into some of our key guidance assumptions. First, we are well-positioned for strong growth across our three segments, which are delivering at or above our expectations, and thus, we are increasing our base revenue guidance. On a currency-neutral basis, we now expect base revenues to grow 6.5% to 7%. This is an increase of 50 basis points at the midpoint from our prior guidance of 5.75% to 6.75%, and is driven by our Q2 revenue outperformance and the confidence we have in our team's continued strong execution and our consistent growth profile. Following our strong FY 2022 growth of 9.4%, we again increased our revenue guidance in FY 2023, which at the midpoint brings our two-year average growth to about 8% or 7% organic, which is well above our 5.5% plus target. Increased base revenue guidance includes both higher organic and inorganic growth expectations for the full-year. We now expect inorganic revenue to contribute approximately 125 basis points of base revenue growth for the full-year, which is an increase of 25 basis points, driven by the strong execution of Parata. Organic based revenue growth is now expected to be 5.25% to 5.75%, an increase of 25 basis points at the midpoint. Both our base revenue and base organic revenue growth continue to include a reduction of approximately 100 basis points, resulting from our planned one-time strategic portfolio exits. While we aren't providing segment-specific guidance, we are on track to deliver strong performance across our segments this fiscal year, in-line with our long-term planned commitments. We expect Medical segment growth to be above the total company range, which includes the acquisition of Parata, Life Sciences growth to be below given strong prior year comparisons and Interventional to be above the total company range. For COVID-only testing, we are now assuming about $50 million in revenue versus our previous expectation of about $50 million to $100 million, driven by the reduced testing volumes as a result of the early peak and rapid decline of the respiratory season. All-in, we are increasing our reported revenue guidance by approximately $50 million at the midpoint to a range of $19.2 billion to $19.3 billion, compared to $19.1 billion to $19.3 billion previously. Regarding Alaris, we continue to only model shipments related to medical necessity in-line with fiscal 2022 demand. Regarding our assumptions on earnings, we continue to expect operating margins to improve by at least 100 basis points for the full-year. We are executing as planned and the actions required for the year to drive margin improvement remain unchanged. Our focus on driving profitable revenue growth, combined with the significant simplify actions in place, including the previously planned operating model programs that we recently announced, gives us the confidence that we will again deliver meaningful margin expansion this year, while absorbing about 200 basis points of outsized inflation and the incremental decline in COVID-only revenue, which has a higher margin profile. Below operating income, our assumptions regarding interest other remains unchanged, and we have narrowed our effective tax rate guidance to 13.25% to 14%. We expect adjusted EPS to be between $12.10 and $12.32, which represents an increase of $0.015 at the midpoint. This reflects a base business increase of $0.115 that is driving our ability to offset incremental headwinds of approximately $0.05 each from COVID-only testing and foreign currency. Our adjusted EPS guidance reflects currency-neutral growth that is around double digits and within a range of approximately 9.5% to 11%. This includes very strong mid-teens base business growth of approximately 14% to 15.5%, which is over 100 basis points higher than we previously anticipated and is driving our ability to absorb the decline in COVID-only testing. Our updated guidance reflects significant progress towards delivering the BD 2025 financial targets we laid out at our Investor Day, including
Operator:
Yes, sir. [Operator Instructions] Our first question will come from Robbie Marcus with JPMorgan. Your line is open.
Robbie Marcus:
Oh, great. Good morning everyone and thanks for taking the questions. Maybe to start, I wanted to ask on guidance. This is the second quarter in a row where you guys have had a really good performance on the top line, beat, and raised guidance, But on the bottom line, we're seeing guidance go up again by a little less than the beat on the bottom line. So, maybe spend a minute and talk through some of the puts and takes and how you're thinking about managing the rest of the year in guidance to be able to offset any headwinds. And it'd also be great – it looks like FX isn't changing on the top line, but it's getting worse on the bottom line. So, maybe throw that in there as well.
Chris DelOrefice:
Yes. Thanks, Robbie. It's Chris. Appreciate the question. I think this is pretty straightforward. So first, just look, another strong quarter and our second increase in guidance, to your point. On revenue, we increased from 6.5% to 7% or 50 basis points on our base. So, at the midpoint, that's 6.75%. And I think important to note, right, our two-year average growth now, 8% or even 7% when you strip out the benefit from tuck-in M&A, so on a pure organic basis. So, really strong, well above our 5.5% profile. As you think of the increase, basically the increase in revenue 100% matched the outperformance in Q2. The way to think of that, if you recall last quarter, we communicated that our second half growth rate would be 6.6. That stayed intact. So, we're holding it to 6.6. Importantly, as you think of the first half to the second half, actually, the organic revenue growth accelerates from 5 to 6, and again, nicely above our 5.5% plus. So, really strong revenue story following a strong FY 2022. On earnings, where I think the core of your question is, so, one, building on the strong growth. We continue to execute against our margin goals. Hopefully, that hasn't gotten lost in this macro environment where you're seeing many in multiple industries with margins declining. So, we're committed to the 100 basis points of margin improvement. We had slight improvement in the quarter. So that holds intact. So basically, the way to think of the raise, you have to, kind of break it down and really understand the base business. So, on the base business, as we noted in the presentation, we raised by [$0.115] [ph]. It exactly equals, kind of margin drop-through on the 90 million increase on our base revenue. And then you noticed we slightly modified our – the midpoint of our tax guide. So, the revenue accounts for about 60% of it, the tax accounts for the best. I think also important to note, we're not getting any year-over-year benefit on tax. It's actually still a year-over-year headwind that's absorbed in our full-year guidance. So, I think it reflects really strong base performance. And I think another important reminder – so anyway, that $0.115, it basically absorbs two factors. You noticed that we moderated down the COVID-only testing by about $25 million. That has a strong drop-through in the margin because there's very little commercial investment. It has a higher GP, as we've shared in the past. So, we more than absorbed that. And then we did absorb some FX pressure on EPS, which was pretty modest. That was $0.05 in lieu of actually dropping for FX like we normally do and adjusting our guide range. It was $0.05. We absorbed that on the strong base performance. FX, there was a little bit – if you remember in the quarter, the dollar strengthened significantly and the euro recovered. So, you actually have to look at the average in the quarter. So, there was a little bit in the quarter with the euro. You also had the yuan and the yen were the other two currencies. So, just modest impacts there. Net-net, it's a raise by [$0.015] [ph] at the midpoint. And then I think the most important thing for everyone to keep in mind, when you just look at our base EPS growth year-over-year, knowing that we're absorbing significant year-over-year declines in COVID-only testing, our actual EPS growth on the base business is nearly 15%, well above our double-digit EPS. So, we feel really good about where we sit, the halfway through the year. We haven't changed any of our, kind of core commitments around margin. With that said, we want to make sure we solidify the future. We want to keep investing. We continue to invest in R&D at higher levels. And this isn't about one quarter, one year. We think this is – what you're seeing here is a great growth story play out that will happen over multiple periods and will be durable.
Robbie Marcus:
Really helpful. Maybe just a quick follow-up. I could probably anticipate your answer here, but given the focus, any updates on Alaris or upcoming data points or catalysts we can be looking out for on the pathway to approval?
Tom Polen:
Hey, Robbie, good morning. This is Tom. Obviously, as we've discussed many times, getting Alaris back on the market is our number 1 priority. And we are confident in the resources that we have invested in our submission and the team and leadership tasked to prioritize this. As you expected and as we've said before, we're confident in our process and that we will get clearance, and we have been and want to remain prudent and thoughtful about the process with the FDA. And so therefore, we continue to not try to predict exact time lines just given how inherently complex these submissions are. So, obviously, once we get clearance, we'll immediately communicate at that point, and that has been and remains our strategy there. But we're fully focused on making sure that our number 1 job is making sure that the FDA has all the information they require to clear the product. Thanks for the question.
Operator:
Thank you. Our next question will come from Larry Biegelsen with Wells Fargo. Your line is open.
Larry Biegelsen:
Good morning. Thanks for taking the question. Tom, I think two for you. One, I just wanted to start at a high level, and congrats on a nice quarter here. The super cycle of new products you talked about, how are you feeling about your target of 5.5% organic growth beyond 2023? Chris mentioned a few times that the two-year CAGR for organic growth is 7% this year. So, could that 5.5% be higher beyond this year? And I had one follow-up.
Tom Polen:
Okay. Good morning, Larry and thanks for the great question. Great to connect as always. We're extremely excited about the pipeline that we have and our outlook going forward. We're not looking to adjust our long-term commitment at this time, but we are feeling very positive about the momentum that we have as you described. I think as we look at where we are today, what stands out, and hopefully it became clear in our discussions this morning, are the number of high-growth platforms that we've built and that we've continued to systematically progress across the company. And we talked about a few of those. Whether or not it's Pharm Systems, which is now the 11th quarter in a row of double-digit growth, and the macro environment of now biologics being – more biologics being in pharma's pipeline and small molecules today, first time in history, and some big blockbuster products coming down the pipe. And we are well-positioned as the leader in injectable drug delivery to benefit from that trend with the significant capacity we've added, as well as the innovation pipeline we have, both for professional delivery, but also enabling wearables and self-injection products that we've been investing in are coming to market now as well. Pharmacy automation, right now, a $500 million-plus platform growing in the teens. Huge trends that are going to continue to fuel that going forward, labor shortages, the need for pharmacists to move more front of the – front-off to be serving patients doing wellness checks, et cetera, we're going to continue to see strong demand for pharmacy automation, and we're really pleased with that platform that we've built. B2B, huge super cycle of innovation there. The FACSDiscover, we've started shipping to the early adopter sites and really a tremendous opportunity to help bring new insights and new discoveries in the areas of cell therapy and immuno-oncology and just understanding the immune system overall. When you think about who is getting Nobel Prizes in those fields that I just described, almost all of them were using flow cytometry. And I'm convinced you're going to see a whole new set of discoveries being uncovered with the new technologies that we're rolling out there right now. Really excited. And of course, that's complemented not only on the capital side with FACSDiscover. And the product we're launching now is just the first in a whole family that we're going to be continuing to roll-out. We're rolling out the high-end sorter first, but we're going to be offering mid-and-lower-end sorters or cell analyzers, utilizing that same technology over the next several years. That's complemented by our new die portfolio and expanding antibody portfolio, as well as informatics technologies that we have launched and will continue to launch. BD Interventional, you heard us talk about a number of great growth platforms that have been developed there, and we're seeing good strong growth out of the BDI segment. This was another strong quarter there. And you're seeing a number of the acquisitions that we've done over the last few years or had done just before BD and Bard came together, things like PureWick and the [indiscernible] innovation that's happening there, TIFA, which we acquired over the last few years and how we're expanding that into new applications, we gave an example of umbilical hernia. Straub Medical and how that's being expanded globally. And you're seeing the benefits of that in the PI business. We're really pleased with the growth momentum that's happening there. And of course, medication delivery, a continuing strong growth in our portfolio there from catheters to picks and eventually through our planning horizon and our aim to get Alaris back on market. So, we're really pleased with the momentum. We're really pleased with the launches we've done to date. We've had about 10 key launches so far this fiscal year that's coming off of 25 key launches last year. And we continue to be on track for about that same number again this year and pretty much every year as we look forward. Thanks for the question.
Larry Biegelsen:
That's super helpful. Just one quick follow-up on Robbie's question on Alaris. It's great to hear the confidence you expressed today. My question is, are you confident you can get it within the – I know you're not talking about specifics, but within the BD 2025 plan? And I know you have 80 basis points of margin improvement in the – for Alaris in the BD 2025 plan. If you don't have it within that time line, can you – do you have other ways to offset the margin leverage you're expecting from it? Thank you.
Chris DelOrefice:
Yes. Thanks, Larry. I'll take that one. Yes, to your point, if you recall, given that we made the decision to maintain investment in service, field support, et cetera, there was about that 80 basis point headwind to our margin as part of Alaris. We've been very clear, while we haven't been – said we weren't going to predict timing, we did say as part of our FY 2025 plan. The good thing about margin, and just if you step back again, we delivered 50% of our goal, right, through FY 2022. We're on-track this year. That would put us 70% towards our goal. We have multiple levers to deliver both. In essence, the way we think of it is how do we get to double-digit EPS growth on a consistent basis. We're not dependent on one variable. And given 70% of the way there, we feel really good between the strong growth profile that we expect to continue and natural leverage you get. The Recode initiatives we put in place, that will continue to accelerate through the back half of the year. We just announced kind of the third leg of Project Recode, operating model simplification. Those have been announced, continuing to drive portfolio mix as we've been doing. So, there's a host of things that I think give us confidence and the ability to actually, sort of navigate the balance between top line growth and margin improvement as we continue to progress through the back half of the year while delivering on both commitments, the 25% margin and double-digit EPS growth. So, I think we're really well-positioned when you think of it that way, gives us a lot of flexibility.
Tom Polen:
And just to add to Chris, as good comments is – so Alaris is included in our strategic plan. There's many other levers we have as mentioned. But we have been, as we've shared before, preparing so that when we do get Alaris clearance eventually, that we'll be well-positioned to serve our customers, right? And so, we've talked about that increased inventory levels that we've done on certain components, et cetera. We've talked about the continued investments we have, kept in service in our selling organization so that when clearance eventually comes, that we can both remediate the pumps that are on the market quickly, as well as support additional customers. So, thank you for the question.
Operator:
Thank you. Our next question will come from Vijay Kumar with Evercore ISI. Your line is open.
Vijay Kumar:
Hey, guys. Congrats on the nice sprint here. My first one is for you. Appreciate all the colors, I think, on pharma, new product cycles, but can you just simplistically outline, what are the categories here that BD is gaining share? It looks like in a pharma, life science, flow cytometry, surgery within hernia, vascular. There's a number of categories. It feels like BD is gaining share. Is that true? And how sustainable is that? And within Life Sciences, any concerns on emerging biopharma funding cycles?
Tom Polen:
Yes. Great question, Vijay, and appreciate the comments. So, we'll go around. We've got the segment presence here in the room. I think you're right. What you're seeing is outperforming market growth rates in a number of categories, and we're really pleased with that, driven really through strong innovation, capacity investments that we've made and strong execution. Why don't we start with the Medical segment and Mike can speak to what we're seeing in both Pharm Systems, but also pharmacy automation and medication management overall.
Mike Garrison:
Yes. Thanks for the question. There's three sort of growth drivers that we've built in Medical. First, Pharm Systems, as Tom mentioned in the opening comments, 11 straight quarters of double-digit growth. And both the combination of our capacity investments, which we built a few years ago and continue to implement, plus our innovation, really to support the sensitive biologics and the requirements that those – that pipeline has coming towards us. We feel really good about that durable growth continuing. In MMS, we're really happy with the way that the teams have come together in pharmacy automation and our dispensing business. That connected med management and the tie around clinical efficiency both in the hospital as the hospitals start to shift care outside of the hospitals and how that ties into the retail markets, the long-term care markets. This is just a really ripe area for innovation, and we're really well-positioned now with that acquisition. It's going really well. And then in MDS, the Vascular Access Management strategy continues to do really well. Continues to resonate with customers, especially those aspects where it makes both the patient experience and the clinical experience a positive one. And so, we see – we don't necessarily look at it in terms of market position. We don't really comment on that. But we do look at it in terms of our WAMGRs. And we tend – we're showing growth over WAMGR. So, we feel good in that area as well. I'll turn it over to Rick or Dave.
Rick Byrd:
Great. So thanks, Mike. Thanks, Vijay, for the question. And Tom, for the opportunity to talk about BDI. So, first off, really pleased with the results in the quarter, 9.3% growth overall with all businesses contributing. And like you said, you pointed out surgery at almost 14%. And so, this strong performance across the segment really reflects the execution of our growth strategy across those key end markets that Chris pointed out, advanced repair and reconstruction, PVD, oncology, incontinence, and our newer innovations in higher growth areas are all really contributing nicely to growth. So, in UCC, we continue to see the growth of the PureWick franchise, aided by the recent launch of PureWick Male. PureWick continues to have really a strong presence in the acute and the alternate care setting for us for chronic incontinence and surgery. Like you said, growth is really driven by continued market adoption of Phasix, our hernia resorbable scaffold. Biosurgery growing double digits, aided by Arista. So, really good there. And then finally, in PI business, we're really – we're seeing improvements across our global supply chain as well as benefits of a lot of the strategic investments that we've made in the past. We have strong global penetration of Rotarex. We're really pleased with the relaunch of Venovo. And then our global expansion strategy is paying off, oncology in China is really strong. So, we feel confident with the overall external market conditions, including the recovery of elective procedures, improving their supply chain. And then you combine that with the success of, again, the strategic investments we've made, whether they be tuck-in M&A or products like as Tom mentioned, Rotarex, Phasix or with our new product launches such as PureWick Male. Team is executing extremely well, and we believe we have the right strategy to drive continued success.
Tom Polen:
And maybe just to add to Rick's good comments there. I think something that stands out for particularly the PI business is a number of the investments and new launches that are happening there are in entirely new markets for BD. And so, they're almost exclusively share gains that are happening that are driving growth, right? So, you think about atherectomy and thrombectomy, that's 100% share gain. I think about the Venclose acquisition that we did and the growth that's coming from that, that's all share gain because we hadn't been in the category. And of course, Venovo stent, we have been off the market. And so, the relaunch of that is regaining – is all regaining market share. And just to more specifically address that question very as well, and maybe, Dave?
Dave Hickey:
Yes, for sure. Vijay, it's Dave. Great question. So, again, I mean, just to reiterate for the segment. So, I mean, as you saw in the in the release, just a tremendous strong quarter for BDB at 18.7% and even good core growth in IDS, if you strip away the headwind from the 800 bps of respiratory climb over from same period last year. I'll maybe pick a couple of highlights. I mean, in BDB, we continue to see really strong growth across the board, whether it's the Life Science research reagents, clinical reagents, the demand for the new instruments. Actually, from a Life Science research reagent perspective, so this is the dyes, the Horizon dyes that Tom talked about, that's actually our tenth successive quarter of double-digit growth now. You've heard us talk about BD Max before, which was obviously instrumental in the COVID, sort of pandemic from a respiratory perspective. But how do we now leverage the BD Max for take-up of IVDs and assay utilization and assay penetration? And again, we continue to see really good growth in molecular reagents, eight successive quarters of IVD double-digit growth, which is great. And then maybe on the automation side, we – when you think about the staffing challenges that the labs are facing, we're really starting to see the traction for BD Kiestra, BD COR that Thomas talked about. If you think – you asked a specific question on the sustainability and the customers relative to BDB. The good thing about BDB and just the breadth of platform and reagents that we have is, we've got a very strong diversity of customer base, so not just by a pharma, for sure biopharma, but academia, large academic medical centers, big research institutions. So, I think the diversity of base really helps us there and the types of research that they're doing, right? So, you think about cell therapy, gene therapy, immuno-oncology, all the stuff in terms of fighting that chronic disease in oncology. So, I think we feel really good about that base. And then from that sustainability, I was just reflecting back as we were getting ready for today, and when you look at the segment overall, even for the first half of this year, we've actually had two PMA supplements approved and eight 510(k)s in the first 6 months of this year. So, that all builds to the momentum as we go forward here. Hope that helps.
Vijay Kumar:
Thanks for that comprehensive answer. And just one quick on gross margin. Chris, is a gross margin performance in the [Q], despite 200 basis points of inflation impact, should we think of back half or third quarter being at or above second quarter levels?
Chris DelOrefice:
Yes. So, a couple of things. One, if you remember, from a full-year standpoint, we're absorbing over 200 basis points. It's a second consecutive year of inflationary pressures. It was actually more prominent in the first half of the year. It will abate some combination of some moderation of inflation, coupled with, of course, the cost improvement actions and mitigation actions that we're taking in the second half. So, we expected modest improvement in GP through from a full-year standpoint. So, I think you would expect basically similar, to be slightly ahead of our Q3 FY 2022 gross margin, which was 52.6%. So, you'll see slight improvement. And then that will further expand as we move into Q4. But we're right on track. And I think the other thing to point out is, remember, we have about five months of inventory that flows through our sales. So, we have a strong line of sight to basically the inflation that is sitting in that inventory, all the cost improvement that has actually been driven that's part of that inventory cost. And as that sells through in the back half of the year, it gives us strong confidence in our cost base to achieve those goals.
Operator:
Thank you. Our next question will come from Matt Miksic with Barclays. Your line is open.
Matt Miksic:
Hey good morning. Thanks so much for taking the questions and congrats on a strong quarter here. I wanted to just – I want to go back to the guidance, Chris, if we could, just because there had been some changes. And I know, Robbie touched on this earlier. But maybe just to clarify a bit further on the bottom line just because a sensitivity around beats and raises this quarter is so significant, it seems. So, if I remember correctly, last quarter, a significant part of the raise was, sort of an FX tailwind. There was also the lower COVID – higher margin COVID headwind as well. But sort of a big part of that lift, offsetting that was an FX tailwind. In this quarter, you've actually got another [indiscernible] FX headwinds that you're absorbing. Is that the right way to think about, sort of the relative puts and takes last quarter or this quarter?
Chris DelOrefice:
Yes, that's correct. Just one comment on FX, which is interesting, right. Our fiscal period starts earlier. We actually – our original guide started at the peak of the strength of the U.S. dollar, right? So, we had significant FX pressure when we gave our initial guide. And to your point, in Q1 the dollar weakened a bit. We adjusted up similar to most companies reporting sort of their first fiscal year. And so, we reversed a lot of that unfavorability in the quarter, gave that back. The base was strong, the base EPS actually expanded, and to your point, offset – we had a takedown in our COVID-only testing in Q1. This quarter is a little bit different. Again, you had strong base EPS. We actually raised by $0.115. It was offset by two things. Again, another $0.05 on the COVID-only testing dynamics, taking that down a bit to how we see the full year given that those dynamics and market has softened significantly, and then a little bit of FX pressure for the reasons I noted previously. So, net of those two items, it's [$0.015] [ph], but I will go back to just what I shared. So again, when you look at our base business, absorbing all the COVID-only year-over-year testing impacts, our base EPS is growing almost 15%, and that's while absorbing over 200 basis points of inflationary pressures. I think it's somewhat unprecedented performance in this environment. We're delivering really strong growth. And we want to make sure that we're maintaining investments to also continue this type of performance well into the future. So, that's how to think of it. Hopefully, that helps.
Tom Polen:
I think just to add to Chris' comment, obviously, the update here has COVID essentially out for the balance of the year, right? So, the number that we have now in COVID guidance is basically the COVID number that we have year-to-date.
Chris DelOrefice:
The other, just given those FX dynamics, right, when FX improved, we only had three quarters to go, right? So when we cycle into our fiscal Q1, which is calendar Q4, there will actually be FX tailwind based on where spot rates are today. There's a lot of moving parts to calculate that directly. But on top line, it could be $75 million to $100 million. So, when you look at other people's guide that has a full true calendar year, that's included. We picked that up next year in ours.
Matt Miksic:
Got it. That's super helpful. And the slides are also really helpful material to, sort of walk through this stuff. The other – again, on guidance on the top line. So, you did make a change, as you pointed out, you're expecting a heavier contribution, positive contribution from your inorganic adds, if you will specifically. And so, I know that last quarter, I don't want to say controversy, but there was this question of you have inorganic adds and you have a portfolio exits, which are basically discontinued products not sold to another company, but coming out of the – coming out of your revenue build. And the way I think you were describing it was those things are, kind of offsetting each – not exactly organic, but we're thinking about it organically. And I would agree with that. Now, you sort of shifted back to more traditional organic description, but you're still sitting those 100 basis points of portfolio exits. So, even though it's $5.25 to $6.25, it is – it seems to be a little bit stronger on the base business on the organic side. Is that a fair way to read the strength on the top line?
Chris DelOrefice:
Yes, yes, exactly. The simple way to think of it is, so our all-in guide that includes the negative impact of portfolio exits and the positive impact of organic is [675] [ph] at the midpoint, right? But even if you strip out just the M&A contribution, we're still at 5.5 at the midpoint. Now, that's not taking any credit for the strategic portfolio exits. That was purely just to make sure you guys had context to – we were taking that bold action, it's helping improve margin given the strong growth profile we have. So, when you think of pure underlying against all the businesses we're investing in, if you want to adjust for that, that's about a point that would take it back up to that same range. But even if you get zero credit for that, our organic growth is 5.5%. And more importantly, our two-year, right, coming off a really strong year, we're 7% organic. None of those numbers give us a positive adjustment for those one-time strategic portfolio exits.
Tom Polen:
And I think we're seeing the benefits. Obviously, given the strength of the business, taking those actions on that portfolio is exactly the – it's the right time to be doing that. As a reminder, those products that we're just exiting have less than half of the average GP of the company. They're growing much less than the average of the company and are in areas that are just not strategic in terms of relevant growth platforms as we go forward. And so, they also come with operational efficiency benefits, organizational efficiency benefits, et cetera. And so, they're just going to make us that much stronger as we go forward and make sure that we're focusing our resources and investments in those areas that move the needle the most for customers and for us.
Chris DelOrefice:
Yes. And the other – just one last comment. You mentioned Parata and the strength there. This is a little unique, right? You get the sort of onetime adjustment for what you acquired. This is a great example of us just strong execution in revenue synergies and taking up that forecast. So, again, I think it's just illustrative of how we're managing, kind of tuck-in and the benefits we're generating from that. As we anniversary Parata, the contribution from all the tuck-in acquisitions we will do on an organic basis, it will add about 50 basis points of growth to our portfolio as we exit this year.
Operator:
Thank you. Our next question will come from Joanne Wuensch with Citi. Your line is open.
Chris DelOrefice:
Good morning and thank you for taking the question.
Joanne Wuensch:
Good morning and thank you for the taking the questions. A couple of miscellaneous things all at once. What was the impact of price in the quarter? If you stop planned exits, does that mean your organic revenue growth rate goes up 100 basis points? And is there a plan to stop planned exits? And then bigger picture, there were a lot of BD Veritor’s and BD MAX’s, et cetera, placed or sold during the pandemic for testing? What happens to all of those now? And how do you increase utilization on them for other things? Thank you.
Tom Polen:
Okay. Great question. Why don't we start on the first two with Chris and then Dave can take for the Veritor, MAX.
Chris DelOrefice:
Yes. So, pricing, Joanne, so the Q will come out this evening and we – aftermarket. And pricing will be disclosed in there as we consistently have. What we've shared is it's the last thing we think about, right, as it relates to inflation mitigation. And so, what we're really focused on is driving cost improvement, portfolio mix, the strength of growth and volume leverage. All of those dynamics are significant contributors to mitigating the 200 basis point inflation. You'll probably see something consistent in terms of what we've done last year. If you think of how last year played out, it accelerated through the year. But you'll be able to see that at the end of the day. In terms of portfolio, I mean, the simple answer to the question is, these were onetime in nature. There's always smaller adjustments you make in your portfolio, but we made a decision to really take a deep look at our portfolio this year, as Tom described. These weren't strategic products. There's market alternatives. The GP profile is significantly reduced. Removing these freeze up capacity and other costs. All of those products, not being sure they still require quality support, regulatory support, there's a lot of tie up as it relates to shipping and thinking of other infrastructure support. So, there's benefit beyond just the GP lift you get. But to answer your question simply, yes, if we stopped doing that, our results would have been better by roughly 100 basis points this year. This quarter was a little light. It was closer to 50 basis points in the quarter. But from a full-year, we're still estimating about 100 basis points. We do view these as one-time in nature this year. We don't anticipate doing that in the future beyond smaller things that we would just absorb and not even talk about.
Tom Polen:
Yes. And obviously, we continue to focus on delivering on our 5.5% plus, but as Chris said, we do not have plans to do that again. These are very discrete products. We've given some examples before things like [indiscernible] or washing instruments for orthopedic procedures that, again, we just don't have a relevant role in those spaces and so we've exited those revenues. And we would not see that repeating in the future. Just one thing as you see price after the close of the market today, just to reinforce a comment that Chris made in the opening comments is that we did see very strong volume this quarter as we think about price and volume and the role of those two together. As we look at volume, we look at it organic volume, and then we take out flu-COVID sales as well, right? Because that's something that's not really indicative of, kind of our ongoing business. And when you look at that organic volume growth, excluding COVID-flu, it's strong mid-single digits, nearly 6% overall volume in the quarter. And so, that's something you'll also see as those further reports come out, something very positive that we're continuing to see across the business. When it comes to Veritor and MAXs, I know Dave had made some earlier comments about the very strong double-digit growth that we continue to see in MAX reagent absorption. But why don't you share some more color on that?
Dave Hickey:
Yes, Joanne, thanks for the question. And you're right. I mean, through the pandemic, obviously, Veritor and BD MAX installed base did increase. We've not given specifics around exactly what those numbers are. We're very pleased. We continue to ship those platforms today. And if I break it down, so for Veritor right now, a lot of our focus is actually on converting the emergency authorizations that we got for COVID and our combination assays to 510(k). And obviously, once that is done, that would leave the Veritor, if you like, with approved assays for flu A, flu B, COVID, RSV, Strep A, which will really create a really nice anchor point of care clearway platform for infectious disease testing. So that is our focus there. For BD MAX, one of the big benefits of that platform that labs sees an attribute is its complete sample-to-answer automation and integration within a two to three hour window from sample to result. We placed many MAXs during the pandemic just for COVID and combination testing. And then when you think about the rest of the menu, we're now starting to drive adoption of our regular IVD assays. So, there are really two strategies. One is to increase assay utilization and assay penetration of our regular IVDs onto that BD MAX installed base and where we got emergency use authorization on BD MAX during the pandemic, like our quad assay for BD MAX, moving those EUAs to 510(k) as well. And [it's that] [ph] IVD traction and momentum that you've seen us sort of perform eight quarters double-digit growth.
Chris DelOrefice:
Thank you for the question, Joanne.
Operator:
Thank you. Our last question will come from Rick Wise with Stifel. Your line is open.
Chris DelOrefice:
Good morning, Rick.
Rick Wise:
Hey, Tom. Hi, Chris. Listen, I'm just listening to everything you're saying today, and I keep hearing you both say in many different ways that – and Chris said it, you're well on track to hit your fiscal 2025 long-term targets. Gosh, I accept it. I believe. I think this quarter supports that notion. So, my question is, is it right for us to believe, and I feel like everything you're saying today is suggesting it, that you're now approaching sustainably perhaps a 6% plus top line territory? Is it right for us – again, I accept that you're going to hit the 25 and 25 on the operating margin. My question on operating margin is more, how are you getting ready, Tom, it's a crazy question, for the next target, which I think it's going to be 30%? I don't know if it's – if that's going to take another 5 years. But is that conceptually the wrong way to think about what you're trying to do, where Becton is going? And maybe just as part of that, you're role in your – just your latest thoughts on the role that tuck-in M&A is going to play? You're doing all these great things internally. What role is tuck-in M&A going to play in this journey? Thank you.
Tom Polen:
Thanks for the question, Rick, and it's a good question. We're focused obviously on continuing to execute our strategy, and we are very pleased with our progress, both on our portfolio and the reshaping that we've been doing. Of course, that includes an – and Embecta spin just not that long ago as well, which we're pleased with how that's turned out and is allowing each organization to focus. As we look ahead, I'll just go back to the growth platforms that we've been systematically building and are continuing to gain momentum in, right? We talked about areas like Pharm Systems, like pharmacy automation, like BDB flow cytometry, innovation super cycle, like our Interventional Solutions, our Medication Delivery Solutions and our continued innovation focus, our continued outperforming of WAMGR and how we've been supplementing that with strong tuck-in M&A that, as Chris mentioned, as Parata anniversaries this summer, we'll be contributing 50 basis points of underlying growth. We continue to have a very strong funnel, we continue to be exclusively on tuck-in. M&A has been part of our strategy. And obviously, we've been very focused. Mike and team have been heads down executing the integration of Parata exceptionally well. To see revenue synergies this early in the game is quite unique. And just as a reminder, that was accretive to our operating margins right from the start, and they're getting expense synergies going now as well, too, right, which only improves that dynamic. So, we're really happy with how we've been executing tuck-in M&A, the capabilities that we've – and track record that we've developed there, which gives us the right to continue to make that an important part of our strategy as we go forward. And I think we've talked about in the past, this is really a new lever for BD, right? We're a 125-year-old company. And tuck-in M&A had not been a systematic part of our strategy historically. Obviously, back in 2015, you saw the beginning of two large transformational M&A deals. We obviously did not do tuck-in M&A during that period of time as all the cash was going to pay down debt. And so, this era where we've done quite a number over the last three years, how you're seeing those build systematically stronger business profiles and growth platforms and how we're going to continue with our focus on cash and profitability to drive that going forward is a new part of our equation that's complemented by our strong organic innovation. One thing we didn't mention on this call is – although we've been talking about historically is that when it comes to innovation, we've made really strong progress in improving our on-time launches and our on-time milestone delivery, getting into the top quartile. And we had exited FY 2022 with our best ever performance. We're beating FY 2022 again in the first half of this year, right? So, we're hitting new records and on-time milestone delivery and on-time launches. And so, we're getting that productivity out of our organic investments as well, which is really positive as we look ahead. When it comes to margin, and Chris can jump in further to this, yes, we feel confident in our 25% margin by 2025, and we've talked about that. It could be opportunity to exceed that, and we would make decisions on do we let that flow through or do we further invest that? I think our first priority will continue to be making sure that we invest in strong growth. We have a lot of exciting opportunities and markets that we participate in. We've described a number of them the day on the call and have been discussing them for some time. We're going to continue to invest behind that, creating a durable growth organization that's supporting, transforming the future of health care in the areas that we've consistently talked about around smart connected care, around enabling the shift, the new care settings and around improving outcomes for patients with chronic disease. And so that's our focus. Let's get to 25% margin first, and then we can look at optionalities from there. Chris, any other?
Chris DelOrefice:
Yes. Just maybe a few small adds. I mean, one, look, I do think the value proposition that BD offers is unique. And we're not changing in our commitments. We talked about 5.5 plus, but to your point, what's been clear, right, our two-year growth, 7% organic. We're clearly in the plus side of the equation. I think for all the reasons Tom noted, we have a portfolio that has the ability that we want to continue to try and drive the plus. But our commitment is 5.5%. I think the nice thing about that is that is maybe underappreciated. There's very few companies in med tech that can deliver that outsized growth, but still have this nice durable profile. It's very de-risked. So, you get this benefit of strong mid-single digits, it's extremely reliable, while we're posting outsized growth and improving margin in a very complex environment and haven't even fully capitalized maybe on some of the levers Tom talked about, like the firepower we'll have with tuck-in M&A going forward, or margin, really, I'll go back to – we're committed to double-digit earnings growth, which isn't easy to do. Obviously, we can moderate that depending on the growth profile, what we want to make sure we do is, consistently invest in the right areas to drive that growth, right? We continue to increase R&D, et cetera. So, all those factors would be sort of contemplated, but certainly confident in double-digit EPS growth, being able to consistently do that. So, I think it's a nice balance of you're seeing an inflection in growth and really strong growth that's differentiated. You're seeing differentiation and execution and you have a de-risked portfolio. It's hard to find all those pieces. It should make people feel good.
Rick Wise:
Thanks to you both.
Chris DelOrefice:
Thanks for the question, Rick.
Operator:
Thank you. There are no further questions. This does conclude this audio webcast. On behalf of BD, thank you for joining today. Please disconnect your lines at this time, and have a wonderful day.
Operator:
Hello, and welcome to BD's First Fiscal Quarter of 2023 Earnings Call. At the request of BD, today's call is being recorded, and a replay of the call will be made available on BD's Investor Relations website on bd.com. The call is also being made available by phone at (800) 695-0395 for domestic calls and area code +1 (402) 220-1388 for international calls. [Operator Instructions] I will now turn the call over to BD.
Francesca DeMartino:
Good morning, and welcome to BD's earnings call. I'm Francesca DeMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the first quarter of fiscal 2023. We also posted an earnings presentation that provides additional details on our performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD 2025 Strategy. Chris will then provide additional details on our Q1 financial performance and our updated guidance for fiscal 2023. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Mike Garrison, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Rick Byrd, President of the Interventional segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the Investor Relations website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically note it as a calendar period. I will also call your attention to the basis of presentation slide, which defines terms such as base revenues and continuing operations. With that, I'm very pleased to turn it over to Tom.
Tom Polen:
Thanks, Francesca. And good morning, everyone. And thank you for joining us. We delivered another quarter of strong performance in Q1. Our results reflect the momentum of our BD2025 strategy, which we are driving through a powerful combination of innovation and strong execution. We exceeded our revenue and earnings expectations in Q1 despite market disruption in China and continue to drive consistent, durable performance in our base business, with revenue growth of 5.2% and $2.98 in adjusted diluted EPS. Our results are a testament to the continued relentless focus by our team of talented associates who are delivering BD products and solutions that are enabling our customers to provide high-quality, cost-effective care to patients around the world. In Q1, we continue to make excellent progress driving all three pillars of our strategy to accelerate growth, simplify the company and empower our associates. Our growth continues to reflect consistent performance of our durable core, which has become known as the backbone of health care and our continued shift into attractive and higher growth end markets through investments in both R&D and tuck-in M&A. These higher-growth transformative solutions are focused in the three areas we see reshaping health care and where we are currently investing approximately 60% of our R&D. And that's in smart connected care, enabling new care settings and improving chronic disease outcomes. Today, we have what I believe is the most exciting innovation pipeline in the history of the company. And through our investments, we are systematically increasing the WAMGR across our portfolio and supporting our strong growth profile. I'll have a few of the end markets that are driving our growth and some of the key products recently launched and in our pipeline that we're excited about. Our Medical segment is focused on improving medication delivery across a wide range of settings, making it safer, simpler and smarter across end markets that include medication management solutions, pharmacy automation, pharma and biotech drug delivery and vascular access management, where we recently launched PosiFlush SafeScrub, consistent with the expected launch timing we shared on our Q3 FY2022 call. A prefilled flush syringe with an integrated disinfection device, PosiFlush SafeScrub, is designed to simplify nursing workflow and enhance compliance with infection prevention guidelines. It's a good example of how we're driving continuous innovation that extends our leadership in our durable core and within the broader $9 billion vascular access management market. Another milestone in our vascular access portfolio was clearance of our new PowerMe midline catheter by the Chinese regulatory agency NMPA. This was designed by our R&D center in China for China and is our first midline in this geography and offers up to 30 days of continuous venous access while reducing patient complications. We're excited about the opportunity PowerMe creates to help develop and category for vascular access in China, and we look forward to the expected launch later this quarter. Our BD Life Sciences segment provides solutions from sample collection and discovery to diagnosis and serves dynamic end markets like single cell analysis, clinical microbiology, point-of-care and the molecular diagnostics market, where we continue to advance our strategy of menu expansion with initial sales outside the U.S. of our BD MAX respiratory viral panel or RVP. This multiplex respiratory panel detects COVID-19, flu A and B and RSV in a single test and is an ideal solution for endemic respiratory testing. This aligns to our strategy to accelerate our growth in the $4 billion molecular diagnostics end market that's growing about 9%. The RVP panel is currently under FDA EUA review for U.S. launch. We also continue to progress our strategy in blood collection at the point-of-care. Point-of-care is one of the fastest-growing categories in diagnostics today that we believe will accelerate as diagnostic testing migrates to new and more convenient care settings such as retail clinics and pharmacies and even the potential of at home. Our BD MiniDraw capillary blood collection system is a disruptive innovation that enables collection of a high-quality blood sample without a venipuncture and is designed to provide a better patient experience across a broad range of care settings. We remain on track for 510(k) submission by the second half of FY2023. Our BD Interventional segment, which provides solutions for chronic disease management, serves end markets that dramatically improve people's lives, such as oncology, incontinence, advanced repair and reconstruction and the $5 billion peripheral vascular disease market, a space that's growing about 6%. Within PVD, we continued our strategy to globalize the BDI portfolio with the recent launch of our Venovo venous stent in China. The first stent in this market, specifically designed for iliofemoral venous disease. Within the $3 billion oncology end market, the space also growing about 6%, we achieved a significant milestone, completing safety testing for a multimodality vacuum-assisted biopsy system, and we're on track for FDA submission and launch in FY2024. The BD multimodality VAB device is expected to be the first vacuum-assisted biopsy system designed to work across all three imaging modalities of ultrasound, CT and MRI, allowing customers to consolidate capital equipment, standardize consumables and simplify physician and nurse training. These launches and milestones are good examples of how we're strengthening our position in attractive end markets across our portfolio. Our purposeful strategic investments in R&D as well as tuck-in M&A and CapEx are supported by our strong flexible balance sheet and disciplined and balanced capital deployment strategy. This framework also gives us the flexibility to return capital to shareholders through a competitive dividend and share repurchases. In Q1, we also continued to simplify our company with programs across our manufacturing network, our portfolio and most recently, our operating model. More specifically, we continue to make progress on our RECODE portfolio simplification program, where we are reducing SKUs of older generation products in order to focus on the most important products needed to deliver care today. We remain on track to remove 20% of our total portfolio by 2025, having achieved more than half of these SKU reductions thus far. In addition, we have numerous initiatives underway to consolidate our manufacturing footprint in more cost-effective locations. All of these efforts are designed to reduce complexity, drive supply chain excellence, and make BD more agile while supporting the achievement of our margin expansion goals. Our BD2025 strategy is balanced, robust and resilient. And our foresight planning and agility are enabling us to deliver strong performance despite the continued macro environment, challenging all companies. To share some perspective specific to health care, overall, the environment continues to stabilize and is in line with our view that challenges are going to persist, not escalate at least through 2023. While inflation is easing in some areas, we do expect that it will remain well above what we have seen historically and have planned for another year of outsized inflation primarily in labor and raw materials. We see continued labor pressure with different market dynamics impacting hiring and increasing wages for certain roles primarily in our manufacturing organization. Across raw materials, some categories of resins used in finished goods are beginning to show signs of improvement while other materials such as packaging and rubber are still inflated versus historic prices. In terms of the COVID pandemic, broadly speaking, we see stabilization. While there continues to be surges in certain pockets around the world, similar to our customers, we have become more accustomed to managing through COVID-driven dynamics and have been effective at avoiding any extended manufacturing and distribution disruptions. Specific to China, we anticipate that the recent COVID restrictions that impacted us in Q1 will affect our peers as well. Our local teams are navigating these restrictions well, which reflects the resiliency and strength of our China organization and the diversity and durability of our business. By successfully navigating the challenging macro environment, we are distinguishing BD and supporting our ability to continue delivering strong performance. Before I turn it over to Chris, I’ll share a few updates on the strong progress our team is making to advance our ESG strategy and goals. In December, we published our second annual ID&E report, which provides details about our progress towards our 2030 ESG goals for promoting a healthy workforce and communities. The report highlights our improvements towards increasing diversity at the management and executive levels and spotlights our global associates who are advancing our culture and driving meaningful change within BD and the communities that we serve. We also published our third annual cybersecurity report. BD was the first in med tech to outline our ongoing efforts to advance cybersecurity in a report, including our work to protect against cyber-attacks and empower customers with information about cyber risks and vulnerabilities. We’re proud to receive continued recognition for our ESG efforts, most recently being named for the fourth consecutive year to both Newsweek’s list of America’s Most Responsible Companies, ranking in the top 25%, and the Bloomberg Gender-Equality Index, recognizing our ongoing commitment to workplace equality. In summary, I’m proud of our progress and momentum. Our associates are bringing our BD2025 strategy to life as we operate as a more agile, innovative med tech leader. BD is well positioned to drive profitable growth and create long-term value. First, our growth profile is consistent and durable. Second, we are enhancing our leadership positions through purposeful portfolio shifts into higher-growth markets, increasing the WAMGR across our portfolio. Third, we are improving our margin profile through our differentiated growth, enhanced simplification programs and ongoing supply chain excellence. And fourth, we are committed to remaining disciplined and maintaining a strong and flexible balance sheet. We see an increasing capacity through our BD2025 time frame to support value creation and continued strong growth through tuck-in M&A. All of this adds up to a compelling financial profile with a long-term targeted base revenue growth of 5.5% plus and double-digit EPS growth. Our updated guidance for FY 2023 reinforces our confidence in our ability to achieve these targets. With that, let me turn it over to Chris to review our financials, guidance and outlook.
Chris DelOrefice:
Thanks, Tom. Echoing Tom’s comments, we delivered another quarter of strong performance in Q1, which demonstrates our consistent, reliable, durable growth profile in our BD2025 strategy, playing out as planned. So first, beginning with our revenue performance. We exceeded our expectations for the quarter, delivering $4.6 billion in revenue with base business growth of 5.2% or 3% organic. We see underlying organic growth more at mid-single-digits when adjusting for strategic product exits, the licensing fee comparison in life sciences, and several COVID-driven comparisons. COVID-only testing revenues were $32 million, which is expected, declined from $185 million last year. Total company base business growth was strong across BD Medical and BD Interventional with approximately 6% growth. Base revenue growth in BD Life Sciences of 3.3% reflects the comparison to licensing revenues that impacted growth by almost 400 basis points. Base revenue growth was strong regionally as well with mid-single-digit growth in the U.S., EMEA and Asia Pacific. Revenues in China declined slightly, which reflects the impact of COVID restrictions, offset by strong performance from new product introductions in BDI and research solutions in BDB. For the full year, we continue to expect to deliver near double-digit growth in China. Our base business revenue performance continues to be supported by our durable core portfolio, and an increasing contribution from the transformative solutions in our innovation pipeline and tuck-in acquisitions. We also continue to benefit from the organic contribution from acquisitions we anniversaried, which was about 30 basis points in the quarter. Let me now provide some high-level insight into each segment’s performance in the quarter. Further detail can be found in today’s earnings announcement and presentation. BD Medical revenue totaled $2.2 billion in the quarter, growing 6.1%. BD Medical performance reflects strong growth in both Medication Management Solutions and Pharm Systems, which more than offset a decline in Medication Delivery Solutions. The decline in MDS of 1% was driven by COVID-related comparisons and the impact of recent COVID restrictions in China as well as planned strategic portfolio exits. We continue to see strong performance in Vascular Access Management outside the U.S. Double-digit growth of 15.5% in MMS was driven by strong demand for our pharmacy automation solutions, including both Parata and Rowa. We’ve been very pleased with customer response and the performance of Parata. As expected, growth in MMS also reflects the comparison to higher dispensing installations and infusion set utilization in the prior year driven by COVID dynamics. We continue to have a very healthy backlog of customer orders for Pyxis and BD HealthSight, which reflects the strength of our connected medication management portfolio. And despite strong growth of 18% in Q1 of last year, Pharm Systems delivered another quarter of double-digit growth of 10.6%, driven by continued penetration in the high-growth biologic and vaccine markets. BD Life Sciences revenue totaled $1.3 billion in the quarter. The decline of 7.3% year-over-year is due to the expected lower COVID-only testing revenues. Life Sciences base revenues grew over 7%, excluding the licensing grow over as previously discussed. Growth was driven by growth in Integrated Diagnostic Solutions base revenue of 1.3%, or 6.4% when excluding the licensing comparison. This strong underlying mid-single-digit growth was driven by BD Kiestra that is helping to address laboratory labor shortages through automation and informatics and continued leverage of our molecular testing menu across our expanded BD Max installed base. In addition, there was strong demand for our respiratory testing portfolio that was partly aided by the timing of orders. High single-digit growth of 9.2% in Biosciences reflects continued growth from new product launches combined with strong double-digit growth in research reagents, enabled by our differentiated content and dye strategy. We continue to see demand for our expanded suite of flow cytometry analyzers and sorters as researchers continue to do even higher parameter cellular analysis for cancer and other immune-related conditions. BD Interventional revenues totaled $1.1 billion in the quarter, growing 5.6%. Growth was driven by surgery growth of 3.1%, which reflects strong performance in advanced repair and reconstruction driven by continued strong market adoption of Phasix, Hernia, resorbable scaffold and double-digit growth in biosurgery, aided by the Tissuemed acquisition. Growth in surgery was tempered by planned strategic portfolio exits and then expected decline in BD ChloraPrep due to a tough comparison to the prior year as a result of dealer stocking. Peripheral Intervention grew 10.8%, which reflects double-digit growth in PVD, driven by the Venovo relaunch, coupled with continued global penetration of Rotarex, and the acquisition of Venclose, which addresses chronic venous insufficiency. Additionally, growth was strong in oncology, within Greater Asia due to an improved backlog situation associated with prior year supplier constraints. Urology growth of 1.8% reflects double-digit growth in our PureWick, chronic, incontinence solutions and endourology that benefited from reduced back order due to improved supplier performance. Offsetting this strong performance was a difficult comparison in urological drainage due to shore step back order release and distributor stocking in the prior year. Now moving to our P&L. We reported Q1 adjusted diluted EPS of $2.98, which included gross margin of 54.7% and operating margin of 22.9% that were consistent with our expectations. While we are no longer providing a specific breakout of the impact to margins from COVID-only testing, you will recall the comparison to higher testing in the prior year is weighted to the first half and as expected is the driver of the decline in reported Q1 margins year-over-year. Excluding the COVID impacts to margins in Q1 of both years, both gross and operating margins in our base business were up slightly year-over-year. The improvement in base margins was delivered despite around 350 basis points of outsized inflation that as expected was primarily driven by selling through inventory that included peak inflation impacts from FY 2022, such as increases in certain raw materials noted earlier as well as the impact of labor inflation and elevated shipping. We were able to offset a large portion of this impact to our simplification and inflation mitigation initiatives and the benefit from strategic portfolio access of lower-margin products as planned. We expect the impact from inflation to moderate as we move through the year. Base margin performance also includes growing over the impact from licensing revenues in the prior year. As expected, we had favorable FX that was recorded in inventory that benefited our GP as it flow through sales. R&D of 6.4% of sales reflects our innovation investments aligned to our strategy in support of our long-term growth outlook. Q1 reflects timing of project spend. We expect R&D to remain elevated in Q2 and normalize over the balance of the year to around our long-range target of 6%. Our tax rate in Q1 was lower than anticipated due to the timing of certain discrete items that were planned for during the year. Regarding our cash and capital allocation; cash flows from operations totaled approximately $400 million in the quarter. Operating cash flow reflects an impact of approximately $300 million from higher inventory balances. The increase reflects the impact of inflation and our strategic investments in raw materials to optimize product delivery and meet customer demand. We've seen good progress in December and January on WIP [ph] and finished goods rightsizing with January inventory dollars down sequentially from December. We are working to moderate strategic raw material purchases as stability improves in select markets. However, we continue to make prudent trade-offs where necessary to ensure we support our customers while delivering strong results. Assuming continued stabilization of the macro environment and supply chain, we expect to continue to manage inventory levels down and by the end of the fiscal year had this be a positive source of cash and meaningful progress towards meeting our long-term cash conversion goals. We paid down approximately $500 million in long-term debt in Q1 and ended the quarter with a cash balance of approximately $600 million and a net leverage ratio of 3 times. As the year progresses and we build cash, we can increase our capacity to deploy cash towards tuck-in M&A. Moving to our guidance for fiscal 2023. For your convenience, the detailed assumptions underlying our guidance can also be found in our presentation. Given our first quarter performance, we are confident in increasing our revenue and EPS guidance, given the strength of our base revenue growth, consistent execution of our margin goals, and reflecting the latest FX rates. Starting with revenues, I will provide some insights into some of our key guidance assumptions. First, we are well positioned for strong growth across our three segments, which are delivering at or above our initial expectations despite the impact of restrictions in China, and thus, we are increasing our base revenue guidance. On a currency-neutral basis, we now expect base revenues to grow 5.75% to 6.75%. This is an increase of 50 basis points from our prior guidance of 5.25% to 6.25% and is driven by our Q1 revenue outperformance and the confidence we have in our consistent durable growth profile. Our base revenue guidance continues to include planned strategic portfolio exits that will enable increasing manufacturing efficiency and capacity and ensure the reliable supply of the products that matter most to our customers. We initiated these actions in Q1 and for the full year, continue to expect the impact to base revenue growth of approximately 100 basis points while being accretive to margin. Offsetting this revenue impact, we continue to expect a positive contribution of approximately 100 basis points from the full year benefit of our recent acquisitions with Parata being the predominant driver. While we aren't providing segment-specific guidance, we are on track to deliver strong performance across our segments this fiscal year, in line with our long-term planned commitments. We expect Medical segment growth to be above the total company range, which includes the acquisition of Parata; Life Sciences growth to be below given strong prior year comps and Interventional to be above the midpoint. For COVID-only testing, we are now assuming about $50 million to $100 million in revenue versus our previous expectation of about $125 million to $175 million and is driven by reduced testing volumes and the continued shift in the market to combination testing for respiratory illness. Regarding Alaris, we continue to only model shipments related to medical necessity in line with fiscal 2022 demand. Regarding our assumptions on earnings, we continue to expect operating margins to improve by at least 100 basis points while absorbing the decline in COVID-only revenue, which has a higher margin profile. Despite the challenging macro environment persisting, our focused execution on driving profitable revenue growth, combined with our simplified programs, gives us the confidence that we will be able to continue to mitigate inflationary pressures and make meaningful progress to achieving operating margin levels of about 25% in fiscal year 2025. We continue to expect over 80% of the improvement in operating margin to come from SSG&A [ph], driven by internal cost containment and leverage. The balance is expected to come from slight improvement in gross margin and R&D as we normalize back closer to our target of 6% of sales. Below operating income, our assumptions regarding interest, other and tax remain unchanged. We continue to expect adjusted EPS before the impact of currency to be around double-digit growth and within a range of approximately 9% to 11%. This includes absorbing about a 350 basis point headwind from the anticipated decline in COVID-only testing, which is about 50 basis points more than we previously anticipated. As a result, this implies a very strong low-teens base earnings growth of approximately 12.5% to 14.5% compared to 12% to 14% previously anticipated. Let me now walk you through the estimated impact from currency. As a reminder, we manage our business and provide guidance on an operational basis, but provide perspective on currency using current spot rates. Since our last call in November, the U.S. dollar weakened against all of our major currencies. Based on current spot rates, which assumes the euro at $1.08 for the remainder of the year. For illustrative purposes, currency is now estimated to be a headwind of approximately 200 basis points, or about $370 million to total company revenues on a full year basis, which is an improvement of approximately 250 basis points compared to our prior view. The currency headwind to adjusted EPS growth has also declined significantly since our November earnings call. At current rates, currency would represent a total headwind of approximately 230 basis points to adjusted EPS growth compared to approximately 420 basis points previously. All in, including the estimated impact of currency, we are increasing our reported revenue guidance by approximately $500 million to a range of $19.1 billion to $19.3 billion compared to $18.6 billion to $18.8 billion previously and are raising our adjusted EPS guidance to be between $12.07 and $12.32, which is an increase of $0.22 at the midpoint compared to our prior guidance range of $11.85 to $12.10. As we think of fiscal 2023 phasing, there are various items to consider. We have outlined more detail in the accompanying presentation slides, but the following are key areas to note. First, regarding margins. We expect Q2 operating margin to be similar to our FY 2022 full year margin. This demonstrates our strong focus on profitable growth given the continued impact of inflation and the grow-over impact of our COVID-only testing revenue, both of which we expect to be most prominent in the first half of the year. As a reminder, COVID-only testing has a higher margin and reinvestment of COVID-only testing profit was weighted to the back half of the year. As the year progresses and we continue to benefit from our simplification and inflation mitigation programs, we anticipate margin expansion to be most prominent and to increase through the second half. Second, regarding FX. At current spot rates, we expect the headwind to revenue and EPS will be over-indexed to the first half with about 90% of the full year impact to revenue and about 80% of the full year impact to EPS occurring in the first half. For the full year, we expect the FX drop-through to earnings to be in line with our BDX operating margin. Lastly, a couple of timing items to note. We expect R&D as a percentage of sales to remain elevated in Q2 and normalize over the balance of the year to around our long-term target of 6%. Additionally, the midpoint of our full year effective tax rate guidance indicates an effective tax rate over 16% for the balance of the year, which is best to assume occurs evenly throughout the year as the exact timing of any other discrete items is hard to predict. In closing, we are very pleased with our performance, which demonstrates our consistent, reliable, durable growth profile and our BD 2025 strategy continuing to progress as planned. As we look forward and as reflected in our FY 2023 guidance, we are well positioned for growth with excellent momentum in our base business. With that, let me turn it back to Tom for few additional comments.
Tom Polen:
Thanks, Chris. The future has never been brighter for BD. We have demonstrated a powerful combination of innovation and strong execution and have the talent, vision and momentum to continue delivering robust performance. As we move through the back half of the fiscal year, you can expect to see continued relentless focus on execution of our strategy. I'd like to thank our associates worldwide once again for their tireless commitment to our purpose of advancing the world of health. With that, let's start the Q&A session. Operator, can you assemble our queue?
Operator:
[Operator Instructions] Thank you. And our first question comes from Vijay Kumar with Evercore ISI. Please go ahead.
Vijay Kumar:
Hey guys. Congrats on the quarter and thanks for taking my question. Tom, maybe at a high level, when I look at this guidance here and Q1 performance, I think your prior comments were Q1 organic to be a couple of 100 basis points below the annual guide. And I'm looking at the annual guide – prior annual guide of 4.75, which included the product exits. So I think the Street was looking at sub 3%. You came in at 3%, slightly better. But the base here was increased by 50 basis points. It looks like underlying business momentum is accelerating. So maybe just talk about what's giving you confidence? I think you mentioned some new products. So what's driving this confidence in organic guide raise?
Tom Polen:
Good morning Vijay. And thanks for the great question. I'll turn that over to Chris.
Chris DelOrefice:
Yes. Thanks, Vijay. Thanks to everyone for joining the call. Maybe a couple of macro comments. One, I just think this represents another quarter of strong execution, consistent with what we shared overall. When you think of our kind of forward-looking view from our updated guidance, I think, a few key things, not that we highlighted and then I'll address your question maybe with where we see some pockets of strength. But one, we did increase to your point, 50 basis points of growth on our base business. That strength is pretty broad-based when you think of it. I'll come back to that. And that's despite the fact that you had the restrictions and impacts in China as well. So we more than absorbed that. We also absorbed the COVID-only testing revenue, which given the testing dynamics in the marketplace are not surprisingly down when you think of COVID only relative to our position in the market. That's a higher-margin offering, and we absorbed that as well. I think importantly, we continue to execute against our margin, and we committed to our – at least 100 basis points of margin improvement and then we incorporated FX. Yes, and to your point, when we're entering the year, I mean, one, Q1 is still under-indexed relative to our full year guide. Right? So that still holds together. We know there was about 100 basis points of headwind associated with the licensing revenue impact in our Life Sciences business that you saw in our results. We had estimated there is maybe about another 100 basis points of other dynamics, comp-related issues, mostly attributed to COVID. We also had some difficult comps in the quarter in certain areas like pharma systems, for example, grew 18%, Q1 last year, and we still delivered north of 10% growth in this quarter. So, I think that continues to be a source of strength for us. I think the flu season, there is probably a timing dynamic there. It peaked a bit earlier than we thought and was a higher spike. As we go through this call, Dave can certainly amplify that, but it's played out like it's played out in other areas with a quick season that's going to abate. So I think you have a timing dynamic there as well. So there is various items such as that. But largely speaking, I think, things are very consistent. We feel really good about the first quarter of the year, and it gave us confidence to increase our guidance.
Vijay Kumar:
Understood. And then just one follow-up for me, Chris. And perhaps, Tom, you can chime in. One on, did you – a few questions here on combo and flu revenue contribution. I think on the prior call you had said you expect somewhere around 150-ish for the year. Did the estimate change? What was the China impact here in the quarter? And Chris, did I hear you correctly on gross margins? Should they be up sequentially here into 2Q? Or should gross margins be flattish or down?
Chris DelOrefice:
Yes, real quick on gross margin, we didn't give specific guidance on gross margin, we more – just to give you kind of an anchor how to expect Q2 to play out. We said it would be in line roughly with how we ended our full year fiscal year 2022, which when you think of the inflationary environment we're in, in the first half of the year, right, we talked about peak inflation rolling through in Q1 and Q2. We had a 350 basis point impact of inflationary pressure in Q1. And so, a Q2 margin similar to how we exited the year is what we're thinking. We did not specifically highlight gross margin.
Tom Polen:
Vijay, on the other two questions that you asked, on China specifically, so China declined slightly in the quarter, obviously due to the COVID impact. We did see at the end of this month – last month, January, starting to see some recovery there. So, we're optimistic for the year, we still – as you know, we delivered double-digit growth in China. Last year, we said high singles or near double or about that this year, and that's unchanged. We think we will be able to recover in the back portion of this year. We still have our four-pronged strategy that we have in China we remain very confident in. We've got a very strong team there that's been navigating that challenging environment. Again, they delivered 10% plus growth in 2022, and we expect another strong 2023. And that strategy that focuses on bringing our global pipeline to China continuing to drive China tailored R&D. And you heard us talk about a new launch there in the midline of a product developed in China for China. We continue to move in to expand our market coverage into lower-tier settings, continue to manage through the BOBP where it exists, that's in our run rate. And we continue to strengthen our local presence in China, both our manufacturing presence as well as clinical expertise as we continue to train thousands and thousands of clinicians each year. That formula has worked very well for us in the past, and we continue to double down on that. I think as we think about the combo test, I'll turn that over to Dave to speak a little bit about what we're seeing there.
Dave Hickey:
Thanks, Tom. Hey Vijay, good to hear you. Thanks for the question. Yes, so just on COVID and combo, as I think about both of those. I mean, as you saw in the quarter, we posted COVID-only revenues of $32 million. And as we said on the call, we now expect COVID only for the full year to be between $50 million and $100 million. I think Chris commented right, we are seeing obviously stabilization in the market. We are seeing a decline in testing for COVID only. Actually, as that testing shifts to these combination tests, and actually, for us, in Q1, our performance in that area did actually help offset that COVID-only decline. We had anticipated that that's the way that was going to become the standard of care. I'm actually very proud of the team in terms of the way they sort of anticipated and reacted and built these combination test supplies to support the Q1 performance. And I think if you think about the installed base that we've grown on BD MAX, the fact that we've released these combination assays on both BD MAX, BD Veritor, BD COR actually now in Europe is CE-marked. I think that dynamic, and we can talk about it later, the dynamic of what that looks like for the full year on the respiratory testing obviously continues to play out. But yes, COVID only, we definitely see a decline.
Vijay Kumar:
Sorry, did the prior guidance on that, I think you mentioned 150-ish for the year. Did that change?
Dave Hickey:
Yes. So for the year, we think COVID only now will be in the range of $50 million to $100 million.
Vijay Kumar:
Sorry, on the combo test. I think flu combo...
Dave Hickey:
So, yes. So, we never really – so, if I think about that, the way – if you think about what we said from a, let's say, a flu season pre-pandemic, we had said that was always in the $75 million to about $100 million range on the antigen testing and so on and so forth. There is obviously a lot of unknowns right now in terms of how the full year is going to play out. Obviously, quarter one, we saw the season start early, if you track those CDC graphs, we saw the season start early, it peaked, and we were able to respond to that. If we were looking at it now and for all the assumptions we have, we would think it will be about 1.5 times, let's say, a normal season. So $75 million to $100 million, we would say 1.5 times. And that's really enabled and driven by the installed base increases that we have and the fact that we have developed to launch these combination sets across those platforms.
Operator:
Okay, we'll take our next question from Matt Taylor with Jefferies. Please go ahead.
Matt Taylor:
Hi, thanks for taking the question. Sorry for the delay there. So, congrats on quarter, even though I'm not a – usually congrats on a good quarter guy, but that was very nice. So...
Tom Polen:
We appreciate that, Matt. Thank you.
Matt Taylor:
Of course, Tom. I had a question, a follow-up on Chris’ comments on just the operating margin expansion improvement being more back-half weighted. I was hoping you could just talk a little bit more about that and maybe unpack that and talk about the sources of it just because there’s been so many moving parts and it’s an important part of the story.
Chris DelOrefice:
Yes. No problem. Thanks, Matt. I appreciate the question. Yes, things are pretty consistent with what we shared when we started the year, and it seems to be playing out as such. Some of the key factors to contemplate. First of all, we talked about that from a full year standpoint, inflationary headwinds being another 200-plus basis points. This is on the back of two other years with last year also being over 200 basis points. So, we’ve been navigating an extremely challenging macro environment, right, when you think of that on a cumulative basis. What we did say around the inflationary pressures, it would be significantly weighted towards the first half of the year will be highlighted in Q1 that you saw flow through because a lot of this was inventory that was built last year that sold through. 350 basis points of outsized inflation. That’s on top of, I think, of normal inflation merit increases that everyone takes that would happen in any kind of environment, more of those 3% level. So, you’re really talking about, call it, 400 basis points plus of costs that you have to contend with within your P&L. So then when you think of the mitigation offset to that, so -- by the way, so when you think of our Q1 performance and margin on the back of a 350 basis point inflationary pressure in the quarter, we’re very pleased with how we started the year, because we knew the front half was going to be kind of the more challenging times. As we progress through the back half, there’s a few things that will play out. One, it starts with our internal focus on cost improvement initiatives, simplify, whether it be Project RECODE, driving outsized cost improvement through our plants and other facilities. We’re very focused on portfolio, whether it be driving mix. We took this bold strategic action around portfolio product exits that contributed within the quarter. And so, you don’t do this was one thing. The strong growth rate, of course, gives you natural leverage. And then as we go through the back half of the year, while we’ll still be in an elevated inflationary environment, the cost of materials will subside. You’re seeing some of that subside in certain pockets of raw materials as an example, while other areas, like labor is continuing to persist. But you should see it trend down from that 350 basis points to get to our average of over 200 basis points that we talked about. So then when you think of kind of the dynamics within the P&L between GP and operating margin and where it will play out, GP, we said would be largely in line to just a slight improvement for the full year. And again, that goes back to the fact that we’re absorbing the significant inflationary pressures. So, you’re doing a lot of work to kind of stay flat to slightly above. And then the majority of it will end up showing up in operating margin as you think of leveraging your cost base there, some cost improvement actions we’re also taking in OpEx, and we also continue to normalize our R&D spend in the second half. If you saw in Q1, and we expected in Q2 to have more outsized R&D above 6%, so the back half will be below 6% to normalize to our 6% rate. So, I think those are the biggest puts and takes as you think of the year, but we’re very pleased again with Q1, how we started and how focused we’ve been on the margin profile.
Matt Taylor:
Okay. I mean that was very comprehensive. Exactly what I was looking for. Thank you so much.
Chris DelOrefice:
Thanks.
Tom Polen:
Thanks, Matt.
Operator:
And we’ll take our next question from Larry Biegelsen with Wells Fargo. Please go ahead.
Tom Polen:
Good morning, Larry.
Larry Biegelsen:
Good morning, Tom. Good morning, Chris. Thanks for taking the question and I’ll reiterate my congratulations on the nice quarter here. Chris, just one follow-up to Matt’s question. How much visibility do you have? I mean, the second half margin ramp is pretty strong. How much visibility do you have on that? And trying to calculate the numbers here quickly, but it implies, I think, pretty low OpEx growth, if I’m not mistaken. Just color on that, please?
Chris DelOrefice:
Yes. Thanks, Larry. There’s a few things that obviously, I would call naturally. Well, kind of like, for example, we had reinvestment of the higher COVID-only margin from the first half and reinvestment was in the back half. That will stop. We talked about timing differences of the R&D spend. I mean, you got a 50 basis point swing just timing there from first half to second half as an example. I had also indicated on the call some of the SSG&A [ph] that we had incurred in Q1, there’s timing elements there. So there’s timing elements in probably R&D, SSG&A. You have the lack of reinvestment that you just stopped at. Those were onetime in nature. The other dynamic that you have in GP that I mentioned is the trend of some abatement while still elevated, but it’s all on a relative basis of the raw material cost in the second half in GP. Short of something significant changing, we have pretty strong line of sight to those dynamics. And then from there, it’s really just continuing the rhythm of our cost improvement initiatives. So, I think to your point, obviously, the macro environment has been fluctuating. So, we keep monitoring that. But I think given where we are, we feel pretty confident and we’re certainly well on track to deliver the, at least 100 basis points of improvement for the year.
Larry Biegelsen:
That’s helpful. And just one quick follow-up. Tom, it looks like Parata is doing really well. I mean the $86 million inorganic contribution in Medical. It looks like there was one other acquisition there, but I assume most of it’s Parata. So any color on how Parata is doing? It looks like it’s doing better than the initial expectations. Thanks.
Tom Polen:
Larry, you’re right. We’re at or actually a bit ahead of the deal model there. We couldn’t be more pleased with Parata. And we’ve got Mike here in the room. So let me turn it over to Mike to talk about what the other acquisition is that’s in those numbers and a bit more about Parata.
Mike Garrison:
Yes. The other acquisition is the acquisition of MedKeeper. That’s a pharmacy automation software that helps automate the processes that a pharmacy tech would use to prepare IV medications in the pharmacy hood. So that contributed a small amount into that acquisition number. From a Parata perspective, I think what we’re seeing there, and we are really pleased with it, is the combination of the energy and the product that Parata provides and the energy that the people from Parata are providing, along with the sort of discipline and coaching that BD and the scale that we provide to access new markets, access acute care settings and help drive the transformation of the pharmacy for acute care. So Parata is continuing to grow very strong in the alternate site in the retail area. And then we’re starting to open up the discussions with IDNs that are looking to transform their pharmacy operations. So I think that bodes really well for the future. We are very pleased with it, and we hope to continue to see the same type of response from our customers.
Tom Polen:
I think we – fair to say, Larry, we don’t see any change in the trajectory around the macro factors that are driving demand for that, right? The labor shortages, the need to repurpose pharmacists to do more things in the retail setting, like wellness checks and vaccines and address patients, all of that, right, drives the demand for automation and robotics. And it’s really a great example of our smart connected care strategy, one of the three transformational areas that we’re focused on. It’s a great example of us bringing that to life. So really good momentum in the Medical segment there.
Operator:
We’ll take our next question from Robbie Marcus with JPMorgan. Please go ahead.
Tom Polen:
Good morning, Robbie.
Robbie Marcus:
Good morning and congrats on nice quarter. Chris, maybe to dig into some of the points you made already. COVID testing is a high-margin business going down. How much of the base business upside in guidance is coming from the combo COVID test? And then a lot of competitors are outperforming on COVID testing and potentially raising numbers for the year. I guess, how are you thinking about just Becton, Dickinson in the framework of COVID testing and your assumptions underlying how testing will be used for the balance of the year? Thanks.
Tom Polen:
Yes. Good question, Robbie. So I'll start with the COVID and Dave can add in here. But I would say a few things. One is, so our COVID testing as you know is primarily in professional settings. And when we talk about our – and molecular, to a degree as well, too, we don't have a strong presence in At Home. We do have an At Home test, but it's not it's a – it's not nearly as big of a presence as in our professional setting. So I think perhaps where you see the most outsized performance there is in company – is from companies with a large At Home presence where you've just seen a lot of the COVID testing migrate to At Home versus in professional settings since it's so easy to do and people can do that without going into a clinician. So I think that's one factor probably influencing some of the delta for us. As you know, we do have a combo test in development for At Home, and we'll share once we get that, hopefully that EUA and able to launch that. Dave, any other comments to add there on COVID?
Dave Hickey:
Yes. Hey Robbie. I mean I think, Tom, you captured well. I think when we did our At Home COVID test; we made a very deliberate decision to pursue a digital strategy. You saw the acquisition that we made of Scanwell. We were very much aligned to the test, treat and trace reporting dynamics. And we intentionally sort of targeted that digital ecosystem with a higher price, higher margin rather than the visually red at-home test. We still think on a go-forward basis, as the sort of, let's say, the sort of the government contracts and things abate, as testing perhaps becomes more regulated At Home, 510(k) environments and so on, a digital ecosystem, again plays into the smart connected care of BD will be important. But I think for us, we just look at it all as we're seeing the softening in the COVID decline. We firmly believe that the standard of care going forward will be these – in an endemic type of approach, these combination tests and we've built a portfolio across BD MAX, BD COR, Veritor and potentially Veritor At-Home across all of these combination portfolios.
Tom Polen:
I think the good thing, Robbie that we would look at as is that we're really getting more to a durable revenue number in that, right? So I think as we look at 2023, it's a number that could be very much in line with how we think about it playing out in future years as well at that level where there's not still significantly high numbers that would drop in the future that were really at a kind of a durable level of performance in those categories. Chris, any other?
Chris DelOrefice:
Well, just the way you started your question, Robbie. So if you think of us absorbing the COVID-only and increasing our base revenue guidance by the 50 basis points, it wasn't like a swap out into combination testing. It was actually broadly based across the business. As Dave mentioned earlier, we still see the combo part of our portfolio at that 1.5 times, and we'll continue to watch how it plays out. There was a little bit of strength there, but it wasn't outsized relative to the other areas we also had stressed.
Tom Polen:
Typically, yes. Just to add we typically wouldn't raise unless it was a highly unusual situation, trying to predict expectations on a full year basis on flu or a flu combo test just because it can drop off so quickly. And in fact, we are seeing, right, that's happening if you look at the CDC charts, those charts are showing significant drop-off like what happened in Australia. Rapid early peak and then a rapid drop, unclear if there could be second or third peaks in the future, but that's not something we can easily predict. So typically in Q1, we try to be conservative around that – those outlooks in that specific product category. More after Q2, we get a sense of where the full year plays out.
Robbie Marcus:
Great. I'll leave it there. Thanks a lot.
Tom Polen:
Thanks.
Operator:
And we’ll go next on Matt Miksic with Barclays. Please go ahead.
Matt Miksic:
Hey thanks. Wanted to follow-up with a couple of questions; one on sort of the margin side and then just a couple of clarifications on the revenue side. And just too sort of maybe summarize and make sure we've got a clear understanding of the sort of dynamics this year. I mean you have these significant restructuring efforts underway that you've talked about, that sounds like on a full year basis you're expecting those to kind of offset the inflationary – outsized inflationary cost at the COGS line, at the gross margin line? I'm guessing you're probably not fully offsetting those here in the first half. But as you pointed out, that 350 basis point of inflationary hedge or inflationary pressure are going to sort of ease in the back half. So full year, you sort of manage that to sort of neutral and then the benefits that you're getting here to get you to that 100 basis points really happened below the gross profit line in the form of leverage, in the form of timing as you pointed out. Is that the right way to think about the overall margin picture front half, back half, just to summarize and make sure I'm clear on it anyway? And then as – I have a couple of quick revenue follow-ups.
Chris DelOrefice:
Yes. I think that – I mean, there's other puts and takes within there. But generally speaking, yes, that's how we see the year playing out.
Matt Miksic:
Great. And then on the revenue side, just some other folks who have had some China pressure in the quarter as you did and obviously managed through that to deliver the beat here. But if you could maybe quantify that is sort of one clarification is give a sense of what the growth might have been if it's a 50 basis point overall hit to growth on the clarification on the combo testing, COVID testing changes that you made in terms of your expectation of COVID-only testing. It sounds like that's – that maybe not so much of an expectation that COVID testing in total is coming down, but it sounds like it's a bit more of a mix shift that's just – you're getting COVID testing in the form of that combo testing. So not directionally inconsistent, it seems with what other folks are talking about. They just don't have that combust [ph] exposure. And then I'll leave it there just with those two clarifying points would be super helpful? Thanks.
Chris DelOrefice:
Yes. I think just real quick on China. Thanks, Matt, for the questions. So I mean, last year is just an interesting proxy, right? We went through restrictions in our fiscal Q3. Despite that, we navigated. We had an impact in the quarter. We actually still grew in that quarter last year and posted around double-digit growth in fiscal year 2022. This quarter, we saw a modest decline, 1%, and in China specifically, and normally if you think of it as a double-digit growth business. With that said, Q1 last year, was a strong comp for us in China. We had a very strong quarter for various dynamics, including some new products that were introduced, et cetera. So we would say the impact is probably just south of 50 basis points, if you want to think about it, plus or minus in the quarter headwind just to give you some direction. We did highlight we still feel great, as Tom mentioned earlier, with the core strategy with that business, short of like further disruptions occurring this year and these being a more kind of acute. We should see again around double-digit growth for the year is what we had shared. So we did see some trends, recent trends, like we're watching it. So we're watching it closely, but it looks like you're starting to kind of see some turnaround in that market. It's still early. So we'll look at it and we'll update, of course, in Q2. But I think longer term, our strategy and performance in China is really strong.
Tom Polen:
I think just to add in there, we had seen even versus the first half of January to the back half of January, we started seeing good recovery towards the back half of January as the COVID outbreak began to subside.
Chris DelOrefice:
Yes. I think, COVID, I can let Dave and Tom jump in here too, kind of half accurate, I think, in your depiction. There’s significant market dynamics on call it, COVID-only testing in the marketplace this year. If you think of last year, there was a lot of government intervention and school requirements and businesses. I mean there’s – a lot of that has subsided. So there’s a portion of the reduced testing that’s just market dynamics playing out in terms of total volume, and that’s not just shifting the combination testing. With that said, we still feel good about our combo assay in having that because we do see that as the assay of choice as folks have are symptomatic going in and want to get tested for flu. So we saw strength in our platform. But as Dave articulated, the flu season did kind of spike early. So we’ll have to kind of continue to watch that as we navigate through Q2. So it certainly wasn’t a one-for-one shift by any means, not even really close to that.
Dave Hickey:
Yes. And I think the only other things that I would talk about, Matt. Just in terms of the market dynamics, we track things like bed occupancy and so on really closely. And if you look at a lot of the data sort of in our first quarter and sort of beds that were occupied by COVID-only patients was like maximum peak of like 6%, which is way down from sort of north of 22% in sort of prior period. So that COVID-only dynamics is definitely softening. And I mean I’ll just reinforce what I said earlier on around these combination assays where the unmet need is if somebody presented symptomatically and you want to know, particularly in the respiratory season, do I have COVID, do I have flu, do I have RSV, we think that is going to be the norm on a go-forward basis. And I think we talked earlier on that we have those on MAX outside the U.S., on Veritor. Two things I would also highlight that is for the combination assay here in the U.S., we are under EUA review with the FDA right now. And actually, just late – or BD MAX, yes. And late last month, we actually did file our EUA for an at-home combination assay. So there are also two EUAs that are under review right now. Who – as I said, right now, the season is extremely quiet. But this is also about us planning and preparing for whatever the respiratory season may be towards the end of this calendar year.
Tom Polen:
Thanks Dave. Thanks Matt.
Operator:
And we’ll take our next question from Rick Wise with Stifel. Please go ahead.
Tom Polen:
Good morning, Rick.
Rick Wise:
Good morning to you. Let me start off with new products. Tom, I was looking for the last couple of quarters, handouts here. And I don’t recall, but it feels like starting off with innovation in our handouts and the passion with which you review everything is – tells us all something very important about the direction you’re heading. And I was just curious from two angles. Which do you see – which would you want us to view as the most impactful to growth margins and to the franchises, which are you most focused on? And separate, but related, maybe you know that, as Chris highlighted, the balance sheet’s getting back in such excellent shape, what are your priorities? It’s clearly tuck-in, but is there any sort of franchise or technology or area we should be thinking about?
Tom Polen:
Great questions, Rick. Thank you. So on the innovation side; obviously, we appreciate the comments there. We’re really pleased with the momentum that we have. And as I’ve said many times, we think we have the most exciting pipeline in the company’s history. If you look at last year in FY 2022, we had 25 new product launches, things like our HealthSight diversion management moving into the operating room or the new Pyxis ES platform or a series of new dyes and the first of their kind in BDB or our core high-throughput platform. Asprex [ph] in the U.S. or PureWick Male are all great examples of products that we launched last year that are going to help drive growth this year. As we think about – and we highlighted quite a few this quarter as well. As we look ahead, as you know, there’s no – you can’t say for BD, hey, there’s these three or four products that are going to drive our performance and that if they go really well or don’t go as well, that it’s going to change our outlook and our thesis. That’s one of the strengths of BD. We’ve got a lot of singles, a lot of doubles. We’ve got triples here and there. But we’ve got a deep bench. What’s – what I’d point you to is we’ve been systematically moving our portfolio into higher-growth markets and shifting our WAMGR up. We talked a lot about that at JPMorgan this year. We gave updates specifically on our progress versus the WAMGR goals that we set at Analyst Day two years ago, and we’re very much on track to those. We’re really pleased with how our portfolio is progressing. We’re really pleased with how we’re executing R&D. We’ve shared before we exited FY 2022 with our best performance ever, 87% on-time launches, 84% milestone delivery. That’s up significantly versus where we’ve been in the past, and so we’re pleased with how our R&D team is performing. We highlighted quite a few of the many exciting launches that we have coming up this year or submissions that we have. Certainly, think about Life Sciences, facts discover is a breakthrough new platform. Any time you’re on the cover of Science Magazine, we’ll consider that an exciting technology, and we’re launching that later this year. A lot of exciting interest from our customers as well as the new dyes that are associated with that to take advantage of the spectral technology and in FACSDiscover. YODA around capillary blood collection, enabling blood collection by non-phlebotomists, non-venepuncture, really highly preferred by patients. 75 out of 100 will prefer or more blood being drawn with that device than a venepuncture. And we see that as starting to enable more routine care in places, like retail. When you look at the majority of clinical decisions being driven by diagnostic data it’s hard for care to move into new settings if you’re not getting that diagnostic data available there. You still got to go into the old system. They have your blood drawn. We’re working to change that. That’s something that we’re going to be excited about as we go forward. In BD Medical, obviously, we’ve got products and pharm systems that we’ve talked about in the past, including Libertas as well as new vaccine delivery solutions that we’ve launched recently in BDI, we’ve talked about quite a few. We highlighted PureWick in the past, PosiFlush in MDS, list goes on again in JPMorgan went through those pretty deeply, and I highlighted a few here on the call today. I think as we think about tuck-in M&A, we’re going to remain extremely disciplined. I’ve shared in the past, of course, many times, we’re still focused on tuck-in M&A exclusively. We’re very focused on maintaining that strong balance sheet that we have, and we are going to continue to increase the amount of cash that we generate, and we feel really good about how that looks over the next several years. We have our very focused priorities. We don’t disclose specific market categories that we’re focused on there. But we’ve obviously pointed very specifically to three areas of focus around smart connected care, around technologies that enable the shift to new care settings and around technologies that help us improve chronic disease outcomes in the chronic disease spaces that we’re focused in, like oncology, peripheral vascular disease, et cetera. And so, over the last three years, 90% plus of the M&A dollars that we’ve spent have been focused in those three categories, and we would certainly expect that continue going forward, that level of focus. Thanks for the question.
Operator:
And there are no further questions at this time. I’ll turn the call back over to Tom Polen for closing remarks.
Tom Polen:
I just want to thank everyone for your time today. Great series of questions. Obviously, we’re – we feel really good about the performance as we started this year, and we look forward to providing updates in the future. Thank you.
Operator:
Thank you, and that does conclude today’s audio webcast. As a reminder, a replay of this call will be available on the BD Investor Relations website. Please disconnect your lines at this time, and have a wonderful day.
Operator:
Hello, and welcome to BD's Earnings Call for the Fourth Quarter and Full Year Fiscal 2022. At the request of BD, today's call is being recorded and will be available for replay through November 17, 2022 on BD's Investor Relations website on bd.com or via phone at 866-342-8591 for domestic calls, and area code +1 (203) 518-9713 for international calls. The replay bridges are now dedicated so you no longer need a conference ID to hear the replay. For today’s call, all parties have been placed in a listen-only mode until the question-and-answer session. I will now turn the call over to BD.
Francesca DeMartino:
Good morning, and welcome to BD's earnings call. I'm Francesca DeMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the fourth quarter and full year of fiscal 2022. We also posted an earnings presentation that provides additional details on our performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD 2025 strategy. Chris will then provide additional details on our FY '22 financial performance and our guidance for fiscal 2023. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Mike Garrison, President of the Medical segment; Dave Hickey, President of the Life Sciences segment; and Rick Byrd, President of the Interventional segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the IR website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. In addition, the results and guidance we are presenting today are on a continuing operations basis, which excludes the historical results of Embecta, which are accounted for as discontinued operations. When we refer to any given period, we are referring to the fiscal period unless we specifically note it as a calendar period. I would also call your attention to the basis of presentation slide, which defines terms you will hear today, such as base revenues and base margins, which refer to our results excluding estimated COVID-only testing. With that, I am very pleased to turn it over to Tom.
Thomas Polen:
Thanks, Francesca, and good morning, everyone, and thank you for joining us. I'm extremely proud of our organization and our performance this year. We closed the year with excellent momentum, having delivered strong and consistent growth in our base business. For the full fiscal year, we exceeded our revenue and earnings guidance and achieved our margin expansion goal. Our performance this year confirms BD 2025 is the right strategy and it's working. Our results reflect our strategy in action and the focused execution and dedication of our global teams who reliably served our customers, controlled costs and increased productivity during a challenging environment. At Investor Day in November 2021, we outlined our plan to build sustained shareholder value creation in five key focus areas. Today, I'm pleased to review the progress we've made to achieve this plan. First, we delivered consistent performance and durably strengthened our growth profile. Our FY '22 results are on track with our long-range targets to deliver 5.5 plus top line and double-digit EPS growth with operating margin improvement back toward our pre-pandemic level. In FY '22, we drove 9.4% revenue growth in our base business. Additionally, we achieved our margin expansion goals in an increasing inflationary environment by both leveraging our revenue performance and realizing savings and efficiencies from several of our multiyear simplification and cost improvement initiatives. As a result, we delivered $11.35 in adjusted diluted EPS. Second, we continue to reshape our portfolio by advancing our innovation pipeline and M&A strategy towards higher-growth markets. In FY '22, we continued to transform our innovation pipeline with about 60% of our new product development invested in three market spaces that are reshaping healthcare and helping to fuel our growth
Christopher DelOrefice:
Thanks, Tom. Echoing Tom's comments, we delivered strong, consistent results this fiscal year which reflects our growth strategy playing out as planned. Through execution of our BD 2025 strategy, we are fulfilling our short-term commitments while progressing towards our long-term goals. Beginning with our revenue performance. We exceeded our revenue growth expectations for the fourth quarter and full year. We delivered $4.8 billion in revenue in Q4, with base business growth of 8.6% or 6.8% organic. Parata contributed about 140 basis points to growth in the quarter and about 40 basis points to the full year. COVID-only testing revenues were $37 million, which is expected decline from $316 million last year. For the full fiscal year, we delivered $18.9 billion in revenue with base business growth of 9.4% and or 8.5% organic. COVID-only testing revenues were $511 million, which, as expected, declined from $2 billion last year. Total company base business growth was strong across all three segments with double-digit growth in BD Life Sciences and high single-digit growth in BD Medical and BD Interventional. Base revenue growth was strong regionally as well with double-digit growth in the U.S., China and Latin America, along with high single-digit growth in EMEA. Our revenue performance continues to be supported by our durable core portfolio and an increasing contribution from the transformative solutions we are bringing to the market through our innovation pipeline and tuck-in acquisitions. We also continue to benefit from the organic contribution from tuck-in acquisitions we anniversaried, which was about 20 basis points for the full year. Let me now provide some high-level insight into each segment's performance in the quarter. Further detail can be found in today's earnings announcement and presentation. BD Medical revenue totaled $2.4 billion in the fourth quarter, growing 10.2% with strong performance across the segment. Growth was driven by strong growth in MDS of 8%, driven by continued execution of our comprehensive vascular access management strategy; MMS growth of 11.5%, driven by strong demand of our connected medication management and pharmacy automation strategies, including our recent acquisition of Parata as customers focus on automation to drive efficiency to help address the constrained labor market, and another quarter of double-digit growth of 12.8% in Pharmaceutical Systems based on our strong leadership position in prefillable solutions for biologics and vaccines. BD Life Sciences revenue totaled $1.3 billion in the fourth quarter. The decline of 11.6% year-over-year is due to the expected lower COVID-only testing revenues previously discussed. Excluding COVID-only testing, Life Sciences base revenues grew 8.3% with strong growth across both IDS and Biosciences. Base business growth was driven by IDS growth of 8.6%, enabled by continued leverage of our molecular testing menu across our expanded BD MAX installed base and continued demand for our leading clinical microbiology and specimen management platforms. And lastly, BDB growth of 7.5%, driven by continued demand for our expanded suite of flow cytometry instruments as researchers are able to do even higher parameter cellular analysis for cancer and other immune-related conditions. BD Interventional revenues totaled $1.1 billion in the fourth quarter, growing 5.7%. Growth was driven by surgery growth of 5.4% and supported by our Advanced Repair and Reconstruction portfolio with strong market adoption of our leading Phasix hernia products. PI growth of 4.8%, which reflects continued expansion of our venous portfolio highlighted by Venclose in the U.S. and the global relaunch of Venovo. PI performance also reflects increased back orders primarily related to a BDI specific European ERP system implementation. Urology growth of 7.2% reflects continued strong demand for our PureWick Female incontinence solutions in both acute and alternative care settings. Now moving to our P&L. Q4 adjusted diluted EPS of $2.75 increased 28%. Base business gross margin of 52.5% was up 80 basis points and base operating margin of 22.5% was up 430 basis points year-over-year. Full year adjusted diluted EPS of $11.35 grew 0.6%. As we anticipated, we made significant progress towards achieving our pre-pandemic margin improvement goals despite increasing inflation pressures. For the full year, base business gross margin of 53.4% was up 110 basis points and base operating margin of 22.4% was up 280 basis points. The key full year drivers of gross margin include our simplification and inflation mitigation initiatives and increased volume utilization given our strong base revenue growth. In addition, as expected, we had favorable FX that was recorded in inventory that benefited our GP as it flowed through sales this year. Base operating margin reflects strong operating expense leverage with base selling and G&A as a percent of sales, leveraging by 180 basis points, partially offset by significant inflationary impacts, primarily in shipping. To put this in perspective, shipping expense increased at a double-digit rate in our base business. This increase in shipping was offset with focused efforts on cost management and leverage of selling and G&A which only grew at about 1/3 the rate of sales and was the primary driver of 21% currency-neutral growth in base operating income. This is a testament to the tremendous work by our organization to mitigate inflation and execute our margin enhancement initiatives. This was also a key enabler in supporting continued investment in R&D at just over 6% of sales to advance our innovation pipeline. Regarding our cash and capital allocation. Cash flows from operations totaled approximately $2.5 billion in FY '22. Operating cash flow reflects a higher inventory balance of about $600 million year-over-year. The increase reflects the impact of inflation, longer in-transit lead times and our strategic investments in raw materials to optimize product delivery and meet customer demand. As expected, our free cash flow conversion this year was below our long-term target. We remain very focused on cash flow conversion and we are taking actions to moderate inventory down. But in the short term, we believe it's a prudent trade-off to ensure we support our customers while delivering strong results. As we execute against our BD 2025 strategy and supply chain constraints normalize, we expect to migrate towards our long-term cash conversion target. In addition to investing in R&D at over 6% of sales to advance our pipeline of innovative programs, we also invested over $2 billion in six tuck-in acquisitions across our businesses that will support our strong growth profile in 2023 and beyond. Beyond our investments in growth, consistent with what we shared regarding the planned use of Embecta proceeds, we paid down $500 million in long-term debt this fiscal year and returned $1.6 billion in capital to shareholders through dividends and share repurchases. We ended the year with a cash balance of $1 billion and a net leverage ratio of 2.8x. Moving to our guidance for fiscal '23. For your convenience, the detailed assumptions underlying our guidance can also be found in our presentation. Our FY '23 guidance aligns with the framework we communicated last quarter and the value creation model and long-term targets we outlined at our Investor Day to deliver 5.5% plus base revenue growth, continued margin improvement and double-digit base earnings growth on a currency-neutral basis. As a reminder, we manage our business on a currency-neutral basis to best represent underlying performance, consistent with what other companies are discussing in their forward outlook, we are accounting for a headwind to our reported results as we translate currency to a stronger U.S. dollar. Beyond that change, our guidance has only strengthened in a complex macro environment, where we continue to see elevated inflation and geopolitical uncertainty. Starting with revenues. I'll provide you some insights into some of our key guidance assumptions. First, on a currency-neutral basis, we expect base revenues to grow 5.25% to 6.25%, which is a strong growth of 5.75% at the midpoint. This midpoint is above our 5.5% plus target we outlined during our Investor Day, given the confidence we have in our strengthening growth profile. Our revenue guidance includes two proactive strategic portfolio management actions that are consistent with our BD 2025 strategy and support our value creation goals. First, building on our FY '22 achievements. Our base revenue guidance includes planned strategic portfolio exits as part of the acceleration of our portfolio simplification and RECODE programs. These actions will enable increasing manufacturing efficiency and capacity and ensure the reliable supply of the products that matter the most to our customers. We expect these actions to impact revenue by approximately 100 basis points while being accretive to margin. Second, offsetting this revenue impact is a positive contribution of approximately 100 basis points from the full year benefit of our recent acquisitions with Parata being the predominant driver. We will continue to be active in portfolio management as a lever to create value for all stakeholders. While we aren't providing segment-specific guidance, we are on track to achieve our long-range plan commitments, and we are assuming strong performance across the segments in FY '23. And we expect Medical segment growth to be above the total company range, which includes the acquisition of Parata, Life Sciences growth to be below given strong prior year comparisons and Interventional to be at the high end of the range. Consistent with what we shared, we expect COVID-only testing revenues and related earnings to be at a level significantly below FY '22, with revenues more in line with the annualization of our Q4 FY '22 results or approximately $125 million to $175 million for the full year. Regarding Alaris, consistent with what we've done in the past, we are only modeling shipments related to medical necessity. While we will be prepared when clearance is received, we continue to anticipate a gradual ramp to revenues upon clearance. Regarding our assumptions on earnings. We expect operating margins to improve by at least 100 basis points over the 22.6% reported in FY '22. Despite the challenging macro environment persisting, our focused execution on driving profitable revenue growth, combined with our simplified programs, gives us the confidence that we will be able to continue to offset inflationary pressures and make meaningful progress to achieving pre-pandemic operating margin levels of about 25% and in FY '25. First, to give you some color on inflationary assumptions. As a reminder, outsized inflation in FY '22 was a headwind of over 200 basis points we expect a similar level of incremental outsized inflation in FY '23. The primary drivers of the incremental inflation are raw material costs and labor, which are about equally weighted. Even though we see some signs of cost normalizing in certain areas, a lot of the outsized inflation is from inventory we manufactured in FY '22 as there's about a four to six-month lag from production to sell-through. Labor costs, especially in our manufacturing plants, have continued to increase. We have taken proactive actions to ensure we are differentiating BD to retain our skilled workforce. Lastly, transportation costs have stabilized, and we've begun to see some downward movement on certain rates. However, we are still above more normalized levels. We remain committed to leading through the macro complexity while making investments to support our customers to offset these inflationary impacts we continue to leverage our strong growth profile and drive outsized cost reduction and other mitigation programs. We expect over 80% of the improvement in operating margin to come from SSG&A driven by internal cost containment and leveraging. The balance is expected to come from slight improvement in gross margin and R&D as we normalize back closer to our target of 6% of sales. Our simplification initiatives include continuing to execute on Project RECODE. You will recall when we announced RECODE, it was intended to deliver $300 million in savings by the end of fiscal year '24, with portfolio and network optimization representing about 70% of the savings. We are accelerating these efforts and are also making significant progress with the third pillar of RECODE, operating model simplification, which will result in BD becoming a more agile and less complex organization. In addition, to provide some color below operating income, we expect an increase of approximately $50 million to $75 million in interest/other. This is primarily driven by increased pension expense, which we fully covered in our guidance, and is a result of the negative movement in the financial markets. For tax, based on what we know today, assuming no major legislative or regulatory changes, we expect our adjusted effective tax rate to be between 13.5% and 14.5%. It would not be unusual for our rate to fluctuate above or below this range on a quarterly basis given the timing of discrete items. Our guidance assumes no material change in average common shares outstanding from our average FY '22 share balance. This takes into account the conversion of all outstanding preferred shares on June 1, 2023, the benefit from the FY '22 share repurchase and associated with the use of the impacted distribution and our commitment to mitigate the dilution from share-based compensation. So on an all-in basis, we expect adjusted EPS before the impact of currency to be around double-digit growth and within a range of approximately 9% to 11%. This includes absorbing about a 300 basis point headwind from the anticipated decline in COVID-only testing; and as a result, implies a very strong low teens base earnings growth of approximately 12% to 14%. Let me now walk you through the estimated impact from currency. As a reminder, we manage our business and provide guidance on an operational basis, but provide perspective on currency using current spot rates. Since our last call in August, the U.S. dollar strengthened against all major currencies. Based on current spot rates, for illustrative purposes, currency is now estimated to be a headwind of approximately 450 basis points or about $850 million to total company revenues on a full year basis. This currency headwind has nearly doubled since our August call. Our guidance assumes the euro at 0.99, which is down about 4% since August. The Chinese yuan, Japanese yen, British pound and Canadian dollar have also all declined even more than the euro since August by almost 2x the euro movement. For context, these four currencies combined are in line with our total euro exposure. The currency headwind to EPS growth has also nearly doubled since our August earnings call. At current rates, currency would represent a total headwind of approximately 420 basis points to adjusted EPS growth. All in, including the estimated impact of currency, we expect revenues to be between approximately $18.6 billion to $18.8 billion and adjusted EPS to be in a range of $11.85 and to $12.10. As you think of fiscal '23 phasing, there are three key items to consider. First, FX. At current spot rates, we expect the headwind to revenue will be over-indexed to the first half. For the full year, we expect the drop-through to earnings to be below our BDX operating margin. Due to the expected benefit from inventory flow-through in Q1, the drop-through is expected to start well below the full year average and most significantly impact the second and third quarters. Second is the grow-over impact of COVID-related dynamics. As a reminder, in FY '22, almost 80% of COVID-only testing revenue was realized in the first half of the year, with strong margin drop-through as reinvestment was weighted to the latter part of the year. In addition, there is also a comp to strong first half performance in FY '22 related to combo testing in the base business. And the third is inflation. Nearly 40% of the full year inflation headwind is expected to occur in Q1 as we sell through inventory manufactured in FY '22 in the first half of the year. As a result of these items, as you think of the progression of our total operating margin expansion through the year, for Q1, you should expect a year-over-year decline driven primarily by the year-over-year comparison of higher COVID-only testing. We expect operating expansion to ramp over the remainder of the year with the majority occurring in the second half. As a reminder, there are some tough comparisons to the prior year in Q1, such as the benefit of about $50 million in licensing revenues in Life Sciences. As a result of these dynamics, we expect Q1 base revenue growth and adjusted EPS to be under-indexed relative to an equal quarterly phasing of the full year. So this guide, coupled with our FY '22 results, has us progressing very well towards our FY '25 goals, including a two-year revenue CAGR assuming the FY '23 midpoint of 5.75% that is well above the 5.5% plus target at around 7.5%, achievement of nearly 400 basis points of margin improvement or over 70% of the way towards our FY '25 objective and two consecutive years of strong double-digit adjusted earnings growth in our base business. In closing, we are very pleased with our performance, particularly given the macro complexity and inflationary pressure we navigated. The consistent execution we delivered and our ability to mitigate these challenges through FY '22 enabled our results. This gives us confidence in our ability to continue this momentum into FY '23 and create long-term value for all of our key stakeholders. With that, let me turn it back to Tom for a few additional comments.
Thomas Polen :
Thanks, Chris. Our BD 2025 strategy is demonstrating strong momentum and performance positioning BD to be increasingly well positioned to drive long-term growth and value for all stakeholders and successfully navigate and differentiate in today's challenging environment. . I'd like to thank our associates worldwide once again for their tireless commitment to our purpose of advancing the world of health. And before I turn it to Q&A, I want to officially congratulate and welcome Mike and Rick to their new roles, leading the Medical and Interventional segments, respectively. Both Mike and Rick are highly effective leaders who have demonstrated strategic and operational excellence, and they're nearly two decades at BD. Their focus on driving growth and meaningful outcomes has been critical as we pursue our BD 2025 strategy, and they are well-rounded seasoned leaders with a track record of developing strong teams that deliver impactful results. Their broad experiences across multiple BD businesses and segments position them well for their new roles as we advance our growth agenda and build BD's future. With that, let's start the Q&A session. Operator, can you assemble our queue?
Operator:
Certainly. The floor is now open for questions. [Operator Instructions] And our first question is coming from Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen :
Congratulations on a strong finish to the year. First for Chris on the top line guidance. It implies only about 4.75%, excluding Parata and testing. You just grew 6.8% organic in Q4, 8.5% for the full year. So why the deceleration in fiscal 2023? It seems conservative given the momentum. And can you talk about assumptions for pricing and those divestitures? And I have 1 follow-up.
Christopher DelOrefice :
Yes. Sure, Larry. Thanks for the question. We're very pleased with our growth rate. As you noted, I think what we're delivering is a testament to our strategy playing out, delivering consistent growth in both our durable core balanced with acceleration through transformative solutions, coupled with the actually organic contribution from the tuck-in M&A that we're starting to see as we anniversary acquisitions more than a year. There's about a 20 basis point contribution to growth. So as you noted, 9.4 this year, really strong year, in a year by the way where we actually had an increasing complex environment. Our ability to grow double digits in China as an example with some of the dynamics we saw play out there, 8.5% organic. I think there's a few things that I think will give you some color to kind of understand. Our underlying growth rate remains extremely strong as it relates to our '23 guide. If you think of it as a two-year period at 7.5% growth over a two-year period comping over that 9.4%, this is well above our 5.5-plus even if you adjust out, from an inorganic standpoint, the growth is still at about 7%. So we -- I also think it's a strong indication that we're actually consistently delivering this growth. On the strategic portfolio exits, let me give some color on that. This is a bit different. It's certainly consistent with our simplification strategies. And really, it's the strength of our underlying business and the strong growth outlook that allows us to take these strategic bold actions to create value for our customers and our shareholders. These are the kind of things that investors should want us to do, and we're very fortunate to be able to take this opportunity. It's consistent with our relentless focus on portfolio. And what we're essentially doing different from SKU rationalization, which is really simplifying the SKUs that we go to market with, that require work, investment, reregistrations, et cetera. These are pure portfolio exits. You almost need to think of them. It's a onetime kind of divestiture as we took a step back, looked at our portfolio, trying to understand where we could best create value, again, both through the lens of our customer and through the lens of our investors. So these are areas, for example, that would fit a typical divestiture growth profile. These are not accretive to growth. These are significantly dilutive to margin, in many cases, well below half our existing margin rate and the right thing to do. I'd also point to the fact that while these were dilutive to margin, they did actually benefit our earnings. And so we had absorbed that in a very strong earnings guide, right, when you think of our bottom line of 9% to 11% double digits at the midpoint on an FX-neutral basis. And that's on an all-in comping over the COVID-only lost revenue year-over-year. And so adjusting for that, we still delivered about 12% to 14% of base earnings growth. So we think this is the right thing to do for the long term. It's the right thing to do. Our underlying business, I actually think it's fair to think of that 1% impact roughly differently, almost like an inorganic adjustment because the rest of our portfolio continues to perform strong. As a matter of fact, we -- if you look at the 5.75, it's above the 5.5 midpoint. And then I'll go back to the two year, which is, again, on an organic basis, over 7%. So hopefully, that helps kind of explain that part of the guide. We feel great about our revenue and certainly feel good about the bottom line.
Lawrence Biegelsen :
That's very helpful. And just, Tom, one follow-up. It's been about -- the comments on Alaris were encouraging in your prepared remarks. It's been about 1.5 years since you filed. What can you share about the review process? And are you still confident you can bring Alaris back before 2025 since I think the BD '25 margin target assumes about 80 basis points contribution from Alaris.
Thomas Polen :
Larry, as always, great to connect, and thanks for that question. So as we've mentioned on several occasions, getting Alaris back on the market is our #1 priority. We remain confident in the resources we've invested in our submission in the team and a leadership task to prioritize this in our process and we are confident that we will get clearance. What we also want to be -- continue to be prudent on Larry and thoughtful about the process with the FDA. And so therefore, that's why we're not predicting time lines given how inherently complex those submissions are -- as you said and as we've shared in the past, the relaunch of Alaris is included within our strategic plan as we provided at Investor Day, and there is no change to that. We just -- as I mentioned before, we want to not predict those time lines, but we are prepared for launch when that clearance comes so that we can best support our customers. And as you know, we did launch Alaris -- the new Alaris pump in Canada this past year, and we're getting very positive feedback from customers there. So thank you for the question.
Operator:
And we'll take our next question from Vijay Kumar with Evercore ISI.
Vijay Kumar:
One, Chris, maybe I want to start with guidance and I had one for Tom. On the guidance, what -- I guess, what are you assuming for vaccine? I think vaccines were $150 million-ish of contribution in fiscal '22. Is that zero? Is that a headwind? And Alaris emergency use, is that similar to fiscal '22? Is that below? And related to that, I think in the past, you've said active discussions with the FDA, has that changed in active discussions with the FDA relative to Alaris?
Thomas Polen :
This is Tom. So no, we continue to have active discussions with the FDA on Alaris. And as I mentioned, things are progressing towards our process, and we'll obviously give an update when we get ultimately clearance on that, but we don't want to try to predict the timing on that. And so therefore, again, as we have been being prudent, we haven't reflected that in our guidance specific approval timing. So we do have the same run rate of medical necessity in our guidance, which is about $100 million, same as '22. We've carried that forward into '23. And to your question on vaccines, it is a headwind in '23 that we're jumping over there. There's relatively limited vaccination demand ongoing for COVID. And so that's definitely a headwind that we're jumping over in MDS, but we have that covered.
Vijay Kumar :
Understood. And Tom, sorry, can you quantify what the headwind is? And related to that, sorry, my second question here. Parata, it looks like your pro forma organic here was really strong, perhaps in the teens. Maybe talk about what's driving this strong contribution from Parata. And is that part of your revenue synergies as part as the deal?
Thomas Polen :
Yes, VJ. So on the hypo, we won't share the specific number there. But it is a -- there's very limited revenue, vaccine-related in hypo that we have planned for '23. Related to Parata, you're right. We have very strong performance in Parata at/or slightly ahead of our deal model on that. So we're off to a great start, and we're seeing really strong demand. And let me turn it over to Mike Garrison here, who, of course, led that acquisition when he was leading MMS and now continues to be over that as is leading the Medical segment. So Mike?
Mike Garrison:
Hi, Vijay, thanks for the question on product. Parata, yes, we're very excited about Parata, also the MedKeeper, the Medbank acquisitions that are in the portfolio. They are just great teams with a passion for their craft. And it may be the things that are differentiating it in our approach, the extensive diligence we did prior to the acquisition, a real focus on culture in the first 30 days of working with the teams. And then we also set up an integration management office within MMS with some of our senior leaders to really guide and focus on each individual work stream across the functions to make sure that the acquisition goes well out of the gate. But I think the main thing is the value proposition is very strong and clear for Parata. It directly addresses the labor shortages and the clinical efficiencies that customers are seeking, especially right now, and as well as their long-term goals around smart, connected care, data-driven decision making, things like that. So it both addresses short-term needs and long-term needs, and that's why customers are reacting so favorably to it.
Operator:
And we'll take our next question from Robbie Marcus with JPMorgan.
Robert Marcus :
Great. Maybe to follow up on some of the '23 guidance questions. I was wondering if you could help us with some detail maybe around what you're assuming for the COVID flu combo tests. We're off to the worst start of flu in over a decade. So what you're assuming in there or just for flu in fiscal '23? And remind us where those tests ended up on sales in fiscal '22? And also, how do we think about Parata down the P&L? It's 100 bps on the top line. Just remind us of what you're assuming on the bottom line for that.
Christopher DelOrefice :
Yes. Thanks, Robbie. Appreciate it. Yes, I can take the Parata question as it relates to the margin, and then either Dave and/or Tom can maybe talk about COVID flu, how we're thinking about it. Parata, what we've shared publicly is it was immediately accretive to BD. We weren't specific with the amount. But actually, we did say it's actually even accretive to our long-range outlook, which is think of it as that about 25% from an operating margin. So it is certainly a positive contributor on the bottom line. I will just reinforce, remember, as you think of our total all in. So Parata, I think, is a great example of adding a strategic asset with a strong growth profile, strong accretion on the margin standpoint. We did have to jump over the COVID-only, which was a $300 million-plus drag on the top line that also had a higher, slightly higher margin profile. So I think when you look at our total guide at 9% to 11%, that's very strong, and we kind of reversed into the math we had shared that the COVID-only was about 300 basis points headwind in total. It implies a 12% to 14% base earnings growth profile. This is really strong, well, very consistent with what we shared at Investor Day, especially again in an inflationary environment, where we're going to have similar levels of inflation year-over-year.
Thomas Polen :
Robbie, this is Tom. Good to connect this morning. We've got Dave on the call down in -- with our Latin America team at their kickoff meeting. But I'll tag Dave into the conversation here in just a moment. But related to flu combo. So we are in our assumptions, we do have that moderating a bit versus this past year, where we saw a lot of demand for the flu COVID combo driven by COVID. To your point, there is a potential. We don't see it as significant of a demand driven by the COVID side of the combo test necessarily as we look going forward in '23. Certainly, there can be a greater potential for the flu side demand and differentiating between flu and COVID. I think as you said, it's off to an early start, the flu season, still to be determined the scale of it. In Australia, we saw an early start to the season, but we saw a very narrow onetime peak in that demand. And so actually, the area under the curve was less than normal. And so there was a severe very short flu season in Australia that did not end up creating significant demand and testing because it was such a short duration still to be determined how that rolls out in the U.S., and so we want to be prudent upfront. Maybe Dave, I'll turn it to you to share some more comment here.
Dave Hickey:
Yes. Thanks, Tom. And Robbie, thanks for the question. And just as I get into answering that, I just, given this is my first chance on the Q&A here, I do want to just recognize and thank the Life Sciences team globally and all the associates for another outstanding year in fiscal '22. I mean you saw the quarter growth of over 8% there, a record base growth of 13.8% for the year. So Life Sciences continues to be strong. On flu respiratory, I'll just build upon what Tom has said is, if you think about it pre-pandemic, we were always in this range right of the $75 million to $100 million, we were considering the normal flu season. I think also to remember that, that was on Veritor only. We have not really anticipated or seen a normal flu season during the pandemic at all. Definitely in October, we are seeing more visits to urgent care centers and things on influenza-like illness. But again, when you look at it, we think the season has started, it's about eight to nine weeks early. It peaked very quickly in Australia. So it's a little bit early to call what it would look like. I think if we were looking at the range for this year, based on just leverage of the Veritor installed base, we would expect that sort of that flu range of that Veritor base to be about 130 million to 150 million.
Robert Marcus :
Great. Really helpful. And maybe a follow-up. Chris and Tom, 100 bps margin expansion is really healthy, given all the headwinds. Maybe you gave some good color on the slides, but was hoping for maybe just a little more details on how do we think about inflation and raw materials costs? Or any of those other headwinds? If you could put any frameworks around -- and then how do we think about FX on the operating margin line as a negative?
Christopher DelOrefice :
Yes, Robbie. Thanks. So yes, as it relates to 100 basis points, as you noted, definitely another strong year of margin enhancement. That would put us about 70% on track to deliver against our FY '25 goal of about 25%. So really strong progress, having delivered almost half of that in the first year. So not only do we feel good about what we delivered last year, continuing that momentum and driving towards our long-term objectives. Yes, there's a couple of ways to think of it. One, the predominant driver of margin improvement this year is really going to be leveraging our strong growth profile, focused on cost containment more at the operating margin level, in selling and G&A. So that's about 80% plus of that 100 basis points improvement that we're expecting. The balance is really, there's a little bit of moderating R&D back to our 6% goal. We've actually been over-indexed two years in that area. So obviously, like other areas, you'd expect to, without impacting project spend, just leverage your base with a strong growth profile, 6% is a good outcome there. The balance, which is really minor then, is in GP. So GP, you're going to kind of see that's where we're experiencing most of the inflationary impacts. As a matter of fact, you're seeing a little bit of relief in shipping. It's still above historic what we call normal levels. You're seeing some benefit there as well that's playing out mostly in the operating margin side. As it relates to where we're seeing the most inflationary pressures, it's still raw materials. It's shifted a bit more from kind of resins to other materials, such as packaging would be an example. We do have a carryover effect, too, of the inventory that was built in '22. And so a lot of that will hit in the first half of the year. And the other big area where you still continue to say, I would say, escalating pressures is labor. So labor and raw materials is about 50-50 each of what we're realizing in GP. Obviously, we're taking a ton of action within GP probably in this order in terms of how we think of them. not necessarily size, but as we always think of driving cost improvement, one, it starts with our growth profile, outsized volume in our plants, leveraging our plants portfolio, favorable mix to the extent we can drive that outsized cost improvement, again, going back to our plant mindset as it relates to growth mindset and driving more efficiency and then other factors such as price as well would be part of that equation lastly. So that's how we're thinking of inflation this year and what we're doing to mitigate it. And we're very pleased with the progress that we've had year-to-date. As it relates to FX, we gave some color. Certainly, the team can support you through that in more detail. The drop-through from sales to earnings is slightly lower as consistent with what we've shared in the past on a full year basis. You're going to see sort of quarterly phasing dynamics play out differently because you have the nuance of how FX impacts cost and inventory and how that flows through. You got that four to six-month lag. So you'll see a little bit more favorability in the first half, and it normalized to the full year drop-through that we shared by the end.
Thomas Polen :
That's great. Maybe just to add to Chris' comment, and it's a good question, Robbie. Back to -- we are facing, as all companies are, serious inflationary pressures, right, that are happening across the industry and all industries. I think just want to call out our plants. They're doing a phenomenal job. The last thing that we look to do in any situation is price. And so as you heard Chris walk through the order of priorities for us, our plants really have risen and almost doubled the level of normal continuous improvement that we've done historically, they've risen to that task and working to offset as much of that cost as possible. The other thing is the action that we talked about earlier around that strategic portfolio exit, as we're bringing in M&A, and we have strong underlying growth, taking this time to evaluate our portfolio and look at where they're nonstrategic products that are diluting our operational effectiveness in our plants that we can get better performance out of our lines, out of our staffing, out of our resource deployment, and take those actions set us up for strength in the long term. We're doing that this year, and that's helping us also have a role in offsetting those inflationary pressures at making us more efficient in our plants and helping make sure that we can deliver the products that matter most that we're focusing our resources on delivering those products that matter most for our customers that are going to be driving value for us and our shareholders long term.
Operator:
And we'll take our next question from Matt Taylor with Jefferies.
Matthew Taylor :
So I had two questions. I guess the first one I wanted to ask was, I know you probably won't comment on litigation, but I was hoping you could address some of the ethylene oxide issues from two angles. One is maybe just talk about some of the things that you have done already with the regulatory agencies to work with them to mitigate risk there to improve the plans? And then any commentary you can make on litigation to get investors comfortable with that risk would be helpful.
Thomas Polen :
Sure. Good question, Matt, and I appreciate it. So as you know, BD is among the world's largest producers of medical products that are critical for patient care. And our devices and products, they have to meet FDA sterilization standards. And just as background, I think everyone is aware that numerous types of devices and other sensitive medical products, for many of them, EtO is the only type of sterilization that can be used. In fact, about 50% of all medical products across the industry use EtO for sterilization. And the majority of those products that use EtO for sterilization, other sterilization methods will damage the products like radiation or steam or chloride dioxide or vaporized hydrogen peroxide, they actually would damage those products. That's why EtO is used. And you wouldn't be able to ensure the required level of sterility given the materials that are used in those products. And so we're very confident in the systems we've been investing in for decades and can say that our sterilization facilities use the best available EtO emissions control technology in the industry. We achieved more than 99.95% destruction of EtO from our stack admissions. And in accordance with the broad FDA challenge, we continue to invest in cycle optimization and EtO technology upgrades, extending outside of our plants now. And so we take the safety of our associates and the communities we're in very seriously and therefore, have a long history of proactively upgrading our emissions control technology supported by continuous investments back to your good question. So if you go all the way back to -- even let's go back to 1997. We proactively upgraded our emissions control equipment in Georgia to thermal oxidizers all the way back then and began routing back then exhaust in Georgia to the primary emissions control equipment. It's something that still isn't necessarily routine across the industry today. We're at the forefront of that. Today, we have programs and procedures in place to ensure compliance with all applicable regulatory requirements, including EPA, OSHA, state environmental protection agencies, FDA. Our facilities are at least 20x more efficient at removing EtO per cubic meter of air than what's currently required by the Clean Air Act. And we're working with the FDA and other industry leaders to develop, look at new sterilization cycles that could even take emissions down further than what's ever been possible before. Just as it relates to our outstanding litigation, there are no new cases that have been brought since the third quarter, and we have not taken any accrual in connection with any of the outstanding EtO cases. We've gone through a rigorous process internally and externally, and we do intend to vigorously defend any such cases, given our strong position in the way that we operate.
Operator:
And we will take our next question from Josh Jennings with Cowen.
Josh Jennings :
Probably two for Chris, just on Alaris. I was hoping to just review just the run rate of Alaris revenues in the U.S. on medical necessity shipments and where premediation or remediation, that revenue run rate sat? And also I want to just think about what you're absorbing on the margin side without -- assuming that Alaris is not going to be back in play in the U.S. in fiscal '23, what was the margin drag in 2022 and that there is a margin drag in '23? And just how you're maintaining the structure of Alaris franchise to be ready for launch once remediation is over and you're able to fully commercialize again?
Christopher DelOrefice :
Yes. Thanks, Josh. Appreciate it. Yes. So I'll just -- I'll share some things that we've shared in the past. One, from a total sales point, we had always talked about that business being roughly $400 million is the way to think of it. From a medical necessity standpoint, we've talked about $100 million per year. That's what we had last year roughly, and we're planning sort of consistently this year. So that gives you that kind of frame as you think of the size. I will remind you when upon clearance, you would expect a gradual ramp over time. We have not shared a specific timeline that's hard to predict. But maybe just to give a little context, some folks have sort of asked like, okay, are we talking less than a year-over-year. It wouldn't be less than a year, it would ramp up over some time frame, probably over a 12-month period that should help you a little bit. But certainly well within our LRP time period. Margin, we haven't shared specifics by year. What we did share, if you go back to the deleveraging that occurred from our FY 2019, there was about an 80 basis point headwind to our margin. And it's -- that largely stays the same, and we'll adjust as the product comes back. If you think of it, we -- one, we made investments in regulatory quality, of course, we maintained our service and field organization. And so as the sales come back, you would get natural leveraging to occur as we've made those investments to continue to support our installed base and customers.
Thomas Polen :
And maybe just 1 other thing to add, Josh, is, as Chris mentioned, so we kept our commercial team. We kept our service team, which as we relaunch again, we'll see the positive flow through since those expenses are already on the P&L and the recovery of that. That 80 bps of dilution that we currently have on the P&L. Just on there is a benefit that we're seeing right now is we're seeing very strong demand on other capital areas within MMS, particularly in the Pyxis area, where we're able to utilize some of those additional service capabilities that we have to actually help us in the installs on the Pyxis side, and maybe since we have Mike here today who again was recently leading that business, maybe Mike, if you just want to comment on some of the broader demand we're seeing on the capital side on the MMS.
Mike Garrison:
Yes. Thanks, Tom. Even though there's a -- we recognized a tough economic environment, the uncertainty there, we're not experiencing the same degree of capital pressure that maybe have been communicated elsewhere. In fact, we finished Q4 with a record year for bookings, have a strong implementation schedule planned for, and I think there's a couple of reasons for that. One is the strategy continues to resonate with the Connected Med Management Solutions, again, addressing the labor shortages and our ability to flex and implement both with business model, but also these highly skilled service, a lot of ex-nurses, ex-IT people. These are people that our customers are increasingly seeing the value of partnering with us because we can flex to meet their needs. So both of those things, I think, are really helping, and we're getting a lot of utilization out of the infusion side of the business.
Operator:
We'll take our next question from Matthew Mishan with KeyBanc.
Matthew Mishan :
Just a clarification for me. I think last quarter, you said that you would expect some organic revenue growth around like 5.5-plus percent base growth, not including Parata. At that time, were the strategic electrics included in that number? Or are those new? And if they were included, does that mean that there was a little bit of softness over the last three months versus what you were thinking?
Christopher DelOrefice :
No. I appreciate the question. Yes. No, that hadn't been contemplated at that point. Again, we took a hard look at our portfolio in the spirit of simplification. This is different from our core Recode program that has a different lens. Similar principles, but a very different lens in terms of a pure exit. We really wanted to make sure we were focusing on our organization in higher value-creating areas. And so this was an add. And again, I think there's so many puts and takes across the year. Looking at this two-year metric, however you look at it, 7-plus percent growth on an organic basis is extremely strong. And we think this is an appropriate action to think we could easily put that back in, right? And our base growth would go up by 100 bps, but this is the right thing to do for all stakeholders over the long term. And we'll be creating significant value and has not impacted our bottom line performance at all.
Thomas Polen :
And they're onetime in nature?
Mike Garrison:
Yes.
Operator:
We'll take our final question from Rick Wise with Stifel.
Frederick Wise :
Tom, you highlighted multiple times your focus on -- among other things, on transformative solutions, M&A, the portfolio. And you and Becton's excellent Chief Financial Officer, both highlighted the balance sheet strength as maybe I think the language was new lever right now. What's your sense of urgency on the external technology M&A front? How do you view your current opportunities? And does the collapse in med tech valuations and multiple compression, does that present more opportunities? Just how are you thinking about it?
Thomas Polen :
Great question, Rick, and great to connect. So -- and I agree, we have a very strong CFO, by the way, as well, too. But so we do have a very strong funnel, and we continue to be very focused specifically on tuck-in M&A. No change to our strategy there, as we've articulated many times. We're going to continue to focus our M&A as we have over 95% of our M&A to date has been in those transformative solution categories, as you called out, smart, connected care, enabling the shift to new care settings and improving outcomes in chronic disease. We've also shared that expect more Parata like in size tuck-in M&As as we look forward. So it may not be -- we've done 19 in the last 2.5 years, maybe fewer deals going forward, but of larger scale and impact, given the benefits that we have and the execution that the businesses are focused on and the ones that we've done to date. I'd say that the other thing is we're going to continue our very disciplined approach to M&A. Really proud of the team, not just for the deals that we've done, but from the deals that we've walked away from. That's something we've -- we're really pleased with, the work that we've done and how our deals are executing to plan and the return that they're delivering for our shareholders in a meaningful way. And so we're going to keep that discipline as well. But we do see opportunities will continue to be paced and appropriate about it as we go forward and staying very true to advancing our strategy, continuing to move us into those higher-growth markets. And you see us being very active. One of our portfolio management, not only through M&A, but obviously, completing the spin of Inventor earlier this year and some of the very targeted onetime portfolio exits that we shared today that are basically puts and takes with the inorganic growth that we see coming this year.
Frederick Wise :
Yes. And maybe just one final one from me. I thought it would be interesting to hear from Mike and Rick, since you throw them under the bus a little bit by mentioning their names, Mike, in your new role at BD Medical and Rick on the Interventional side, the boss just said growth and meaningful outcomes is a priority. But I'd be curious to hear about your key priorities and when we speak this time next year, what are your priorities for this year? And what should we expect to see over the coming year? We can pretend Tom is not listening.
Mike Garrison:
Thanks, Rick. This is Mike. Yes. So the -- my priority is the same as it was in the MMS role, is that getting Alaris back to market. It's a top priority for the company. And so it remains my top priority. Beyond that, a lot of it has to do with making sure that our innovation is productive, that dollars that we're spending in R&D get value out to customers. And because innovation that never makes it to a customer isn't productive at all. I think that constantly creating a culture where we're developing and coaching our talent to be better each day and have a continuous improvement mentality. I think that's really critical, especially in the current environment, the same way that our customers are facing labor pressures, we are, too. And so if we're the best place to work and people feel that they can belong a greater purpose that we provide, I think that's really, really important. And then finally, I think that there's just an approach to leadership that I hope that we have a performance-based culture of commitment. So whenever we make a commitment, we meet the commitment and we keep our mindset around that. So maybe a bit of a lean processes, but in an abundant mindset would be the way that I think about it. And I'm really -- last thing is Rick actually interviewed me and hired me 18 years ago. So everything I have, I owe to Rick. So thanks, Rick.
Rick Byrd:
Too kind, Mike, thanks. So Rick, thanks for the question. So as I round out pretty much 60 days in the role, I'm truly inspired by the opportunity that we have in BDI to collectively enhance patient lives. So innovations like PureWick, Phasix, Venovo, just to name a few, are truly life changers for patients. And then also, as I go around the business, the commitment, the capability of the team, from our salesperson, R&D, manufacturing technicians in the plants, doesn't matter. Everyone is really focused on the patient. And so first, as Chris mentioned, and we had a great year, right? BDI grew at 7.1%, which is at the high end of our long-range plan. And again, as we said, our commitment there for next year is right there again. So we're on track for that long-range plan. So my priority is keep driving these innovations, keep meeting our commitments as a segment and continue to have a difference in chronic disease treatment and then on the associates within BD and then all the customers that we serve. So really a great opportunity, and I appreciate the question. Thanks.
Thomas Polen :
I think, Rick, maybe just to share one of the other things is, as we said, within the quarter, we saw some backorders in BDI. One of the things that I know, Rick, just you're focusing on helping the team is bringing some of the operational excellence from having led MDS for many years, bringing some of those capabilities from the broader BD operating side into the BDI segment. And maybe just a couple of comments there because that's a big focus.
Rick Byrd:
Great. No, I think we have a great opportunity to improve the supply chain to give an example of the ERP system upgrade, finally, bringing in fully integrating BDI into the beauty system as well. These are going to provide efficiencies to hold deliver products to our customers reliably, on time and things like that. So again, I've spent a lot of my time first off in BDI, looking at opportunities that we can continue to streamline things, drive operational effectiveness. Exactly. So thanks, Tom, for that.
Thomas Polen :
The great benefits of obviously being able to rotate talent across diverse groups of businesses. And I think Rick's background, as everyone knows, MDS is probably the most operationally heavy business within the company, just given the billions of products we make on syringes and catheters and bringing that where the BDI businesses have been very innovation-driven and growth driven. It's a very nice complementary skill and leadership to be able to bring in those capabilities over. So great question. .
Thomas Polen :
Yes. Thanks, Rick, for the question.
Operator:
And there are no further questions at this time. I'll turn the call back over to Tom Polen for any closing remarks.
Thomas Polen:
Okay. Thank you, everyone, for the very good questions today. I just want to take a moment and thank our team again around the world for an extremely strong FY '22, a challenging macro environment. And all of the work and sacrifice that all of our 75,000 associates around the world have made this past year to deliver for our customers and the patients that we mutually serve. Obviously, we've outlined a very strong outlook for FY '23, and we look forward to continuing to focus relentlessly on executing our BD 2025 strategy and bringing that to life. So thank you very much, and have a great rest of the day.
Operator:
Thank you. And this does conclude today's teleconference. You may disconnect your line at this time, and have a wonderful day.
Operator:
Hello, and welcome to BD's Earnings Call for the Third Quarter of Fiscal 2022. At the request of BD, today's call is being recorded and will be made available for replay through August 11, 2022 on BD's Investor Relations website on bd.com or by phone at 866-342-8591 for domestic calls and area code +1-203-518-9713 for international calls. The replay bridges are now dedicated, so you no longer need a conference ID to hear the replay. [Operator Instructions]. I will now turn the call over to BD.
Francesca DeMartino:
Good morning, and welcome to BD's earnings call. I'm Francesca DeMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the third quarter of fiscal 2022. We also posted an earnings presentation that provides additional details on our performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD2025 strategy. Chris will then provide a financial review and our increased revenue and EPS guidance for fiscal 2022. Following the prepared remarks, Tom and Chris will be joined for Q&A by our segment presidents, Simon Campion, President of the Medical segment; and Dave Hickey, President of the Life Sciences segment. Before we get started, I want to remind you that we will be making forward-looking statements. I encourage you to read the disclaimer in our earnings release and the disclosures in our SEC filings, which are both available on the Investor Relations website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. In addition, the results and guidance we are presenting today are on a continuing operations basis, which excludes the historical results of embecta, which are now accounted for as discontinued operations. When we refer to any given period, we're referring to the fiscal period, unless we specifically note it as a calendar period. I would also call your attention to the basis of presentation slide, which defines terms you will hear today, such as base revenues and base margins, which refer to our results, excluding estimated COVID-only testing. With that, I'm very pleased to turn it over to Tom.
Thomas Polen:
Thanks, Francesca. Good morning, everyone, and thank you for joining us. We are very pleased with our strong Q3 results. We exceeded our revenue, operating margin and earnings goals and delivered another quarter of consistent strong performance in our base business, with revenue growth of 9.3%. Our results continue to demonstrate the durability of BD's performance even during an uncertain market environment, with year-to-date base business growth of 9.6%. I want to thank our team of over 75,000 talented associates, who continue to deliver on the Growth, Simplify and Empower pillars of our BD2025 strategy. Our performance reflects the team's agility and strong execution, which puts us ahead of the curve in our ability to manage inflationary pressure, mitigate supply chain challenges and optimize supply for our customers. BD 2025 continues to serve as our true north and is proving to be the right strategy to reinvent and transform health care now and positions us to continue to deliver strong performance in the years to come. This is evident in our year-to-date results and the proof points of our performance, which include
Christopher DelOrefice:
Thanks, Tom. Echoing Tom's comments, our Q3 results demonstrate the strength of our business and the momentum of our strategy. Additionally, the investments we are making in inventory, transportation, portfolio simplification and innovation are also enabling our growth and our ability to deliver our critical health care offerings to our customers and their patients. We continue to deliver strong performance, while simultaneously managing the persistent macroeconomic pressures through our simplification and mitigation programs. Through this balanced approach and the effectiveness of our BD2025 strategy, we're making strong progress against both our short- and long-term commitments. So turning to our revenue performance. We delivered $4.6 billion in revenue in the third quarter, with strong base business growth of 9.3% or 8.8% organic, which excludes the impact of acquisitions. Importantly, however, we are benefiting from the organic contribution from tuck-in acquisitions we anniversaried, which was about 30 basis points this quarter. Our revenue performance continues to be supported by our durable COR portfolio and an increasing contribution from the transformative solutions we're bringing to the market through our innovation pipeline and tuck-in acquisitions. Price contributed 190 basis points to growth year-to-date. While this continues to be well below inflationary levels, it's one of many factors that is ensuring we can deliver our health care offerings to our customers. COVID-only testing revenues were $76 million, which is expected to decline from $300 million last year. Year-to-date, COVID-only testing revenues were $475 million. BD's unique ability to continue to deliver strong performance during this uncertain environment is reflected in the performance across our segments with both Medical and Interventional growing 7.9% and Life Sciences base revenues growing 13.2%. Total company base business growth was also strong regionally with double-digit growth in the U.S., Greater Asia, excluding China, and Latin America, along with high single-digit growth in Europe. Despite the COVID-driven restrictions, we grew low single digits in China. Let me now provide some further insight into each segment's performance. Our Medical segment delivered $2.2 billion in revenues in the third quarter, growing 7.9%, driven by strong performance in our Pharmaceutical Systems and Medication Delivery Solutions businesses. MDS revenues increased 6.4%, reflecting continued strong demand for our durable COR products. Performance in MDS reflects continued competitive gains in catheters and momentum in our comprehensive Vascular Access Management strategy despite the challenging environment in China during the quarter. Performance in MDS also reflects higher hospital utilization levels year-over-year in the U.S. and Europe. MMS revenues grew 3.6%. In our dispensing business, strong growth was driven by continued customer adoption of our connected medication management and pharmacy automation solutions. Worldwide performance in our infusion business was about flat with a similar level of demand in the U.S. for pumps under medical necessity compared to the prior year. Pharm Systems revenues grew 16.3%, driven by the continued acceleration of demand for prefilled devices for biologic drugs and our strong leadership position that is being supported by our ongoing capacity expansion and supply availability. BD Life Sciences revenue totaled $1.3 billion in the third quarter. The decline of 5.1% year-over-year is due to the lower COVID-only testing revenues previously discussed. Excluding COVID-only testing, Life Sciences base revenues grew 13.2% with strong growth across both IDS and Biosciences despite supply constraints and the impact from restrictions in China. IDS revenues declined 10.5%, which reflects the decline in COVID-only testing, partially offset by strong base business revenue growth of 12.8%. Performance in our IDS base business was driven by continued adoption of our broader respiratory panel as well as strong growth in IVD assays, leveraging our increased BD MAX install base. IDS base revenues were also driven by continued demand for specimen management products with strong growth in our durable COR products aided by price management. Biosciences revenues increased 14.2%, reflecting continued strong demand for reagents, driven by our antibody and dye strategy and continued adoption of our e-commerce platform. Performance in Biosciences also reflect strong instrument growth driven by recently launched products and strategic procurement of critical components that enabled us to fill orders to relieve some of the backlog from the end of Q2. BD Interventional revenues totaled $1.1 billion in the third quarter growing 7.9% with strong performance across the segment. Revenue growth of 6.4% in Surgery reflects strong worldwide performance in advanced repair and reconstruction, driven by continued strong market adoption of Phasix hernia resorbable scaffold and the revenue contribution from the Tepha acquisition. Performance also reflects double-digit growth in biosurgery. Revenues in Peripheral Intervention grew 9.1%. Strong performance reflects competitive gains driven by Venovo's return to the market and continued global penetration of Rotarex and the acquisition of Venclose expanding our focus across chronic disease settings. Partial backorder recovery also contributed to performance in the quarter, offsetting the impact on deferrable procedures from macroeconomic factors, such as labor constraints. Urology and Critical Care revenues grew 7.7%, driven by continued strong demand for our PureWick chronic female incontinence platform in the acute care and alternative care settings. Strength in acute care was also aided by some backorder recovery. Now moving to our P&L. In Q3, we delivered adjusted net income and EPS above our expectations, with adjusted net income of $786 million or 14.2% reported growth and adjusted diluted EPS of $2.66 or 16.7% reported growth. As we anticipated on a year-over-year basis, margins improved significantly. We delivered base business gross margin of 52.9%, up 180 basis points and base operating margin of 22.2%, up 450 basis points year-over-year. Base operating margin includes a favorable impact of approximately 75 basis points from an employee benefit-related item that has a related negative offset in our other income and expense line and thus is neutral to our adjusted EPS. Q3 base gross margin increased in line with our expectations. Key drivers of gross margin include our simplification and inflation mitigation initiatives, such as mix optimization and price management, along with increased volume utilization given our strong base revenue growth. These actions enabled us to offset the impact of inflation and deliver margin improvement. In addition, as expected, we had favorable FX that was recorded in inventory that benefited our GP this quarter as it flowed through sales. Q3 base operating margin reflects very strong operating expense leverage with base SG&A as a percent of sales, leveraging by about 200 basis points, excluding the employee benefit-related item, partially offset by inflationary impacts primarily in shipping. R&D of 6.2% of sales reflects our innovation investments aligned to our strategy in support of our long-term growth outlook. Our tax rate in Q3 was lower than anticipated due to the timing of certain discrete items that occurred in the quarter. Regarding our cash and capital allocation. Cash flows from operations totaled approximately $1.5 billion year-to-date. Q3 cash flow from operations reflects a higher-than-normal inventory balance by about $400 million as we continued our strategic investments in raw materials, such as electronic components as part of our actions to optimize product delivery to meet customer demand in this uncertain environment. During Q3, we paid down approximately $500 million in debt and ended the quarter with a strong cash balance of $2.6 billion and a net leverage ratio of 2.7x. In addition, we are pleased by our recent debt upgrades from both Moody's and Fitch, which reflect the strength of our business and disciplined approach on balance sheet management and capital deployment. Our current cash and leverage position and continued focus on cash flow provide us the flexibility to advance our balanced capital allocation framework in support of our BD2025 growth strategy. Turning to our fiscal '22 guidance assumptions. First, some macro considerations that support our guidance. Our guidance assumes the continued easing of COVID-19 restrictions and no significant or lasting disruptions to deferrable procedure volumes. Our guidance also assumes there are no prolonged and larger scale restrictions and countries continue to be more efficient in managing safety protocols and the containment of any new COVID variants to allow continuity of care for patients. Regarding China, specifically, we expect continued recovery from the recent restrictions over the balance of the fiscal year. Additionally, while we anticipate continued inflationary and supply chain pressure in Q4, we are not planning for significant escalation of macro headwinds. Moving to our updated guidance for fiscal '22. We have increased and narrowed both our revenue and EPS ranges. We now expect base revenues to grow 8.75% to 9.25% on an FX-neutral basis. This is an increase of 125 basis points at the midpoint from our previous guidance of 7.25% to 8.25% growth. 100 basis points of the increase is driven by strong growth and continued momentum in our base business. Additionally, with the closure of Parata, we're increasing our forecast by 25 basis points. For COVID-only testing, we now assume up to $500 million in revenue. This reflects year-to-date revenues of $475 million and minimal additional revenue in Q4 as testing demand has slowed as expected. Based on current spot rates, for illustrative purposes, currency is now estimated to be a headwind of approximately 225 basis points or about $425 million to total company revenues on a full year basis. This is an incremental impact of about 25 basis points or approximately $50 million compared to our prior guidance and is primarily driven by the strengthening of the U.S. dollar versus the euro. All in, we are increasing our total reported revenue guidance by $190 million at the midpoint to a range of $18.75 billion to $18.83 billion. We now expect base operating margins to improve by approximately 275 basis points, over 19.6% in fiscal '21. This is an increase of 25 basis points compared to our prior guidance and solely reflects the Q3 employee benefit-related item that has a corresponding negative adjustment to other income and expense and is neutral to adjusted EPS. Despite this challenging macro environment persisting, our focused execution on driving profitable revenue growth, combined with our simplified programs, gives us the confidence that we will be able to continue to offset inflationary pressures. A few additional items for your models. We now expect approximately $30 million in year-over-year improvement in interest/other compared to our prior guidance of $60 million to $75 million. This reduction reflects the offsetting impact to the Q3 employee benefit item that was recorded in G&A. Again, these items are neutral to adjusted EPS. We have narrowed our expected effective tax rate to a range of 13.5% to 14% from 13.5% to 14.5% previously. Our updated guidance still assumes share repurchases that, at minimum, offset any dilution from share-based compensation and thus does not assume a material change in shares outstanding. Altogether, we are raising our adjusted EPS guidance to a range of $11.28 to $11.35 compared to $11.15 to $11.30 previously, which reflects an increase of $0.09 at the midpoint. This reflects our strong Q3 base business revenue performance and increased outlook in Q4 and a margin profile that maintains our full year margin improvement commitments. We expect minimal impact from incremental COVID-only testing revenues as we intend to reinvest that to support our momentum into 2023. We still expect margin on COVID-only testing to be modestly above our base business margins for the full fiscal year. Additionally, while the Parata acquisition has an accretive margin profile, the income is expected to be offset by onetime deal-related costs. Regarding FX, based on current spot rates and our inventory outlook, we expect minimal incremental impact as incremental translational FX headwinds are expected to be offset by favorable FX on inventory flow through. As you think about Q4, the following are a few key considerations. Starting with base growth in Q4, we increased our organic growth and expect strong mid-single-digit growth, excluding the impact of acquisitions, above the 5.5% plus targeted growth profile we outlined at our Investor Day. This includes absorbing the impact of a difficult prior year comparison in Q4 of fiscal year '21 where the delta variant's surge drove high acuity and demand for infusion sets and products used in the care of COVID. Additionally, we delivered initial shipments of our combination flu COVID assays and benefited from the normalization of lab utilization and research activity. We also have a tough comparison to $316 million of COVID-only testing revenue in Q4 of last year as we expect minimal additional revenues this year with the decline in testing. Regarding margins, we expect sequential improvement in base gross margins and at a level near year-to-date gross margin of 53.8%. While the impact of increased inflation on our business is expected to continue, we see a larger benefit from our offsetting initiatives. Regarding base operating margins, we continue to expect significant year-over-year margin expansion in Q4. Sequentially, the improvement is driven by gross margin as well as continued strong leverage in selling and G&A and slightly lower R&D expense. For the full year, we continue to expect to invest in R&D at about 6% of sales. While it is premature to provide guidance for fiscal year '23, especially in a macro environment that remains uncertain, we recognize that offering a more proactive perspective during this time is helpful. To begin, while we expect macro challenges to persist, we are not assuming they worsen and would anticipate that as we move towards the back end of the year, there may be some modest relief from some of the current supply chain complexity. We will reassess the environment ahead of providing guidance in November. So with that caveat, on an operational basis, excluding the impact of currency, which, based on current spot rates, would be a headwind to consider for next year, we remain confident in the strong value-creating framework we outlined at our Investor Day and expect to deliver 5.5% plus base revenue growth and double-digit adjusted EPS growth. This framework continues to be supported by a strong growth profile and continued margin improvement. We expect the COVID-only testing revenues and related earnings would be at a level significantly below FY '22 and more likely at a run rate similar to the implied Q4 FY '22 or approximately $100 million for the full year. We will have a positive contribution from the full year benefit of revenue and income from Parata that will partially offset the reduced COVID testing. So importantly, despite the anticipated reduction in COVID-only testing, on an all-in basis, we would expect adjusted EPS to be right around double-digit growth, which implies very strong double-digit base adjusted EPS growth. Based on what we see, it appears current external thinking largely reflects this. We will share more details regarding FY '23 on our year-end earnings call in November. In closing, we are very pleased with our strong performance to date and the consistency of execution against our strategy that is enabling these results. This gives us confidence in our ability to continue this momentum into FY '23 and create long-term value for all of our key stakeholders. With that, let me turn it back to Tom for a few additional comments.
Thomas Polen:
Thanks, Chris. Our BD2025 strategy is proving to be an effective winning strategy as reflected in the proof points of our execution and our continued strong performance. We expect continued momentum and remain well positioned to drive long-term growth and value for all stakeholders. I'd like to thank our associates worldwide once again for their tireless commitment to our purpose of advancing the world of health. Before we turn to Q&A, I want to officially congratulate and welcome Simon in his new role as the Head of the Medical segment and thank Alberto Mas for an exemplary nearly 30-year career at BD. We expect to announce Simon's successor in BD Interventional soon. I'd also like to welcome Rishi Grover, our new EVP and Chief Integrated Supply Chain Officer. Rishi brings more than 20 years of experience in manufacturing and supply chain roles, and we're thrilled to have him join our executive leadership team. Rishi succeeds Alex Conroy, who will be retiring after more than 30 years at BD. I'd like to thank Alex for his contributions to BD throughout his career that include a vast array of roles and responsibilities. Most notably and recently, Alex led the organization through unprecedented challenges, including the COVID-19 pandemic and global supply chain crisis. For the purpose of today's Q&A session, Chris will take financials, Dave will answer life science questions, Simon will address BDI, and I will take BD Medical. With that, let's start the Q&A session. Operator, can you assemble our queue?
Operator:
[Operator Instructions]. And our first question comes from Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Congratulations on another strong quarter here. So Tom and Chris, I wanted to just ask about 2023, a couple of follow-up questions and one on pricing. So Chris, on 2023, could you just talk about, is that base sales growth of 5.5% plus, is that organic? How much do you think at this current rates FX would impact sales and EPS? And what's assumed for Alaris returning to the market? And I just had one follow-up on pricing.
Christopher DelOrefice:
Let me -- maybe why don't we first start just with a quick comment on the Alaris, which we'll do one upfront and then I can walk you through the 2023.
Thomas Polen:
Larry, this is Tom. Thanks for the good questions. So first off, just overall on '23, as you heard from Chris, we feel really good about our overall position for '23. And obviously, Chris gave some very specific color on that today. It is still early though, and we're not going to get into any specific product assumptions today. We'll click down into that level on our regular Q4 guidance call. But specific to Alaris, really no change to what we've shared before. Alaris remains our #1 priority. We're confident in the resources that we've invested in our submission and the team and the leadership that we have working on this. And we're focused on making sure that we get all the information to the FDA that's required to get clearance on that product. And so no change from that as -- again, as we think about the Q4 and guide for '23, we'll share more, but we're not going to get any product line details at this time.
Christopher DelOrefice:
Yes. And so I'll build on some of the comments that we made in the opening comments. So first, as we think of 2023, we certainly know there's still a lot of uncertainty that remains in the marketplace. We actually wanted to try and get some context because we know there's questions out there. One, obviously, we have significantly strong growth profile in '22, right? Our guide would apply on an organic basis about 8.25% growth when you strip out Parata. So folks, we knew there was questions about how you're going to cycle over that growth? Can you still deliver at your 5.5% plus? In addition to that, we knew there was sort of the open question as it related to COVID testing? And how do you think of that dynamic? And what it may do in terms of your earnings profile? So I think with that as a backdrop, we wanted to just reaffirm. We're extremely confident in our 5.5% plus growth profile that we outlined. Actually, I think an interesting way to think of that is if you do kind of 2-year math, it would imply a growth rate of about 7% '22 to '23. So any way you look at that, it's a really strong base growth profile. We do see the impact of COVID-only testing dropping significantly as we said. We're planning for roughly $25 million kind of this quarter based on what we said and kind of see that more as a more normalized run rate. Obviously, if there's upside to that, it provides that embedded hedge to our portfolio that we've always talked about. So that will be a headwind that gets contemplated. With that said, you see the power of our capital allocation strategy going to work. We're pleased to announce the closing of the Parata acquisition. So that will be an offsetting element against the COVID-only revenue. That is not part of the 5.5% plus. So you think that the 5.5% plus as pure organic. We always said we're not reliant on the onetime lift from tuck-in M&A. And when we do benefit as part of that strategy is the organic lift we get as we cycle and anniversary those acquisitions. And then from an earnings profile, we're committed to the double-digit base adjusted EPS earnings growth. I think importantly though, the most important thing that we share, despite that, kind of COVID-only headwind, we think we can get right about a double-digit adjusted EPS growth profile as well on an all-in basis given the strength of the business, and we'll continue to drive margin improvement into next year. All of that, obviously, we always think and talk about guidance on an FX-neutral basis. So it doesn't contemplate the currency that we've been talking about. That will impact every company. We're not different in that regard. I can try and help give you a little bit of context, obviously, as we set the year. But one simple way to think about it is euro is the predominant currency that has changed and impacted BD certainly. If you look at the change from '21 to '22 where currently we've talked about a $425 million headwind, the percentage change in the euro from '21 to '22 is exactly the same as the current average rate we're planning in '22 to the current spot rate at 1 02, which would imply basically a similar kind of year-over-year headwind on currency. I think you're going to do some sort of margin drop-through on that. For BD, the margin tends to drop through at a lower rate given mix of business and other dynamics. With that said, I do think it's important to think of underlying as the most important metric on an FX-neutral basis, right? We're still generating that local cash. We have a very efficient cash allocation model, and we'll be able to put that cash to work. So all in all, I think with where we are with '22, it's a great year. We're on track to finish out a very strong year. And I think you can see based on what we share, we feel confident having momentum going into 2023.
Lawrence Biegelsen:
Right. That's super helpful. Given the time here, I'll drop there. I appreciate the comprehensive answer, guys.
Operator:
We'll take our next question from Vijay Kumar with Evercore ISI.
Vijay Kumar:
I'll limit myself to just one question, maybe a two-parter. One, on fiscal '23, the 5.5% organic, that does not include Parata, correct? And Chris, when you said double-digit EPS, that's on a reported basis? I just want to confirm. When you look at free cash flows year-to-date, it's been trending in below. I know there's some inventory buildup. Anything else that's going on in the free cash line item?
Christopher DelOrefice:
Yes. Thanks for the question. Yes, just to confirm, the 5.5% plus does not include Parata. Our commitment that we outlined in Investor Day, again, you always run the business on an operational basis and think of operational commitments. So both a double-digit commitment on base revenues and then what we just shared here despite the COVID only grow over, given the drop in COVID-only revenue, we're confident in right about a double-digit growth profile on an all-in basis as well, which is a great signal on the strength of our total business and the continued momentum we have as it relates to margin improvement that we've committed to as well. If you remember, we committed to about 25% through the 2025 period. We shared that last quarter. As it relates to FX, again, this is going to apply to any company. Actually, we've been absorbing currency this year, but those commitments we make are always on an FX-neutral basis. You will have to adjust for revenue, and there will be some translational drop-through on that, that would have to be contemplated as you think of the final growth rate. But we need to wait and see where FX lands. But again, that's not different from anyone, and it doesn't impact your -- it's certainly not reflective of your underlying business. And it doesn't impact the underlying cash that you've earned locally. And we have a capital deployment model that we'll continue to put that to work to continue to drive our strategy as it relates to tuck-in M&A and other things. So we're feeling really good about that growth profile. Regarding free cash flow, there's been a -- there's really 3 big dynamics. We remain extremely focused on cash. Remember, there's a few ways to look at us. One, we committed to a net leverage ratio of around 2.5x. We're right at 2.7x now. We've been executing on our M&A strategy. So you can see we're putting that at work. We paid down debt as well, consistent with what we shared as part of the embecta spin. So we continue to execute against our capital allocation strategy. In addition to that, on the strength of the business and a disciplined approach we've applied to the balance sheet and how we're navigating that, we did get 2 debt rating upgrades this past quarter. So that was great to see. There are some differences in cash flow. The biggest difference is really just the year-over-year nuances as it relates to COVID-only testing and losing the higher base on COVID-only testing. There was also we also funded the pension. You can see that in the Q. And then the third thing that we talked about as well is the one trade-off we've made intentionally is investing in inventory. And there's about a $400 million investment we're making there that I would call outsized inventory levels, driven by 3 factors. One of the most critical ones, of course, is procuring strategic components, raw materials, et cetera, to enable the strong growth profile. As you can imagine, there's still long lead times. We have a very efficient supply chain. And a lot of our product is spending time not in the plants, but rather on the water, so to speak, getting to customers. So we've made that investment. And you do have -- everyone will have inflation kind of flow-through inventory as well. So we're not different in that regard as well. That explains the free cash flow. We remain very focused on that. We're going to continue to look at inventory. But in the short term, I think it's a prudent trade-off and is an enabler to these strong results.
Thomas Polen:
And Vijay, this is Tom. Just to add to Chris' comment on that. We view that increase in the inventory levels impact on cash flow. We call it transitory in nature. That's a strategic investment. But as we see supply chain stabilize, we can back off on that additional inventory. As shipping times, transit times, get back to a more normalized level, right, it's going to be more than a month additional nowadays. To get product, let's say, from Asia to the U.S., right, as that normalizes, that will naturally pull back inventory levels as well. And so we see that just as a temporary investment to help navigate the very dynamic circumstance that exists today. But we already have the plans on starting to pull that down as we look ahead.
Vijay Kumar:
That's helpful, Tom. Congrats on the [indiscernible].
Thomas Polen:
Thanks, Vijay.
Operator:
We'll take our next question from Robbie Marcus with JPMorgan.
Robert Marcus:
Great. Congrats on a good quarter. Maybe to start, Chris, just maybe walk us through some of the drivers of operating margin expansion next year. I realize you're not giving exact numbers. But the base business has been sequentially down just a little bit each quarter in fiscal '22. With next year, how do we think about the drivers of that margin expansion?
Christopher DelOrefice:
Yes. Thanks, Robbie. So first, as it relates to this year, the margin has played out exactly as planned. As a matter of fact, year-to-date, we're sitting at basically 80% of our full year goal, that 250 basis points where we actually increased our margin improvement more to account for, call it, an accounting dynamic and reclass of line related to employee benefits. But we remain well on track. We did explain at this quarter as it relates to GP specifically, would be the low watermark as you think of timing dynamics, in particular, the outsized inflation that started at the beginning of the year, how that rolls through inventory. And then from the time we started the year, things have only gotten a lot more complex. Inflation increased and supply chain complexity increased, which also increased things such as transportation, et cetera. So as we've come into the year, just to maybe give you a little bit of context on margin, there's probably been about 100 basis points of -- to our P&L as it relates to outsized inflation above what we contemplated coming into the year given the additional complexity. It's about a 50% increase from what we originally planned. Despite all that, we're still holding our margin commitment for the year, which is really strong. As you think of the components this year, and I share that because it will play into next year as well, our volume leverage we talked about coming into the year was supposed to be about 100 basis points. Given the strong revenue growth profile, we've done stronger there. That's been part of navigating the outsized inflation on the other end that I just articulated. And then really beyond that, it's been cost improvement programs that we've dug into and enhanced. We've also been delivering our portfolio actions. There's multiple components to that one. Given the strong growth profile, right, we've been able to be more aggressive with navigating portfolio mix and simplifying our portfolio. We have price management as part of that, that we're fully executing against, which is a very strong. And then the third component to navigate this year has really been, again, on the strong growth profile, the leverage we're experiencing in operating margin and selling and G&A. So as you think of '23, it's going to be all those same levers. You don't navigate this complexity doing just one thing. We certainly -- with another strong growth profile, we'd expect leverage in terms of volume flowing through our plants. We'll continue to drive a strong CIP agenda. We'll start to get more benefit from the SKU rationalization program as part of Project RECODE we talked about. You'll start getting early benefit from some of the architecture simplification work we also talked about. And you'll certainly continue to get more leverage on the operating margin with the strong growth profile on sales and G&A. In addition to that, we've always talked about kind of the simplification principle beyond just supply chain. And we're looking to also drive simplification through all of our functions. So that will also help. So we continue to build an inventory of things that we're doing that give us confidence as we move into '23. And then, again, maybe just a reminder for everyone, our goal is to get to about 25% by 2025. It implies roughly 100 basis points per year after 2022. And if you think of that, kind of normally, you would probably just do that on a ratable basis. I think you can anticipate 2023 under-indexing that 100 basis points given you're going to have the rollover of this outsized inflation. And then on the back end, towards '25, you'll get more of the full benefits from Project RECODE. And we also talked about the leverage you get from Alaris coming back. So those things will give you a slight lift in, call it, '24, '25. And '23 will probably slightly under-indexed versus kind of that 100 basis points equally, but it will still improve year-over-year.
Robert Marcus:
That's really helpful. And maybe just a quick follow-up. Your pricing, I think you said 190 bps positive is one of the best, if not the best, in large-cap med tech. How sustainable is that? Do we think of that as you're able to take that as a onetime? Or is this the new normal on pricing as we move forward into subsequent years?
Thomas Polen:
I'll take that, Robbie. So just as we think about inflation, and Chris hit a lot of the things that we do to offset that pricing just being one and the last thing that we look at. We put an inflation task force in well over a year ago, recognizing what we saw was going to be inflation this year, and we expect to continue to be inflation in '23. And so just to make that clear, we've done a ton looking at and taking action around improving our own internal continuous improvement within our plants, restructuring our organization, getting costs out within that, looking at our supply chain and how we get costs out there and taking action, and we're seeing those things come through. It's helping our margin. And we are -- as part of that, where we can offset those internally, we do pass on pricing. We do expect to continue to drive very large significant actions within BD to offset inflation as we look ahead. But we'll continue also where we can't fully offset that to continue to pass that through in price. And we do that in all markets around the world and across all business areas.
Operator:
We'll take our next question from Travis Steed with Bank of America.
Travis Steed:
Great quarter. I did want to put a finer point on '23 [indiscernible] margin around [indiscernible]...
Thomas Polen:
Travis, you're breaking up. We can't hear you very well.
Travis Steed:
All right. Can you hear me now? Is that better?
Thomas Polen:
Yes, keep speaking.
Travis Steed:
Okay. Sure. Sorry about that. So just put a finer point on some of the FY '23 comments. I was getting around $12 in earnings for FY '23, just to make sure that's the right ballpark. And on the 100 basis points inflation versus prior expectations, talk a little bit about what's changed there. And to think through like the total inflation impact you're absorbing this year, is that closer to 150 to 200 basis points, $400 million to $500 million? Just trying to think about if there is some relief what the opportunity could be on that front.
Thomas Polen:
Maybe we want to start with the $12 commentary. Chris, I'll turn that to you.
Christopher DelOrefice:
Yes. I think as it relates to kind of sharing any specifics on a number, we wouldn't do that for sure. I think we laid out the framework that's pretty clear. We did say that we, of course, look and are aware of kind of external thinking and the time coming into this print, it seemed reasonable knowing that folks would not have contemplated the carryover on currency. Anyway, that's -- I don't think there's much more to add there. I would just go back to, again, the commitment on the 5.5% plus growth profile, double-digit adjusted EPS growth on the base and even having confidence of right around double-digit growth, adjusting for the drop-down of the COVID-only testing.
Thomas Polen:
And Travis, on your comment around what changed as we went through the year. I think very similar to what probably every business around the world and particularly in the U.S. would have seen we recognized and we took the position very early on well over a year ago, again, that there was going to be no company that escapes inflation and no company that escapes supply chain challenges, and we've been taking action to that extent. Those challenges, labor became more expensive as you went through the year, right, particularly in areas, like manufacturing, where there were shortages and you had to pay more to get talent to run plants. Think about as you saw low watermarks for unemployment, trying to staff, for example, overnight shift. When now there's tons of jobs for people to work day shift, having to change that in all of our plants, which we pretty much run most of our plants 24/7. Shipping continued to increase as we went through the year, and you saw that as well. Things like power significantly, as you can imagine, we use tons of power in our manufacturing plants running large presses, et cetera. Those costs went up as well. And so those were general inflationary pressures that you saw across the country, very much in line with inflation continued to go up as we went through the year just versus everyone's expectations, and that certainly we didn't escape any business. And so what was maybe starting the year towards that 150, 200 basis point headwind ended up being more of a 250 or so as Chris mentioned. And again, we are really pleased with the team's work to overcome all of that and still deliver on our expectations that we set at the beginning of the year. I think that really speaks to the power of the strategic planning that the team has done, the strong execution and the foresight to make investments in areas like the strategic inventory builds that we did and navigate a very challenging environment.
Christopher DelOrefice:
Just one other frame for everyone because I know you're all navigating. Things have changed a lot from the start of the year to where we are. And when you think of that through the lens of BD, there's really been 2 key things that have changed, one kind of a macro factor, right? When we started our initial guide and talked about what the year would be like we were contemplating pretty significant outsized inflation. As the year progressed, whether it be the conflict in Ukraine and Russia, the COVID China shutdown, the complexity only grew. Inflation grew, as I noted earlier on the call. And the supply chain complexity increased. So again, about a 50% increase on what we originally contemplated about a 100 basis point headwind. Then when you think of what's happened from BD. Our initial guide, when you kind of restate everything for embecta, we were at 6%. We're sitting here at 9% at the midpoint, right? That's 300 basis points or about $0.5 billion. So with more complexity, we've actually strengthened our growth profile and overcome all of those headwinds. And then I know there's a lot of puts and takes quarter-to-quarter. Obviously, there was also on the revenue side. Outsized COVID testing, we benefited from. That took our number up $300 million. But when you look at the EPS drop-through, it was north of $0.60 from the beginning of the year, inclusive of absorbing FX headwinds. And when you look at that then and think of what we've done from a margin standpoint, we've delivered exactly what we can actually slightly above our commitment. So we absorbed $100 million -- 100 basis points of headwind on the cost side, delivered outside performance as we've headed through the year on top line and fully held our margin commitment both on the base and EPS. So I know there's lots of puts and takes as you go through the quarter. Even tax as an example, when you restate our guide for the initial tax, it would have been 13% to 14% ex embecta. We're now 13.5% to 14%. So we know we had some onetime timing items in this quarter, but we're actually absorbing tax pressure as well in those numbers. So you'll have a Q4 true-up, of course, given the timing here. But we're not even benefiting there as you think of kind of updating. So it's been a very strong year. We're really proud of what everyone has done, our 75,000 employees navigating the complexity during this time and feel good about the momentum we have going into next year.
Travis Steed:
No, that's great. And maybe just one follow-up on the overall hospital environment. You just talk about utilization trends, hospital staffing, capital spending and also the China recovery. Does China return to double-digit growth in FY '23.
Thomas Polen:
And just to clarify, great question. We're expecting China, and I think this is really impressive and reflects on the strength of our China team, to still deliver right around double-digit growth this year despite the Shanghai shutdown. And even despite the Shanghai shutdown, we delivered -- we still delivered growth this quarter in China, which I think is an exceptional achievement of our team there. And to reflect on how dynamic of a year there's been for them to still be on track to deliver right around double-digit growth for this full year, again, really reflects a lot of great planning and execution on behalf of our China team. Why don't I turn it to Simon and Dave to make some colors on utilization kind of on the procedure side and then what we're seeing in the lab side. So we'll start with Simon.
Simon Campion:
So for sure, you mentioned labor. We definitely saw some pressure on labor in Q3. I think it was particularly relevant in the Peripheral Intervention space. But despite that, we still posted really, really robust growth in BDI and PI, in particular, both domestically and internationally. And then just to follow up on Tom's comment on China, we posted in BDI another quarter of double-digit growth. We continue to invest there in Surgery with the Tissuemed acquisition in PI with the recently approved Venovo venous stent in China, which is -- which we've done cases already, and it's gone tremendously well. And we just also recently got approval on the Covera covered stent graft. So anytime we put anything into China, we get a really robust return. And as we've noted before, it's doubled since Bard is acquired by BD, and we look forward to continued robust growth there.
Thomas Polen:
Great, Simon.
David Hickey:
Yes. Thanks, Tom. And for Life Sciences, similar theme. I mean again, another great quarter for us in terms of double-digit growth. The team continues to execute extremely well both in IDS and BDB. If I think about IDS, one of the best bellwethers or measures we have for utilization is the specimen management business. That was a big growth driver for us in the quarter. So that's a really good indication. On the BDB side, which I think, as you know, is split into both clinical and research businesses on the -- as Tom mentioned, the Life Science research reagents and instruments and the clinical reagents growth above expectation for us. So just solid returns overall in terms of utilization and growth levers. On labor, it's interesting. As you sensor some of the labor shortages and challenges within our health care customers might be going, that's where I think we're very well positioned with some of our automation platforms when you think about the slide we had in the back on innovation relative to BD COR that just got approved or the molecular module got approved here in the U.S. I think if our customers do see headwind with labor shortages, we have fully automated, connected, integrated automated solutions, both for clinical microbiology, the molecular testing that we're just ready and continue to deploy to help our customers address those headwinds.
Thomas Polen:
Great. And maybe just to give just a couple of other statistics that we look at, at a macro level and utilization. As we think about Q3 and what we saw versus last year in the U.S. acute care sector, the average trend we saw over -- was about 100% of pre-COVID levels in Q3. That was up just a little bit versus Q2, where we were at -- we saw 98% to 99% of pre-COVID level, so it went up a tick in Q3. In the non-acute sector, we saw Q3 rates in the non-acute sector, we're slightly over 100% versus pre-COVID, which was also similar to what we saw in the prior quarter of Q2. And then as mentioned, we do see sequential improvements continue to occur as we look ahead. We do see in certain areas impacts of labor shortages certainly impacting certain procedures. I think the procedures that tend to be in BDI business are less impacted by them. It can be more acute in nature, let's say, putting in a fistula for someone to get dialysis that really becomes a prioritized procedure or getting your vasculature open to prevent an amputation of your leg as another example where that's a priority procedure. And at the same time as well, David mentioned a lot of fantastic automation solutions in the Life Science sector, but we have the same in BD Medical. And I think a great example of that is the Parata Solution. And if anything, that's become more attractive since we've acquired that. That is the answer to pharmacy labor shortages, and, it is the answer to higher labor costs. It automates routine tasks that can be done by robots and software. And we're seeing really strong demand on that herein as its early days in our hands. So we're really excited to have that as part of BD.
Operator:
And we'll take our final question from Rick Wise with Stifel.
Frederick Wise:
It's hard to not ask a question about your capital priority thinking updated thoughts from two perspectives, both on the M&A side and the portfolio side. I mean Chris and his team are clearly doing a brilliant job in, I think, driving even more financial flexibility for you to make decisions. And I'm sort of curious, do you feel bolder about thinking about portfolio addition and subtraction generally now given that financial flexibility? And maybe talk about your thoughts, do you feel like, given the current environment and the market and valuations, are there more opportunities? Could we see your tuck-in strategy accelerate here?
Thomas Polen:
Thanks for the good question, Rick. So I just -- I'm going to step back a little bit as we think about our portfolio strategy. And as you mentioned, we've been very active in executing our portfolio strategy, shifting BD into those higher-growth spaces, those 3 transformative solution spaces that you've heard us talk so much about, a smart connected care enabling new care settings and improving outcomes in patients with chronic disease, all high-growth markets that are reshaping the future of health care and where BD will be at the forefront of. And so some of those portfolio actions that we've been doing over the last couple of years include the spin-off embecta. It also includes 19 tuck-in acquisitions over the last few years. And these are all going very well. I think that's important to also hover up and look at. You heard Chris discuss that those that have already anniversary-ed are adding 30 basis points to our underlying growth today because they're doing well. They're in high-growth markets and they're driving BD's growth rate up. Of course, the spin-off embecta also adds to that growth further. 90% of the M&A that we've done to date, of those 19 deals, 90% of it of the spend has been in transformative solutions spaces, those higher-growth spaces that are reshaping our pipeline. And so as we look ahead, we're certainly going to continue to be very disciplined and focused on executing tuck-in M&A in line with our strategy. And that's doing M&A that's strategically aligned in advancing our leadership and expanding our position in those prioritized high-growth transformative solution spaces that I talked about. Those are deals that are accretive and meet rigorous financial metrics that we have. We've walked away from a lot of deals that don't meet those metrics. We're going to stay disciplined to that. And we're proud of we walk away from that perspective. And then finally, where we see significant leverage and synergies, and I think that's been a hallmark of all the deals that we've done. They've been able to leverage whether or not it's BD global presence, strong BD commercial channels, strong BD manufacturing or procurement capabilities, to add more value as part of BD than they could stand alone. And that's a core principle that we're going to continue to execute against. So we certainly have a robust funnel. As we look ahead, we're obviously, in the very near term, very focused on the Parata acquisition execution and making sure that, that's a success. I know, again, we really very much welcome the Parata team to BD. And I know they're excited to be here, and we're seeing really strong early momentum with us having come together. If anything, I would just say expect to probably see a focus on more Parata-cized deals in the future, still very much tuck-in, but along that size versus smaller ones. So and again, we're very active in our funnel management from that perspective. We do see -- we certainly see whether or not in the environment before we've been very active in M&A., we still see many opportunities as we look ahead. Thanks for the question, Rick.
Operator:
There are no further questions. We'll now turn the floor back over to Tom Polen for closing remarks.
Thomas Polen:
Okay. Well, I'm going to keep this very brief. It was a great discussion. Thank all of you for the very good questions. We wish you a great rest of the day and a wonderful summer. Thank you.
Operator:
Thank you. And this does conclude today's audio webcast. Please disconnect your line at this time, and have a wonderful day.
Operator:
Hello, and welcome to BD's Earnings Call for the Second Quarter of Fiscal 2022. At the request of BD, today's call is being recorded and will be available for replay through May 12, 2022, on BD's Investor Relations website at bd.com or by phone at 866-342-8591 for domestic calls and list the Area Code +1-203-518-9713 for international calls. The replay bridges are now dedicated, so you no longer need a conference ID to hear the replay. For today's call. All parties have been placed on a listen-only mode until the question-and-answer session. I will now turn the call over to BD.
Francesca DeMartino:
Good morning, and welcome to BD's earnings call. I'm Francesca DeMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the second quarter of fiscal 2022. We also posted an earnings presentation that provides additional details on our performance. The press release and presentation can be accessed on the IR website at investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued execution of our BD2025 strategy. Chris will then provide a financial review and our updated outlook for fiscal 2022. The Q2 results, we'll be discussing today include the results of our former diabetes care business as a spin-off of embecta, that was completed on April 01, subsequent to quarter end. On April 14, an 8-K was filed to provide re-casted historical financial information reflecting the results of operations of our former diabetes care business as discontinued operations for the 2019, 2022 and 2021 fiscal years and the first quarter of fiscal 2022. On today's call, we'll give an updated outlook for fiscal '22 for both legacy BD, which includes our former diabetes care business and BD RemainCo. We anticipate recasted financial information for the second quarter of FY '22 will be available by the end of May. In the meantime, to assist you with FY '22 RemainCo models, we're providing estimated impacts of excluding our former diabetes care business from our Q2 results. We don’t expect the Q2 recated financial information to differ material from the estimated impact nor affect the updated outlook for FY '22 that we're providing today. We also do not plan to comment on diabetes care after this quarter. In addition to our prepared remarks, you can find this information on our earnings presentation that is posted on our IR website. Following the prepared remarks, Tom and Chris will be joined for Q&A session by our segment presidents, Alberto Mas, President of the Medical segment; Simon Campion, President of the Interventional segment; and Dave Hickey, President of the Life Sciences segment. Before we get started, I want to remind you that we will be making forward-looking statements today. I encourage you to read the disclaimers in earnings presentation slides and the disclosures in our SEC filings, which are both available on the Investor Relations website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically note it as a calendar period. I would also call your attention to the basis of presentation slide, which defines term you'll hear today, such as base revenues and base margins, which refer to our results excluding estimated COVID-only testing. With that, I am very pleased to turn it over to Tom.
Tom Polen:
Thanks, Francesca, and good morning, everyone and thank you for joining us. We're very pleased with our strong performance in Q2 with revenues of $5 billion and base revenue growth of over 10%. These results reflect the continued focused execution of our BD 2025 strategy and another quarter of consistent strong growth in our base business. We exceeded our revenue, margin and earnings goals while advancing our innovation pipeline and our tuck-in M&A strategy, and year-to-date, we generated $1.1 billion in operating cash flow. In addition, we successfully executed the spin of our diabetes care business on April 1, which is now a standalone and publicly traded company named Embecta. It trades on NASDAQ under the ticker EMBC. I'm very pleased with how our strategy is progressing and coming to life. Through our efforts to grow, simplify and empower our company, we are creating an agile and resilient organization that is well positioned to deliver strong performance. Our durable core reflects our leadership position in areas of healthcare that remain in high demand. These are the products and solutions that form the backbone of healthcare around the world and create a very stable business, that weather storms and uncertainty. Through the performance of our durable core and our cash flow initiatives, we are fuelling our growth strategy with investments in organic innovation and tuck-in M&A. The investments we are making are targeted toward higher growth spaces aligned to the irreversible forces that are transforming the future of global healthcare across smart connected care, a shift to alternative care settings and improving chronic disease outcomes. You are beginning to see the impacts of that shift in our growth. Through the simplified pillar of our BD 2025 strategy, we are reducing complexity and driving excellence across supply chain operations, which delivers efficiencies and enhances our margin profile while improving customer satisfaction. And we're doing this by improving asset utilization and labor productivity while also enhancing our supply chain resilience, responsiveness and sustainability, all of which are more critical than ever in today's environment. Our focused execution of our strategy is creating momentum and gives us confidence in our outlook, despite the challenging macro environment, which has evolved dramatically since our last earnings call. The conflict in Ukraine, increased supply chain challenges, energy price escalation, increased inflation and COVID-driven shutdowns in China are impacting nearly every company in the world. And while BD is not immune to these challenges, we believe the actions we've taken to drive our growth and simplification initiatives and empower our talented organization of over 75,000 associates, uniquely position us to lead in this environment and give me continued confidence in our ability to execute during these times. I'd like to take a few minutes to share some additional thoughts on the evolving macroeconomic environment. Starting with supply chain and inflation. Like most organizations across healthcare, BD has faced increased inflationary pressure and supply chain constraints. However, our simplification strategy is driving our ability to largely offset these pressures and enabling our associates to respond to these rising challenges. An example is every year as part of our enterprise risk management process, we invest to systematically validate alternative suppliers for our most critical products and this isn't something we started this year. We've been doing this for a decade and it's showing benefits in this environment. More recently, we were able to, we've invested in additional inventory to secure access to scarce raw materials and electronic components such as semiconductor chips, and we've directly contracted for alternative transportation methods to ensure the continuity of supply for our customers. In addition, we're investing in capacity expansion and regional sourcing to create an agile supply chain that will be more responsive to events around the world. A key piece of our Simplify strategy is our ReCoDe effort, which includes a focus on portfolio simplification, including SKU rationalization. Our strong growth profile has enabled us to accelerate the elimination of lower margin SKUs and optimize our mix, which enables plant efficiency and for us to produce more of the products that are most critical to our customers. All of these strategic actions have helped us to move with speed and efficiency to mitigate the challenges of this environment. And we believe we are unique in our response. Now regarding COVID, the global healthcare system continues to be more agile and better prepared, amid the emergence of new variants and spikes in COVID cases. And thus, while COVID 19 isn't behind us, healthcare utilization levels, deferrable procedure volumes and lab activities are consistently returning to pre-COVID levels in much of the world. However, the medical industry continues to be impacted when new variants develop and waves of COVID emerge. As you know, this is currently happening in China, as the government takes meaningful steps to prevent the spread of new variants. These efforts have had an unexpected impact on healthcare procedures, lab testing and the supply chain as reflected in our second quarter China results. And while this is continuing into the third quarter, we expect to mitigate most of the impact over the balance of the year assuming there isn't any additional extended waves that require more significant COVID prevention actions. We continue to monitor the situation very closely. Despite the above complexities, the need for critical healthcare products and services has never proven to be more important and our portfolio is well positioned to support clinicians and patients around the world. Moving on, I'll now provide more detail on the progress we're making on organic innovation, which is a key enabler to our growth strategy. As we shared in the November Investor Day, we've been focused on enhancing our R&D productivity, and it's having an impact. We significantly improved our on-time milestones and on-time launch metrics, which are both over 90% year-to-date. In addition to enhanced productivity, our increased investments in organic innovation are contributing to our performance. Some recent examples of how we're progressing our pipeline to drive future growth include BD Evolve, which is a fill at time of use, time delayed drug delivery system and was released for clinical trials in January. Multiple clinical trials are now underway by our pharmaceutical customers, and we see significant commercial interest with several signed development agreements. We also launched new-to-world BD reagent technology in April, which was developed with novel dye technology and AI guidance. The new BD Horizon RealYellow 586 flow psychometry reagents are the first in the series and they have the potential to accelerate discovery and drug development by enabling greater insights from biological samples. And we received 510-K clearance of our TREK bone biopsy device that was submitted to the FDA last quarter with launch expected later this fiscal year. This device allows for faster sampling and is available on a broad range of sizes to accommodate variety of procedural needs. Beyond these achievements, we also hit several key milestones across our pipeline this quarter. Consistent with our strategy to bring new transformative solutions to our portfolio that improved chronic disease outcomes, we released BD Libertas a pre-filled wearable injector that enables simple self-administration of larger volume doses for chronic disease. We've completed five clinical trials with our 5 ML product and are accelerating development of our 10 ML product with clinical release targeted in late FY '23, or early '24. The BD Core MX module and the CTGCTV2 Assay on BD Core are now under FDA review. Already CE marked outside of the US clearance in the US will give BD access to the high volume sexually transmitted infections testing market on a fully automated and integrated platform. This assay already cleared on BD Max as the only FDA cleared triplex assay for the three most prevalent non-viral STIs. The Aspirex mechanical aspiration thrombectomy system is also currently under FDA review and is expected to launch this fiscal year. Already CE marked outside the US, the system is uniquely designed with a three-in-one method of action that removes fresh thrombus and to our thromboembolic material and peripheral vasculature. Also expanding our venous portfolio is the recent FDA approval of the Venovo venous stent. The relaunch of Venovo reflects strong execution by the team with shipments to customers already occurring this month. In addition to organic innovation, our strong cash flows are also enabling execution of our tuck-in M&A strategy. Fiscal year-to-date we've complete -- we've committed approximately $500 million through the completion of four acquisitions. In addition to three acquisitions in the prior quarter, in Q2, we closed Cytognos, whose differentiated flow cytometry assays for the detection of minimal residual disease in cancer brings an important addition to our Biosciences business and accelerates our strategy to support chronic disease management. We believe that the current environment coupled with our strong cash flow and robust M&A funnel positions us well to create value through our tuck-in M&A strategy while remaining disciplined. Beyond our investments in R&D and M&A, our discipline capital allocation framework gives us the flexibility to also return capital to shareholders through a competitive dividend and share purchases when appropriate. I'm excited by the significant progress we continue to make advancing our BD2025 innovation-driven growth strategy to deliver even more significant impact toward improving outcomes for patients and providers and in that spirit, we also recently announced the inaugural members of our external Scientific Advisory Board. The SAB is comprised of top medical key opinion leaders, science and technology experts and experienced innovation leaders. The SAB is a new governance mechanism for BD, which will meet to review and advise on BD's technology capabilities, our innovation pipeline, tuck M&A opportunities and early stage investments. Finally, I'd like to comment on the strong progress we're making, advancing our ESG strategy and goals. One of the actions we announced this quarter that I'm particularly pleased with is the formation of our sustainable medical technology institute. This is another step forward as we advance our 2030 ESG commitments and BD's focus on ensuring our portfolio leads the way on reducing the environment impacts of medical products. We are proud to receive continued external recognitions for our ESG efforts, including recently being named Newsweek's inaugural list of America's most trusted companies and the Forbes 2022 list of best employers for diversity, as well as ranking number one in the healthcare equipment and services industry informs America's best large employers list. In summary, I'm very pleased with the progress that we're making, advancing our BD 2025 strategy and our strong execution navigating a challenging environment, which is reflected in our strong Q2 performance. This performance gives us confidence in our updated guidance, which raises the midpoint of our revenue and EPS ranges. We remain well positioned to deliver consistent and sustainable growth and create value for all of our stakeholders. With that, let me turn it over to Chris to review our financials and outlook.
Christopher DelOrefice:
Thanks Tom. So echoing Tom's comments, our Q2 results demonstrate the strength of our business and the momentum of our strategy. Additionally, we remain committed to supporting our customers and their patients and have made investments in many areas, including inventory, transportation, portfolio, simplification, and innovation, so that we can continue to do our best to ensure continuity of delivering critical healthcare offerings. We are delivering strong performance while simultaneously managing the increasing macroeconomic pressures through our simplification and mitigation programs. This balanced approach is helping us make strong progress against both our short and longer term commitments. Turning to our revenue performance, we delivered $5 billion in revenue in the second quarter, comprised of $4.8 billion in base business revenues, which had strong growth of 10.2% or 9.6% organic, which excludes the impact of acquisitions. Our revenue performance is supported by our durable core portfolio and an increasing contribution from the transformative solutions, we are bringing to the market through our innovation pipeline and tuck-in acquisitions. Price contributed 180 basis points to growth in Q2. While this is well below inflationary levels, it is one of many factors that is enabling our investments to ensure we can continue to deliver our healthcare all offerings to our customers. COVID only testing revenues were $214 million, which is expected to decline from $474 million last year. BD's unique ability to continue to deliver strong performance during these uncertain times is reflected in the performance across our segments with medical growing 6.4%, life sciences base revenues growing 17.1% and interventional growing 11.2%. Total company base business growth was also strong regionally with double-digit growth in the US and Europe, along with mid-single digit growth in Latin America, which helped to offset lower the normal mid-single digit growth in China, which was impacted by restrictions implemented to mitigate the spread of COVID late in the quarter. Let me now provide some further insight into each segment's performance. Our medical segment delivered $2.4 billion in revenues in the second quarter growing 6.4%. Strong performance across our pharmaceutical systems, medication management solutions and medication delivery solutions businesses was partially offset by an expected decline in diabetes care. Excluding diabetes care, BD medical revenues grew 7.5%. MDS revenues increased 5.3%, reflecting continued strong demand for our durable core products. Performance in MDS reflects execution of our comprehensive vascular access management strategy, including early momentum of our one stick hospital stay, which is driving competitive gains in catheters and vascular care devices, particularly in the US. Performance also reflects a tough comparison due to a decline in syringe utilization for vaccinations. MMS revenues grew 7.8%. In our dispensing business, high single digit revenue growth was driven by continued strong worldwide demand for connected medication management solutions in both acute and non-acute care settings. Within our infusion business, revenue growth reflects strong performance in infusion sets driven by increased pump placements outside the US during the course of the COVID pandemic. Farm systems' revenue grew 12.2% driven by continued strong demand for prefill devices supported by our differentiated and expanding supply capacity. Demand for these devices continues to be aided by the fast-paced vial to pre-filled device conversion for biologics, vaccines and other injectable drugs. Growth was also aided by the expansion of services provided to small and mid-sized pharma customers through the recent acquisition of ZebraSci. BD Life Sciences revenue totaled $1.5 billion in the second quarter. The decline of 4.2% year-over-year is solely due to the lower COVID-only testing revenues previously discussed. Excluding COVID-only testing, Life Sciences base revenues grew 17.1%. IDS revenues declined 6.8%, which reflects the decline in COVID-only testing partially offset by strong base business revenue growth of 21.8%. Performance in our IDS base business includes sales of our new combination flu COVID assays for BD Veritor and BD MAX that were ahead of our expectations and also reflects the soft comparison to the prior year where the flu season was limited. Demand for our combination assays was driven by strong adoption of a broader respiratory panel in timing of dealer stocking. IDS-base revenues were also driven by strong demand for specimen management products and strong performance in our molecular diagnostics portfolio, driven by growth in both BD Core and BD MAX reagents with increased utilization across our larger install base. Biosciences revenues increased 5.6% driven by continued strong demand for research reagents as a result of lab utilization, having returned to more normal pre-COVID levels and increasing adoption of our e-commerce platform. Instrument production in the quarter was limited by supply challenges for electronic components and as a result, we ended the quarter with a record backlog. We expect to fulfil those orders over the balance of the year. BD interventional revenues totalled $1.1 billion in the second quarter, growing 11.2%. This reflects strong performance across the segment with double-digit growth in the US and China. Our strong global performance is driving our ability to offset the impact of planned product line discontinuations, particularly in PI and UCC of lower margin and nonstrategic products as part of our portfolio simplification strategy. The segment's result also reflect the easier prior year comparison resulting from the Delta variant. Revenues in surgery grew 17.5%. Again, as a reminder, Q2 reflects a soft comparison to the prior year when revenues declined 7.7%. Excluding the soft comparison, revenues grew in the high single digits driven by hernia, biosurgery and infection prevention including the recent acquisitions of Tepha and Tissuemed. Revenues in peripheral intervention grew 8.5%. Performance was driven by double-digit growth in the US with strength across our peripheral vascular disease, end stage kidney disease and oncology platforms. We continue to expand our peripheral vascular innovations and are driving strong growth through share gains from our recent acquisition of Straub and Venclose. Urology and critical care revenues grew 8.8% driven by continued strong demand for our PureWick chronic female incontinence platform in both acute and non-acute cares settings as we continue to expand our addressable market and deliver transformative solutions for alternate care settings. Also contributing to growth was continued back order recovery in acute urology and continued solid performance in targeted temperature management with our smart, connected care enabled Arctic Sun platform. Now moving to our P&L. In Q2, we delivered adjusted net income and EPS above our expectations with adjusted net income of $937 million and adjusted diluted EPS of $3.18. We delivered base gross margin of 55.2% and base operating margin of 24% in Q2. Key drivers of gross margin include a benefit from our strategic portfolio initiatives, including mixed optimization and increased volume utilization given our strong base revenue growth. And while inflation was broadly in line with our expectations, we did realize an escalating impact during the quarter that was largely offset by our simplification and inflation mitigation initiatives. In addition, as expected, we had favorable FX that was recorded in inventory in 2021 that benefited our GP this quarter as a blow-through sales. We leveraged our base SSG&A as a percent of sales by over 200 basis points, driven by our focus on leveraging our base G&A expenses partially offset by inflationary impacts primarily in customer shipping. R&D of 6.4% of sales reflects some accelerated phasing of investments and planned increases year over year, consistent with our strategy to support our long-term growth outlook. Our tax rating Q2 was higher than anticipated due to the geographic mix of sales. Regarding our cash and capital allocation, cash flows from operations totaled approximately $1.1 billion year to date. Q2 cash flow from operations reflects a higher than normal inventory balance as we may strategic investments to increase stocking of raw materials, such as electronic components, as part of our actions to optimize product delivery to meet customer demand in this uncertain environment. We ended Q2 with a strong cash balance of $3.1 billion and a net leverage ratio of 2.8 times. Our cash balance includes the receipt of a cash distribution from embecta at the end of Q2. In accordance with the tax free nature of the spin and consistent with our capital allocation priorities, including our net leverage goals, we intend to utilize $1 billion of the embecta distribution over the coming quarters for debt pay-down. The remaining $400 million of the distribution provides additional flexibility and will likely be deployed early in fiscal '23 with a bias towards share purchases, subject to market conditions and other strategic considerations. With the spin of embecta now complete, we've achieved our targeted dividend payout ratio of about 30% as we've maintained our dividend. Our current cash and leverage position and continued focus on strong cash flows, provide us the flexibility to advance our balanced capital allocation framework and support our BD 2025 growth strategy through investments in R&D, capital and M&A. As Francesca mentioned to assist you with your FY '22 models, we provided our best estimates of the impact of the spin on certain line items for Q2 in today's slide presentation. We estimate a $260 million impact to revenue, a 100 basis points to adjusted gross margin and 160 basis points to adjusted operating margin and $0.45 to adjusted EPS. Turning to our fiscal '22 guidance assumptions; first, some macro considerations that support our guidance; while we still expect some global COVID-driven variability, our guidance assumes that continued easing of COVID 19 restrictions and no significant or lasting disruptions to deferrable procedure volumes. Regarding China specifically, we expect to mitigate the impact from the current lockdowns over the balance of the fiscal year as we are assuming the restrictions will ease in May with recovery ramping up through fiscal Q3. In addition, our guidance assumes that the core congestion does begin to ease and will not have a lasting impact on our China business and other markets. While there could be additional lockdowns in China and other markets, our guidance assumes countries continue to be more efficient in managing safety protocols and the containment of new COVID variants to allow continuity of care for patients. Additionally, we anticipate continued inflationary and supply chain pressure over the balance of the year and into next fiscal year, but we are not planning for significant escalation of macro headwinds. While these pressures are meaningful, we believe we are on track with our margin recovery initiatives and will continue to proactively manage this. We expect to be able to largely offset these incremental inflationary impacts, given our strong performance in Q2, an increased focus in the back half of our fiscal year to execute our company-wide mitigation initiatives. As our first half results include diabetes care, we are providing guidance today on a legacy BD basis that includes diabetes care. So you have a like-for-like comparison versus our February guidance. Then we are also providing remain guidance for the full fiscal year, which excludes diabetes care in all four quarters, along with the spin impact for each guidance metric. This is also laid out on the FY '22 guidance summary slide in the guidance section in our RemainCo earnings presentation. As a reminder, going forward, our first half diabetes care results will be reflected as discontinued operations, and we will only be discussing RemainCo performance. Now moving to our updated guidance for are fiscal '22. We are well positioned for strong growth across our three segments, given our performance and momentum in our base business and thus on a legacy BD basis, before adjusting for the diabetes care spin, we are increasing our base revenue guidance. We now expect legacy BD base news to grow 6.75% to 7.75% on an FX neutral basis from $18.3 billion in fiscal '21. This is an increase of a 100 basis points from our previous guidance of 5.75% to 6.75% growth. On a RemainCo basis, we expect base revenues to grow 7.25% to 8.25% on an FX neutral basis. This is an acceleration of approximately 50 basis points over BD legacy growth as our diabetes care business was a negative contributor to growth rates. The spin impact also includes a small contribution of revenues BD will earn in connection with agreements with embecta. For COVID-only testing, we continue to assume approximately $450 million in revenue. As expected, testing demand has slowed and our full-year COVID-only revenue expectations are waited to the first half of the year. Based on current spot rates for illustrative purposes, currency is now estimated to be a headwind of approximately 200 basis points or about $400 million to total company revenues on both a BD Legacy and RemainCo basis on a full year basis. This is an incremental impact of 75 basis points or $150 million compared to our prior guidance and is driven by of the strengthening of the US dollar. So all in, we are increasing our legacy BD total reported revenue guidance by $50 million to a range of $19.6 billion to $19.8 billion. On a RemainCo basis, we expect total revenues of $18.5 billion to $18.7 billion. On a Legacy BD basis, we still expect base operating margins to improve by approximately 200 basis points over 21.7% in fiscal '21. Despite a more challenging macro environment anticipated over the back half of the year, our focused execution on driving profitable revenue growth, combined with our simplified programs, gives us the competence that we will be able to offset the incremental inflationary pressures. On a RemainCo basis, the embecta spin enhances our anticipated base margin expansion by approximately 50 basis points. And as a result, we expect base operating margins to improve by approximately 250 basis points in comparison to 19.6% in FY '21 as recasted. We also still expect operating margin on COVID-only testing to be modestly above our base business margins. A few additional items for your models; on a RemainCo basis, we expect $60 million to $75 million in year-over-year improvement in interest other which reflects a minimal benefit from the use of embecta proceeds compared to our legacy BD expectation of $50 million to $75 million. On a Legacy BD basis, we now expect an effective tax rate of 13% to 14% for the full year compared to 12.5% to 13.5% previously due to geographic mix as reflected in our revised guidance. For RemainCo, we anticipate an effective tax rate of 13.5% to 14.5%, which reflects the tax rate, excluding our diabetes care business. Our updated guidance still assume share purchases that at a minimum offset, any dilution from share-based compensation and thus does not assume material change in shares outstanding. All in on a Legacy BD basis, we expect adjusted EPS to be between $12.85 and $13 compared to $12.80 to $13 previously, which reflects an increase of $0.025 at the midpoint. The core drivers of the increase include $0.125 [ph] driven by the momentum and strength in our base business with the series of strategic mitigation actions we discussed earlier expected the largely offset increased inflationary pressures and a $0.05 headwind from a higher effective tax rate. So operationally, this is an increase of $0.750. We expect an estimated incremental negative impact from currency of about $0.05 resulting in a $0.025 increase to our adjusted reported earnings guidance at the midpoint. On a RemainCo basis, we anticipate adjusted EPS of $11.15 to $11.30 cents. This reflects an adjustment from the embecta spin of about a $1.70. This accounts for a half year of TSA income of about $35 million that will be realized in the second half of the fiscal year and recorded in other operating income on an adjusted basis and it includes the contribution from supply agreements, with embecta and the benefit from financing, which are both expected to be minimal. As you think about the TSA income next year for your models, it would not be accurate to double the half year of TSA income as the services provided and income received will decline over time. As a reminder, BD shareholders received embecta shares upon completion of the spin. As you think of the commitments we made during our Investor Day on a BD RemainCo basis, our long-term targeted growth profile has been enhanced and increases our confidence in our ability to deliver our 5.5% plus base revenue growth target. Additionally, we are now targeting more than 400 basis points of base operating margin expansion through fiscal year '25 against the re-casted fiscal year '21 margin. And notably, based on what we know today, all things being equal, we think BD RemainCo can deliver the absolute pre-pandemic operating margin level of legacy BD, which was about 25% by the end of that same time period. As we previously shared, this will lend itself nicely to double-digit EPS growth and a strong value proposition. As you think about phasing for the balance of the year, the following are a few key considerations as you think of your RemainCo base revenue and earnings. We continue to expect base revenue growth to be fairly rateable in the back half of the year. Regarding our margins and P&L, first on a year-over-year basis for Q3, we expect significant improvement in base operating margin compared the re-casted 17.7% in the prior year. Additionally, we expect the Q3 year-over-year improvement to be larger than what we delivered in Q2. Sequentially from Q2 to Q3, we expect a modest step down due to a stronger Q2, primarily driven by product mix most notably our flu COVID combo test and increased inflationary pressures in the second half. As a result, Q3 is now projected to be the low watermark for the year. In Q4, we expect the impact of increased inflation on our business to continue. However, we see a larger benefit from our offsetting initiatives flowing through. In addition, we continue to see our SSG&A and RD dollars relatively evenly spread over the remainder of the year, which will drive strong operating leverage on Q4's higher revenue dollars. At the midpoint of our full year guidance range, our average tax rate for the balance of the year is about 14.5%, which is best to apply for the subsequent quarters. So in summary, we are advancing our BD 2025 strategic objectives. Our underlying business is strong as evidenced by our strong base revenue and earnings performance. We remain focused on execution and our confident in delivering against our performance goals, despite navigating a complex macro environment as evidenced by our updated guidance, which increases the midpoint of both our reported revenue and adjusted EPS. Further, we are well positioned to deliver consistent and sustainable value with our long-term commitments enhancing with the completion of the spin. I'll now turn the call back to the operator to open the line for Q&A.
Operator:
[Operator instructions] We will take our first question from Vijay Kumar with Evercore ISI. Your line is now active.
Vijay Kumar:
Hey guys. Congrats in a good print here and thanks for taking my question. My first one maybe on the updated guidance here. We did close to 9% organic for first half and I'm looking at the legacy BD [rate] (ph). The midpoint of 7.25%, which implies mid-single 5.5-ish for the back half. I just want to make sure this is a comp issue or is there any timing impact first half versus the second half? Any change in first half or second half organic cadence on an underlying basis?
Christopher DelOrefice:
I appreciate the question. It's Chris. Hope you're well. Your math is correct. So again, our first half growth extremely strong here at about 9% on a year-to-date basis. Obviously we had benefited from some one-time items, but we also overcome some headwinds in that period too. I think when we talked last quarter and we would frame this quarter as probably from call it underlying adjusting for some of those puts and takes around seven-ish percent growth, the back half, you're right, 5.5% growth. I think there's a couple things to contemplate there. Of course, China, there will be a pretty significant impact in Q3 as they recover. We expect that recovery -- the recovery started in May. We expect that to ramp through June and we expect to make the majority of that up in the back half. Additionally, we do have some comps as you think of the back half of the year in particular our life sciences business. We did have our Triplex launch there. So if you look at Q4 that was a peak performance period for that business. So there's a couple kind of comps along with the China situation that will cycle through Q3 into Q4 to consider there in the back half, but 5.5% growth is consistent with our long-term outlook of 5.5-plus on top of a front half of 9%. So all in a really strong year. I think the other thing I would point to, if you look at the quarter performance from a top line standpoint, we actually increased our organic guide more than the beep on the base business in Q2. So it actually implies stronger second half performance. So we actually did strengthen our second half outlook, despite some of those headwinds that I noted. So hopefully that helps.
Vijay Kumar:
Yeah. That was helpful for us. And maybe one on the longer-term LRP guidance that you laid out at the Analyst Day. Appreciate all the details in the earning deck and making comparison easier. The longer term 5.5 on top $400 plus and margins in double-ish earnings. Are there any cadence issues when we think Chris for fiscal '23, and I'm not asking for a specific '23 guidance, I know it's early for that, but just thinking about any moving pieces here, I think FX, COVID diagnostic testing drop off, comes to my mind. So when you think about the base of $11.15 to $11.30 in fiscal '22, should we still expect that LRP to be intact for fiscal '23 over the base?
Christopher DelOrefice:
Yeah, it's a great question. Obviously, to your point, there's a lot of moving parts and one, if you remember our Investor Day guide, we actually stripped out testing. We see testing as something that'll move more to kind of the endemic opportunity here that gets more embedded in the base. So we need to see how that plays out this year. Obviously I think an important caveat just to see how COVID dynamics, the macro-inflationary environment plays out as well. So I think some big considerations, but what I would point you to over the long term horizon, definitely over the long term horizon, obviously there's can be fluctuations year-to-year, but you're seeing it play out this year. One definitely the enhanced growth profile, the five-five plus we're well north of that this year, given our strong focus on innovation and R&D, the benefit we're getting from tuck in acquisitions. As a matter of fact, just as a reminder, you'll see that we did provide the one-time lift associated with the tuck-in acquisitions, which was roughly 60 basis points. That was never part of our five, five plus. What was part of our five, five plus was taking those acquisitions and growing them. These are profitable double-digit growth opportunities. They're actually enhancing our growth profile on a year-to-date basis by about 30 basis points above that 60 basis points. So true organic growth once we've cycled over the anniversary. So I think we're going to continue to focus on our growth strategy. We remain confident in the five, five plus the spin of diabetes certainly enhances that confidence. You did see a 50 basis point lift here, just in this year alone, as a result of that. As we've talked about, that was a drag on growth. As you think of operating margin, I shared a couple key things. One, this was a very important year for us is when we had committed the 400 basis points, we were going to deliver half of that in one year. So doing that in the face of the inflationary environment we're in with inflation, normal inflation being 2%, we're talking about 8%, 4X inflation happening is quite a testament to cost improvement. I don’t know if you picked up in the talk track, but we did commit that we are going to do better than 400 basis points over that timeframe. Not only that, we think that by 2025, we can get back to the legacy operating margin of about 25%. And if you ask how we're going to do that, if you think of all the structural change we've made this year, it's a compensating for the inflation. We've actually done more cost improvement and enhancement through our simplification programs. That are actually creating more underlying value that we expect to carry over the long term. So definitely we feel really good about our long-term Investor Day outlook, of course, assuming this environment that we're in at some point kind of settles back to more normal here, hopefully as we exit this year into next year. There may be a little bit of typical choppiness from year-to-year within that. But we certainly expect to deliver continued strong growth in each year and strong margin improvement this year.
Vijay Kumar:
That's helpful, Chris. And thanks for taking my questions.
Operator:
We'll take our next question from Travis Steed with Bank of America. Your line is now open.
Travis Steed:
Hi, thanks for taking the question and congrats on a great quarter. Chris, I'd just love to get a little bit more color on some of the operating margin bridge. I see you have 19.6% as the base for FY '21, 250 basis points on top of that gets you to kind of the low 22% range. When I'm thinking about '23, it sounds like you're comfortable somewhere around 50 basis points to 75 basis points of operating margin expansion in '23. Just love to see if that's how we should be thinking about it, which gets me to like a low $12 range for earning next year. If you have any early comments to that.
Christopher DelOrefice:
Yeah, no, thanks. I appreciate the question. Look, again, I think as it relates to '23 it's a little premature to give specifics at this stage. I think certainly though with, call it my 200 basis points delivered this year, 250 basis points, if you adjust for Embecta. And with -- to get to what I said by the end of 2025, to get back to the 25% operating margin legacy, you're going to expect kind of a relatively ratable call it glide path to get there. The only thing I would point out is I do think '23 will be a transition period, because you're still going to have the structural impact of inflation that's been ongoing, that'll carry over into '23. So I do view that a little bit as a transition year and you'll get more lift as the environment normalizes over that time is how I would probably think of a ramp curve if that makes sense.
Travis Steed:
Yeah, it does. Thank you for that. I appreciate the extra color. And then when we look at some of the incremental inflation impacts that that you're offsetting pretty much essentially all the way offsetting, love to get a little bit more color on some of the pressures that you've seen and also when you think about pricing, it was 1.1% last quarter, 1.8% this quarter. Is that how we should be thinking about it going forward, kind of the high 1% to 2% range, into '23 as well?
Tom Polen:
Hey Travis, this is Tom and good morning, I'll start in and turn it over to Chris. I think in terms of what we're seeing on the inflation side, we saw earlier on quite sometime early last year, we recognized obviously the impacts of inflation as well as supply chain challenges. And we made a very clear statement that while there is going to be no company that would -- was going to avoid inflation and supply chain challenges, that we were very committed to looking to be the best in our industry at navigating those. And that's been the mindset that our entire team has approached this environment over the last two years. And I think you can see the commitment and actions of our team coming through in our performance from as well. And so I've got our team empowered and focused on executing our strategy. And as part of that, they're navigating this complex environment and we're pulling a number of levers to overcome what are shipping chips, resin, just general raw material and inflation points that we see and those levers that the teams are pulling range from continuous improvement being notably increased in our plants in this environment. We're taking additional cost containment actions across all areas of the business. We're driving an acceleration of our portfolio optimization and product mix. That's always been part of our recode simplification initiative. We saw this as an opportunity, particularly with the strong revenue growth that we're seeing to accelerate, exiting lower margin products and products that are adding complexity in our plants, that when we move those out, we can actually run our plants more efficiently and get out more of the products that our customers need most, which is really important in this environment. And then lastly, we looked at as a last resort. We are taking pricing actions as well and as you can see, we're able to to get those, which are just a portion of the overall inflationary costs that people are seeing in this environment. So all of that's being done to ensure that we're positioned to best serve our customers and our patients and really proud of the team's work there, Chris, any additional comments?
Christopher DelOrefice:
I think the only build is just to reinforce I think the strong underlying growth profile is really creating opportunities to drive some of that simplification. For example, the strategic skew rationalization efforts, right? We're absorbing that within our growth rate. It unlocks value in the form of margin, drives enhanced mix, new product innovation launches is a way that will more look to create value in the marketplace and get value back for that versus thinking of things just as price. It's really a bigger picture though. The price is actually extremely modest relative to the level of inflation but thanks.
Travis Steed:
Thank you.
Operator:
We will take our next question from Robbie Marcus with JPMorgan. Your line is open.
Robbie Marcus:
Oh, great. Thanks for taking the question and congrats on a nice quarter. Sorry to kind of follow up here, but maybe if I, I focus in on the second half implied guide here, it looks like there's something like $0.30 benefit from FX. And I was wondering if we're going to start to see, it sounds like, you're adding more into inventories. I would imagine it's at a slightly higher cost than previously. If we're going to start to see the impact of that flow through in fiscal second half, or if that's more a '23 impact. I'm just really trying to get to sort of the normalized earnings power going forward. Thanks.
Tom Polen:
I would just say, maybe I'll make a comment, Robbie, this is Tom good morning. On the inventory situation, that's a very strategic investment that we're making to increase inventory on what I would describe a scarce raw materials. So think about raw materials like semiconductors and chips or other components that are difficult to get. You can see companies across the industry running into challenges on those. We have a very systematic approach to secure those assets and we'll take the higher impact in our inventory to be able to best serve our customers. And that's a commitment that we make. I don't think that -- we'll end up taking that down as situations stabilize over time. So we don't see that as a long term, we've been very, very focused on our cash flow as, you know, moving that from 75% free cash flow conversion to 90% as an ongoing 90% plus as an ongoing target. We're not changing that at all. And we continue to have a very strong focus on inventory. We just see this as a transient and strategic investment that's paying off for us and it's paying off for our customers.
Christopher DelOrefice:
Yeah. Thanks Robbie, for the question, let me let me, let me just anchor on kind of the full year and then I'll provide you some set. I can second half context, and of course as always we can engage further in the discussion. But in terms of the guide adjustment, the best way to think of it is sort of the a 100 basis points of organic growth. We actually increased our top line by about $180 million at the midpoint. If you look at the EPS walk that we had provided, we're dropping about just under $0.13 through, which is basically at a BD margin drop through with that raise. So nothing's changed. We've actually reconfirmed our margin profile as a result, we've taken the guide up for the, the stronger growth profile above actually what was delivered in Q2. So from a full year standpoint everything remains intact. There there's no currency really just drops through it at a margin rate. The margin obviously fluctuates based on currency mix dynamics and/or margin mix in those respective markets. I don't think there's anything unexpected there. As a matter of fact, the currency that we talked about that was a carryover benefit into the year has played out as expected. So I don't think there's anything there to contemplate and then I think as you think of second half margins what you can expect to see there will be a small sequential decline on Op margin from Q2 to Q3 is really primarily driven by the fact that last year Q2 to Q3, you had nearly a 250 basis point decline from Q2 to Q3, and it was our low watermark, and we're actually going to be increasing the improvement in operating margin in the quarter year-over-year, versus what we did this quarter. We did 180 basis points this quarter. We will have a step increase there. So you'll see it relatively stable, but a small dropdown accounting for that low point base that we're jumping off of from last year. And then we'll continue to increase from there is sort of the glide as you think of the second half. But again, so if I tie this into your question about going forward, I think the important way to think about this is on track for the 200 basis point of margin improvement for the full year 250 basis points adjusted when you do the pro forma for embecta, which was half of what we said as part of our full year Investor Day commitment. Quite a big progression in one year, especially in phase of the inflationary pressures, which should set us up nicely over the long term.
Robbie Marcus:
Great. And maybe just sneak in two very quick questions here, one what was the size of the combo flu COVID 19 testing revenues in quarter, and should we assume going forward that there's no revenue from the cannula agreement with embecta, or was this more just a timing issue? Thanks.
Christopher DelOrefice:
Yeah, I can, I can take the second one maybe holistically. There will be, as, as noted in some of the public documents there will be various third party agree between Veta and BD. There will be a small contribution to top line, which would contemplate more supply agreements. We highlighted that as part of the 50 basis points lift. There was a small contribution. There there'll be a full year benefit next year. Obviously, but again, it was, it was not substantive. We had the TSA we said it was worth $35 million this year. It won't quite double next year because what's typical in the spin. Really the spirit of the TSA is to support and beta standing up as a standalone public company. And it gives us an opportunity to support them. We leverage our, our stranded costs to do that. So basically it keeps us whole from a supporting BECTA stranded cost standpoint. And then we, we shed those down as the TSA goes down in parallel. So there's no impact on a net basis from an income. So you should expect the 35 to lift next year, but not quite double,
Tom Polen:
Maybe just we could turn it over to Dave's answer, not just the, the COVID combo test question, but maybe just give some overall color and what was a, a strong momentum in life sciences across both IDs and, and significant demand we're seeing in BDB as well. So, Dave?
Christopher DelOrefice:
Yeah. Thank, thank you Tom. Robbie, thanks for the question. I mean, just pulling back a little bit, I mean, just want to recognize the life science segment colleagues around the world for just a tremendous quarter. And that's two successive quarters now, 17% growth excluding testing. If I talk about the test, just the overall testing dynamics at that highest level, so, you remember that we have the COVID testing piece, which is like the single antigen and molecular tests. And you hear Chris talk about, that was 214 million for us in the quarter 400 million year to date. I think you'll recall that we'd also said that, we were biasing our sort of all COVID performance to the, to the first half of the year because we are seeing Moderate some moderation in testing. We expect that moderation to continue through the balance of the year. So that overall testing dynamics are playing out with what we said. I mean, we're very close to 90% of the full year testing expectation for the combo. This is obviously the flu and COVID assay both on our max and our veal platforms. We've not given that number specifically because that's, that's in a mix of a lot of puts and takes in the overall base business. There was growth there as, as Chris had said, if you think about that as a, as a compared to the prior to the same period prior year, that's where we saw some of the growth come from. We do expect from a strategy perspective going forward, we do see value in the overall COVID combo portfolio. As we think Colby will move to more of an endemic situation. It's just too early to call out as to what that number would be for the, for the full year, even getting into early Q1 '23 when nobody knows what the dynamics of the flu are going to be right now. Yeah.
Christopher DelOrefice:
Thanks David and Robbie, maybe just a couple other small things to just give you a little color in terms of what would've comprised the, the revenue there, obviously there was almost no flu season last year, so you kind of got back to flu season. Additionally obviously the combo has a slightly higher value proposition. You benefited from that. Additionally there was a little bit of stocking giving. It was, it was new and you did have a lot of testing demand in that period where it was hard to get access to tests. So those were sort of the factors that, that played into where we were. But again, adjusting for that really strong underlying, especially in the back of still having back water in, in certain areas, both in life sciences and total.
Tom Polen:
And Robbie, this is Tom, as, as Dave said, I think we've said from the moment we launched the test that the combo test will be the go to kind of replacement for the base flu test. And so we, we do think flu testing, which was as, as Chris mentioned, was base was completely absent last year that this year we did see flu back as something that was causing infections, we expect that that would continue going forward. Of course, the rate at which that, and the size of that market every year varies each year. But we do believe that that combo test now back in our, our revenue will continue to be persistent as the go-to product for flu test.
Christopher DelOrefice:
Yeah. And Rob, we just one just on strategy piece, just one more piece, there would be, we're very committed to just looking at what, what are the unmet needs for, our patients around the world on a go forward basis. So we, we are committed to, developing more combo tests and we talk to the analyst day around the potential for an at home combo test, using the, the platform that we acquired in, in December. So the innovation piece of the strategy still continues and, and obviously as timelines firm up on that, we'll commune as it gets better though.
Operator:
[Operator Instructions] And we'll take our next question from Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Good morning guys. Thanks for taking the question and congrats on nice quarter here. Tom, on Alaris any update on the timing is it is fiscal 2023, reasonable assumption for, for when that's back in the us and at the investor last year, you talked about a new pump launching outside the us in fiscal 2022, I believe. Sorry if I'm wrong on the date. I can't remember if it was '22 or three, but any update on that? Thank you.
Tom Polen:
Yeah. Thank you, Larry, for the question. We've mentioned on several occasions that getting Alaris back on the mark, it is our number one priority. And while we're not providing any updates on, on timing, as, as we had had shared before, we are confident in the resources that we're investing in our submission and the team and the leadership that's tasked to make that happen. And so, we, we still think it's not prudent to predict the timeline given just how inherently complex these submissions are. And particularly that, that certainly applies to our filing. So as we had said, we don't expect clearance in '22, therefore any of our guidance doesn't factor that in, into our numbers for 20 gone what's in medical necessity and we'll continue to provide an update as, as that progresses, but we continue to remain focused on making sure that the FDA has the proper information for us to get clearance on that. And that will remain our focus in terms of the new pump for Europe. No, we remain very excited on that product and it is launching later this, later this year. So absolutely, Yeah.
Lawrence Biegelsen:
And then thank you. Thank you for that just quickly, the supply constraint in Biosciences. Can you quantify that and, were there other supply constraints that hurt you this quarter? Thanks for taking the questions.
Tom Polen:
Yeah. Larry, let me make a, maybe a comment overall on supply constraints and then ask Dave to comment on, on Biosciences. We certainly saw record backlogs across the company. So demand was even much higher than what you saw as post in our revenue. And that's across every one of the segments. We saw demand in a number of categories, outstrip our ability to supply, even though we were producing at record levels. And, that's part of what gives us confidence as we look ahead you, we are working each and every day to, to get more out of our plants. We certainly see shortages in longer transit times for raw materials. We see shortages from certain suppliers. We work very aggressively with suppliers to help them secure raw materials. We even go so far as to put our own folks to help run supplier factories in certain cases, but we take, we take that part, those partnerships very seriously to optimize getting product to our customers, but we did end with a, a record backlog across each of the segments. And specifically to Biosciences turn to Dave. Yeah.
Christopher DelOrefice:
Larry, thanks for the question. So we, we've got, I mean, when you look at the backlog overall, we, we've not quantified it in terms of, the absolute number of instruments. This is, this is an instrument topic for us. It primarily sort of relates to the clinical side of the business. But as Chris had said in his in remarks, we anticipate with the supply with some of the supply securements that we've done the procurement leverage that we've been able to get. We expect this to clear up over the course of the year. So it just becomes a timing topic for us in the year. And the team is very confident about that. What we are doing to sort of mitigate any short term is we're obviously working on an allocation strategy. the research instrument base is, is still very strong. So we're prioritizing what we have to get everything out. And then we're just driving hard and aggressive on procurements Of those chips and those electronic components. We have a lot of the instruments sort of ready, built, ready to go. So as those things come in, we'll just execute and chip in the back half of the year.
Operator:
We'll take our next question from Rick Wise with Stifel your line is now open.
Rick Wise:
Hi Tom. Hi, Chris. Let's start off perhaps with BD interventional, we haven't had a chance to dive into that strong quarter. Clearly comps helped a couple things. Maybe you could comment on and, and more expansively. I was a little surprised by that China double digits help us understand, what's happening there and how sustainable that performance is. And curious in general, are you all seeing the electric procedure volume recovery continue into April and maybe last on interventional help us think about the key drivers beyond recovery, beyond comps as we look at not just the next quarter, but the next sort of year ahead. Is, is it product, is it execution? Is it pipeline, help us think through the, the drivers there? Thank you.
Christopher DelOrefice:
Go ahead, Simon.
Simon Campion:
Good morning, Rick. Listen, fir firstly again, just reflection on the quarter really solid quarter across all, all three of our business units and, and, the soft compare in, in some areas certainly helped helped us, but I'm still, very proud of the team for executing across are broad and complex and clinically relevant portfolio. And then you might recall from, from analyst day all the plans that we had and please to say that all, all those, you know programs that we that we shared with the broad community at analyst day, that they, they are all on track now specifically about perform in, in the quarter in China, in particular the peripheral inter intervention business is extremely strong in China. And you, you you'll have heard us say in the past that BDI in China has doubled in, in revenue since since bar was acquired by BDI. And that has been led by, by peripheral intervention and the oncology business in particular. We, we had some background challenges with Encore probes over the past several months, and that's, that's begun to alleviate, we had a, a backlog in, in sterilization and that's begun to alleviate and that has certainly helped drive our business forward. But even in, in ESKD and [indiscernible] in China they, they performed a extra ordinary well in the last quarter as they do as they do very, very frequently and that performance NPI was also reflected in surgery. And, and to a lesser extent in, in UCC as well now, moving forward our, our outlook for the future, as, as we're, we're focused on, on innovation and trying to out execute the competition. And, I've heard Tom mention in his, in his prepared remarks about the relaunch of the, of Ben Novo. So we've just brought that back into the market in the last in the last two weeks. And, and that's supported by the three year vernacular data which, which I think is unparalleled data in the in the Venus space. We're super pleased with the response from our sales team and our customers to the relaunch of that product. And that will certainly be a driver this year and next year, particularly when we couple that with the with the expected clearance anticipated clearance of the thrombectomy catheter which we hope to receive this quarter or, or next quarter. And that will put us in a very, very strong position in the venous space the track biopsy device, the Tom refer to as well, that's, that's due for launch imminently. And then in our UCC business the puric platform continues to, to, I would say, exceed our expectations and in late Q3, early Q4 we do expect to launch the mail version of puric, which we hold will be a, a driver of growth. And then finally a comment on our, our acquisitions NAFA acquisition has really performed very, very well. The tissue made acquisition, which was a acquisition for the China biosurgery market that we hope to bring to other geographies, but the Chinese team again, has executed on that. And then and then van close as well has performed very, very well in in the PI space. And just referring back to TIFA and, and the plans that we shared with you about our, our, our anticipated expansion to the breast space over the next several, several years now, we do expect to begin enrolling patients in a pilot study here in Q4 in one of the categories that we're investigating for breast. So a lot of, a lot of momentum behind the PDI team across all businesses and in the usual ways innovation in organic M&A and executing the field.
Rick Wise:
Great. if I could follow up Tom you highlight, and I love your language, you're investing in three irreversible forces. That sounds great. So my question is just reflecting on Chris's commentary about your cash position and your priorities. I was a little surprised that you're going to deploy the 2 billion more towards share repo as opposed to M&A clearly it's going so well. So just wondering if you could put all that in perspective, help us think about your priorities and maybe on the M&A side. Okay. Is it AI informatics, robotics, new care? What's top of mind for you. Thank you.
Tom Polen:
Sure. Yeah. Thank you for the question, Rick, and, and I'll, I'll start off and then I'll turn it to Chris. So, as we had described that at, at analyst day, we've really rethought how we view our portfolio and our approach to growth. And we, are looking at how we invest in our, in our large essential to healthcare durable core portfolio and fast growing transformative solutions. And those three areas that you mentioned, smart, connected care, new care settings, chronic disease outcomes. And we're, we're really pleased with the performance of both. Hopefully there's something I said in the in my prepared remarks that, that I think is an important takeaway for everyone, which is our for we've had a focus over the last several years of increasing BDS R&D execution capabilities. And you may have heard me say that we reached a peak performance past actually year to date where over 90% on time milestone deliveries and on time launches, that's absolutely top quartile in the industry and something that we're really proud of, the momentum that we've had there. If you look at the pipeline that we shared at analyst day as well, all very much on track, and you're seeing a us announce those executions. And as we look at milestones for those things also very much on track, which is giving us a lot of confidence as we look out over the LRP and the years ahead to your point, we've been, we're really pleased with how we're executing that tuck and M&A strategy, right? We've got very strong core growth. We're staying very disciplined to making sure that we're creating value for our shareholders through the, in the acquisitions that we're doing. We don't have to go out and buy growth. We've got strong growth in our core, and we're adding value on top of that with 80% of those tuck and M&A focused in those high growth transformative solutionaries. And you heard Chris describe that. So we're gonna continue there. We have a very strong, robust pipeline. We think that actually this men, if anything, is creating incremental opportunities for us as we look ahead, and so we're gonna stay active and disciplined in there, but we do see the opportunity for that to continue to shift BDS growth rate upward. As we look ahead over the next coming years in terms of our decision and how we're using the cash from the, the spin. Let me turn it over to Chris on that.
Christopher DelOrefice:
Yeah. Thanks, Tom. Yeah. Rick, thanks for the question. So first of all, the, the tax free nature of the spin requires you to think about allocating between either debt and or share purchase. What we actually outlined in the script was we're going to prioritize a billion dollars of debt. Paydown, that's very consistent actually with our capital allocation strategy, maintaining a strong net leverage ratio, which gives us a lot of financial flex to actually support the strategy that, that Tom just outlined the, the balance of about 400 million plus will be opportunistic about. We do have a bias for that smaller remaining portion towards Sherry purchase, but of course will be dependent on market conditions and, and other strategic considerations. And then just to double down a little bit on, so that that's discreet and separate decision that, that we're taking associated with the spin beyond that our capital allocation strategy remains exactly intact as, as Tom articulated the most important thing. Actually that I think he shared is we're doing all this from a position of strength, underlying strength. It allows us to be extremely disciplined and identify S that have strong margin profile, strong growth profiles strategically fit against those three irreversible forces drive transformative solutions. So we will look to continue to drive strong cash flow with, by the way, higher R&D investments. We of course have continued to prioritize our, our dividend which actually the payout ratio know increased post spin another value to BD shareholders. And then we expected about one and a half to 2 billion of excess cash after doing all of those things where tuck in M&A would continue to absolutely be our, our priority. But importantly, we did agree that we would make sure at minimum we would do repurchases that avoid any dilution from share base comp. So that's the capital allocation strategy that we're, we're executing now. Thanks.
Operator:
We have no further questions on the line at this time. I will turn the program back over to Tom Polen for any additional or closing remarks.
Tom Polen:
Okay. Thank you operator. And thank you today for, for joining our call and for all of the questions. I hope everyone took away a couple key points from our discussion today. BD is very well positioned to continue to deliver value in uncertain times. And we're seeing that driven by the execution of our BD 2025 strategy, which has led by our innovation driven growth strategy. This is we had strong base business performance across all three segments. We're continuing execution, delivering enhanced margin profile, amidst macroeconomic pressures. We've now successfully completed the spinoff of our diabetes care business as part of our simplification strategy. And today we further increased revenue and EPS guidance on strong results. Despite continued market uncertainty. As we wrap up today's call, I want to just take a moment to thank the 75,000 members of the BD team and those listening today who are working around the clock to ensure production and availability of essential products for patients and providers and who are going above and beyond to support our customers. I want to thank our teams who are working to bring new innovations to market that improve outcomes for patients and providers, and that are reshaping the future of healthcare through both our durable core and transformative solutions. And I want to thank our teams who are working to make BD stronger by simplifying our network, our portfolio, and our processes, as I've said many times while every company is navigating macro challenges, we're focused on being the best in our industry at doing so and to approach every challenge and every opportunity with a growth mindset. And we're doing exactly that. So thank all of you for attending today and be well,
Operator:
Thank you. This does conclude today's audio webcast. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to BD's Earnings Call for the First Quarter of Fiscal 2022. At the request of BD, today's call is being recorded and will be made available for replay through February 10, 2022, on BD's Investor Relations website at bd.com or by phone at 800-839-2461 for domestic calls and Area Code 1-402-220-7219 for international calls. The replay bridges are now dedicated so you no longer need a conference ID to hear the replay. [Operator Instructions]. I will now turn the call over to BD.
Francesca DeMartino:
Good morning, and welcome to BD's earnings call. I'm Francesca DeMartino, Senior Vice President and Head of Investor Relations. On behalf of the BD team, thank you for joining us. This call is being made available via audio webcast at bd.com. Earlier this morning, BD released its results for the first quarter of fiscal 2022. We also posted an earnings presentation that provides additional details on our performance. The press release and presentation can be accessed on the Investor Relations website at investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris DelOrefice, Executive Vice President and Chief Financial Officer. Tom will provide highlights of our performance and the continued progress we have made against our BD2025 strategy. He will then turn the call over to Chris for the financial review and our updated outlook for fiscal 2022. Following the prepared remarks, Tom and Chris will be joined for a Q&A session by our segment presidents, Alberto Mas, President of the Medical segment; Simon Campion, President of the Interventional segment; and Dave Hickey, President of the Life Sciences segment. Before we get started, I want to remind you that we will be making forward-looking statements today. I encourage you to read the disclaimers in today's presentation slides and the disclosures in our SEC filings, which are both available on the Investor Relations website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue percentage changes are on an FX-neutral basis unless otherwise noted. When we refer to any given period, we are referring to the fiscal period unless we specifically note it as a calendar period. I would also call your attention to the basis of presentation slide, which defines term you'll hear today, such as base revenues and base margins, which refer to our results excluding COVID-only testing. With that, I am very pleased to turn it over to Tom.
Thomas Polen:
Thanks, Francesca. Welcome aboard. We're very happy to have you on the team. Good morning, everyone, and thank you for joining us. We are very pleased with our strong performance in Q1. It reflects the continued execution of our BD2025 strategy and another quarter of consistent strong growth in our base business. We made meaningful progress and delivered on our revenue, margin, earnings and cash flow goals while advancing our innovation pipeline and our tuck-in M&A strategy. Our performance, along with the progress we are making delivering across our key priorities, gives us the confidence to increase our full year revenue and earnings guidance for both our base business and COVID testing. We were able to deliver these results in an uncertain market environment, demonstrating demand across our broad portfolio of products essential to patient care, along with BD's unique ability to deliver strong performance in the face of an ongoing global pandemic. The market impacts from COVID-19 dynamics continue to be in focus, particularly in the health care sector. However, we've witnessed a global health care system that's more agile and better prepared as each new variant has emerged. In Q1, health care utilization levels continued at rates similar to what we saw in the fourth quarter of fiscal '21, remaining slightly below pre-pandemic levels until mid-December, then only declining modestly as a result of Omicron. While we saw some slowdowns in deferrable procedures in the back half of December in certain regions due to hospital-imposed restrictions and staffing constraints, overall, our customers were able to continue to provide care to support patients and sustain a solid base of deferrable procedures. These challenges to procedure levels had minimal impact on our business in the first quarter. In addition, we saw routine lab testing returned to normal levels in Q1 and research lab activity remains strong. With that said, as we look ahead, there are some pressures today related to staffing constraints that are impacting the delivery of some deferrable procedures, coupled with supply chain dynamics. We continue to watch these market dynamics closely. Despite the continued recovery, uncertainty and inflationary pressures, I'm pleased with our team's focus on execution. Our segments are delivering strong profitable growth and our strategic initiatives to enhance margins are progressing well. As seen in our results, we're off to a strong start, being very active and intentional in executing our inflation-mitigation initiatives across procurement, shipping and continuous improvements in our plants as well as appropriate pricing-related actions. Further, we intend to be best-in-class in navigating the current inflationary environment. We see signs of continued pressure on shipping, labor, raw materials and electronic components over the remainder of the year since our last guidance update. However, we believe we have a clear path to accelerating margin recovery, and we expect to offset any inflationary impacts through various cost-containment and pricing-related initiatives already realized in Q1 that will enable us to deliver on our full year objectives. I'll now give a high-level summary of our financial performance. Q1 revenues of $5 billion reflect continued strong momentum in our base business. And through our focused execution, we grew base business revenues 8.3% in the first quarter. We also saw increased demand for our professional and at-home COVID tests relative to our previously communicated guidance, which was fueled by the Omicron variant. As expected, in comparison to the prior year, COVID-only testing revenues declined, driven by lower antigen test pricing and volumes and a number of new entrants to the market with over 40 EUAs now granted in the U.S. We have also continued to execute our cash flow initiatives, and we delivered strong operating cash flow of approximately $700 million. Our strong cash flow continues to enable investments in R&D and tuck-in M&A, which are fueling our BD2025 strategy. In Q1, we closed 3 acquisitions, Scanwell, Tissuemed and Venclose. And just this week, we announced the acquisition of Cytognos, whose differentiated flow cytometry assays for the detection of minimal residual disease in cancer, bring an important addition to our biosciences business. These acquisitions advance our strategy to expand in higher-growth spaces that complement our durable portfolio and bring new transformative solutions across smart connected care, new care settings and improving chronic disease outcomes. Our disciplined capital allocation framework gives us the flexibility to deploy capital towards value-creating opportunities in both R&D and M&A for future growth as well as return capital to shareholders through a competitive dividend and share repurchases when appropriate. As we look across the balance of FY '22, our Q1 momentum and focus on execution are driving our strong FY '22 outlook. As we have communicated, we see our growth profile as derisked as we're leaders in areas of health care that remain in high demand and are driving base revenues. We have strengthened our growth profile through new product launches and acquired assets in the higher-growth spaces that are adding to our performance. And we continue to support increased testing demand. While we expect the recent demand surge to be temporary, in the event that COVID-19 cases persist longer than anticipated, our testing portfolio provides a natural hedge against deferrable procedure softness and other COVID-related headwinds. In addition to our derisked growth profile, we're also confident in our ability to improve our gross margins given the strong progress we've made to date through focused execution against our detailed plans to offset inflationary pressures and deliver cost improvements. All of this gives us the confidence to increase our full year revenue and earnings guidance while remaining appropriately prudent given the current uncertain environment. So turning to innovation. We remain focused on enhancing our R&D productivity, and it's having an impact. During the quarter, we progressed our innovation pipeline, launching several new products. Examples include BD COR, where we recently launched our molecular MX module, which fully completes the CE Mark system. The MX is built off of our BD MAX assay technology, which will allow us to leverage the BD MAX menu of infectious disease tests into the high throughput lab segment. We also launched BD Kiestra IdentifA, which received the 510(k) clearance this quarter and is designed to fully automate and integrate the preparation of microbiology bacterial identification testing using smart connected robotics. Beyond these achievements, we also hit several milestones across our pipeline. We submitted the 510(k) to the FDA for our TREK bone biopsy device. The TREK biopsy system will provide interventional radiologists with an easier and faster way to perform bone biopsies without the need to use multiple devices, thus reduces the cost per procedure, inventory needs and reduces procedure time. Our Pyxis ES version 1.7 software is now live in limited commercial release at 4 sites in anticipation of full commercial launch. This software adds new capabilities like enhanced automation and controlled substance management via improved connectivity with our C2 Safe offering and enables deeper integration of pharmacy and nursing areas. We're also very proud of our new BD FACS Discover S8 CellSorter, which is currently profiled as a cover story of the January issue of Science Magazine. The S8 is a landmark advancement in flow cytometry that has the potential to transform a wide range of disciplines from immunology and genomics research to cell-based therapeutics. For the first time, we can sort cells at high speeds while separating cells not only based on which antibodies or other markers we see, but also based on new imaging parameters. To put this leapfrog technology in perspective, the most advanced flow cytometers today can analyze and sort cells based on 3 non-fluorescent parameters and have processing speeds of up to 15 megabytes per second. The S8 analyze and sorts on 11 nonfluorescent parameters and has processing speeds of up to 2,000 megabytes per second. We encourage you to visit bdbiosciences.com/celvieu to learn more about this exciting new innovation. I'm excited by the significant progress we continue to make advancing our BD2025 innovation-driven growth strategy. To that end, I am pleased to report that our Board of Directors recently approved the spin-off of embecta, which is scheduled to occur on April 1. We remain on track for a successful embecta spin. We continue to believe the spin is a significant value-creating opportunity for our shareholders as both BD and embecta are well positioned for success. embecta will be one of the largest pure-play diabetes companies in existence today with an ability to focus on its strategic goals, drive strong cash flow and allocate its capital more efficiently and effectively to drive higher revenue growth. Further, we expect the spin-off will not have an impact on the long-term growth targets we laid out at Investor Day. And instead, we expect it to enhance both our sales and earnings growth profile and create an opportunity for additional shareholder value. Finally, regarding our progress on advancing our ESG strategy, which serves as a framework through which we address the most relevant ESG issues for our company and our stakeholders. We continue to make strong progress against our goals. We launched our inaugural 2021 Global Inclusion Diversity and Equity report, in which we shared our ID&E foundation, strategy and actions towards the healthy workforce and communities pillar of our 2030 ESG goals. BD's commitment to ID&E sets a new standard for how the company will work together to innovate new products and solutions, and we firmly believe that the more diverse people and perspectives there are at the table, the better outcomes we can produce to deliver what's next in health care. We also published our second Annual Cybersecurity Report to update stakeholders on the state of health care cybersecurity, BD's impacts on advancing cybersecurity maturity and anticipated trends for 2022. We're very proud to be the first and only med tech company to publish a cybersecurity report. Through our leadership position in health care cybersecurity in our annual report, we're working to address cybersecurity challenges specific to our industry. We also continue to receive external recognition of our ESG efforts, including just recently being named one of America's Most Just Companies in the Annual JUST 100 Ranking and ranking in the top 3 within our industry. I'm proud of the progress we're making advancing both our BD 2025 and ESG strategies. The actions we're taking are driving excellent momentum. We believe we are well positioned to deliver and create value for all of our stakeholders. With that, let me turn it over to Chris to review our financials and outlook.
Christopher DelOrefice:
Thanks, Tom. Echoing Tom's comments, our Q1 results demonstrate the strength of our business and the momentum of our strategy. We are enhancing our growth profile through the portfolio and investment actions we are taking, while also executing on margin improvement and inflationary-mitigation programs to deliver our long-term margin expansion targets and double-digit earnings growth profile. To that end, I'd like to recognize our associates across supply chain for their contributions. We have an incredible team around the world that is not only addressing the challenges that all companies are facing in today's environment, but they are excelling and driving performance. Turning to our revenue performance. We delivered $5 billion in revenue in the first quarter comprised of $4.8 billion in base business revenues, which had strong growth of 8.3%, and 7.8% organic, which excludes the impact of acquisitions. COVID-only testing revenues were $185 million, which, as expected, declined from $866 million last year, as this was our highest revenue quarter for COVID testing last year given higher pricing and volumes. The year-over-year decline in total company revenues of 5.9% is entirely attributable to the decline in testing revenues. BD is uniquely positioned to deliver strong performance during these uncertain times. The breadth and diversification of the total BD portfolio, including COVID diagnostic testing, provides insulation against COVID-driven procedure fluctuations, as demonstrated by the revenue performance across our segments, with BD Medical growing 6%, Life Sciences based revenues growing over 17% and Interventional growing 3.8%. Total company base business growth was also strong regionally, with double-digit growth in the U.S., China and Latin America. Let me now provide some further insight into each segment's performance. Our Medical segment delivered $2.4 billion in revenues in the first quarter, growing 6%, led by our Medication Delivery Solutions and Pharmaceutical Systems businesses. MDS revenues increased 7.3%, reflecting strong demand for our durable core products, particularly in the U.S., driven by competitive gains in catheters and vascular care devices. Our leadership position in these markets allow us to provide a strong value proposition to our customers in terms of the breadth of our portfolio as well as the cost and quality of our products. Importantly, as input costs such as resins have increased, we've been able to take appropriate price actions and accelerate cost mitigation programs while continuing to invest in innovation to support our strong value proposition. In MMS, revenues were down slightly due to the difficult prior-year comparison given the high number of infusion pump placements last year in the U.S. and Europe to support COVID-related hospital needs. Excluding this impact, our MMS business reflects continued execution of our medication management strategy, which drove strong demand worldwide for our dispensing solutions. This was particularly evident in the U.S., where we saw another strong quarter of customer signings. The traction we are getting reflects the value our Pyxis platform provides our customers. Revenue growth of 1.6% in Diabetes Care reflects our category leadership position. Growth was aided by the timing of certain orders. Pharm Systems revenue grew nearly 18%, driven by continued strong demand for pre-fillable devices. Growth was also enabled by our focused execution on capacity expansion that allowed us to fulfill certain orders earlier than originally anticipated. Demand for pre-filled devices continues to be aided by the fast-paced vial to pre-filled device conversion for biologics, vaccines and other injectable drugs. BD Life Sciences revenue totaled $1.5 billion in the first quarter. The decline of 24.8% year-over-year is solely due to lower COVID-only testing revenues previously discussed. Excluding COVID-only testing, Life Sciences base revenues grew 17.2%, with licensing revenue in IDS contributing about 400 basis points to the segment's base growth and about 100 basis points to the total company based revenue growth. In IDS, base business revenues had strong growth of 20.3%, including about 600 basis points from licensing revenue. Performance was driven by our specimen management, microbiology and molecular platforms as routine lab testing returned to pre-pandemic levels. Growth in BD MAX IVD assays was also strong, reflecting the leverage we are getting on the larger installed base. Performance in our base business includes sales of our combination flu COVID assay that were in line with our expectations. Indications are the respiratory season will be a normal to low flu season. Biosciences revenues increased 9%, driven by strong demand for research solutions as a result of lab utilization returning to normal levels and continued research on COVID variants. Contributing to Life Sciences Q1 growth were the 2 new FACSSymphony instruments that we launched in FY '21. As the evolution of flow cytometry continues to move from large labs to more midsized independent labs, we now provide a complete suite of analyzers for researchers from the benchtop A1 to the A5 SE, our first spectral analyzer that enables researchers to do even high-parameter cellular analysis to gain broader insights into pioneering new discoveries and treatments for cancer and other immune-related conditions. Our new e-commerce site also contributed to growth in Q1. BD Interventional revenues totaled $1.1 billion in the first quarter, growing 3.8%. BDI's performance reflects strong growth in Surgery and UCC. Q1 performance was impacted by temporary supply chain disruptions, and consistent with our ReCoDe initiative, product line discontinuations of lower-margin products in our PI and UCC businesses. While these strategic discontinuations create a temporary headwind to revenue growth, it demonstrates our commitment to simplifying our portfolio and enhancing margins. We had a strong start to the year in our Surgery business, with revenue growth of nearly 9% despite some modest slowdowns towards the end of December due to Omicron. Strength in the quarter was driven by double-digit growth in advanced reconstruction and repair, with strength in hernia as deferrable procedures recovered, and the recent acquisition of Tepha. Tepha provides us with a vertical integration strategy for our current Phasix platform, but more importantly, it provides us with exciting new opportunities to expand our horizon into new high-growth areas of tissue repair, reconstruction and regeneration. Double-digit growth in biosurgery and high single-digit growth in infection prevention was also driven by the recovery of deferrable procedures and continued market adoption of Sterile BD ChloraPrep. Revenues in Peripheral Intervention declined 3.1% as a result of a product recall from fiscal '21 and the previously mentioned supply disruptions and product line discontinuations that support our margin enhancement goals. However, we saw continued acceleration in our atherectomy platform in China as we have leveraged the capabilities of our sales force. We are also experiencing positive momentum from our recent acquisition of Venclose. Urology & Critical Care revenues grew 7.7%, driven by continued strong demand for PureWick in our acute urology portfolio. We're also seeing continued adoption of our PureWick solutions in the home as we advance our strategy to expand our addressable market and deliver transformative solutions for alternate care settings. Also contributing to growth was remediation of Q4's temporary supply disruption within acute urology. Now moving to our P&L. We delivered adjusted net income and EPS above our expectations in Q1, with adjusted net income of $1.1 billion and adjusted diluted EPS of $3.64. We had strong execution of our margin enhancement initiatives in Q1 and delivered base business gross margin of 55.4% and operating margin of 24.3%. We remain on track to deliver our full year base margin goals, with our base margin performance in Q1 ahead of our expectations for the quarter and also above our full year base margin expectations, due to our ability to realize some of our inflation mitigation and pricing initiatives sooner than we previously anticipated. In addition, our Q1 base business operating margin also included a benefit of about 40 basis points from licensing revenues in Life Sciences that was included in our full year plan. Excluding the licensing revenue, base gross and operating margin would have been nearly 55% and 24%, respectively. Other key drivers of gross margin in Q1 include a benefit from increased volume utilization given our strong base revenue growth and, as expected, favorable FX we experienced in 2021 but was recorded in inventory and benefited our GP this quarter when sold. We did realize a negative impact from inflation in the quarter, which was broadly in line with our expectations and was partially offset by our cost improvement and inflation mitigation actions, which are occurring as planned. We are making very good progress with strong sequential improvement and our full year base gross margin improvement goal remains on track despite continued inflationary pressures. SSG&A was in line with expectations and increased year-over-year, driven by variable expenses, including selling and commissions, and inflationary impacts, primarily in shipping, that we have previously shared. The increase in SSG&A as a percent of sales is a function of lower testing sales. However, we did leverage SSG&A versus our base revenue, which is contributing to our base operating margin improvement. R&D increased year-over-year, consistent with our strategy to invest more to support our long-term growth outlook. As anticipated and communicated on our prior earnings call, our tax rate benefited from the timing of discrete items, resulting in a lower effective tax rate in the quarter. Regarding our cash and capital allocation. Cash flows from operations totaled approximately $700 million in the first quarter. We ended Q1 with a strong cash balance of $1.9 billion and an adjusted net leverage ratio of 2.8x. Our cash balance reflects our strategic investments in M&A during the quarter. Our current cash and leverage position and continued focus on strong cash flows provide us the flexibility to advance our balanced capital allocation framework and support our BD2025 growth strategy through investments in R&D, capital and M&A. During Q1, we invested in R&D at over 6% of sales to advance our innovation pipeline. We also invested over $400 million in 3 additional tuck-in acquisitions across our businesses that will support our strong growth profile in 2022 and beyond. Turning to our fiscal '22 guidance assumptions. First, the macro considerations that support our guidance. While we still expect some global COVID-driven variability, our guidance assumes the continued easing of COVID-19 restrictions, the stabilization of deferrable procedures and no significant disruptions to deferrable procedure volumes. Additionally, we see signs of continued inflationary and supply chain pressure over the balance of the year, with some stabilization by the end of the year. However, we believe we have a clear path to margin recovery, and we expect to offset any incremental inflation impact through various cost containment and pricing-related initiatives already realized in Q1. Our guidance doesn't contemplate a more significant step increase in market-driven supply chain and inflationary disruption. A few comments on testing-specific assumptions. Our base business revenue assumptions include sales of our combination flu COVID assays. We anticipate a normal to light flu season based on what we've seen so far from the CDC surveillance reports. Moving to our updated guidance for fiscal '22. We are well positioned for strong growth across our 3 segments, which are delivering at or above our initial expectations and, thus, we are increasing our base revenue guidance. While we aren't providing segment-specific items, relative to our revised total company base growth outlook, we expect our Medical segment growth to be slightly below and our Life Sciences and Interventional segment growth to be slightly above total company growth. We now expect base revenues to grow 5.75% to 6.75% on an FX-neutral basis from $18.3 billion in fiscal '21. This is an increase from our previous guidance of 5% to 6% growth and is driven by our Q1 revenue outperformance and confidence in the strength and resilience of our base portfolio, and our Q1 acquisitions, which account for about 25 basis points of the increase. For COVID-only testing, we are now assuming $450 million in revenue, which is a little more than double our original expectation of $200 million. As we communicated last quarter, higher testing revenues position us well to manage through this period of uncertainty and also provide the potential to create value through reinvestment in our business. Given our increased testing revenue expectations, we currently plan to reinvest a portion of the testing profits over the balance of the year, but we'll ensure they are value-creating opportunities and would not invest at a level that would result in our full year testing margins dropping below our base margins. Should those investment opportunities not materialize as anticipated, we would allow the incremental profits to flow through. Based on current spot rates, for illustrative purposes, currency is now estimated to be a headwind of approximately 125 basis points or about $250 million to total company revenues. This is an incremental 75 basis point headwind compared to our prior view. All in with our base revenue, COVID-only testing revenue and the illustrative currency impact, we now expect reported revenues in the range of $19.55 billion to $19.75 billion in fiscal '22, compared to $19.3 billion to $19.5 billion previously announced. We still expect operating margins in our base business to improve by approximately 200 basis points over our fiscal '21 base operating margin of 21.7%. Given the planned reinvestment, we also still expect operating margin on COVID-only testing to be modestly above our base business margins. A few additional items for your models. We now expect $50 million to $75 million in year-over-year improvement in interest other or an incremental $25 million benefit. We still expect an effective tax rate of 12.5% to 13.5% for the full year. Our guidance still assumes share repurchases that, at a minimum, offset any dilution from share-based compensation. All in, we are raising our adjusted EPS guidance to be between $12.80 and $13, which is an increase of $0.50 at the midpoint from our prior guidance of $12.30 to $12.50. This includes absorbing the negative impact of currency, which we estimate to be about $0.10. The increase reflects our strong Q1 base business performance and our expectations for increased COVID testing net of reinvestment. As a reminder, our fiscal '22 guidance continues to include our Diabetes business. As Tom mentioned, the embecta spin has now been approved by the Board of Directors. As we proceed towards the spin date, I want to provide a few reminders Restated financials for RemainCo will not be made public until the completion of the spinoff. Given the higher but declining margin profile of embecta, one should expect BD margins to be lower after they're restated. However, off the restated FY '21 financials, we are still targeting about 400 basis points of base operating margin expansion through FY '25. BD is expected to receive a distribution of approximately $1.44 billion, equivalent to multiple years of cash generated by the Diabetes Care unit. We remain excited for what's ahead for embecta and making this a successful and value-creating opportunity for everyone. As you think about phasing for the balance of the year, the following are a few key considerations as you think of our base revenue and earnings. Regarding sales, we remain confident in the durable nature of our portfolio and the strength of our underlying sales. In Q2, we expect some impact from Omicron on hospital staffing and procedures. But recall, Q2 is a relatively easy compare due to the significant COVID resurgence we experienced in Q2 of fiscal '21. As a result, we anticipate base revenue growth in Q2 to be above our full year guidance range, with the remaining quarters being equally balanced. Regarding our margins and P&L, as I noted, Q1 had the benefit from licensing, which added about 40 basis points to operating margin, which will not repeat in Q2. While we expect improvement versus the prior year, we also previously shared that Q2 would be the quarter with the largest inflationary impact. So given those 2 dynamics, you would expect a sequential step down in margin, and we expect Q2 to represent the low watermark for base operating margin for the year. We remain well on track to achieve our base operating margin guidance of approximately 200 basis points improvement. As we progress through the second half of the fiscal year, in Q3, we expect the impact of inflation on our business to stabilize and see a modest pickup of cost improvement and price-related benefits flowing through, with Q4 being the highest benefit. As a reminder, we see our SSG&A and R&D costs relatively evenly spread through the year. As expected, our tax rate in Q1 benefited from the timing of discrete items. At the midpoint of our full year guidance range, that would imply we expect our average tax rate for the balance of the year to be about 13.7%, which is best to apply for the subsequent quarters. Regarding COVID-only testing sales, we expect the vast majority of testing revenues to occur in fiscal Q2 and then trend down as Omicron subsides. In future years, we would not expect this level of COVID-only testing to repeat. In summary, we are continuing to advance our BD2025 strategic objectives with focused execution against our key priorities. As we look forward, and as reflected in our FY '22 guidance, we are well positioned for growth with excellent momentum in our base business, increased investments in our innovation pipeline, tuck-in M&A momentum, strong progress executing our balance sheet and cash flow initiatives and clear visibility to meaningful margin improvement. Thanks for your time. Operator, we can now open the line for Q&A.
Operator:
[Operator Instructions]. And our first question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Maybe my first question, some clarification on the Q1 numbers here. Can you quantify what the contribution from combo test. There's some confusion on whether it was an abnormal contribution. I think in the past you've said it's about $75 million to $100 million. So was it in line with expectations? Has anything changed on combo test? And this licensing fee, it looks like maybe it was $40 million or $50 million contribution from a dollar perspective. Is that the right way to think about it?
Thomas Polen:
Vijay, this is Tom. Thanks for the good question. So on flu COVID combo, testing is very much in line with our expectations. The -- as you said, it was $70 million to $80 million or so is what we expected for the full year, and you would expect a portion of that to be in Q1, and it played out as such. Essentially, it's relatively immaterial to overall BD, as you can imagine, if you take the 75 80 and you spread it over a couple of quarters. So that's what was in our numbers. We have not seen any -- it's a normal to light flu season this year. It's certainly higher than it was last year when there was essentially no flu. But if you look at the CDC data, it is on track for a light to normal flu season. but nothing above our expectations at this point in time. I'll turn it over to Chris for the other question.
Christopher DelOrefice:
Yes. And just to confirm, on the licensing revenue, yes, so it was worth 40 basis points. You can do the math. It's roughly $50 million. We also had -- you heard me reference, we're actively driving our ReCoDe initiative and SKU productivity and have been very intentional about making choices there to enhance our profitability. Given the strong growth profile, this affords us the luxury of being able to absorb some headwinds as we simplify our portfolio. And primarily in the BDI business, there was some impact there as well, and that actually had a negative impact in the quarter of about 30 basis points.
Vijay Kumar:
That's extremely helpful, Chris. And maybe my follow-up on the guidance here. You guys [indiscernible] Q1 by about $250 million on the revenues versus street models, $0.60 on EPS. The guide raise was of a similar magnitude. When I look at your gross margin execution, ex licensing, it's well over 55%. It feels like perhaps the guidance is conservative, maybe talk about the assumptions that went into the 2Q to 4Q implied guide?
Christopher DelOrefice:
Yes, thanks for the question. Let me approach this 2 ways. So let me first talk about the quarter and how we delivered in the quarter maybe relative to what folks are seeing from kind of an external expectation standpoint. So obviously, we're very pleased with our Q1 results, clearly reflected strong base revenue growth which exceeded our expectations. As you noted, there was also a strong execution against our margin enhancement objectives, actually realizing benefit earlier in some areas, which will help us going forward because certainly we're seeing continued market-driven supply and inflation pressure as you look out into the back end of the year. Finally, we -- as you noted, we did realize incremental revenue from COVID-only testing. You can see that in our results. That actually had a strong margin as well in the first quarter. The good thing here is the strength is nicely balanced between our base and the increment from testing. There were a couple of timing items as we think comparing to, again, kind of more what I would frame as external expectations. First, we had signaled there was -- we had expected a discrete tax item in Q1, which did play out as expected. So we had a lower effective tax rate in the quarter. We're still confident in our full year expected tax rate. So thus, you would expect a slight increase over our full year average through the balance to go there. You had highlighted the licensing impact, which I don't think was contemplated in the external view. That was planned on our side. Those 2 items alone explain what I would call the delta you're seeing between our total results relative to the external view. I think the other 2 new considerations to think about that don't really show up in the quarter, one is we talked about reinvestment of the testing upside, which will obviously happen through the course of the year as we find those value-creating opportunities. And then we talked about the negative FX, which was worth about $0.10, which, again, that will also play out through the back of the year. So actually, when you think of that, that implies that we actually have a stronger balance to go on the back end to account for absorbing those items. So similar to what you said, bigger picture, I think the simple way to think of this is we increased sales by $250 million. That included a base increase of $150 million, testing of $250 million to $400 million. We did offset currency headwinds of $150 million. So that nets to the $250 million. I think also importantly, if you take our Q1 actual results against our new base guide and look at our implied guide for Q2 to Q4, it's actually in line with our previous guide, which means we did not take our revenue projections down in the future. And I think everyone is acknowledging there's actually more uncertainty given Omicron. We mentioned how we exited December heading into January. So that's actually signaling strength in how we feel about the back half. And then our EPS, we increased $0.50, absorbing $0.10 of currency. And if you do the drop-through on EPS to sales, it's an extremely high conversion of sales to earnings, implying strong margin on that, fully leveraging our base and gives us confidence actually that we're on track to deliver our margin commitment. So I think in light of all that, we see this as actually especially strong in light of continued market uncertainty and is reflective of our strong base business growth and our focus on execution.
Operator:
And our next question comes from Robbie Marcus with JPMorgan.
Robert Marcus:
Yes. And congrats on a good quarter. Chris, maybe I could just follow up on that a little bit and get a little more from you. You raised EPS by less than the beat. Should we think of that as any changes to the inflationary environment? Or maybe what went into the view to not raise it as much? Was the licensing, did it come earlier than expected? Or just anything we can get and help us phase through the rest of the year versus where we were before.
Christopher DelOrefice:
Yes. Thanks, Robbie, for the question. I guess I'll reiterate some of the things that I just shared. To your point, extremely strong quarter. You saw the results relative to external expectations. There were 2 timing items. We had signaled tax in Q1, that was not contemplated in the external view. The licensing also wasn't contemplated in that external view. Those were both items that we had planned and we had communicated the tax. So when you think of those 2 items alone, we're actually giving more than, call it, an adjusted external view. And then I think the last piece that isn't being considered is, there are new items in the back half of the year. Again, FX, right, which is going to play out, there's $0.10 there that will play out post Q1. And in addition to that, we had highlighted the fact that we are going to do some reinvestment on some of the margin drop-through on the incremental testing that happened in Q1. So that kind of explains it. Again, I think the easiest way to think about it is, we delivered 8.3% growth in Q1. Our revenue guide has us holding the 8.3% and then actually holding the same guide on the balance to go, which means we're equally confident in our original guide despite the fact that everyone would acknowledge that there are more headwinds as it relates to Omicron, et cetera. It also implies at $0.50 on $250 million of sales an extremely strong drop-through to profit, right? It's highly variable. It's actually at a GP level or plus, which means all that revenue, we're fully leveraging our base and it only implies a strengthening perspective on our margin outlook. And again, we're extremely excited about the start of the year. I feel good about where we are. Obviously, we did talk about -- we do see continued inflation pressures as the year progresses. We're working really hard. The team is doing an outstanding job mitigating those. But it is certainly a unique environment. But I think a great start to the year. The guide increase signals more confidence than when we entered the year despite what I would argue is actually more complexity.
Thomas Polen:
And Robbie, this is Tom. I think you've heard me used the word prudent pretty nonstop since the COVID pandemic hit. And so I would view our guide today is prudent with -- as the market continues to remain more stable, that there's opportunity for upside as we move through the year.
Robert Marcus:
That's actually very helpful. So it sounds like there's an extra $0.20 or so of reinvestment going back into the business. How should we think about where that's going and when and where we might see that materialize?
Christopher DelOrefice:
Yes. Thanks, Robbie. Yes. Obviously, so one, as the CFO, of course, it's going to be contingent on there'll be strong value-creating opportunities. We've always looked to innovation, I think, first. I think also anything that we can do to accelerate the great programs that we have in place to build capability and execute against our Simplify agenda, which will lead to margin, I think, would be the 2 areas that we would continue to prioritize. I would likely see that kind of phase more second half. Certainly, with the new guide in our plan, some of that will happen in Q2, but it will probably be more kind of spread throughout the year is the way to think about that.
Operator:
We'll take our next question from Matthew Mishan with KeyBanc.
Matthew Mishan:
Just first, could you go a little bit deeper on the Peripheral Intervention issues around the recall and supplier constraints and how long that's expected to last? And is there any way to quantify the magnitude? And was that originally contemplated in the guidance as well?
Thomas Polen:
Matthew, this is Tom. I'll turn that over to Simon.
Simon Campion:
Matthew, Simon. Yes, I'd be happy to provide that information, but before I do so, I think it's fair to say we're reasonably happy with the performance of BDI in the quarter. And with respect to PI, we're happy with the position of that portfolio. We're happy with our competitiveness. We're happy with our ability to continue to strengthen that portfolio as you've seen the acquisition of Venclose during the quarter. So the issues we face are -- I would classify them as extremely acute in nature and I feel time-bound. Three issues generally have been the source of the majority of the problem today. But this time last year, we recalled the Venovo venous stent and so we've got a headwind for 4 quarters at this point in time. We expect 2 things from that. Number one, it's almost annualized. And number two, we do expect it to be back in the market in the second half of this financial year. And just to reiterate, that is not an implant issue. In fact, in September of last year, we published 3-year data from the [indiscernible] study on Venovo, which showed 84% [indiscernible] and 0 fractures and 0 migration. So we are very confident that this is going to have an impact on the market again. Second issue was the backorder and supplier challenges in the NPI. PI does have the most complex portfolio, the most complex products and the most complex supply chain certainly within BDI. And we've experienced headwinds from raw material capacity to COVID impact in supplier sites to sterilization capacity in the past number of quarters. We do see light at the end of the tunnel on a number of those issues, particularly in relation to sterilization. And we expect to begin to see material improvements in our performance with respect to back order by the end of this quarter. And then finally, as Chris and Tom have remarked, SKU rationalization has impacted PI more so than any other business this past quarter. And as we discussed in other fora, these product discontinuations are being done strategically with a view to enhancing margins and increasing efficiencies across our entire cycle from manufacturing to sales rep time allocation.
Thomas Polen:
I think just to add, Simon, those strategic product exits that we've been doing in PI, but also in other areas of the company as part of our ReCoDe initiative, across the board, those -- with the strength of our revenue, we've been in a position to accelerate that strategy in a number of ways. And those products that we're discontinuing typically always have growth rates that are far below the company average and margins that are far below the company average. And so it's addition by subtraction as we think about that long term, as we simplify our portfolio and focus in those higher-growth spaces that are going to be driving the future of the company. So thank you, Matthew, for the question.
Matthew Mishan:
Okay. And just lastly on Alaris. And I'm sorry if I missed it in the prepared remarks. I know it wasn't previously assumed in guidance, but it says that FDA clearance of Alaris is not expected now in FY '22. Did something change in the conversations with the FDA?
Thomas Polen:
No, Matthew. That's very -- that's exactly what we said when we gave guidance. That's no change at all. We continue to be focused on advancing Alaris and there's no updates.
Operator:
[Operator Instructions]. We'll take our next question from Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Congrats on the nice start to the fiscal year. I'll ask both my questions upfront. I heard pricing a lot so far on this call. Where do you guys see opportunity to take price? And what's embedded in the guidance for net price change year-over-year? And second, Chris, the guidance for the base business implies second half growth is below the range, I believe, based on your quarterly phasing, by our math, maybe 4%. Is that conservatism? And what does it imply about your ability to grow 5%, 5.5% plus beyond fiscal 2022?
Thomas Polen:
Okay. Thank you for the question, Larry. Why don't we start with the last question first. I'll turn it to Chris on the growth pretty clear answer.
Christopher DelOrefice:
Yes, Larry, thanks for the question. Yes, the full balance to go is actually equal to our guide. What we did signal though was Q2, we're still navigating through kind of a recovery period, if you remember the resurgence last year. So it's really more I would think of it as kind of outsized on the BDI side of the business, in particular. There are a couple of small comp dynamics in Q4 as well, right? We had some new product launches. So if you look at the comp from last year, it's very strong. So it's really just more comp dynamics, I think, as it relates to 5 5 plus for the long term, that this more than validates that we're well on track and strong there. As a matter of fact, our continuing to look at growth versus '19 as an example, too, is extremely strong, actually moving to over 5% with -- and that's -- and considering the fact that you have a year of COVID in there, that's a strong signal for the trajectory of the business.
Thomas Polen:
And on pricing, Larry, so as you know, as you know BD very, very well, we've been focused on pricing for many years and had begun the journey with putting in resources in every business that are dedicated to pricing, pricing leadership at the company level as well. And obviously, in an environment where there's record levels of inflation, it's been an area that has been ever more important. And so we began our journey of working on pricing in an inflationary environment last year and began taking actions. And you're starting to see and will continue to see the impacts of that flow through in the year. We take those actions very serious in discussions with our customers. We understand they work in a reimbursement-constrained environment. And so if you look at where we are implementing price most significantly, it is -- and we're very transparent with our customers, by the way, on where we're raising price and why we're raising price and the impacts of inflation as the driver of that. But where you see it most is in those products that we're selling for a dime, a quarter or low dollars, where BD over decades has invested billions of dollars of capital in creating extremely efficient, fully automated manufacturing facilities that allow us to be one of the only companies on the planet who can sell billions of devices at dimes and quarters and dollars. And because of the way that we've just continued to refine our manufacturing capabilities over the year in a best-in-class ways, any increases in variable costs like resins, as an example, or chips, et cetera, they tend to flow right through and directly impact product margins and profitability. And so we can share what those impacts are on those raw material increases with our customers, and we have those discussions, and we've been raising price actively, particularly in those product categories. And so while we're not giving out -- not sharing a specific number on price through the year, we are -- have been very, very active on that. And it's -- we're doing it in every region around the world, it's not a U.S. or Europe thing, it's equal across all geographies and directly related to passing through a portion of the inflationary impacts that we're getting on raw materials. Of course, at the same time, we're taking a number of actions beyond pricing, passing it all through to our customers, and that includes us taking cost actions within the company, continuing to drive significant continuous improvement in our manufacturing plants and always look at ways to be more efficient and look at prices, that last resort. But we have certainly been doing more price this year than we have seen historically.
Christopher DelOrefice:
Larry, just one other quick thing. I don't know if this helps, I wasn't sure if your comment was operational. But obviously, the FX phasing will be certainly more back-end loaded in terms of the negative currency impact, maybe another consideration. And then further to just Tom's comment on pricing from a progress standpoint, I think what I can share, we did not split out the dynamic, but it's part of our plan as it relates to -- we talked about an inflation impact and then cost improvement programs and price. Cost improvement is actually a large portion of it, to Tom's point, where we're getting a net 50 basis points improvement for the full year of the 200 basis points. The other 150 is coming from volume and strong growth and some FX benefit that carried over from last year. And on pricing, we entered the year with plans, with 80%, 90% of firm plans in place and 50% of that action. We now have 100% plans fully identified and 7% of it is already fully executed, with the balance really more timing tied to triggers and other events. So really good progress there.
Operator:
We'll take our next question from Matt Taylor with UBS.
Matthew Taylor:
I just had a follow-up on the thread on all the supply chain inflation issues and your ability to mitigate them. So wanted to understand better the forecast and what you're assuming for the second half of the year in terms of some of those headwinds abating. And Tom, I appreciate your comments on the nickel, dime and quarters, the lower-cost products. I was wondering specifically if you could also raise price on reagents or anywhere else in the portfolio?
Thomas Polen:
Thank you for the question, Matt. So on the supply chain and inflation perspective, we don't have -- there's not assumptions that there's any major material reversal of the cost. There are some areas where we expect continued trending. Resins, for example, have been heading in a moderately to minorly favorable direction, as an example. We expect that to continue. But overall, we don't see major abatements in areas like shipping, as an example, or chips. That's -- we bake that into our outlook as we go forward. We do think those supply chain dynamics will continue certainly longer than most of the world thought at this time last year, and we see them -- many of them continuing through '22. So we have that built into our considerations and outlook. The other question was.
Matthew Taylor:
Just on reagents or any other areas...
Thomas Polen:
Yes. Thanks, Matt. Certainly, we do look at those, and we have raised price in a number of areas as appropriate across the portfolio. There are a few products, of course, in today's environment that aren't impacted by inflation in areas such as shipping or computer chips, et cetera. Instrumentation will be a good example of electromechanical inflation that we see and we raised costs there in areas such as service, where spare parts, certainly, the cost of those go up. And we do share the increases of those as well. So the answer is yes. But by far and away, the most significant increases would be on those products that we are just extremely efficient at producing and where the percentage of COGS made up of raw materials are disproportionately high.
Christopher DelOrefice:
Just one small add that may help you think about how this sort of could play out through the year. Inflationary impacts kind of started more in the second half of last year, right? So as you go through this year, what you're going to see in the first half is kind of a full impact of continued inflation. As you get to the back half, you'll see some stabilization to some continuous increases, but to a smaller degree. And then think of the opposite as it relates to kind of the offsets that will drive, call it, the net, right? That will ramp a little bit slower, although we were -- we actually exceeded our expectations for Q1, but you have just sort of the natural ramp that happens as you put actions into place throughout the year. So that may help you as you sort of think of the timing dynamics. We did talk about GP or GP operating margin, Q2 kind of being the low watermark as it relates to the full impact of inflation flowing through. And that is GP and up margin because a lot of the inflation is also in the area of shipping. So you should think of both line items in that regard.
Thomas Polen:
And Matt, just maybe one other item to add is we have been very active and we put this in place last year. We have a formal inflation task force that we've established, with multiple different pillars within that and dedicated groups, working on everything from rethinking our logistics chain, and that includes looking at alternative shipping partners in a number of areas. For example, how can you ship from Asia to the U.S. or from Europe, U.S. to Europe in more efficient ways? What parts of our supply chain have traditionally used airfreight, as an example, that we can move on to rail or boats? We've been taking actions and rethinking that, both how we get products to customers, but also from raw material suppliers into our plants. And of course, looking at the materials themselves, where there's alternative vendors and working with existing vendors on different technologies that could be more cost effective for us to use. All of those are different components within our inflation task force, it's been very active, and we're seeing the impacts of that as well.
Operator:
We will take our final question from Rick Wise with Stifel.
Frederick Wise:
Tom, Chris. Tom, just this excellent quarter, just the superb margin performance, et cetera, makes me think back actually to our December -- mid-December 2019 meeting as you were about to step into the CEO role. And I'm curious about 2 aspects of your comments back then. One, you highlighted your growth-focused priorities, particularly inorganically. I'd be curious to hear just maybe update -- your updated thinking on M&A and opportunities for the rest of the year, how aggressive you hope to be or what the opportunities are. But the second part, and even more particularly, today, we've heard again and again about the clear path to that 400 basis of operating margin improvement. I was hoping you could be a little more granular about the 3 things you highlighted back in December 2019. You said we're going to reduce the manufacturing footprint. You're going to unify the end-to-end operational processes. And we've heard Chris highlighted the SKU rationalization reduction. Where are we on those initiatives? How much more is there to go? Sorry for the long question. Appreciate any color.
Thomas Polen:
Thank you, Rick, for the question. And hopefully, get to see you again soon in person. As the pandemic here, it's been a while since we were able to connect live, which I always enjoy. So I appreciate it. It's a great, great question. Certainly, as we look back and we laid out the BD2025 strategy, I do see that we're beginning to transition from how we view the first phase of that strategy into the second. The first phase of that strategy, and I remember our discussion well, we talked about an initial focus on, including strengthening our balance sheet and cash flows to increase flexibility. And you've seen really pleased with the team's work around accounts receivable, payables, inventory. You've seen our free cash flow conversion moved up meaningfully. over that period of time. And that's allowed us to have flexibility to do what you just mentioned, M&A opportunities. And I think we are among, if not the highest, number of acquisitions within med tech this -- over the past 2 years. We clearly demonstrated our interest there. We've also spent a lot of time accelerating innovation and reshaping our portfolio and driving strong execution in that portfolio. If you recall very early on, we jump-started that with the Growth and Innovation Fund. We gave that strategy a further boost by reinvesting a portion of the COVID testing proceeds last year. And we're beginning to see the results of that work. And the energy across the organization as our mindset is very strongly pivoted to growth. And I am pleased with the cadence of the company M&A and how we've built those capabilities as a new lever for the organization. Obviously, just this quarter and the first few weeks of Q2, we've done 4 acquisitions. This year, I believe we did 6 or 7. Last year up to 17, over the last 2 years since we've met. And we are going to continue that focus. We shared at our Analyst Day that 80% of our M&A has been focused in transformative solutions. The 3 areas that we've described repeatedly, smart connected care, enabling new care settings and improving outcomes in chronic disease, focused within higher-growth sectors within those markets. Expect our tuck-in M&A strategy to continue to be focused within those while selectively doing deals that help secure and strengthen our position within our durable core, which is also doing very well as evidenced through our performance this quarter. On the -- as we think about M&A opportunities, we certainly have -- continue to have a strong pipeline going forward. We've made commentary, we continue to not have any transformational M&A within scope of our strategy at this time. We're focused on tuck-in M&A. We do have the ability to go larger than what we've been doing, more in the up to $2 billion. And we can -- we will flex over $2 billion for the right strategic opportunities and value-creating opportunities. And so we'll continue to evolve the size of those as we go forward. On the -- as we think about -- and maybe one last thing there, too, when we talk about M&A items coming in, of course, a major milestone here this week with the Board approving the spin of embecta, and that's part of our portfolio strategy as we now have dedicated Diabetes Care business. We will be one of the largest dedicated diabetes companies on the planet, able to have a focused management team, with focused cash flows, driving a focused strategy in that space to create shareholder value, while we focus in the other remaining areas for BD. Focus our talent, our resources, our capabilities in those areas that are most strategic to us. And I think it's a value-creating opportunity very clearly for what will be now 2 stand-alone companies. But a major milestone. And interestingly, a milestone that was achieved, nearly to the day, 100 years. It was January of 1922, end of January 1922, when the first insulin was injected. It was used in therapy on a teenager up in Canada. And it's interesting nearly 100 years later is when we just are spinning out the world's largest insulin injection company now as a stand-alone organization. So on the Simplify side, we're really pleased with the progress there. And you could hear from whether or not the actions that we've been taking and how we've been exiting certain product lines, that thousands of SKUs that we're getting rid of as we simplify our portfolio to focus on those products that matter and we're going to drive our growth and help simplify our plans. We have dedicated teams working on our network simplification strategy. Those have all been identified and are underway around our manufacturing footprint. And while SKU rationalization, you've heard it's well underway. We'll continue to execute that. Largely over the next year, that will be completed as that. At the same time, you can see very clearly, we are hyper focused on our margin strategy. ReCoDe is part of that, but it also includes areas around the supply chain and inflation management that I talked about, includes pricing as part of that as well. We made a commitment during our Analyst Day around the 400 basis points of improvements in getting back to pre-'19 margin levels by 2024, and we've got that in our sights and are hyper-focused on delivering to that goal. So we're very pleased with the progress we're making. As we look ahead, we're going to continue to focus on executing that strategy that we outlined as part of BD2025 and shared more details on at our Analyst Day, and we look forward to continue to update you on the progress.
Operator:
And at this time, I'll turn the call back over to Tom Polen for any closing remarks.
Thomas Polen:
Okay. Thank you, and thanks, everyone, for your questions. Before we sign off, I just want to thank BD's 75,000 associates around the globe who live our purpose every day to advance the world of health, who are working tirelessly to support our customers and frontline health care workers around the world and are committed to executing our strategy. I'm proud of how we've started fiscal '22. I'm looking forward to continuing to deliver on our goals and making meaningful impacts for our customers and their patients around the world. On behalf of the entire executive team, thank you for your efforts and sacrifices. And operator, with that, we will end today's call.
Operator:
Thank you. And this does conclude today's audio webcast. Please disconnect your lines at this time, and have a wonderful day.
Operator:
Hello, and welcome to the BD's Fourth Quarter and Full-Year Fiscal 2021 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through November 11, 2021, on the Investors' page of the bd.com website, or by phone at 800-839-1246 for domestic calls and area code +1(402)220-0464 for international calls. The replay switches are now dedicated; you no longer need a conference ID to hear the replay. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Nadia Goncalves, Senior Director of Investor Relations. Ms. Goncalves, please you may begin.
Nadia Goncalves:
Good morning and thank you for joining us today. This call is being made available via webcast at bd.com. This morning, BD released its results for the fourth quarter and full-year of fiscal 2021. You can find the press release along with an accompanying presentation on the Investor Relations website investors.bd.com. Leading today's call are Tom Polen, BD's Chairman, Chief Executive Officer, and President; and Chris DelOrefice, Executive Vice President, and Chief Financial Officer. Following the prepared remarks, Tom and Chris will be joining for Q&A by our Segment Presidents
Tom Polen:
Thank you, Nadia, and good morning everyone and thank you for joining us. Before I get started, I would like to officially welcome Chris DelOrefice, BD's recently appointed Chief Financial Officer. Chris brings deep healthcare and MedTech experience to BD across both operations and corporate finance. Many of you already know Chris from his most recent role as Head of Investor Relations at J&J. We were thrilled to have Chris join the team and while he's only been with us for two months, he's already immersing himself and making a very positive impact. I look forward to Chris sharing his perspective with you both today and at our Investor Day next week. I would also like to welcome Dr. Carrie Byington, who is recently appointed to the BD Board of Directors. Dr. Byington is Executive Vice President and Head of University of California Health, where she leads the nation's largest academic health system. Dr. Byington brings deep and highly relevant experience to BD, as we work to advance our BD 2025 strategy and accelerate innovation in smart connected care, enabling the transition to new care settings, and improving chronic disease outcomes. On today's call, I will provide highlights of our performance and the continued progress we've made on our BD 2025 strategy. I'll then turn it over to Chris for the financial review and outlook for fiscal 2022. After our prepared remarks, Chris and I will open the call up for Q&A. Now let's jump into our results and key highlights for the year on Slide 7. We were very pleased with the strong close to fiscal 2021, which drove full-year revenues, EPS and cash flows ahead of our expectations despite a volatile environment. This reflects our continued laser-focus on execution and the strength and expansiveness of our diversified business and geographic model. Revenues grew over 15% to more than $20 billion in fiscal 2021, with $2 billion in COVID testing revenues and strong 8.1% growth in our base business. Our adjusted EPS increased 28% to $13.08. And through continued execution of cash flow initiatives we instituted in fiscal 2020, we further improved our operating cash flow by over $1.1 billion compared to the prior-year. Overall performance reflects strong momentum in our base business with a return to more normalized growth rates across all three segments versus pre-pandemic revenue level. As hospitals have been able to return to serving both COVID and non-COVID patients, and the overall healthcare utilization levels increased, we saw a strong demand for our broad portfolio of products that were essential to patient care, including new products delivered across our innovation pipeline. At the same time, we were proud to have supported our customers and the patients they serve, by bringing to market and scaling a broad range of innovations to help the world diagnose, treat, and prevent COVID. Turning to Slide 8, at the highest level, our strategy has been deeply rooted in helping healthcare systems balance four key priorities. And those are improving outcomes, driving efficiencies, expanding access to care, and more important than ever, improving the clinician experience. BD is uniquely positioned to help our customers deliver against these three key priorities across discovery and diagnosis, medication delivery, and interventional treatment. And through our innovation-driven growth strategy, we're investing in our broad, foundational durable core portfolio, while also shifting a larger portion of our business into higher growth, higher impact areas. And those three higher growth higher impact areas that we're focused on, you've heard me talk about before are smart connected care, enabling the transition of treatments in new care settings, and improving chronic disease outcomes. In addition, by simplifying our product portfolio, we're driving growth through increased efficiency and margin expansion. Turning to Slide 9. Importantly, we significantly advanced our strategy this past fiscal year, taking bold steps to position BD for the long-term. Beginning with the actions we took to strengthen our balance sheet and enhance our working capital and cash flows. These actions have positioned our cash and net leverage well. Giving us the capacity to increase investments in R&D and tuck-in M&A, accelerating our innovation pipeline, and advancing our strategy to drive growth in fiscal 2022 and beyond. In FY 2021, we invested over $1.2 billion in R&D, 21% more than last year, with increased funding for key projects through our new growth and innovation fund. We also continued our increased pace of tuck-in acquisitions, completing seven acquisitions in fiscal 2021, as well as a number of additional early phase investments as we also began to build our long-term inorganic funnel. In addition, we reinvested over $200 million in profits from COVID testing to drive our growth strategy. Through investments in our commercial organizations indeed and accelerate our simplification strategy by investing to speed up our recode portfolio and architecture program. And today, these investments are meaningfully advancing our strategy to expand in higher-growth spaces, across smart connected care, new care settings, and chronic disease outcomes. And just a few recent accomplishments that I can share here underscore our growing momentum. We're looking forward to sharing a lot more of those accomplishments next week at Analyst Day. These include new manufacturing lines that are now operational and will support demand for vaccination devices globally. And this investment is in addition to our $1.2 billion commitment to expand capacity for our pre-fillable syringe, and advanced drug delivery systems, which represent high-growth opportunities in our durable core. Emergency used authorization for BD Veritor At-Home, which is the first at-home COVID antigen test to use a smartphone to interpret and report results. This platform is a great example of how we're applying digital capabilities to bring new first to world innovations to market and expanding care to new settings. We also received 510(k) clearance of expanded indications for Rotarex Atherectomy System to include treatment of in-stent restenosis, which is a first of its kind label expansion and it's a great example of how we expand optionality for physicians and customers in the treatment of chronic disease. We also received U.S. FDA approval of our new high throughput molecular system BD COR. In today's challenging labor environment, BD COR's advanced robotics and software algorithms provide customers a way to do more testing with less available staff while providing important new clinical insights for cervical cancer screening and management through our BD Onclarity, HPV Assay. Now beyond BD COR, as you know, we have a portfolio and pipeline of unique automated solutions that help our customers perform in a tight labor market from helping nursing staff and pharmacists be more efficient with medication management, to increasing efficiency in diagnostic testing for labs experiencing staffing shortages. We're engaging with customers in these markets and are seeing great interest in our solutions. At our Investor Day, we'll share more about how we are well-positioned, not only capitalize on this opportunity, but how we've been very actively optimizing our investment mix to both expand our durable core platforms and simultaneously add technology and platform innovation in higher-impact and higher-growth spaces that we expect to enhance our long-term growth profile. Through our disciplined capital allocation framework, we're balancing these investments and future growth with a return of capital to shareholders through our competitive dividend, while also resuming our share repurchasing program, having repurchased $1.75 billion in fiscal 2021. We also just announced our 50th consecutive year of dividend increases, and we're very proud to be one of only 16 companies across all industries to achieve that milestone. Turing to Slide 10. We'll remain disciplined in our approach to portfolio management as we systematically advance and deliver against our strategy. And earlier this year, we announced the decision to spin-off our diabetes care business. The proposed spin represents a value creation opportunity for all stakeholders and is intended to enable growth acceleration for both BD RemainCo and NewCo with more efficient business processes and allocation of resources and capital. NewCo will be able to invest its capital in growth opportunities, including high-growth geographies markets and next-generation products. We continue to make good progress and the spin-off remains on track for the first half of calendar 2022. Regarding our BD Alaris pump, we recently received CE mark and Health Canada approval for the updated BD Alaris system. We also achieved a significant milestone earlier this year with the filing of our BD Alaris 510(k) submission. We have dedicated resources supporting this and continue to make progress. Alaris is an important tool for clinicians and there continues to be strong demand for our platform during the pandemic. Turning to Slide 11. I'd like to share some details about our enhanced ESG strategy Together We Advance. BD has been a longstanding leader as a case study for sustainable business models and innovating for shared value. Our strategy serves as a framework through which BD addresses the most relevant ESG issues for the company and its stakeholders and aims to further our leadership role and build on our commitment to improve and advance individual and public health at a global scale. The health of our company, our planet, our communities, and the people we serve are directly connected. And when we successfully address the health of one, we often solve for challenges of another. And under our strategy, we announced the suite of goals for 2030 and beyond with commitments in five areas that are most important to BD and our stakeholders, and where we have opportunities to create meaningful measured change over the next decade. And those specifically are climate change, product impacts, responsible supply chains, healthy workforce, and communities and transparency. And we're acting on these commitments. And for example, we recently signed on to the United Nations Race To Zero campaign. We look forward to sharing more about the advances and impact we having in each of these areas. Before I turn it over to Chris, as we look ahead, we expect the greater resiliency exhibited by healthcare systems during Delta will continue along with continued recovery and patient demand post-Delta. While there are inflationary pressures occurring across most every industry, we have been very active in addressing these challenges. We have put specific defined actionable plans in place to help mitigate these pressures, which are coordinated through an inflation taskforce that we've established with work streams across procurement, shipping, cost structure, and continuous improvements in our plans. And in this environment, it's also required to initiate pricing actions, which we have begun. Looking ahead, while we believe there will be longer term macro solutions like expanded shipping and resin capacity. We're not waiting for those to occur. Our aim is to be best-in-class in navigating the current environment. We believe we have a clear path to accelerating margin recovery. We're proud of the progress we're making advancing our BD 2025 and ESG strategies. We have excellent momentum in our base business heading into fiscal 2022, a stronger balance sheet, and steadily increasing cash flows, despite inflationary pressures, all positioning us well for the future. With that, let me turn it over to Chris to review our financials and outlook. And again, Chris, welcome.
Chris DelOrefice:
Great. Thanks, Tom. Appreciate it. Before I jump in, let me first say I couldn't be more excited about joining BD. BD is a purpose-driven company that has both a deep and broad portfolio that includes leadership positions, many important areas in healthcare. Combined with our innovative pipeline of products and solutions, we have a tremendous opportunity to shape the delivery of healthcare and make a meaningful impact on healthcare outcomes around the world. I look forward to engaging with the investment community next week during our Investor Day, and sharing more specifics around our strategy and the actions we are taking to support our growth agenda and deliver long-term value. So with that, let's get into our results. Echoing Tom's comments, we delivered on our commitments in 2021, have strong momentum as we enter 2022, and we're well-positioned for the future. Slide 13 summarizes our high-level revenue performance. Fourth quarter revenues of $5.1 billion increased 7.3% on a reported basis, and 5.9% on an FX neutral basis. And we're ahead of our expectations. Our base business revenues increased 9.8% driven by strong performance across all three segments. In Q4, we saw continued improvement in overall healthcare utilization levels and routine testing and lab activity and higher acuity. The breadth and diversification of the total BD portfolio, including COVID diagnostic testing, provides insulation against COVID-driven procedure fluctuations. For the full fiscal year, our revenues grew 15.6% or 8.1%, excluding COVID testing, which demonstrates the strength of our business and the momentum of our strategy across our segments with base growth of 6.8% in the Medical segment, 8.4% in Life Sciences, and 10.7% in the Interventional segment. Base business growth was also strong regionally, particularly in the U.S., China and Latin America. Compared to fiscal 2019, base business revenues grew 4.5% or about 7% when adjusting for the Alaris ship hold. Turning to Slide 14, our Medical segment delivered $2.5 billion in revenues in the fourth quarter growing 7.7% led by our Medication Delivery Solutions and Pharmaceutical Systems businesses. MDS revenues increased 11.3% and reflects strong demand for our core products, driven by higher acuity, and increased utilization in the U.S. and Europe and competitive gains in catheters and vascular care devices. In MMS, Q4 revenues were comparable to the prior-year despite the high number of infusion pump placements in Europe last year to support hospital needs. We continue to see solid growth in our dispensing platform and a high number of committed contracts with Q4 being one of our strongest quarters to-date for committed contracts. Revenue growth of 5.4% in diabetes care benefited from the timing associated with certain sales and slightly better than expected market demand. On a normalized basis, we see diabetes growth about flat. Pharm systems growth of 12.3% reflects continued strong growth driven by demand for our prefilled devices and enabled by capacity expansion. Demand for prefilled devices is being aided by the fast-paced vial to prefilled device conversion for biologics, vaccines, and other injectable drugs. Turning to Slide 15, BD Life Sciences revenues totaled $1.5 billion in the fourth quarter increasing 1.5%. However excluding COVID testing, Life Sciences grew 15.8%. Performance reflects strong double-digit growth in our base business in both Integrated Diagnostics Solutions and Biosciences, partially offset by declining COVID testing revenues. In IDS, 16.2% growth in the base business was driven by specimen management and microbiology, lab utilization improved, and demand increased for both core products and products used during the care of COVID patients. We're also seeing strong growth in sales of BD MAX IVD assays, which were up about 20% year-over-year. IDS base revenues also included sales of our combination fluid COVID assays for both Veritor and BD MAX that began shipping in Q4. Early demand is robust, and we believe the combination test will become the standard of care for symptomatic testing across laboratory and point of care testing as we enter the flu season. Despite increased demand driven by the Delta variant, and shipping our highest quarterly volume of over 30 million tests, COVID testing revenues declined in Q4 from $452 million to $316 million due to lower pricing in the market. Biosciences revenues increased 14.6% driven by research solutions, as lab utilization is returning to normal levels. We continue to see solid demand for research reagents globally. Our recently launched e-commerce site is a new vehicle for growth and has been well received with strong traffic. Turning to Slide 16, BD Interventional revenues totaled nearly $1.1 billion in the fourth quarter growing 8.3%. As we previously communicated, we began to see an impact on the Delta variant on elective procedures in certain U.S. states in July and August. While we contemplated some continuation of that impact, it was slightly greater than anticipated in our surgery and Peripheral Intervention businesses as hospitals reduced access and restricted elective procedures. Our surgery business grew 16.8%, reflecting the year-over-year recovery in elective procedures, with double-digit growth in infection prevention and biosurgery and strength in hernia despite some impacts from the Delta variant. Growth in infection prevention also reflects continued market adoption of our sterile ChloraPrep product. Revenues in Peripheral Intervention increased 5.5%. We saw continued strong performance in atherectomy as we have leveraged the capabilities of RPI sales force and an oncology as more people completed cancer screenings. PI also continues to be impacted by a product recall which impacted growth by about 300 basis points. Urology and Critical Care revenues grew 3.8% driven by continued strong demand for PureWick, as well as continued adoption of the recently launched Arctic Sun with our Targeted Temperature Management platform. Partially offsetting this growth was a temporary supply disruption within acute urology that is now remedy. We expect shipments to be caught up within the first quarter of FY 2022. For the full fiscal year in 2021, UCC grew 7.6%. Turning to Slide 17, and our Q4 and full-year adjusted P&L. For the quarter we delivered adjusted net income and EPS above our expectations, with net income of $770 million and diluted EPS of $2.59. On a currency neutral basis, net income declined 7.8% primarily by lower COVID testing pricing and testing-related one-time costs and reinvestment in the business, as well as higher shipping costs due to inflation, and increased R&D levels. EPS declined slightly less, or 6.5% reflecting a lower share count due to share repurchases. Our full-year adjusted net income and EPS were $3.9 billion and $13.08 respectively, with growth of 31% and 28% driven by strong revenue growth and operating margin expansion of over 100 basis points on an FX neutral basis. We delivered Q4 and full-year operating margins in line with the expectations we previously communicated for the company and for the base business. Turning to Slide 18, cash flows from operations totaled $4.6 billion in fiscal 2021, an increase of over 30% versus fiscal 2020. This improvement in our cash flow has allowed us to advance our balanced capital allocation framework and support our BD 2025 growth strategy through investments in capital, R&D, and M&A. During fiscal 2021 we invested in capital expenditures to support high-growth opportunities, including the new manufacturing lines Tom previously mentioned. In addition to investing in R&D at over 6% of sales to advance our pipeline of innovative programs, we also invested $500 million in tucking M&A across our businesses that will support our strong growth profile in 2022 and beyond. Beyond our investments in growth, we returned capital to shareholders through $1 billion in dividends and $1.7 billion in share repurchases. We ended the fiscal year with $2.3 billion in cash, and an adjusted net leverage ratio of 2.6 times. Our current cash and leverage position gives us flexibility to create value through multiple levers. And I look forward to sharing more with you about our capital allocation strategy to our upcoming Investor Day. Now turning to our fiscal 2022 guidance on Slide 20. First the macro assumptions that support our guidance range. While we recognize there will continue to be some variability, we assume there will be continued easing of COVID-19 restrictions as vaccination rates continue to increase and not expect to see continued stabilization of procedures and are not assuming significant disruptions to procedure volumes. Additionally, while we do not expect conditions to return to normal levels, we do not anticipate worsening macro supply chain constraints or inflationary pressures. Finally, we have not assumed any impact of legislation changes that would impact the broader market. Given a significant sales and income generated from testing in fiscal 2021, we previously provided a preliminary guidance score that excluded testing to help you model our underlying base business performance, we will continue to provide our revenue guidance split between base and COVID only testing through this year, along with context regarding testing margins relative to our base business. So a few specific comments on testing assumptions. Our base business revenue assumptions include sales of our combination flu COVID assays at a level comparable to a normal flu season, which you should think of as $75 million to $100 million. For COVID only testing, which is in addition to our base business combo test revenues, we assume the demand would be significantly less in fiscal 2022. Given the variability in the COVID environment driven by uncertainty around the length and intensity of break to outbreaks, our current assumptions are largely based on confirmed orders. We are assuming about $200 million of COVID only testing revenue. If testing revenues were to be substantially higher, we first would compensate for any resulting procedure softness impacting our base revenue and income, which positions as well to manage through this period of uncertainty. Any further upside would be used to create value through either reinvestment or allowing incremental profits to flow through. Regarding Alaris, as Tom noted, we are confident in the progress we were making and the resources that we've invested behind this program. As we previously shared infusion pump clearances are inherently complex, particularly our filing and not so would not be prudent to predict timelines. Consistent with what we share previously, we do not expect and our guidance does not include a 510(k) clearance in fiscal 2022. Additionally, it is difficult to predict how things will play out as shipments are only being made under the medical necessity process. But at this time we've assumed that our Alaris Capital revenues will be generally in line with fiscal year of 2021. Let me now share some perspective on what is underlying our base guidance. We are well-positioned for strong growth across our three segments with a balanced and robust innovation pipeline resulting from investments in increased productivity in R&D. Growth will be further enabled by the strategic acquisitions we've added to our portfolio that are positioned in high-growth categories. While we aren't providing segment specific guidance relative to total company base growth, we do expect our Medical segment growth to be slightly below, Life Sciences growth to be inline, and Interventional to be slightly above total company base growth. In the Medical segment, we are continuing to extend our leadership position with competitive gains in significant categories such as peripheral catheters and prefilled devices, while investing in solutions transforming healthcare through smart connected care and new care settings. Life Sciences holds leadership positions in attractive and growing categories and is investing in higher-growth spaces by enabling smart, automated laboratory workflows with solutions such as BD COR. Improving chronic disease treatment with clinically differentiated assays, research tools, and companion diagnostics, where we expect continued above market growth in research reagents and migrating point of care diagnostics to alternative care settings. Interventional is continuing its strategy of evolving from product to category leadership in chronic disease treatment, while continuing to invest in accretive high-growth spaces. These investments include increased product offerings, both organic and inorganic, expanded labeling and investments in the non-acute care space. Our PureWay product line and acquisition of Straub Medical are good examples of how we are driving growth for our BDI strategy. Turning to Slide 21 and our guidance for fiscal 2022, we expect base revenues to grow 5% to 6% on an FX neutral basis, compared to $18.3 billion in fiscal 2021. For COVID only testing, we are assuming $200 million in revenue. Based on current spot rates for illustrative purposes, currency would be a headwind of approximately 50 basis points, or about $100 million to total company revenues. All-in base plus COVID only testing and the illustrative currency, we expect reported revenues in the range of $19.3 billion to $19.5 billion in fiscal 2022. We expect operating margins in our base business to improve approximately 200 basis points over fiscal 2021 base operating margin of 21.7%. Due to the current COVID test pricing levels, we expect operating margin on COVID only testing to be modestly above our base business margins. A few additional items for your models. We expect up to $50 million in improvement in interest/other giving debt refinancing activities we completed in the fourth quarter of fiscal 2021. As you're aware, interest/other can fluctuate due to deferred compensation which is offset in SSG&A. We plan for an increasing effective tax rate of 12.5% to 13.5% given discrete tax items in 2021 will not repeat. And in terms of share count, while priority remains tuck-in M&A, we expect share repurchases to also be a consistent part of value creation. In addition to the year-over-year benefit from share repurchases completed in fiscal 2021 where our ending shares outstanding were $288 million; our guidance assumes share repurchases that at minimum offset any dilution from share-based compensation. All-in, we expect adjusted EPS to be between $12.30 and $12.50, with EPS excluding COVID only testing being well above the $12 floor we provided in August, on our third quarter earnings call. Turning to Slide 22, regarding margins, let me first take a minute to reground everyone on where we are today. There are a few key considerations that have resulted in some margin pressure, some of which will be naturally restored, and others that will be addressed by existing margin improvement programs, with further improvements through new initiatives we are pursuing. Our total operating margin of 23.9% for the full-year did improve versus 2020. In 2021, our total margin profile benefited by over 200 basis points from the COVID-19 testing margin net of investments we made to accelerate growth and other value creating programs. So it's best to look at our base operating margins excluding COVID-19 testing of 21.7%, which also improved on an FX neutral basis versus 2020. However, they do lag pre-pandemic levels as our base operating margin was primarily impacted by four key factors
Nadia Goncalves:
Thanks, Chris. Ashley, we're now ready to open up for Q&A.
Operator:
Certainly, the floor is now open for your questions. [Operator Instructions]. We'll take our first question from Vijay Kumar with Evercore ISI. Please go ahead.
Vijay Kumar:
Hey guys, congrats on a good print this morning, and thanks for taking my question. And Chris, welcome to BD. I guess to start with on the fiscal 2022 guidance here. Maybe a little bit more clarity on what is being assumed for vaccine contribution. And I think you mentioned Alaris pump sales in line with fiscal 2021. Maybe clarify what those numbers are. And on the combo test, is that -- what sort of assumption should we have on ASP for the combo test because I was curious on your pricing comment for COVID in fiscal Q4?
Tom Polen:
Yes. Hey, Vijay, good morning. This is Tom. Thanks for the good questions here and make sure I address all of them. So Alaris, as we said, we expect that to be essentially flat to 2020. One thing about that as about $100 million contribution in 2022 and 2021. Put in perspective, that's, as Chris mentioned, that's about 2020 was closer to $300 million. So even in our -- as we think about the 8.1% growth this past year that absorbs about a point of Alaris coming down from the -- when we were getting very large numbers of additional medical necessity orders as people were adding to their fleets. So that's the assumption on Alaris. On vaccines, it's -- we still are towards the high-end of that $100 million to $150 million range that we'd expected for vaccination campaigns. And so we expect that's just kind of part of the MDS business. Now, I don't know if we were going to call that out as a guide in that growth, but we don't see it as a notable headwind in the growth rate of that business in 2022. We still have solid demand for those products. And as we said, we now have visibility to 2 billion units of syringes specifically for COVID vaccines, which we're obviously proud of being able to help deliver 2 billion COVID vaccines around the world. And I think we've shipped about 1.2 billion or 1.3 billion of those so far. So that gives a little bit of color, in terms of how much we left to ship in 2022. On the combo assay, great question. We've got Dave Hickey here, obviously, the President of our Life Sciences businesses. And so let me turn that question over to him.
Dave Hickey:
Thank you, Tom. Vijay, thanks for the question. So yes, just to reiterate on the combo. Just to reiterate what Chris has said, right. So if you think about what's come back into the base business for FY 2022, we do expect that as we get into the flu season, the respiratory season for both BD Veritor, and for BD MAX, that these combination tests will be the sort of the go-to test, particularly for people who might be symptomatic. And people who are sort of saying, do I have flu, or do I have COVID. So we do expect that to be the combo test. The installed bases are there to support that testing. And we've put into the range for next year, an estimate of around $75 million to $100 million back into the base business. From a pricing perspective, we do expect it to be a premium price, over the traditional tests as we've indicated; we're just not sharing specific pricing at this time.
Vijay Kumar:
Understood. And Tom I think I heard Chris mention the goal is exciting fiscal 2024 operating margins to be above pre-pandemic levels, fiscal 2019 operating margins were 25.3%, so when you say above pre-pandemic, is that the target in -- is exiting fiscal 2024 are you expecting to be above 25.3% or is that the annual goal fiscal 2024 overall margins to be above 25.3%. Maybe just give us some broad strokes on what's the exit there is that Alaris coming back and then base business execution or something else that's being done?
Tom Polen:
I'll turn that to Chris, good question. And I think that the exact term you use was above.
Chris DelOrefice:
Yes, that's right. Yes and thanks for the welcome as well, Vijay. Yes, just to clarify. So you're right, the pre-pandemic level was just over 25% fiscal year 2024 is our target to get above that level. We'll certainly share more next week in terms of specific initiatives. I think the way to think of it is we already had a lot of simplification efforts underway with Project Recode. Those can contribute about $300 million. That's one bucket. In addition to that, I articulated on the call even as it relates to actions we're taking and demonstrated at the end of 2021 and heading into 2022, we're increasing our initiatives, pricing, mix, portfolio optimization, and new initiatives on spend optimization as well. And then certainly, lastly, the Alaris ship hold that was an 80 basis point drag on the business going back to them. So while we're not being committed as it relates to timing, as you think through kind of the longer term timeframe, and that we will share next week, you would expect that to have a benefit over time. Thanks for the questions.
Operator:
We'll take our next question from Bob Hopkins with Bank of America. Please go ahead. Your line is open.
Bob Hopkins:
Well thank you and good morning, and thanks for taking the questions. And, Chris, welcome. My one -- really only have one question or one topic I wanted to cover. And, Chris, this is probably for you because it seems like a key part of this call is your assumptions on the improvement in base business operating margins from 2021 to 2022. So, a couple of things, I'd love you to comment on Chris if okay. One is I'm struggling a little bit with how to think about the starting point because Q4 base business operating margins are obviously a lot lower than full-year 2021. So maybe help me understand what's the right starting point. And then, secondly, I'd love you to talk a little bit about, how much of that 200 basis point improvement in base business you're assuming for the full-year is gross margin and just what are your assumptions on pricing embedded in that? So there's a lot in there. That's my one question. But I would love you address those things and thank you very much.
Chris DelOrefice:
Yes, thanks, Bob. I appreciate the question. Great question. So look I think going forward, we're going to continue to provide transparency as it relates to kind of the base performance of the business. I understand your question as it relates to kind of jump off points as it relates to quarter keep in mind, there were a lot of quarterly fluctuations as we navigated 2020 through COVID and 2021 with inflationary dynamics. I think it's simplest to kind of normalize and just look at things on a full-year basis. So as you think of our operating margins from 2021 of 21.7%, on the base business, there's really a few key drivers. One is we've talked about through this about having our utilization levels impacted due to pandemic, our strong growth profile through 2021 and 2022, we now anticipate being well above in driving almost 100 basis points of utilization upside 2021 to 2022 full-year to full-year. In addition to that last year, we had the impact of currency. There was a headwind on earnings, they got trapped in inventory, and as that bleeds through, we actually have about a 50 basis point improvement heading from 2021 to 2022, that goes through to operating margin. Lastly, where we're investing a lot of our time, of course is navigating the inflationary dynamics. And we talked about the net 50 basis point improvement in terms of outsized inflation, which we would anticipate being north of 200 basis points in full-year 2022 offsetting that will be a series of initiatives. There's not one thing it's actually a very well balanced plan. We have talked about on the call; we're continuing to drive cost improvement in our plans. We're taking enact actions on the procurement side of the business as well in terms of spend. We're looking at things from an SSG&A standpoint as well and leveraging that. And then, yes, there is going to be a strong focus on pricing portfolio mix, driving growth through higher GP areas. And the net of all of those we actually expect a 50 basis point improvement. Maybe lastly, just to give you some color on kind of where we are, because I think this is important. We've entered the year with specific action plans against those goals. So we have risk adjusted plans, very detailed targeted actions to deliver the improvement we need to mitigate against deflation. If you go a step further and look where we are from kind of an execution standpoint, 80% to 90% of those have been fully identified and the plans are moving, and some of them are just more timing dynamics in terms of when we may take price or when we'll evolve our portfolio. And of that number, almost half of that is actually already banked coming into year flowing through our inventory and P&L. Now that's quite a testament to the work that we did in the back half of 2021 and already have strong progress. So we look forward to sharing more as the year progresses, but we feel good about the plan and the progress that we'll achieve through the year.
Operator:
Well take our next question from Robbie Marcus with J.P. Morgan. Please go ahead. Your line is open.
Robbie Marcus:
Great. Nice quarter and thanks for taking the questions. Appreciate it. Maybe just on the diabetes spin you talked about higher than company margins. Is there any color you could add to how much, and will we have the Form-10 by the Analyst Day next week?
Tom Polen:
Go ahead, if you can.
Chris DelOrefice:
Hey, Robbie. How are you doing? It's Chris. Yes, as we said, the Form-10 will be later this year. That will -- we don't anticipate that being out by next week. Look, it's a good question. It's premature to share. We have to wait until the Form 10 is out, there will be much more detail there. But I really think the more important dynamic here is, right, this is actually just a portfolio transaction, and there is going to be sort of a reset of margin. And by definition, we had shared that, it is accretive, there will be a reset of margin, but more importantly, it's been diluted to both growth and margin growth, top-line growth and margin growth. So it could be an acceleration from that. And as we get into Investor Day, we can certainly share more as it relates to kind of the longer term impact as it relates to margin. And what I just shared in terms of our longer term margin improvement goals. We still feel really good about where we're going to position margin over time, and all these efforts going against that. And lastly, I think just the value creation opportunity this creates, I talked about the cash infusion of multiple years we get that gives us additional flexibility to think through how to reinvest and utilize those -- that cash infusion we can talk more about that as well over time.
Robbie Marcus:
Great. Appreciate it. And then maybe just one other, you talked about doing seven acquisitions this year, $500 million total. How do we think about the contribution of those to revenues in 2021 and 2022? And where do you put M&A in terms of capital allocation priority? How do you view the market right now in terms of asset availability and valuations? It'd be great to get your take on that? Thanks.
Tom Polen:
Yes. Robbie. This is Tom and good morning. So we'll try not to share too much of the thunder from next week, but it's good question. And we'll get more into this, but we've spent about $500 million this year. If you look at the acquisitions that we made last year, think about over the last 20 months or so we've invested about $900 million, that drives about $100 million this year and $200 million next year roughly from those tuck-in M&As. So if you do the math, that's about a little under a five times what we're paying in terms of revenue that we're getting from those acquisitions next year. And as you know, that's good value that we're getting, and we're obviously performing above our cost of capital on those acquisitions. We're clearly at those levels of multiples that were being able to get those assets for, we're not buying growth, we're absolutely growing what we buy leveraging our channels, our global position, our manufacturing capabilities, et cetera to scale these assets in ways that we're uniquely positioned to do so. We'll also share with you next week, the mix of how those breakout into the amount of spend and acquisitions that are going towards kind of that durable core base portfolio that we have versus those more transformative solution areas that I've talked about. Those three categories that we discussed and you'll see the weighting of those. They're highly weighted in high growth markets. That revenue that I described is growing north of double-digits as we go-forward. We continue to see opportunities. As we look ahead, we have a robust funnel. You can expect us to continue to drive that strategy forward. Obviously, it's been important part of why we focus so heavily on cash flow. Actually, if you look at our cash flow over the last two years since 2019, it's grown at 18% CAGR. That's not by accident, we've had very focused programs driving that that's something we're very proud of. And it positions us, as Chris mentioned, to drive a balanced strategy between tuck-in M&A strategy to drive our growth, as well as continue to return value to shareholders, as you've seen us doing so. Thanks for the question, Robbie and looking forward to more discussion next week.
Robbie Marcus:
Great. Maybe just to clarify is there any revenues associated with the deals we should be thinking about in the model for next year?
Tom Polen:
It's obviously built into our guidance. Chris, any other comments in there?
Chris DelOrefice:
No, I think Tom shared the directional right. These were about $100 million in the current year 2021. And we've talked about essentially doubling that. So on an incremental basis, you can think of about another $100 million. So it's a contributor to growth of 30 to 40 bps gives us a lot of confidence in our growth profile, and then the capacity to do more of that over time. We'll certainly talk more about next year.
Operator:
And we'll take our next question from Matthew Mishan with KeyBanc. Please go ahead. Your line is open.
Matthew Mishan:
Hey, good morning guys and thank you for taking the questions. First, how should we be thinking about the return on the $200 million of investments you guys made from the bolus of COVID testing? And when you'd expect to see some of those happening. And then just were those really one-time costs or successful programs, maybe just folding into more traditional M&A at this point?
Chris DelOrefice:
In the context, it's more traditional R&D at this point, sorry.
Tom Polen:
Yes, Matthew, this is Tom, good morning. The -- good question. We are not that that spend is done, right. So we're not that's not recurring spend, as we've always communicated that got cutoff last year in Q4. So that is out of our P&L going forward. And we'll share more details actually about exactly where that money was spent. And you'll see throughout the discussions next week at our Investor Day, each of the different businesses highlighting the programs that they've invested in and you'll see how that help to accelerate our growth outlook as we go-forward over the long-term. It is mixed across both innovation as well as accelerating our simplification strategy as well, and we'll share more details on that next week. But there it is balanced across both of those categories. And when we say the growth agenda, how it's balanced on that side, it is majority of the growth money that we're spending is in R&D, but there is money that we spend on expanding channels, so specifically telesales in Europe, non-acute sales channels in the U.S., and you'll hear more about those specific investments from our leaders in the U.S. region and from our European leaders next week as well. And we're excited to be able to share that. I know there's been a -- we've been busy over this last year. We're really proud of the progress that we've made on our strategy. And we're really looking forward to having our leaders share with you those details of that progress next week. Thanks for the question.
Matthew Mishan:
And --
Chris DelOrefice:
Yes, go ahead.
Matthew Mishan:
And just on the Pharma Systems business. I think you've announced some, I know that's been a very successful business for you. I think you've announced some capacity additions. I'm wondering when do those capacity additions actually benefit that that area.
Tom Polen:
Yes, obviously, it's a great business already. I think we're three or four years of consecutive acceleration in that business. We have Alberto Mas on the line. Maybe Alberto, if you could just comment on when do we start seeing some of that that capacity benefit to business and where that stands.
Alberto Mas:
Yes, hello. Good morning. We're going to see it along the way. So it's not lumpy. It's we're just -- we're just -- what we're going to see in capacity in 2022. In this business, you need about two to three years of advanced planning on these things. So we're going to see it along the way it's not going to be lumpy. So you're going to see that in the next three to four years.
Tom Polen:
Great start. Is it fair to say, Alberto, there is a little bit of a benefit of summing that -- some of that business continues to come online. The early phase does come online in the back half of next year?
Alberto Mas:
Or throughout next year that's what I'm trying to say it's think of this as a smooth over the next three or four years. It's going to be coming online quarter-by-quarter.
Matthew Mishan:
Not -- not one?
Tom Polen:
Yes. And Matt --
Matthew Mishan:
Yes.
Tom Polen:
We see that helping to continue to fuel what is that high single-digit, double-digit growth profile of that business.
Matthew Mishan:
Perfect. That is the reference I was looking for. Thank you.
Operator:
We will take our next questions from Larry Biegelsen with Wells Fargo. Please go ahead.
Larry Biegelsen:
Good morning. Thanks for taking the question. Welcome, Chris. So one question for Chris, one question for Tom, I'll ask them both now. Chris, maybe I'll ask Bob's question a different way. Can you talk a little bit about the margin in EPS cadence in fiscal 2022, how much below the operating -- the base operating margin of about 23.7%, you expect Q1 to be is 100 basis points, the right way to think about it. And consensus is I think 2.84 for EPS right now. I'd love to get your reaction to that, just to calibrate it correctly to start the year. And, Tom you guys are doing really well in China. There are a lot of investor concerns about multinational companies' ability to continue to grow there, given the value-based purchasing and the recent document 551. How are you feeling about your ability to continue to grow strongly in China and any reaction to some of those initiatives? Thanks for taking the questions guys.
Tom Polen:
Start with Chris.
Chris DelOrefice:
Yes, thanks, Larry. Appreciate the question. Yes, I'll try to amplify some of the color that I provided earlier. So as we think of the year as the year progresses, first from the top-line, just to reiterate, we do actually expect relatively normalized growth with the exception of Q2 like I had shared because of the comparables. And then there's the dynamic of COVID only testing, which you'd expect to be more first half. So I would consider that that dynamic. From a margin standpoint, certainly first half, we anticipate to be lower. This is simply a matter of the inflationary dynamics that started in 2021, rolling through inventory. And the peak of when that rolls through and those costs actually hit is more like Q2. So kind of first half definitely less favorable margins versus the second half and Q2 in particular being kind of the high mark of that low, so to speak. And then obviously as the initiatives that we've already taken again, there's a lot of that banks, right, if you recall had shared about 50% of its already happening. But again, you get the dynamic of it flowing through inventory, so you end up with kind of the second half dynamic in the margin improvement throughout the back half. So the last item was just more of a discretionary tax item, I alluded to that could actually end up with some favorability in Q1, but those are very difficult to predict. So hopefully, that helps some.
Tom Polen:
And Larry, this is Tom, thanks for the question and good morning. Great to connect. For China, you're going to hear from James Deng, our President of China actually next week. And so I know he's looking forward to sharing the progress there. As you said, we had a very good year in China this year. And we think we're kind of back to a strong growth rate looking forward, 551 for us, we don't see specific impact in our categories. It's something that we've spent a lot of time talking about. Obviously, we have four plants in China; they're focused almost exclusively in China, for China, and particularly focused in some of the categories that there is more local competition in like catheters, vacutainer tubes, pen needles, et cetera. But we make those businesses, those products, mostly in China, for China as well, so we can compete as a local organization in those. The other thing is we have a record number of new product launches coming out in China over the next three years. You'll hear from Simon and team in China, we're really pleased that we ended 2021 having doubled the size of the bar business in China since acquisition, that was a big focus of ours on revenue synergies. And there continues to be the impact of those registrations that we've been making over the last several years. The impact of those will be continuing to rollout with new launches as we look forward. I know again, Simon will talk next week, maybe share a couple of comments now on some of the launches that you're having in China that are occurring. So we feel good about the outlook for China. We're -- as all we're watching the situation very cautiously being prudent in our investments there. But we've got a great team, we saw strong performance this year and we do have a strong outlook in China for the next year as well.
Chris DelOrefice:
Yes. Thanks, Tom. So just some color, over the next three years, the Interventional segment expect to commercialize further 22 to 25 new products in China. And just an example of how we've been successful there in addition to what Tom said about doubling our business, but we recently just got approval or clearance for our Targeted Temperature Management technology in China. And we've actually just got our first two purchase orders this month from that, at margins that are creative to BDI, to BDX, and the sustained, and I would say prolific growth of our business in China. We expect to continue over the next period of time.
Tom Polen:
Thanks, Chris.
Operator:
And we'll take our next question from Josh Jennings with Cowen. Please go ahead. Your line is open.
Josh Jennings:
Hi, good morning. Thanks for taking the questions. Just have one, sorry to keep focusing on the margin progression here, but wanted to better understand the impact in fiscal 2021. And then how to think about the impact in fiscal 2022 of China value-based pricing. I felt like that was a bucket that was called out on the third quarter call as a big headwind for margin and this year. I just wanted to understand better the impact this year and whether that with all the positive momentum you're experiencing, whether that turns into a margin tailwind in fiscal 2022. Thanks for taking the question.
Tom Polen:
Hey, Josh, maybe you just let me comment on value-based procurement. I'll turn it over to Chris for other items. We saw the bigger impact of VBP kind of is behind us. There is still some impact going forward, but like the business and the market is China is challenged with restructuring their cost base to manage through any of that. And so and that's exactly what they've been doing is restructuring cost base, as we think about that going forward to offset those headwind. So maybe Chris any other comments?
Chris DelOrefice:
Yes, no, Josh, I would just add that yes, it was an impact that was previously discussed. It was smaller relative to the main drivers that I framed as it relates to the progression from 2019 to 2021. And we always are doing continuous cost improvement initiatives that offset some of these things that happen. As Tom noted, China is well-positioned and we're thinking of that market more holistically. There is strong double-digit growth in 2021, actually at over 20%. And so when you think of it from a total portfolio standpoint, we feel real -- nicely positioned as it relates to both a growth profile, and then have nice actually margin enhancement as a result of that as we go-forward. So thanks Josh.
Operator:
Your final question will come from Matthew Taylor with UBS. Please go ahead. Your line is open.
Tom Polen:
Hi, Matt. Good morning.
Matthew Taylor:
Hey, good morning, Tom. How you doing?
Tom Polen:
Good.
Matthew Taylor:
Good, good. And Chris, welcome. Congrats on your new role at BD. So just wanted to ask two questions that are kind of related. Just conceptually when you gave us the update in the $12 floor a few months ago, could you just talk about, what's changed to give you the confidence to now put out the guidance in the mid-$12 range, and how things have developed here over the last couple of months?
Tom Polen:
Okay, sure. I'll turn that to Chris.
Chris DelOrefice:
Yes, thanks -- thanks Matt. Appreciate the question. Look, I think, it really starts with our focus on growth. I think a strong base growth profile that we guided on, coupled with if you look at the cash flow that we shared through 2021, that gives us a lot of flexibility on tuck-in M&A, right. So we have strong organic growth profile, the enhancement we're making to our R&D portfolio. And then that coupled with the tuck-in M&A capability that we will now be able to have on an ongoing basis. Tom earlier talked about the acceleration of deals that we've done recently, those alone can contribute about 40 basis points to growth. So one, I think, there is just a very strong growth profile there. Two, is just the disciplined focus on margin improvement. We knew that was something to focus on in addition to the cash management approach we've taken over time, that's enhanced growth. And so those are the two main drivers. As a matter of fact, we're actually cycling over a headwind on tax. That's been offset by some of the capital deployment we've been able to put at work with share repurchases. So you'll see us be more disciplined there with other value creating levers too due to the strong cash flow that we have.
Tom Polen:
Maybe also we're finishing the year full stronger, right than what we thought at the time. So we're -- we had a really strong Q4. We're seeing that that strong demand in our base business. So we're going in. The beat that we're seeing here is a combination of not only stronger COVID diagnostics, but stronger performance in our base business as we wrap up the year. So I think that's an important point to -- a contributor to that as well.
Chris DelOrefice:
Okay. Thanks, Matt.
Matthew Taylor:
Okay. Thanks for that confidence answer.
Tom Polen:
Okay. Well, operator, if there's no more --
Operator:
Well at this time --
Tom Polen:
I'm sorry, go ahead.
Operator:
Sir, I apologize. I just was going to turn the floor back over to Tom Polen for any closing remarks.
Tom Polen:
I just thanks everyone for the good discussion today. We obviously are really looking forward to discussing all the great work that the team has been doing here over the last 20 plus months as we've been advancing our BD 2025 strategy. I personally I'm really excited to -- for next week's event. We're going to be able to share with you where we've been investing, how we've been refining, and making significant changes in our portfolio to optimize growth and margins. And you'll hear from a wide range of leaders on how they're executing and bringing to life our 2025 strategy to create value for our customers and shareholders next week. So everyone stay well, and we'll look forward to continue great dialogue next week. Thank you.
Operator:
Thank you. And that does conclude today's teleconference. Please disconnect your lines at this time. And have a wonderful day.
Operator:
Hello, and welcome to BD's Third Fiscal Quarter 2021 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 12, 2021 on the Investors' page of bd.com website, or by phone at 855-859-2056 for domestic calls and (404)537-3406 for international calls using the conformation number 9447085. I would like to inform all parties that your lines have been placed in a listen-only mode until the question and answer segment. Beginning today's call is Ms. Kristen Stewart, Senior Vice President of Strategy and Investor Relations. Ms. Stewart, you may begin.
Kristen Stewart:
Hi. Good morning, everybody. And thank you for joining us. This call is being made available via webcast at bd.com. This morning, BD released its results for the third quarter of Fiscal 2021. You can find the press release along with the accompanying presentation on the Investor Relations website at investors.bd.com. Leading this morning's call is Tom Polen, BD's Chairman, Chief Executive Officer, and President, as well as Chris Reidy, Executive Vice President, Chief Financial Officer, and Chief Administrative Officer. Following the prepared remarks, Tom and Chris will be joining. For Q&A by our 3 segment presidents. Alberto Mas, President of the Medical Segment, Simon Campion, President of interventional segments. and Dave Hickey, President of the Life Sciences segment. During the call, we will be making forward-looking statements, and it is possible actual results could differ from our expectations. Risks, uncertainties, and other factors that could cause such differences can be found in our earnings release and in our SEC filings, including our 2020 Form 10 and subsequent form 10-Q. We will also discuss non-GAAP financial measures regarding our performance. Reconciliations to GAAP measures that include the details of purchase accounting, and other adjustments, can be found in our earnings release and its related financial schedules. They are also in the appendix of the Investor Relations presentation slides available on the BD.com website. Unless otherwise specified, all comparisons will be on a year-over-year basis versus the relevant period. Revenue present changes are on an FX-neutral basis, unless otherwise noted. When we refer to the base revenues, we're referring to our total revenues less our COVID diagnostic testing revenues, which include COVID-related revenues from Veritor, BD MAX, and Swabs. When we refer to base margins, we are adjusting for estimated COVID diagnostic testing profitability and the related profit we have reinvested back into our business. When we refer to any given peer group referring to the fiscal period, unless we note it as a calendar period. Finally, when we referred to NewCo during today's call we're referring to the planned spin out of our Diabetes Care business into an independently public traded Company following the effective trade date of the spin, which [Indiscernibl4e] announced on the second-quarter earnings call. RemainCo refers to BD post-separation. As a reminder, this transaction is subject to market regulatory, and other conditions, including final approval by BD's Board of Directors and the effectiveness of the Form 10 registration statement that will be filed with the SEC. With that, I'm very pleased to turn it over to Tom. Tom?
Tom Polen:
Thank you, Kristen. Good morning, everyone, and thank you for joining us. On today's call, I will provide highlights of the quarter and discuss the continued strong progress we have made on our BD 2025 strategy. I'll then turn it over to Chris for the financial review and outlook. After our prepared remarks, Chris and I will then open the call up for Q&A. But first, I want to comment on the other announcement we made this morning regarding Chris' intention to retire from BD, and join the Board of our Diabetes spin-off. On behalf of the Board of Directors, the leadership team, and the Company, I want to express my gratitude to Chris for his leadership and service to BD. I'm confident the CFO transition ahead will be seamless, and his leadership and experience will make him an excellent Director for NewCo's board. Now let's jump into our results. We were very pleased with our third-quarter performance, powered by strong growth and momentum in our base business across all three segments. Revenues totaled $4.9 billion and our adjusted EPS was $2.74, both ahead of our expectations. Total revenues were up 26.9% on a reported basis, and up 22% on a currency-neutral basis. Results included COVID diagnostic testing revenues of $300 million, which contributed 4.8% to growth. Excluding COVID testing revenues, our base business revenues were up 17.6%, better than we expected across most business units. The strong growth reflected the anniversary of the initial COVID wave and the temporary halting of elective procedures and its impact on the medical device utilization in the year-ago quarter. But Q3's result also reflects the continuing momentum driven by the successful execution of our BD 2025 strategy. Excluding COVID diagnostic revenues, base business revenues in Q3 Fiscal '21, increased 3.9% relative to our pre-pandemic third quarter Fiscal 2019 on a currency-neutral basis, which includes the impact of the Alaris ship hold. If you exclude the U.S. infusion systems’ business, our total revenues would have increased 6.6% relative to our pre-pandemic third-quarter fiscal 2019. Our Pharmaceutical Systems and Urology/Critical Care franchises continue to be standout performers, where revenues are up 17% and 11%, respectively over 2019 levels. Bioscience revenues were up 9%, surgery and peripheral intervention revenues were both up 8%. Elsewhere, we see opportunities for improvement ahead in fiscal '22 and beyond. For example, our MDS revenues are up about 2% versus 2019 levels, reflecting the continued impact of COVID as well as the impact of China volume-based purchasing. As hospital utilization improves, we should see further improvements here. Also, as I mentioned, Medication Management Solutions revenues were impacted by the Alaris ship-hold, and we expect our revenues to improve once we receive our 510(k) clearance for our BD Alaris system. While I am pleased with how we are accelerating our revenue performance and profile, I'm equally pleased with the process we're making in improving our working capital and cash-flows. Cash flow performance has been a key focus for us since I became CEO, and that is evident in our working capital metrics. Year-to-date cash flows from operations totaled $3.7 billion, an increase of 80% from the prior-year period. This improvement in our cash flows allowed us to advance a more balanced capital allocation strategy this quarter, which included the repurchase of $1 billion in BD stock at an average price of approximately $242. This marks the first time we have repurchased shares since 2017, and the largest amount we have repurchased since 2012. Even with this repurchase activity, we ended the third quarter with nearly $3.2 billion in cash and an adjusted net leverage ratio of 2.4 times. Overall, I'm really pleased with our performance in the quarter, particularly with the continued positive momentum in our base business. This gives us the confidence to raise our base revenue assumption. We now expect our base business to grow approximately 7.5% to 8% on an FX-neutral basis. This is higher than our previous expectation of mid-single-digit growth. We continue to expect COVID diagnostic testing revenues of 1.8 billion to 1.9 billion, with more revenues coming from international markets than we previously anticipated. We now expect currency-neutral revenue growth overall of approximately 14%. Our positive base business momentum and a lower tax rate allows us to raise our adjusted EPS guidance by $0.10 while continuing to reinvest in our business and overcome lower COVID testing profits, including a provision for excess and obsolete COVID testing inventory. We now expect our full-year adjusted EPS range to be $12.85 to $12.95. Chris will provide you further details on our financial outlook later in the call. Next, I want to provide an update on our BD Alaris pump remediation, which remains my number one priority. Last week, we announced to our customers a positive step in our remediation efforts. Working with the FDA, we are now initiating remediation of existing Alaris system devices in the field by updating the software to version 12.1.2, following submission of the 510(k), which includes this software version. This new software version is intended to remediate the issues identified in the February 4, 2020 recall notice, and provide programming, operational, and cybersecurity updates to affected devices. However, this software update has not been reviewed or cleared by the FDA. To address the question on Alaris clearance timing, we remain confident in our submission and the process we are undertaking, including working closely with the FDA. As Chris will later discuss, we believe it is responsible to not definitively predict the FDA clearance in our FY '22 outlook. We believe this is a prudent approach given the inherent difficulty in predicting FDA clearance timelines. Next, I want to update you on our BD 2025 strategy of grow, simplify, and empower. First, I'd like to focus on our growth pillar. We continue to strengthen our market leadership positions in our durable core business, while purposefully investing in new innovations that help accelerate and shape irreversible trends that we see transforming global health now and in the decade ahead. I've spoken about these three innovations and growth focuses before, and we've been purposely shifting more of our R&D and tuck-in M&A investments into these spaces, which are growing over 6%. Through this, we aim to lift our weighted average market growth rate and performance over time. And this year, we've launched several innovative products and solutions across the continuum of care, across our business units, and across the globe. And after completing our strategic portfolio review last month, I can share with you that our pipeline is very deep and wide across our businesses. It's been further enhanced by our acquisitions over the past 18 months. And you'll hear much more about our innovation pipeline at our Investor Day on November 12. But let me highlight a few of our organic innovations that we're advancing in the near term. In our Life Sciences business, I'm pleased that we will start shipping our BD MAX and BD Veritor combination flu COVID assays this month, in time for the upcoming respiratory season. Our BD Veritor combination test can detect and distinguish between COVID, flu A, and flu B in a single rapid test with a digital readout. We see the combination test becoming the standard of care moving forward, in advancing our strategy to enable better outcomes in non-acute settings. Another innovation area I'd like to highlight is our Biosciences business. Biosciences has been a strong performer this year, and we expect the unit to deliver high-single-digit growth for the full year. In June, we launched our new eCommerce site, bdbiosciences.com, which is an entirely new and innovative digital marketplace designed to provide a best-in-class online purchasing experience for our flow cytometry customers. Early feedback has been outstanding, and we're already seeing excellent traction and early adoption. We also have an exciting wave of new product introductions this summer. With the launch of our FACSymphony A5 SE, which is our first BD spectral analyzer and provides an even higher cellular parameter analysis. We've launched our FACSymphony A1 as well, which offers high-end technology and a cost-effective benchtop design. In addition to these launches, we have a healthy innovation pipeline of modular, scalable new instruments, and next-generation dies (ph) that will allow our customers to fully leverage our complete and integrated solution suite of instruments, reagents, informatics, single-cell multi-omics, and scientific support services. Our products and solutions are being used to uncover new insights on the immune system and develop treatments for many related chronic diseases. You can hear more about our Life Sciences strategy from Dave Hickey, our Executive Vice President of BD Life Sciences, and Puneet Sarin, our Worldwide President of BD Biosciences at the upcoming UBS Genomics 2.0 and Medtech Innovation Summit. On Wednesday, August 11th. Next, let's turn to our inorganic innovations that we've added to our portfolio. As you know, we continue to be focused on tuck-in M&A as a means of adding innovative products and solutions that leverage our core market leadership position and advance us into higher growth adjacencies. Year-to-date, We've completed 7 tuck-in acquisitions, while at the same -- at the time of the acquisitions, these individual deals, were not meaningful from a revenue perspective. As we integrate these transactions into our portfolio, we expect them to strengthen our growth profile. Our 3 most recent transactions, Velano Vascular, Tepha Inc., and ZebraSci are good examples of our M&A strategy. Let me begin with Velano Vascular, which is being added to our MDS business. Velano has an innovative needle-free technology that enables high-quality blood draws from existing peripheral IV catheter lines, eliminating the need for multiple needle sticks. This technology will help customers transform the patient experience through the vision of a 1-stick hospital stay. Velano's PIVO device will be integrated into our sales teams bag of broader catheter solutions initially in the U.S. This is a great example of how we're expanding and strengthening our base business. The second transaction is Tepha Inc., a leading manufacturer of a proprietary resorbable biopolymer technology. Over the past several years through our long-standing relationship, we've been commercializing this platform VR Phasix Resorbable Hernia mesh platform. The acquisition benefits are two-fold. First, it provides us with a vertical integration strategy for our current Phasix platform. But more importantly, it provides us with exciting new opportunities to expand our horizon into new high-growth areas of tissue repair, reconstruction, and regeneration. Lastly, we acquired ZebraSci, a pharmaceutical services Company. This acquisition provides the opportunity to expand our Pharmaceutical Systems business beyond injectable device design and manufacturing to include best-in-class testing for drug-device combination products. ZebraSci allows us to further engage and collaborate with biopharmaceutical companies, and particularly smaller companies, where a large amount of the pipeline is, to support the transition of their molecules into pre-filled combination devices. Next, I want to update you on our simplify initiatives, which are advancing well. Through Project Recode we are optimizing our portfolio, optimizing our plant network, and simplifying our business processes. Project Recode remains on track to achieve 300 million of cumulative savings by the end of FY '24. We are also continuing the rollout of our BD Production System, which is a standardized BD approach to driving a next level of lean processes and continuous improvements across our plants. The BD Production System is already helping to drive improvements in quality and reductions in our inventory days. We also continue to advance Inspire Quality, our quality, regulatory, and risk mitigation program. The last pillar of our BD 2025 strategy is empower, which represents the changes in our culture and capabilities that we're driving to empower our strategy. In Q3, we completed our Voice of Associates survey with over 86% participation. And what stood out was that our associates said we're making strong progress, with improvements in 95% of the metrics since our last survey in 2018. And most notable were improvements in our focus areas of growth mindset, strong teams, quality, and excitement about the future of BD. We're also advancing our 2030 sustainability strategy, which addresses a range of challenges in our industry while helping to make a difference on relevant issues that affect society and the planet. Our strategy will ensure we remain focused on shared value creation. Meaning, how we address unmet societal needs through business models and initiatives that also contribute to the commercial success of BD. Next, I want to provide a brief update on the progress of our proposed diabetes spinoff, which remains on track for the first half of calendar 2022. We're making steady progress with our separation activities. We recently announced that 2 directors from BD's board will be appointed as future directors of the Diabetes NewCo. Retired Lieutenant General David Melcher will serve as a Non-Executive Chairman of the Board. And Dr. Claire Pomeroy will serve as a Director. Their appointments will be effective upon the completion of the spin, at which point they will transition from the BD board to the board of NewCo. Lieutenant General Melcher brings extensive experience in spinoffs, having served as the CEO of Exelixis, following its spinoff from ITT, and under his leadership, Exelixis spun off its Mission Systems business as a separate public Company. Dr. Pomeroy brings broad experience in healthcare delivery, administration, medical research, and public health. I am confident their combined experience along with future planned board members will help to set NewCo well on its path to becoming a successful, independent, publicly-traded Company focused on growth. While continuing to evaluate additional board members, we are also continuing to build a new Diabetes Care leadership team through a combination of current BD leaders and new hires. Including Dev Kurdikar, who will be NewCo CEO, Jake AlgaWise (ph), who will be CFO, and most recently, Jeff Mann. Jeff Mann joined our Diabetes Care organization and will be General Counsel and Head of Corporate Development for NewCo. Jeff brings more than 2 decades of experience in M&A and transactions, securities law, and corporate governance. Most recently, he served as general counsel and secretary of Cantel Medical Group. We are also progressing with the Form 10, which will have the carve-out financials. And we expect it to be publicly available around the end of the calendar year. Before turning it over to Chris, I will leave you with some key thoughts. First, our base business momentum and our recovery from COVID continues. And it is broad-based. We expect that momentum to carry into fiscal '22 and beyond. As Chris will share with you, today's results underscore our confidence in strong mid-single-digit top-line growth for our base business next year. Second, we are executing well against our innovation-driven growth strategy, which includes our internal R&D, as well as advancing our tuck-in M&A strategy. And third, I'm proud of the substantial progress in advancing our BD 2025 strategy and how that will unleash our growth potential in the years to come. We will deliver innovations for our customers, and power our associates, and create value for you, our shareholders. I've been with BD for 20 years, and I've never been more excited. We just completed our annual strategic review process, as I said, and the road ahead is looking more exciting than it did a year ago. We look forward to sharing our BD 2025 strategy in greater detail at our November 12th Investor Day. We hope you can join us. With that, let me turn it over to Chris, to review our financials and our outlook.
Chris Reidy:
Thanks, Tom. I'm also very pleased with our overall performance in the quarter, particularly with the base business, which showed continued strong momentum. Third-quarter revenues of $4.9 billion increased 26.9% on a reported basis and 22% on a currency-neutral basis, and we're ahead of our expectations. Our current quarter results also include 300 million in COVID diagnostic testing revenues compared to 98 million in the prior-year period. Excluding COVID diagnostic revenues in both periods our base business revenues increased 17.6%. Our base business reflects continued strong performance as the market continues to recover from the COVID pandemic, the impact from which was most acute in Q3 of last year. The BD Medical segment revenues totaled 2.4 billion and were up 7.7% versus the prior year. MDS revenues increased 24%, reflecting a strong recovery in the U.S., led by strong growth in catheters and vascular care devices. Additionally, worldwide revenues included 18 million from COVID vaccination devices. In MMS, the double-digit increase in our dispensing revenues was more than offset by the expected declines in our Infusion Solutions. As you may recall, when the pandemic started, we saw a higher level of demand for infusion pumps and sets globally. Diabetes Care benefited from an easy comparison to the prior year, the timing of sales, and slightly better than expected market demand. Pharm Systems continued to deliver strong growth with revenues up 12% driven by demand for our prefilled devices. BD Life Sciences revenues totaled $1.4 billion and were up 43%. This included the 300 million in COVID diagnostic testing revenues, 212 related to our BD Veritor system, with the remaining 88 million from BD MAX collection, transport, and swabs. Year-to-date COVID diagnostic testing revenues were over 1.6 billion. Despite lower average selling prices driven in part by geographic mix, we are still on track to deliver on our target of total worldwide revenues of 1.8 billion to 1.9 billion for the fiscal year. Excluding COVID diagnostic testing revenues, our Life Sciences segment grew revenues 27% driven by strong performances in both Integrated Diagnostic Solutions and Biosciences. IDS revenues increased 49%. Excluding COVID diagnostic testing, IDS revenues increased 27%, driven by strong double-digit performance across Specimen Management and Microbiology. Biosciences increased 27% driven by both research and clinical solutions. We continue to see strong demand for research reagents and instruments as lab activity is returning to normal levels. We also continue to see steady demand for research re-agents globally, fueled by COVID research activities related to vaccines and variants, especially from academic research and biopharma companies. BD Interventional sales totaled nearly 1.1 billion and were up nearly 35% reflecting the COVID anniversary impact on elective procedures. Surgery revenues increased 68% and peripheral intervention increased 32%. Both businesses saw the greatest recovery in the U.S. and Western Europe, which experienced the greatest impact on elective procedure volumes in the prior year quarter. We saw sequential improvement in both surgery and peripheral intervention. However, in the last several weeks, we are seeing some impact from the COVID Delta variant on elective surgeries in certain U.S. states. Urology and Critical Care revenues were up approximately 14%, driven by continued growth in our PureWick and targeted temperature management franchises. Now, turning to our P&L, as we expected and as communicated, our gross margins this year are being negatively impacted by COVID-related expenses, manufacturing variances, and FX headwinds, which are more acute in the second half of the year. Also as expected, our gross margin declined sequentially. Our gross margin was 51.5%. However, this included a net negative 90 basis point impact from COVID testing and reinvestments. The 90 basis point impact includes a negative 140 basis point impact from an inventory provision related to COVID testing. Adjusting for the net impact of COVID testing and reinvestments, our underlying base business gross margin was 52.4%. On a sequential basis, our base business gross margin declined from our second-quarter rate of 53.7% due to 3 factors. 70 basis points of incremental FX headwinds, 40 basis points from inflationary pressures, including higher raw material costs and inbound freight, as these costs rolled through our inventory, and 20 basis points of other expenses, including Alaris quality remediation. Now, turning to SSG&A. Our total SSG&A spending increased 21% on a currency-neutral basis to 1.2 billion or 25.2% of revenues. As a reminder, in the third quarter of fiscal 2020, we implemented several cost-containment measures in response to the COVID pandemic. In addition, we are continuing to see higher shipping costs. This quarter also included higher expenses related to our COVID profit reinvestment initiatives. As a reminder, the COVID testing reinvestments we made in FY '21 will not re-occur. Our R&D spending totaled 321 million, an increase of 31.1% on a currency-neutral basis. The higher R&D reflects the timing of project spending, including a higher spending related to the BD innovation and growth fund. Our R&D spending was 6.6% of revenues, which is higher than our long-term target of 6%. On a currency-neutral basis, our operating income increased 26.5% as compared to our revenue growth of 22%. Our operating margin of 19.8% was slightly below our guidance of below 20%. The inventory provision related to COVID testing I referenced earlier, negatively impacted operating margins by approximately a 150 basis points. Interest and other expenses were essentially flat year-over-year at 98 million. The adjusted tax rate was 5.8%, lower than we previously expected, due to discrete tax items that occurred this quarter. The lower tax rate essentially offsets the impact from COVID diagnostic inventory provision in the quarter. The average diluted share count used to calculate our EPS in the quarter was $291.9 million. We repurchased a total of 4.1 million shares for a total of 1 billion at an average price of approximately $242. Our adjusted EPS increased 24.5% over the prior year to $2.74 on a reported basis, and were up 25.9% on a currency-neutral basis. Now, I would like to turn to guidance for the balance of the fiscal year. Our guidance continues to assume no major widespread hospital restrictions on elective procedures related to the COVID pandemic. However, we did start to see some impact on elective procedures from the COVID Delta variant in the last one to two weeks in certain U.S. states, and have assumed some continuation of this in our guidance. That said, given the continued positive momentum of the base business, we are pleased to be able to cover this and still raise our currency-neutral revenue growth to about 14% up from our previous range of 10% to 12%. Our revised revenue range would incorporate a base business currency-neutral growth assumption of 7.5% to 8% Further, we have reaffirmed our previously communicated COVID diagnostic test revenue range of 1.8 billion to 1.9 billion. We now expect a favorable 250 to 300 basis point impact from currency. This brings our total reported revenue growth to approximately 16.5% to 17.5%. For the full year, we now expect our fiscal 2021 adjusted EPS to be in the range of $12.85 to $12.95. This higher guidance reflects the positive base business momentum and a lower tax rate. These benefits allow us to continue to invest while offsetting the COVID testing inventory provision and lower COVID selling prices. Next, I wanna share with you our expectations for gross operating margins for full-year fiscal '21 and provide you with an estimate of the net impact of COVID testing and the related reinvestments of profits on our margins. We expect our full-year adjusted gross margins to be in the range of 53.5% to 54%. And this range includes a net neutral to slight positive impact from COVID testing and reinvestments. We expect our full-year adjusted operating margin to be in the range of 23.5% to 24%. This range includes a 200 basis point contribution from the net impact of COVID testing and reinvestments. Finally, I'd like to address FY '22. We plan to provide our specific fiscal 2022 guidance on our November earnings call. But we wanted to provide some directional color today. To give you a sense as to what a floor could look like in fiscal '22, we have taken the following approach. As you know, there is a great deal of uncertainty around the level of COVID testing. Therefore, we have not modeled any testing revenue beyond the typical flu season. With the continued momentum we are seeing, we have increased confidence in our ability to deliver strong mid-single-digit revenue growth in fiscal '22 over our fiscal '21 base revenues, which as a reminder, adjust for COVID diagnostic testing revenues. With respect to Alaris, our filing is comprehensive and more complex than most submissions. As we have previously stated, it is possible that the review could be in line with [Indiscernible] timelines. However, as we have also mentioned, it was more likely to take longer for the FDA to review and ultimately grant clearance. It is inherently difficult to predict clearance timing. We are not assuming Alaris 510(k) clearance. It is difficult to predict how things will play out as shipments are only being made under the medical necessity process. At this time, we have incorporated the assumption that revenues associated with Alaris will be approximately similar to FY '21. We believe it is prudent and responsible not to definitively predict FDA clearance timelines. That said, we remain confident in our submission, and the process we are undertaking, including working closely with the FDA to obtain comprehensive 510(k) clearance. We expect to drive base business gross, and operating margin expansion. We expect the operating margin for our base business to expand more than our traditional annual target of at least 50 basis points and translate into double-digit operating income growth. For reference, we expect our base business operating margins to be between 21.5% to 22% in fiscal 2021. With these assumptions, we expect an adjusted EPS floor of at least $12. This represents approximately low-teens growth over our expected base business earnings in fiscal 2021. Now before opening it up to Q&A, I want to take a moment to comment on today's announcement of my upcoming retirement. With our strong base business momentum, our strengthened balance sheet and improved cash flows, which is evident by the increased number of tuck-in acquisitions that we've been doing and the restart of our sharp share buyback program for the first time since 2017, I feel that now is the right time for the transition as the Company is well-positioned to continue to drive shareholder value and impact the lives of patients around the world. I look forward to helping to ensure a seamless transition to the new CFO. And I'm very excited about the value creating opportunities ahead for NewCo and helping to ensure the success as a member of their board. With that, let me turn it back to Tom.
Tom Polen:
Thank you. Chris and Kristen, I think it's now we should open up the Operator -- open up the line to Q&A.
Operator:
Great. The floor is now open for questions. [Operator instructions] Your first question comes from the line of Bob Hopkins with Bank of America.
Bob Hopkins:
Great, thank you and good morning. Can you hear me okay?
Tom Polen:
We can, Bob. Good morning.
Bob Hopkins:
Great. Great. Good morning. And Chris, congratulations on your decision.
Chris Reidy:
Thank you very much.
Bob Hopkins:
Yeah. Absolutely. So I guess the first question I would have, and thank you for all the detail today in the early thoughts on 2022. It looks like you're suggesting operating margins in 20 -- next year will -- might be in the 22% to 23% kind of range. That's still multiple hundreds of basis points below where you were in fiscal '19. So can you just help us understand the difference between 2019, and this new guidance for 2022 and why you're those couple hundred basis points below that level?
Chris Reidy:
Sure.
Tom Polen:
I'll let that Chris respond.
Chris Reidy:
Sure, Bob. Thank you for your comments too. Yeah. We -- as we think about margins, we do see the opportunity to get back to those 2019 margins over time, and we'll see that as Alaris comes back into the market, and as recode and our normal continuous improvement occur, and we'll see that improvement also as we grow mid-single-digits and we provide leverage that drops to the bottom line and that will also increase. There's a number of things that have pushed those margins down. We've talked about those in the past. You have Alaris, the ship hold. Obviously, there's an impact, but that will come back. We also have the drop in the China volume-based procurement is an impact, and obviously we're seeing some pressure from inflation, et cetera, that have run through. So, they have come down, but the model is intact, and we're very confident that we can drive those margins back to the '19 levels in the next -- in the near term as Alaris comes back and as we get the continuous improvement from Recode.
Bob Hopkins:
Okay. Just to make sure I'm hearing it. So, the primary difference between those 2 is you guys see it as, really, those 3 things
Chris Reidy:
Yes. So, a couple of things will help us improve. And the other thing that I should mention is there is some FX drag on margins as well, and that's been flowing through. But as we think about improvements going forward, we'll see improvements from utilization as utilization comes back. And so that will help -- will also comparatively to the margins that we have this year. We’ll see continuous improvement, Recode kicking in. We'll see less one-time items. We took in a number of one-time items this year, the spending in the Veritor proceeds, et cetera, so those come back. So you would expect to see us getting back to those kind of margins as Alaris kicks in, in '23, and we see that impact and as we make continuous improvement in '22 and '23.
Bob Hopkins:
Okay. Thank you.
Operator:
Your next question comes from the line of Vijay Kumar with Evercore ISI.
Tom Polen:
Good morning, Vijay.
Vijay Kumar:
Morning, Tom. Thanks for taking my question. Chris, all the best to you.
Chris Reidy:
Thank you, sir.
Vijay Kumar:
I hope you enjoy a good rest. –Tom, maybe starting with the margins back on Bob's question. It's -- one way of looking at it is your pre-pandemic gross margins were 56%. I think your base for the fiscal '21 is 53.5 to 54. Walk through the delta about 70 bps is -- seems to be inflationary costs, 70 bps. FX, you do have these inventory charges related to COVID diagnostics and Alaris for moving parts. I guess my question is, when do inflationory costs abate? Do we have to annaulize? Is that a mid of next year? Should FX still be a drag next year, and when you think about COVID inventory charges, are we done with that in Q4 or is that going to be a drag in fiscal '22?
Tom Polen:
Hey, Vijay, let me -- I'll take a little bit of that question and, again, let Chris comment further on the margin details. When it comes to just the inflationary question that you had, certainly I think we felt the most significant impact of inflation already, and we have a good view of where that's going to be in '22 as we've rolled up our costs. As you know, it's been an unprecedented period of time there as you look at everything from the cost of resins to electronic components and shipping. And shipping is up 4x to move products, let's say from Asia or Europe to the U.S. or vice versa. We are also being very proactive in -- we're not looking to absorb all of those increases in raw material costs over time. We are beginning to pass on some of those. We've raised our shipping rates for customers, and we are passing on price increases. Of course, as you know, we do have long-term contracts and tenders around the world, and so that's not something that we can pass through with those price increases immediately, but we do have a very active program to share those increases. We have to share those increases with customers that will not happen overnight. I’d just share that will also be something that will have an impact as we look forward. We're not going to absorb all of those raw material costs just within BD. Chris, other comments on margin?
Chris Reidy:
Sure. Yeah, I think it would be helpful to look at the flow from third quarter to the fourth quarter. We do expect margins to improve. I think we said that our margins would be 53 to 53.5. That's up a full point from the Q3 margins, and that's coming from improved utilization combined with some of our continuous improvement efforts. We'll also have less one-time airfreight that we saw in the back half of '21, and we will have some pricing actions as well. We do expect it to improve operating margins more than the normal 50 basis points relative to that '21 to '22, and that again comes from utilization. As that improves next year, there's less impact from FX. We have seen FX flowing through our inventory, and so you'll see that abate going forward. And then, we see our continuous improvement items offsetting any continued flow-through of inflationary pricing. When we look at the impact on our raw materials, resins as you know, is a big piece of that. Resins is a combination of some inflationary pressure, but it's also a function of other things; supply and demand in the oil market. And we took a big hit on that in '21, and we would expect that to abate somewhat, and that's something that we're watching very closely as we think about giving guidance in '22.
Vijay Kumar:
Got you. And maybe Tom, [Indiscernible] more on the Q4 revenue guidance and some of the comments you made on reinvestments. The Q4, it looks like 3Q, your base grew 4% for pre-pandemic 3Q, 19 levels. Q4, I'm not sure if I'm doing the Math correct, but I'm getting to a 2% slight B-cell versus 3Q. Is that just conservatism, and related to that -- the reinvestments that we are making should we expect any new products looks through in fiscal '22? Thank you.
Tom Polen:
Yes. It was a little bit difficult to hear what you said there, Vijay on the Q4 topic, I'll let Chris comment on that. But as we've said in the past, we do expect that -- and we'll share a lot more about this on our Investor Day in November, which obviously we hope to see you there -- is we expect the impact of our investments of the COVID profit reinvestments to begin having an impact in the back half of next -- towards the tail end of next year. And we'll talk about what those specific programs are. Some are for short-term R&D lifecycle management programs that we'll be hitting, but also include non-R&D initiatives such as reinvestments we made to establish new, for example, telesales organization in Europe that's helping us access smaller hospitals that we weren't calling in before and we're getting new growth from, or expanding our non-acute sales channel in the U.S. We used some of those investments to accelerate investments there, tapping into a high growth market as the non-acute space is now growing much faster than the Acute Care market where we've had our traditional sales strength in. And so obviously, those commercial investments have near-term payoff. We expect actually the investments that we're making on the commercial side this year, to be fully-funding, self-funding next year. So they're quick paybacks and we'll see those benefits as we've said, that strong mid-single-digits profile in our base business next year. On the other question, let me turn that over to Chris.
Chris Reidy:
Yeah. Vijay, I would just remind you that, going back in history, if you look at the Q4 of FY '19, that's a tough compare. That was the biggest MMS quarter for a number of reasons. And so that's what you're seeing as you're doing your calculation.
Vijay Kumar:
That's helpful, guys. Thank you.
Operator:
Your next question comes from the line of Robbie Marcus with JPMorgan.
Tom Polen:
Hey Robbie. Good morning?
Robbie Marcus:
Good morning. And I'll hand my congratulations, Chris we'll be sorry to see you go.
Chris Reidy:
Thanks Robbie, appreciate it.
Robbie Marcus:
I don't wanna be the dead horse here, but I wanted to focus on the fourth quarter margin guide, and the floor of $12 for next year. It's been, probably, if I go back, a decade-plus since we last had operating margins as low as you're guiding for fourth quarter. And even to get to a floor of $12, versus where you are in that fourth-quarter margin, is pretty tough to do. So I was hoping you could really, as best as you can, walk through the building blocks of why the fourth quarter margin is so low, especially after you said last quarter it'd be in the low twenties for the back half of this year, it looks more like high teens. And then some of the building blocks you used to get to a floor of $12 and on top of that, how you're thinking about what a floor means in relation to where numbers might settle out?
Tom Polen:
Hey Robbie. This is Tom. So on the -- let me take the -- I'll let Chris address the Q4 question that you had. On the $12 floor, I think Chris walked through very clearly how we built up the $12 floor there. And essentially that takes out all COVID -- standalone COVID diagnostics. So all of that comes out. Any standalone COVID testing that we were to have would be incremental to the $12 and you know how much that is this year. Again, it's very difficult to predict what type of COVID testing is going to occur next year, and so we thought it's most prudent to focus on projecting our base business. We do have some Veritor flu sales and flu - COVID combination, which is really a next generation flu test. Built-in but much more aligned to what you would see in a normal flu season, rather than increased demand from testing for COVID patients. As I said, we have no COVID standalone revenue. And so that's how we've built in our $12 floor. As Chris also mentioned, we don't have Alaris 510(k) assumed at all. We do believe that just given inherent inability to predict FDA approval timing, it's not prudent to try to peg when that would be. And so we do not have anything beyond Alaris revenues being flat year-on-year, which as a reminder, we said was a little over a $100 million in FY '21. And so we have that flat going into '22. So that's that. Those are the main factors, Chris went through a number of others. We can circle back on any other questions you have there, but let's go back on your Q4 question. I'll turn it over to Chris.
Chris Reidy:
Sure. Thanks. Tom. And what I would remind you, Robbie, is that we have pointed to the fact that we are making investments this year and not to really look at the second half margins. We said they were going to be lower. You said not to use those as indicative base to jump off for '22, which is what we're saying today. The Q4 margins are pressured by an additional amount of COVID reinvestment. So we made that reinvestment announcement earlier. It takes a while. It tends to be back-end loaded, so there's a preponderance of reinvestment there in the quarter. We continue to see some drag from FX in the quarter, although less than the third quarter. We also expect to see the impact of inflationary costs running through our inventory. And we see that coming through in the fourth quarter as well. So when you sum all that up, we talked about the baseline of 21.5 to 22 as the jumping-off point. We said that it was more than our 50 basis point target going forward. And that -- how much more is where you have to plug it in to get to the $12 number that we gave as a floor. And I think Tom articulated what that $12 floor was meant to be. It doesn't have any testing assumption for COVID in it, although we would assume some water level of standalone testing. It also assumes the testing for flu and COVID combination, which is equal to a normal flu season. It's still pretty early to call that and that's something that we'll give more clarity on as we get into November. It is, just that, a baseline. We wanted to make sure people understood that we can grow more than normal off of '21. And get to at least that $12 level and to close out anything lower than that. And then we'll build from there as we give more specific guidance in November.
Robbie Marcus:
Great. And maybe just 1 quick follow-up. The tax rate came in a little lower this year. What do you think we should be thinking as we head into next year?
Chris Reidy:
I think you flow that through for this year. And then for next year, we should be -- we've traditionally guided 14% to 16%. I think you should consider that being at the low end of that range.
Kristen Stewart:
Operator, next question, please.
Operator:
Your next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question. Chris, congratulations on your decision.
Chris Reidy:
Thanks Larry.
Larry Biegelsen:
Just a couple of questions on the margin. When we look at the 20 to 20.5 base for Q4, what's the ramp through fiscal 2022 look like? On the last call, you said it would ramp through the year. And Chris just a multi-part question on the margin. So I apologize in advance. You had guidance to '25 to '26 post-Alaris, post-China VBP, so is the difference here mostly inflation? You talked about the moving parts and the $200 million reinvestment. That alone, you said would come off -- that's a 100 basis points. So just lastly here or any other headwinds, tailwinds to consider on that he margin commentary.
Chris Reidy:
Okay. There were multiple parts of that, I'm not sure I got them all. So let's start with -- I would say from the phasing, let's talk about the phasing. I think, it's still too early to tell. We can't give that kind of specificity for November. I would say, one of the things that I did mention was utilization. I do think that builds throughout the year, but that's as much clarity as I would give to that. What's the second part of the question?
Larry Biegelsen:
Well, just on the -- people have looked at this closely. Post Alaris, recall the China VBP. You gave guidance of 25% to 26% for the operating margin. Is the difference really here mostly inflation? And just lastly, the $200 million reinvestment in 2021, that goes away next year. That alone is a 100 basis points.
Chris Reidy:
That does come back from that baseline and that's in the assumptions that get us to more than the normal 50 basis points. So that does go away and it does come back in margins. The difference between the -- weather it's the 56ish on gross margin or 25 to 26 on operating margin, is not really inflation it's more around the China VOBP, Alaris and some FX impacts that on the combination of those bring you down in the area of about a 150 basis points on a gross margin basis for example. If you take a step back, we're pulling all the levers that are necessary to drive that up. So the base business is doing well. That's a great foundation. We're reinvesting the Veritor proceeds that drive revenue growth going forward, but also to drive Recode and help there. We've got a balanced allocation strategy. You saw us buying back shares. That will help on the bottom line, we're divesting non-strategic businesses that will help with the growth profile going forward. So all of those things give us great confidence that we'll get back to those kind of margins in the near future as we take those steps. And we're headed in the right direction and the fundamental assumption of mid-single-digit growth on the top. And double-digit TSR in the bottom implies a certain amount of leverage that we feel very comfortable with. We feel good with that operating model, it's intact and that will drive margins up over time.
Larry Biegelsen:
Thanks [Indiscernible] I'll drop given the multi-part question there. Thanks for taking the question.
Tom Polen:
Sure. Larry any time.
Operator:
Your next question comes from the line of Richard Newitter with SVB Leerink.
Tom Polen:
Hi, Richard.
Richard Newitte:
Hi. Thanks a lot. And that last one was really the question I was looking to ask, but just -- if you could just go through those parts a little bit more thoroughly. You've got China VOBP, you have inflation, you have Alaris. And then FX as the bad guys, but then you have reinvestment growing away as the good guy. Could you just add those up again for us 1 more time? Just to make sure I'm clear on what the pluses and minuses are. I think that would be helpful. Thank you.
Chris Reidy:
Okay. I think you did a good job of it. That is the summary. You have exactly those parts and that is the headwind. The Alaris headwind is something that should come back to us in 2023 overtime. And I think you've got the parts.
Richard Newitte:
Okay. And then going back to I think it was Robbie's question, maybe just putting a little bit more of a framework about how to think about what a floor truly means and any kind of broad strokes, how to thinking about what testing could look like based on everything that you know today.
Chris Reidy:
Yeah.
Richard Newitte:
And what a reasonable base case might look like based on what, you know today?
Chris Reidy:
I would refer you back to the prepared remarks because I think we were very clear as to what's included in that $12, and what is not included. The ability to estimate what testing is going to be next year is very volatile. Frankly, if you asked me two weeks ago, it would have been a different answer than it is today with the Delta variant, and it'll be very different in November. So when we give November guidance, we'll give you a better sense of that, but the floor is exactly what it is. It's no testing other than a normal flu season and nothing in for Alaris. And that's all I'll say about that.
Richard Newitte:
Okay. Thank you very much and good luck, Chris. Congratulations
Chris Reidy:
Thanks a lot.
Operator:
Your next question comes from the line of Travis Steed with Barclays.
Travis Steed:
Congrats Chris again, from
Chris Reidy:
[Indiscernible]
Travis Steed:
On the calculus for the mid-single-digit revenue growth and the double-digit shareholder return. When you think about that, is there a minimum operating margin that you're committed to longer-term, with that calculus?
Chris Reidy:
I think it's really an improvement in the margin year-in, year-out, and that's been the model. And we're very confident that we can return to that and to drive those margins back up to the '19 levels and beyond as we move forward.
Travis Steed:
Okay. And then do you expect Alaris to be accretive right away to operating margin or is there going to be a period where it takes a bit longer to get accretive? And then, on the COVID testing margins, you mentioned a lower price point, OUS. Is there a big difference in margins on COVID testing U.S. and OUS?
Tom Polen:
I'll just take that. On the ex-U.S., then 1 of the main differences is, as we had shared in the past, we did launch a manual test. Ex-U.S. particularly in Europe. We don't sell that in the U.S. and that is at a lower price competitive with manual -- manually read lateral flow test. So that's one, there's a product mix difference. And there is a slightly lower price, even on the base Veritor in some cases, given the way that those products are purchased in very large quantities on government -- country-based tenders. Therefore it gets a little bit better pricing, given the scale of the purchasing. So that's the main thing there on Veritor as we think about the mix. Again, we're really pleased that we're right in the revenue range that we project. We're actually ahead of what we projected at the beginning of the year and then have continued to be in that 1.8 billion to 1.9 billion outlook for the full year there. On your other question, Travis was uh?
Travis Steed:
On the operating margin difference.
Tom Polen:
The operating margin.
Travis Steed:
Okay. Yeah
Tom Polen:
Chris, on that one.
Chris Reidy:
The operating margin from -- when it comes back, okay. Yes
Tom Polen:
Yes.
Chris Reidy:
The only thing I would say is you're -- you should be thinking about when Alaris comes back that the -- it takes a while for the sales to ramp. And that's all I would say on that.
Tom Polen:
And we have said before, Travis, as well, we do have -- we very purposely kept a number of expenses on the P&L that stay at the GP line, that as Alaris does, is 510(k) approved. Those expenses will now get absorbed by the higher revenue as soon as the higher revenue starts to come through. Those expenses at stay on the GP line, for example, are very large service organization that we know we need. It's extremely experienced strong team, deep relationships with our customers. And we've kept that those expenses in place because we want that team in place to continue to service our customers, as we ultimately get the 510(k) approved, and back fully to market. Same thing on our commercial side, right? We've kept our -- while the revenue has gone down we've kept that commercial team in place. We have many, many people with decade-plus experience and long relationships with our customers who have great expertise in that -- not only that space, but overall medication management. And so we want to keep that expertise in place as we think about it long term. So those expenses, of course, as revenue ramps, we don't see the need to add those service or sales investments because we've actually kept them in place. Similar to what we had when it was at much higher revenue number.
Travis Steed:
All right. Great. Thank you.
Tom Polen:
Yeah.
Operator:
Your next question comes from Matthew Mishan with KeyBanc.
Matthew Mishan:
Thank you for taking my questions and good morning.
Tom Polen:
Morning.
Matthew Mishan:
Not just throw another moving piece at you, but I'm assuming that the floor doesn't include the diabetes spend. Do you have a better sense of what dilution is from that and impact to our operating margin on a pro forma basis?
Chris Reidy:
I'll take that. The floor does not contemplate that. As we complete the spin and as we get closer to the spin, we will make adjustments to any kind of outlook or guidance that we have. The $12 relates to BDX as a whole. And as it relates to dilution, what we have said is that the dilution to RemainCo would be primarily stranded costs. We'll have transition service agreements in place, and we'll have some time to offset any potential dilution that we have during that transition services period of time. And more to come on that as we get closer to the spin date.
Matthew Mishan:
Okay. And then -- excellent. And then, let's a little bit talk about the guidance for next year. I think everyone assume s there will be some COVID testing, so there will be upside from that, but the flu season, is also probably a little bit lower than what's normal. What is the normal flu season for you as far as revenue goes so we can adjust that Delta?
Chris Reidy:
And then the first thing I would do is just correct your statement that we didn't give guidance for '22. Using the term guidance is inaccurate. We just gave you a floor and a way to think about it. I just want to make sure that that's clear. And what we said was a normal flu season. And we have talked about in the past that, that normal flu season is in the range of $80 to $100 million and it remains unclear as to what type of flu season, flu/ COVID season we have. Last year, the flu season was basically nonexistent. That's why we outlined that assumption as clearly as we did.
Matthew Mishan:
Okay. My apologies. And it seems like that COVID testing, the upside would be greater than downside from flu at that point. Is that correct?
Chris Reidy:
I'm not sure what you just said there, but I think the -- would there be some COVID testing standalone that's something we'll give insights going forward in November.
Tom Polen:
Just a reminder, Matthew, we do have a COVID flu combination test, rapid test. Which we will can step -- that's in that flu category as well. So we do think even if there's a lighter flu season, the availability of symptoms; we will be testing for combination as well. We do expect there will be some continued testing of COVID only as well. But the ability to predict that number right now, again, we're not giving guidance. We just shared a floor number. If there is to predict how much standalone COVID testing is going to happen next year, it is not something one should do. Thanks for your question.
Operator:
Your next question comes from the line of Matt Taylor with UBS.
Chris Reidy:
Good morning, Matt.
Matt Taylor:
All right, thanks. Good morning. Thanks for taking the question. And congrats, Chris, you'll be missed.
Chris Reidy:
Thanks.
Matt Taylor:
I think we've got margins [Indiscernible], so I'm going to ask a couple of growth questions. The first one is I wanted to ask you about your assumptions for disruption. I know there are some states that are seeing that [Indiscernible] procedures now. Would you characterize the build into your guidance as relatively minor? Any framing that you can do for us in terms of how much disruption you think we could see here in the coming month?
Tom Polen:
Yeah. This is Tom. Appreciate the question there. I can give a little bit of color on what we're seeing overall, both in just general utilization, and then I'll talk about what we're seeing more recently in just the last 1 or 2 weeks. As I think most folks are aware, we have one of our informatics platforms is called MedMined which is a software that allows us to see real-time admission data, utilization data, test data, outbreak data, resistance data, literally real-time. It's hundreds of hospitals across the U.S. And so some of the details that we see generally are over Q3. We saw about 91% to 92% utilization versus pre-COVID, about 92% exit in June. And that was a sequential improvement from Q2 average, which was in the 80's. And we expect to see further sequential improvement as we think about Q4 overall. In the non-acute sector it was already -- we saw a 105% utilization versus pre-COVID in May June, and sequential improvements from Q2, which was in the 95% range. As we think about the impact of -- and Europe by the way, with the data we look at show the bed utilization first pre-COVID utilization overall versus pre-COVID was estimated around 92%. Exited the quarter around 93%, which was sequentially up from Q2, which was about 86%. So as we think about the impact of COVID Delta variant in the last 1 or 2 weeks, we've seen it really, as was expected I think, when there would be outbreaks, that you'd start seeing them in concentrated geographic pockets. And that's certainly what you're seeing with the Delta variant. The last number I had was 16 meaningful U.S. healthcare systems that had stopped or significantly reduced elective procedures. And many of those, or the largest ones of those U.S. systems that have done that, that was as of last week, that was the number I had was 16. They were down in Florida, Louisiana, a [indiscernible] number of those were in the south. So it's -- we're seeing it in those areas, but not, certainly not across the country broadly. And we're not seeing really any significant change globally. Certainly there's pockets where that's happening, but for example in Europe, which is a major market for us we're not seeing a change there. We have built in some continuation of that into our guidance. And so if it doesn't continue at that level, that could be an opportunity. But again, being prudent as I think we've been all year long, we took an approach that said, well, if the Delta were to continue and there were to be some impact on procedural volumes, we would be absorbing that within our guidance. It would have to be a significant change versus what's being seen.
Matt Taylor:
Great. Thanks for that. I just had one quick follow-up. You did a bunch of tuck-ins. I was wondering if you could quantify the contribution we could expect from those, as you purchased that we're going forward.
Tom Polen:
We see that as built into our outlook map. And when we talk about the strong mid-single-digit performance next year, and continuing to help fuel our mid-single-digit growth profile. None of those acquisitions have any meaningful impact in Q3. Many of them closed, actually, either at the very end of Q3 or even more recently in Q4. So not an impact in Q3, and part of our growth equation, as we look going forward. But as you said, we're excited about the tuck-ins we're doing. It's combination of both strengthening our base business like what you see in Velano, offering really unique innovation and into an already extremely strong portfolio and a bag that we have. 2 areas that are entering us into new spaces. Like what you saw with Tepha or the ZebraSci, which both enters us into new spaces, but connect us deeply with an important customer segments, small biopharma, providing them services. That -- ZebraSci is the leader in providing them combination drug-device testing services allows us to build those relationships further. And as you know, many of the new drugs coming into the pipelines are in that small biotech segment that we think is attractive to invest behind. Thanks for the question.
Operator:
At this time we have reached our allotted time for questions. I would now like to turn the call back over to Tom Polen for closing remarks.
Tom Polen:
Thank you, Operator. Before we sign off and on behalf of the board and the entire executive team, I want to thank BD's 70,000 associates around the globe. This past quarter, I had a special opportunity to travel to a number of our sites, including our warehouse in Georgia, 2 of our plants in Nebraska, who've all been working tirelessly to produce essential medical devices. Some that are being used for the pandemic response. And I'd like to say a special thanks to them and all of our manufacturing associates around the globe. They are the essential part of our frontline team and make me proud to be BD. And so I thank you, directly, on behalf of the entire organization. For all of you listening, I hope everyone stays safe and healthy. And thank you for joining in. Hope you have a great day.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to BD's Second Fiscal Quarter 2021 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through May 13, 2021 on the Investors page of the bd.com website or by phone at (855) 859-2056 for domestic calls and area code (404) 537-3406 for international calls using confirmation number 6334356. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Kristen Stewart, Senior Vice President of Strategy and Investor Relations. Ms. Stewart, you may begin.
Kristen Stewart:
Thanks Regina, and good morning everyone and thank you for joining us. This call is being made available via webcast at bd.com. We have a lot of exciting news to discuss today. Earlier this morning, we issued two press releases. The first discusses our second quarter results of fiscal 2021. The second announces our intention to spin-off our diabetes business into a separate public company. You can find these press releases along with an accompanying presentation that we will be referring to during today's call on the Investor page of bd.com. Leading this morning's call today is Tom Polen, BD's Chairman, Chief Executive Officer and President; and Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer. Given the announcement of the spin-off of our diabetes business, we will also have Dev Kurdikar, our Worldwide President of Diabetes Care, who has been named CEO of NewCo to provide his early thoughts on the transaction. Following our prepared remarks Tom and Chris will be joined for Q&A by our three segment presidents, Alberto Mas, President of the Medical Segment; Simon Campion, President of Interventional Segment; Dave Hickey, President of the Life Sciences Segment. And before I turn it over to Tom, I want to address a few items. During the call, we'll be making some forward-looking statements and it is possible that these actual results could differ from our expectations. Risks uncertainties and other factors that could cause such differences can be found in our earnings release and our SEC filings including our 2020 Form 10 and subsequent Form 10-Qs. We will also be discussing some non-GAAP financial measures with respect to our performance. Reconciliations to GAAP measures that include details of our purchase accounting and other adjustments can be found in our earnings release and its financial schedules. They are also in the appendix of the Investor Relations presentation slides available at the bd.com website. Unless otherwise specified all comparisons will be on a year-over-year basis versus relevant period. When we discuss revenue percent changes they are on an FX-neutral basis unless otherwise noted. To avoid any confusion, when we refer to any given period, whether that's on a quarter or year basis, we will be referring to the period in fiscal terms, unless we specifically call it out as a calendar period. Finally, when we refer to NewCo, during today's call we are referring to the independent publicly traded diabetes company following the effective date of the spin, while RemainCo refers to BD post separation. And with all that said, I am very pleased to turn it over to Tom. Tom?
Tom Polen:
Thanks Kristen. Good morning everyone and thank you for joining us. Today we will provide an update on how we are executing on creating value for our stakeholders through our BD 2025 strategy. We have a lot of exciting updates for you, so let's jump right in. Our second quarter results came in better than expected and we delivered strong revenue and EPS growth. We are very pleased with the continued momentum in our core business, and therefore, based on our first half results and our projections for the second half we are reaffirming our fiscal 2021 guidance. We are making steady progress on each of our growth initiatives, which include very purposely shifting our investments and portfolio into higher-growth categories and shifting our weighted average market growth rate over time. We are advancing our product pipeline as well as our tuck-in M&A strategy, which now includes making selective investments in earlier stage and potentially disruptive technologies. And this morning we announced our intention to spin-off our Diabetes Care businesses into a separate public company. We see this planned spin as a significant value-creating opportunity for all stakeholders for our patients, customers, associates and shareholders. As an independent public company, we believe the diabetes business can leverage its global leadership position and unleash its growth potential in this attractive market category through the more efficient allocation of its own capital. For RemainCo BD, this transaction allows us to focus on our prioritized core businesses. We expect this transaction to strengthen our mid single-digit revenue and double-digit total return growth profile. We expect the spin to be completed in the first half of calendar year 2022 subject to customary closing conditions, including final approval by the BD Board of Directors and the SEC declaring our registration statement effective. We are progressing well against our simplification initiatives, which are focused on reducing complexity, enhancing our product quality, refining our customer experience and improving cost efficiencies. Our recode initiatives are progressing on track to generate savings of $300 million by the end of FY '24. And these initiatives help unlock value and allow us the flexibility to reinvest back into our business to fuel future growth. Chris will talk more about our capital allocation strategy later in the call, but we expect share repurchases to return as part of a more balanced capital allocation strategy, as our balance sheet position and cash flows have strengthened over the past year. We also continue to be guided by our purpose of advancing the world of health and continue to make great progress on our ESG initiatives. On Earth Day, we reaffirmed our climate change targets, which includes our pledge to be carbon neutral by 2040 across our direct operations. Last week as I was preparing for our Board meeting, I reflected on where we were a year ago where we are today and the progress we've made. First, we achieved my number one priority since taking over as CEO. Last week, we announced that we submitted our Alaris 510(k) premarket notification. This is an important milestone in our commitment to our customers and our patients. The Alaris pump is the leading infusion pump in the US market administering more than one million infusions each day. Second, we've significantly strengthened our balance sheet and cash flows. Over the past year we've improved our net leverage ratio by a full turn from 3.4x to 2.4x and taken actions to meaningfully strengthen our cash flows. Third, we answered the call to action with COVID. We developed a series of innovative COVID diagnostic tests and scaled these to diagnose patients and help control the spread. We secured our global supply chain to ensure that our essential medical devices were available to treat COVID patients in ICUs around the world including BD devices used in the treatment of an estimated 90% of US ICU patients. And today we continue to add capacity and enable over 1 billion doses of COVID-19 vaccine to be delivered using our injection devices. I am very proud of our team's impact when it matters most. Fourth, we reinvested in growth. We set up the BD Innovation and Growth Fund and advanced impactful new innovation programs in each of our businesses. We acquired 11 tuck-in acquisitions since the beginning of 2020 along with early-stage investments and we're reinvesting some of BD Veritor profits back into the business and behind our BD 2025 strategy. Fifth, we started to shift the BD culture to one of a growth mindset. We've been systematically advancing our leadership capabilities and culture in this area which includes partnering with the Neuro Leadership Institute to embed an enhanced focus on innovation and growth across our culture and mindset and the progress we're making with shifting the culture is very real and tangible. And today, we are announcing our intention to spin-off the diabetes business. We believe this spin-off will be another value-creating opportunity for our shareholders. But what excites me most is not what we've done it's where we're going and what's to come over the next several years all of our future successes and milestones to come. The BD 2025 value-creation story has only just begun. And later this year we are planning to host an Investor Day and we'll look forward to sharing greater insights into our 2025 strategy and pipeline. So with that let's turn to Slide 8 and our second quarter results. Chris is going to run through our financial results in greater detail later on. But just to highlight, we are very pleased with our second quarter results as the BD team continued to execute well. Our second quarter revenues totaled $4.9 billion, up 15.4% on a reported basis and up 12.2% on an FX-neutral basis. I was particularly pleased with the continued momentum of our core businesses which were above our expectations in all three business segments. To call out a few, our market-leading BD Pharmaceutical Systems business continues to deliver robust revenue growth of nearly 10%. Medication Delivery Solutions business was up over 8%, as we continue to deliver on our COVID vaccine injection devices commitments and our results were also driven by higher patient acuity. Our Bioscience business turned in double-digit growth as research activity has rebounded and urology and critical care continued to perform well driven by PureWick and targeted temperature management. In China, where we began to anniversary the impact of COVID-19 we saw a strong revenue growth of 62% and we continue to invest support our future growth including reinvesting some of the profits from our COVID diagnostics. Our R&D spending was up 18.7% year-over-year on a currency-neutral basis. Adjusted EPS was $3.19 representing year-over-year growth of 25.1% on a reported and 22.7% on a currency-neutral basis. The performance of our business particularly our core, gives us comfort to reaffirm our fiscal 2021 guidance ranges which include currency-neutral revenue growth of 10% to 12% and adjusted EPS guidance of $12.75 to $12.85, up 25% to 26% on a year-over-year basis. Turning to slide 9. As I discussed before, we are proud to play such an important role in the COVID-19 pandemic response, across the continuum of care, from diagnostics to treatment and now prevention. As vaccination campaigns continue to progress, I am pleased to announce, that we now have cumulative commitments for over 1.7 billion injection devices to administer COVID vaccines globally. These commitments will stretch through our fiscal 2022 period. And therefore, we now see higher demand in our MDS hypodermic business, as being durable into next year. We also see potential opportunity for our prefilled business in the future, and are now working with several partners at various stages of formulation testing on possible pre-filled COVID-19 vaccines. Turning to slide 10. I will provide an update on our COVID-19 Diagnostic Testing business. We recently announced several emergency use authorizations or EUAs from the FDA. We received EUAs for our combination COVID flu assays for both BD Veritor and BD MAX and we believe combination tests are going to be important in the next flu season. Next, we extended our EUA for the BD Veritor COVID-19 test to include a claim for screening asymptomatic individuals by serial testing. Several peer-reviewed publications have supported the benefits of serial rapid antigen testing, and we are continuing to develop our BD Veritor at-home test. Our test is designed to deliver a clear, digitally displayed record of test results on a smartphone to eliminate the reading guess work, and we also designed it to allow the data to be digitally shared by the user to eliminate errors and report sharing. Our BD Veritor at-home antigen test is also expected to have some other features that we believe will further differentiate it versus others on the market. Our antigen tests will all be manufactured on the same production lines to leverage economies of scale and our capital investments. Turning to slide 11. Growth through innovation is central to our BD 2025 strategy. We are advancing our R&D pipeline across all three of our segments. And as you can see on this slide identified by the green circles, several products have launched or achieved clearance since the beginning of the year. I've already covered our regulatory clearances related to COVID Diagnostics, and I'm happy to share that we've made steady progress in our medical segment, with a healthy cadence of relevant portfolio expansions and extensions across the MDS portfolio, such as the broadening of our leading peripheral IV catheter position with the introduction of our first passive safety catheter in the United States, the BD Cathena IV safety catheter. We launched a new catheter stabilization solution for peripheral IV catheters with the BD Secura stabilization device and further advanced the safety of the BD PhaSeal optimal product family with a locking injector. In interventional, we're launching Sensica, a smart connected folly catheter, which can be an important tool for the ICU. It provides weight-normalized urine output data that is one of the early parameters used by clinicians to help identify acute kidney injury. BD Sensica can wirelessly transmit this data to the hospital's electronic medical record. We're also looking forward to launching Pristine later this quarter. Pristine is our new long-term hemodialysis catheter with unique side hole-free symmetric wide tip distal lumen design. The design of the product is intended to help minimize thrombus adhesion, facilitate blood clot aspiration prior to hemodialysis treatment and help minimize recirculation rates in both forward and reverse. Turning to slide 12. As I have often said over the last year, Alaris was my number one priority and last week, we announced a very important milestone. We submitted our 510(k) premarket notification to the FDA for our BD Alaris system. I am extremely proud of our MMS regulatory affairs, quality and R&D teams for their dedication and hard work, to ensure a comprehensive submission. We're also very appreciative of the FDA's collaboration. We recognize this is one important step and we look forward to working with them through the FDA review process to obtain clearance for the updated BD Alaris system. Just to give a sense of what is included in the submission and how comprehensive it is. The 510(k) submission is intended to bring our file up to date for all changes to the pump, since the last 510(k) was cleared. We are also implementing updated features and addressing open recall issues, including through a new version of the BD Alaris system software that will provide clinical, operational and cybersecurity updates. These updates are part of our overall commitment to safeguard infusion programming. And included in the software will be updates to our BD Alaris Guardrail Suite and BD Alaris EMR interoperability, including cybersecurity updates, network security and advanced data encryption. From a hardware perspective, our submission includes updated PCU, LVP, syringe and EtCO2 modules, as well as our existing PCA module. We plan to continue to advance the BD, Alaris system with future updates and subsequent submissions. We filed a substantial amount of data to support the filing. This is a complex and comprehensive submission. Therefore, we would expect that the FDA review process will take some time to complete. And while we're not intending to predict the FDA-specific time line, we certainly recognize that our stakeholders would like to have some input for modeling purposes and we believe it would be prudent to think about Alaris' clearance sometime during the second half of our fiscal year 2022. We plan to update you if there are any significant developments. And for now, we expect to continue to ship to our customers who qualify under medical necessity. We've learned a lot of valuable lessons and gained insights during this journey that we're applying to our ongoing next-generation pump platform programs as well as our quality and risk management systems. Turning to Slide 13. We are making significant progress with our tuck-in M&A strategy. Year-to-date, we've closed five acquisitions and we have a robust funnel of opportunities at various stages. We continue to exercise financial discipline, in addition to ensuring deals meet our strategic and operational criteria. This includes them being accretive to our growth profile, supporting our key innovation themes, advancing our strategic positions, meeting our financial hurdles and creating shareholder value. As part of building a more holistic approach to expanding our inorganic growth funnel, we also expanded our evaluation and selective investment in early-stage strategic opportunities. On Slide 14, we highlight our key innovation themes and with some of our tuck-in acquisitions and R&D products across our three business segments that align to these themes, some of which I've already highlighted. So within this theme of applying smart devices, robotics, analytics and artificial intelligence to improve care processes, I've already discussed our Smart Foley catheter Sensica. We also continue to develop new modules of Kiestra, our total lab automation system. Kiestra as you know can improve standardization, significantly enhance lab efficiencies and staff productivity. Within Medical, our health site platform is designed to continue to support enterprise-wide medication management. We continue to evolve our capabilities with health site diversions, which was originally launched in fiscal 2019 for Pyxis. We have scaled tremendously over the last year in terms of our commercial sites and we have plans to expand into the OR, followed by integration of infusion data and central pharmacy. Within this theme of enabling new care settings, you've seen us acquire Med Bank and GSL Solutions to expand our medication management offering into the faster-growth non-acute settings and strengthen our existing dispensing leadership position. Our PureWick dry dock urine collection system has been helping women with urinary incontinence outside of the acute setting and contributing to the strong growth in our UCC franchise. And I've already talked about how we're excited about the upcoming launch of our BD Veritor at-home COVID-19 test that enables the expansion of testing into everyday settings. Lastly our third theme is improving diagnosis and treatment of chronic diseases. I already mentioned Pristine and I've talked about in the past our BD Oncology HPV assay, which offers extended genotyping that supports risk stratification. And we look forward to launching this assay on our BD core system in the United States later this year. One other product that we haven't talked a lot about is our BD Libertas subcutaneous drug delivery system for the administration of viscous biologics. Our Pharmaceutical Systems business is excited to offer this option to our biopharmaceutical partners as a combination product. These products not only add value to our customers, patients and health care system but they add to our confidence in a sustainable, durable, mid-single-digit growth profile. Now turning to Slide 15. As I've described so far on this call, we are making substantial progress in advancing our BD 2025 strategy, which is about unleashing the growth potential of BD, delivering innovation to our customers, empowering our associates and creating value for our shareholders. And I'm really excited today to announce a bold step in our BD 2025 strategy. Our intention to spin-off our diabetes business to our shareholders which we believe is a value-creating transaction. Our Diabetes Care business generated $1.1 billion of revenue in fiscal 2020, is a global leader in insulin injection devices. Consistent with our continuing focus on delivering shareholder value, we undergo strategic reviews to identify ways to create value and determine that the strategic priorities of BD have diverged from those of our Diabetes Care business. We believe a spin-off will position both companies for long-term growth and success by allowing both to focus on their respective core markets, innovations and customer outcomes. Each company will be able to more efficiently allocate its resources and capital, best positioning the respective companies for their success and value creation. We see tremendous potential to create value for our Diabetes Care business ahead. And let's turn to slide 16, to dive into some of the benefits in greater detail. We see the spin-off as an operating catalyst for our Diabetes Care business. As an independent public company, NewCo will be able to more effectively allocate its human, operational and financial resources to implement a refined growth strategy that will allow it to focus on innovation, and improving the care of patients living with diabetes. Being a separate entity, will also better enable NewCo to attract and retain talent, align management and employee incentives, and have a stock currency that it can use for future acquisitions. For RemainCo BD, we expect the spin-off to strengthen our mid-single-digit FX-neutral revenue growth. We estimate the uplift to our revenue growth rate to be about 30 basis points. And see this as strengthening our double-digit total return growth profile. The spin-off will allow RemainCo to focus on our R&D tuck-in M&A and customer growth strategies, simplify our overall focus and maintain financial flexibility. Considering all of these benefits, we believe this transaction has the potential to create value for our shareholders, which will be owners of both companies. Slide 17, provides an overview of the relevant transaction details. And I've already covered many of these topics. The spin-off is expected to be implemented by a means of a distribution of 100% of the shares of a newly traded -- publicly traded entity to BD shareholders, and is intended to be tax-free for U.S. federal income tax purposes. Over the next several months, we'll be filing our Form 10, which will include the carve-out financial statements. Again, we expect the spin-off to be completed in the first half of fiscal year 2022, subject to market, regulatory and other conditions, including final approval by the Board of Directors and the effectiveness of a Form 10 registration statement that will be filed with the SEC. Turning to slide 18, NewCo will be led by an experienced management team. And I am very pleased to share that Dev Kurdikar, who joined us earlier this year, as the Worldwide President of Diabetes Care will be the CEO of NewCo. Dev has a long history, in the medtech sector, most recently serving as the CEO of Cardiac Science. Dev has been engaged with the business now for the last few months and will share some of his preliminary thoughts in a moment. I'm also very happy to announce that Jake Elguicze, the Former Treasurer and Vice President of Investor Relations of Teleflex, has joined BD and will be the CFO of NewCo upon spin. Jake brings extensive experience, in treasury, financial planning, reporting and analysis and investor relations. We're confident that Dev and Jake are the right team, to lead NewCo as they embark on this journey that we believe will create value for all stakeholders. So with that, I want to turn it over to Dev to provide his perspectives on today's announcement, Dev?
Dev Kurdikar:
Thanks Tom, and hello to everyone listening to today's call. I'm incredibly excited to embark on this journey. I see a tremendous opportunity to build shareholder value and advance care for patients who suffer from diabetes. I'm also very humbled, to be leading this amazing organization. The Diabetes Care business has a long history of caring for patients living with the disease, dating back to BD's introduction of the world's first specialized insulin syringe, almost 100 years ago in 1924. Since then, BD has played a leading role in the delivery of insulin, including helping to drive the adoption of insulin pens, which utilize our pen needle technology, as a leading modality for insulin injection. Our Diabetes Care business now reaches more diabetic patients, than any other medical device company in the world today. We manufacture eight billion devices per year and are the global leader in insulin injection devices. As Tom mentioned earlier, the business generated nearly $1.1 billion in revenue in fiscal 2020, derived from the sale of insulin injection devices such as, pen needles and insulin syringes as well as other accessories. One factor that attracted me to this opportunity was the global breadth of the business with 48% of the revenues generated outside the United States, including 17% in emerging markets. And why is this important? As you can see on slide 21, diabetes is a growing chronic condition across the globe, with some of the higher prevalence rates expected to be in the emerging market regions. The International Diabetes Federation estimates that the number of adults living with diabetes is expected to grow from 463 million in 2019 to 578 million in 2030 and 700 million by 2045. Most of these patients will likely continue to rely on traditional injection devices for their insulin needs. The rapid growth of the disease will likely place a significant burden on healthcare systems around the world, as patients with diabetes are often afflicted with multiple co-morbidities like cardiovascular disease, hypertension, diabetic retinopathy and lower limb complications. While I've only been with the company for a few months now, I can assure you that my passion and vision for NewCo is one of growth. Injection devices like pen needle and syringes are likely to remain a key part of their treatment paradigm for people with diabetes on a global basis for the foreseeable future. We will look to leverage our global footprint to capitalize on these demographic trends. However, we'll also look to invest in novel insulin delivery technologies, including our internal type 2 patch technologies. We also plan to supplement our internal R&D product development efforts more broadly and accelerate our growth profile through strategic M&A to broaden our product offerings and enter adjacencies on new growth categories. Let me end by saying how excited and humbled I am to have this opportunity to lead NewCo. I am confident that our team will work tirelessly to advance care for our patients while building shareholder value. With that I'll turn it over back to Tom.
Tom Polen:
Thanks Dev. We see this as a great opportunity for those BD associates that will be part of NewCo and we're happy to have you and Jake on board. Turning to slide 25. I'd like to provide an update on our ESG initiatives across BD. Over the past quarter, we continued to advance our company-wide ESG initiatives, including our recent commitment to be carbon neutral across direct operations by 2040. We also continue to make progress towards identifying our 2030 goals and we look forward to sharing more details behind our 2030 sustainability plan with you in future engagements. Before turning it over to Chris, I want to say again how proud I am of the organization for the progress we've made in advancing the BD 2025 strategy. We are purposely shifting our focus to growth opportunities. Simplifying the organization to remove complexity as I firmly believe complexity gets in the way of growth and we're empowering our associates with a growth mindset. We are committed to doing the right things, the right way and fulfilling our purpose of advancing the world of health. I also want to reiterate how excited I am for what's ahead for both RemainCo BD and NewCo. BD's Board of Directors and management team believe our plans to spin-off the Diabetes Care business will create value for all stakeholders. With that, I'll turn it over to Chris.
Chris Reidy:
Thanks Tom. And before I turn to the results, let me also share my enthusiasm for the spin-off of our Diabetes Care business. I see the transaction is a win-win for all stakeholders, our shareholders, our employees, our customers and our patients. I'm confident that we have the right leadership to navigate NewCo on this exciting journey ahead. Now let me turn to the second quarter financial results. Slide 27 summarizes our high-level revenue performance. Our revenues came in just over $4.9 billion, up 15.4% on a reported basis and up 12.2% on an FX-neutral basis. As Tom mentioned, we were very pleased with our results. Our core segment results excluding COVID-19 diagnostic testings were ahead of our expectations across all segments. Now turning to slide 28. Our medical segment delivered 4.7% FX-neutral revenue growth led by our market leading BD Pharmaceutical Solutions Systems business, which continues to deliver robust revenue growth of nearly 10%. We are proceeding with our capacity expansion to support the future growth of this business unit. MDS grew a solid 8.1%, which included $43 million from COVID-19 vaccination injection device revenues. We also benefited from higher patient acuity and higher utilization internationally particularly in China where we anniversaried the impact of COVID-19. Now turning to slide 29. Our Life Science segment delivered revenue growth of nearly 38% on an FX neutral basis. Our COVID-19 diagnostic testing revenues totaled $480 million and are included in our Integrated Diagnostics Solutions business. While BD Veritor ASPs were as expected in the low to mid-teens, the market's overall demand for symptomatic COVID diagnostic testing was lower. Looking at our IDS business excluding COVID testing, our routine diagnostic testing has not yet fully recovered to pre-COVID-19 levels. There was virtually no traditional flu this year, so we did not have our usual flu test revenues and this impacted our IDS growth rate by 540 basis points and our BD Life Sciences growth rate by 410 basis points. The impact to our overall BD growth rate was 110 basis points. Our Biosciences business unit delivered strong growth of over 12% as research lab activity has recovered nicely. We are seeing strong demand for research instruments and reagents as well as from biopharmaceutical companies for vaccine research and development. As shown on slide 30, the BD Interventional segment was flat this quarter, which was better than expected given the COVID-19 resurgences. The performance in surgery and PI reflected the early impact from the COVID resurgence. However, we did see recovery in elective procedures as the quarter progressed and this trend has continued into April. Our urology and critical care franchise continues to deliver solid growth led by our Purewick and targeted temperature management product lines. Turning to our results by geographic regions on slide 31. In the United States, revenues were up 1.9%. As we had discussed on our February earnings call, we did see some early impact from COVID-19 resurgence, which waned as the quarter progressed and we exited March with improved momentum and this continued in April. International revenues were up 25.7% on a currency-neutral basis as we begin to anniversary the initial impact of COVID-19, particularly in China where our revenues were up 62%. We also benefited from our COVID-19 responses, our diagnostic testing and vaccine injection delivery device revenues. Now turning to the P&L on slide 32. As expected our gross margin was sequentially lower as compared to our first quarter. Our gross margin was 53.8% driven mostly by the lower COVID diagnostic testing revenues. On a year-over-year basis, the gross margin included a 70 basis point negative impact from foreign exchange and 70 basis points from reinvestment initiatives. Favorable impacts from our continuous improvement initiatives were offset by product quality-related expenses. Our SSG&A spending rose 9% year-over-year on an FX-neutral basis, including a 380 basis point impact from deferred compensation, which as you know is fully offset in other income expense. The remaining increase in SSG&A is primarily related to higher shipping costs and investment spending as part of our BD Veritor profit reinvestments. Our R&D spending ramped sequentially as planned as we reinvested some of the BD Veritor profits behind new pipeline innovations. R&D increased 18.7% year-over-year on an FX-neutral basis to $295 million, representing 6% of our revenues. Our operating income grew 14.3% on a year-over-year reported basis and 13% on an FX-neutral basis. Our operating margin was 24.5%, up 20 basis points on an FX-neutral basis. Deferred compensation was an 80 basis point headwind. Our interest and other expenses totaled $111 million versus $170 million in the year ago period. The reduction of interest other net on a year-over-year basis, primarily reflects a decrease in deferred compensation offsetting increases in SSG&A as previously mentioned. It also reflects reduced interest expense due to debt repayment and refinancing activities and lower interest rates. Our tax rate was 12% lower than expected due to discrete tax items that occurred this quarter. Our adjusted EPS increased 25.1% over the prior year to $3.19 on a reported basis and were up 22.7% on an FX-neutral basis. The average diluted share count used to calculate our EPS in the quarter was $293.6 million. Now turning to slide 33, I'd like to provide an update on our capital allocation priorities, but first I want to update you on the great progress we made with our cash flows and balance sheet on a year-to-date basis. For the first half of the year, our cash flows from operations have more than doubled growing from $1.2 billion to $2.8 billion, driven by the improvement in our net income as well as working capital. We ended the quarter with $3.7 billion in cash and equivalents and our net leverage ratio was 2.4 times, a full turn lower than a year ago. Going forward our capital allocation strategy will be more balanced than it had been in the past as we were paying down our debt. Now more of our cash can be deployed to support our growth strategy, tuck-in M&A, maintaining a competitive dividend and returning capital to our shareholders through share repurchases. As a reminder under the existing share repurchase authorization plan, we have just under 7.9 million shares or roughly $2 billion remaining. Also note that we would expect BD's dividend to be unaffected by the diabetes spin-off and therefore would increase BD's payout ratio. Next I want to address our fiscal 2021 guidance and provide some general commentary on our overall outlook, which you can see on slide 34. From a reporting perspective, we will continue to report our diabetes business with our BD results until the spin-off of the diabetes business is complete. We're very pleased with the results for the quarter how we are building momentum in our core, advancing our pipeline and achieving critical milestones. We are also pleased with the early progress we see from BD Veritor profit reinvestments. We believe these projects should begin to provide incremental growth beginning in late 2022. We are reaffirming our fiscal 2021 financial guidance ranges. We continue to expect reported revenue growth of 12% to 14% for the full year 2021. This reflects FX-neutral revenue growth in the range of 10% to 12%. BD Veritor revenues towards the higher end of the $1 billion to $1.5 billion range and foreign currency adding approximately 200 basis points. We also continue to expect adjusted EPS in the range of $12.75 to $12.85, which represents growth of 25% to 26% year-over-year. Now we wanted to give you some color as you consider your models for the back half of the year. We continue to reinvest some of the Veritor profits to fund projects in line with our BD 2025 strategic pillars of growth simplify and power. Our investments continue to put temporary pressure on both our gross and operating margins in 2021. As we mentioned last quarter, we continue to expect our operating margins in the second half of the year to be in the low 20s, reflecting our reinvestment initiatives as well as higher raw material costs. As a reminder, we expect the reinvestment pressures that you're seeing on our margins to lift next year. As you've seen in the past from time to time there can be some volatility in our tax rate. We now expect our FY 2021 tax rate to be slightly lower than FY 2020's tax rate. This helps to offset some gross margin pressure from the lower ASPs from Veritor as pricing is now approaching compared to our flu test price a bit faster than we originally anticipated. Regarding 2022 given the momentum we are seeing our progress with our R&D pipeline the reinvestments of our BD Veritor proceeds and our tuck-in acquisition strategy we have increased confidence in our core outlook. In fiscal 2022, excluding COVID-19 testing and Alaris 510(k) clearance, we expect our revenues to grow solidly in the mid-single digits. As you heard Tom mention, while we're not intending to predict the FDA's time line we recognize the desire to have some input for modeling purposes. We believe it would be prudent to think about Alaris' 510(k) clearance sometime during the second half of our fiscal 2022. We believe it would also be prudent to model both our revenues and our margins gradually ramping as we scale our selling and manufacturing efforts. In conclusion, we are really pleased with our second quarter results and the momentum across our businesses. We are excited about our plans to spin-off of the diabetes business and see this as an important opportunity to create value for our shareholders. With that, Tom, Alberto, Simon, Dave and I are happy to take any questions you have. Operator, please open up the line for Q&A.
Operator:
The floor is now open for questions. [Operator Instructions] Our first question comes from the line of Bob Hopkins with Bank of America.
Kristen Stewart:
Hi, Bob. Good morning.
Bob Hopkins:
Good morning. Boy a lot to unpack here. So I'll just ask kind of two straightforward questions. First is kind of a housekeeping on the diabetes side. You told us it was roughly 67% of revenues in fiscal 2020. I'm just curious what rough percentage of operating profit it was in that year? And then I've got one follow-up. Thank you.
Tom Polen:
Yeah. On that first one Bob, we'll be clearer on that as we do the carve-out financial statement. So you can expect to see that going forward. But as you know, we don't break it out at that level at the operating basis – on an ongoing basis. But as we do carve-outs that will be clearer.
Bob Hopkins:
Any rough sense though just as I'm sure it will be –
Tom Polen:
Too early to say right now as we're still going through the midst of that.
Bob Hopkins:
Okay.
Kristen Stewart:
And Bob – Bob just to note so maybe what we can say is that the Diabetes Care business it certainly is profitable and the gross and operating margins are above our corporate average. Certainly, the company's positive cash flow which is going to allow it to pursue the growth agenda that we discussed, and then again as we file the Form 10 later this year the more detailed carve out financials will be available then.
Bob Hopkins:
Okay. Great. And then one quick follow-up. So many things we could ask about 2021, but you offered a few little comments on 2022, so I'll skip right over to next year for a quick second. What do your comments suggest about the – kind of the outlook for operating margins next year relative to where you're ending in the back half of 2021?
Tom Polen:
Yes. So as you can see this year, we're spending and investing to drive future growth from the Veritor proceeds. And so that will be something that does not reoccur next year so you will see a lift. And clearly, you would get a lift from Alaris coming back because that was a drag on our operating margins as well. And I would also add the – in terms of FX you see some FX pressure that we pointed out this year. We'll continue to see some of that rolling through our inventory for the remainder of this year. That should turn around next year as well.
Bob Hopkins:
Any sense for what that roughly sums to though just directionally?
Tom Polen:
Yeah. We're not going to give 2022 guidance this early. A lot of that will be impacted as you know by what happens to COVID testing. And we're pulling all the levers we can to make COVID testing more sustainable as we think about the combined COVID and flu assay and we're also – we're working on the at-home test. So that should have some ability to have sustainability in COVID testing. But clearly, it will come down. And where that goes will have a big impact on operating margins and gross margins in total as you would know.
Kristen Stewart:
And Bob, just as a reminder, we've said, we expect to reinvest about $200 million of Veritor profits back into the business this year, right, which are onetime expenses hitting the R&D line as well as the GP line as we discussed that will come out next year, which will be obviously a tailwind. The re-launch of -- the expected re-launch of Alaris, obviously next year would also be a margin tailwind from that perspective as we start getting absorption back in that plant as well as it tends to be a higher-margin item. And so those are all positives as well as continued volume returning in as we think about the recovery post-pandemic, particularly in areas like BDI, which we saw and we can talk about later on. We saw good continued recovery, particularly in the back end of the quarter in March, and we continue to see that strong momentum and Simon can comment on that later on, as we look at April in procedure volume recovery. So thanks for the question, Bob.
Bob Hopkins:
Yes. Thanks.
Operator:
Your next question will come from the line of Robbie Marcus with JPMorgan.
Kristen Stewart:
Hey. Good morning, Robbie.
Tom Polen:
Good morning, Robbie.
Robbie Marcus:
Good morning. As Bob said, there's a lot to unpack here. Maybe I could ask about some of the base businesses here, particularly maybe the Interventional business seemed a bit weaker than expected and the Medical business continues to benefit from COVID. So, I was wondering if you could tease out some of what's impacting interventional? And how do you expect that to recover? And then, on the flip side within Medical, how much of that is benefiting from COVID here and should start to come out over the balance of the year?
Dave Hickey:
Yes. I can start with maybe just some comments on Medical, and then turn it to Simon on Interventional. So certainly, in Medical you see a couple of things happening. One is we see continued durable growth you saw last year in Pharmaceutical Systems. You saw it again in the quarter that they were in 8% plus I think last year growth, and we see that durably higher than average company growth is my intention there. And you saw us obviously communicate I think, it was last quarter or the quarter before, over $1 billion, $1.2 billion of incremental investment, capital investment in that business to support the long-term growth outlook. So that's number one. We also reaffirm that we expect -- we are in discussions and we have collaborations going on with several pharma companies about putting COVID vaccines in prefilled syringes. So again, another opportunity as we think about that business long-term. In MDS, we also commented that I remember, a year ago or less than a year ago, we were talking about that we could do up to one billion syringes to help in the COVID vaccination. We now -- today announced, we have orders -- commitments in hand for 1.7 billion syringes that spans well into FY 2022. And so we see, while we were wondering was there going to be a cliff of syringes into 2022, we see that demand in our MDS business as being durable into 2022. And certainly, as we think about potential even further demand, from things like booster shots, that would just make that demand even more durable. Overall, that business continues to do well in terms of taking share in the catheter space as well as a series of new innovations. They obviously had had some benefits from higher acuity patients in the ICU, which are maybe using products like midlines or PICCs, which have higher ASPs than peripheral catheters for shorter-time stays, but there's strong durable trends there I think in MDS. And obviously MMS, we look forward with the submission of the 510(k) to have bigger growth opportunities as we look ahead to 2022. I think I'll turn it over to Simon on BDI. But I would say what you saw is that the impact from the pandemic was very minimal in the first two months of the quarter last year for BDI. And so, I think you see just that comparable happening given our product mix. And then, we did see strong trajectory and uptake in March and we saw that continue into April. Simon.
Simon Campion:
Yes. Good morning, Robbie. It's Simon. So let me just add at the bottom here with UCC, a really strong quarter as you see driven by double-digit growth in PureWick and TTM. So, it will continues to be a mid to high single-digit performer for us this quarter. Peripheral, as Tom has mentioned, Peripheral we did see impacts early in the quarter in this space and particularly in the ESKD business and that is -- that should not be a surprise to you based on what you've probably heard from others involved in that space, but a sequential improvement through the end of March and into April and the outlook remained positive there. And then, with Surgery, no great surprise to us. Two factors driving that. Number one, hernia is not an emergent procedure. So, patients have had hernias for several years. So that is typically impacted first when a resurgence happens and they are treated later, when the recovery is initiated. And secondly, the Q2 of last year for us had a particularly high growth in ChloraPrep, I would say, higher than normal. So that's a bit of an offset, as we move into this quarter. But the sustainability of our business, I think, is demonstrated in China, for example, this past quarter. We were very significantly impacted in Q2 last year in China and it has rebounded really strongly in Q2 of this year. So we remain confident in our ability to recover our business as the resurgence abates here.
Chris Reidy:
I would just add two comments. In terms of Interventional it actually exceeded our expectations in the quarter, because we had seen January and the resurgence from COVID and we had seen that going into the February call. And that did turn around in March and happy to see it turn around in April. But I'd also take a step back in terms of the core momentum and point to the fact that we see that improving. It's helping us with the outlook for the remainder of this year. And I would also point to the fact that we showed that confidence in what we said about 2022 by moving the core guidance for 2022 from low single to mid digits to solid mid-single digits. And that's reflective of the momentum across the business that we see as sustainable.
Robbie Marcus:
Great. And I realize you're not going to be able to comment on COVID testing or Alaris sales necessarily for next year, but maybe if we think about the balance of fiscal 2021 here. I just want to make sure I have some of the data points right. One is that, at the high end of Veritor testing, that implies another $250 million or so in each of fiscal 3Q and 4Q. And as we think about a second half approval next year for Alaris, just maybe remind everyone about the process of how long it takes from order to delivery to booking revenue, just so we can appropriately scale up our sales and the models for next year? Thanks.
Tom Polen:
Just so, Robbie, on the question around Veritor, just as a reminder, we've always used, and emphasized the word, towards the high end, not the high end, which is what you just calculated. So if you -- you're maybe a little bit less per quarter than what you said to get towards the high end of the range, right? But to your point, we're almost -- we ended the first two quarters at almost $1 billion of revenue on Veritor. So you could think, we're on basically roughly two-thirds of the way through that number halfway through the year, which gives us confidence in reiterating that towards the high end of that range. And as you said, it's maybe a little bit less than what you indicated, would be split by quarter there. On the Alaris, we do have a backlog of orders that we would be able to ship initially. And then as we think about upgrades, those are shorter install times than, let's say, Pyxis, so it would be a couple of months typically in that space, from an order to implementation for Alaris.
Robbie Marcus:
Great. Thanks.
Tom Polen:
Yes.
Operator:
Your next question comes from the line of Vijay Kumar with Evercore ISI.
Tom Polen:
Good morning, Vijay.
Vijay Kumar:
Hey, guys.
Chris Reidy:
Good morning.
Vijay Kumar:
Good morning, Chris. Good morning, Tom. Thanks for taking my question. One -- actually, a couple on the spin itself. I guess, the base business is now going to accelerate by 30 basis points. So if I look at the prior guidance of 5% to 6% top line, are we now looking at perhaps the base being north of 5.5%? And on the spinco I heard some comments on patch pump. What should the growth rate for spinco be? Is that going to accelerate the north of 5%?
Tom Polen:
Yes. Go ahead, Chris, take that one.
Chris Reidy:
Yes. Let me take the first one. So you're absolutely right. We put in that, there would be growth of 30 basis points. And just think of that as a $1 billion or so of revenue, which has been relatively flattish compared to the rest of the $17 billion growing that mid-single digits. If you do that math, you can see the drag that that has of 30 basis points. And I would remind you that, our guidance is a recurring mid-single-digit kind of growth rate and so that 30 basis points gives us greater confidence in the ability to achieve that on an ongoing regular sustainable basis. So that's a positive. We haven't addressed the growth rate of spinco going forward. You heard Dev say that his emphasis is on growth. And we think that, being a separate public company, it unleashes that growth potential, because right now spinco would be fighting or diabetes care within BD is fighting for investment against other items that we are -- feel more strategic. So as a separate company, it can invest, whether that is internally more investment in R&D or through M&A, it can do that. So more to come on the growth profile of spinco as a separate entity, but that's kind of directionally the way to think about it.
Tom Polen:
And, Vijay, you did ask about the -- this is Tom, about the patch. So that does continue in -- the patch pump. That continues in our pipeline with external development partner, as we've shared in the past. And certainly, as we approach the actual timing of the spin, you can expect that there will be further discussions on the strategy of the diabetes business and updates on that and other products within our R&D pipeline and on Dev and his team's vision for the business post spin. But those discussions as is typical in these situations wouldn't happen until we get closer to the spin.
Vijay Kumar:
That's helpful, Tom. And maybe a follow-up. I think the press release noted the transaction to strengthen the mid-single top-line and double-digit TSR profile. Just wanted to clarify are there any dissynergies? I'm assuming there are some. I know in the past you had spoken about double-digit EPS. Is that still intact on an underlying basis? Perhaps parse out the double-digit TSR versus what it means for EPS.
Chris Reidy:
Yes. So as we said this strengthens -- the spin actually strengthens and gives us more confidence in both the top-line and the bottom-line. And that will be clear as we talk about the operating margins as we said from the SpinCo. So this gives us more confidence in that and so it supports that effort.
Vijay Kumar:
There is no change from prior LRP correct?
Chris Reidy:
You did mention Vijay that the stranded cost there would be some stranded costs in any transaction like this. We feel good about the fact that we can address those stranded costs. And obviously, we'll have a couple of years of TSA agreements that will mitigate those for a couple of years. So we're not concerned about stranded costs having an impact.
Tom Polen:
And Vijay as a reminder we've been reaffirming ever since I've been in the role mid-single-digit revenue growth double-digit TSR and reaffirming that this actually strengthens our position on both of those. So the Diabetes Care was growing below the company on revenue and on operating income.
Vijay Kumar:
That’s helpful. Thanks, guys.
Tom Polen:
Okay.
Operator:
Your next question will come from the line of Larry Biegelsen with Wells Fargo.
Tom Polen:
Good morning, Larry.
Larry Biegelsen:
Good morning. Thanks for taking the question. One on the diabetes spin, one on the underlying growth assumed in the guidance for fiscal 2021. Just to start with the diabetes spin. Tom diabetes is seen as a high-growth area. It did grow 3% before 2020 for a few years. Why not invest in it? I mean the slide presentation suggests that this is an attractive area.
Tom Polen:
Yes. So it's a great question. As we think about other opportunities in the company that we have whether or not it's across our Interventional segment and just the tremendous technology opportunities that are happening there in our BD Medical segment as well future of medication management and the opportunities in the non-acute space, the opportunity again to apply automation and informatics across both our Interventional and Medical and our Life Science business are significant for us. We see very attractive opportunities in those areas. And also of course diabetes business as we look at it, it has a more unique business profile relative to our other franchises. So, for example, they have very distinct patients, physician and distribution channel dynamics as compared to our other businesses. As you think about our BD Medical, excluding Diabetes, our Interventional and our Life Science franchise they have very significant overlap in call points right? They all call on health care systems. It's where we sell the majority of our Life Science products, our Interventional products and our BD MMS and MDS products into that channel. That's very different than diabetes. And as we think about that digital footprint that we've been building out how we're leveraging data and connectivity connected into electronic medical records across the segments that's also a different dynamic than what we see in the diabetes care business, which is again it's not connecting into EMRs in the same way, it's more directly outbound in the patient. And as you think about future technologies like patch pump or other options they also will require a very different commercial channel than is the -- what's inherent in the rest of the BD businesses be the eye life sciences or the rest of Medical. So we think that absolutely there are tremendous opportunities for BD Diabetes Care business which is why we're excited that spinning them will be -- allow them to unleash that potential not competing with other programs in the company allowing them to attract the best talent, reinvest their profits back into driving their strategy in a very focused way and will allow RemainCo BD to also be more focused in executing our strategy. So that's why we again reiterate why we're so excited about this being a tremendous opportunity for not only the business, but for our shareholders and our associates.
Larry Biegelsen:
That's helpful, Tom. And Chris what are you assuming for the underlying growth ex-COVID testing in fiscal 2021? I'm getting about 4% at the high end. But this -- if I'm doing the math right it implies about let's call it flat sequential underlying sales in fiscal Q3 and Q4, I'd call it $4.4 billion. But your sales typically increase in fiscal Q3 and fiscal Q4 if I look at historical seasonality. So is this math right? And is this just conservatism given the recovery that we're seeing. Thanks for taking the questions, guys.
Chris Reidy:
Sure. So, number one is that the core is actually accelerating and so the growth rate in the core will be ramping and we're now saying we'll end the year at mid-single digits in the core. So, a couple of things going on as we think about and contemplate the remainder of 2021. So, number one that core momentum is increasing. We did mention that Veritor is still within that towards the high end of that 1% to 1.5% range. But it has moderated slightly as volumes have come down a bit from the last time we gave guidance. And so that offsets that a little bit. And when you're looking at the pure dollars it's that Veritor testing and the COVID testing that's impacting the pure dollars. So, the bottom-line is -- the good news is the momentum is in the core moderating slightly on COVID testing as we look out the second half of the year. You put all those together and we're right where we said we would be in terms of both the topline and the bottom-line. On the bottom-line, we're also seeing a little bit of an impact on the profitability of Veritor as the prices begin to move more rapidly towards the typical flu pricing. And so that's having an impact and that's being offset in the second half of the year. So, we're still within the guidance range on the top and the bottom.
Kristen Stewart:
And keep in mind Larry too in Q3 there is that large amount of revenues associated with medical necessity in MMS so that does have a little bit of upticks--
Chris Reidy:
On a year-on-year basis. Last year there's a very large -- yes.
Kristen Stewart:
And stronger revenues for the second half of the year in MMS too for the European revenues too for pumps.
Tom Polen:
That's when pandemic was in it's in its peak. Yes.
Kristen Stewart:
Thanks for the question. Next question.
Operator:
Your next question will come from the line of Richard Newitter with SVB Leerink.
Richard Newitter:
Hi good morning. Just maybe going to the tuck-ins that you've been executing on and I'm sure you'll get a little bit more into this when you have your Investor Day later on this year. But is there any particular asset amongst the five that you did year-to-date and I think you pointed to six last year? Anything that's more needle-moving or that will be contributing in your mind as we head into fiscal 2022? And then also how should we think collectively of what these might be able to add in terms of basis points to growth on top of that mid-single-digit normalized rate in 2022 just ballpark?
Tom Polen:
Yes. So, we obviously view that as a form of -- we think about organic and inorganic innovation opportunities as both fueling that growth profile that we have and that we've defined. I think as we think about just the five that we've done this year, obviously, six last year, there are a number of them that are meaningful within the businesses that we have. We're really excited about the new catheter for example in BDI in their Peripheral Intervention business which is where that will show up. It's going to be a great product for them. It's really a breakthrough technology that's in a market that again is growing much faster than the company average. As we think about the two acquisitions in MMS that get us into the non-acute medication management area. That's an area that's growing much faster than the acute care medication management. As we've made very clear in our strategy helping to enable the shift of care into the non-acute sector is important to us. And we want to have a continue our leadership in the acute but be the leader also in enabling the trend that's happening building up the capabilities in the non-acute sector. And so those two acquisitions I think we'll look back on as being very strategic in enabling that. And both of those markets are growing in the teens. So, again, very positive growth rate there. And there's a couple that we haven't disclosed yet and you can see on the slide 13 that we had shared products like an infection prevention product. We haven't launched a new infection prevention product for a while. Obviously, our ChloraPrep franchise and a great commercial organization that drives that product globally. This will be a nice new addition to their bag and we'll talk about that forthcoming just like we did with Pristine. We had acquired that last year but we didn't announce it until now until we're actually launching it. So we'll do the same there. And the same factor with a new vascular access product that we're excited about that we just closed in the last month or so which we'll talk about very forthcoming as we bring that to market. So a number of different opportunities all very relevant in driving our business strategy. All of those acquisitions are participating in markets and we expect to grow faster than the BD average and again, it's part of our growth strategy.
Richard Newitter:
That's helpful. And then just looking forward, do we think of now that you're obviously grooming the portfolio a little bit with the diabetes planned spin-off now, do we kind of think of you guys as potentially moving up the size of the kind of the M&A target pool that you'll be willing to do going forward into 2022 and beyond once the spin-off occurs?
Tom Polen:
Yes. Richard, we're still very focused on tuck-in M&A. Obviously, for us as a company of our size, tuck-in M&A can be probably in a couple of billion-dollar range in terms of deal size, but we certainly are not looking to do anything on the transformational side of like a CareFusion or Bard-type size. And that's very consistent with the strategy that we've communicated. Could you see larger tuck-in M&A deals than what we've done to date? Yes, but they would still be tuck-in M&A.
Richard Newitter:
Thank you very much.
Operator:
Your next question comes from the line of Josh Jennings with Cowen.
Josh Jennings:
Hi. Good morning. Thanks for taking the questions. Just one question on Alaris and one follow-up. On Alaris, a lot of focus there some great updates by the Becton team today. I was just wondering if you could help us understand, how much of a drag the Alaris mediation has been on the core business's organic revenue growth? And just thinking about coming back on board in the second half of fiscal 2022 and how to attempt to forecast that return might help just to understand what the drag has been. I mean, may be difficult to parse out just because the pandemic the medical necessity orders et cetera, but any help there would be really appreciated.
Tom Polen:
Sure. I'll turn it over to Chris to share some thoughts on the -- that element that there certainly has been a drag and we've been investing. As we've shared we have a team of over 200 people who have been working on that submission. They'll continue to be engaged in responding to any FDA questions. And obviously, we'll pivot them towards innovation opportunities as we move forward beyond that as well. But maybe just another point as you think about the timing of it, I can give a little bit more color is, if you look back right just factually look back and say over the last few years, how long has the FDA taken to clear pumps. And the date -- the clearance time ranges from 161 days to 412 days. So those are the facts. So call it 5.5 to 14 months. So that's a little bit of the logic. While we're not predicting the FDA time line right now, clearly the timing of approval within FY 2022 will have a meaningful impact in the answer to your question in terms of how we see the recovery and how much that contributes in 2022. And again, as I mentioned before, as we get further in the review process we'll provide updates as we can. But right now we're saying it will be prudent based on again historical clearance timings as I just described. So think about the clearance during the second half of our fiscal year 2022. So Chris, maybe any comments on the drag that it's been...
Chris Reidy:
Yeah. Just to give a little bit on the revenues the -- in last year, we had medical necessity revenues of about $130 million or thereabouts. And don't forget, we had some non-medical necessity earlier in the year. So you're thinking about $200 million of revenues last year. The run rate prior to that was about $450 million thereabouts. So you could see that step down. And then this year, we see less medical necessity a little bit over $60 million or so in the first half of the year. We see that tailing off in the second half of the year. So that gives you some things to work with to show that there is certainly a drag on growth rate from the step down offset by some of the medical necessity revenues, but certainly a step down in both 2020 and 2021. As you think about next year, what we were giving you a sense of is that we think it's prudent to model that as during the second half of the year. It could happen sooner, we'll work to try to make it happen sooner, but it's prudent to think about it in the second half of the year. And we did point to the fact that there is some ramping that will happen. The good news is that we'll get the full year benefit of that coming back to us in FY 2023 regardless. But we do expect to see some of that ramping in the second half of the year.
Kristen Stewart:
Great. Thank you, Josh.
Josh Jennings:
Thanks a lot. Pretty helpful.
Operator:
Your next question will come from the line of Matt Taylor with UBS.
Tom Polen:
Hey, Matt. Good morning.
Matt Taylor:
Hi, guys. Good morning. Thanks for taking the question. So I just wanted to circle back on the spending comments and see if we could get some help on understanding how you're going to reinvest the Veritor profits over the next couple of quarters, the impact on the margin. So maybe the way to ask this question would be to start with how much of the $200 million have you spent already, or just to ask spending was about flat sequentially. Is that a good way to think about modeling the second half and getting to that low 20s margin?
Chris Reidy:
So we did give some insights into the impact of that spending. We did point to a lot of folks don't realize that some of that actually hits our gross margin and so we pointed to the fact that there was a 70 basis point hit to the gross margin number within Q2. We -- the way to think about that spending in the $200-plus million is that it is more ratable. We do see some -- you would expect some of that to ramp a bit. And so we're not being precise about exactly how much was in each quarter. But it is -- there's more to come. And so it is putting pressure on the margins which is why we're saying that the guidance for the second half is what it is as we expected it would be. So it is important to keep in mind that that investment that we're making does drive future growth, it's not something that will impact margins going forward. It's not going to repeat. And it is as a result suppressing both gross margin and operating margins this year.
Matt Taylor:
Okay, okay. That's helpful. And then I want to ask one on the guidance slide that you have here saying that, you're assuming that the acute care-oriented businesses do not return to pre-COVID levels. I guess can you talk about how close they're going to get to that, or when you think they will return to pre-COVID levels, or just recent trends it sounds like April was a continuation of March. Anything like that to help us kind of triangulate how the recovery is expected to progress.
Chris Reidy:
Sure. So we have seen some improvement in utilization in March for example and that continue in April. But as we said, we don't expect that to get back to the 100% level. It does get up into the 90s by the back end of the year. We're more in the 80s, high 80s now. So we expect that to start creeping back but not completely get back in the second half of the year.
Tom Polen:
And there are areas as we look at that maybe Simon – it's something we monitor very, very closely. We feel very good in terms of where we're – in all of our categories, particularly on the – all of our categories overall. But on the procedural side, we feel very good about our share positions and where we're trending there. So maybe Simon to comment what you see from a recovery because it does vary. We do have some areas that are at 100% of prior year today and some procedure areas that just take a little bit longer. Again, I think that's associated with the severity of the condition as it still opened up and it varies on geography as well.
Simon Campion:
Yes. So obviously, our European business was disproportionately impacted I think in the last quarter. But as Tom alluded to, we do track this every couple of weeks. We've done monthly surveys with customers. And sequentially, as I noted earlier on, it has improved across the two main businesses that are impacted PI and Surgery and some aspects of those businesses or some platforms did strike 100% of pre-COVID levels in March and that continues into April. As I noted earlier, hernia is one of those areas that's severely impacted early and recovers late. So that's a bit of a laggard. But in general, the procedures that are critical to health care are coming back. And not only do we see it in our numbers but the survey data that we gather from physicians and we typically survey about 300 a month, they are indicating that their volumes are rebounding. And obviously, patients that were put on hold are now going to start to come back over the next four to six months as well. So it's – we're in a reasonable spot.
Tom Polen:
Very good.
Matt Taylor:
Thank you, guys.
Tom Polen:
Thanks for the question, Matt
Operator:
Your next question will come from the line of Matthew Mishan with KeyBanc.
Tom Polen:
Hi, Matthew. Good morning.
Matthew Mishan:
Good morning and thank you for squeezing me in. First just a quick clarification. The revenue growth of mid-single digits for FY 2022 excluding Alaris and testing, obviously testing is like the negative. But is Alaris a good guy or a bad guy for next year? Because I think first half would be less medical necessity but then you have the timing of the FDA.
Tom Polen:
So we would expect that to be a net good guy.
Chris Reidy:
Yes, a net good guy. So when we're doing that we're saying specifically excluding the COVID testing, which will get more clarity on as we go forward. And excluding the come back of the 510(k) from Alaris. So that would be incremental to that mid-single-digit core growth.
Tom Polen:
Yes. We will continue of course to ship under medical necessity for those customers that qualify. But once we get the 510(k), which again, will have more clarity on the exact timing of that, which will be meaningful. To answer how much of that will fall in 2022, we certainly expect a full year in 2023. But stay tuned on that but in any situation we would expect it to be a positive.
Matthew Mishan:
Okay. And then just your thoughts on Alaris' impact on the overall portfolio. Think of it like a Pyxis. Did it have a negative impact on the Pyxis? And when it comes back will it have a broader portfolio impact outside of just Alaris?
Tom Polen:
Yes. We have seen no impact. Of course, the customers have very, very broadly stuck with Alaris. Alaris is the market-leading product for a reason. We've talked about the percentage of infusions, particularly in the US that happened with Alaris and it's a tremendous number. And customers – we do expect the majority of customers to upgrade to the new product as we end up launching that, hopefully in 2022, as we noted is our expectation. So because of that we don't see any impact on Pyxis. Obviously, there is a great value that one gets from having the full BD enterprise medication management suite that allows you to do things like diversion analytics and other parts of our HealthSight platform to use data from not only dispensing but infusion, as well as our software that's in the central pharmacy. And so all of those things remain the case going forward and we think customers will continue to see strong value in that.
Matthew Mishan:
Thank you very much.
Kristen Stewart:
Operator, we'll take one last question.
Operator:
Our final question will come from the line of Jason Bednar with Piper Sandler.
Tom Polen:
Good morning, Jason.
Jason Bednar:
Hey good morning. Thanks for taking the question, squeeze me in. I'll just start with one on the spin and then I'll have a follow-up. Just on the spin what should we be thinking about for the balance sheet for NewCo? You mentioned NewCo has the flexibility to make investments and advance the strategy, but also seems reasonable that maybe some level of debt will transfer over to the Diabetes Care business. So are those decisions made, or will they still be kind of in-process? How to think about that?
Chris Reidy:
Yes. So no that's -- those are decisions that will come as we move forward and we'll provide more details on that closer to the spin date. We do expect that the capital structure along with the existing cash profitability will provide them the flexibility to pursue inorganic growth opportunities. So we want to make sure that they have that kind of flexibility and then it will be part of what goes into the equation in terms of how much debt they'll carry.
Jason Bednar:
Okay. Great. That's helpful. And then what's the right time line to think about for the at-home COVID test? I know it's still in development, but just timeline there. And then what's the right way to think about the go-to-market effort? We do have a proxy out there with an at-home offering that has an established price point. So do you come in at a similar level, or do you have a feature set that maybe justifies a higher price point?
Tom Polen:
Yes. We -- so as has been our practice until we get the EUA in hand we don't project a specific launch timings. But we've been very active in development on that for a bit. It's been advancing very well in our pipeline. And so stay tuned as soon as we get an EUA for that product. You and everyone else will be among the first to know on that. And obviously, we are taking actions to prepare for that channel which we recognize is a unique channel versus the other ones and we're taking those actions to prepare for that launch. So we think we'll be well positioned when we do get the EUA and stay tuned. We'll look forward to announcing that.
Jason Bednar:
All right. Thanks so much.
Tom Polen:
Okay. Thank you, Jason.
Operator:
I will now turn the call back over to Tom Polen for closing remarks.
Tom Polen:
Okay. Well thank you everyone for the excellent questions. And before we sign off I would be remiss not to wish, Vince Forlenza a wonderful retirement. And I expect that Vince is listening. Vince's last day on the BD Board was last week and I've mentioned in the past that Vince's leadership transformed BD. And I'm also grateful for the time, I got to work alongside him and for his mentorship. So on behalf of everyone at BD I just want to wish Vince all the best. And lastly, on behalf of the Board and the entire executive team I want to thank BD's 70,000 plus associates around the globe. Your efforts and sacrifices have not gone unnoticed. We are making great progress. We're making meaningful impacts for our customers. And most importantly, we are advancing care around the world. I've never been more excited about what lies ahead for us. For those who remain part of BD and for those that will ultimately become part of NewCo these are exciting times. And I hope everyone stays safe and healthy and thank you for listening today.
Operator:
This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to BD’s First Fiscal Quarter 2021 Earnings Call. At the request of BD, today’s call is being recorded. It will be available for replay through February 11, 2021, on the Investors page of the bd.com website or by phone at (855) 859-2056 for domestic calls and area code (404) 537-3406 for international calls using confirmation number 6993448. [Operator Instructions] Beginning today’s call is Ms. Kristen Stewart, Senior Vice President of Strategy and Investor Relations. Ms. Stewart, you may begin.
Kristen Stewart:
Thanks, Stephanie, and welcome to BD’s review of our first fiscal quarter results. Joining me today, we have Tom Polen, Chief Executive Officer and President; Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer. During the Q&A portion of the call, we will have our three segment presidents joining us as well
Thomas Polen:
Thank you, Kristen, and good morning, everyone, and thank you for joining us. We are very pleased with our Q1 results, which were ahead of our expectations, reflecting the tremendous efforts and execution of BD’s 70,000 associates. The essential role of our products and solutions and healthcare and a greater resiliency of the health care system in treating both COVID and non-COVID patients. While our fiscal year has just started, I’m proud of the team for the momentum we are building and their dedication to our purpose of advancing the world of health. Revenues increased 25.8% on a reported basis or 24.3% on an FX-neutral basis, with 20.3 percentage points of growth coming from our COVID-19 diagnostic revenues. While we did see some benefits from timing in the quarter, we are very pleased with the performance of the base business, which was up 4% against the backdrop of COVID resurgences around the world. We are seeing the early benefits of some of the actions we have taken to drive our base performance. Our adjusted EPS were $4.55 or up 72% versus the prior year. This was also well above our expectations as a result of three factors. First, our revenues came in above our plan, driven by higher acuity, driving increased demand, greater resiliency and procedural volumes and exceptional execution in COVID diagnostics. Second, we benefited from favorable product mix, like Veritor, but also from our higher acuity products. Third, our investment spending, such as in R&D, was lighter and earlier in ramping. So as you can see, we started this year with strong momentum, and that is despite the COVID resurgence. We did start to see some impact of the resurgence on our more elective procedure related businesses late in December, and that continued into January. However, we are feeling more confident in the resiliency of our base business relative to what we saw early on in the pandemic. While the health care markets continue to be dynamic with COVID-19, and there are a number of moving parts, the momentum within BD and our conviction in our strategy lead us to raise our financial guidance for fiscal 2021. Our focus is not only on fulfilling our near-term commitments, but also on advancing our strategy and creating value for our shareholders over the longer term. And I’m feeling even greater confidence with the progress the BD team is making in advancing the BD 2025 Grow, Simplify and Empower initiatives and our ability to create substantial shareholder value. Today, I want to focus my remarks on three key topics, and then I will turn it over to Chris, who will provide additional remarks on our quarter’s performance and comment on our outlook, then we will take your questions. So let’s jump right in. First, let me start with the Alaris remediation and our overall quality and compliance initiatives. Alaris remediation has and continues to be my number one priority, and the team is making strong progress. Our focus remains on submitting a comprehensive 510(k) filing for the Alaris system, and we remain on-track to submit it in late fiscal Q2 or early fiscal Q3 2021. We also continue to make progress on executing our holistic Inspire Quality initiatives throughout the organization. Second, as you know, we have a very strong focus on growth and ensuring a durable mid-single-digit revenue growth profile, so let me share some of the exciting highlights in our pipeline and other growth initiatives. We continue to increase our investments and strengthen our pipeline across three innovation themes that leverage our core strengths. First, we are applying smart devices, robotics, analytics and AI to improve care processes. Second, we are enabling new care settings to enhance patient experience and lower costs. This includes investing in products designed for use in the home markets and in sales channels to support these patients. And third, we are investing to improve diagnosis and treatment of chronic disease. So in line with these innovation and investment priorities, in Q1, we acquired the medical assets of CUBEX, which expands our medication management offering by combining a cloud-based, easy-to-deploy analytics platform with a smart tabletop dispensing device to create solutions for the fast growing non-acute care market. This extends our medication management solution from the hospital into the long-term care surgery centers and other non-acute locations. Another smart device we plan on launching this quarter is the Sensica automated urine output system, which leverages BD’s leading position in acute urology, along with BD’s broad EMR interoperability capabilities and installed base. Also within BD Interventional, the BD PureWick urine collection system and catheter continues to be a significant driver of growth for our urology and critical care business. PureWick is a female external urinary catheter and urine collection system that we sell into the acute care and long-term care settings, but we are now actively extending that directly to patients with our new PureWick dry dock system for the home. And this launch is exceeding our expectations. And in fact, PureWick revenues now exceeds Lutonix. An exciting launch later this year, designed to improve the diagnosis and treatment of cervical cancer, is the U.S. launch of our new BD COR with our BD Onclarity HPV assay with extended genotyping. With BD COR, BD is going to enter the high throughput molecular testing market with a very unique, fully automated sample-to-answer platform in a highly differentiated assay with unique claims that can improve risk stratification and support risk-based patient management. The system has been CE-Marked and has been very well received by our customers during our launch in Europe. These are just a few of the many products in our pipeline, and you can find further details on our new innovations in the supplemental earnings presentation posted to our website. As we have previously shared, we are investing a portion of our Veritor profits to advance our BD 2025 strategy. We expanded the size of the BD Innovation and Growth Fund, and additional innovation projects are being initiated on a rolling basis. We are investing to accelerate our simplification initiatives, including recode and enhancing our quality and compliance programs. We are also increasing funding in our BD University to support advanced employee education and leadership development as part of our strategy. As we always do with our spending, we are taking a disciplined approach, and the timing of the spending was lighter in Q1, and we expect it to step up in Q2 and remain higher for the balance of the fiscal year. As we have mentioned before, we continue to actively evaluate tuck-in acquisitions to supplement our growth strategy. And we executed on three strategic tuck-in transactions so far this year, including CUBEX’s medical assets that I mentioned earlier. We continue to apply a disciplined financial and strategic evaluation process to these transactions and have a robust funnel up. Lastly, I would like to update you on our COVID diagnostics outlook and specifically Veritor. Antigen testing continues to become more widely used in both traditional and nontraditional settings. We have been highly successful with our BD Veritor Plus COVID-19 launch. Veritor has been well received for the ease of use, performance and automated digital data and informatics capabilities that are provided with our handheld platform. We have nearly tripled our active reader base since the pandemic and now have more than 70,000 BD Veritor analyzers globally, which we intend to leverage in the future with planned non-COVID menu expansion, which we have already begun investing behind. As previously shared, we continue to make good progress on advancing new COVID diagnostics in our pipeline, including combination flu A/B and COVID-19 assays on both BD MAX and Veritor. We also continue to explore home testing on BD Veritor. It has been our practice we will provide updates to these programs upon launch. Turning to the quarter’s performance. Our Q1 COVID-19 diagnostics revenues were higher than we expected at $867 million, which included better than expected BD Veritor rapid point-of-care antigen test revenues of $688 million and higher BD MAX COVID assays and collection swabs and transport devices. The higher than expected Veritor revenues were the result of our ability to scale our manufacturing faster, which is a testament to our manufacturing excellence, as well as realizing higher pricing than we anticipated. However, since we have been saying since last fall, we do expect pricing to move lower as capacity came online, and this is what is playing out. We recently lowered our pricing to allow the broadest patient access to our best-in-class BD Veritor Plus System. We believe this price adjustment is in the best interest of our customers and patients around the world as we have now ramped our manufacturing capacity, and there are emerging mutations that are making it more transmissible. We also believe this is in the best interest of our shareholders as we believe this move allows us to maintain a leadership position in the point-of-care market. With respect to our fiscal 2021 Veritor revenue guidance, as we have been discussing, there continues to be many variables at play besides the evolving pricing environment, including the rollout and adoption of vaccines and the circulation of new COVID variants. It is also difficult to pinpoint when the market supply for antigen tests will exceed market demand. For modeling purposes, we would suggest using an ASP in the low to mid-teens. Given all this, we expect Veritor revenues to be toward the high end of our previous range of $1 billion to $1.5 billion. We continue to expect Veritor revenues to be more weighted to the first half of our fiscal year. And given the evolving pricing and capacity environment, we would expect our fiscal Q2 revenues to be lower than our just reported Q1 results. Before turning it over to Chris to review the financials, I want to close with a few thoughts. While we were very pleased with the performance of Veritor and other COVID diagnostic revenues in the quarter, what excites us more was the improving momentum and resiliency of the base business. While we saw some headwinds in our procedure based businesses from the resurgence late in December and that continued into January, the impact was much more limited than at the start of the pandemic. Moreover, given the momentum in our base business, the investments we are making in our BD 2025 strategy, we believe we are positioned to emerge strong. We remain on-track to submit our Alaris 510(k) filing in late fiscal Q2 or early Q3, and we are making great progress in advancing our BD 2025 strategy. And I’m particularly pleased with the investment programs we have identified and initiated. These investments allow us to further fulfill our purpose of advancing the world of health, bringing new innovations to patients and expand access. Increased spending will be more evident in our P&L later in this fiscal year, but we believe these initiatives will translate into revenue accretion beginning in late FY 2022 and beyond. The investments we are making are also towards simplification initiatives, which reduce complexities, drive cost efficiencies, enhance our quality programs and improve cash flows. This quarter, we made several advancements on this front, including inventory reductions that we absorbed in our gross margin in the quarter that helped us strengthen our cash flows. Our ReCoDe efforts are on-track to achieve our targeted $300 million in cost savings by the end of fiscal 2024. We are also advancing our sustainability initiatives because we view sustainability as a strategic imperative. And we recently announced the first of our 2030 and beyond goals, our climate change targets. We are committed to reducing Scope one and two greenhouse gas emissions 46% by 2030 and to be carbon-neutral across direct operations by 2040. The science based target is aligned with the 1.5-degree C global emissions reduction pathway. And we look forward to sharing more detail behind our 2030 sustainability plan with you in future engagements. And finally, I’m very proud of the organization for being named for four consecutive years to the Human Rights Campaign Foundation’s Best Place to Work for LGBTQ Equality list and for the second straight year to the Gender Quality Index. Inclusion and diversity is an important focus for BD as we continue to attract, develop and retain the best talent as well as benefit from diversity of background and thought. I look forward to answering your questions during the Q&A portion of this call, and I will turn it over to Chris now.
Christopher Reidy:
Thanks, Tom, and good morning, everyone, and thanks for joining us today. We are very pleased with our fiscal first quarter revenue and adjusted earnings per share performance, both of which exceeded our expectations. Total revenues were over $5.3billion, in line with our January 12 pre-announcement. Revenues increased 25.8% on a reported basis and 24.3% on an FX-neutral basis. COVID-19 diagnostic revenues accounted for 20.3 percentage points of growth. The better than expected performance came from three areas
Kristen Stewart:
Thanks so much, everybody. And with that, I’m going to open it up to the operator, Stephanie. Stephanie, could you please read the instruction?
Operator:
[Operator Instructions] Our first question is coming from David Lewis from Morgan Stanley.
David Lewis:
Well good morning and thank you for taking the question and congrats on a nice start to the year. Just two for me, team. So first, just earnings reconciliation, Chris, obviously, beat by more than $1.50, raised by $0.30. And I know you gave some parameters there. But we had pricing reductions in our model. We had 20% reinvestment of that upside in the model, even when you make those kind of adjustments as well as stocking, it is still a little hard to reconcile the upside in the quarter relative to the guide. So I appreciate it is a less visible environment. But is there anything else? Is that investment going higher or anything else we may not be thinking about that would explain why we are not getting this sort of that pull-through in the second, third quarter? Because I think that is going to be the key question this morning of the call.
Christopher Reidy:
Sure, David. Thanks for the question. And I would say, first of all, it is early in the year, obviously. So we are raising - but some of the factors that you mentioned we do see playing out in the remainder of the year. So we had a few things going on. Obviously, we mentioned that Veritor, we would expect that revenue to come down in the remainder of the year and moderate, as we talked about. We also had timing in the base business that we would expect to moderate. And to your point, we do expect the investment spending both in the Veritor reinvestment program that we have discussed as well as R&D and quality to ramp. So we started those programs in Q1. We watch that spending with some prudence as we looked at the pandemic playing out. And so we got started, but the ramp really comes in the second, third and fourth quarter. And so when you put all of that into context, you also have to take into consideration a little bit of impact from the resurgence that we saw that we mentioned we have playing out in Q2. So with all of those factors coming into play, we felt that it was prudent to think about the guidance that we gave as appropriate at this point.
Thomas Polen:
Dave, this is Tom. Thanks for the comment. Just to reiterate what Chris mentioned, that other topic is that we still are in the middle of a pandemic. We want to be prudent, right. We did see some increases on impacts in procedure volumes in this late December and throughout January. It was certainly less than what we had seen earlier in the pandemic. But there are new strains underway, et cetera. And when we gave guidance at the beginning of the year, we said it excluded, right, the impact of a resurgence. Well, there has been a resurgence. And we have been navigating that very well and actually are raising our outlook in the middle of a resurgence. So we will continue to evaluate as things go forward, but we are certainly pleased with how we started the year.
David Lewis:
Okay. So the state of factors you have mentioned, but we are not missing anything, it doesn’t sound like. Okay. The second question for you, maybe Tom, more strategic. This is obviously going to be very good year. We will see significant upside. The balance sheet is obviously in dramatically better shape now than it was a year ago. As you think about 2022, Tom, how are you thinking about the durability of COVID testing? I know it is a challenging question. And then the ability to sort of manage through what is likely going to be sort of a volatile or void driven earnings period as you head into 2022? How are you thinking about sort of 2022 and beyond COVID-wise and sort of managing the earnings process? Thanks so much.
Thomas Polen:
Yes, I will start on that, and then I will turn it to Chris as well to share some comments. Let me maybe focus on specifically COVID testing, and then Chris can make some broader comments on the broader business. And we have shared, by the way, in the past, we still remain very confident and expect our revenues, excluding COVID diagnostic testing, and Alaris pump revenues to grow in those mid-single digits on an FX-neutral basis for 2022, and that remains our aim and our expectation. In terms of COVID testing as we go into 2022, certainly, as I had shared before, as we got into COVID rapid testing in last July, obviously, we didn’t have a high expectation that there would be much testing in 2022. And as kind of each quarter has passed since that launch, in July, we have said we are feeling more confident there is going to be some level of testing in FY 2022 and that certainly remains the case. I think one of the ways to think about, as our capacity has gone up in the space, as we recognize the new strains coming in the market, as antigen testing continues to increase in its receptivity and people understand now the value in increasing ways of getting a test result in 15 minutes, you saw us take some actions this quarter to get pricing in that low to mid-teen level, which we think will be more - actually position us well to, as I said, to maintain a leadership position for whatever market continues to evolve going into FY 2022, right. That is part of the thinking. Where the actual market ends up in 2022? I don’t know at this point in time. I think there definitely should be some level of testing. And our aim is to make sure that we are positioned to be a leader in however that testing evolves. And other things that we are investing in as well, be it our combination assay, which is progressing well in our pipeline, the flu COVID assay for our exploration of home testing are all aimed with that thought in mind as well. So maybe, Chris, just maybe some broader comments on FY 2022.
Christopher Reidy:
So yes, obviously, we are not going to go through 2022 with any level of precision, but I think it is important to give some high-level comments on it. And as Tom mentioned, the level of COVID testing is a variable that will have a big impact on 2022. We do see the sustainability of testing, but at what level, it is really hard to guess at this point. In addition, there is a lot of other uncertainty around COVID in general, the resurgences, mutations, the uptake of the vaccines. And in our business, obviously, Alaris and when that comes back in 2022 will have an impact. I would remind you that on our November call we said we expected our revenues, excluding COVID diagnostic testing and the Alaris pump revenues, to grow in mid-single digits on an FX-neutral basis. And we continue to see that as a reasonable assumption. We can’t predict when the FDA clearance for Alaris and our focus on making a comprehensive filing to support a timely approval is there, but we would expect some clearance sometime in fiscal 2022. We would also not look at the second half of 2021 as a proxy of what to expect in 2022 because both the gross and operating margins are impacted by several factors. Our operating margin in fiscal 2021 reflects these incremental investments we are making as part of the investment program of Veritor that really helps drive durable growth aligned with our 2025 strategy. And we don’t expect those investments to continue into 2022, so exiting 2021, they’ll roll off and that should help margins going into 2022. The other thing I would point out is that Q1 fiscal 2022 will obviously be the most difficult comp from a margin perspective, given the very strong quarter we just reported. For example, most likely face the most difficult comparison with COVID revenues as well as from the impact of the timing and stocking that we talked about. So we would expect our operating margin to compress year-over-year from the 31.6% that we just achieved. So we will update you more on our thoughts on 2022 as we progress through the year, but we just thought it is important to provide some of those highlights.
Thomas Polen:
Yes. And as you mentioned, Dave, we feel really good about the progress of our strategy overall and the underlying business momentum that we continue to build upon.
David Lewis:
Thanks so much for the detail.
Thomas Polen:
Thank you.
Operator:
Your next question comes from Robbie Marcus with JPMorgan.
Robert Marcus:
Great. Congrats on a good quarter also and thanks for taking the question. I wanted to touch on one of the slides in the back you have that the underlying basis ex-COVID grew 4% in the quarter, which was a really healthy rate. How are you thinking about that base business ex-COVID growth through the cadence of the year here? That is a pretty healthy start in what was a tough quarter. How should we think about that component of the business throughout fiscal 2021?
Thomas Polen:
Okay. Thanks, Robbie. I will let Chris answer that.
Christopher Reidy:
Yes. I think one way to think about that is what I mentioned about 2022 is that we expect the base business to be ramping at a mid-single digits. So that is consistent with that. So I think that we feel the underlying business is solidly in that kind of perspective and as we talked about the base business, we expect to be kind of in that low to mid-single-digit level for the full year. And so there is some pressures in the second half of the year on a business-by-business basis. As you think about MMS, there will be some issues. It is going to be lumpy in the remaining quarters. MMS had a significant amount of revenue in the third quarter during the pandemic last year. Other parts of the business will ramp nicely. China, for example, as we lap the COVID impact that really was in Q2 there in China, so we will start seeing some revenue growth from that. But again, that is more of a compare. It is not an indication of the underlying business. But the underlying business really is in that low to mid-single-digit basis. We have some general issues with compared to the - based on the Alaris ship hold. Some of that has been negated by medical necessity. So there is a number of factors going on. But the bottom line of it all is think about the base business, for the remainder of this year in that low to mid-single-digits and exiting into 2022 in the mid-single-digit basis.
Robert Marcus:
Great. Maybe just a quick follow-up. You are generating a pretty significant amount of cash here. You got the balance sheet in a great spot last year when things were looking pretty down for COVID, and now things are looking up. So how are you approaching the uses of this cash, particularly as we go into next year? And to follow-up on the last question, there is a question mark about how to bridge some of the earnings. What are you thinking about uses of cash, M&A opportunities across the business? And how much of that might get returned to shareholders?
Thomas Polen:
Robbie, I will start with it and turn it over to Chris for some further details. Obviously, you see us investing behind our growth strategy. You see us making investments in capacity, for example, capacity investments in rapid testing, capacity investments in helping the vaccination campaigns, whether or not that is with needles and syringes or the $1.2 billion investment you saw us announced last quarter related to our pharmaceutical systems, pre-fillable devices. We are going to continue to invest in growth. Part of that investing for growth is also our tuck-in M&A strategy, and you saw us begin to accelerate our efforts in that. Last quarter, you are seeing that continue into this fiscal year. And you heard me mention, we have a robust funnel to continue that. We remain very focused with an emphasis on tuck-in M&A as I have been iterating since transitioning into the role that I’m in today. As we think about more broad deployment of capital to create shareholder value, maybe Chris, comment on that?
Christopher Reidy:
Sure. Absolutely. And I would just say a few things first. We were very proud of the fact that we really focused on cash during the pandemic. And if you look back, in fact, at the third quarter of last year, our cash flow actually increased year-over-year despite the fact that the revenues were suppressed from COVID. And that was the result of a number of actions that we took in the business around inventories, receivables, payables. And so we are very proud of that. We are really focused on cash. As we mentioned at your conference last month, Robbie, we paid down $265 million of debt. That kind of gets us down to the target. So we see the leverage ratio floating down naturally without the need to pay down debt, which really says that the $5 billion-ish that we have paid down debt over the last couple of years, that strong cash flow that we are generating will be available to allocate to other value enhancements. So we have talked about primarily the tuck-in M&A and share repurchase. And as we get through this pandemic and as that safety net of cash that we have had to ride out the pandemic isn’t as necessary, we will have the ability towards the end of this year. And you have seen our tuck-in M&A ramping up, the pipeline is good. We continue to look at a number of opportunities. And by the end of this year, I think we will be also talking about giving that cash back to shareholders. Because once we get through this period, we don’t see the need to build up cash on the balance sheet. And so we would be returning that to shareholders after a certain amount of tuck-in M&As. So this puts us in a very good position. We have got great cash flow generation and better than ever, and that puts us in a great position to allocate that appropriately.
Thomas Polen:
And we continue, just as Chris mentioned, these are all programs with momentum. We have a cash committee that meets basically every week, and we continue to have teams dedicated to that work. So I appreciate the recognition there, Robbie, an d we are going to continue that work.
Christopher Reidy:
I think that recognition also came from Moody’s. We felt really good about the fact that they upgraded us to investment grade. In fact, not only did they upgrade us, but they kept the positive outlook, which we really appreciated as well. And so that puts us full investment grade across all three rating agencies, and we fully intend to stay that way Kristen Stewart Thanks for the question. Operator.
Operator:
[Operator Instructions] Our next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar:
Good morning guys and congrats on a solid [indiscernible]. So maybe I will limit to one question, perhaps a two parter. On the revenue guidance, Tom, did anything change outside of the Veritor coming in at the high end? And the reason I ask is, you guys just did 6 80 in Q1. The guide of 1.5 implies a pretty drastic fall off in Veritor revenues in the back half. And Chris, the margins here, I think, would imply a sub-25% op margins for 2Q to 4Q to get to the guide. That is below your pre-pandemic levels. I’m curious if there are any incremental expenses in the back half.
Thomas Polen:
Hey Vijay, a nice approach with the two part one question. So on the revenue side on Veritor, so I think the key thing to talk about there is the pricing comment that I made is one big piece that drives that, right. We said we were above 20% in the last quarter. And as we think about looking forward, we talked about modeling low to mid-teens. So that is the number one adjustment there. And again, that is not new news at all the fact that we have been talking about that we expect pricing to head in that level as our capacity comes online and we are in a better cost position, et cetera. And as more capacity is coming into the marketplace, and so we have taken actions as planned. And that is why we gave guidance. It said expect the revenues to be highly weighted to the first half of the year, and we have said that from day one. I think there remains uncertainty around the effectiveness and timing of the vaccines, especially with additional variants that are out there, et cetera. But we can’t predict what is going to happen there on the second half of the year. And so we remain projecting that there will be very strong demand for antigen testing in the first half of the year and that the second half of the year is less certain. Obviously, if demand stays very high and depending on the dynamics with capacity and demand and how those curves cross over, maybe there could be an opportunity in the back half of the year, but it is way too early for us to think about that as - because it is far from certain or able to be confirmed. So our aim is to position ourselves to be a leader in the space however it ends up evolving. And as we go forward, there will be more clarity there, but certainly a very dynamic environment. Maybe, Chris, on part two.
Christopher Reidy:
Sure. On margins, Vijay, Q1 margins were obviously very, very strong. And that was a function of a very, very strong. And that was a function of a number of things. First, the COVID testing, obviously. But the base business was very, very strong as well. And we drove some synergy and continuous improvement kind of margin improvements as well. So all things were positive in Q1. As we think about the rest of the year, you would year, you would expect that COVID testing to moderate as you model expect that COVID testing to moderate as you model that out, obviously. And then don’t forget you also have the unwind of the timing that we saw of the $100 million in Q1. That unwinds in the remainder of the year. But the most important thing is the ramping of investments that we have discussed. So we are investing in R&D. We are investing in quality. We are investing in the Veritor reinvestment program. And all of those things kind of ramp in Q2, Q3 and Q4. And so don’t think about that as an indication of our pre-pandemic margins. It is just completely different. And then those investments go away into 2022. The beauty of it is they begin to drive improvements in growth, in revenue generation, in margin expansion, and those things will kick in towards the latter half of FY 2022. So you get the pickup in margins by them going away and then the benefit of those investments in driving revenue growth and margin improvement going forward. So you can’t look at that as - those are different than pre-pandemic margins. So that is the way to think benefit of those investments in driving revenue benefit of those investments in driving revenue about 2021 as it plays out.
Vijay Kumar:
Thanks guys.
Operator:
Your next question is from Bob Hopkins with Bank of America.
Robert Hopkins:
Well thanks for taking the question and good morning. I will just stick to one topic, especially, Tom, since you mentioned it is still your number one priority. On Alaris refiling, are you guys just waiting on FDA at this point or is there more work that BD needs to do? And if there is more work, what still needs to be done? I’m just looking for a little bit more detailed update there. Thank you.
Thomas Polen:
Sure. And thanks, Bob, and good to connect. So as I mentioned, we remain on-track for the submission in late fiscal Q2 or early Q3. And we are not waiting on anything specific from the FDA. These are very comprehensive submissions, right, think 1,000 plus page filings that take time to prepare and have a lot of comprehensive data in them. And so, we have always said from the start, our focus isn’t in rushing into a submission, but it is around ensuring a comprehensive submission that is going to achieve our ultimate goal, which is a timely FDA review an d clearance. And so that remains our focus from that perspective. Obviously, Q2, Q3 is coming up upon us here. The teams are making great progress, and we continue to iterate that time line. We will continue, as we have in the past, as we get to those dates, we will provide updates at public conferences or as appropriate.
Robert Hopkins:
Okay. So not that everything is into the agency and you are just waiting to hear back from them? You guys are still putting the package together to submit?
Thomas Polen:
Correct. You can expect that, once we are still putting submit, we will communicate that in appropriate form, but we are preparing to submit in the time line that I mentioned.
Robert Hopkins:
Great. Thanks very much.
Operator:
Your next question is from Richard Newitter with SVB Leerink.
Richard Newitter:
Thank you very much. Just given that you are clearly accelerating tuck-in M&A from the capital deployment standpoint, which makes a ton of sense, especially with the COVID windfall and your free cash flow generation, should we be thinking about the contribution for what you might do on a more aggressive kind of M&A front going forward as maybe bringing you more towards kind of upper mid-single-digit kind of growth profile or even maybe high single digits? I’m just trying to think through the shift in the reprioritization here, clearly, more aggressive, more on offense. Is that where we are headed once we return to a more normalized environment?
Thomas Polen:
Okay. Thanks for your question. Obviously, our number one focus is on durable mid-single-digit revenue growth, and that is our aim here. And so we really see - we often refer to it inside as inorganic innovation. We look at our pipeline. We look at the market spaces that we participate in. I walked through three of our three key areas of innovation focus earlier in the call, and we evaluate constantly what products and initiatives we can fund organically and drive in-house to advance that strategy and create shareholder value and value for patients and providers. And we also are constantly looking at the external landscape as well to see what may be out there that could get to market sooner than we could or maybe has some great talent that create some really exciting innovations outside of BD that we can bring in-house. And so we are going to continue to do that, but it is all in line with, I would say, a more holistic approach to driving that durable mid-single-digit revenue growth profile that people really have come to appreciate form BD. Thanks for the question.
Operator:
Your next question comes from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Hey guys, good morning. Thanks for taking the questions. Just some things on Veritor. Can you just talk about your capacity now? And you mentioned that you are making additional investments in testing, so where would that you know capacity there where would that get you and just how to reconcile the capacity expansion that you are going through with the thoughts on the slowdown in demand? How do I reconcile this? Is this also about building for at-home testing and you tee some thoughts on exploration there? Can you just tell me what that means? Thanks.
Thomas Polen:
Sure, Brian, and good to connect, as always. So the capacity is, as we have communicated in the past, right, that we are at going to 12 million tests in March is what we communicated on our last earnings call. And we are on-track for that. And we are also on-track for the MAX capacity expansion that we had described before. I don’t think it is a fair thing to say that we continue to sell all of that capacity as we look forward. That is not known to us, particularly in the back half of the year. But we are positioned. This is a global pandemic that is going on in the world. As we think about opening up businesses and schools and other things, people are going to look at what different types of testing technology they can use, and our aim is to make sure that things are available to health care systems as needed. So we are doing that. And we have also shared, right, we are actually depreciating those assets within the year. So that as things unfold in 2022 and 2023, those assets won’t be burdened on our P&L because we are able to fund that within the profits that are generated within this fiscal year. So that is our approach. Nothing more than that. At this point, we probably don’t want to comment more on the home space other than to mention that we are actively exploring that, has been our practice as we advance our work in that and the combination assays that we have shared that are in development. We will really end up sharing more about those as we actually gain EUA and head towards launch if those occur. So I think that is it. Maybe we do have Dave Hickey on the phone. I can pause. And Dave, I don’t know if there is any other comments to add from you.
Dave Hickey:
No. I mean, Tom, you have captured it eloquently. I think capacity, we moved to 12 million tests per month from next month. You mentioned MAX. So MAX, actually, we did increase capacity to 1.9 million tests per month for the molecular assay from last month actually. And there are a variety of additional topics like the claims, home testing, OTC that we are exploring right now as well as additional menu to leverage the 70,000 plus Veritors that are going to be out there. And as those decisions take place, we will share more details as we get those decisions.
Thomas Polen:
Yes. And those markets still are not well defined today, as you know, Brian. So thanks for the question.
Brian Weinstein:
Thanks.
Operator:
Your next question comes from Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Good morning, thanks for taking the question. Just one for me on. You have the BTK panel coming up on February 17th. As you guys know, that tends to get outsized attention by investors. So it sounds like you guys requested the panel. What do you think the hot topics or key issues are going to be? Every panel has them. Do you expect FDA and the panel to debate whether it Should be six-month efficacy, that is the focus or 12-month data? Your level of confidence in the outcome? And do you still see this as kind of a $150 million opportunity, which is kind of what Bard thought it was before the acquisition.
Thomas Polen:
Thanks, Larry, and great question. Let me maybe make a short comment here, and then we have Simon Campion on the phone, and we will turn it over to him, who is deeply versed in this. So first off, just as a reminder, we have nothing in our forward-looking plan for BTK approval, right. It is not in our 2021 plan. It is in no forward-looking outlook that we have as we think about how we model things within the company. Today, Lutonix revenues are less than 1% of our overall BD revenue. And this indication, specifically, again, is not included in our forecast. As we go into the panel, and Simon will share more detail on this, the one thing that we have is we know this is a highly underserved market, and we know that our clinical trial data shows very strongly that it is safe, that Lutonix is safe in this patient population. I think it is the first product that is gone through a trial in the U.S. that has the ability to do that. Now the question is, are the clinical outcomes that were shown in our trial sufficient enough for it to be warranted for an approval. And so Simon, let me turn it over to you to talk a little bit more about that.
Simon Campion:
Yes. Thanks, Tom. So as Tom just reiterated, the safety profile of DCBs and the BTK in particular has been, I think, has been well discussed. And the data that we are providing is demonstrating continued safety of the Lutonix product. We did request the panel meeting, as you know, below the knee patients with critical limb ischemia are in a very bad way. It is the most serious from of peripheral arterial disease. They have multiple comorbidities. And some of the most important things for this patient population are
Lawrence Biegelsen:
Thank you.
Thomas Polen:
Great. Thanks for the question.
Operator:
Your next question is from Larry Keusch with Raymond James.
Lawrence Keusch:
Good morning everyone. So Tom, I wanted to just touch on the investment spend that you guys talked a lot about. And certainly, you have really amped up the conversation around that over the past couple of quarters. And I guess I’m really focused in on the R&D side of things. I feel like I have heard this story in the past here at BD, and there is been some challenges with innovation and really getting products out onto the market that were considered to be more than just evolutionary. So I get the sense that things are probably different this time around, but I’m just trying to understand if there is a new approach or are you investing differently or anything that you can kind of speak to help us get comfortable that these investments hopefully can lead to visible new product introductions.
Thomas Polen:
Truly. Yes. Good and fair question. So let me start with just over all R&D effectiveness, and I can give a little bit of color on the types of initiatives that we are investing in here and also how we think about our overall innovation system. So as you know, John DeFord joined us as our Chief Technology Officer about three years ago. And really, under his leadership, there is been tremendous progress within the organization and with the segment teams, the business teams in advancing our ability to drive innovation. Actually, over that time period, we have gone from kind of the midpoint of not being where we wanted in terms of on-time milestone delivery or on-time launches to being as we benchmark ourselves to being in the top quartile within the industry of hitting our milestones and, most importantly, hitting our launches, right. Our launches are now about 80 plus percent of our launches are on time, which is up very notably over the last three years, up over 30 percentage points or around 30 percentage points, in fact. So we see the progress being made. And that is the result of a lot of system improvements, new capabilities brought in, taking some of the best practices actually from Bard and the acquisition and applying those across the company. So that is something we are going to continue to build upon. As we think about the innovations that we are investing in, as we look at those, there is a few, as I think about them, kind of new to world innovations that are in our pipeline. I mean, one is some of the ones we have already talked about, right, non-COVID menu expansion on Veritor and MAX to capitalize on our expanded footprint. We have a strong track record of developing new assays on MAX and Veritor, right. It is just examples of that. Other initiatives are accelerating programs that we already had in our pipeline and allowing them to come to market a year or two earlier than we originally projected. That is an area of investment that we are making, and there are a number of areas in each of the segments which we are accelerating new products into the pipeline, but they are all very much in line with our strategy and areas that we are confident that we have internal capabilities in. Of course, what we are also doing that is complementing that is that tuck-in M&A strategy that I mentioned before. And we do think about often, and we will have those discussions internally, if technologies are better developed in-house or that we should be going outside because we don’t have those capabilities in-house. And we will either look at do they exist today in someone else’s pipeline and is that an opportunity for tuck-in M&A? Or do we need to be doing collaborations with outside groups. There is many R&D programs that we have today, I think probably a record level of R&D programs where we have external partnership s in place. Actually, the BD COR would be one that I mentioned before. We have very strong external partnerships with the robotics because that is a very advanced automation system. And so we brought in robotic experts that helped us with that launch, and it is going really well in Europe. And we will bring it to the U.S. here, but that is one that we probably wouldn’t have been able to develop in the same way if we had tried to do it on our own, but we are seeing successes with that approach, and we are seeing it in many other areas as well. So that is kind of maybe just a little bit of color, Larry, in how we think about it overall. But with that progress that we have made and the way that we have thought through making these investments and how we also think about where it is smarter for us to do tuck-in M&A, we are confident in those investments.
Lawrence Keusch:
Okay. very good. Thank you for that.
Operator:
Your next question comes from Matt Taylor with UBS.
Matthew Taylor:
Hi thank you for taking the questions. So I just wanted to ask about the Veritor pricing from the standpoint of how that came about. I usually would think about it as being more of a competitive dynamic, but it seems like, for your comments, you are being a little bit more proactive to lower price to make it a better value proposition for stakeholders. And so I wanted to understand
Thomas Polen:
Yes. Good question, Matt. So yes, you are right. It is a combination of - we have always said that we believe the pricing would head in this direction. Our capacity is increasing, and we want to be proactive in maintaining that leadership position. But there is additional capacity coming in the industry now as well, too. And there will be further capacity coming in. We are not the only company who is adding in capacity. And so we think about that holistically and where pricing as a result of that is going today and where we best position our products to remain a leader in that, and that is how we develop it, and we spend a lot of time thinking those things through as to when and how we optimize our pricing, again, to also serve what is a continued evolving customer base as more nontraditional areas of health care wanting to do antigen testing and making sure that it is appropriately priced to enable the broadest access to the product while we are still in the middle of a pandemic. And so we have gotten very positive receptivity so the pricing. We have already started to roll that out a couple of weeks ago last month. And so good question. Thank you, Matt.
Matthew Taylor:
Thank you.
Operator:
Your next question is from Josh Jennings with Cowen.
Joshua Jennings:
Hi, good morning. Thanks for taking the question. Just one quick one on Veritor, just with the U.K. and South African variants. I think the U.K. ran some studies on rapid antigen testing and confirmed that there was no change in sensitivity or specificity. If we think about the South African variant and the U.K. variant and future variants, what is back in doing to just monitor those variants and ensure that the sensitivity and specificity aren’t altered by some of the mutations in the virus and then the subsequent antigens that you guys are testing for? Thanks.
Thomas Polen:
Good question, Josh. And that is certainly something that our teams are all over. Let me turn it over to Dave Hicky, who we have got on the line, the President of our Life Science segment.
Dave Hickey:
Thank you, Tom. And Josh, great question. So to your point, there have been obviously several newly identified variants reported recently, and there could well be others, right, recognizing that this is an RNA virus, very much like influenza and HIV that are known to mutate. And for us, we have got two different types of platforms, right. So we have obviously got the BD Veritor antigen test. We have got the BD MAX and molecular PC assays. So let me take MAX first. So for BD Max and for the assays that we have on the MAX, we have already completed an in-silico analysis, which is a computer model based on sequencing. And to look at those mutations. And from everything that we can see around those mutations and the lineage of the sequence, we have no impact on the BD MAX assays. For BD Veritor, which is obviously more a minor assay based on the top of the protein, based on early analysis again there, we have no evidence to show that the U.K., South African and, indeed, Brazilian variant will have an impact on the test. But we continue to take actions to look at that, further confirm and monitor the performance. And again, we have done that for the ones that are already out there and any potential new emerging strains. And this is a critical topic for us because I think the thing to remember here is as these variants come online and come out, which are reportedly more transmissible, it makes the importance of rapid testing and access to testing as important, if not more important, than ever. Thanks for the question Josh.
Operator:
Thank you. There are no further questions at this time. I would like to turn the floor back over to Tom Polen for closing remarks.
Thomas Polen:
Okay. Well, thank you, and thanks, obviously, to everyone for your questions. Just before we sign off, I would be remiss if I did not thank BD’s 70,000 associates around the globe who every day rally around our purpose of advancing the world of health. Your efforts and achievements this quarter were noticed. You continue to work tirelessly to make sure that our needed products reach the frontline to combat this pandemic while executing on our strategic agenda. I’m proud of how we have started our fiscal 2021, and I’m looking forward to continuing to deliver on our goals of developing innovative devices and making meaningful health impacts to people around the world. On behalf of the entire executive team, thank you for your efforts and sacrifices. Onward we go together. And like you, I’m proud to be BD. Thank you for listening today, and we look forward to connecting at in future investor meetings with everyone who is joined the call. And until then, I hope everyone stays safe and healthy. Thank you.
Christopher Reidy:
Thanks, everyone.
Kristen Stewart:
Thank you.
Operator:
Thank you. This does conclude today’s teleconference. Please disconnect your lines at this time, and have a wonderful day.
Operator:
Hello, and welcome to BD's Fourth Fiscal Quarter and Full Fiscal Year 2020 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through November 12, 2020, on the Investors page of the bd.com website or by phone at (800) 585-8367 for domestic calls and area code (404) 537-3406 for international calls, using confirmation number, 4475229. [Operator Instructions] Beginning today's call is Ms. Kristen Stewart, Senior Vice President of Strategy and Investor Relations. Ms. Stewart, you may begin.
Kristen Stewart:
Thanks, Crystal, and good morning, everyone. Welcome to BD's review of our fiscal fourth quarter results. Joining me today, we have Tom Polen, Chief Executive Officer and President; and Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer. During the Q&A portion of the call, we will have three segment Presidents joining us. Alberto Mas, President of the Medical segment; Patrick Kaltenbach, President of our Life Sciences segment, and Simon Campion, President of Interventional segment. A few logistics before we get into the call. This call is being made available via webcast at bd.com, where you can also find accompanying slides. Unless otherwise specified all comparisons will be made on a year-over-year basis versus fiscal 2019 and percent changes are on FX-neutral basis. During the call, we will be making some forward-looking statements and it is possible that actual results could differ from our expectations, risks, uncertainties, and other factors that could cause such differences can be found in our SEC filings, including our 2019 Form 10-K and subsequent Forms 10-Q. In particular, there continues to be significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic. The commentary we are providing today includes our best estimate based on the information that we currently have. We have made certain assumptions in how we are managing our business, but that could change as we move forward. We will also discuss some non-GAAP financial measures, with respect to our performance. Reconciliations to GAAP measures that include the details of purchase accounting and other adjustments can be found in our press release and its related financial schedules and in the appendix of the Investor Relations slides. These are all available on the bd.com website. With that, I'll turn it over to Tom. Tom?
Thomas Polen:
Thanks, Kristen. Good morning, everyone. I hope you're doing well, and thank you for joining us. For today's call, I want to address three main topics. First, my high level perspective on the quarter and full-year performance; second, I'll give an update on several hot topics we're fully focused on; and finally, I will share progress on BD strategy. Then I'll turn it over to Chris for a review of the P&L and an update on our outlook. So let's jump right in. First, I'll start with the quarter and the full-year performance. In Q4, we had better-than-expected revenue and not only our COVID-related diagnostics testing, but also our core business that allowed us to not only deliver EPS upside, but also importantly gave us the opportunity to make some strategic investments aligned to our BD 2025 growth strategy. Revenues were up 4.4% on a reported and FX-neutral basis as we were able to offset the overall impact of COVID-19 and grew despite the Alaris ship hold. I want to acknowledge the exceptional execution by our Integrated Diagnostic Solutions business this quarter, particularly the BD Veritor team. The team exceeded our commitments, successfully developing the BD Veritor COVID-19 assay in an accelerated timeframe, securing several regulatory approvals, scaling up manufacturing and continuing to advance the science behind the utility and effectiveness of rapid antigen point-of-care testing. Total COVID-19 testing revenues allowed us to offset the ongoing COVID headwinds and other businesses from lower hospital utilization, surgical procedures, routine lab testing volumes, and research spending. In fact, because of our COVID testing revenues, we were able to move from a net negative COVID impact in Q3 to a net positive COVID impact in Q4. If you exclude COVID-19 testing and look at performance of the base businesses, we are very pleased with the sequential improvement across all of our three segments during the quarter. As you would expect, the pace of the recovery varied by both product category and by geography. So all in, the BD team was able to deliver Q4 mid single-digit sales growth, overcoming the headwinds from COVID-19 and the Alaris ship hold, the latter we estimate to be 240 basis points in the quarter. Our Q4 adjusted EPS was $2.79 down 15.7% on a year-over-year basis. While our revenues returned to growth, we did continue to see some COVID-related pressure, dilution from our May equity issuance and headwinds from the last quarter of the Gore royalty contributed to our EPS decline. As I look back on the year, we faced a number of challenges from the Alaris ship hold to COVID-19 and its significant impact on healthcare utilization globally. In our fiscal Q3, COVID-19 had about a $600 million negative impact to our topline. However, the BD team executed strongly, swiftly launching multiple innovative COVID-19 diagnostic solutions and focusing on execution to return to growth in Q4 and finished the year with revenues flat on an FX-neutral basis. I'm proud of the team for their hard work, closing the year strong and offsetting the continued COVID-19 headwinds. Now I want to turn to several hot topics. Let's start with review of our COVID testing in the quarter. As I said, I was very pleased with the IDS team's execution this quarter with COVID-19 testing sales coming in at approximately $440 million with Veritor revenues at over $340 million in the quarter. We are able to ramp-up Veritor manufacturing capacity faster than originally expected, a testament to BD’s world-class manufacturing excellence. We’re also able to sustain a higher average selling price for longer than we anticipated. Looking ahead, we do expect price erosion as additional competitors have come to market and more may do some. We continue to work diligently to expand our BD Veritor and BD MAX manufacturing capacity. Our previously communicated capacity expansions remain firmly intact. We continue to monitor the supply and demand dynamics of the market. And we'll provide you with updates on additional capacity expansions to the extent any further new capacity comes online. On the customer side, we continue to see very strong demand for BD Veritor and BD MAX COVID-19 tests. Regarding BD Veritor, we've seen strong adoption and interest from both traditional and non-traditional accounts in the U.S. Since the last quarter, we have doubled our U.S. installed base of active Veritor Readers to over 50,000 units, and we continue to see strong instrument demand, further extending our footprint. We believe that this broadened Veritor footprint will provide us with additional future growth opportunities beyond COVID-19 testing for current and future planned assays. On September 30, we received the CE Mark for our COVID-19 assay on BD Veritor. And we've been very pleased with the reception of the assay in international markets. We've signed a number of contracts and are actively leveraging one of BD strengths, which is our large international footprint. And in fact, we are now shipping Veritor instruments and assays to customers across Europe, Asia, Latin America and Canada. As we head into the flu season, we recently launched a combination COVID-19 flu RSV Test in Europe on our BD MAX system with our partner CerTest. We continue to work toward the launch of combination flu and COVID-19 assays on our BD MAX and BD Veritor platforms globally. Now let me take a minute and walk through our thinking on the outlook for Veritor. You've heard me say before that there are a number of variables at play. There's the ramp-up of our manufacturing, the number of competitive products and ASPs. And then you have to take into consideration many variables around COVID-19 vaccines, like their timing, availability, effectiveness, and how widely they are adopted. But taking all of that into consideration, we are comfortable forecasting fiscal 2021 Veritor testing in a range of $1 billion to $1.5 billion with the weighting of these revenues being more in the first half of the fiscal year than the second. I know many of you also have questions on the long-term durability of COVID-19 testing and the outlook for fiscal 2022 and beyond. Again, there are many factors at play and there are a variety of scenarios that we are planning for and we will be ready to execute. I would say though, that we do now believe that there is a higher likelihood for testing to continue into fiscal 2022. However, given the uncertainty around demands and ASPs, we believe it would not be prudent to model a continuation of revenues at the same level as fiscal 2021. This leads me to our next topic. Our COVID-19 testing reinvestment plans. We are electing to reinvest a portion of our FY2021 COVID-19 testing profits back into the business to ensure long-term durable growth. These profits will be invested consistent with our strategy and value creation framework of grow, simplify, and empower. Our top focus is investing in growth. We activated the organization and investment plan in Q4, initiating a bottoms up process to identify high impact projects and programs based on risk-adjusted returns and our capacity to execute. As part of this initiative, we increased investments in the recently launched BD Innovation and Growth Fund. We have also kick-started other programs that accelerate go-to-market investments in the U.S. and internationally and ongoing R&D projects. You've heard me talk about our simplification efforts around Project Recode. We plan to look for ways to optimize that program even more. We are also using COVID-19 profits to accelerate further investments in our Inspire Quality Program to enhance our risk management systems. We believe these investment programs should generate returns beginning in late FY2022. Our current reinvestment plans contemplate fiscal 2021 Veritor testing revenues of, as I said, $1 billion to $1.5 billion. Veritor testing revenues are above this level, we plan to make additional investments towards long-term growth, yet still allow a portion of the higher revenues to flow through the bottom line. Next I'd like to take a moment to update you on our readiness for a COVID-19 vaccine campaign, where we continue to make great progress. To date, we now have commitments for over 800 million needles and syringes, which includes commitments from countries like the U.S., UK, and Canada and various non-government organizations around the world as they prepare for COVID-19 vaccination campaign. Last June, we estimated the total vaccine syringe and needle opportunity over a 12 to 18-month period could be in the $100 million to $150 million range and we continue to feel this is an achievable objective. Now I'd like to update you on Alaris. The highest priority of the organization continues to be preparing for a comprehensive 510(k) filing obtaining clearance for Alaris and returning our market-leading infusion pump franchise to growth. Over the last quarter, the team has made further progress and retired risk. We are systematically working our way through various testing stages, and we continue to engage in open dialogue with the FDA about our progress. My confidence level today is higher than it was last quarter, that we will be able to submit our 510(k) in late fiscal Q2 or early fiscal Q3 2021. As I mentioned in the past, our focus remains on ensuring a comprehensive submission that will ultimately help enable timely FDA review and clearance. While it was not our intention to predict the FDA's timelines, given the size and complexity of the submission, we do not assume any revenue contribution from a 510(k) clearance in fiscal 2021. The last item on my hot list is I want to comment on innovation and our product pipeline. Category innovation remains one of the core drivers of our growth strategy. We have been focused on improving our pipeline execution and R&D effectiveness, and we continue to make great strides to that end. This quarter, R&D spending increased 8% year-over-year. The first meaningful increase for the company in many years. Looking ahead, we will continue to focus on driving new innovation and a higher level of R&D investments, including through our new BD growth and innovation fund, which we established earlier this year. Through the fund, projects are funded for a maximum of two years and it would be completely new product development opportunities, unfunded or underfunded line extensions that have significant incremental revenue opportunities or commercial programs designed to accelerate product adoption. We received a lot of great submissions across all three segments and we initiated the first round of funding in Q4. Looking ahead to the next year or so, we are advancing a robust product portfolio with many singles and doubles like we've long been known for. We also have some more notable programs in the pipeline, and I'd like to highlight a few of those for you now. The IDS team is acutely focused on advancing our combination COVID and flu assays on both our BD Veritor and BD MAX platforms, as soon as possible for the benefit of patients. I also want to highlight the great strides of our Women's Health & Cancer franchise that they are making. In July, we received FDA approval of the BD Onclarity HPV Assay for extended genotyping, which can improve risk stratification and support risk-based patient management. We are receiving great customer feedback on this assay. And in fiscal 2021, we look forward to bringing this assay and BD COR, which is our new high throughput molecular diagnostic system with fully integrated specimen processing. We look forward to bringing that both of those to customers in the United States. The BD COR system and our Onclarity assay are both available in Europe, and we've been receiving very positive feedback on the initial rollout. In BD Medical in Q4, we launched the BD UltraSafe Plus 2.25mL passive safety system, which adds to our proven high-growth safety portfolio in Pharmaceutical Systems. It has been designed to deliver up to a two ml dose volume, while enabling an ergonomic and safe injection experience for both patients and healthcare providers. We have launched – we have secured a number of pharmaceutical partners that plan to commercially launch our new product towards the end of fiscal 2021. Also in BD Medical, during fiscal 2021, we will launch the BD Pyxis ES 1.7, which adds new capabilities and deeper integration of pharmacy and nursing by enhancing automation in the operating room with the Pyxis Anesthesia Station. In BD Interventional, we had a robust year of product launches across its three businesses. Of particular note, the Peripheral Intervention team launched the 0.18 and 300 millimeter LUTONIX DCBs in the U.S. and launched LUTONIX in Japan. PI also launched the elevation Single Insertion Multiple Sample Breast Biopsy device in addition to the Caterpillar Embolization device, which represents our first foray into the world of interventional oncology. Our Surgery business launched a completely robotic compatible version of our market-leading anatomically configured 3DMax Inguinal Hernia Mesh as well as the Pureprep Infection Prevention product. Finally, our UCC business capitalized on our developing position in female incontinence by launching drydock 2.0, which is designed to help women who suffer from incontinence to use PureWick at home. Fiscal 2021 promises to be another year of innovative product launches across the Interventional segment. The team worked hard to minimize the impact of COVID on our product launch schedule, leading to further commercialization of products across all businesses. For competitive reasons, we won't share any specifics with you, but suffice to say you should expect further commercialization activity of new products in our oncology, infection prevention and acute urology platforms in particular. Finally, I want to provide an update on our FDA PMA submission for the LUTONIX Drug Coated Balloon and its use in below the knee. The FDA has recently notified us that our PMA supplement remains non-approvable. We are working collaboratively with the FDA to determine what our next steps maybe, if any. As a reminder, our entire LUTONIX business today represents less than 1% of our overall sales, and we do not include any revenues in our forecast related to this submission. Before we move on, I want to take a moment and acknowledge John DeFord, who will retire from BD at the end of the calendar year. As you all know, John has had a remarkable career and has made a tremendous and lasting impact since joining BD three years ago. While he will continue to serve as an advisor and a consultant for us. Of course, we are going to miss John's leadership and we are going to miss his humor, but we are very excited for Patrick's appointment to the Chief Technology Officer. And we are confident that he is the right leader to deliver on our innovation strategy and product pipeline in our next phase of value creation. And as Patrick takes on this important new responsibility, we could not have asked for a better successor than Dave Hickey to lead BD Life Sciences and build on Patrick's track record of success. Dave has been leading the IDS team and the BD Veritor COVID-19 launch. Finally, I want to provide a quick update on our strategy. When I became CEO earlier this year, I outlined my vision for BD’s next phase of value creation. It's what we call BD 2025, which included three drivers grow, simplify, and empower. And the drivers build upon BD strengths, our world-class manufacturing, global scale, our strong category leadership and deep capabilities in software and informatics. And we've made great progress in fiscal 2020 in building the foundation and beginning to execute against our new playbook. As I mentioned, we've been steadfast in strengthening our R&D capabilities and continuously improving our R&D effectiveness. And I'm excited about what is to come from the BD growth and innovation fund. We also look to augment our internal innovation strategy through tuck-in acquisitions. In fiscal 2020, we executed on six tuck-in transactions in higher growth markets, and I'll highlight just three. First is NAT Diagnostics, which is an early stage, privately held company, developing a molecular diagnostic platform for point-of-care testing. This acquisition broadens our point-of-care testing capabilities in infectious disease. And while this product is still under development and a few years from launch, we are very excited about the technology and our point-of-care diagnostics business more broadly, and how this adds in a molecular capability to that. Another acquisition we closed on this year was Straub Medical, a privately held medical device company, that markets mechanical atherectomy and thrombectomy devices that treat peripheral arterial diseases. This acquisition expands our robust portfolio of PAD and Venous Solutions within our BD Interventional segment. And the third acquisition I'd like to highlight is Adaptec, an innovative startup company that developed Sensica UO, which is an automated urine output measurement solution. It captures hourly urine output measurements and integrate this into the electronic medical record through the BD HealthSight platform. This is actually going to be BD Interventional’s first connected smart device, which leverages BD’s interoperability position that we have today and about 70% of all U.S. hospitals. We have a robust funnel of deals and we continue to increase our focus here as we move into fiscal 2021. Our efforts around simplification and Project Recode and Inspire Quality, all remain on track. If anything, we have the opportunity to accelerate some projects with some of the COVID-19 test reinvestment proceeds. As I reflect on FY2020, I am proud of how the company worked to navigate through the headwinds of COVID and the Alaris ship hold. Our response to these challenges along with a successful launch of COVID-19 testing enabled BD to deliver flat revenue performance on an FX-neutral basis for the year. As I look ahead, there are some challenges that we face as a company, namely COVID and the Alaris remediation, the latter of which I am confident we will resolve. But there are many more opportunities ahead to drive growth and accelerate our impact on healthcare around the world. We have the right strategy. We're making the right investments. With that, I'd like to hand the call over to Chris Reidy, and then I'll make a few concluding remarks.
Christopher Reidy:
Thanks, Tom, and good morning, everyone. Thanks for joining us today. We are pleased with our fiscal fourth quarter revenue and adjusted earnings per share performance. Overall revenues were $4.8 billion up 4.4% on both a reported and an FX-neutral basis. We estimate the net impact of COVID was a positive 210 basis points as COVID-19 testing revenue more than offset the ongoing negative impact from lower utilization across our businesses. Even after adjusting for the net COVID-19 effect, we are pleased that we're still able to grow our revenues despite the Alaris Pump ship hold. We estimate the negative impact of the Alaris ship hold was 240 basis points. BD Medical revenues totaled $2.3 billion and were down 4.9% year-over-year. We estimate COVID negatively impacted the business by about 370 basis points. We estimate the Alaris ship hold negative impact was 450 basis points. Medication Delivery Solutions saw sequential improvement consistent with healthcare utilization trends, but still continue to be impacted negatively by COVID-19 on a year-over-year basis. Internationally, MDS is declined, largely reflected the impact of China's volume-based procurement, as well as inventory reductions we took in the quarter. Medication Management Solutions, the Alaris ship hold continues to have a negative impact on the business units overall results and there was a difficult comparison with the prior year. International MMS sales were very strong driven by infusion pumps sales in Europe. In U.S. dispensing, we saw a solid growth and close the year with strong new committed contracts. In Diabetes Care, sales declines reflected ongoing market price pressures. Pharm System sales were up double-digits this quarter and ended the fiscal year with a strong 9.4% growth driven by our pre-filled and safety syringe portfolios. BD Life Sciences revenues totaled $1.5 billion and were up 31.4%. We estimate the net positive impact of COVID was 26.2 percentage points in the quarter. Our Preanalytical Systems business was down 3% year-over-year. We have seen sequential improvement as routine lab testing volumes improved. Our Diagnostic Systems business was up 97.3% driven by just over 440 million in COVID-19 testing. Biosciences sales were down 9% globally. However, we saw a sequential improvement in reagent sales as research and testing continues to resume. BD Interventional revenues totaled just under $1 billion and were down 3.5% for the quarter. We estimate the net negative impact from COVID was 11.2 percentage points. Our Surgery and our Peripheral Intervention businesses, both saw a solid sequential improvements as elective procedures continue to return closer to pre-COVID levels in several geographies, most notably in the United States. The Peripheral Intervention business was particularly strong in Japan on the heels of a successful LUTONIX launch. The Urology and Critical Care business performed well with the U.S. returning to growth though offset by an international decline. Now turning to the P&L. Gross margins were 54.8% or 55.1% on an FXN basis, the latter down 200 basis points year-over-year. While we benefited from higher margin COVID-19 testing revenues, it was more than offset by the continued drag from lower volumes, which drove unfavorable manufacturing variances. We are actively managing our cash and inventory balances globally, and we expect to see more COVID-related manufacturing variances in fiscal 2021, negatively impacting our gross margin line. SSG&A expense of $1.2 billion was 25.1% of revenues up a 110 basis points year-over-year. SSG&A includes a $25 million investment to the BD Foundation this quarter in support of our longstanding commitment to advancing the world of health and supporting the communities where we live and work. We continue to see higher shipping costs related to the pandemic and we also had elevated levels of spend related to Veritor in the quarter. R&D expense of $279 million, representing 5.8% of revenues was up 20 basis points year-over-year. In dollar terms, spending was up 8% on a year-over-year basis as we invested in COVID diagnostics and other growth initiatives. We expect fiscal 2021 spending on R&D to continue to be higher as we continue to focus on innovation and implement some of the reinvestment plans, Tom mentioned earlier. Operating income was $1.1 billion resulting in an operating margin of 23.9%. On an FX-neutral basis, margins decreased 320 basis points, mainly reflecting the contractions in gross margin as well as higher SSG&A and R&D. Interest/other expense net was $110 million, resulting in a decline of $4 million on a year-over-year basis. We had favorability in interest expense this quarter as we repaid debt. The adjusted tax rate came in as expected in the high teens at 18.7%. Preferred dividends in the quarter were $22.8 million. Adjusted earnings per share were $2.79 as previously discussed and this includes a $0.02 headwind from FX. For the year, we generated $3.5 billion in cash flows from operations and our free cash flows were $2.7 billion net of $810 million in capital expenditures. In line with our goal of continuing to increase the strength and flexibility of our balance sheet, we paid down $950 million of debt in the quarter, bringing our total debt repayment to $1.7 billion for the year. This resulted in a net leverage ratio of 3x – 3.0x as of September 30, 2020. Now we wanted to share some broad thoughts on fiscal 2021. As we look ahead, the greatest uncertainty we see is the recent COVID-19 resurgences around the world and the potential impact this may have on general healthcare utilization, procedure volumes and diagnostic testing, including COVID testing. Our guidance assumes no major system-wide shutdowns of elective procedures. Assuming no significant changes in utilization and procedure volumes associated with COVID-19 resurgences, we are comfortable forecasting low to mid single-digit FX-neutral revenue growth excluding the COVID testing revenues. Our COVID testing revenues in fiscal 2020 were approximately $580 million. On a total company level, inclusive of COVID testing, we expect FX-neutral revenues to grow in the high single to low double-digit range. Using current exchange rates, we expect FX to add approximately 100 basis points to revenue growth on a reported basis. We expect our adjusted non-GAAP EPS for fiscal 2021 to be in the range of $12.40 to $12.60. Again, our guidance assumes no significant changes in utilization and procedure volumes associated with COVID-19 resurgences. This also does not assume any potential upside to our 1 billion to 1.5 billion in Veritor testing revenues. While we are not giving quarterly guidance, I want to point out some quarterly phasing, as you think about the upcoming year. Given that we are at September year end, we will not anniversary the initial COVID-19 impact into our fiscal Q3. In addition, U.S. biosciences also has difficult comparisons in fiscal Q1 due to licensing revenue in the prior year. And in Medication Management Solutions, our infusion business has tougher comparisons throughout the year, given the timing of the ship hold and shipments under medical necessity, as well as European sales related to COVID. As Tom mentioned earlier, we do not assume any revenues associated with the Alaris 510(k). However, offsetting these headwinds I just discussed, we would expect our COVID-19 testing revenues to be more heavily weighted to the first half of our fiscal year. In addition, we will anniversary the launch of our COVID testing in the fourth quarter. And taking all of the above into consideration and looking at the Street consensus, we would suggest a phasing that shifts earnings from Q4 into the first half of the year. I also want to take a moment to address FY2022 by making a few observations. Regarding our COVID-19 testing revenues, we see this as perhaps the biggest variable to our fiscal 2022 outlook. Depending on the level of success of Veritor in fiscal 2021, it could make for a difficult comparison to our revenues and earnings in fiscal 2022. And regarding Alaris, as Tom mentioned, we have a higher level of confidence today in our ability to submit the 510(k) at the end of fiscal Q2 2021 or early Q3. We would assume a contribution beginning sometime in fiscal 2022. Keep in mind, we ship pumps under medical necessity in fiscal 2020, thus, we would not necessarily assume there's a one-for-one pent-up demand when we obtain 510(k) clearance. Regarding the remainder of our business and assuming a more normal healthcare utilization environment, we would assume the business will return to an underlying mid single-digit growth rate in fiscal 2022. And with that, let's move on to Q&A.
Operator:
Thank you. We will now open the call for questions. [Operator Instructions] Your first question comes from Bob Hopkins with Bank of America.
Robert Hopkins:
Hi. Thank you, and good morning.
Thomas Polen:
Good morning, Bob.
Christopher Reidy:
Good morning, Bob.
Robert Hopkins:
Good morning. So just the – first question is maybe a clarification on the 2021 guide that you're giving. Can you just sort of sum all that up for us in terms of what does it imply for revenue dollars and how much it's assumed in there in terms of total COVID testing, not just Veritor? And then I know you said you're going to reinvest some of that. Like, what is sort of the, maybe the net EPS impact of COVID testing, including that reinvestment?
Thomas Polen:
Yes. So on the issue of the guide related to – you know that we guided Veritor at $1 billion to $1.5 billion. When you add BD MAX, that's running at around 400 in that area, so you can add that on top of that.
Robert Hopkins:
Okay. And then any clarity on just a thoughts on reinvestment, just trying to get a – because what we're trying to do obviously is get a sense of the underlying business versus – EPS contribution on the underlying business versus total testing. So what are the kind of reinvestment plans implied?
Thomas Polen:
So the way to think about how much is within the $1 billion to $1.5 billion of revenue that we're forecasting. Our guidance assumes a certain amount of reinvestment of that. So not letting it all flow through. As you think about – if Veritors looking like it'll be above $1.5 billion, we would look to invest more than that going forward. And we would likely have some investment depending on the investments in the pipeline and we'll talk to that in a moment. And let some of it flow through to the bottom line as well. So we'll assess that as we're going through the year. But if it's over the $1.5 billion, we would look to invest more, but still allow a portion of that flow to the bottom line as well.
Christopher Reidy:
I think it's fair to say, we plan to reinvest among the initial $1 billion to $1.5 billion range. We're investing roughly 20% of the profits back into the business bump.
Robert Hopkins:
Okay. Thank you very much.
Operator:
Your next question comes from the line of David Lewis with Morgan Stanley.
Thomas Polen:
Good morning, David.
David Lewis:
Good morning, guys. How are you? So I appreciate. It's a very tight guidance in a very uncertain environment. I think a lot of investors will largely view this as a floor. But I did want to come back to the underlying business team one more time here. I think everyone's trying to compare the forward year 2021 to a base year, which is 2019, and I appreciate you all has a different comparisons there. But I think when people want to try to get to is if we take out some level of Veritor, we get to sort of some earnings number that's sort of in that 10, 10.50 range with reinvestment, maybe it's in 11 range. But if we look at the implied revenue growth 2021 over 2019, it's sort of low-single digits adjusted for pumps. And if we look at the margins, they seem kind of down in 2021 versus 2019. So for Tom and Chris, what investors want to hear is, it could be suggested that there's a problem in the underlying business or it could simply suggest that you're being conservative to begin the year. Help us understand the strength of that core business, and whether you think 2021 underlying margins can be up over the base year in 2019. And how you think that underlying business is sort of performing relative to that classic 5% BD growth rate that you're trying to get to? And then I had a quick follow-up.
Thomas Polen:
Yes. David, good question. So I think if you look at it on an underlying basis, we are in that range that we're talking about that we've talked about around that 5% plus. We're in that. So if you look at we're in the low to mid-single digits in the core, of course, that has, and it maybe on that lower side of that. You've got the Alaris headwind, of course, which is still annualizing in the year as well. So that is a headwind that is built in to the core. If you take that out, you're back in right in that range that you mentioned before. So I'll let Chris add some more commentary on that. But just a reminder on that, we still do have annualization of the Alaris impact built into that.
Christopher Reidy:
Yes. I would say David, the core is strong. You saw that in the fourth quarter as well. It's doing well. The margins are improving. To your point around the 2019 to 2021, there are a number of things. We are seeing synergies from the BARDA transaction over that period of time kicking in. Then obviously it's impacted. You have to take out the COVID impact, the drag, and then the add back for Veritor. But keep in mind, if we had a bit of a drag during that period in the China VBP and the Alaris, and when you adjust for that, we are seeing growth in the margins and feel very comfortable with the long-term view of the underlying 5% and 10% on the bottom, and that's very consistent with what we've seen.
Kristen Stewart:
And David, the only thing I would add is that, our assumption is that we still are not getting back to a normalized level throughout fiscal 2021. So our guidance and margin forecast would still assume that the overall business continues to see headwinds on a margin perspective as we're still not back to pre-COVID levels overall.
Christopher Reidy:
I think to your point, we are looking – you're seeing some depression of the margins from the investments that we're making as well. So we're not letting it all flow through. We're making the investments that we outlined.
David Lewis:
Totally understand. So there's some COVID adjustment factor there. Okay. Very good. I think investors will appreciate that clarity. And then just Tom, as you think about COVID testing for next year, obviously it's for this year for you guys. First half, obviously hard and second half that's very consistent with some of the PCR providers have suggested in terms of what their assumptions are for peak testing. Can you sort of help us understand your capacity expansion plans sort of first half and second half, and what is embedded in terms of price pressure for next year and where's that coming from? And thanks so much.
Thomas Polen:
Sure. Good questions, David. So as you think about what we've shared before, we shared 8 million tests per month by October, which we’re in. 12 million tests per month starting in March of 2021, that's our capacity ramp on Veritor. And so those capacity plans remain firmly intact and so that's the basis of our outlook that we've shared. I made the comment, of course, we do continue to monitor the supply demand dynamics of the market, and we'll provide you with any updates on additional capacity expansions beyond that if we were to make those, but we won't provide those until that capacity were to come online. So that's just a little bit of background there. As we come to ASPs, we had said $20 ASP, we did a little bit better than that in Q4, as I mentioned. But we do expect to see pricing headwinds, ASP erosion, as there are more competitors in the market now than there were at the start of Q4. And we expect that there will be other entrance. And so we would expect that $20 ASP could come down as we move through the year. Okay. Thanks, David.
Operator:
Your next question comes from Amit Hazan with Goldman Sachs.
Thomas Polen:
Good morning, Amit.
Amit Hazan:
Thanks. Good morning.
Christopher Reidy:
Good morning.
Amit Hazan:
Good morning. Just one clarification for this coming fiscal year on utilization. Can you just talk a little bit more to what you're assuming in the guidance for underlying hospital admissions and utilization versus what you've been seeing and what the impact would be, not just on BD Medical, but just on the entire business routine diagnostic testing as well.
Thomas Polen:
Yes. Great question, Amit and good morning. So during the quarter, as I mentioned, we did observe sequential improvements across our businesses that are more elective procedure oriented, as well as in lab testing volumes. We saw them through the quarter evolve to around 90%. We've got – obviously we have access to some pretty unique information through our BD MedMined platform, which is in about 338 hospitals that gives us literally real time insights into hospital trends on inpatient admissions, ICU admissions, ER trends, ER outpatient versus inpatient, we can see that literally on a daily basis, what happened yesterday in these institutions, which are broadly distributed across the U.S. And so, as we look at that, we see hospital inpatient admissions trending around 85% to 90%, and we've posted some of this data in our deck so that we can share that more broadly. We thought there would be some information that you'd be interested in. So our projections and outlook do not assume any significant change to that on the positive nor on the downside as we think about the potential of a COVID resurgence. We do see, and as we talk to healthcare providers around the world, there's been a lot of preparation and learnings from the initial COVID surge, how to better keep facilities open, how to make patients more comfortable. We’re still coming in for elective procedures. So I think we certainly don't expect that it would retrench back if there is a significant resurgence, retrench back to the lower utilization levels that we saw last year. But of course, that's difficult to predict, and it could be somewhere between where it is today and there could be, could it stay where it is, could be, could it get better if there's not a large resurgence could be. But we've taken a more moderate kind of middle of the road assumption that it will be relatively stable as it is today as we think about our forward-looking guidance.
Kristen Stewart:
Simon, do you want to share some of your survey work that you've done through?
Simon Campion:
Yes. Just to back that, I think we shared some survey work on the August call, and we've repeated that survey work with about 600 physicians in our Surgery and PI business. And they are seeing volumes rebound I would say significantly, their capacity is at I think quite significant level compared to pre-COVID, their office-based volumes are increasing for the most part, so the funnel of patients is pretty robust. And there's still some – what we turn rollover patients as well that are in the mix of patients that were scheduled earlier this year, but have the procedure postponed. And so they're still in the mix as well. So it's pretty robust on the elective side right now.
Kristen Stewart:
Thanks for the question Amit.
Operator:
Your next question comes from the line of Vijay Kumar with Evercore ISI.
Thomas Polen:
Good morning, Vijay.
Vijay Kumar:
Hey guys. Good morning, Chris. Thanks for taking my question. And Chris, maybe on the guidance here. I guess if I just look at the gross COVID tailwinds, right, $1.5 billion at the high-end on Veritor, $400 million of MAX that's about $1.9 billion here. And I think we had somewhere something north of $600 million in 2020. So on a net basis we're looking at $1.2 billion, $1.3 billion of net diagnostic tailwinds for fiscal 2021?
Christopher Reidy:
That’s right.
Vijay Kumar:
So you get high singles, you pick up high singles just on the tailwind. FX is another point, is that implying like the base is going to be flattish for next year. And the reason I ask is, you have $800 million of headwinds in 3Q. And assuming just to normalize this rate, shouldn't the base be up, contribute a few hundred basis points of topline next year?
Christopher Reidy:
No it doesn't imply that, we'd have to look at how you're doing the math, but it would imply more in that mid-single digits on the underlying ex-COVID testing. So thinking that 4% to 5% range, which is very healthy. We do still see the drag. As I pointed out in some of the prepared remarks, we see that tough compare in Alaris against the first quarter. We do still have the tough compare against the first half of the year in the base business until we overlap the COVID period, but then rebounding in the second half of the period. So when you cut through all of that you think in the mid-single digits for the underlying business.
Thomas Polen:
I think that's just an important point to reiterate Vijay as Chris mentioned, right. Because of the timing of our fiscal year, we don't anniversary the lower utilization rates from a COVID impact until Q3, right. The first and second quarter, our compares are still at a pre-COVID basis of utilization. And so that obviously has an impact on that. And so it still be – even despite that in those mid-single digits, low-single digits, and the base business is actually quite strong.
Vijay Kumar:
Understood. And then one quick on margins and free cash flows here. Maybe at [indiscernible], I just want to check if I'm doing the math right. Is the implied operating margins for fiscal 2021, is that that close to a 26.5% and free cash flow conversion where back to north of 90%, were there any timing impact or this now getting back to historical trends of BD printing north of 9% free cash conversion. Thank you.
Christopher Reidy:
Yes. So we have to work with you on the math there too. But I think, what we're saying is if you use Q4 as a jumping off point of the year. We’re likely to have some headwinds as we talked about. And we are making adjustments for the investments that we were talking about, what have you, Veritor does lift that. But taking all that into consideration, we would expect to see some good margin growth compared to the baseline of where we were in 2020. But it doesn't quite get to the 26 number that you're talking to.
Vijay Kumar:
Understood. So just on the free cash Chris, was there any one-time effect?
Christopher Reidy:
I'm not sure what your question is there. We did give the free cash flow – what was your question on that Vijay?
Vijay Kumar:
Where there any timing elements that benefit free cash flow or is this normalized free cash conversion metric, we should be looking forward to them?
Thomas Polen:
Nothing looking forward, but obviously a lot of impacts throughout the year, lumpiness from the COVID drop through and what have you. We did a lot to offset that. We reduced the inventory levels as we talked about. So it did feel like a lot of lumpiness, but we were able to offset a good portion of the drag to be in a solid position as we exited the year. But going forward, I don't see anything that would be lumpy in nature.
Vijay Kumar:
Thanks guys.
Operator:
Your next question comes from the line of Robbie Marcus with JPMorgan.
Thomas Polen:
Hey. Good morning, Robbie.
Robert Marcus:
Hi, good morning. Two questions both on free cash flow and capital allocation. Maybe just to follow-up on Vijay’s question. I think part of the question is there's a number of exclusions in the fiscal 2021 guidance that some of them appear to be cash exclusions. I just want to see – should free cash flow conversion next year take a step down on legal and some of those other items? Are there further offsets in the working capital to make it look more normal?
Christopher Reidy:
Good question, Robbie. So, no, I think some of the cash impacts that we consider kind of below the line or having the past been integration spending in EUMDR. Those were the biggest ones. And the integration spending has been – will be lower going into 2021. EUMDR is still with us. We continue to invest to make sure we're in good shape with the regulations there. So there will be a portion of that, but the free cash flow conversion will increase in 2021.
Robert Marcus:
Got it. That's helpful. And maybe a broader question just on your theory and thought process behind guidance. I don't envy you having to give guidance here in the middle of the pandemic for forward 12 months. We've seen guidance that we've had a lot of beats, but then lowered guidance over time. How did you approach fiscal 2021 guidance here? What ends up to be a pretty narrow range? How should we assume – what's your tolerance levels around it? What were some of just the strategic thinking that you and the Board did? And I'm really trying to get at how confident are you that this is more of a floor and a beatable target rather than it could be better, could be worse in certain areas. Thanks.
Christopher Reidy:
Sure. It’s a great question. Obviously, we've been following things very, very closely. We do see, as we said sequential improvement in our businesses. And so we took that into account. Obviously we're watching the potential for a resurgence very closely. And I think we were very clear when we gave the guidance that we're not assuming a major resurgence that would have a big impact on utilization and in elective surgeries. So we are not assuming that. And that's something that we'll have to wait and see. But at the same time, as we look at the course of the business and the way hospital systems are able to handle the current level, that gives us a certain amount of comfort and visibility as we go forward. I think the other thing that we have in here is the fact that Veritor gives us some natural offset if there is some level of utilization impact, it would probably go hand in hand over the course of the year with a bit more incremental Veritor testing. So there's some opportunity there. And obviously we have built in some piece of our investment of the Veritor revenues and we can gate that to some extent. And so with all of those things, we felt comfortable again, assuming that there's no major change in the resurgence that we could achieve the guidance that we gave.
Robert Marcus:
Appreciate the color.
Operator:
Your next question comes from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Hey guys. Thanks for taking the question. Just a couple of questions on Veritor testing. I'll kind of rapid fire a couple of these. So first are you guys looking to kind of expand your offering there? And are you thinking about anything on the non-instrumented side? And then you mentioned that you doubled the installed base here recently to over 50,000 units. Does that include the roughly 11,000 into the nursing homes? And I'm curious what the utilization you would expect in total for Veritor post-pandemic in order to help us gauge the long-term value creation that you're driving there. So a few on Veritor. Thanks.
Thomas Polen:
Yes. Good questions, Brian. So the double install base of over 50,000 does include those that have been put in the nursing home. As I mentioned, we are looking at what additional menu we can put on that platform. We have a number of opportunities that we think are pretty exciting. Of course, we've never had an install base in the nursing home segment itself. And so part of that work that we've done is actually identifying what specific assays are relevant to the nursing home segment. There's other segments that we now have Veritor placements, and we wouldn't have looked at before in terms of – is there some unique menu that is more relevant to these segments that haven't been traditional call points for us. And so we're actually just wrapping up. We've just wrapped up that work. And again, we'll be using. That'll be an area of investment is in additional menu expansion on Veritor, where you reinvest some of those profits to add additional menu that we think are relevant to some of the new call points that we have Veritor placed in. So we see longevity there beyond the COVID-19 testing itself. Of course, as you know, we are expanding the menu there, very actively working on our COVID-19 flu assay. As we've always said, we’ll provide timing on that when we're ready to – when we get EUA, and we launched that same thing on BD MAX beyond the assay that we've already launched in Europe with our partner CerTest. So we feel really good about the momentum on Veritor. We hear great feedback from our customers on that. And again, we do see longevity on the install base, not only for COVID-19, which as I mentioned before. We think we'll have more longevity. If you ask me this time last quarter, said how much testing is going to happen in FY2022? I would just say that I feel more confident today that there will be longer testing runway beyond 2021 of COVID testing into 2022 and potentially beyond. Obviously then our work on adding menu to that will prolong the growth opportunities for Veritor beyond the COVID window. Thanks Brian for the call. Go ahead.
Brian Weinstein:
Yes. Obviously, is there anything on the non-instrumental? Or are you guys looking to develop anything that would be an antigen test that would not be on the Veritor platform?
Thomas Polen:
Yes. We're looking at that Brian. And again, if we decide to do that, we'll share that when we're ready to launch it. But I would just say at this point, particularly in developed markets, we are very confident in the value that the instrumented platform brings. Again, just as a reminder, our instrumented platform is at a very different cost base than most any other instrumented platform right in that $250, $300 range. So it's not a significant capital, it’s not a challenge for any customer when it comes to that. It wouldn't even be a challenge significantly to bring it into the home necessarily, and we get the benefits, right. Remember, we’re one of the original inventors of lateral flow testing. Our first technologies were manual as we're all, and all of those technologies move to instrumented platforms because they got higher performance on flu and RSV and COVID is of course even a more critical assay to get right. And we see the benefits of an instrumented platform when it comes to sensitivity specificity. We still believe strongly in that. We continue – you've seen us put out a number of – support a number of publications, whether or not it's comparisons of technologies or recent publication, you probably saw around the role of antigen testing versus molecular testing when it comes to projecting infectivity, and that was relative to cell culture methods, which are the reference for, I believe that for patient to be infective. So we're going to continue to invest very heavily behind scientific evidence, and you can expect more of that from us. Again, it would support the value of Veritor and the technology that we're deploying.
Brian Weinstein:
Great. Thank you.
Operator:
Your next question comes from the line of Larry Keusch with Raymond James.
Thomas Polen:
Hey, Larry. Good morning.
Christopher Reidy:
Good morning, Larry.
Lawrence Keusch:
Yes. Good morning, everyone. Two questions. I guess, first, Tom for you. You obviously said in a couple of spots during the call that you are more confident in the timing for the filing of the Alaris 510(k). So just again, want to get a little sense of what makes you more confident than where we were three months ago? Is it just – again, you've knocked off some of the key objectives there that we're in the way. And as part of that question, given some of the hardware recalls that you've had recently. How does that get handled? Does that have to find its way into a filing as well? And then I guess, Chris for you, obviously heard the commentary around pulling some of the 4Q for 2021 into the first half as you talked about the various headwinds and tailwinds. As you look at the first quarter numbers that are out there for the consensus, do you have any – just any high-level thoughts as sort of how those feel?
Thomas Polen:
Good questions, Larry. So when it comes to – let me take the first two and then I'll turn it over to Chris for the third. So in terms of what gives us more confidence, I think you nailed it. It's the fact that we are systematically working our way through the various testing stages. And so we've completed that much more testing since the last update. And that gives us confidence. We also continue to have very active and ongoing dialogue with the FDA around our progress. And that's why as I made earlier, we do have greater confidence in the timelines that we’ve shared last, which is late Q2, early Q3 of this fiscal year. When it comes to the hardware recalls, that's really part of our remediation of the Alaris franchise. It’s us looking at all the different complaint history and are there any further improvements we can be making to the platform. That's also part of our 43 response and activities. And so there's no other filings or anything, those are all built into the current 510(k) submission work. They do not have any impact on the timing of the 510(k) submissions.
Christopher Reidy:
Yes. And then in terms of your question regarding the phasing, I'd say we commented in our prepared remarks that as we looked at the consensus, we did feel that consensus was a bit high in Q4. We wanted to correct that and that we think that some of that should be moved to the first half. I would say move a little bit more of that to the Q2 then to Q1, but Q1 is a bit light given what we're looking at. And so we just wanted to kind of get the quarterly phasing right up front out of the box as we enter the year. And so that's why we were very specific around, take it out of the fourth quarter, put it in the first half. And I would add a little bit more in Q2 than Q1.
Lawrence Keusch:
Okay. Terrific. Thanks guys. Appreciate it.
Operator:
Your next question comes from the line of Lawrence Biegelsen with Wells Fargo.
Lawrence Biegelsen:
Good morning. Thanks for taking the question.
Thomas Polen:
Good morning, Larry.
Lawrence Biegelsen:
Good morning. One on international, one on fiscal 2022, we heard a lot of good color commentary on this call that what you're seeing in the U.S., but obviously we're seeing things deteriorate in places like Europe. How do your comments about the COVID impact in the U.S. compared to what you're seeing outside the U.S., and I have one follow-up.
Thomas Polen:
Yes. So we're seeing still strong performance in Asia in terms of utilization. We're seeing very strong control of COVID across pretty much all Asian nations at this point. But as you mentioned Europe, we are seeing quarantine measures tighten. I would say that – again, European countries are much better prepared this time to continue to deliver care through that period of time. Can there be an impact on procedure volumes as we look forward? Yes. Out of Europe, it may be slightly less prepared, obviously there's different factors in public versus private healthcare systems as well that influenced that. But I think from what we're seeing now, we're definitely seeing better management and continued use of procedures early in this resurgence. But again, that's one of the caveats that we had to make. We can't predict the extent of everything on a forward-looking basis. And so our assumptions, we do recognize that particularly in Europe, there can be some increase, but if it's a significant increase, that would be something that’s not in our current assumptions.
Lawrence Biegelsen:
Thanks for that, Tom. Chris, in your prepared remarks, you gave some good color on fiscal 2022. I heard that 5% plus topline growth and double-digit EPS growth, the algorithm, it sounds like you expect to return there in fiscal 2022, but in your prepared remarks, I heard kind of topline on an underlying basis. So I'm assuming you kind of want us to adjust for the COVID testing delta there. But I didn't hear anything on how to think about EPS. Should the starting point be the guidance you gave for $12.40 to $12.60, or is there some different way we should be thinking about EPS growth beyond fiscal 2021? Thanks for taking the question.
Christopher Reidy:
Yes. I think you got – for the most part, I think you are talking about it, right. Obviously, we feel good about – there's going to be a lot of movement in 2022 from a number of things on the topline. And the biggest variable obviously is what happens to Veritor and you heard Tom say, that we feel better about the testing going into 2022, but we've also said it wouldn't be prudent to assume the same level of testing in 2022 from 2021. And we'll obviously update you as we go from quarter-to-quarter. But you would expect to see some drop off in that piece. And obviously that slope, whether it's a cliff, it doesn't look like it's a cliff in 2022 right now. But it's certainly a downward slope as we think about it. And some of what we're doing in terms of the investing of Veritor spending will help mitigate some of that slope to a certain extent. So we're watching that very closely. But as we look at it, the other variable is when does Alaris revenues start coming back to pre-ship hold kind of levels. And we were very clear. We did not include anything in our 2021 guidance for that. And we're not predicting where that's going to be in 2022, but at some point 2022, we would expect that to start kicking back in. It's probably not as big a pent-up demand because of the medical necessity amounts that we've had in 2020 and potentially into 2021. But those are the things to keep in mind. But we do feel that the base business in 2022 on an underlying basis will be very solid and continue to be solid. So that's just some ways to think about it.
Thomas Polen:
And then maybe Larry, this is Tom. Let me just maybe add on a little bit to Chris's good comments there. I'd say what you're seeing us do is from in the face of a pandemic and the utilization impact, you're seeing us work our way back to that driving durable, sustainable growth, right. We all recognize the markets are anything but predictable. And we worked hard – your earlier question was, spend a lot of time thinking about that range, you can debate and should you have a wide range or a narrower range that at least keeps people from getting on either end of it, which is where we ended up at. But we believe we’ve executed well against challenges in remarkable times. So you can see us doing that as we offset the COVID headwinds this quarter. And I think if you take, for example, this year, in our worst months, we saw significant headwinds across our business. We develop COVID testing. We saw the return of procedures, and we turn a negative headwind into a tailwind, and we showed mid-single digits growth. If you think about prior to COVID, we thought about our end markets growing about 4% and our investments in R&D being in higher growth markets and select investments in tuck-in M&A further supplementing that growth. We feel still strong about that path forward to 5% plus growth that you’ve heard me talk about. And of course, what we're doing now is, this year, in fact with Veritor of course, we're going to be nearly double that level. But what we're doing is we're taking a portion of those profits and we're further investing in our growth and innovation fund. We're investing behind further growth opportunities and right, we're continuing that work on accelerating inorganic innovation or our tuck-in M&A. Again, all in the spirit of driving that durability and consistency of our growth profile. So just to summarize that, we feel good about our capabilities, our innovation, and the factors that are in our control as we think about the business going forward.
Lawrence Biegelsen:
Thanks so much.
Operator:
Your next question comes from the line of Rick Wise with Stifel.
Frederick Wise:
Good morning, everybody.
Thomas Polen:
Good morning, Rick.
Frederick Wise:
Nothing else is clear. It's very clear that innovation is a top priority for you. And one element of that as you discussed is R&D spending, and you emphasize strongly the 8% growth there. So my question really is how do we think about R&D going forward? I mean, you've historically or in recent years has been more around that plus or minus 6% of sales range. Are you suggesting that I mean, that we should think about that either as a percentage of sales or growth as meaningfully higher going forward? Just again any perspective there would be great. Thank you.
Thomas Polen:
Let me comment on just at a high level perspective and then turn it to Chris to talk about kind of how we think about it within the P&L. So obviously you're going to see R&D at, what we'll call higher than a normalized level in 2021 because of the reinvestment of the Veritor proceeds. I would expect it to see that. Of course, as I mentioned, that 8% growth that you saw in Q4 were coming off of relatively flat R&D growth over the last five, six years during the synergy window. And so it is – as you mentioned, it's a notable step up and we will be continuing to increase R&D because of not just our base strategy has that in it, but we're using this opportunity to reinvest those Veritor proceeds and leveraging that growth and innovation fund and the way that we're selecting incremental projects through that process, which was a process that was very successful, obviously at BARDA and the John has helped implement here at BD. So as we think about going forward on the P&L beyond what we're going to see in 2021, I'll turn that over to Chris. But you would expect to see R&D growing in line with revenue on a forward basis beyond 2021, at least in that level.
Christopher Reidy:
Sure. So what I would say and reemphasize, we clearly are, as you said, focus on innovation, and you would expect R&D to increase. You're absolutely right that we did emphasize that 8% growth year-over-year because we need to get back to that 6% mark. We had fallen below that over the last few years, and it's important that we get back there. I think that is probably a good proxy for 2021 to use because that 6% is off of a much higher revenue base as well. So from a dollar standpoint, that's a pretty big step up. So that's a good proxy to think about is that 6% of revenue going forward.
Frederick Wise:
Thank you. And just last for me. First, just want to make sure I understood. I don't think you said – what assumptions are you making about flu as you give us your first half and fiscal 2021 projections. And just last, Chris, congratulations, leveraged down to 3x. Is that where you both want to be? Where are we heading? Just help us think through at a high level your balance sheet goes as well. Thanks so much.
Thomas Polen:
Yes. Great question. And let me take the first one on flu and then Chris on leverage. So flu is certainly light in the Southern hemisphere, so it's unclear what the impact will be this season. I think for us, COVID obviously overwhelms the whole thing. I mean, we're selling every Veritor test we can make. So the whole balance between are we making Veritor tests or COVID tests. We're selling at this point obviously a lot of COVID tests. We are making flu tests and we are shipping flu tests. But if flu tests aren't being utilized that level, we'll make more COVID tests at least for the first couple of quarters. And then obviously we do have a combination assay in development that we look forward to launching later this year. And again, we'll give more color on that. So I think it is fair to say that, I mean, the reality is, is if people are isolated more and are wearing masks and are doing things, will there be a lighter flu season in the Northern hemisphere as well, logic would say so, but the impacts on our business, I think will be different this year because of the role of COVID and the presence of COVID.
Christopher Reidy:
And I would say in terms of the 3x leverages, we're proud that we got down to 3.0x this past quarter on a net basis. And as we've always said, that was the initial commitment, but then we would expect that to continue to float down with increasing EBITDA as we go forward. And so that is still the commitment. We wouldn't want to operate just at the 3x level. We think a company like ours should be in that 2.5-ish kind of range at least. And so we would expect that to float down that way over time.
Frederick Wise:
Thanks so much.
Thomas Polen:
Thanks for the question.
Operator:
Your next question comes from the line of Jason Bednar with Piper Sandler.
Thomas Polen:
Good morning, Jason.
Unidentified Analyst:
Hey guys. This is [Jerome] for Jason. Thank you for taking the questions. I just wanted to refer back to a slide you guys have in your deck where you point out that procedures that rarely trended above that 100% of normal range. Obviously pretty interesting data set. Just wondering if you had any feedback on whether that would be primarily related to patient willingness or challenges of processing those patients through the hospital. And then I guess, any thoughts on the relative outperformance of the inpatient versus outpatient as it seems to show?
Kristen Stewart:
Yes, it's Kristen. Just to comment on that. I mean, we don't have any further data on this. It's just come from the MedMined dataset, we will say just obviously anecdotally just because of the data that we see, which is the data that you see. Certainly, I would say that there has been general apprehensiveness around patients going into care settings in the United States, which this is. This is a dataset of 338 U.S. hospitals. Just to be clear, this is a U.S. dataset. So that likely is influencing some of the trends here.
Thomas Polen:
Maybe Simon as well.
Simon Campion:
Yes. Thanks, Tom. And again, referring to that survey that we've just completed. Certainly, the majority of physicians we spoke to reflected on patient sentiment being one of the driving factors moving here. And some significant data came out about the oncology patient set, breast cancer and colon patients in particular. The decline in screening that's happened in the early phase of COVID is going to contribute to an extra 36,000 deaths – 33,000 deaths in the U.S. from cancer because of a lack of screening in the early phases of COVID. And so as you walk around different cities in the U.S. and certainly where I live in Rhode Island, you see billboards now with hospitals and practices encouraging patients to go attend. And I think the protocols that they've implemented are certainly establishing great framework for patients to feel comfortable about it. But still, I think hospitals want to do procedures, physicians want to do them, and the big variable here is getting the patients back in for screening and subsequent procedures after that.
Thomas Polen:
Thanks for the questions, Jerome.
Operator:
Your next question comes from the line of Matt Taylor with UBS.
Thomas Polen:
Good morning, Matt.
Matthew Taylor:
Hey. Good morning, Tom and Chris. Thanks for taking the question. So I just wanted to ask you about the forward years. You made some comments before. I guess what I'm wondering is if there is a testing cliff at some point if you have a tough compare, are there things that you would do proactively like a buyback or you phase down some of those investments that you're making now in growth to kind of smooth earnings and help with that transition?
Christopher Reidy:
Sure. Great question. And thanks to allow us to add some clarity there. That's exactly the thought process. As we initially looked at this, we thought that it could be very much a cliff from 2021 to 2022, and that one way to mitigate that, that cliff would be to make investments in 2021 that help us drive long-term growth, but also are kind of one-year investment boluses that will kind of mitigate that cliff to a certain extent. That logic still continues as we think about testing extending into 2022 because it wouldn't be characterized, as I said by a cliff, but it certainly the potential for a downward slope. And by making some of these investments in 2021, it would help mitigate that slope to a certain extent. The biggest variable is what that slope looks like. But I think we're very comfortable that we can do that in 2021, and then see where that testing in 2022 is going. So it's looking less like a cliff. Those investments certainly are the kinds of investments that we could make. That would be an expense in 2021, but not only would go away in 2022, but would potentially drive increases in 2022 in earnings by investing in a variety of things, R&D, M&A kind of deals that become more accretive in year two, that kind of thing. So it's exactly what your question implies what we're doing.
Thomas Polen:
Thanks for the question, Matt.
Matthew Taylor:
Thanks, Chris. Thanks, Tom. I just had one follow-up on the pricing in testing. Have you actually seen any price pressure yet, or is this just something that you're thinking could happen and so you're being conservative in baking in some potential pressure for Veritor especially?
Christopher Reidy:
Yes. It's still latter. We haven't seen the pressure yet. But as Tom mentioned, I think earlier in Q4 the ASP was a bit higher than we had signaled. But we don't think it's prudent to continue to think that that would hold up as other competitors move into the market and the different dynamics that we'll be facing as we go throughout the year. So we had originally signaled the $20 ASP and we think it was – it certainly was higher than that in our Q4. But we think that will be under pressure as we go through, and that is what we have in our guidance assumptions.
Matthew Taylor:
Great. Thank you.
Kristen Stewart:
And Crystal, we'll take just one more question just given the time, apologies to those left in the queue.
Operator:
Thank you. Your last question comes from the line of Josh Jennings with Cowen.
Thomas Polen:
Good morning. Josh.
Joshua Jennings:
Good morning. Thanks for taking the questions. I was hoping you maybe able to share just the percentage of the revenue base levered to hospital's capital equipment budgets. And if you could talk about just the recovery of the capital franchise maybe hard to parse out lot of moving pieces with Veritor instrument placements and the Alaris ship hold. But anything you can share just about those non-Veritor instrument and Alaris Pumps, but on the – the rest of the capital franchise recovered in fiscal 4Q and the outlook for the chunk of the revenue base in fiscal 2021.
Christopher Reidy:
Yes. And this is consistent with what we've said in the past. The percentage of revenue that are focused on capital is in that kind of 15%-ish range. We've said that in the past. And you might imagine where that is. It's in, in areas like KIESTRA and in the M&A side for the most part, a little bit in Biosciences. We have seen pressure on capital during the third quarter, particularly and we have seen that improve. A lot of it has to do with the inability to install during the third quarter because hospitals weren't allowing people to come in that were not patients appropriately. So we did see that pressure, we saw that sequentially improve into Q4. And so we would expect that to continue to improve through 2021 as well, and we don’t – assuming that there's no major resurgence. As we said, our guidance contemplates that assuming and being at normal levels in 2021.
Thomas Polen:
I would say that – as we – we did see some improvements on the capital in the research area, BDB, we saw it across the Board. I’d say dispensing is another area, obviously capital part of that’s operating leases. We still do sell some in capital. But I’d comment, we did see the U.S. dispensing business returned to the modest growth in Q4. And we ended the year with strong net gains and committed contracts with a very strong Q4 in committed contracts and we ended the year net positive there from a competitive perspective as well. So we're seeing good signs there. As you mentioned, it's a little bit difficult with Alaris to fully compare that, but we were seeing the restarting of it, and we’re able to get back into labs now to do those installations, the Kiestra installation. There is a big complex, those are big complex walls, change electricity sockets, but they weren't happening throughout the pandemic that are restarting now.
Joshua Jennings:
Great. Thanks for that. Just one follow-up. Just on the – LUTONIX is a small piece of the overall corporate revenue pie. But a little bit more important for the Interventional segment. The VOYAGER PAD Analysis at TCT was probably the most compelling rebuttal of the Katsanos Meta-Analysis. Maybe you could help us or give an update on the state of affairs of the drug-coated balloon market, and relative to the high watermark in 2018. And really just – my questions is just trying to get a sense of with this VOYAGER PAD data out there, the other data sets that have been presented over the last 12 months, I mean, could LUTONIX from where it sits today, become a growth driver for Interventional over the next 12 to 24 months. Thanks for taking the questions.
Simon Campion:
Yes. Hi, it’s Simon. As I think over the past pre-COVID, certainly we had seen a, I think a significant rebound in our LUTONIX business in or around the 70% to 80% of Q1 2019 numbers, so before Katsanos, and so on. Over the past several months or Q3 was our Q3, that obviously deteriorated quite a lot. But I'd say coming out of September, we were pretty much at the pre-COVID levels, which were in that 70% to 80% of pre-COVID levels. That's all making sense. And again, some recent work that we've done a year ago and I just repeated, a year ago about 80% of physicians that we surveyed were less than comfortable with Paclitaxel safety based on Katsanos and based on the FDA panel and so on and so forth. And now that has flipped. The recent data that we got that has flipped that 80% are now comfortable with Paclitaxel safety and the VOYAGER data, and the data that was provided at panel and so on and so forth. I think that reiterate the safety of Paclitaxel in general and LUTONIX specifically. So it was a significant driver for us in Q4. In the peripheral business, both domestically and in Japan where we've had a really successful launch since we commercialized fully in December. And we continue to get FDA approvals on the 018 platform, and the 300 millimeter balloon platform and the low profile AV platform. So we're pretty pleased with where we are right now on LUTONIX.
Joshua Jennings:
Okay. Thanks.
Thomas Polen:
Thank you for the question.
Thomas Polen:
So thanks everyone for the good dialogue this morning. We've shared with you the challenges, opportunities, and successes that shaped Q4 and fiscal 2020, and that are influencing our expectations for the year ahead. One thing we didn't talk about though, were the people of BD, the 70,000 associates around the globe, who rallied around our purpose of advancing the world of health at a time when the need was most urgent. So I want to close with a message to the BD team. Thank you for your focus on our purpose, for your resilience when it came to executing our most critical priorities and your willingness to embrace bold new ideas, you delivered a strong Q4 that exceeded our expectations to finish a trying year on a high note. By building on the bold actions we took in FY2020, and by continuing to execute our long-term strategy to grow, simplifying and empower, we will address healthcare's immediate needs while bringing more innovative new solutions that will support our growth across all three of our segments. In FY2021, there will be no shortage of opportunities for you to think boldly make a meaningful impact and change more lives for the better. On behalf of the entire executive team, I want to say thank you to BD associates around the world for your efforts, sacrifices, and achievements over the past year. You showed the world and each other just how vital BD is to the delivery of healthcare. Thanks again, and let's keep going forward.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello and welcome to BD's Third Fiscal Quarter 2020 Earnings Call. At the request of BD, today's conference is being recorded. It will be available for replay through August 13th, 2020 on the Investors at bd.com website or by phone at (800) 585-8367 for domestic calls and area code (404) 537-3406 for international calls using confirmation number 3197917. [Operator Instructions] Beginning today's call is Ms. Monique Dolecki Senior, Vice President of Investor Relations. Ms. Dolecki you may begin.
Monique Dolecki:
Thank you, Stephanie. Good morning everyone and thank you for joining us to review our third quarter results. We hope that everyone continues to be healthy and safe. With safety in mind, we are again taking a more virtual approach to our call today while also to exercising social distancing. Joining me in person we have Tom Polen, our Chief Executive Officer and President; and Chris Reidy, Executive Vice President and Chief Financial Officer and Chief Administrative Officer. Joining by phone we have Alberto Mas, Executive Vice President and President of the Medical segment; Simon Campion, Executive Vice President and President of the Interventional segment; and Patrick Kaltenbach, Executive Vice President and President of the Life Sciences segment. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A sections of our recent SEC filings. In particular there continues to be significant uncertainty about the duration and contemplated impacts of the COVID-19 pandemic. The commentary that we are providing today includes information regarding the July trends we are seeing in our businesses. We have made certain assumptions in how we are managing our business but that could change as we move forward. We will also discuss some non-GAAP financial measures with respect to our performance. Reconciliations to GAAP measures that include the details of the purchase accounting and other adjustments can be found in our press release and its related financial schedules and in the appendix of the Investor Relations slides. A copy of the release including the financial schedules is posted on the bd.com website. It is now my pleasure to turn the call over to Tom.
Tom Polen:
Okay. Thank you, Monique and good morning everyone. I hope you and your families are doing well and staying healthy. If I had to summarize Q3 in two words, it would be execution and impact. I'm very proud of our team for the performance they delivered in the third quarter given the challenging environment. What stands out to me the most is the progress the BD team made executing and delivering on both our short and long-term agenda creating value for patients, customers, and shareholders. We launched the COVID-19 assay on Veritor, secured injection device orders for future vaccination campaigns, and scaled manufacturing to ensure continued supply of critical medical technologies across the continuum of care. We announced several U.S. government collaborations to expand U.S. capacity in critical to COVID product areas. We worked closely with our customers as they resumed medical procedures throughout the quarter. And we saw those procedures continue to increase as we exited the quarter. At the same time, the team never lost sight of the long-term advancing our growth strategy, driving our innovation pipeline, and executing on our cost savings and simplification initiatives. I'm confident the steps we're taking now will help BD emerge from the pandemic strong and put us in the best position for the long-term. Let's jump into the quarter on slide four. Our third quarter results reflect the impact of COVID-19 on healthcare around the world as we saw strong demand for COVID-19 related diagnostics and significant pressure on the parts of our portfolio that support elective procedures research routine care and lab testing. We anticipated we'd see the biggest negative impact from COVID-19 in Q3 and it's largely played out that way. All-in COVID-19 had a net negative topline impact of $600 million in Q3. Chris is going to provide more detail on performance during the quarter and our perspectives on recovery. But let me share a high level summary of what we're seeing starting with Interventional. Across the Interventional segment, we saw sequential improvement each month during the quarter as hospitals and patients started to resume elective and non-urgent procedures. In June, China delivered positive year-on-year growth in all three BDI businesses. We continue to watch China closely since they're further along in their post-COVID restart. We exited Q3 seeing BDI procedure volumes at approximately 80% of pre-COVID levels. Moving on to the Medical segment, we're really pleased with the continued strength in our Pharmaceutical Systems business which is growing high single digits on a year-to-date basis. We view both the pharma systems business and Diabetes Care businesses as more insulated and less impacted by COVID-19. As you know the rest of the segment's portfolio is closely tied to overall healthcare consumption, so naturally the impact of lower hospital utilization was very pronounced across the medical device consumables portfolio even more so than we had initially anticipated. That said we're encouraged that we saw demand for medical device consumables improve in June. Lastly, early demand for infusion pumps under medical necessity did spike in April as expected and then tapered down throughout the quarter. Now, looking closer at Life Sciences, as expected, we saw very strong demand for COVID-19 diagnostic tests and supplies during the quarter which was offset by a deferral of routine lab work as well as delays in capital investments on both the research and the diagnostic side. In Q4, we expect continued strong demand for our COVID-19 diagnostics solutions with the addition of the Veritor assay to the portfolio. In addition we did see reagent orders begin to pick up in June for both research and clinical applications which demonstrates that researchers continue to get back into the labs. While this remains a dynamic situation we're providing revenue and EPS guidance for Q4 and the total year as we have improved near-term visibility. Based on what we know today we believe our guidance range reflects the trends we saw in June and July and accounts for our expectations as we close out the year and Chris will go into more detail later on the call. Despite the challenging environments it's clear that BD's durable capabilities and critical health care portfolio have been and will continue to be a vital part of the COVID-19 solution. And I'm confident that the actions we've been taking position BD increasingly well to support our customers through the pandemic and return to growth as the global economy and health care industry continue to stabilize and recover. Turning to slide five, on our last call, we discussed how the strength and diversity of BD's portfolio enables us to support the world's response to COVID-19 across the full continuum of care. The BD team made significant progress executing this agenda during the quarter positioning us well to finish the year with momentum. So, let me share a few highlights with you starting on slide six. First, today marks one month since we launched the SARS-COVID-2 antigen assay for the Veritor Plus system, which received FDA, EUA in early July. We believe this platform is a real game changer, dramatically expanding access to COVID-19 testing at the point of care and reliably diagnosing SARS-COVID-2 in 15 minutes. In the first month since launch we received very strong demand for both the Veritor Plus system and the SARS-COVID-2 assay including from our traditional customers as well as nontraditional accounts. In our first month of launch we've shipped more Veritor Readers than we normally do in an entire year. This is a strong indicator of the unprecedented interest and demand for near real-time point-of-care COVID testing. As one example we're proud to partner with the U.S. Department of Health and Human Services on their efforts to expand access to rapid point-of-care testing in nursing homes through their initial order of 2,000 Veritor Plus systems and 750,000 SARS-COVID-2 antigen test kits. To support the very strong demand we're seeing we are leveraging our world-class manufacturing scale and expertise to significantly increase supply capacity. And we're feeling good about both our original goal of producing 10 million tests in Q4 and our scale-up to our initial eight million tests per month run rate by the end of the fiscal year. In addition, last week we announced a $24 million investment from the U.S. Department of Defense in collaboration with HHS to support the additional scale-up of U.S. manufacturing, which is expected to bring global production of the Veritor assay to 12 million tests per month at the end of February 2021. We're putting the full capabilities of BD behind this including not just those in our Life Sciences segment, but we're pulling in talent from both BD Medical and Interventional to support the scale-up. Detecting and containing coronavirus globally will take a collaborative industry-wide response. And we're proud to partner with AdvaMed on the national diagnostic supply registry to help ensure widespread availability of testing. The Veritor assay joins a portfolio of three molecular solutions for our COVID-19 testing that BD has already delivered for use with the BD MAX molecular system that includes two with EUAs and two with CE Mark. We're now producing one million COVID-19 rapid molecular diagnostic tests each month for use on BD MAX. And as I've shared we're investing in further expanding BD MAX capacity so we can produce an additional 900,000 tests per month. The installation of these additional production lines is well underway and remains on track to be at our new 1.9 million BD MAX tests per month run rate by the end of the calendar year. Cumulatively we've produced more than 3.5 million rapid molecular tests for BD MAX. In addition to investing to expand capacity, we're also investing to expand our portfolio. Our R&D teams are actively advancing our work to develop flu plus COVID assays for both our Veritor and MAX platforms, so we can better support health care providers and patients. I'm very proud of the entire BD team for driving scale and impact through our COVID-19 diagnostics solutions. If we move on to slide 7. To date, we've now received orders for 470 million needles and syringes from the U.S., Canada and the U.K. and other entities in anticipation of vaccine programs we expect late this year or early 2021. These orders represent a mix of safety and conventional device types. While we anticipate initial shipments to the U.K. in fiscal year 2020, the majority of these orders will be delivered in fiscal year 2021. In addition, we formed a strategic public-private, partnership with the Biomedical Advanced Research and Development Authority known as BARDA. BARDA will invest an estimated $42 million into a $70 million capital project to expand U.S. manufacturing capacity for injection devices. The new capacity is expected to be online within 12 months. And once completed BARDA will have priority access to injection devices from these new manufacturing lines to support mass vaccination campaigns for COVID-19 and future potential pandemics. As the world's largest manufacturer of syringes and needles, we are focused on fulfilling routine customer demand such as for annual flu vaccination, programs while also ensuring we can support surge demand for pandemic response. We are continuing active discussions with governments around the world about the need to place injection device orders quickly to ensure timely delivery for 2021. As expected I also want to provide an update on Alaris. We are working diligently and with urgency to prepare the 510(k) filing. Our focus is on ensuring a comprehensive submission that will ultimately help enable timely FDA review and clearance. We expect to submit the updated 510(k) in late fiscal Q2 or early fiscal Q3 2021 based on ongoing dialogue with the FDA. We recognize there's a focus on the time line for the 510(k) submission and that's important. But taking a step back, we feel really good about the overall collaborative process we are engaging in with the FDA. In our pre-submission conversations, the focus has been on having a complete and robust submission and we have been spending additional time on aligning the testing protocols upfront, which is time and effort well spent. We believe the more work we do upfront to ensure the most robust submission, the better we are enabling a timely review and clearance process. As expected, our team has completed quite a bit of the testing and other work required for the submission. And we have a much better visibility to our submission timing now than we did when we last updated in May. When it comes to human factor testing, we've completed 100% of our formative testing which is a significant milestone involving 12 different human factor tests in the middle of the pandemic. We are pleased with the data and outcomes. We have also completed a substantial software system verification. Completion of formative human factor testing and software verification retires significant risk to the submission. We are taking a bit longer to ensure full alignment with the FDA on the final phase of human factor testing which is referred to as a summative testing. And again we feel this investment in time now best serves us in meeting our ultimate goal of a timely 510(k) clearance. We have submitted our summative testing protocols to the FDA and expect feedback shortly. Concurrently we are continuing to recruit clinicians for the next phase of human factor testing. And once we have that feedback from the FDA, we will be able to complete the summative testing. In addition, in our ongoing feedback discussions with the FDA, we made the decision to include an update to our specialty EtCO2 module which is important for clinical care and especially COVID response. The EtCO2 module is used to help monitor patients on ventilators, while medication is being administered. We believe this is the right decision for the Alaris system over the long term the patients we serve and far outweighs the additional time line of a few weeks it takes to include it again providing the most comprehensive submission to the FDA to help enable a timely review and clearance. I can't emphasize enough, how seriously we take this matter. As with any project of this magnitude and complexity, there are always obstacles along the way. But we're confident that we have the right resources, the right plan and the right team in place. We'll continue to address any issues that may arise in a way that ensures the most comprehensive submission to achieve our ultimate goal of a timely clearance. This dedicated team is executing well. And we will keep you updated as we make further progress on key milestones. Moving on to slide 8, and our innovation agenda. Each of our segments are focused on driving consistent durable growth for the long-term. They are doing this through innovation in areas where we are our strongest, where we see disproportionate new growth opportunities and that are aligned with emerging health care and technology trends. During the quarter we launched four new products and we remain on track to deliver our robust innovation pipeline for the year as shown on this slide. Taking a closer look in BD Life Sciences. Let me call out a few milestones in our Biosciences business. This quarter we launched an upgrade to the BD FACSMelody to expand from two-way sorting to four-way sorting, enabling customers to capture more cell types. This capability is available as an upgrade to our existing installed base and helps to further strengthen our position in the fast growing entry level sorter market. During the quarter we also launched software version 1.1 for FACSDuet. This software enables the automated preparation of antibody reagent cocktails, which is traditionally a manual time consuming and error prone step in clinical flow cytometry workflows. This release enables our team to continue driving the successful launch of the FACSDuet base model, as well as extend into the larger leukemia lymphoma and mixed lab markets. In BD Medical, we continue to see good traction with BD PhaSeal Optima, a next-gen closed system drug transfer device we launched late in FY 2019. Our customers are increasingly choosing Optima to protect health care workers handling hazardous drugs, because of the product's safety, ease of use and demonstrated performance as the device minimizes residual drug loss in vials compared to other similar systems. Sales of Optima have grown sequentially throughout FY 2020 despite the challenging pandemic period and the launches helped drive high single-digit growth across our CSTD platform. I also want to comment on our pharm systems business, which is a great example of the diversity of BD's portfolio and how it's a real strength and strategic advantage. Pharm systems continues to perform very well, growing high single digits on a year-to-date basis. We continue to be positive about the outlook for this business. In addition to favorable market trends enabling strong growth in the prefilled syringes platform, we've also been investing in advancing our self-injection systems to meet the needs of our pharmaceutical customers. And lastly in BD Interventional, we recently received FDA clearance for our next-generation targeted temperature management system. The AS Stat Temperature Management System offers a way to noninvasively control temperature within a narrow range for all appropriate patients. We have now leveraged and integrated BD's capabilities around EMR integration and data analytics into the AS Stat system, which also incorporates advanced algorithms and capabilities to enhance the patient and the physician experience. In our Peripheral Intervention business, which is a global market leader in biopsy and implantable ports, we recently launched our first interventional oncology product Caterpillar. This novel technology is used for embolization of the arteries serving tumors. While commercializing new products during the pandemic has been challenging, the device has been used in more than 50 interventions to date with excellent feedback on its deliverability, visibility, under angiography and ability to cause rapid and sustained embolization of the artery. While still early, we believe the positive response from customers is a good indicator of the growth opportunity ahead. Before I pass it over to Chris, I want to briefly comment on slide 9 and the other drivers of our long-term growth strategy simplify and empower. As we discussed last quarter, we've been extremely focused on cash and expense management throughout this pandemic period. And this discipline was reflected in our SSG&A this quarter. In addition to helping to strengthen our bottom line, these efforts ensured we flow investments to the most significant opportunities. In addition, Project Recode remains on track. As you'll recall Project Recode is our comprehensive internal simplification initiative that we expect to deliver approximately $300 million in savings over the next four years. We're focused on operating the business with discipline including how we can best deploy resources to maximize our impact. And lastly in empower, in July, we released our FY 2019 sustainability report, sharing our latest progress against our 2020 sustainability goals and reinforcing that ESG remains a fundamental element of our strategy. We look forward to announcing our 2030 impact goals later this year. And as always you can find our quarterly sustainability updates in the appendix of today's presentation. All-in, I'm proud of the progress that our team is making. With the successful launch of Veritor and significant injection device orders from multiple governments, we are clearly delivering on our short-term COVID-19 response plan. We're making the necessary investments and are working as quickly as possible to fully resolve the Alaris matters to ensure the completeness of this complex system to aid the FDA's review and clearance. At the same time, we continue to execute against our strategy for long-term value creation. While we continue to navigate a challenging environment, I'm confident the steps we're taking now will put BD in the best position for the long term. With that, let me turn the call over to Chris.
Chris Reidy:
Thanks, Tom, and good morning, everyone. I'd like to begin with some comments regarding BD's ongoing response to the COVID pandemic. First, I'm very proud of our organization as we have continued to adapt to the rapidly changing environment and evolving needs of our customers and associates. We have responded with both strength and agility to ensure the continued safety and well-being of our BD associates and to also best serve our customers and their patients as they battle the pandemic. Second, we continue to see strong demand for our COVID related solutions. This includes diagnostic test on our BD MAX platform where we are continuing to increase capacity to meet demand. We are also actively ramping our efforts around the recently launched rapid antigen test on BD Veritor point-of-care system. And we continue to grow our pipeline of orders for syringes and needles to support future global vaccination campaigns. Third, as we continue to adapt and meet our customer needs, we also remain focused on the execution of our long-term strategy, which positions us well for the future. In addition to the COVID related solutions, we launched four additional products in the quarter and we remain on track to execute against our new product pipeline for fiscal year 2020. We are also continuing our work on Project Recode as part of our plans to simplify BD, which will help drive future operating margin expansion. We are confident that BD will emerge from this global health crisis from a position of strength and will continue to create and deliver value to all stakeholders. With that context, let's move on to our results for the third quarter including a review of the COVID impacts. As Tom discussed our third quarter performance reflects the impact of the global COVID-19 pandemic. Revenues declined 9.4% on a currency neutral basis. This was driven by approximately $600 million in net COVID headwinds, which impacted growth in the quarter by approximately 1400 basis points. As we shared previously, we saw significant impacts to our results in April and May. We were pleased that the sequential improvement we saw from May to June across our businesses continued into July with Q3 being the trough in terms of negative impact of COVID to our businesses. I'll discuss more regarding the trends across our businesses later in my presentation. Third quarter operating margins were 20.1%. This reflects the impact of high decremental margins on lost revenues due to COVID-19 as well as COVID-related investments. Adjusted EPS was $2.20, which represents a decline of 28.6% year-over-year or 25% on a currency-neutral basis. Following our $3 billion equity issuance in May, we retired both the $1.9 billion term loan and the $695 million we had outstanding on the revolver. Our liquidity position remains strong with $2.9 billion of cash as of June 30. Prior to the equity offering, we plan to pay down approximately $1 billion in debt in fiscal 2020 and we remain on track to do that. Combined with the revolver pay down in May, we will have paid down a combined $1.7 billion by the end of fiscal 2020. Moving forward, we believe it's more meaningful to talk about our leverage on a net basis with leverage being 3.1 times net of cash as of June 30. Moving to Slide 13. Before I discuss our revenue performance by segment, I'd like to provide some color on the COVID impact in the third quarter. As we expected, continued adherence to COVID-related stay-at-home measures resulted in a decline in elective procedures and lower hospital admissions and procedure volumes as well as fewer routine lab tests and related specimen collections. In addition, we saw reduced demand from research labs due to closures. There are also some delays in capital instrument installations as facilities and staff were not easily accessible due to COVID. During our third fiscal quarter, these headwinds resulted in a gross impact of approximately $800 million to revenues. In terms of recovery, we are pleased to see sequential monthly improvement from May to June across our businesses and in some cases like elective procedures, we saw sequential improvement throughout the quarter. Gross headwinds in the quarter were partially offset by approximately $200 million in COVID-related tailwinds. This was driven by strong demand for COVID-19 diagnostic testing and infusion pumps. As we anticipated demand for Alaris infusion pumps under medical necessity was significantly higher in the month of April compared to May and June. Now turning to slide 14 in the medical segment. BD Medical revenues declined 6% in the third quarter, including a net headwind from COVID of approximately 600 basis points. In the Medication Delivery Solutions unit, our performance reflects the impacts of declines in hospital admissions due to COVID, which resulted in fewer procedures. The majority of our MDS portfolio catheters flush and the like tracked closely to hospital admission trends. If we look at the U.S., as an example, admission rates were down most significantly in April. We saw a sequential improvement over the quarter exiting with admissions at approximately 80% to 85% of pre-COVID admission levels. Lower procedure volumes drove reduced customer demand and resulted in distributors rebalancing inventories in May and June following distributor stocking that took place during March and into April in the U.S. and Europe. MDS performance also reflects distributor inventory reductions and lower volumes related to the ongoing volume-based procurement process in China, which were in line with our expectations. Similar to the U.S. and Europe, we saw an improvement in the impact related to COVID in China as the quarter progressed. Revenues in the Medication Management Solutions unit reflects strong demand for infusion pumps in the U.S. under medical necessity and strong growth outside the U.S. particularly in Europe. Within the quarter the majority of the U.S. medical necessity demand occurred in April as expected. This strength was partially offset by delayed capital installations of dispensing systems due to COVID as anticipated. And similar to our MDS portfolio, lower hospital admissions also impacted sales of infusion sets in MMS. Pharmaceutical Systems performance reflects our continued ability to meet high demand for pre-fillable syringes. Pharm systems third quarter revenues also reflect some timing of customer orders within the year. Year-to-date pharm systems revenues grew a strong 8.1% and we expect continued momentum in the fourth quarter. Third quarter performance in our Diabetes Care business reflects distributor and retailer reductions to inventories as expected after inventory increases that occurred towards the end of the second quarter due to customer stocking related to the COVID pandemic. Now turning to slide 15 and the BD Life Sciences segment. Revenues declined 7.8% in the third quarter, including a net headwind from COVID-19 of approximately 1,700 basis points. In Diagnostic Systems, growth was primarily driven by strong demand for COVID-19 diagnostic testings on the BD MAX platform. This was partially offset by a decline in routine diagnostic testing due to COVID. Results in pre-analytical systems were impacted by fewer specimen collections due to lower routine diagnostic testing. And in the Biosciences units performance reflects slower research and clinical lab activity due to COVID-19 that led to reduced demand for instruments and reagents. Now turning to slide 16 in the BD Interventional segment. Revenues decreased 19.2% in the third quarter, including a net headwind from COVID of approximately 3,000 basis points. Revenues in both the Peripheral Intervention and Surgery units were impacted by the deferral of elective procedures due to COVID. Within Peripheral Intervention, the impact of COVID was most notable within oncology across the U.S., Europe and China, as women delayed mammographies and in our ESKD and PAD platforms in the U.S. and Europe. Sequential improvement was seen during the quarter across all platforms. Revenues in China were flat year-over-year as the declines in oncology were offset by solid performances in End-Stage Kidney Disease and PAD. Within the Surgery unit the impact was primarily related to hernia repair and infection prevention in the U.S. and Europe as well as biosurgery in the U.S. Third quarter performance in Urology and Critical Care reflects the impact of COVID-19 on the acute urology portfolio due to lower hospital admissions. We continue to see solid performance in our targeted temperature management and home care portfolios. As Tom mentioned, China delivered positive growth in the month of June in all three BDI businesses. We are continuing to watch China's recovery closely. For your reference, we have included a slide in the appendix of today's deck that provides our total company third quarter results by geography. I'll now turn to slide 17 and our gross profit and operating margins for the third quarter. Gross profit margin of 51.7% declined 340 basis points on a currency-neutral basis. This reflects the impact of decremental margins of approximately 80% on lost revenues due to COVID headwinds in the quarter. This was driven by the mix of impacted revenues as well as the high fixed cost nature of our business which resulted in unabsorbed manufacturing variances which were expensed in the quarter. The COVID impact to gross margin also reflects investments, we made in PPE facilities and the like to ensure the health and safety of our associates. The COVID impact was partially offset by gross margin leverage of approximately 50 basis points driven by our ongoing synergy and continuous improvement initiatives. Currency had negative impact of 50 basis points on gross margins in the quarter. Operating margin of 20.1% declined 480 basis points on a currency-neutral basis. This reflects the COVID impact to gross margin as well as additional operating expenses and investments related to COVID. This includes increased shipping cost investment in areas such as IT to support associates working from home, as well as new product development including our BD Veritor rapid diagnostic test. The COVID impact to operating margin was partially offset by operating expense leverage of approximately 70 basis points that reflects our ongoing discipline and initiatives to reduce expenses particularly within G&A. I'll provide more details on that in just a moment. Higher deferred compensation expense due to strong stock market performance in the quarter also negatively impacted operating margin in the third quarter. As a reminder deferred compensation expenses recorded within SSG&A and is entirely offset in the P&L in the other income net line item. Currency had a negative impact of 50 basis points on operating margin in the quarter. As we look forward we continue to expect COVID pressure on gross margins to improve as revenues return. However in the immediate term looking to the fourth quarter we continue to anticipate decremental margins of approximately 80% on related to COVID headwinds. Turning to Slide 18 which recaps the third quarter income statement, as discussed revenues declined 9.4%, this includes a 10 basis point decline and pricing in the quarter which was slightly better than anticipated. Gross margin was 51.7% as I discussed a moment ago. SSG&A as a percentage of revenues was 25.4% including the expenses related to deferred compensation. As a reminder this is fully offset in other income. SSG&A expenses were down 6.7% year-over-year on a currency-neutral basis or 8.9% excluding the impact from deferred compensation. This decrease reflects our ongoing expense discipline and the proactive measures we took to mitigate the impact of COVID. Some of these items include compensation reductions at the management level and suspension of the company's 401(k) match, as well as hiring restrictions. The decrease in SSG&A, also reflects lower T&E expenses as the majority of our associates continue to work virtually. R&D as a percentage of revenues was 6.3% as we continue to invest in innovation to support our COVID response plan and our long-term growth strategy despite COVID-19 pressures. Our third quarter tax rate was 5%. This was driven by discrete items that occurred within the quarter that were contemplated in our prior guidance range. For the full year we continue to expect our tax rate will be between 14% and 16% with a high teens rate in the fourth quarter. Preferred dividends on our BDX B shares that were issued during the quarter were $9 million. Adjusted earnings per share was $2.20 as previously discussed. This includes an FX headwind of $0.11 in the quarter which was more than we anticipated. As expected the expiration of the Gore royalty impacted adjusted EPS growth by about 580 basis points. As a reminder, we will anniversary the expiration of the Gore royalty this month. As we look forward we continue to monitor several macroeconomic factors and the potential impacts to our businesses. First, countries states and even localities are in various stages of the COVID-19 pandemic. As a result there is still great uncertainty regarding future infection levels, recovery rates and resurgence as well as general health care utilization. Second a continued weak macroeconomic environment will likely keep pressure on the overall healthcare system, utilization and consumer spending. Third the pace at which deferred procedures return to normal continues to be one of the biggest variables. This will depend on several factors including disease condition and acuity. COVID-19 testing availability, reopening and resurgence in countries around the world, and state-by-state within the U.S. and patient willingness to seek care. It's difficult to predict how that will all play out over the long term. And finally the timing effectiveness and timeline for potential COVID-19 vaccines around the world and the impact of the vaccine on surveillance testing is all yet to be determined. Looking forward while we are encouraged by the sequential improvement, we expect to continue to see unfavorable impacts from COVID-19 in our Surgery and Peripheral Interventional business due to elective procedures and we cannot anticipate the pace at which those procedures will fully return to normal. Moving on to the acute and non-acute area where our MMS, MDS and UCC businesses participate. We are continuing to monitor hospital admissions and utilization levels for both COVID and non-COVID patient care, as well as care in the non-acute setting. As we have shared previously we do not expect demand for infusion pumps under medical necessity to continue at the same level going forward. In diagnostics, we are continuing to monitor COVID and non-COVID testing volumes globally. As I mentioned earlier we anticipate continued strong demand for our BD MAX diagnostic test for COVID-19. Also as we expected we have seen very strong demand in our rapid point-of-care antigen test on the BD Veritor platform and we are working to scale up manufacturing of both our Veritor Readers and assays. And lastly in our Biosciences business, the pace of recovery will continue to depend on levels of research activity and clinical testing and how quickly they scale up to normal operations and capital spending. Now moving on to Slide 20, before we move on to our guidance for the fourth quarter and fiscal year, I'd like to spend a moment highlighting the trends we saw during the third quarter related to the impact of COVID across our businesses. We shared this slide with you on our May earnings call which at that time depicted our results for April. This slide has been updated to reflect the third quarter COVID impact. When comparing the Q3 slide to the month of April, you'll note several things and I'd like to speak to two of those. First the quarter shows an improvement versus the month of April as the recovery continues to progress. The other trend worth noting is in our MDS business where we saw a larger COVID impact in May versus April. We saw improvement sequentially in June from the May low point. In total the COVID impact to our MDS business was approximately $200 million. On average in the third quarter, our businesses were impacted by approximately 25% to 40% versus our pre-COVID expectations. We exited the quarter with the month of June approximately 20% to 25% below pre-COVID expectations or said another way June had recovered to 75% to 80% of pre-COVID expectations. We were encouraged to see that exiting the third quarter and into July COVID headwinds started to abate and tailwinds started to improve. Note that we saw a sequential improvement in recovery rates in July versus June. Recovery rates across elective procedures, hospital admissions and routine testing range from 80% to 85% versus our pre-COVID expectations in the month of July. We are also seeing strong early demand for our Veritor rapid point-of-care antigen testing and continued demand for COVID-19 test on BD MAX. As expected there was a small amount of demand for infusion pumps under medical necessity as well as continued delays in large capital installations. Turning to slide 22, despite the continued variability and uncertainty due to the pandemic, we are providing a view into our revenue and EPS expectations for the remainder of the year based on what we are seeing today. For the fourth quarter, we expect revenues to be down low-single-digits and adjusted EPS to be between $2.40 and $2.60. As a result, we expect a revenue decline of a negative 2% to a negative 1.5% and EPS of $9.80 to $10 for the full fiscal year 2020. As a reminder, our fourth quarter of fiscal year 2019 was a record quarter with over $730 million in sales in MMS, creating a very tough comparison. All in, we feel good about the remainder of the year based on the latest view of our business and assessment of macroeconomic environment. Before we open the call for questions, I'd like to summarize the key messages from our presentation today. First, we continue to be uniquely positioned to respond to COVID-19 by leveraging our core capabilities across research, diagnosis and patient care. Despite a challenging and dynamic environment, our third quarter results reflect encouraging trends across our businesses in June. We have established a solid guidance range for the fourth quarter and the full fiscal year as we have improved near-term visibility into our expected results. Based on what we know today, COVID-related headwinds appear to be abating and tailwinds are improving driven by high demand for BD Veritor. And lastly, we remain focused on executing on our long-term strategy and continue to deliver value to customers their patients and our shareholders around the world. Thanks, and I'd like to now open the call up for Q&A.
Operator:
The floor is now for questions. [Operator Instructions] Our first question comes from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Hey, guys.
Tom Polen:
Good morning, Brian.
Brian Weinstein:
Thanks for taking -- good morning. Thanks for taking the question. No surprise, I'll start out on antigen. Can you give us an idea a little bit more about the demand and where it's coming from. And we saw the HHS deal and we saw the news from the governors' consortium, I guess that was on Monday or Tuesday. But beyond that can you talk more about where you're seeing the demand start to come from? And your thoughts on the size of what that market could be considering between you and the other player there. There's going to be about 30 million tests per month in the market by next spring.
Tom Polen:
Hey, Brian. This is Tom. Good morning. So as we mentioned earlier on the call, certainly demand is expected, as I think has been said by others, to exceed supply in the foreseeable future at least. And we certainly see that ourselves. Demand, as I mentioned before, is coming from many of our traditional customers, healthcare providers themselves. We've had quite strong demand there as well as non-traditional accounts. Nursing homes for us would have been a non-traditional account. We've seen announcements come out recently from states looking to acquire rapid antigen tests and the use in other settings. I think the value of near real-time 15-minute testing has gotten increasing traction. I'd say we've really seen the awareness of that increase over the last couple of weeks even more so. And that probably also coincides with increases in COVID rates across the country. So again, very, very strong demand, as I mentioned, both on the instrument side, which we've shipped already in the first month more than we normally would ship in a year. And our supply plans are on track to our ramp plans that we've shared before. But the demand is broad across both traditional and non-traditional segments.
Brian Weinstein:
Great, thanks for that. And then, as we think about a little bit longer-term here and start thinking about 2021, based on what you're seeing, can you talk about some things that we should be thinking about when evaluating how things could play out, especially considering the extended time line on Alaris, the recovery rates that you just mentioned currently being at about 80% to 85% of pre-COVID expectations in July and how COVID-19 testing could play out? Can you kind of give us some goalposts to be thinking about around those things and other things as we think about trying to factor in 2021 here?
Chris Reidy:
Sure Brian. This is Chris and I'll start with that. And obviously normally on this call we get questions about the following year at this time of year and we hesitate to give any indications. This is probably even a tougher year to do that. We're giving guidance for the next two months, because we have a sense of the near-term visibility, but when you think about where things end up with hospital utilization and elective procedures of where does it top off, that's a tough one to call. Clearly we're seeing a good trend. We talked about that in our prepared remarks. June was better than May. July was better than June. So, that's a good indication. But where that tops out at, you see hospital utilization in that 80% to 85% range. Does it stay there? Does it get back to 100%? Those are the calls that you have to make. So that's a high variable and we'll be monitoring that obviously as we approach the November call. When you think about margins, clearly the decremental headwinds from COVID impact are strong 80%. And so, we're going to continue to see that with the -- into the fourth quarter. And then we'll have some lapping next year. But as that comes down, that headwind will lessen certainly over time. And then, on the more traditional stuff that we look at, FX right now looks like a push to slight tailwind. Resins, looks like it's a slight tailwind. We would expect to see some headwind in 2021 as we continue some of the COVID investments from this year and the full year impact of that. And on T&E, we are seeing some favorability from lower T&E. and we would expect that to carry over into the beginning of next year. And then we'll see with what kind of recovery, as people may be coming back from virtual work that might increase and have a little bit of pressure. Those are some of the things that you can start to think about, but it's a tough one to call this early. Thanks for the questions, Brian.
Operator:
Your next question comes from the line of David Lewis with Morgan Stanley.
David Lewis:
Hi. Good morning. Thanks for taking the questions.
Tom Polen:
Hi, David.
David Lewis:
I guess, Chris, I wonder if you could help us sort of better understand some of the key drivers into the fourth quarter. And then we obviously have Veritor interventional recovery and some comparable issues to consider. But maybe just sort of comment on some of the headwinds and tailwinds such as stocking dynamics, things that are harder for us to model. And we have the net COVID impact in the third quarter of $600 million. What does that impact look like in the fourth quarter? And then I had a quick follow-up.
Chris Reidy:
Sure. So as we said, we are seeing those headwinds abate and you can see that trend through June and July. So we would expect that $600 million to come down significantly, but it's -- there still will be a headwind and so we have that and those headwinds do go down at the 80% level. So, I think, we've given you a lot of transparency into that. And so, that should help with the models. The biggest thing that I would point to in the fourth quarter that, I think, people have to remember, is the tough compare that we have particularly in MMS. And MMS had a record quarter at $738 million; as I mentioned in the prepared remarks last year, and that's a real tough grow over. And so, with that, the decremental margins being 80% on the COVID impact, that's significant. I think the other is that there are COVID operational investments that we have. Those will continue and drag into the quarter. And the other thing to remember about the fourth quarter is, generally, if you think about the Alaris ship hold, that's certainly impacting us again. The demand on the medical necessity, we're not expecting that to be what it was in the third quarter. So those are the kinds of things that we look at in the fourth quarter to get to the guidance that we gave.
David Lewis:
Okay. And then, Tom, just a quick question on Alaris. The following is, sort of, six months push versus the prior September, which is actually kind of consistent with our expectation. But with factor testing, kind of, in the bag here, what are the biggest outstanding deliverables in the submission? And timing aside, I think, investors are most focused on what's your level of confidence you can return a safe pump to market. Thanks so much.
Tom Polen:
Okay. Dave, thanks for the question. So we -- as I mentioned before, we have completed quite a bit of the testing and other work required for the submission and we have a much better visibility to submission timing than we did and when we gave you update last, in May. I think from a human factor testing, we still have the other part of it. We did the -- we've completed 100% of our formative testing, which is the initial phase. Again, 12 different human factor tests, as I described, and we're pleased with the data and outcome. Now we've got to progress to that next stage, which is a broader set of testing. So that's still in front of us. A little bit of some of the other testing that we have completed. We've completed a retrospective risk assessment on the changes that have -- every change that's been made to the Alaris system since the initial 510(k). That work is almost complete. We see that as retiring significant risk to the submission. We've completed software verification based on the original scope, closing out most outstanding anomalies. Of course, that software is not going to be released until all of our integrated testing is complete. But this is -- that's a tremendous amount of work and a testament to the team being agilely working from home. I think the other area is, V&V and reliability testing. So we're pleased with our progress there, good progress made on both fronts, but we've -- we're at -- we've begun testing on selected components in certain types of tests. And we await feedback from the FDA on the overall set of protocols. And so, at this point, that testing is -- it's not necessarily that workstream on a critical path for the overall project, but it's still more testing that's in front of us. Just to give a little bit more color of the testing that remains. So, thanks for the question.
David Lewis:
Okay. And Tom your confidence, you can return a safe pump to market here, timing aside, regardless of timing.
Tom Polen:
We don't -- we remain very confident in the safety of the Alaris product. And as I said, we've been working very collaboratively with the FDA on advancing this submission. So, we feel good about that progress that we're making.
David Lewis:
Okay. Thanks so much.
Operator:
Your next question comes from the line of Kristen Stewart with Barclays.
Kristen Stewart:
Hi. Thanks for taking my questions. Chris, I was just wondering, how we should think about gross margins going forward, just as we balance some of the decremental margins, as you've talked about, just with the Veritor assay coming in, as you've talked about the different capacity coming online and then think about kind of the puts and takes that you've talked about with FX and resin and everything else. I appreciate you've had a lot of moving parts here, but it seems that we should have continued pressure but obviously some moving parts particularly as we think about modeling, out next quarter and even thinking about 2021.
Chris Reidy:
Sure. So thanks for the question, Kristen. We're looking at Q4 margins in the 54% to 55% kind of range. And when you're thinking beyond that, also remember that there's continued higher shipping costs as well. And you know what, we've been able to continue to drive leverage. In the charts that we gave on the third quarter, we broke it out where you could actually see the impact from the decremental margins from COVID. So we'll still have some of that, as we described earlier. We'll have some -- so that impact will lessen as the impact of COVID lessens in the fourth quarter. And that's why we get from that 51-ish percent kind of range up to the mid-54s. And in the mix as well, is the COVID investments that we have, as well as our ability to continue to drive underlying leverage through continuous improvement. So that gets you kind of to that 54% to 55% range. One other thing that I neglected to mention earlier in the question regarding Q4 is, also you saw the lumpiness of our tax rate. Those discrete items were anticipated for the year, but a lot of them fell into the third quarter. So as you're modeling the fourth quarter, you would expect to see a high-teens Q4 tax rate. And then, also keep in mind, the preferred shares and the dividend and that's what leads you to that $2.40 to $2.60 kind of EPS range.
Kristen Stewart:
Okay. And then, that 54% to 55%, does that seem like a reasonable number to think about as a jumping off point, as we think about 2021 as well? Obviously, recognizing there's a lot going on with COVID and whatnot, but a reasonable point to look forward to...
Chris Reidy:
There's certainly is a lot going on. But yes, I think that's a reasonable jumping off point. So that's why we're trying to give you -- on that chart we're trying to break down the various contributors. So as the COVID impact abates you can -- that's a big driver at 80%. So as that goes away it starts coming. It starts improving. Again and again, we feel really good about the fact that we're able to on an underlying basis continue to drive improvements through, continuous improvements and synergies. And as we mentioned, Recode is a project that we will continue and think about that as a continuation of the simplification of the combinations of the companies that we've had over the number of years.
Kristen Stewart:
Okay. Thanks so much.
Chris Reidy:
Thank you, next question.
Operator:
Your next question comes from the line of Rick Wise with Stifel.
Rick Wise:
Hi.
Chris Reidy:
Good morning, Rick.
Rick Wise:
Good morning.
Simon Campion:
Good morning.
Rick Wise:
Good morning, Simon and Hi Chris. You're going to be surprised to hear me say, I'd like to talk about fiscal 2022.
Simon Campion:
That's a first forward looking.
Rick Wise:
I know, that's right, but I thought, you said. I do -- I'm not looking for guidance but more just reflect -- if I reflect on things, it seems reasonable to think that fiscal 2022 might be a year when that thing gets more back to normal, the economy hopefully recovering, volumes returning, maybe a vaccine all sorts of things testing in better shape. And my question really revolves around that return to growth, and how you, Tom and Chris are thinking about Becton. How would you have us think about Becton and what may be a more normal year? Does that -- if we assume that fiscal 2022, is a more normal year you return to fiscal 2019 or 2018, kind of mid-single-digit top line low double-digit bottom line. Or do we think, because of things like Project Recode, all the cost reduction the efficiency, the new products, the expanded testing, that actually maybe your normalized growth as we think a little longer term about the company is actually a little better or you're a little more optimistic. I think that maybe, it'd be interesting to hear your thoughts.
Chris Reidy:
Sure. I'll take a start at that. And then, I'm sure Tom will chime in with his view. But you're absolutely right. 2021 is going to be a mixed bag. And the compare is very different. So as you think about 2022, as we think about it, we're still very much focused on the five plus on the top and the 10 plus on the bottom. And all of what you talked about in some of the growth drivers go towards, getting to that five plus on a sustainable basis. So we feel really good about the underlying business, the sustainability of that, mid-single digits kind of five plus kind of growth on the top. And things like Recode are designed to get us that kind of multiple to get you to the 10% on the bottom, on a sustainable basis. So we feel good about it getting back to that kind of level. And we feel good about the fact that where the business is on an underlying basis, performing extremely well in the face of all of the COVID impact that, we've had. And that is lessening. As we said, we see those headwinds abating. Now obviously that could change, with the change in the course of the pandemic. We're just calling that based on what we see today and so that does seem to be abating somewhat. And you've seen some of the tailwinds that have been increasing. But again, how much of that continues into 2022 will play out over time.
Tom Polen:
And maybe I think, Chris that was very well said. I think Rick maybe the only thing I could add is, our -- we are running the company. Obviously we're managing it through COVID, but we are very much executing not only our short-term opportunities areas like Veritor and MAX and helping on the vaccination campaign around the world, but very much executing our long-term strategy. And so, as we think about for example our new product development pipeline and how we've been executing it, I've shared in the past, we've been really focused on continuing to improve our on-time delivery of products or on-time milestones. This year despite COVID we're going to improve. We're very much on track to improve our performance year-on-year again this year, even better than we had last year. Really proud of how the team is executing that. We just finished our strategic portfolio review. And we went through all the segments. And we're making those tough trade-offs, in terms of which programs give us the best returns and growth profiles going forward. And we're allocating and making sure those investments are continuing or adding in new opportunities that we see. And we're executing those pipelines on the Recode, as I mentioned. We've allocated resources to that this year. They're executing they're on track. And even in areas like our plant I continue to be astounded. In the middle of managing -- with our large manufacturing scale, you can imagine the complexity that COVID adds in. We watch our supplier base, a huge team that's just watching suppliers and any economic challenges they have. And how do we start preparing for backup suppliers to make sure there’s no interruption in our supply chain. A lot of that is incremental, going on in COVID. And even during that, right our operations team is very focused on continuing to deliver, the routine CI savings. And they're again doing very well on that this year, incremental to the work that they're doing on COVID. And so, hopefully the takeaway from that is that, we are managing and navigating COVID with a high level of discipline, while at the same time, maintaining very much so our execution discipline on the long-term strategy.
Chris Reidy:
And the only thing I would add from a slightly different perspective too is, given the level of uncertainty what you can count on us is a, high level of transparency. And I think -- I hope you'd agree that what we just gave on the third quarter and into July is very transparent. We've been very clear as to what we expect in the fourth quarter from Veritor for example. We'll go to great pains to break that out, so that as we navigate through that, it will be very clear, what's coming from Veritor. And what's coming from the base business.
Tom Polen:
And MAX.
Rick Wise:
Yeah. The disclosure there's something and we all appreciate it. Just as a quick follow-up if I could. Chris, you highlighted the 3.1 times net leverage on June 30th. Last quarter you said, post-Bard leverage reduction timing was pushed out. Maybe just help us understand what's your latest thinking there? Where are you heading? And what's that all mean for capital allocation? Thanks a lot.
Chris Reidy:
Sure. So nothing's really changed from a standpoint of our intent to delever the company. I think with the pandemic, as we've discussed right now, we're focused on cash. We're continuing to pay down deb. But at the same time, that net leverage, the gross leverage has been pushed off a little bit but we will continue to work that down over time. We feel good about the fact that the net leverage is where it's at. So that really hasn't changed. We'll see --we feel really well positioned in this time of uncertainty from a cash and liquidity standpoint. And as we've talked about that that gives us the firepower to invest in new products, invest in things like Veritor protection for example. And so it gives us the firepower to do that. It will continue to fuel M&A of tuck-in acquisitions et cetera. So we feel really good about the balance sheet. As we come out, as you think about 2022 for example, our overall capital allocation really hasn't changed. The good news is we do throw off a lot of cash and so we feel good about our dividend. We've had a long history of increasing the dividend. We've continued that through everything. I think you can expect that from us going forward as well. I look forward to the day when pandemics and the --this is sort of behind us and that strong cash generation leads us to a point where we can start buying back shares again. And we will come to that and get through this period. But the overall capital allocation really hasn't changed.
Operator:
Your next question comes from the line of Robbie Marcus with JPMorgan.
Tom Polen:
Good morning, Robbie.
Robbie Marcus:
Good morning. We can all take your supply of the Veritor antigen test and MAX out against the ASP and we can come up with really big numbers over the next 12-plus months. How should -- how do you want to frame the revenue potential in fourth quarter and even into next year as you're sitting here? I know you haven't given guidance for next year but what's your latest base case thinking on antigen testing for COVID over the next 12 months or so?
Chris Reidy:
So I'll start with --just to be very clear on the fourth quarter, we have talked about the 10 million tests and that is what is in our guidance is the 10 million tests. So we said that the demand for that is very strong. We feel good about our ability to produce that at that level. But that's what's in the guidance for the fourth quarter. And longer term I'll turn it to Tom.
Tom Polen:
Yes. And we've shared as we think about the fourth quarter right we assume the 10 million tests July through September at about $20 ASP per test, which is what we had shared in the -- historically. As you think about 2021, obviously it's going to depend upon -- the number one factor will be the intensity of the COVID pandemic and its duration timing of vaccine et cetera. And so I think the most that we can focus on is that we will --the 8 million tests per month by the end of September. And then we'll be ramping up production of more than -- right at 12 million tests per month at the end of February. Those are the numbers. The percent utilization of those is to be determined as things evolve. We want -- we don't think it's appropriate for us to comment on that at this point in time.
Robbie Marcus:
Okay. Thanks. And maybe as a quick follow-up. You answered this briefly before on capital allocation but you raised some capital during the quarter. Part of that was to have potential firepower to go on the offensive for M&A should that come up. What's your latest view on where M&A would be most appropriate in the portfolio? What you view the current environment like? And do you think there are willing sellers out there right now?
Tom Polen:
Thanks, Robbie. So I would just say, as we've shared in the past, we always are evaluating and have historically. Tuck-in M&A has been a long part of BD's history in how we've grown many of the businesses that exist in the company from BDB to Vacutainer to of course --much of the Bard portfolio came in through tuck-in acquisitions and licensing inorganically. We continue to look at opportunities across all three of the segments and we're very focused on deals that we would look at. We're not -- as we've made very, very clear we have zero interest in any large transformational deals. We won't be doing those. We're looking at tuck-ins, which is traditionally what BD has done going back in time and has been critical to Bard. We prioritize very much and are looking at accretive deals. We're not looking at --we have zero interest in any significant dilution at all. So those are some of the key criteria I'd say we're looking at. Specific areas as I've shared before, we're not looking at areas far aside from our existing businesses. We're looking to leverage where we have strengths and competitive advantage and really rounding out those portfolios as we've done again in each of the three segments over time. And Chris anything to add?
Chris Reidy:
Yes. No nothing to add other than to emphasize that the key metrics there are strategic fit in our core businesses and non-dilutive accretive deals. We're not looking for a lot of dilution. And returns -- ROIC greater than the cost of capital in year four .Those are the kind of standard metrics we look at. But first and foremost a strategic fit.
Tom Polen:
Thanks, Robbie.
Operator:
Your next question is from Vijay Kumar with Evercore ISI.
Tom Polen:
Good morning, Vijay.
Vijay Kumar:
Good morning, Tom. Good morning, Chris. Thanks for taking my question. One, just maybe a cleanup question on Q4 Chris. The tailwinds that you guys saw in 3Q $200 million, obviously the pump revenues go away for Q4. Are the tailwinds also decreasing for Q4? And I think you made a comment on the preferred dividends and share count. Perhaps, could you just remind us really on, what we should be expecting for share count in preferred dividends in Q4?
Chris Reidy:
So let me take the first part of that. So just to make it clear I mean, we said that the $600 million in the last quarter we're modeling in the area of around $200 million net impact in Q4. And we do expect the tailwinds to go up with Veritor. We --Tom gave the number 10 times 20, so that's $200 million. We expect --I think we noted in the charts we expect BD MAX to be another $100 million as we -- impacts out there. And you would expect the Alaris to be --medical necessity to come down from third quarter to fourth quarter. So when you net all that out and with the abatement of the headwinds that we're seeing in elective procedures, hospital utilization going up a little bit still not back to normal but abating that's kind of where our thinking is. And the --I missed the last part of your question but I think it was Q4 share count. And you could use in your models about $293 million.
Vijay Kumar:
Okay. That's extremely helpful for us. And just on one fiscal 2021 then. Tom, we can do the math -- like Chris said on the Veritor antigen test. But more stepping outside of numbers, it just feels that from your comments stepping up on capacity for these antigen tests. It feels like you guys are a little bit perhaps more incrementally bullish on the prospects for antigen test. Is that the right way to look at it? And syringes, obviously, you saw the orders for that. Is there a dollar number, sort of, what The Street could monitor for 2021? Thank you.
Tom Polen:
Yes. On antigen tests, I think, what's fair to say is that we've seen as I mentioned very strong demand right off the bat. I mean we're only -- we're literally at a month today. It's the anniversary. And we have very strong -- extremely strong demand on that product both on the Readers antigen tests themselves. I think what's very, very clear is there is a high need to know this person have COVID right now. And I don't want to wait a day I don't want to wait two days, three days, four days depending on how the system -- how effective the testing system is if you're sending samples out, you can get up to those durations. And I think there's a whole need where that just doesn't work that type of testing turnaround time and people -- high value on this getting an answer within 15 minutes. So that's -- and that ease of use there is unbeatable on the antigen testing approach. So right we're very focused on -- a we've been engaging a wide range of customers on that. As I mentioned, we've -- we're deploying not just the resources of life sciences, but of BD against that opportunity on the scale-up and making sure we have the right infrastructure to support the broader base of customers. Even logistically right shipping this volume out of product, and so again we're applying the full capabilities of the company behind this. So I think that's a fair approach to it. How that evolves again from a disease prevalence rate and consumption through 2021 no one knows the answer to that. But as long as it exists I would expect there's going to be a high need for antigen tests.
Vijay Kumar:
Just on the syringes, Tom.
Tom Polen:
Yes. On syringes as you said you heard us we gave a number on this call that was incremental to the number we gave last time right? So we have continued orders coming in not only in the U.S. but in other parts of the world. We think that's still relatively -- no change from what we had shared historically, right that we have capacity to add one billion units over the next -- we had always shared 12 months to 18 months. And we still see that opportunity side. I did call out right the devices that we are selling are a mix of safety devices and conventional devices. Safety devices have a bit higher ASP than conventional devices. So we'll see how that mix evolves over time. But overall, we're right in line. We're still on track to be able to produce that one billion units over the next 12 months to 18 months. And you can see right at over 450 million or -- well 470 million units right those orders are starting to come in quite steadily. I think that answer..
Vijay Kumar:
Yeah. Okay.
Tom Polen:
Thanks, Vijay.
Operator:
Your next question comes from the line of Bob Hopkins with Bank of America.
Bob Hopkins:
Great.
Tom Polen:
Good morning, Bob.
Chris Reidy:
Good morning, Bob.
Bob Hopkins:
Good morning. So thanks. I just have two questions and I'll include them upfront. Given the kind of focus on testing I was wondering if you could -- just to be clear what was the total COVID testing revenue in Q3. And what is total COVID testing revenue assumed in the Q4 guide? And then the other thing I'd love you to comment on is that the one kind of incoming e-mails I've gotten on this report more than anything else is just that Q4 earnings are way below where The Street was guiding and it's about an $0.80 year-over-year decline, 25% year-over-year decline. So if you wouldn't mind trying to just, sort of, break that down for us those $0.80. And you've mentioned a bunch of things on the call today. But I was wondering if you could just summarize the factors that are leading to that kind of $0.80 year-over-year decline and the kind of $0.50 below or so what The Street was modeling.
Chris Reidy:
Sure. So let me start on the first part of your question was the COVID-related testing that we saw in Q3. That was $100 million on MAX. So think about $100 million on MAX and $100 million on the Alaris medical necessity or thereabouts. So that was the $200 million of tailwinds that we were talking give or take. On Q4, we've talked I think you can think about that $100 million going up to $300 million because the MAX is if we're running at full capacity and so we expect that to be about $100 million in Q4 and then you add in the Veritor of 10 million x 20. So that's $200 million gets you to the $300 million kind of thing. So moving on to the second part of your questions. I think again the revenue decline we're still seeing low single digits kind of a decline in the fourth quarter. I think the COVID impact particularly in the MDS business in Q3 was something that folks had been missing is very much driven by hospital utilization and you saw what that was. So we would expect that to continue because although utilization is getting better it's still under pressure. And so we do expect that revenue decline of low single-digits. Then you drop that at a decremental GP. I think on the last call, we were signaling kind of in the 75% range. It's really coming in closer to the 80% range. And again that's a testament to the fact that these are very high-margin products that are being impacted by COVID. And then in addition, we're doing the right things in terms of not building inventory during this period of time. And that's a very important point because as you're not building inventory, you've got absorption of variances that come in and hit the quarter. And we're taking that charge this quarter. We're not capitalizing it in inventory and carrying it forward. So that is a big part of what gets you up to the 80%. Obviously we're making COVID investments as well. And those investments range from what you would anticipate in terms of cleaning and those kinds of, things PPE those will continue. But in addition it would include all the work we're doing to scale the Veritor and the MAX. And so those are some investments we're making. I think the other thing that the -- would be new news compared to your models is the tax rate. And as we think about Q3 earnings the $2.20, we acknowledge the fact that that's -- is probably $0.20 of tax benefit there. But in addition compared to what we were expecting and what I think The Street was expecting the drag from FX was about twice what we would have thought at $0.11. So I think when you do that we're kind of in line with The Street for the third quarter. Then as you think about the fourth quarter though our range for the tax rate for the year isn't changing. So that just assumes a very high-teens tax rate in the fourth quarter. So I think when you plug that in and then you do the calculation for the preferred shares all of that kind of gets you into the range where we're at.
Bob Hopkins:
Great. Thanks for the detail.
Chris Reidy:
Hopefully that helps.
Bob Hopkins:
Yes.
Operator:
Your next question comes from the line of Larry Biegelsen with Wells Fargo.
Chris Reidy:
Good morning, Larry.
Larry Biegelsen:
Hey, guys. Thanks for taking the question. Good morning. Good morning, Chris. One on testing or just actually two on testing. I'll ask them both upfront. As people have said on this call, we can do the math on the potential sales. I guess, my question is we also know the margin is relatively high. I don't know, if you would bless kind of a 75% incremental operating margin or not, but that's kind of what people believe. So the EPS contribution could be quite high, if the demand is strong. So I guess my question is will you let this drop to the bottom line? How should we think about that versus reinvesting? And then just, Tom, I know you don't know how sustainable the testing is. But long term once we have COVID under control is Veritor for COVID similar to kind of flu, which is about $100 million per year? Or is there any reason why this could be a greater long-term opportunity? Thanks for taking the questions.
Tom Polen:
So let me start with the last question then Chris can discuss the margins, which by the way we have shared. We're not sharing the specific margins of Veritor, but we have said that they're higher than the company average I think is the comment that we've shared in the past and probably what we're comfortable to continue to share, which is to your point. So on the long-term opportunity for COVID testing, I think again very difficult to predict at this point in time. I think, there's still a lot of uncertainties, even around the vaccine. Are you --is it going to be a permanent vaccine? Is it going to be a vaccine that you have to get every year more like the flu, I think those things will --if it's something like polio that gets eradicated because of a vaccine that you get a couple of shots of it upfront and then it's longer term that obviously will lead to a very different outcome than if it's something that you have to get annually. And if you forego that annual vaccination then now you're susceptible to get COVID. These things, I think are still being understood and will evolve. What I think we can say is that look we're placing a lot of Veritor instruments right now, and I shared that upfront in my commentary around demand just for the instruments in the first quarter. We certainly see point-of-care diagnostics as an area of focus of investment for the company and we have I think an example a clear indicator of that is we acquired a point-of-care molecular company earlier this year pre-COVID coming up. Because we saw the attractiveness of this space and we're continuing to invest in that area very heavily. I think the broader footprint of Veritors out in the marketplace, could you say regardless of how COVID evolves will that create a bigger opportunity for Veritor of consumption of --how long COVID will last is an unknown, but will they be using will there be more people out available to use flu strep other tests on Veritor? And will there be a societal continued shift to want to have testing results faster than they were before COVID happened. And I think those are all trends that I do think are going to be more permanent after COVID. Point of care is an area that, I would say, we are increasingly bullish on overall as a market. People understand now. Of course, people, a lot of people understand lab testing a lot more now than they did pre-COVID, because they have a lot more interest. And when you --understanding too when you have to wait days to get a result when you really need to know the answer, I think people also understand the value of that point-of-care technology. And so we do see that as a long-term trend and it's an area of continued investment. And we see some near-term opportunities that could continue to prevail for Veritor due the larger placement base. And then of course, we are continuing to invest in new technologies in that space as well.
Chris Reidy:
And back to the first part of your question, I think it is fair to say, and we have said in the past that the margins here would be higher than the company margins. I think some of the numbers you're quoting seem a little rich to me particularly in the short term. This fourth quarter, I don't think you can expect us to ramp production and immediately get to those kind of margins in the fourth quarter. So I think some --the models that I've seen have just assumed we can get to those kind of margins day one. That's not practical, but clearly building over time to margins that are higher than the company average.
Larry Biegelsen:
Thanks, guys.
Chris Reidy:
Thanks.
Operator:
Your next question comes from the line of Amit Hazan with Goldman Sachs.
Tom Polen:
Hi, Amit. Good morning.
Chris Reidy:
Hey, Amit.
Amit Hazan:
Let me --just a couple of quick ones. I know we're running late on time here. I wanted to ask the first one on just routine testing and get a sense from you, if the recovery there is similar to what you cited elsewhere. And even if we think about getting into not just diagnostics but even PI oncology and things like mammo whether you have any insight to the pace of that recovery? It just all seems very relevant to downstream procedure revenue?
Tom Polen:
Yeah. We --let me start with that. This is Tom, Amit. And actually we do have Simon on the phone as well. We have all of our segment presidents. And Simon, I'll ask you to comment on the oncology piece in a moment. I know that was one that we did see a little bit more impact in COVID than some of the other procedure areas as mammographies have been delayed. But just before we get to that, when it comes to actually more laboratory-based testing IVD testing that is one that we recognize that non-COVID diagnostic testing and specimen collection improved from about 75% in June to about 80% in July One of the indicators that, we look at very closely are the national reference lab volumes and I think it's fair to say that the information that they share in terms of overall underlying testing demand correlates very well with demand signals that we see in our Vacutainer business, which is of course a large business for us on the diagnostic testing side. Obviously, our IDS business gets a little bit more fluctuated because it is an infectious disease diagnostic testing. It's gotten both MAX and now going forward Veritor. And so we'll see more fluctuations there. But as we think about our PAS business very much we see the impact there correlated with what you would see in national reference labs. And the commentary that, they have around increased improvements from June to July match right with what we've seen as well. Simon maybe some further comments on the procedure side?
Simon Campion:
Yeah. Good morning. So certainly with oncology we did see an impact over the quarter, but month-by-month, we saw sequential growth as well. So it was slightly heavier impacted than some other parts of the PI business. But we also completed a survey. We actually surveyed 815 of our interventional customers of which 119 were involved in oncology. And most of our business as in oncology is either a implant or ports or biopsy and we've recently gone into interventional oncology. And what they're saying is that -- we've got interesting information that the patients that they've been treating are -- is a good mix between rescheduled cases and new cases. And these customers are also saying that their office volumes are beginning to rebound and they have a positive outlook as to what office volumes look like over the next 60 to 90 days. So while it was impacted the funnel was certainly impacted earlier on during COVID the outlook remains reasonably positive for oncology as well as other parts of the business too.
Amit Hazan:
That's great. And Tom one for you on vaccination if I can. I'm just understanding dynamics a little bit better. Obviously, there's just a whole bunch of vaccine companies now going at risk at the same time. They're building inventory ahead of data, two doses per vaccine generally. And obviously that could suggest demand that -- for actual syringes that could be several multiples greater than population size. You've obviously made the comments today again about the one billion in incremental synergies --syringes over the next 12 to 18 months and the Bard investment taking 12 months. And you're obviously the biggest syringe player in the world. So the question is are we heading for supply challenges with regard to syringes injection devices for COVID vaccination?
Tom Polen:
Yes. I can't answer that. We don't know. At this point we are -- we've got visibility to supply the orders that we've received is a fair way to say it right? We don't as I mentioned that one billion units we've gotten 470 million units' worth of demand on that. And when I said the one billion units, right we mean that as truly incremental to just our ongoing demand remaining the same. And so that is another factor. Of course, we make way more than one billion units. We make billions of units a year of syringes on a global basis. And we're assuming all that base gets consumed normally. That includes a strong flu vaccination campaign that we would have syringes sufficient to provide that. And then this is incremental to that. And so right people will have to make choices. People could say I don't know if that's true that all those -- the base syringe consumption would remain normal that people wouldn't reallocate the syringes for other purposes in that. But there is a large base of other syringes that we're providing to the market as well. So what we can say right now is the current visibility of demand that's coming in from governments around the world is still within our supply capabilities.
Amit Hazan:
Thanks.
Tom Polen:
Good question. It's something we're obviously watching closely as well.
Operator:
Your next question is from the line of Larry Keusch with Raymond James.
Larry Keusch:
Hi, good morning, everyone. Tom I wanted to just go back to Alaris and just kind of think through the time line a little bit relative to the update that you provided today. I think as I sort of recount how this came about when the issues first came up you were sort of talking about an early fourth quarter FDA filing. And then of course given the pandemic and challenges with human factor testing that pushed out again. So I'm just trying to square now that we think about the revised timing what sort of changed? Do you need to do more testing than you initially thought as you got into deeper discussions with the FDA? Is there something that you're doing incremental that you believe puts you in a better position. You obviously talked about the end tidal CO2. And does the observations of the manufacturing facility also sort of play into the time line as you think about it?
Tom Polen:
Okay. Good question, Larry. So first-off, we had always shared that the original assumption was end of Q4 right? And obviously with -- that was pre-COVID pandemic and we indicated that that would have impacts on our ability to do the testing. And it has and we recognize that. As I shared we've completed quite a bit of the testing and we had shared that versus when we had given an update in May that we felt that we would have quite a bit of that testing done by now and that we'd have much better visibility in our submission time line and that is the case. And it's the basis upon which we've given the update today. As I answered I think it was David's question earlier on this topic I'd already walked through the testing that we've done on human factor testing as well as some of the other testing that's been completed. In terms of incremental things, we have continued to have dialogue with the FDA and understand their feedback. So that's been part of the process. And that's been a really strong part of the process our collaboration with the FDA and it's something that we think is very important to get aligned on the testing. So that when again we submit the actual 510(k) that we're in a position to make it as comprehensive as possible so that the FDA is put in a position to be able to give us as timely of an approval hopefully as is possible that we do our best job in enabling that. The one thing that is added in -- and there may be others. But certainly one thing that I mentioned is the EtCO2 module which was in development before but we did make the decision that based on feedback from the FDA and where the technology ultimately came out in development that as we are working in parallel with our product development road map we made the decision to include that update in the 510(k) module. As I mentioned it monitors patients on ventilators while medication is being administered. And given the importance of having this in generation module in, we felt it was the best decision and the FDA agreed to include that in the filing. Just on the 483 itself that you brought up what I would say there is that resolving the 483 items, the 510(k) submission is not contingent upon that specifically. And so maybe what I can just make a couple of comments on that is that we have been separately from the 510(k) submission work we've been continuing our remediation efforts associated with that Form 483 that we mentioned on our last call. In addition to providing a comprehensive response to the FDA we've already begun taking actions. That includes initiating a voluntary field action at the end of June and another earlier this week that we announced. And so we're going to continue to take action including initiating program changes process improvements and field actions when necessary in a way that provides the best-in-class support to our customers and minimizes disruptions to patient care which is more important than ever given the COVID-19 pandemic. So, as I said before we continue to stand behind the safety of the product which continues to provide significant clinical benefits to patients and health care providers. And as I said before to be clear the timing of our 510(k) filing is not dependent on resolving every item in the 483. We are taking all appropriate actions to ensure that comprehensive 510(k) submission as we also work in parallel to resolve the 483 observations.
Larry Keusch:
Okay. Terrific. Thanks. That's all I had.
Tom Polen:
Great. Yeah.
Operator:
Your next question is from the line of Matt Taylor with UBS.
Tom Polen:
Good morning, Matt.
Chris Reidy:
Good morning, Matt.
Matt Taylor:
Hey, good morning. Good morning guys. Thanks for taking the question. I wanted to ask one about the installation progress and time line. You called out the fact that hospitals are not allowing a lot of large capital installations and there's been some tempering of the appetite there. I'm just wondering what the funnel looks like. Are you seeing any cancellations? And when do you think that will pick up relative to the improvement in utilization?
Chris Reidy:
Sure. So clearly, the -- where we saw that the most was access to facilities and installation. And that was certainly true in April and May. I think we commented that in June that we saw that getting better. And we certainly saw that to be the case in July as well. So it really has to do -- what we've seen thus far is really more access related than any lack of appetite for installations. We haven't seen any cancellations that were other than deferrals. And so we haven't seen that. Certainly that's something that is -- I talked about as our watch outs going forward. But at this stage, we haven't seen that manifest itself yet. It's really just about the installations at this point.
Matt Taylor:
And then just to follow-up on that. Conversely the negative impact on demand from hospital operations, do you think that the continued stimulus being given to hospitals could help you in some of these areas? Is there encourage to spend it on COVID-related things?
Chris Reidy:
Yes. Clearly, that's the case. And I think that's what's helped bridge a lot of hospitals from a cash flow standpoint. So I think those programs have certainly helped from that standpoint. So absolutely.
Matt Taylor:
Thank you very much.
Tom Polen:
Thanks, Matt.
Operator:
Your next question comes from the line of Josh Jennings with Cowen.
Tom Polen:
Hey, Josh.
Chris Reidy:
Hey, Josh.
Josh Jennings:
Hi, good morning, Tom and Chris. I just wanted to ask about China. I think they're ahead of the curve in terms of the COVID recovery. You guys were down 17%. The China business in fiscal 3Q seems like medical was the biggest anchor in China. Anything you can do just division-by-division to help us understand the impact in fiscal 3Q? And then what's assumed for China guidance in fiscal fourth quarter? And then I just have one really quick follow-up.
Chris Reidy:
Yes. So one thing I would mention and I think we mentioned it in our prepared remarks is that across BDI for example we were positive in June. And so we are watching China as we said very closely. And we are seeing some recovery there. Bear in mind that we also have in China in the medical area that you mentioned in the medical segment that we do have the impact of the volume-based procurement. So we did see -- I think also in our prepared remarks, we said that we continue to see some of that distributor stocking impact -- destocking impact as we go through that. Really no news on that volume-based procurement. That continues. It's a continuous thing. But outside of that, the recovery is happening in China and improving across the businesses.
Josh Jennings:
Great. Thanks. And then just on the pump business medical necessity. It was a tailwind in fiscal 3Q. I believe you mentioned when you called out April on your fiscal 2Q call that the run rate in fiscal 2Q for medical necessity was around $10 million for the quarter. Is that the normal run rate outside of the COVID tailwind on the quarter?
Chris Reidy:
Yes. I'm not sure what you're referring to there because we're -- there is no normal run rate on medical necessity. That was something new. We did mention I think in the quarter in April, I think we might have noted how much that was. And I think we said, it was in the $70 million kind of range for medical necessity. And as I mentioned, the quarter was in the $100 million kind of range. And so obviously May and June were significantly lower than April. And I think -- and we're not expecting too much in the fourth quarter in terms of medical necessity. And obviously, that's a function of resurgence and everything else, but we're not anticipating anything significant there.
Josh Jennings:
Great. Thanks.
Operator:
Our next question is from the line of Richard Newitter with SVB Leerink.
Richard Newitter :
Thanks for squeezing me in guys. Just one question. I'm curious can you give any color on where this initial demand that you said is very high for point of care, where what sectors of the economy? Or what types of uses are you seeing the highest levels of that elevated demand for this type of test? Just trying to get a feel for kind of where this is probably going to have the biggest use. And if you have any initial comments there? Thanks very much.
Tom Polen:
Richard this is Tom. Good question. As I had shared before, it is a broad sector of both traditional customers and customers who are new to us where this demand is coming from. And we also of course a lot of this given the -- of course our traditional customers we often are engaging with them directly. So think about hospitals and clinics and those types of locations. We are dealing with them directly and we see strong demand from those areas. We of course are also providing this product through most all the major distributors and they are mostly directly managing a broader nontraditional customer base who are approaching them or calling us and then we refer them through distributors. The ship-tos are much broader than we would ever be set up to manage directly and we typically sell Veritor through distributors anyway. But there it's -- as you saw I mean HHS announced acquiring for nursing homes. Normally that's a whole new customer segment. It's normally not doing Veritor point-of-care testing as an example. There are schools that in states that are buying them to test symptomatic kids when they're in the -- as they're thinking about starting up school. What if a kid says I've got X Y Z symptoms that mimic COVID what do you do? Do you send them home and wait a couple of days to get a test result? Or is it really important for you to know if that kid has COVID before they leave the building, so that you can determine what do you do with all the other kids and the teachers that were in that classroom with that child. These are the questions that the people are working through. We've had employers order the product for similar types of purposes in use of understanding, again if employees come up with symptoms et cetera while at work. How you triage and make decisions for the rest of the workforce that's there and helping keep the environment safe? So those are just a few of the examples that we see the testing. But hopefully, just gives a color that it is much more diverse base than would traditionally be doing flu or strep or our normal point-of-care test.
Richard Newitter:
Thank you.
Operator:
Your next question is from the line of Jason Bednar with Piper Sandler.
Unidentified Analyst:
Hi. Good morning guys. This is Andrew [ph] on for Jason. Thank you for taking the questions. I just have two real quick ones here and I'll ask them both upfront. Any updated thoughts on the BTK Lutonix product? How are you preparing for a rollout strategy at this point? And then the second one is I know it's super early, but any updated or any thoughts you can offer on the upcoming flu season, any challenges, headwinds, tailwinds anything that we need to contemplate in our model? Thank you.
Tom Polen:
Yes, Andrew, good question. On BTK, so we have nothing in our outlook in Q4 for BTK. I think we shared that in the past, but just to reiterate that. Of course, we have -- last we had shared is that we had submitted additional information as part of that PMA review and it continues to be under active review by the FDA. But we'll provide an update as we hear information from the FDA on that, but nothing to share at this point in time. In terms of the flu season, as I mentioned, we're making sure that first off that we have product to help support the flu vaccination campaigns this year. Obviously, we’re also expect to continue to provide flu testing on the Veritor platform. And as I mentioned, we are -- we do have combination COVID-flu tests in development on both our MAX and our Veritor platform. And so those are -- we have teams actively working on both of those to support where we could have flu and COVID needing differential diagnosis as that season intensifies going forward. The other thing that we watch is -- and no one knows the answer to this. We have seen some evidence that the incidences of using PPE and social distancing and quarantine have reduced the rate of -- or the intensity of the flu season in other geographies around the world, which are still in their winter seasons. How that's going to actually happen in the Northern Hemisphere is still to be determined. I don't think anyone knows the answer to that and it has big variables on how society is effectively quarantining and masking as well. So -- but all factors that we're watching closely and that we're preparing for.
Unidentified Analyst:
Okay. Thank you.
Operator:
Thank you. I would now like to turn the floor back over to Tom Polen for closing remarks.
Tom Polen:
Okay. Well, thank you operator, and thanks everyone for the good discussion on today's call. While our results this quarter show the impact of COVID-19 on the entire health care industry, they also demonstrate our focus on execution and making an impact during a consequential time. I'm very proud of the way our team has rallied around our purpose of advancing the world of health to find impactful solutions to help the world respond to COVID-19 and I'm proud of the BD team for their continued focus on executing our long-term strategy, so we can emerge from this pandemic period strong and well positioned to drive growth. Thank you all for your time today.
Chris Reidy:
Thanks everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day. Speakers, please hold the line.
Operator:
Hello, and welcome to BD’s Second Fiscal Quarter 2020 Earnings Call. At the request of BD, today’s call is being recorded. It will be available for replay through May 14, 2020, on the Investors page of the bd.com website or by telephone at (800) 585-8367 for domestic calls and area code (404) 537-3406 for international calls using confirmation number 2189907. I would like to inform all parties that your lines have been placed in listen-only mode until the question-and-answer segment. Beginning today’s call is Ms. Monique Dolecki, Senior Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Stephanie. Good morning, everyone, and thank you for joining us to review our second quarter results. We hope that everyone is healthy and safe during these unprecedented times. With safety in mind, we are taking a more virtual approach today in exercising social distancing while conducting this call. Joining me in person, we have Tom Polen, our Chief Executive Officer and President; and Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer. Joining by phone, we have Alberto Mas, Executive Vice President and President of the Medical segment, Simon Campion, Executive Vice President and President of the Interventional segment and Patrick Kaltenbach, Executive Vice President and President of the Life Sciences segment. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today’s call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our second fiscal quarter press release and in the MD&A sections of our recent SEC filings. In particular, there’s significant uncertainty about the duration and contemplated impact of the COVID-19 pandemic. The data we are providing today is based on our preliminary April sales results and the trends we are seeing in our businesses. We have made certain assumptions in how we are managing our business, but that could change as we move forward. We will also discuss some non-GAAP financial measures with respect to our performance. Our second quarter results include a $39 million non-cash charge to write down the carrying value of developed technology related to the planned retirement of the BD Accuri flow cytometer platform within our Biosciences business. In addition, we are working with the FDA with respect to certain features of our Alaris infusion pump products that are additive to our current remediation efforts. As a result, we have recorded a charge of approximately $200 million to reflect the estimated probable future costs relating to remediating Alaris’ products. It is possible that this estimate could increase over time. Any remediation actions will continue to be guided by our proactive commitment to patient safety. In addition, due to challenges associated with the global COVID pandemic, among other factors, we no longer expect to submit our Alaris 510(k) filing in the fourth quarter. We are working closely with the FDA to assess how quickly we can get back to our previous plan and we will provide an update on our August earnings call. These items, along with details of purchase accounting and other adjustments can be found in the reconciliations to GAAP measures in the financial schedules, in our press release and in the appendix of the Investor Relations slides. A copy of the release including the financial schedule is posted on the bd.com website. It is now my pleasure to turn the call over to Tom.
Tom Polen:
Thank you, Monique, and good morning, everyone. I certainly hope you and your families are doing well as we navigate this unprecedented time. Our thoughts are particularly with those personally affected by COVID-19, including healthcare workers on the frontline who are caring for patients and battling this virus. As you’ve seen in our press release, our second quarter results were ahead of our expectations even though the Q2 impact for COVID-19 was larger than we anticipated. While we’ve seen strength in our portfolio that’s more directly tied to COVID-19 diagnosis and treatment, we’re also experiencing significant pressure in other areas such as products relied on elective procedures, research, and routine care. Chris will cover this in more detail later in the call. This remains a dynamic situation, and the timing and phasing of research and more elective healthcare returning is hard to predict. That’s why we’ve decided to withdraw our guidance for FY 2020. As I’ve shared in the past, you can expect transparency and straight talk, and so Chris will share with you what we know so far including what we saw in April, and he’ll give you more color on the many factors impacting recovery. Before we get into the impact to our business, I want to spend time on BD’s response to COVID-19, because I believe it embodies what we stand for and our purpose and what makes BD unique. And so on Slide 4, I’d like to start by sharing my deepest thanks to the BD team around the world. I’ve been with the company nearly 20 years and it never ceases to amaze me how our team rises to the occasion for our customers, especially during times of uncertainty. What I’ve seen in the last two months is truly inspirational, and I’m so proud to serve alongside this team. Turn to Slide 5. We defined four priorities that have guided our response to COVID-19 since January when we convened our crisis management team. First was to protect the health and safety of our employees. Second, maintain business continuity and mobilize our world-class operations to help combat the pandemic. Third, bring new solutions across the entire continuum of care from discovery and diagnosis to delivery of care. And fourth take proactive measures and continue to advance our strategy so that we ultimately can emerge from this pandemic strong and in a better position. And while we are actively working to address near-term pressures related to COVID-19, we will always operate our business for long-term value creation. I’ll discuss each of these in more detail now. First, protecting the health and safety of our associates, on Slide 6. We took a number of actions very early on to help safeguard our team, including adapting the workplace for social distancing, increasing cleaning and disinfection protocols, and adding temperature monitoring at our manufacturing and distribution centers, beginning in February. We’ve also increased personal protective equipment for employees, including leveraging our 3D printing and large scale molding capabilities to manufacture our own face shields so we can further protect our employees. Even as we made our own difficult decisions to furlough a small percentage of our manufacturing associates, we preserved full access to healthcare benefits for impacted associates in the U.S., including covering both the employer and the employee payroll reductions during the furlough period. Turning to Slide 7 and our second priority, mobilizing global operations. As you know, world-class manufacturing excellence is a core competency and focus for BD. All of our critical to COVID manufacturing and distribution centers are operating at or near full capacity. You can imagine that’s not easy in this environment. We have BD associates stepping up around the world to make this happen. Just one example is we’ve had more than 100 of our manufacturing associates from Malaysia volunteer to temporarily relocate to live in Singapore during the border closure. They moved away from their families to Singapore in the middle of the pandemic just to help maintain operations at our Singapore plant. Two thirds of all BD associates or more than 43,000 of our workforce who work in our manufacturing plants, distribution centers, and field service roles have continued to come into BD or to customer sites nearly every day during this crisis to help ensure our products and solutions are there when patients need us most. And I thank each and every one of them for that. We’ve leveraged our scale and ramp production to the highest degree possible in this environment, and three examples stand out to me. First is to reduce the risk of exposure to caregivers. Some clinicians move the Alaris system from the bedside to outside the patient room dramatically increasing demand for IV extension sets. BD team responded with urgency, increasing production of these sets 100-fold within just a month. We’ve dramatically increased the number and types of specimen collection swabs from about 500,000 each week in February to an expected 3 million in June – 3 million a week in June. We’ve significantly scaled production of our BD MAX reagents used for open-assay tests including our new molecular assay for COVID-19. We have increased output of open-assay kits by more than 80-fold between February and June and we’re currently manufacturing six times more each month than we did all of last year and we continue to scale that up. We’re also looking ahead recognizing a potential second wave of COVID-19 which could align timing wise with flu season. We’re preparing additional capacity to ensure we can address both demand for a flu test and an antigen COVID-19 assay. Given that the symptoms are pretty similar, we’re also anticipating potential higher demand this fall as well. I also want to reassure you that we’ve ramped production as we’ve ramped production our commitment and focus to delivering the highest quality products has remained extremely unfocused. While we’re experiencing historically high demand for critical to COVID products, there’s also negative pressure on product categories tied to routine health care visits and lab testing, elective procedures, and non-COVID research. For example, during Q2, we began to see a significant decline in elective procedures. During the end of the second quarter, demand for research reagents and instruments slowed dramatically as research institutions and labs temporarily closed due to lockdown. As a result, we have temporarily slowed or suspended production at a few of our non-COVID related manufacturing sites to preserve liquidity. We’re in frequent contact with our customers and we’re closely monitoring demand signals and we’re ready to start immediately – resumed production immediately as soon as those procedures and research restarts. Our ability to adapt and mobilize our global operations to respond to the pandemic is a testament to our best-in-class manufacturing capabilities, the dedication of our employees and the strength of our public-private partnerships. Throughout the pandemic, we’ve regularly engaged federal, state and local government officials around the world to help safeguard operations and minimize the risk of supply chain disruption. It’s clear the strength of our global operations network is a significant advantage for BD and the healthcare providers who rely on us. Turning to Slide 8, another advantage unique to BD is the strength and diversity of our portfolio, which I believe, as I’ve said in the past, is unmatched in our industry. We’re leveraging our expertise and capabilities to deliver solutions across the continuum from research to understand immune response to diagnosis and surveillance, to medication management, delivery and critical care, and ultimately to prevention as we look ahead to a potential vaccination campaign. First, in order to treat a disease, you have to better understand it. And that’s why scientific research on COVID-19 continues to move forward even as many labs and institutions pause or postpone other important studies. And our Biosciences business has been helping researchers better understand how the immune system responds to COVID-19 and why some people are more effected and others show only mild or no symptoms. And we believe this scientific research is key to better understanding and ultimately battling COVID-19. Turning to Slide 9. We’ve launched a full portfolio of COVID-19 diagnostic solutions which help healthcare providers answer two basic questions, who has it and who had it? And so as you think about who has COVID-19, we’ve leveraged our strength in molecular diagnostics to bring the market three molecular tests, two as a CE mark and two that have received EUA approval from the FDA in the U.S. These tests are designed exclusively for the BD MAX system, which has already in use at over 1,000 laboratories worldwide. The tests are conducted on onsite, mostly at hospital labs, and increased time to result to just two to three hours of up to 24 samples at a time. We’ve now shipped test kits to more than 500 hospitals around the world and moving forward we’re able to provide approximately 250,000 tests per week or about 1 million a month. We’re also hard at work developing a forced [ph] diagnostic point-of-care antigen test that leverages our Veritor platform targeted to diagnose COVID-19 in less than 15 minutes. There’s broad interest in this test and with nearly 30,000 Veritor devices already in mostly non-acute care centers across the U.S. We expect this could be a real game changer for testing capacity and helping and restoring the economy. This test is still under development and we’re evaluating performance with samples now. Pending that outcome, we would submit for EUA authorization and we’ll keep you updated as this progresses. To test for who had COVID-19, we’ve partnered with BioMedomics to market a serology test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. In fact, the published data in the Journal of Medical Virology was one of the world’s first for COVID-19 serology test. Given the latest guidelines from the FDA on performance characteristics for EUA approval of serology tests, we’re currently validating performance of a second generation enhanced version of this kit which is produced and we are testing moving forward with that testing now. We are proud of the portfolio of COVID-19 diagnostics. We’ve built and launched in record time to help address this urgent public health need. Turn to Slide 10. And our solutions for treatment and care. BD’s global scale is nearly unparalleled enabling patient care in almost every country around the world. In fact, about 90% of patients that enter an acute care setting are touched by a BD product. Although overall hospital utilization is down due to COVID-19, countries and healthcare providers have been preparing for the worst, setting up surge field hospitals and expanding ICU beds. BD teams around the world answered the call working to help set up these facilities and ensure access to critical to COVID medical technologies. For an example, we recently saw increased demand for our Pyxis rapid emergency deployment offering where we can deploy and install Pyxis med stations in about a week to help set up temporary field hospitals like we did at the McCormick center in Chicago. We’ve also seen high demand for our portfolio of vascular access devices, infusion sets and injection devices which are critical to safe and effective medication delivery. Hospitals have also turned to our targeted temperature management devices to help in the care of symptomatic COVID-19 patients and we’ve seen strong demand for our acute dialysis catheters as one of the complications of serious COVID-19 is a multiple organ failure including acute kidney injury. I also want to comment on infusion pumps, which as you know are critical devices in acute care and especially the ICU as each patient on a ventilator is often connected to multiple infusion systems. Outside of the U.S., we have more than tripled manufacturing and customer shipments of our infusion pumps for EMEA in response to COVID-19. We’ve accelerated the distribution agreement that will expand BD’s offering an infusion and help address rising demand for infusion pumps in select countries throughout Europe. And I’ll speak to this in further detail later on. In the U.S., we’ve established a process for existing customers at the BD Alaris system to receive additional Alaris pumps upon certification of medical necessity. Our team is continuing to work diligently and with urgency to prepare the comprehensive five, 10-K filing we discussed in February. And while our team has been driving to submit that filing in the fourth quarter due to challenges associated with the global pandemic among other factors, we anticipate extending our initial timing for submission until after Q4. We don’t have a more precise timing at this point and we’re actively continuing to collaborate closely with the FDA to ensure we meet their expectations. I want to ensure you that we are committed to getting this done and done right. It’s our top priority and we’ve added significant dedicated resources. We’re making significant incremental investments and we’re rotating in top talent from across BD to drive this program to completion. My executive team is directly on this on a daily and weekly basis to ensure that we are best positioned to work through any potential obstacles that might challenge our progress. And as I said, this is the critical priority for the company. In connection to the charge that Monique described, we’re working with the FDA following their onsite inspection of our MMS facility in San Diego during the quarter. The FDA made a number of observations in a Form 83 notice we received an April and why we were early in the process. We were already beginning to implement certain corrective actions to address the observations. We’re also taking this seriously and we’re working collaboratively with the FDA and making necessary investments and keeping our focus on quality and doing what’s right for our customers and patients. We’re going to continue to keep you posted on our progress here. Finally, looking ahead to the development of a potential vaccine, we’re an active and ongoing discussions with multiple countries around the world to provide the maximum support possible for the world’s response to COVID-19 including production of syringes for potential large scale vaccination campaign. As the world’s largest manufacturer of needles and syringes, we have already ramped up production of injection devices in anticipation of a surgeon demand for these products. It’s important to acknowledge, of course, that BD is not immune to the financial impacts of the coronavirus, which we certainly saw in China this quarter. And while our underlying pre-COVID business remains strong as evidenced by our solid Q2 results. We expect to continue to see significant pressure on certain businesses as we move forward. And on Slide 11, I want to give you a better sense of these headwinds and the uncertainties around the pace of recovery, which Chris is going to explain in more detail. So elective and non-urgent procedures are down significantly, which is having a direct impact on our Surgery and Peripheral Intervention portfolio. There’s a wide range here with elective procedures for oncology and end-stage renal disease being least impacted and our hernia and peripheral arterial disease and biosurgery businesses being the most impacted. As some states begin to allow elective procedures to resume this month, there’s clear interest and willingness by hospitals and physicians to restart elective procedures in a controlled and phased way. A survey of our top accounts that we’ve done indicates that 80% of our customers want to begin resuming these elective procedures by some degree by early June. While our customers clearly want to restart procedures, there are some questions of patient’s readiness to return and we’re monitoring that closely as well. We certainly have to date has seen sentiment among patients mix, particularly for procedures that fall in the mid-range of procedure prioritization. Secondly, with non-COVID hospitalization down, we’re monitoring the impact of our business both in terms of products used in inpatient care as well as to capital budget. Since China and several other countries are a few months ahead of the U.S., we’re closely monitoring their recovery and utilization to see what we can expect as we look forward. In diagnostics, we’re seeing strong demand for our comprehensive portfolio of COVID-19 offerings, however, the deferral of routine care as you know is having a significant negative impact on diagnostic testing overall, which of course leads to temporarily lower use of sample collection devices. Again, we’re closely watching China here to see what we can learn about the pace of recovery for routine tests and sample collection. And in research where temporary lab closers have had an immediate and significant impact on demand for our Biosciences reagents and research instruments. We expect recovery is going to take some time. We’re paying attention to when researchers going to be able to head back to work and how long it’s going to take for lab testing and experiments to restart. In anticipation of the pressures, we’re now seeing in our business. We’ve been very prudent and proactive taking swift action to reduce costs and reinforce our strong liquidity position. And Chris is going to speak in greater detail to those in just a few moments. At the same time, we’re taking proactive measures. We’re also continuing to advance our long-term growth strategy and prepare for our next phase of value creation. In each of our segments, we’re deeply focused on executing our strategies to grow, simplify and empower as shown on Slide 12. We’re always going to drive growth through category innovation and we’re not taking our foot off the gas when it comes to R&D. Across each of our segments, we have a strong portfolio with a robust innovation pipeline that’s weighted towards solutions for faster growing markets. During the quarter, we continued our strong cadence of delivering our R&D pipeline, introducing nine new products in the quarter. Let me share a few highlights of our strategic progress to demonstrate why I’m confident we’re seizing the right opportunities to emerge from this pandemic strong. In medical, I mentioned earlier we had accelerated the distribution agreement with Medcaptain Medical Technology Company, who developed in CE marked and innovative new infusion pump platform that’s tailored for the European market and we’re very pleased with the first steps in this collaboration and it’s enabling us to help advance our medication management presence in the region as well as our global expansion strategy. In interventional, we’re continuing to execute our strategy and advanced solutions for faster growing markets. During the quarter, we released both the 300 millimeter and AV low-profile Lutonix balloon. Supported by these launches, we continue to see sequential improvement in the use of drug coated balloons prior to COVID. We were also early in our launch of Dry Dock 2.0 which is a technology designed to enable the continued use of the PureWick female incontinent device in the post acute and in the home. Shortly after the close of the quarter, we completed the acquisition of Straub Medical, which is a privately held company focused on devices that treat or restore blood flow to clotted or blocked vessels. This acquisition further expands our portfolio with a proven device with – it’s approved with dual indications for arterial atherectomy and thrombectomy in the U.S. It has solid existing sales in Europe and China. We’d be leveraging our strong existing channel and expertise in endovascular technology as we bring this product to the U.S. and accelerate existing sales around the world. Finally, within BDI last week, we completed the submission of additional data for Lutonix BTK filing. This is now continuing FDA review. Turning to Life Sciences. This quarter we launched the FACSymphony S6 system, our new cell sorter with six-way sorting and up to 60 panels of detection. The S6 enables an end-to-end solution for high parameter cellular analysis and reinforces our commitment to research solutions. We also launched the BD Kiestra ReadA instrument in Europe and we submitted the five, 10-K filing with the FDA this quarter. Continuing to execute on our strategy of modular laboratory automation solutions, the BD ReadA system – the BD Kiestra ReadA system transforms the manual hands-on workflow of plate reading into a fully automated and digital process that enhances lab efficiency and reduces time to result. I also want to give you an update on our launch of the BD core system in Europe, which as you’ll recall, is a fully automated molecular platform for high volume labs. When we announced this new innovation last quarter, we were still very early in the launch. The BD core continues to exceed our expectations and installations move forward even in light of COVID-19, I think reinforcing the customer interest in this platform. Also during the quarter, we completed the acquisition of NAT Diagnostics, an early stage company with a very innovative platform in the fast growing molecular point of care market. This acquisition will ultimately extend the breadth of BD solution offerings into molecular point of care testing. We are advancing this new molecular point-of-care platform in development and we’ll keep you updated as this system advances closer towards launch in the next few years. I’m excited about the progress we’re making and the three agreements we’ve completed, the Straub Medical, NAT Diagnostics, and Medcaptain, which are evident that we continue to invest in growth in all three segments even during this pandemic. And while we’re navigating real near-term pressures, I’m confident the steps we’re taking now will put BD in the best position for the long term. With that, let me turn the call over to Chris.
Chris Reidy:
Thanks, Tom, and good morning, everyone. I’d like to begin my comments by addressing BD’s response for the COVID-19 pandemic. First, as the coronavirus emerged, I was very proud to see the response and collaboration across our team and the immediate focus on ensuring the safety and wellbeing of our BD associates around the world. Also vital to our crisis response was our focus on taking care of our customers and the communities we serve. Beyond the actions we took at a company level, I’ve been truly amazed by the reaction from our associates, from our frontline to our back office staff and everywhere in between our associates that put the wellbeing of our customers and our communities above their own personal priorities. Second, from a cash perspective, we took early and prudent actions to protect our business during the time when liquidity is paramount. And lastly, as we contemplated these actions, we did so with the continued focus on our long-term strategy. We’re confident that BD will emerge from this global health crisis from a position of strength and will continue to create and deliver value to all stakeholders. With that context, let’s move on to our results for the second quarter, including a review of the COVID-19 impacts. As Tom mentioned earlier, performance in the second quarter was ahead of our prior expectations. Revenues grew 2.4% on a currency neutral basis, despite a larger than anticipated impact from COVID. As you’re well aware, the virus worsened significantly in China during February and subsequently spread beyond China’s borders quickly becoming a global pandemic by mid-March. I’ll provide more color on second quarter revenue growth and the impact from COVID in a moment when I take you through the results by segment. Second quarter adjusted EPS was $2.55, which represents a decline of 1.5% year-over-year or 1.9% on a currency neutral basis. EPS performance was above the high end of our guidance range due to revenue over performance and lower operating expenses as well as a small benefit related to foreign currency. As expected, the expiration of the Gore royalty impacted adjusted EPS growth by about 600 basis points. Operating margin of 24.7%, we’re also ahead of our expectations for the quarter, largely driven by lower deferred compensation expense due to weak stock market performance in the quarter and lower operating expenses. Turning to Slide 16, I’ll provide an update on cash and liquidity and the early improvement actions we took during the quarter to reinforce our strong liquidity position. In March, we successfully completed $1.9 billion of term loan funding at very favorable rates. This resulted in an increase in our gross leverage to 3.9 times at March 31. During the second quarter, we also increased capacity available under our revolver by $381 million to $2.63 billion to further strengthen our liquidity position. It’s also important to note that we remain committed to achieving our below three times gross leverage target, continuing to delever remains a very important commitment to the company and we currently plan to pay down approximately $1 billion in debt in FY 2020. However, due to the near-term anticipated pressure on EBITDA and given our current focus on cash conservation and the importance of liquidity, we now expect it will take longer to reach out deleverage target. In addition to our treasury related actions, we have instituted a number of cash conservation measures. This includes lowering capital expenditures as well as working capital initiatives with a focus on inventory management. From an operation standpoint, as I mentioned earlier, our employees are going above and beyond to serve our customers in their patients and this includes keeping our plants operational. Manufacturing teams are ramping up much needed products and we’re making additional investments as a result of the increased demand we are seeing in some of our businesses due to COVID-19. In other areas where scaling back and have made the difficult decision to temporarily furlough some employees as we manage inventories and adjust in near-term demand levels. In addition to the temporary furloughs, we felt it was important and consistent with our values to share the impact across our global team. So we’ve taken actions more broadly across the company to reduce salaries at the management and Board levels and also for senior leaders. The executive team and Board took the largest percent reduction. The decision was also made to suspend the company match for the 401(k) and other benefit plans for the remainder of the calendar year and to limit hiring to critical positions. While difficult, the actions we are taking today will reinforce our financial strength as we emerge on the other side of the coronavirus pandemic. Now moving on to Slide 17, before I discuss our revenue performance by segment, I’d like to take you through the COVID impact in the quarter. All in, we estimate that COVID reduced revenue growth by approximately 140 basis points in the second quarter. This is about double the impact we had estimated at the time of our last earnings call, which was prior to the escalation of the virus in China and the global spread of COVID during the last two weeks of March. As you would expect, the majority of the COVID headwind in the second quarter was in China. This was driven by strict adherence to stay at home measures which resulted in lower hospital utilization and a decline in elective procedures as well as fewer routine lab tests and related specimen collections. In addition, there was reduced demand from research labs due to closures amid the stay-at-home measures. Within the U.S. and Europe, there was a net tailwind from COVID in the second quarter. This was driven by increased demand for critical healthcare devices during the pandemic. We also saw the initial use of BD MAX for COVID testing. While demand increased in the acute care setting, this was partially offset by a decline in the non-acute area as people generally stopped seeking care outside of treatment related to the virus. Turning to Slide 18 and the Medical segment, BD Medical revenues in the second quarter declined slightly compared to the prior year, including a net headwind from COVID of approximately 40 basis points, but then the medication delivery solutions unit as anticipated, our performance reflects distributor inventory reductions related to the ongoing volume-based procurement process in China which were in line with our expectations. Outside of China, we saw strong growth in our vascular access management portfolio of solutions. With respect to COVID, the most notable headwind in the quarter was in China and was driven by significant declines in hospital utilization. In the U.S., COVID was a net tailwind that was driven by surge demand and distributor stocking partially offset by the impacts from lower routine and elective procedures and acute care and lower utilization in the non-acute setting. We also experienced COVID-driven surge demand in Europe in the second quarter. Revenues in the medication management solutions unit reflect limited installations of Alaris pumps as anticipated. Within the quarter, Alaris sales on the medical necessity approval were approximately $10 million. Alaris pending order volume on the medical necessity was high at the end of March. However, these orders were not filled before the quarter end. As a result, the revenues associated with those orders were recorded in April. We currently anticipate demand for Alaris pumps on the medical necessity will continue in the third quarter as hospitals respond to the COVID situation, albeit to a lesser extent than April as we expect demand to follow the evolution of the virus curve. In Pharmaceutical Systems, growth of over 11% reflects our continued ability to meet high demand for prefilled syringes and it was also aided by the timing of shipments. Within our diabetes care business, we saw an increase in sales of insulin pen needles and syringes as distributors and retailers increase their inventories on hand as a result of the COVID pandemic. Diabetes Care performance also reflects a tough comparison. The timing of what is that drove a strong Q2 last year. Turning to Slide 19 in the BD Life Sciences segment. Revenues increased 7.1% in the second quarter, including a net headwind from COVID of approximately 120 basis points. Revenue growth was driven by strong performance in diagnostic systems and pre-analytical systems units. Growth in diagnostic systems was driven primarily by a point-of-care BD Veritor flu assay and our swab collection and transport systems. This was due to a stronger flu season in comparison to the prior year and was aided in March by COVID-19. We also continue to see strong growth of our BD MAX instruments and assays for routine testing as well as an increased demand globally for using COVID-19 testing. This was partially offset by a decline in routine testing and our microbiology and women’s health and cancer products due to the COVID-19 pandemic particularly in China. Performance and pre-analytical systems reflect solid growth in wingsets in develop markets as well as favorable comparison due to distributor ordering patterns in the prior year. Within Europe, we saw some stocking of specimen collection devices related to COVID. This was partially offset by a decline in routine specimen collections due to the COVID-19 pandemic, particularly in China. Performance in the Biosciences unit reflects a tough comparison to the prior year, driven by the timing of licensing revenues and tenders in emerging markets. Results in the Biosciences unit also reflect reduced demand for instruments and reagents as research lab activity slowed significantly through the COVID-19 pandemic, particularly in the U.S. and Europe as well as in China. Turning to Slide 20 and the BD Interventional segment, revenues increased 3.3% in the second quarter, including a net headwind from COVID of approximately 350 basis points. Excluding the impact of COVID on elective procedures, revenue growth and peripheral intervention was broad-based, including continued strong performance in our WavelinQ, Covera and Venovo products. Additionally, there was an improvement in the year-over-year decline in DCB related revenues driven by continued commercialization of DCBs in Japan and sales related to two new product launches in the U.S. Within PI, the decline in elective procedures in China resulted in reduced demand across our portfolio. Revenues in the surgery unit were broadly impacted by the global slowdown in elective procedures due to COVID, particularly related to hernia repair across the U.S., Europe and China as well as biosurgery in China. Prior to the outbreak of COVID-19, growth was strong in both hernia and infection prevention. Revenue growth in urology and critical care continue to be driven by performance and targeted temperature management, home care and PureWick. I’ll now turn to Slide 21 in our gross profit and operating margins for the second quarter. As you’ve already heard from some of our peers in MedTech, COVID will put pressures on margins in the near-term given the high fixed cost nature of our business. In addition, we’ll see an impact from the lost revenues carrying your gross margin rate that is higher than the company average. We expect this pressure on margins to improve as the revenues return. In this quarter, gross profit margin of 54.7%, declined 110 basis points on a performance basis. We had anticipated a year-over-year decline in gross margins due to the impact from lower Alaris sales and volume based procurement in China, particularly partially offset by our continuous improvement and synergy and initiatives. Due to a larger than anticipated impact to revenues from COVID and the related impact to mix, gross margin came in slightly below our expectations. Currency had a positive impact of 50 basis points on gross margin in the quarter. Operating margin of 24.7%, increased 110 basis points in the quarter or 70 basis points on a currency neutral basis. This was driven by lower deferred compensation expense recorded with an SSG&A that is offset in the P&L and the other income net line item. Excluding the 110 basis point benefit from deferred compensation, operating margins decreased 40 basis points currency neutral. Unfavorable gross margin performance was partially offset by lower ongoing initiatives to reduce expenses, particularly within G&A. Currency had a positive impact of 40 basis points in operating margin in the quarter. Now turning to Slide 22 which recaps the second quarter income statement. As discussed, revenues grew 2.4%. This includes 10 basis points of positive pricing in the quarter. For the full fiscal year, we expect pricing to decline approximately 40 basis points versus our previous estimate of 50 basis points to 60 basis points. Gross margin was 54.7% as I discussed a moment ago. SSG&A as a percentage of revenues was 24.2% including the benefit from deferred compensation. On an underlying basis, excluding deferred comp SSG&A expenses grew at a rate below sales and reflect our ongoing focus on discipline spending and the achievement of Bard cost synergies. R&D as a percentage of revenue was 5.8% as we continue to invest in innovation and future growth, despite COVID-19 pressures. Our tax rate was 16% in the quarter in line with our expectations and our full year guidance range of 14% to 16%. As expected, we paid preferred dividends of $38 million in the quarter and as a reminder, the preferred shares converted on May 1. Adjusted earnings per share were $2.55 as previously discussed. In these uncertain times, we believe it’s critical to maintain our unwavering commitment to transparency and to share with all of our stakeholders the anticipated financial effects of COVID-19 on our business to the best of our ability. Unfortunately, despite having April results, as we navigate these unprecedented times, there are still too many variables to guide the fiscal year or even the third quarter. As we look forward, we are considering the following macroeconomic factors. First we’re in the early stages of recovery and there’s still great uncertainty regarding the scope and duration of the pandemic. Key to the recovery and the impact to BD is the return of general healthcare utilization. While we have begun to see some improvement in China as they are earlier in the recovery phase, the U.S. and Europe are lagging and this can be seen in our April results, which I’ll speak to in just a moment. Second, we are clearly operating in a much weaker macroeconomic environment and as you know, a weaker environment generally puts pressure on the overall healthcare system utilization and consumer spending. And finally, the pace at which deferred procedures return to normal is the biggest variable. This will depend on several factors including disease condition and acuity, COVID-19 testing availability, reopening of countries around the world and state by state within the U.S. and patient willingness to seek care. It’s too early to call how that will all play out. And that brings me to the bottom of this slide. As we move forward, we expect to see the biggest unfavorable impact of COVID-19 in our Surgery and Peripheral Intervention businesses because surgeries or other procedures in which our products are used are being deferred. We cannot anticipate the pace at which those procedures will return and how our customers will manage pent-up demand. Moving on to the acute and non-acute area where our MMS, MDS and UCC businesses participate. We see some pluses and minuses. We expect these dynamics to shift going forward and I’ll provide more details on the next slide. In diagnostics, as I mentioned earlier, we expect to see strong growth of our BD MAX instruments and assays for use in COVID-19 testing. In addition, we had good traction with our serology test in April and as Tom mentioned, we’re currently validating performance of an enhanced version of the kit. Additionally, we currently have point-of-care test for coronavirus in development leveraging the BD Veritor system. The team is working 24/7 to get this test to market as early as possible, but as Tom mentioned, we could still face some unforeseeable issues during the clinical evaluation phase. As a result, it’s too early to talk about a specific timeline for this potential product and what the market opportunity may be, but it could be a meaningful driver of growth. And lastly, in our Biosciences business, our recovery will largely depend on when research labs and institutions reopened and how quickly these scale up to normal operations and resume capital spending. We have also seen some impact on clinical flow applications like leukemia and lymphoma testing because hospitals are focused on COVID-19. On the positive side, there is potential for a modest benefit should NIH or other COVID-19 stimulus programs receive funding. Now moving on to Slide 24. This is a view into what we saw in the month of April, which includes our preliminary sales results. Going forward, our Surgery and PI businesses will continue to see significant pressure as a result of elective procedure deferrals. In the month of April the decline and procedures impacted Surgery revenues by 50% to 70% and Interventional revenues by 30% to 40%. In China, Surgery revenues are still approximately 50% of pre-COVID expectation and across the U.S. and Europe, Surgical and Interventional revenues are down 60% to 90%. In terms of loss revenues, we saw a decline of approximately $60 million in our Surgery business and $50 million in Peripheral Intervention. Moving on to MMS, we saw increased demand for infusion pumps under medical necessity, which we do not expect to continue at the same pace moving forward. This was partially offset by continued delays in Pyxis and [indiscernible] installations, which we do expect to continue going forward. This resulted in a net tailwind to MMS of approximately $70 million. In our MDS business in the United States, we continue to see reduced demand in our acute and non-acute businesses due to continued softness and routine and elective procedures. Within the month of March, these negative impacts were offset by tailwind from COVID-related surge demand and distributed stocking. Conversely, in April as the virus curve began to flatten, the COVID search demand began to abate and the distributors acted accordingly. As a result in April, we saw revenue in the U.S. that was approximately 15% to 20% below pre-COVID expectations. In China while hospital volumes in April broadly returned as isolation restrictions have been lifted, revenues was still approximately 30% to 40% below pre-COVID expectations. And lastly in Europe we saw the continuation of some COVID surge demand with revenues approximately 5% above our pre-COVID expectations. Combined, we started the decline of approximately $50 million in April in MDS largely driven by lower volumes in China and the U.S. Correspondingly in UCC, we saw a decline of approximately $20 million related to Foley catheter demand in April. Moving on to diagnostics and pre-analytical systems continues lower routine testing volumes resulted in fewer specimen collections and lower non-COVID diagnostic testing. Conversely, demand for COVID related testing remained high. In terms of revenues, we saw a decline of approximately $40 million for the month of April. In addition, we expect more meaningful delays in large capital installations such as Kiestra as we move forward. And lastly in our Biosciences business, we saw a decline of approximately $20 million in April due to lab closures. We expect a continued negative impact on capital spending related to ongoing reduced research activity. If we aggregate the pluses and minuses across the portfolio, we estimate that COVID-19 had a negative impact of approximately $240 million in the month of April. And this impact was partially offset by a tailwind of approximately $70 million related to increased demand for Alaris Pump under medical necessarily in MMS that we do not anticipate will continue at the same pace moving beyond April. I would also like to remind you once again of my earlier comment regarding the pressure on margins due to the high fixed cost in our operations and lower sales on high margin products. We hope this level of transparency is helpful as you think about the diversity and enduring nature of the BD portfolio. And as you can see there are a number of variables which make it very difficult to provide guidance as the COVID-19 situation continues to progress and we get more clarity around each of these variables, we’ll keep you informed. Before we open the call for questions, I’d like to summarize the key messages from our presentation today. As the world faces the COVID-19 pandemic, we are uniquely positioned to respond by leveraging our core capabilities and expertise to deliver solutions across the full continuum of care from research, to diagnosis and surveillance, to medication management, delivery and critical care. Our second quarter results reflect the strength and diversity of our portfolio despite the increased impact from COVID-19. Going forward, we have put initiatives in place to actively manage our business as we navigate the negative near term impact of the virus. Importantly, these measures include the actions we took to reinforce our strong cash and liquidity position. As we look forward, we remain confident in our ability to deliver value for all stakeholders and emerge from this crisis in a position of strength. Thanks for that. Now like to open the call up to Q&A.
Operator:
Floor is now open for questions. [Operator Instructions] Thank you. Our first question comes from Kristen Stewart with Barclays.
Tom Polen:
Good morning Kristen
Chris Reidy:
Hey Kristen are you there?
Tom Polen:
Are you on mute?
Kristen Stewart:
Are we okay?
Tom Polen:
Yes we can now.
Kristen Stewart:
Oh good.
Tom Polen:
Hey Chris.
Kristen Stewart:
Hi, good morning. Thanks so much and thanks for all you guys are doing out there on the frontline. And really thank you for all the transparency, the slide deck is really fantastic. So I really appreciate all that you guys put into that. I’m sure that was a lot of work.
Tom Polen:
Thank you.
Kristen Stewart :
I just wanted to kind of ask a little bit more and dive into just kind of what you are seeing just kind of on the medication management side, just with the puts and takes there. So, I was just kind of curious just in terms of -- with medical necessity and just kind of what you are seeing with the increase on sets and whatnot. I know you talked about the $70 million and kind of inferred that that was not something we should extrapolate going forward. I’m just kind of curious as to, I guess, why not assume kind of a continued benefit for that kind of product line. I guess, we had all hoped that since you were getting medical necessity that that could be something that we could expect to continue for the rest of the year, and maybe just any additional details that you could give on that, a little bit of slippage on that 510 K. If there’s anything you can add, that’d be helpful. Thank you.
Tom Polen:
Hey Kristen, this is Tom. Good question. So let me talk about maybe the 510(k) piece first, and then I can turn it over to Chris to give a little bit more color on the financial components there. So, on the 510(k), the main factor there that really drove the commentary around the delay is, of course one of the biggest areas of testing which we have to complete as part of the filing is human factor testing. So that’s -- for those not familiar with it, that’s going to – all the variety of people who could be using the pump, training naive healthcare workers, people who aren’t familiar with using the pump, having them use the instructions for use and be able to successfully make infusions. Of course in a pandemic, it’s more challenging to access the nursing staff, et cetera, to get that testing done in a timely way. So that’s the number one main item. And then in addition, we are evaluating feedback that we got from that 483 to understand are there any implications to the 510(k) submission. It’s too early to comment or there’s nothing that’s specific from that, but it’s something that we’re evaluating. Again, we’re continuing to work very collaboratively with the FDA, and we’ll provide you an update on the August earnings call. Again, we’re very focused on getting that in as soon as possible, but we’re also extremely focused on making sure that it gets done right, so that once it does get submitted, it can go through the process as fast as possible. Right? So, let me turn it over to Chris just to give an update on the numbers. And just maybe one caveat is, I think the $70 million that you referred to, that’s a net number in MMS that has a higher number for infusion that’s partially offset by some takes in other areas.
Chris Reidy:
That’s exactly right. So, I guess the way to think about this is, in the second quarter we had $10 million of medical necessity that really wasn’t COVID-related, that was kind of normal medical necessity that we would have expected when we gave guidance last quarter. We had something similar to that in the month of April as well. But above and beyond that, we had a spike in medical necessity for Alaris Pumps as you might imagine in the peak of the fight against the pandemic. And so that spiked, we did have a bit of offset from the Pyxis installations and Rowa installations, et cetera, but the bulk of that was the spike in the Alaris. Now, as we look going forward, we would expect that spike to abate somewhat. Not completely, but we would expect it to abate in May and in June and not be at the same levels as it was in April. We would also expect to see a little bit of a spike in the deferral of Pyxis and Rowa installations and keep that – that would keep going. So that would offset. So as you think about the next few months, we just wanted to make sure people were clear that we would expect that $70 million to come down in May and June.
Tom Polen:
Again, that’s just based on assumptions that COVID-19 will abate over that period of time and then hospitals may recognize that the need for this additional building of ICU beds may not need to continue at the same pace, but if that were to change, of course, the situation would change.
Kristen Stewart :
Got you. And then I guess what can you tell us a little bit about what you are seeing in terms of early days now just across the country here in the United States? You guys are in a unique spot just with all your touch points at hospitals, just from a recovery perspective. Are you seeing signs that in some places that things are starting to get a little better, just in terms of surgeries, and what you’re seeing maybe within the Interventional business or just in terms of hospital census [ph] starting to pop back up, are you starting to get a little bit more optimistic, or are things -- I’m sure things are very regionalized and anything you can kind of add there that’d be helpful.
Tom Polen:
So good question. I think that your last comment there is very accurate, it is very regionalized. And we certainly – we’re doing a lot of primary research surveys of our customers directly to have that real time data. And what our data shows is again a very regionalized kind of healthcare recovery areas like Texas, a few other states we see elective procedures really ramping back up strongly. Again, you’ll see that though in pockets you’ll see certain hospitals could be back at 90% of elective procedures and in hernia to where they were before. And then the hospital down the road is saying we’re not doing that for another 30 days. And they’re basically still at a 90% drop-off. But we are seeing it generally begin to increase in certain regions early in late April in particular. And I think we’ve reflected that a bit. But it’s still early days. I think the other thing is I’m getting increasing calls, probably fair to say over the last couple of weeks if you step back a month or two, a lot of the dialogues that I was having with CEOs of many of our largest customers were around getting access for diagnostics for patients in need of coronavirus diagnosis today. Today, I get a lot more of those calls where those needs are being better met today and people are looking at now getting access to tests to start screening patients prior to them coming into elective surgery. And that is happening, I’d say much more on a national basis. So even if they haven’t actually started doing the procedures yet, pretty standard across the nation I see the people are starting to think about and putting in place timelines for how they are going to get those elective procedures back up and running. And they are thinking about how testing is going to be used to actually test people before they come in. And so we’re seeing that occur. And I think that’s a sign, a positive sign of people’s intentions and the timing of those intentions. So we’ll continue to keep you updated as that progresses but just a few of the things that may be helpful.
Kristen Stewart:
Thank you so much. Take care.
Tom Polen:
Okay, thanks Kristen. Be safe.
Kristen Stewart:
You too.
Operator:
Our next question comes from line of David Lewis with Morgan Stanley.
Tom Polen:
Hey David.
Chris Reidy:
Good morning David. There seems to be a pause David?
David Lewis:
Good morning.
Chris Reidy:
There you are.
David Lewis:
Can you hear me?
Chris Reidy:
Yes we can.
David Lewis:
Great, that’s good news. I got one thing right this morning. So just a quick diagnostic question, a diagnostic follow-up, either for Tom or Roberto. So the first question is just on, I appreciate the update on Veritor this morning. I wonder, I know it’s kind of a fluid situation, but are we talking weeks away or months away? And then if you could get approved, what type of potential manufacturing capacity can we think about post EUA approval? Then I have a quick follow-up.
Tom Polen:
A good question, David. So it’s – we’re in clinical testing right now with patient samples. So at that phase we have an assay that we’ve developed and we’re testing for performance to generate data that if it works we could submit for EUA approval. So that’s where we are. I always – we’re cautious and one of the things we always talk about internally is of course typically it’s a three-year process to develop these assets and get them through clinical studies and approved. We are doing that in three months essentially. And so, even where it could be a couple of weeks away from submitting an EUA in the general timeline of what you can learn in that window. You are learning almost a year of what you had normally learned because that also includes manufacturing, scale-up, et cetera. And so that’s why we’re a bit cautious to give specifics yet because there’s still a lot to learn even though it’s a relative – could be a relatively short period of time. So more to come as we complete our clinical testing, we started that clinical testing last week. I can share that. And again, pending the results of that testing we have already had discussions with the FDA on pre-EUA filing discussions. And so we know what it takes to get that product through. And again, pending the testing results, the study results we’ll be in a position to file. Concurrently we have been working to ramp up our production of that assay. So our manufacturing teams are ready, we’ve actually started to invest in some additional equipment as well so that we would be in a position to scale that over the balance of the year in a meaningful way.
David Lewis:
Okay. That’s very helpful.
Tom Polen:
We’re doing millions of tests, right, millions of tests, not a million millions a week.
David Lewis:
Okay, so production capacity is not going to be limited there. Thank you. And then just kind of related questions for you, Tom or others, of BD MAX production right now is sort of a third of your peers within that testing, can anything be done to ramp up BD MAX production capacity? And then just, love to get your kind of macro views on serology or immunity testing, what do you think there’s significant demand for point-of-care immunity test or you think most of that demand is really going to get filled by some of the larger IVD analyzer companies? Thanks so much for all you are doing this morning.
Tom Polen:
Yes, thanks David. So on MAX, you are right, there are peers that have much higher volume on very different platforms of course. They are high throughput platforms which are designed for that. Obviously the benefit of BD MAX is that it is more of a real time system that’s much more usable in select hospital settings that aren’t going to have those high throughput platforms. So, at this point in time, I’d say that million tests a month is where we’re at with our current systems and instrumentation that we have in manufacturing. We have approved and are proceeding to invest an additional capacity there. But the timing of that coming online, I’m not ready to share that, but we are investing for additional capacity recognizing that we’ll need that in the future as well. But about a million tests a month is what we’re saying right now. In terms of immunology testing, we are seeing strong demand for point-of-care immunology testing. And we think that will continue certainly a central lab based approach is a good one. It does use a different specimen, the whole blood, obviously the convenience of the finger stick we see interest in that from an employer’s, as well as healthcare providers being used from screening think about patients coming in and being able to do testing much more real time than having to send samples out and maybe a less invasive sample collection procedure as well. So we are seeing strong demand and we expect that will continue.
David Lewis:
Thanks so much.
Operator:
Your next question is from Richard Newitter. [SVB Leerink LLC]
Tom Polen:
Hi Richard, good morning.
Richard Newitter:
Hi, can you hear me?
Chris Reidy:
Yes we can.
Richard Newitter:
Okay, great. Thank you. And thanks for all of the detail in this morning’s presentation or release. It was very helpful. I wanted to just maybe go back to the testing question, follow-up on David’s, the old line of questioning here. So very helpful on color with respect to how your portfolio fits in perhaps on the hospital testing side. Can you give us any sense as to how you think the back to work on the more of the private sector and just kind of employers in general, what the algorithm is potentially going to be either at a national level or whatever you’re seeing out there as a conversations are being had. Just trying to get a sense for how serology fits in with a point-of-care testing and/or kind of high-throughput testing, so what was other automated systems? Thanks.
Tom Polen:
It’s a great question, Rich. I don’t have the algorithm figured out specifically yet. I would say that that, again, as we’re thinking – as we’re talking to our customers, we’re getting a lot of interest on antigen testing to screen patients, at least before they come in for elective surgery. So I can make that comment that they’re more focused on antigen testing what I’m seeing then antibody for at least patients screening before they come in for surgery. Certainly as we think about employers getting their associates pace back to work, it’ll be a mix. I would imagine. We are of course spending a lot of time ourselves thinking through that question. And we were very focused on prioritizing. We actually just communicated yesterday some phasing for starting to get some of our associates back to work next phase of our commercial teams being able to support customers in the field starting this month in the U.S. as an example and then starting to get increasing numbers of R&D associates back to work as the priority after that. And then we’ll be working on more office based associates in extended period of time after that. And so I think you also expect regardless of the use of testing some phasing of people getting back to work based on the importance of them really being in what do they have to access in a work setting that they can’t access from home.
Richard Newitter:
That’s helpful. Thank you. And just on the ramping production of the, the swab kits that you referenced, I think, you said millions per week by June. That’s a substantial ramp from where you had been. Do you think that that will no longer – or seems to be a bottleneck for the testing situation, at least in the U.S. by that point in time? Is that the right level? And can you go even further than that? Thank you.
Tom Polen:
Yeah. Good question. So just to clarify that’s three million a week by June is where we expect to be, that’s up from 500,000 a week at the start of the crisis so it’s a dramatic ramp. And of course we’re heading strongly in that direction where we already at a couple of million a week. So the big thing that’s happened there is – and we’ve been right in the middle of that working with the FDA, other partners from across the industry as well as organizations like the Gates Foundation. At the start of the pandemic, there were very few products that were validated for testing. And so that was clearly a constraint at the beginning. What’s happened now is there has been a lot of systematic work across the swab manufacturers as well as the test providers. And again organizations like the Gates Foundation who have been driving some of that testing in collaboration with the FDA to systematically expand to beyond viral transport media, which was limited to in the beginning to now other types of swabs including dry swabs and swabs in sailing, which have dramatically increased the capacity of the different types of devices that are available. And so, yes, I’m not hearing significant issues on swab stopping testing. Today, I was getting a ton of those calls a month ago and that was an issue and we were very actively managing to make sure that testing didn’t stop having our teams coming in at midnight on Sundays to package things up and drive them to the hospitals around the country and regionally to make sure the testing didn’t stop. And we were really proud of the work that we did there. We don’t get those calls anymore at this point in time or they are much more rare if they do occur.
Richard Newitter:
Thank you very much.
Operator:
Your next question is from the line of Bob Hopkins with Bank of America.
Bob Hopkins:
Great, thank you. And good morning.
Tom Polen:
Good morning Bob.
Bob Hopkins:
Yes good morning. Again I appreciate all the detail. So just maybe one follow-up on April. And I realized this is a little bit short term, but we’re also hungry for information. Regarding the $70 million, I realize you’re saying that probably won’t be sustained, but I’m just curious if we sum up everything for the month of April, the positives and negatives related to COVID and then just the other parts of the business by my math that may be suggested in April, the total company revenues maybe down high single digits year-over-year. Is that ballpark or am I missing something?
Tom Polen:
No, we’re mid-teens down. So in total at the 240 level that’s mid-teens and then somewhat offset by the $70 million.
Bob Hopkins:
Okay. So that mid teens would not include the $70 million benefit that you are seeing. That’s right. Okay, okay. And then the other thing I want to ask about is thinking a little bit longer term Tom you mentioned, hopefully, the progress being made on vaccines obviously vaccine will be a part of the solution there. I’m just curious if we do get a vaccine do you guys have the capacity to meet that demand for J&J is out talking about a billion doses. Kind of how do you frame that for investors that BD being part of the solution and your ability to meet potential demand?
Tom Polen:
Hey, it’s a great question, Bob. And it’s something that we’ve been very active in talking to governments around the world. And what’s important here is, is that people have to be proactive in beginning to order and stockpile these devices now, it cannot be waited until the last minute and expect that those products will be able to be manufactured because to your point, that scale can’t be produced in that period of time. So we are seeing some governments around the world, we’ve gotten very large orders already beginning that stockpile to cover the citizens in their country of vaccines. Others haven’t done that yet. And we’ve been really pretty much on a daily basis working with our public policy team to create greater awareness in governments of the need to start doing larger scale buys now. We have presented our production capabilities over the next a year. There are opportunities for us to invest further in capital, some of that we’re doing proactively our self. But it needs to be done from a stockpiling perspective. And again, I think, there’s further actions needed to do that. And again, we’re working to help ensure that happens. That includes here in the U.S.
Chris Reidy:
And just to be clear on your first question, Bob, when you adjust for that $70 million it comes out to low double digits impact on a year-over-year basis.
Bob Hopkins:
Thank you very much.
Operator:
Your next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question. And yes, thank you for all the color. Just a couple of questions from me. One, Chris on the P&L I appreciate the color on the margin impact. Any other color you can provide on the P&L? For the second half it sounds like R&D you are going to maintain that spending. How should we think about SG&A and maybe some of the other lines of the P&L? And I had one follow-up.
Chris Reidy:
Okay. Thanks, Larry it’s a good question. And the way to think about it is a lot of what’s being negatively impacting the business such as a surgery and PI we’re fortunate to have very high gross margin profiles. So, think in the 70 plus kind of range. In addition to that, as you think about the impact you’ve got to consider manufacturing variances which are going to impact the P&L as we adjust for the revenue and adjust our inventories accordingly which is the right thing to do. So, as we think about it, we’re also making investments in COVID-related ramping as we’ve talked about on the call here. So we’re making those investments. We’re also investing in the safety and health of our associates making our own PPNE which we talked about, facilities cleaning and those kinds of things. So those are additional costs. And then we’re also seeing higher shipping costs as you are probably not surprised by. So when you take that and then we’re taking – offsetting that we’ve taken cost mitigating actions that we talked about in our remarks. We limited travel and hiring freeze early in the second quarter and we saw the benefits of that. But we’ve also taken salary deductions for management and the Board, the 401k match, so that offsets things. So when you net all of that out, you should be thinking about the margin impact of the lost revenues going forward in that 75% kind of range when you net everything together. So hopefully that gives you some more color.
Larry Biegelsen:
Very helpful thanks. For my follow-up, Tom, how are you thinking about the long-term implications of coronavirus. You mentioned for BD and the industry, you mentioned in the slides, the shift of care to the non acute settings, for example. How does that impact BD? Thank you for taking the questions.
Chris Reidy:
So we’ve been – of course in our strategy, we’ve been very specifically developing additional solutions for the nonacute sector, be it our Rowa platform for retail pharmacy, our Veritor platform or even commercial teams that we’ve put in place, bringing our medication management solutions and including catheters, et cetera, into the surgery centers and non-acute. So we’ve been shifting our resources in that direction. It’s been a faster growing segment, but we’ll certainly only increase in that direction going forward. I think you heard some of the announcements that we talked about today on our new product development platforms like the acquisition of Nat DX, which will give us a point-of-care molecular platform, to supplement, right? So Veritor will be a lateral flow based. This platform will be molecular based similar time to resolve we would expect as Veritor. Again, that’s an investment that we’re making, seeing that we expect diagnostics will continue to shift in that direction. We’re making other investments even in our PAS business that allow self blood collection and other types of sample collection that are much more appropriate for the retail setting, et cetera. So we definitely see it a trend. It’s something we’ve been investing in and will only continue to double down on that as we go forward.
Larry Biegelsen:
Thanks guys.
Operator:
Thank you. Your next question comes from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Hey guys, thanks for taking the questions. Probably not surprisingly coming from me, some very Veritor questions here for you. Just kind of rapid fire. So, Tom, I wanted to confirm did you say millions per week? I think that’s what you said I wanted to confirm that. And then are we talking about a COVID-19 assay and are there any plans for a combo flu AV COVID assay on that? Can you speak to the performance characteristics that you’re expecting to be seen on that, especially relative to, I know you have to compare relative to PCR when you’re doing these studies?
Tom Polen:
Sure. Good, questions, Brian. Good morning. So yes, you heard right on Veritor that would be where we would be ramping up towards. We wouldn’t have that available necessarily at launch. We will have that ramping up towards that way. We have plans and we’ll share those plans from a timing perspective later on. From a performance perspective, again, we’re in studies right now, so it’s inappropriate to say what our performance is. We’re getting actually that right now in clinical specimens, obviously we recognize the comparative to PCR is typical obviously for anything. We also recognize that these assays, they won’t be as sensitive as PCR, no lateral flow assay is as sensitive as PCR, but no PCR assay is as ease of use, cost base, mobile as what you see in a platform like Veritor, which is why you see wide used applications in flu and strep testing still today. And it has a very important role. We see and we hear also from be it the FDA, the White House, other key constituents, our customers see a very important role in need for a lateral flow based COVID assay. We are focused on getting the COVID asset out first, Brian, the antigen test. And then to your point, can we add in a – combine that with our flu test in a single strip. Absolutely we’ve started to think about that. That of course becomes much simpler to do once you confirm that the COVID assay is secure done, we’ve launched that, then the ability to put that down with a flu test, both of which are now well characterized assays would be a next phase for us to think about.
Brian Weinstein:
Okay, great. And then as a follow-up going back to the pump business for a second, would you be willing to share some of the bigger observations that you received in the 483, just a kind of broad stroke, the things that you are going to be kind of looking to deal with here?
Tom Polen:
Yes, Brian, we don’t share those at this point in time, obviously we’re in – we’re working very closely with the FDA in that response. We’ve actually already submitted our response plans on that. We’ve already started taking actions on many of those and we’ll share more as we go forward.
Brian Weinstein:
Understood, thank you.
Tom Polen:
Yes, okay, thanks Brian.
Operator:
Your next question is from Rick Wise with Stifel.
Tom Polen :
Rick good morning.
Rick Wise:
Good morning, Tom. Good morning, Chris. Let me start again if I could with your excellent representation of what happened in April. Very clear. But I wanted to make sure I understood and pauses for the short term nature of it. Other large companies have been commenting on recent weekly trends and stuff like that. I’m looking for something specific but have it indeed, did things get less bad or improve somewhat state as you will that last week of April into May? Are you seeing that? And as we think about, the reason I ask is that that $240 million negative April impact shouldn’t we assume that that gets less bad? Yes, the $70 million positive will be less of a positive contribution, but shouldn’t we assume that in coming months as things reopen that the $240 million goes down month by month?
Chris Reidy:
Yes, so it’s really hard to predict. There wasn’t enough in the last week of April differential to really give us a sense of that. And when you think about it’s really elective procedures. So we didn’t see enough of a change in the elective procedures to be able to call May and to get any sense of anything changing. To your point around what might be up and down, we think that the lab closures, the impact in May might get a little bit worse and capital spending levels over the next couple of months would also be something that could get a little worse. And so it’s just there’s so many variables, it’s what makes May and June, very, very hard to predict. And, I think we’ll learn more as time goes on as you said, but there was nothing about the last week of April, that would give us a sense of where this is going. It’s just too early to tell at this point.
Tom Polen:
And Rick, maybe we take advantage we’ve got. We do have Simon on the line. May be we turn over to Simon just for a quick comment on what you are seeing on the procedure side at a high level.
Simon Campion:
Yes, hey, Rick Eric, it’s a final so in certain pockets we did see an uptick certainly in England on the ventral hernia. They are heavily reimbursed. They are also England, in particular, is very much outpatient based. So, they get the patients in, they treat them, they get reimbursed nicely and the patients go home. So that’s been – that has picked up nicely at the back end of April. And also another point worth noting is something hit the back end of April, our salesforce began to receive more calls from their customers about beginning to re-attend cases. So, Tom said, we’re about to let those at those guys loose here again in the in the middle of the month. And in fact just yesterday we began as shipping them all their PPE so that they can attend cases and go back into hospitals where they’re allowed. So there are several things in certain pockets that are pointing in the right direction in respect to some aspects of our elective business.
Tom Polen:
And just to clarify, our reps will not be going in just to hospitals unless they are specifically requested to attend a case. And I think as we see that – while we’re seeing that in some very small subsets that Simon just described, I’d say as we think about medical and life sciences, as Chris commented on not seeing that at any real difference at the end of April. For example, I can specimen collection or MDS, anything notable there difference.
Rick Wise:
That’s great. And Tom, maybe just one for you, your grow, simplify and empower initiatives, just focusing on the simplify aspect from a couple of angles, I know you’ve focused and prioritized optimizing manual factoring efficiencies, cost reduction initiatives, SKU reduction, et cetera. What’s happening to all those initiatives right now and you could – is this an appropriate time to accelerate those initiatives? Actually, ironically would that be helpful as we contemplate Becton’s potential fixed costs as you might – as we recover from this COVID period. Thank you.
Tom Polen:
Hey Rick, great question. Absolutely. So near term over the last two months, we’ve actually – the work on the SKU rationalization has in fact accelerated to your point with folks at home, the ability to engage actually the sales team in working through products – the product list of what we’re looking to remove from the portfolio, the substitute products actually been able to – number of teams have been able to engage them in a way which has been much more than we would have been able to do traditionally. Actually I think we had a number of businesses already starting that product simplification initiative. And that expanded pretty significantly across the company to other businesses during this window of time where the marketing teams, et cetera, were also had bandwidth to accelerate that work. So that’s been one that we’ve taken advantage of this period to double down on. In terms of the manufacturing, network consolidation that does continue to move forward. We haven’t been able to necessarily accelerate that during this period of time. Obviously manufacturing teams focus primarily on supply right now and navigating that. Of course you can imagine every day there’s items that we have to manage in our supply chain, as well as in our own facilities. But that is fully still moving forward in all ways and we’ll continue to keep you updated on that.
Rick Wise:
Thank you.
Operator:
Your next question comes from Robert Marcus with JPMorgan.
Robert Marcus:
Great. Thanks for taking the question. I’ll ask both of them all in one. I noticed you took down your CapEx for the year by about $200 million hoping you could just touch on your thoughts around pipeline delays that are potential coming out of this. What should and shouldn’t be effected. And then also, how are you thinking about your ability down the road, is this reduction in CapEx temporary? Could we see something more permanent come out of this? Really just how you are thinking about capital investing and your capital allocation in general plus the pipeline? Thanks.
Tom Polen:
Yes I’ll start with that Robert, thanks for the question. And as you might imagine, the first thing that we wanted to make sure of is that we were able to mitigate the cash impact from the headwinds from COVID. And we’ve made great progress on that in a few short weeks. And we are able to mitigate a substantial part of the, what we see as the capital impact. And we think that was the prudent thing to do. Now, one of those things that we did to get there in addition to some of the P&L items that we talked about that clearly impact P&L and cash. But from a cash perspective one of the items that we did take down was the CapEx. And we’re prioritizing mission critical capital spending, and we’re cutting and basically delaying some of the investments that we’re making that are more discretionary. And we’re being very careful on that because we want to make sure that we’re not cutting anything that would inhibit any capacity going forward So we’re being very targeted on that and it clearly is not a permanent adjustment in CapEx. We would expect that when we come out of this pandemic that we would, some of those things that we’re cutting, we will are just deferring and we’ll have to spend that. And so you can expect us to go back to the normal $900,000 to $1 billion kind of thing. And that is particularly true as we think about investing in areas that are necessary for COVID. We continue to invest in those areas, and ramp and make sure that we have capacity as terms articulated on a number of fronts. We’re ramping capacity. So think of that as a temporary reduction. Thanks for the question.
Operator:
Your next question comes from Matt Taylor with UBS.
Matt Taylor:
Hi. Good morning. Thank you for taking the question. So I just wanted to circle back and if we could revisit some of Bob’s question about the vaccine, given that could be a material ramp up, could you just remind us what kind of share you have, the global syringe market, how material that is for you today? And what it could mean if you were to get an order for, say, one billion syringes in Q1, would you be able to get there and how material would that be?
Tom Polen:
Good question, Matt. So we don’t share our specific shares on a global basis. We are, as we said, the leader in worldwide, we’re clearly the leader in the U.S. And we make billions and billions of syringes and needles a year. We make billions and billions of them specifically just for the U.S. market as well each year. So to be able to provide it, let’s just say in your example, a billion syringes spontaneously, there’s not capacity to just provide those in a month. We have provided plans to different governments around the world where we can provide hundreds of millions of product and over months, periods of time. And there is opportunity to go above that, but it needs to be done in partnership with those governments. So again, some of those governments we’ve engaged have strongly engaged with us to do that. Others are still working through their plans. On that point, what’s most important is you’ve got to get ahead of that and start to start to get those orders and things in now. The other thing is, it’s just a little caveat there is the reason I hesitate is there is global capacity as well, there’s certain products that we sell, for example, in the U.S. that we don’t sell ex-U.S. and there’s many products that we sell ex-U.S. that we don’t sell in the U.S. So for example, we pretty much exclusively sell safety devices in the U.S. We have a lot of capacity of non-safety devices ex-U.S. In a pandemic vaccine delivery situation one may not prioritize the need for safety needles on the end of a vaccine delivery. And so you can free up additional capacity to come into the marketplace. But those, again that’s working with the governments on the specific requirements. And the stockpiling, again, some governments have already started taking those actions aggressively, others we’re really focused on getting them to act sooner.
Matt Taylor:
Understood, thanks for that. And then one follow-up, obviously you’re seeing increased demand for fusion pumps. I was just wondering if you could offer some thoughts given you touched so many points in the acute care setting, whether you think that hospitals and providers will in the medium term or the long run actually, permanently increase the size of their ICU or acute care capacity to be able to be responsive if there is a second wave or just ongoing COVID management.
Tom Polen:
It’s a good question. I honestly don’t know the answer of that. That’s something that I would imagine that that many hospitals are thinking about what it could be a second wave in the fall and next winter. And thinking about how they balance that, including some of these field hospitals that have been set up and how you think about those. In fairness, we haven’t had deep discussions with our customers on the long-term implications of ICU beds and how they may or may not maintain that over a longer period of time. Certainly, particularly in the U.S., I think, that may be a little different in some areas like in Europe where you’ve seen countries, you’ve seen the stats of ICU beds per capita in different countries in Europe and how disparate those are. What we have heard were some of those countries that did not have as many ICU beds may want to permanently maintain a higher ratio of ICU beds. But I think that’s on some that were well below benchmarking levels.
Matt Taylor:
Great, thanks for the clarification.
Tom Polen:
Yes.
Operator:
Thank you. Your next question comes from Josh Jennings with Cowen.
Josh Jennings:
Hi, good morning. Thanks for taking the questions. I had a follow-up similar question to Matt’s most recent question. But just thinking about the potential need for hospitals to build out the capacity, maybe individual fleets, more Pyxis systems as they move forward to reopening and they are looking at distinct COVID-19 wards, or units, or floors versus non-COVID-19 units or floors and the potential to avoid cross-contamination even of medication delivery or these pumps?
Tom Polen:
Josh, we’re not seeing widespread requests for that at this point in time. And I think the question would be would they be reallocating? Remember, overall hospital utilization in the U.S. is still relatively low rate, it’s not 90% across the board in normal terms, so how much they would allocate to COVID-specific wards, et cetera. I think that’s still being figured out. Obviously all hospitals were being dedicated to that at this point in time. We don’t see – it’s not visible today that there would be some type of spike in pump or Pyxis growth as people are trying to build a separate COVID systems from their main wards. But something we’ll monitor but we’re not seeing that today.
Josh Jennings:
Great. And then just to follow-up, I heard you mentioned that the Lutonix BTK submission was put forward or filed. Any incremental details you can share about back and forth with the FDA? What was required – what more was required from Becton for that submission? And any comments on just your confidence for approval? Thanks a lot.
Tom Polen:
Yes, we can’t comment really with many details at this point in time. Obviously it includes a number of additional clinical data studies that were generated on BTK. And we submitted those various data sets to the FDA. So again, we believe that there remains a significant unmet need for that patient population that there’s not strong alternatives for today. We strongly believe in the safety of the BTK product and it’s under active review. So we’ll continue to keep you updated as it progresses. But we’ve submitted the data that we believe isn’t complete and so it’s now under the review process. Thank you.
Operator:
Thank you for your questions. We will now turn the floor back over to Tom Polen for your closing remarks.
Tom Polen:
Okay, well thanks everyone for the great discussion today. As I close today’s call, I’m reminded of something a mentor of mine once shared, which is that crisis doesn’t make character, it reveals character. And that’s truly the way, I think, that we’ve seen BD respond here that the COVID-19 crisis has really revealed the best of BD reinforcing the commitment of our associates who never forget that there’s a patient at the end of everything we do. It’s revealed the breadth, the depth and necessity of our product portfolio reinforcing the central role we play from discovery and diagnosis to the delivery of care and treatment of disease and it’s revealed our ability to adapt and innovate, mustering our resources to bring new solutions to help solve healthcare’s biggest problems. That track record is why healthcare providers and health officials worldwide have put their trust in us during the most significant health crisis in the past century. And it’s what gives us the confidence that we will continue to drive growth, innovation, and value creation in the many categories we serve long after COVID-19 has been contained. I think it’s fair to say that the road to recovery for the healthcare industry and global economy is going to take some time. It’s likely to have its own bumps, but I’m confident BD will navigate these near term challenges, take the necessary actions and execute our strategy to emerge strong. I’ve been so inspired by the response of BD associates. We have an incredibly dedicated and committed team. And I can’t thank the team enough for going above and beyond in these challenging times. I want to thank all of you for your time today. Stay well.
Chris Reidy:
Thanks everyone.
Operator:
Thank you. This does conclude today’s teleconference. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to BD's First Fiscal Quarter 2020 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through February 13, 2020, on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 6886458. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Monique Dolecki, Senior Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Pasha. Good morning, everyone, and thank you for joining us to review our first fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our fourth fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Our first quarter results include a charge of $59 million related to a voluntary recall in the MMS infusion business to address certain software and alarm prioritization matters. This item along with the details of purchase accounting and other adjustments can be found in the reconciliations to GAAP measures in the financial schedules in our press release and in the appendix of the Investor Relations slides. A copy of the release including the financial schedules is posted on the bd.com website. Leading the call this morning is Tom Polen, Chief Executive Officer and President. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Alberto Mas, Executive Vice President and President of the Medical segment; Simon Campion, Executive Vice President and President of the Interventional segment; and Patrick Kaltenbach, Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Tom.
Tom Polen:
Thank you, Monique. And good morning, everyone. You saw in our earnings release this morning where we brought down revenue and EPS guidance for the year, and let me just say that resetting expectations is certainly not how I want to start my first call as CEO. And so, before we jump into what's happening with Alaris, I want to say that how we're going to discuss topics on today's call is what you can expect from me – straight talk, accountability, and an unwavering commitment to quality and regulatory compliance, our values and doing what's right. At our core, BD is a very purpose-driven company. It's what defines who we are, how we operate, and what actions we take. And you can expect that our purpose and values will be at the heart of how we respond to the current situation with Alaris. Every company is going to face challenges, and the real measure of the company’s strength isn't whether or not we face challenges, it's how we respond. And I'm personally focused, along with my entire leadership team, on fully resolving this situation. So, let me take you through what happened starting with what we said in November and even more recently and how our conversations with the FDA have continued to evolve, even specifically this week. In November, we told you we were planning to make some improvements to our Alaris pump software, including upgrades to alarm prioritization and optimization. We indicated then that we were in active discussions with the FDA about the timing and implementation of these improvements. Relying on our quality process within the infusion business and how we've managed Alaris software updates over time, the team believed we could take a phased approach to releasing Alaris software updates and that these releases did not require a 510(k) clearance. We then issued the first phase of our software updates in December, and we resumed shipping as we shared with you last month. Through our ongoing dialogue with the FDA, including an in-depth discussion this past Monday, we learned that the FDA disagreed with our conclusion about the need for a new 510(k) clearance for these software upgrades. And in light of the consent decree, the FDA has requested that we combine all Alaris software enhancements, recall remediation updates, and changes made to the Alaris system over time into a single comprehensive 510(k) filing, which we're going to submit in the fourth quarter of FY 2020. We're actively continuing to collaborate with the FDA to ensure we meet their expectations for this upcoming regulatory submission. I want to be clear here that while we relied on our infusion quality process and system, we've now learned that in this case it did not meet FDA's expectations, and we're committed to taking the appropriate actions to get this right. I also want to be clear that we fully stand behind the safety and the clinical benefits of our product, which is used in the care of 70% of patients undergoing infusion therapy, and that's a responsibility we do not take lightly. We've provided guidance to our customers on how to mitigate potential risks until our software is fully remediated. We've also created a dedicated team of clinical consultants to support live training for healthcare providers, and we will continue to support existing customers to ensure they have access to the Alaris system under medical necessity. As CEO, my foremost focus is on ensuring the right supporting processes, capabilities, and execution within the company to ensure we deliver on FDA expectations. Chris will discuss this more, but as you saw in our news release, based on this situation, we reduced our guidance range by approximately $400 million in revenue and $0.60 in EPS for fiscal year 2020. I also want to comment on China's volume-based procurement initiatives and which we've shared would be impacting our MDS catheter business and that we now have a much better sense of how the situation is evolving than we did last month. So, while it's progressing faster than we initially forecasted in November, we expect to fully offset the impact at the BDX level. We've got several upsides from the rest of our business in China, which are expected to grow double digits during the year, and there are also a few other areas that we're doing better than expected in so far, including flu testing, DCBs, and FX. We are a strong company with a diverse portfolio, both in terms of our products and our geographies, and there's a lot of good things happening across BD. And I want to highlight just a few. First, our Q1 results were in line with the expectations we shared with you in November. The businesses and the regions delivered solid performance, led by Life Sciences where we saw an incremental benefit from the flu and our Interventional segment where we saw growth from new products and DCBs also started a bit better than expected. During the quarter, we continued to make good progress on the BD-Bard integration. We remain on track to deliver $100 million in cost synergies this year, which brings our total to $300 million over the three-year deal period. We also continue to scale our commercial programs as part of our commitment to achieve $250 million in revenue synergies by 2022. We've continued to make good progress there with things we've talked to you about in the past, such as the European biosurgery incubator, vascular access management, and our international product registrations. Another strength in FY 2020 is our ability to deliver on a robust pipeline of new products, and we're already off to a solid cadence with 11 new launches so far in Q1. And there's three I'd like to just call your attention to. In Medical, we're continuing to innovate in our vascular access portfolio. And we recently launched the new PowerPICC Provena catheter with SOLO 2 valve technology, which makes the catheter easier to care for. Our early feedback from customers is extremely positive. In Life Sciences, we recently introduced the BD COR molecular system that's targeted in Europe. This flagship innovation completely automates the molecular laboratory workflow, and our initial system configuration is available with the BD Onclarity HPV assay, which is used for cervical cancer screening and diagnosis. We're still very early in this launch, but we feel really good about the progress we've made so far, having already signed 10 high-value volume accounts in Q1. Of course, we're new to the HPV market, and so all of that is new business for BD. In Interventional, we received clearance for EleVation, our next-generation vacuum assisted breast biopsy device, which helps ensure tissue samples, high-quality tissue samples regardless of the density of the breast tissue. It's early, but we're getting very positive clinical feedback here as well. We're excited by these and our other launches and our long-term innovation pipeline. What you see on slide five captures our major launches for FY 2020, but it's only a small portion of the total active R&D projects that we expect to bring to market over the next three to five years. We're also entering several new higher growth market spaces with our overall R&D pipeline focused in markets growing 1% to 2% faster than our existing product portfolio. And we see elements of our automation and informatics capabilities in the pipeline across each of our three segments, including now in Interventional where we're starting to leverage BD's capabilities to digitize the legacy Bard portfolio. Before I turn things over to Chris, I want to make some comments on the coronavirus. First, as it comes to the coronavirus, the health and the safety of employees in China and around the world is our top priority. We're closely tracking the virus in China and we're paying particular attention to the guidance from the US CDC, the WHO and health officials in China. As you'd expect from us, we're also supporting response efforts in China by providing in-kind and monetary donations to the Wuhan Red Cross and Project Hope. BD doesn't manufacture – we don't have any manufacturing or distribution operations in the Wuhan or Hubei province and we are adhering to the guidance from the Chinese government and extending the Chinese New Year holiday until February 10 at our offices and facilities in Suzhou and Shanghai. From a supply chain perspective, about 95% of the products we manufacture in China are sold and used within China. We currently have sufficient inventory of the few products that we export from China to meet current demand. And within China, imports of goods and raw materials are being received as expected. In terms of business impact, of course, the situation is still very dynamic. We are closely watching and balancing two trends. First, we are seeing fewer people go to the hospital to seek standard care. At the same time, we have received and installed several urgent orders for additional BD MAX molecular systems, which are being used in coronavirus testing. Chris will take you through how we're contemplating this within our guidance. We'll continue to closely monitor the situation and keep you updated as it evolves. With that, let me turn the call over to Chris.
Christopher Reidy :
Thanks, Tom. And good morning, everyone. Before I take you through our first quarter results and guidance for the full year, I'd like to reinforce Tom's remarks on the Alaris pump issue. As you would expect from us, we take this matter very seriously. We did not anticipate the current Alaris pump situation to materialize the way that it has and I assure you that the senior management team is fully committed to resolving the situation. So with that, let me review our first quarter results. As Tom mentioned, we delivered solid performance in the first quarter. First quarter revenues grew 2.5% on a currency neutral basis. Revenue growth was in line with our expectations. I'll provide more color on the first quarter revenue growth in a moment when I take you through the results by segment and geography. First quarter adjusted EPS was $2.65, which is at the high-end of our guidance range. Adjusted EPS declined about 2% year-over-year and was about flat on a currency neutral basis. As expected, adjusted EPS growth reflects solid operating performance, offset by the expiration of the Gore royalty and a very tough compare to last year's first quarter tax rate of 11.2%. Operating margins of 24% were in line with our expectations for the quarter. We also continued to de-lever during the first quarter, paying down approximately $90 million of debt. At December 31, our gross leverage ratio was 3.5 times and we remain on track to achieve our commitment to de-lever to below 3 times this calendar year. Moving on to slide 10, I'll review the medical segment revenue growth. BD Medical revenues declined 1.1% in the first quarter, in line with our expectations. As expected, first quarter performance in the Medical segment was impacted by the new volume-based procurement process being adopted in certain Chinese provinces, which is specific to our catheter business within our medication delivery solutions portfolio of China. Outside of China, we saw strong growth in our vascular access management portfolio of solutions. In addition, as anticipated, revenues in medication management solutions declined due to limited installations of Alaris pumps. In pharmaceutical systems, strength of over 9% reflects our ability to meet high demand for prefillable syringes as a result of our ongoing investments in capacity as conversion from vials to prefillable devices continues. As expected, diabetes care revenues were about flat compared to the prior year, driven by anticipated pricing pressure in the US and the timing of orders that drove the strong Q4 last year as discussed on our previous earnings call. Now, turning to slide 11 and the BD Life Sciences segment, revenues increased 7.4% in the first quarter. Revenue growth was driven by strong performance in diagnostic systems and biosciences units. Growth in diagnostic systems was brought based across point-of-care, flu, our molecular diagnostic platforms and our microbiology solutions, as well as our woman's health and cancer portfolio. With continue to see over 20% growth in BD MAX and are receiving very positive feedback on our BD COR launch in Europe. Very strong growth in biosciences was driven by licensing revenues and demand for instruments and reagents. This was partially offset by a tough comparison due to the divestiture of the advanced bioprocessing product line during last year's first fiscal quarter. Growth in pre-analytical systems reflects a tough comparison to the prior year when revenues grew 7.6%, driven by additional capacity brought on to meet demand for our pushbutton blood collection sets and the timing of distributor orders. Now, turning to slide 12 and the BD Interventional segment, revenues increased 5% in the first quarter, with mid-single-digit growth across all three business units. Revenue growth in peripheral intervention was broad-based, including performance in our WavelinQ, Covera and Venovo products that continue to perform extremely well. DCB-related revenues was slightly better than planned as the trend we have been seeing since the FDA letter has improved. Excluding the DCB impact, revenues in peripheral intervention grew over 8%. First quarter revenue growth in surgery reflects strong double-digit performance in biosurgery and high single-digit growth in hernia. We saw robust growth across the US, Europe and China. As you may recall, we relaunched Progel last year and are now approaching our historical run rate in sales. Revenue growth in urology and critical care continues to be driven by performance across our acute urology, home care and targeted temperature management business. Moving to slide 13 and our geographic revenues, developed markets grew 2% in the first quarter as growth in the US in the Life Sciences and Interventional segments was partially offset by a decline in the Medical segment as anticipated due to the infusion pump software upgrade, as previously discussed. We also spoke saw strong performance in Europe in vascular care within MDS. Molecular diagnostics, lab automation in women's health and cancer and diagnostic systems and hernia and biosurgery within the surgery unit. Emerging markets revenues grew 5.1% for the first quarter. Performance was driven by nearly double-digit growth in China and the broader Asia-Pacific region. China revenues reflect strong double-digit growth in Life Sciences and Interventional segments as anticipated. The Medical segment's performance in China was also in line with our expectations as strong double-digit growth across MMS, diabetes care and pharmaceutical systems was offset by the impact of volume-based procurement related to peripheral catheters in MDS. As we started the new fiscal year, the situation in China remained fluid. When we provided guidance in November, we told you about a new volume-based procurement process that several provinces had adopted, which was modeled after similar initiatives for generic drugs and other spending categories. While the program covers a wide variety of consumable medical products for BD, it's focus on our $200 million peripheral catheter portfolio within our MDS business. While we anticipated that it would expand, we have now seen volume-based procurement expand at a faster rate. In addition, we are seeing distributors reduce inventory levels in large part due to, and in anticipation of, this new procurement process and we are assuming that will continue. As Tom said, we expect to fully offset the impact at the BDX level. However, as a result of these dynamics, we now expect low-single-digit growth in China for the full fiscal year. Excluding the MDS portfolio, we are seeing high double-digit growth in China and are pleased with our performance in that region. Now, turning to slide 14 which recaps the first quarter income statement. As discussed, revenues grew 2.5%. This includes 80 basis points of pricing pressure, which is in line with our expectations as we had anticipated pricing would be most acute in the first quarter as certain prior-year pricing agreements annualize. For the full fiscal year, we expect pricing to decline approximately 50 basis points to 60 basis points. Moving down the P&L, gross profit grew approximately 3% year-over-year. Gross margin was a solid 56.5%. SSG&A as a percentage of revenue was 26.5%. This reflects additional deferred compensation expense due to strong stock market performance in the quarter. For your reference, deferred compensation expense is fully offset in the other income net line. On an underlying basis, SSG&A expenses grew in line with sales and reflect our ongoing focus on disciplined spending and the achievement of Bard cost synergies. R&D as a percentage of revenues was 6%. For the full fiscal year, we expect to invest $1 billion in R&D which reflects our continued commitment to drive innovation. As a result, operating margins decreased 50 basis points or 40 basis points on a currency neutral basis which is in line with our expectations. Our tax rate was 15.3% in the quarter, in line with our full-year guidance range of 14% to 16%. And as expected, we paid preferred dividends of $38 million in the quarter. As a reminder, the preferred shares will convert in May of this year. Adjusted earnings per share were $2.65 as previously discussed. Now, turning to slide 15 and our gross profit and operating margins for the first quarter. Gross profit margin of 56.5% improved 30 basis points on a performance basis. This reflects our continuous improvement initiatives and cost synergies, partially offset by the impact of pricing. Operating margin of 24% declined 50 basis points in the quarter or 40 basis points on a currency neutral basis. As previously discussed, this was driven by higher deferred compensation expense recorded within SSG&A that is offset below operating income in the other income net line item. Excluding the impact of deferred compensation, operating margins would have increased 40 basis points currency neutral. Currency had a negative impact of 10 basis points on both gross and operating margins in the quarter. Now, moving on to slide 16 and our full fiscal year 2020 revenue and P&L guidance. As you've already heard from Tom, we are revising our revenue growth guidance to 2.5% to 3.5%, specifically due to the Alaris situation. Our updated range reflects several scenarios based on our ongoing conversations with the FDA, with the bottom end of our range assuming a very limited ability to ship Alaris pumps this fiscal year. By segment, for the full year, we now expect BD Medical revenue growth to be about flat. We expect both BD Life Sciences and BD Interventional revenue growth be at the high-end of our previous guidance ranges of 6% to 7% and 5% to 6% respectively. We now anticipate low single-digit growth in developed markets in fiscal 2020. In emerging markets, we now expect mid-single-digit growth, driven by a diversified base of low single-digit growth in China, as previously discussed, and strengthen in EMA. Based on our new guidance for FY 2020, we now expect revenue growth in the second quarter to be approximately 2% and EPS to be between $2.40 and $2.50. This includes an approximately $20 million to $30 million headwind from coronavirus within the quarter. This impact is contemplated within our full-year guidance range. Moving down the P&L, we have updated our gross profit margin, SSG&A and operating margin guidance to reflect the infusion pump impact. Our updated SSG&A and operating margin guidance ranges also include the first quarter impact of deferred compensation. For the full fiscal year, we now expect gross margin to be about flat year-over-year at the midpoint of the range and operating margin to improve approximately 50 basis points on a currency neutral basis. The balance of our P&L guidance expectations for the full fiscal year 2020 remain unchanged. Moving on to slide 17, this reflects our revised EPS guidance for the total year. As you can see, we now expect to deliver adjusted EPS of $11.90 to $12.10, which reflects our latest view on FX and the impact of Alaris pumps. In summary, we delivered a solid first quarter, in line with our expectation. We continue to make good progress on the BD-Bard integration and on bringing to market our robust innovation pipeline, launching 11 new products during the quarter. Moving to the balance of the year, we take the news we delivered today very seriously and we are fully committed to resolving the Alaris situation and returning to our long-standing track record of delivering value to customers, their patients and shareholders. Thanks. And I'd like to now open the call up for Q&A.
Operator:
[Operator Instructions]. Our first question comes from the line of Robbie Marcus with JP Morgan.
Robbie Marcus:
Great, and thanks for taking the question. Maybe we could just start with the pump impact, and help us understand of the $400 million plus or minus that you lowered guidance by, how much exactly is for the pump? Will this linger into fiscal 2021? I'll just ask all my questions here. Maybe as you walk us down through the P&L, it seems like there is a 40% contribution margin hit from that $400 million to the $0.60. Help us get to that number.
Tom Polen:
Hey, Robbie, this is Tom. I'll take the first two questions and then turn it to Chris for your last one. So, of the $400 million, that is essentially pump capital that we're unable to ship. Of course, we have a very large install base in the field. We aren't expecting any meaningful impact on our consumable business there. We actually have seen some increase in consumable demand certainly because of the flu season. And as we mentioned, we stand very strongly behind the quality of the products and its continued usage in delivering 70% of infusions, particularly in the US. Lingering into 2021, what I could say at this point is, look, we know what we need to do to address this situation, and that's to submit the updated 510(k) within Q4, as I shared. So, that's what we're focused on right now. The timing in which we're going to get – we're working collaboratively with the FDA, and I'd say we'll give you updates as that progresses in terms of our ability to open up and resume shipping. So, as we continue that collaboration with the FDA, we'll have more visibility and we'll keep you updated.
Christopher Reidy:
I would just add to provide clarity to the guidance change. Up until the infusion pump issue this week in our meeting with the FDA this week, we were fully planning to reaffirm our guidance for fiscal year 2020. The 2.5% to 3.5% revenue growth guidance assumes essentially, on the low-end, that we sell virtually no pumps. And of our 450-ish kind of US infusion pump business, the range above that would expect the normal range of guidance that we would've had prior to this issue as well as the potential of selling some pumps under medical necessity.
Robbie Marcus:
And so, maybe just quickly, what's the breakdown of how much you're lowering for pump versus coronavirus and for the increased reimbursement?
Christopher Reidy:
So, what I would say is, it's 100% pumps because as you think about the puts and takes that we had this year, we are seeing upside on the flu side. We're seeing better performance in DCBs as we talked about. So, we have some strong performance in the rest of the business. China, outside of the value-based – volume-based procurement is doing extremely well, strong double digits across Interventional and Life Sciences. So, we had some upside. We did take into consideration the acceleration of the volume-based procurement. That stepped up. Just to kind of give you a sense, that's $200 million peripheral catheter business for us. Last quarter, we took it down by about $40 million. We've accelerated that by about $60 million, partly because of accelerations in the province tenders that we are seeing, but even more dramatically, the distributors taking down inventories in anticipation of these tenders. And so, that's an additional $60 million. So, we've taken down an additional $60 million. So, that takes us down to about $100 million left in that business going forward. That $60 million, plus the coronavirus of about $20 million to $30 million, we're offsetting with the strong performance, as I talked about, in other parts of the business. So as I said, going into this week, we had all of that in the mix and would have still reaffirmed our guidance for the year. So, you can think about the takedown as entirely the Alaris pump issue.
Robbie Marcus:
Thanks a lot.
Operator:
Our next question is coming from the line of David Lewis with Morgan Stanley.
David Lewis:
Good morning. Thanks for taking the question. Just wanted to start initially, Tom, if you go back historically and look at the Baxter Colleague recall, that share loss built, Tom, over a series of years. So, do you have any early comments on what can be done to support customers and incentivizing them to wait for resolution? Or how customers are going to evaluate this, buy from another provider or wait decision during this interim ship-hold period?
Tom Polen:
Hey, David. So, what I would say is, of course, customers have been increasingly selecting the Alaris product, as you know, for many years and we've seen that in continued share gains in the category. I would say, going into FY 2020 this year, we've had really – that momentum is continuing to be very, very strong. So, high level of customer engagement and interest, going right up to this point, and continuing to convert to the platform. So, I think people's conviction in terms of they see the value of the product, obviously, not only the power of having one integrated system, but the interoperability ability which we have. We'd expect nearly 90% of all interoperable pumps in the US are BD pumps today. It's a capability that we have that we think is at another level than others are able to offer. And we also, of course, have the integrated medication management solution that connects more broadly. And so, feedback early on is that customers still see that value and will be working to help people as possible to wait for that. Of course, we have a very, very large install base, and that normally takes – we see people upgrade every – let's say, 10 years in general. We see people begin to refresh their fleet. So, we also recognize people have flexibility in terms of do they do that right now or do they wait until we get our updated 510(k) in place. Of course, we'll have a better sense of how fast we'll be able to re-engage with customers as we continue our dialogue with the FDA and as we get that 510(k) updated and submitted. And that's our number one focus right now, is getting that filing done, which will reflect not only the upgrades that we're making right now, but it's going to reflect the changes to the software that have also been made historically, will all be included in this updated 510(k) that we'll be submitting.
Operator:
Our next question is coming from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Hey, guys. Thanks for taking the question. Can you be a little bit more specific here on the steps that are required with respect to submission of the 510(k)? The software upgrades that that you're doing, can you tell us kind of where you are there, why that would take so long to maybe submit sometime in the fourth quarter? It seems like some of these software upgrades were kind of already done and you've got to kind of repackage them? I just want to dig into what specifically did the FDA come in say that they didn't like about your quality systems. What changes do you think you need to make more broadly on the quality system side? Thanks.
Tom Polen:
Yeah. Hey, Brian. It's Tom. So, let me start with your last question and then work our way forward. So, as I mentioned, based on the quality system in our infusion business, we've made software upgrades over time to the Alaris system. And over that period of time, and we're talking – not this year, we're talking a number of years, our quality process determined that those upgrade that we've been making in that business did not require a 510(k) clearance. And so, most recently, on the most recent changes and updates that we've made, we follow that same process and our team determined based on that process that those recent updates in November also did not require an new 510(k) clearance. And so, we released that software improvement in December and we resumed shipping, as we had shared with you last month. Since what we've learned – and as I mentioned, we had a key meeting with the FDA as recently as this Monday. Through our ongoing dialogue with the FDA, we learned that the FDA disagreed with that determination about the need for a new 510(k) clearance for the updated software. And that applies not just to the upgraded software that we're talking about in November, but that decision process that had occurred over time. And so, as I said, we're collaborating with the FDA on their request to combine all the Alaris software enhancements and remediation upgrades with the additional changes made to be Alaris system over time, over years, into a more comprehensive regulatory filing which is going to be submitted this summer. And so, while you're right, we are ready to – we have the information ready for the recent software upgrades, the work that has to take place between now and the submission date is more referenced to the historical changes that have been made over multiple years going back and some additional testing that we need to do on those historic changes to reflect the testing requirements today. So, that's the work that has to be done.
Operator:
Our next question is coming from Bob Hopkins with Bank of America.
Bob Hopkins:
Hi. Thanks for taking the question. And good morning.
Tom Polen:
Good morning.
Bob Hopkins:
Morning. On Alaris, I guess the question I have is a little bit bigger picture. In your view, is this 100% Becton-specific issue with the FDA or is the FDA changing their requirements for pumps broadly? The reason I ask the question is I'm struggling to understand kind of how you got caught off guard and how this went from sort of a software upgrade to something much more significant?
Tom Polen:
Bob, this is Tom. I can't comment on other organizations, but what I can say is that it's not unprecedented where there are situations where over time a product evolves and then the FDA looks and says, wait a minute, your current 510(k) needs to be updated to reflect those series of changes over time. And in this case, there was a process in the business and there's a specific quality process within the infusion business, within the consent decree that the team was following that said, each of those individual changes didn't require a 510(k) process. Again, when the FDA looks back at it over a 5, 10-year period, they say, wait a minute, you actually need to put in a 510(k) given that series of changes that have been made. And that's the exact work that we're doing.
Operator:
Our next question is coming from the line of Kristen Stewart with Barclays.
Kristen Stewart:
Hi. Thanks for taking the question. I guess just to not to beat a dead horse, but on Alaris, I guess once you do submit the software upgrade platform, I guess, in the summer, what would be the timeline that you would expect for this package to be approved by the FDA? And then, what would be your expectation for it to be rolled out to customers? I'm just trying to gauge again, going back to the impact for FY 2021 and, I guess, how should we just think about this in terms of customer waiting on the sidelines and just the degree with medical necessity? How difficult is that for customers to qualify for? Thanks.
Tom Polen:
Yeah. thanks, Kristen, for the question. So, let me answer your last question first. When it comes to medical necessity, we are working collaboratively with the FDA to put in place a process for customers to continue to get access to new Alaris pumps under medical necessity. And that's again as required for medical necessity and that process is getting finalized now. We'll be reviewing that process with the FDA and then providing that to customers. Of course, it is a life sustaining product in many cases and there will be needs for medical necessity pumps, we expect, and we have requests for those now, certainly in house. When it comes to clearance and timing for that, I'd say, of course, we're very focused right now on getting that 510(k) submitted. Clearance timing, we're working again with the FDA. I think it's probably not prudent to speculate until we get the feedback from the FDA. In parallel, though, I would say that the work on the catch-up 510(k) that I've described, we've started that work in full and have momentum well underway. That's why we have a good sense of and confidence in the timing of submission. Thanks, Kristen.
Operator:
Our next question comes from a line of Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys. Thanks for taking the question. Tom, just one on – just trying to go through the math. The $400 million cut to pump revenues, is that assuming no placements at all, pump placements? If the market is $2 billion, I'm just trying to map work here on the impact for the back half there. Or if this is just a software, given you guys are so deep in the connectivity part, on the digital part, this is connected to your Pyxis. Cancustomers purchase an older version of the pump and then upgrade the software once the FDA, I guess, approves the new 510(k)? And related to that, do you think this has any impact on Pyxis at all now because I know you have some bundled up sales going on? Thank you.
Tom Polen:
Hey Vijay. Tom. Thanks for the question. So, we don't expect any impact on Pyxis. We continue to have strong momentum there. And again, we have late stage ongoing discussions with customers who we think many of them will wait for the Alaris product to be able to resume shipping in order to either convert or to upgrade their fleet. Again, we stand by the safety of the products, and so this is a delay in terms of when we can ship new pumps is what we're focused on. By the way, when we ship under medical necessity, we will be shipping, we expect, the prior version of the software, to your question, and we can't ship – I think you had alluded to, can we just go back and ship the prior version of the pump more broadly. And, no, the answer is no, we can't do that. We're limiting shipments of pumps exclusively to that under medical necessity as we work with the FDA. And again, we'll keep you updated as we progress and once we get past the 510(k) submission.
Christopher Reidy:
And I would just say, in response to your first part of your question, just again for clarity, that the low end of our range, the 2.5%, would assume that there are essentially no pumps sold and the entire amount of revenue was taken out. And we would have to assume that there would be – pumps sold under medical necessity would be limited, but the rest of the range up from the low end of the range would account for some sales of pumps under medical necessity, as well as the normal range that we would have in the guidance.
Tom Polen:
As you can imagine, given the situation, we want to be particularly prudent and make sure that, again, as we work collaboratively with the FDA here, we'll know more as those discussions progress.
Operator:
Our next question is coming from the line of Lawrence Keusch with Raymond James.
Lawrence Keusch:
Thanks. Good morning. Just a two-part question here. So, I guess, once you have this new software package cleared by the FDA, I'm curious as to where that puts you relative to overarching FDA desires within the pump space? It's my sense that the FDA has been a little bit frustrated that a lot of the pumps out there really are not up to the standards that they would like. So, I'm trying to get a sense of where this ultimately puts you once you kind of go through the pain of getting this all done. And I guess the second part of the question is, in other areas of the business where there have been software upgrades over time such as Pyxis, have you gone back and had a review there or might you need 510(k) filings there as well? Thank you.
Tom Polen:
Hey, Larry. Thanks for the question. So, in terms of the question regarding the overall pumps, this catch-up 510(k) is going to be extremely comprehensive. And so, to your point, we feel that this will put us actually a good spot in terms of getting full compliance. Again, we're working with the FDA, so that, at the end of the day, once we get this 510(k) established, the new one, we'll be fully meeting the expectations of the FDA and we're having that active dialogue, obviously, understanding their expectations, how our process may have led us to make some different decisions there. But we're getting all of that reflected and put into an FDA that will be completely comprehensive with the latest expectations and requirements. And that's the reason for that submission timeline because we are being prudent and fully comprehensive to the full expectations of the FDA. So, you could say that should put us in a good position going forward. On Pyxis is not a 510(k) approved product. It's not regulated in the same way as it's a dispensing system. So, certainly, on other products in the company, we are assessing that, but it doesn't pertain to Pyxis.
Lawrence Keusch:
Thank you, guys.
Operator:
Our next question comes from the line of Rick Wise from Stifel.
Rick Wise:
Good morning, Tom. Hi Chris.
Tom Polen:
Good morning.
Rick Wise:
Two questions from me and I'll just ask them upfront. I was last night rereading your comments at the BD annual meeting where you very clearly restated/emphasized your goals for a 5% to 6% durable top line growth, I think was your language, and low double-digit bottom line. I guess I'm wondering how you're thinking about those goals today. Two, what impact do we imagine this has on your goal of 50 basis point to 100 basis point annual improvement in operating margin? And last part of this, it's sort of all of a piece. We're all going to have to contemplate what to do with our fiscal 2021 and beyond numbers. I'm sure you're not ready to give guidance. But do we imagine that wherever we end up this year – and obviously, I hope it a little better than you're shaping today. But the longer-term guidance, should we imagine that you'll frame – taking these long-term goals, framing the longer-term outlook off this year or would we imagine, no, fiscal 2021, if all goes well, could be a year of accelerated growth relative to these targets? Thank you.
Christopher Reidy:
So, let me take a shot at that, Rick. Thanks for the question. I'd say that we're only a quarter into this year. So, clearly, it's a little tough to talk about 2021 at this point. This is very recent developments that occurred this week with the FDA which we're addressing. With size of the impact for FY 2020, keep in mind that a big chunk of the revenue base is coming out this year which does create a bit of an easier compare year-over-year. That's not our focus. Our focus is getting through this issue and working with the FDA to get the pumps shipping again. And I think there's nothing about this situation that changes are 5% to 6% double-digit growth going forward, the underlying business is extremely strong and continues to be strong and will continue to be strong. As I said, the only thing taking our guidance down is this issue. We'll get past this issue and be back to that same standard of delivering value going forward.
Operator:
Our next question is coming from the line of Richard Newitter with SVB Leerink.
Richard Newitter:
Thank you for taking the question. I just was curious on the – going back to the China volume-based pricing pressure that you've kind of – took that guide a little bit more conservative based on what you saw between the two quarters. I guess what gives you confidence that this is the right level of headwind to put in there for that issue? And just remind me again, sorry if I missed it, what was contemplated in the full year outlook and what gives you confidence this doesn't kind of become a moving target. Thanks.
Tom Polen:
Richard, let me just start and then I'll turn over to Chris. Certainly, as we've shared, it was just getting started when we gave guidance. It hadn't started really rolling out across the provinces. It was in discussion. Very few of them had at started their processes and others were beginning the dialogue. And so, the pace of that happening and the number of provinces was still uncertain. And we made that very clear, I think, when we shared that at that time. So, we've had another quarter to understand how that's involving and I would say it's evolving a bit faster than we had originally thought it would. Again, we've seen – this has happened in the generic drug industry. So, we have surrogates to see the model, the pace at which it goes and we've also seen some of the tenders now go through in the last quarter and we've been able to see exactly what pricing changes are being finalized in those tenders. And so, now we've been able to say, okay, here's the exact pricing reductions that we're going to see and the number of provinces and we've built that in. As we mentioned, as Chris said, so the $200 million business today in China, again, that's out of a $1.2 billion total China business, it is a significant drop in that $200 million business. We've built that in. At the same time, we are redirecting resources from that portfolio of businesses into some of the areas and opportunities we see in Life Sciences and Interventional and we see some opportunities for acceleration in China in those two. It's not a level to offset fully, as you've heard from Chris, but it's certainly that combined with the increased level of flu testing, DCBs and other areas that are doing better than expected. It offsets it for us across the company, and thus why Chris' comment that the complete change in guidance here is 100% associated with the Alaris pump.
Christopher Reidy:
The only thing I would add to that is that the other thing that we saw as the situation developed is the distributors taking down their inventory levels much quicker than we would have originally anticipated as they saw this issue develop as well. So, a big chunk of that happened since the last time we spoke. And we really see that mostly impacting the second quarter. And so, the biggest hit from that additional $60 million that we took China down will hit us in the second quarter and then moderate somewhat in the third and fourth quarter. But, again, just to kind of go through the math, $200 million business. The last time we spoke, we took it down by $40 million, $200 million being the FY 2019 number. We took it down by $40 million and we're now taking it down an additional $60 million. So, the impact this year across that is $100 million just for that specific item, taking that business down to $100 million going forward. And there will be some spillover into next year, but as you might expect, to a somewhat lesser extent.
Tom Polen:
Richard, maybe just to give you a little bit more color because it can be a little tricky. The comment on the distributors, the way that works – and it has a little bit disproportionate impact in the first year – is of course we're selling, we and other companies in China, we sell our products to distributors who then sell them to the customers. And so, if we've been selling them at a certain price to the distributors and they have a large inventory of those, they see this process now happening and the ability to now – they don't get stuck with a bunch of inventory at a higher price if the market price is going down. And so, they're bringing down their days inventory on hand, both so that they wait to see the pricing of all because they don't have bought at high prices and selling at low, and the other thing is they're looking at who's going to win these tenders becomes more uncertain in this environment. And so, again, they don't want to get stuck with a large amount of inventory and you see the channel then taking down the inventory concurrent with the situation. That's all comprehended in the updated guidance that we've given, but just want to give a little bit more color on why we made the comment on distributors have an impact.
Richard Newitter:
That's really helpful color. Thank you.
Operator:
Our next question is coming from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
Good morning. Thanks for taking the question. Just one the pump and one on DCBs, Tom. So, first, on the pump side, is the consent decree new? I'm sorry if I missed that. And what's the status of your next generation pump? Alaris has, obviously, been very successful, but I think it's been in the market for a while. And I'll just ask my follow-up up now. On the below-the-knee refiling, what's the status there? And how do you think the 12-month data link and the new metanalysis could impact the chances of approval? Thanks for taking the questions.
Tom Polen:
Sure, Larry. I'll take the first question and I'll turn it over to Simon. So, the consent decree, of course, that's been in place from CareFusion at the time of acquisition. That does put certainly heightened regulatory oversight over that business, which also can influence certainly a dialogue with the FDA as well and expectations. And so, that's always been in place. That's nothing new and we're moving forward there. As we think about timing of our next generation pump, we do have a next generation pump in the pipeline. I'd say we – it's progressing well. We certainly don't want to talk about timing of submission of that today. The Alaris pump remains – it certainly is clearly the most preferred product by clinicians across the US and you can see that based on the trajectory over the last several years. And we remain very confident that it will be in a position to continue not only because of the benefits of the product itself, but how it's integrated across a broader medication management suite of solutions. It is very well positioned to be of continued preference going forward. We've got to get this 510(k) catchup submitted, so that we can return to making that available to our customers and for patients. So, Simon, on DCB?
Simon Campion:
Yeah. Good morning. Simon. With respect to the submission on BTK, I would say that we're well advanced in our preparation of that submission and I would say we'll be going into FDA sooner rather than later. So, that's about the size of things on that. And then, with respect to – I think you were asking about the more recent data that was published by Katanos, if you saw the information from Link [ph], a couple of weeks ago where we published three-year safety data, we continue to not see any safety signal with our data. And indeed, despite the limitations of the Katanos 2 paper, I think you will note that the significance with respect to the hand signal [ph] that they were seeing was not – or did not exist when you use a low dose DCB, which is what we have. So, is it going to material the impact FDA? I don't know. But we're well advanced in our preparation for that and the data that we continue to – really supports the safety of our products.
Operator:
Our next question is coming from the line of Matt Taylor with UBS.
Matt Taylor :
Hi. Thank you for taking the question. I just wanted to have two little follow-ups on this Alaris situation. The first is, for the comprehensive 510(k) that you are filing and you guided to the end of the year for that, can you talk about any risks or upside there could be to the timing? How is that progressing? Is that a date you're pretty confident about? Is there any risk that flips or could get pulled forward?
Tom Polen:
Yeah. Thanks, Matt. Again, we just had this – the most recent discussion with the FDA this Monday. So, I don't want to – certainly, we're very focused on – and we're already starting that work on the 510(k). We had had some of that momentum going well before then. But we're going to be in a better position to give you an update on that once we get through it. Our goal right now is to submit and seek clearance as quick as possible and to meet the expectations of the FDA. So, I think it will be premature to speculate on any timing of the clearance process. Thanks.
Matt Taylor :
Assuming that you do file that…
Tom Polen:
Sorry, Matt. I think we lost you.
Christopher Reidy:
We go to the next question.
Operator:
Our next question is from the line of Josh Jennings with Cowen.
Joshua Jennings:
Good morning. Thanks. I was hoping to just ask about the Interventional business. You commented about the paclitaxel drug-coated balloon headwind improving. Any details you can provide just relative to that 50% decline stake that you put in the ground historically? And then, also any details just around the shifting of products from vascular surgery into the peripheral and what those products were and any rationale for that? Thanks a lot for taking the question.
Tom Polen:
Josh, I would let Simon answer that.
Simon Campion:
Yeah. So, Simon here, Josh. I think we've seen a sequential increase in performance here with respect to SSI DCBs. I won't give you the specifics, but it's – I would classify it as a material increase in our performance prior to what we saw in Q3 and Q4 last year. And then, with respect to sales force alignment, we transferred some of our PleurX business which is our drainage catheter business from the surgery business into the peripheral intervention business, and that's simply synergistic with the call points that we have there. We focus heavily on breast biopsy and implantable ports and delivery of chemotherapy. So, taking care of patients at the end of their life in relation to their pre-existing cancer, PleurX is a perfect fit for that sales force. So, that's what we've done.
Tom Polen:
Thank you, Josh.
Operator:
Our next question is coming from the line of Matthew Mishan with KeyBanc.
Matthew Mishan:
Great. Thank you for taking the questions. Just a quick follow-up and then a broader one. Does this also expand to the syringe in the pain pump in addition to the LVP pump? And then, as I think about Becton, I think the broader value proposition in medication management you have in the hospital, on the good side, I think that probably allows customers to be patient as you kind of work through some of these issues, but on the other side of it, would this not also affect the overall conversation or conversion of some of the broader portfolio with some of your customers or is it not related and maybe some delays in the conversion in other areas?
Tom Polen:
Hey, Matthew. Thanks for the question. So, Alaris as a system it includes – it's all one system, right? So, the Alaris system which is – one of the reasons the customers do prefer it so much is that it includes an LVP, the syringe and the PCA. They all snap on as modules that you can choose from based on the patients and the types of medications that the patient requires and the administration route. So, those are all fully in scope and comprehended within the guidance that we gave you an update on. In terms of broader medication management strategy, I think you're exactly right that customers deeply value the full set of solutions there and that that provides an impetus that people want to move in that full direction and not necessarily say I want to just move to having an isolated product that's not helping me manage medications, it's just literally doing a pumping activity and I can't use the data to do things that I can, like how we're using data from pumps and Pyxis and other things to do diversion analytics that you just can't do with other solutions. So, I think you're right there. We don't see at this point impact even as we are doing broader medication management deals. Of course, there's multiple other products as part of that suite of solutions. There's Pyxis, there's Pyxis Logistics, there's Pyxis Prep, there's HealthSight, there's a number of other products. And those products, of course, can still be used with the existing Alaris space. So, there's nothing stopping people from continuing to add those products on as they continue to use their Alaris products and utilize the data coming off of Alaris to be used as part of that full solution. Thank you for the question.
Operator:
Our final question is a follow-up from the line of Kristen Stewart with Barclays.
Kristen Stewart:
Hi. Thanks for taking the question. Just going back to, I guess, China, what's the risk that – I know you're talking about the $200 million business, but just that it continues to spill into other product categories within the broader China business for you. Maybe just talk about the number of provinces that you are seeing and, I guess, just risk that it spreads more broadly within medical products. Thank you.
Tom Polen:
Thanks for the questions, Kristen. I'll turn it over to Alberto to answer that.
Alberto Mas:
Yes. The first thing that I'll say is that we're seeing no evidence of the [indiscernible] procurement applicable to any other category at this moment. The way that we tend to think about it is that there's probably three big variables for you to consider, whether they will consider any new categories that we're in. The first one will be the total spend of that category – is it in the top 10 or in the top 20 spend in the hospitals? And the two biggest parts of portfolio they have left, which is flush and PICCs do not fall into that category. The number of competitors – and again, the other categories within MDS, there's a significantly a less amount of categories. We're talking about a handful versus the peripheral catheters where there are over a dozen, approaching 20 plus small players. And then, the perception of commoditization as well is another factor. We do not think these conditions are necessarily all that applicable today to the other categories.
Tom Polen:
Thank you, Alberto. Thank you, Kristen.
Operator:
There are no further questions at this time. I will now turn the floor back over to Tom Polen for closing remarks.
Tom Polen:
Great, thank you. So, as we close today, I want to reiterate BD's strong commitment to product quality, regulatory compliance and patient safety. You expect it, our customers deserve it and our patients depend on it. While I'm very disappointed that we had to lower our guidance today, I'm also confident that we'll look back on this moment as a catalyst for driving a better BD. Let me assure you that we are taking accountability, we're acting with urgency and we're proceeding with an unwavering commitment to our purpose and the patients we serve. I'm also confident that our broad portfolio, our global reach and our passionate team of associates provide an incredible opportunity to drive long-term growth and enable us to make a bigger impact on customers, patients and shareholders around the world. Thank you.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to BD's Fourth Fiscal Quarter and Full Fiscal Year 2019 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through November 12, 2019, on the Investors webpage of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 5994332. I would like to inform all parties that your lines have been placed on in a listen-only mode until the question-and-answer segment.
Monique Dolecki:
Thank you, Dorothy. Good morning, everyone and thank you for joining us to review our fourth fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our fourth fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Our fourth quarter results include a non-cash charge in the period related to product liability matters of $582 million pertaining to certain legacy Bard surgical products. This item along with the details of purchase accounting and other adjustments can be found in the reconciliations to GAAP measures in the financial schedules in our press release and in the appendix of the Investor Relations slides. A copy of the release including the financial schedules is posted on the bd.com website. As a reminder, to provide additional revenue visibility, we will speak to our fourth quarter and full year 2019 revenue results on a comparable currency neutral basis. The comparable basis includes BD and Bard in the current and prior year periods, and excludes intercompany revenues and revenues associated with divestitures among other adjustments. Before I turn the call over to Vince, we would like to comment on the leadership change that was announced back in September. We are very pleased to have appointed Tom Polen as BD's next CEO effective January 28, 2020. Vince will remain Chairman of the Board upon his retirement as CEO. While the company is energized for our next phase, it is truly bittersweet for all of us, who have worked closely with Vince over the years. He is a wonderful person, who has showed us that the secret to success lies in simple things like hard work, perseverance and having a little fun along the way. We're also excited to announce that our next Analyst Day will be held on May 28 of 2020. Tom and the management team will share our vision and strategy for BD's next era of value creation. So please save the date and look for more information in the coming weeks.
Vince Forlenza:
Thank you, Monique, and good morning, everyone. Before we discuss the company's performance, I would like to spend a few moments reflecting on the previously announced CEO succession. As Monique just mentioned, I will retire as BD’s CEO on January 28 of 2020, while continuing to serve as Chairman of the Board of Directors. The Board has unanimously elected Tom Polen, our current President and COO to succeed in as BD's next CEO and President. Tom's appointment reflects the leadership role he has played developing and implementing BD's strategy and vision. We believe that it is the right time for a leadership transition, given where we are in BD's journey. As we begin the final year of the BD Bard integration, we're looking ahead to our next phase of value creation, including how we leverage the capabilities we’ve built to better serve our customers. You will know Tom well, and we are confident that Tom's vision, energy and drive make him the right leader at the right time to deliver on BD's strategic and cultural evolution. With that, let me turn it over to Tom to say a few words.
Tom Polen :
Thanks, Vince. I've had a privilege to work alongside Vince and to learn from him for more than 15 years. What stands out the most is what an authentic and purpose-driven leader he is. Vince is committed to doing what is right for customers, associates, shareholders and our communities. Vince has led the company during the most transformative period in BD's nearly 125-year history. Under his leadership, BD evolved from what was largely a medical device manufacturer into one of the top five leading companies in med tech today. Vince has made a lasting impact on our team, our company and the entire med tech industry. And for that, we're all grateful. It is an honor to have the opportunity to follow Vince as BD's next CEO, and to lead this company as we prepare for our next phase of growth and impact, while staying true to our purpose and core values.
Vince Forlenza:
Thanks, Tom for your kind words and congratulations again. Now let's move on to Slide 4, and our key achievements for the year. As expected, we finished fiscal year 2019 with very strong underlying performance and momentum across our businesses. For the full year, we grew revenues 5.1%, which includes the impact of DCBs. Revenue growth reflects the planned back half acceleration that we have been discussing with you throughout this year. As expected, growth was broad-based, reflecting the breadth and depth of the portfolio. We also drove approximately 60 basis points of margin expansion and delivered double-digit EPS growth before the impact of currency. And we achieved all of this while overcoming significant headwinds and the impact of divestitures, while continuing to make strategic business investments. At the same time, we are delivering on our Bard commitments. If you turn the Slide 5, I'd like to highlight the value we've already created with the BD plus Bard combination, as we head into the third year of the deal model. We're very pleased with the progress we've made so far. Our core has grown stronger, and we are delivering more impactful solutions to our customers. On an underlying basis, both companies are driving strong revenue growth with legacy Bard growing over 6% and legacy BD growing over 5% creating durable and sustainable top-line growth. Underlying earnings growth has been in the mid-teens. The integration of our two companies and cost and revenue synergy capture are on track. In addition, we are well on our way to quickly reducing our leverage to below 3 times over the three-year deal period. Lastly, Bard has entered BD into higher growth markets that we will continue to leverage and build upon beyond the deal period as we enter our next era of value creation. WavelinQ, Venovo, Covera and PureWick are good examples of products in these new higher growth categories. Before I move on to guidance, I would also like to highlight the great work that has been done in new product innovation across the other segments. They also continue to fuel growth from the new Alaris Pump, Pyxis ES and our HealthSight platform in the Medical segment to our expanded BD MAX menu, BD FACS Research and clinical instruments and continued expansion of our BD Horizon brilliant dyes and Life Sciences, just to name a few.
Chris Reidy:
Thanks, Vince and good morning, everyone. Before I move to Slide 8, I'd also like to take a moment to congratulate Vince on his upcoming retirement as CEO of BD and thank him for his many years of partnership, friendship and wisdom. Under Vince's leadership, BD has transformed into a top five leading med tech company, laying the foundation for our next phase of growth. Vince is known and respected for his deep commitment to our purpose, our culture and the development of our associates. I think it's an understatement to say that you'll be missed by all of us. I'd also like to congratulate Tom on his appointment. I look forward to my continued partnership with Tom as he guides BD through its next phase of growth and value creation, while remaining committed to BD’s purpose and core values.
Vince Forlenza:
Thank you, Chris. Turning to Slide 21 and our planned product launches by segment. As we've been discussing with you, we have a very robust pipeline across the entire company. There are a number of things we're excited about. I'll touch on just a few recent launches here, starting with the BD Medical segment. Early in fiscal year 2020, we expect to launch BD InSyte Autoguard blood control pro, our latest generation of active safety PIV catheters. This catheter adds new features to the world's best selling PIV catheter, which allow a nurse to know that the cannula is in the vein potentially increasing first stick success and ease of use. We are also continuing to build our BD HealthSight platform with new applications as part of our connected medication management strategy. BD HealthSight Clinical Advisor represents the next generation platform and integration of MedMined’s Surveillance Advisor. This application will deliver expanded access to timely patient insights for infection prevention and antimicrobial stewardship. We also look forward to launching the BD Intevia, the 1 ml disposable auto injector, a two-step push on skin device that is designed to effectively and safely inject a variety of drugs of different viscosities and different volumes. This is BD's first device to combine syringe and auto injector technology in a true systems integration approach. Now, moving on to the BD Life Science segment. In fiscal year 2020, we continue to ramp the launch of our BD COR high throughput molecular system, building off of strong interest and excellent feedback from initial placements in Europe. The initial launch includes the BD Onclarity HPV assay for the detection and extended genotyping of HPV. The COR system performs the sample preparation and processing steps necessary to complete molecular assay workflows and decreases manual user interactions. The system is CE-IVD marked and is not yet available for sale in the U.S. or other markets with additional registration requirements. Over the coming years, we plan to continue seeking regulatory authorizations to sell the BD COR systems around the world, while expanding the content menu to include many additional assays for infectious diseases including enteric disease, STIs and viral load. We are also looking forward to a full access launch of the BD FACSymphony S6 high parameter cell sorter, which offers 6-way sorting, and supports the simultaneous analysis of up to 30 parameters, giving researchers the ability to better understand cell phenotypes for immunology and multi-omics research. This will be a unique high parameter sorting solution significantly raising the competitive bar. We will also extend our capabilities on our successful FACSMelody platform with new enhanced 4-way sorting capabilities, broadening the application space. Within the BD Interventional segment, in our Critical Care business, our new Arctic Sun Stat launch will allow us to leverage BD's informatics capabilities that will enable this platform to move from a standalone device to a solution. BD Targeted Temperature Management solution will be the first and only comprehensive TTM solution that is in indicated to treat all appropriate patients from adults to neonates. We're particularly proud of the new guardrail and monitoring features of the Arctic Sun Stat that wirelessly connect to the EMR at the point of care enabling advanced analytics that supports data-driven clinical decision and benchmarking. In our dialysis access platform, we are excited that the WavelinQ product platform, our new innovative solution that provides a minimally invasive non-surgical option for creating critical AV fistulas for patients with end stage kidney disease. We'll launch a next generation device that will continue to facilitate excellent procedural success rates with optimized ability and better connectivity. And in our oncology platform, we are looking forward to launching our Caterpillar embolization device and Elevation breast biopsy device later this year. Before I move on, I would like to point out that we have included slides in the appendix of today's presentation that provide an update on our sustainability initiatives and awards we were proud to have earned during fiscal year 2019. We hope you find the information useful in understanding BD's commitment to these important initiatives. Moving on to Slide 22, I would like to reiterate the key messages from our presentation today. In the year of significant headwinds, we delivered a strong finish to fiscal 2019 in line with our planned second half acceleration. Growth was broad-based across businesses and regions, which reflect the breadth and diversity of our portfolio. The integration of BD and Bard and related costs and revenue synergy capture are on track, and we are confident in delivering on our commitments in the third year of the Bard deal model. And last but certainly not least, I would like to take a moment to thank the 65,000 BD associates around the world, who embody our values and come to work every day to fulfill our purpose to advance the world of health. It's been a great privilege leading a team of such talented associates over the years. As we move forward, I'm excited by the opportunities ahead to continue to build upon our capabilities and invest in our growth-based strategy. I would also like to thank our analysts who provide excellent coverage on the company and our shareholders for choosing to invest in BD. Your partnership and support over the years has helped BD become the company we are today and provides us with the ability to continue to do great things for our customers and their patients around the world. We look forward to sharing more with you at our upcoming Analyst Day in May as we enter the next era of value creation for BD. So thank you. We will now open the call to questions.
Operator:
The floor is now open for questions. . Thank you. So first question is coming from the line of David Lewis with Morgan Stanley.
David Lewis:
First off, Tom, congratulations and Vince thank you for your leadership and value creation. I think Monique got it right with her bittersweet comment. But thank you both.
Vince Forlenza:
Thank you very much.
David Lewis:
And then just two quick questions from me and I'll ask them both here in the interest of speeding things along. One for Chris and maybe one for Tom really centering on 2020. So Chris, just first off, EPS a little below the street. We discussed the impact of FX at our conference a few months ago. I'm kind of curious on your philosophy this year, is it fair to say that the 250 basis points embeds some cushion for FX volatility across the year, given the experience this prior year? And then for Tom, 5% to 5.5% is a little tighter than normal. So how should investors interpret that range relative to the deal model of a 5% to 6%? And what are some of the key tailwinds or headwinds to consider this year? Thanks so much. Nice quarter.
Chris Reidy:
Thanks very much, David, and thanks for your nice remarks. The -- on FX, you're right that at your conference, we did talk about the volatility of FX. And we were indicating that we weren't going to chase that because we do have underlying growth of 15.5% to 17%. And we didn't want to damage lack of investments that drives revenue growth in the future. And so as a result, we wouldn't chase it. And we were seeing volatility that was getting worse. And we indicated it was about 200 basis points back in September. Since then we've actually seen a little bit of a worsening. It's come back more recently. But on a 30 day average, it certainly has gotten a bit worse with the volatility in currencies like the yuan and the pound with Brexit. So, we see a lot of volatility in those currencies. And so our estimate for the year of $250 does take into consideration there might be a little bit of movement over the course of the year. And we don't want to be chasing that within our guidance range. So we did take that into account in the guidance range that we gave. But right now as we see it, it's in that 200 basis point to 250 basis point area. And again, we're very committed to driving that 15.5% to 17% underlying and to do any more than that we think wouldn't be prudent.
Tom Polen:
Hey David and thank you again also for your kind comments. Regarding our range, so certainly the deal model is very much intact. We are within that 5% to 6% range. And as we had shared in the past, of course, we're annualizing the impact of DCBs and we also have assumed no BTK approval within the year. And so we think about it as we -- the -- if DCB stay at the level that they are today, so no improvement in DCBs, and no BTK approval, we would be at the bottom half of the 5% to 6% range. And if we were to get a BTK approval, or we see a notable improvement in the DCB run rate, we could end up moving above that. But at this point, we are making the assumption that its status quo on DCBs and we have not included BTK within our guidance. Therefore, we thought it was appropriate to tighten the range to the bottom half.
Operator:
Our next question is coming from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Hi, good morning. Vince, congrats on the retirement. I hope you stay in touch and can meet up at The Stone Pony for a beer, go see Bruce again. And, Tom, congrats to you. I look forward to our first Springsteen experience together so.
Vince Forlenza:
Hey, Brian. Just before you go on, just send me the date. I’ll be there.
Tom Polen:
And I’ll provide the beers.
Brian Weinstein :
Deal. As far as Medical goes, I wanted to ask you a little bit there. Can you talk about the cadence given some of the timing things that we typically see in Medical as well as the comps that we're going to be coming up against, and also the China commentary? So it sounds like there's a lot of things to kind of consider as it relates to Medical. And then the guide in total looks to be a little bit below trend over the last couple of years, from what we've seen out of the Medical segment. So anything to be aware of, or any kind of color that you can give us by product category that would inform and kind of what you guys are thinking there? Thanks so much.
Tom Polen:
Okay. Hey, Brian, this is Tom. I certainly very much look forward to continuing that tradition, even Vince had started there so. Yes, as we think about BD Medical, as we noted, FY ‘19 we saw 5.1% growth for the full year. We noted in our comments earlier. We have seen some pressure specifically within really MDS China related to pricing on some of the very basic medical devices that we sell there. And so we've reduced the guidance then to 4% to 5%. So just a slight reduction versus the actual that we saw in FY ‘19, reflecting that observation that we've made. And that's really the only thing. We continue to see very strong performance in MMS through FY ‘19 as well as Pharm Systems for the year -- in FY ‘20, sorry.
Operator:
Our next question is coming from the line of Kristen Stewart with Barclays.
Kristen Stewart:
Hey, guys. Feeling kind of left out without the Springsteen invite here.
Tom Polen:
Sure, Brian would expand it.
Kristen Stewart:
And maybe we can all go to a Giants game or something, I don’t know.
Vince Forlenza:
After last night, I don't know where they’ve been.
Kristen Stewart:
I know, and they’re looking for you to have this season. But anyway, I was wondering if you could just kind of talk to your updated thoughts kind of on capital deployment. You're making some pretty good progress on paying down the debt and kind of getting close or making your way towards getting down to that 3 times levered number that you've kind of said rating agency. How are you just thinking about the model, as you look ahead? And Tom, how are you thinking about it? And Vince, thanks for all the years and Tom congratulations as well, as you take on over.
Chris Reidy:
Great. Kristen, this is Chris. So I'll take that question. And we're going to give a lot more specificity to that very question at the Analyst Meeting in May and we look forward to that. But I would point you back to this past January, where I did give a little bit of color on that at a conference. And so as we think about coming to the 3 times leverage, and to be clear, that was the commitment we had, we would expect to float that down to the kind of the mid 2s, mid to low 2s over time, befitting a company like ours that we should be, strong balance sheet and be in the zone. So the 3 times was just a commitment to the rating agencies to do that in three years. But we would expect to float below that. The good news is we throw off a lot of cash. And so we often think about the $6 billion of debt that we repaid over the last couple of years or three years. But as we look at ‘21 to ‘23, between that cash as well as the additional earnings growth that we have, over that three year period we'll have about $11 billion with some basic assumptions to allocate once we've done with dividends and CapEx. So it's a high class problem to have. And so as we think about allocating that, I think it gives us room to do a number of things. First and foremost, we will look at the M&A and tuck-in acquisition and we've talked about how we're not interested in doing another big deal, we've been very public about that. So this would be an acceleration in tuck-in acquisitions. And some of the investments we've made, particularly the Bard transaction opens up opportunities for us in those areas, as well as in Life Sciences and Medical. So we see lots of opportunities. And over these last couple years, we've done some very good acquisitions. But they've been limited. So we expect to expand that. And then we still believe that there will be money left over from that $11 billion to buy back shares and that'll be part of the model on a yearly basis. We're committed to not letting the cash build up on our balance sheet. So it's a combination of those two areas, I think. And the underlying dividend, I think the payout ratio is about right, might be some tweaking there. We will be thinking more and talking to people about that. But I think it's in the right zone. And again, we talked about our CapEx, we’re in the right zone with CapEx. You see it's increasing a little bit this year from $900 million to $1 billion. I think that's about right. I don't think there's a lot of movement there. So that gives you a little bit of a sense, but more to come with some specificity in May.
Operator:
Our next question is coming from the line of Bob Hopkins with Bank of America.
Bob Hopkins:
And definitely best of luck to Vince and Tom. I was just wondering if I could just get a quick commentary from you guys on two topics. One was just any update on the BTK regulatory filing, is it kind of just in the FDA’s hands or is there still more back and forth? And then I was also wondering if you could just drill down a little bit more on China price pressure, like what product specifically, what percentage of total China does that represent? And how does that impact the growth guidance for China overall that’s embedded in your guidance for this upcoming fiscal year? Thank you very much.
Vince Forlenza:
Right. So we'll start with Simon and I will talk about BTK and then Tom will talk a little bit about China.
Simon Campion:
Good morning, Bob. Simon here. So on BTK, as we commented last time, we were going to have an interactive session with the FDA. That has taken place. We're currently going through an available data set that we have on BTK. And over the next couple of months, we would expect to file that data with FDA. This is an active PMA. So we continue to work on it and continue to interact with FDA and we’d expect in the next couple of months to be able to file something.
Tom Polen:
Hi, Bob. This is Tom. Just a quick note, as we mentioned earlier, we do expect continued strong double-digit growth in both Life Sciences and the Interventional segment in China. And so as you indicated, the topic we see in China is specifically concentrated in Medical and even more specifically we see within the MDS business. And so let me turn it over to Alberto to answer your question in a bit more detail.
Alberto Mas:
Yes, I think it's important to put this in overall context for the Chinese government and then authorities have tried a few initiatives in the past to control healthcare expenditure. Frankly with mixed results, this is their latest version of trying that. They're calling it a value-based purchasing and tendering process. This new process significantly overweighs the price component, hence the pricing pressure that we're seeing. We're seeing this playing out in MDS basic products, not necessarily in broader categories. So in Q4 we’ve seen some selected cities and provinces introducing this new tendering system. And we're expecting continued impact in fiscal year '20 as Chris and Tom have already highlighted. So we've been prudent and we're moderating our growth in MDS, specifically in MDS basic products categories in China somewhat.
Vince Forlenza:
Yes. So to be clear, it's not a national program at this point. It's actually a couple of provinces with some cities experimenting. And we'll have to see how this works. We've seen this happen in other geographies around the world. It has not played out very well for the governments because of the lack of focus on quality. So we'll see what happens here. And we'll keep you informed.
Operator:
Our next question comes from a line of Rick Wise with Stifel.
Rick Wise:
And Vince, it's been just a pleasure knowing you all these years. Let me start with the new product pipeline. I mean clearly a couple of years you are spending roughly $1 billion on R&D. I'm just curious maybe, Tom, as you're reflecting on that R&D spend, what are your top priorities as you look ahead? And maybe highlight for us if you could, just as part of that, the products you'd have focus on most that have the most growth potential as we look at the fiscal year ahead?
Tom Polen:
Hey, Rick, this is Tom , and thanks for the question. So as we think about R&D, obviously, you heard Vince walk through quite a wide and diverse range of the portfolio. And so as we think about specific products, I wouldn't extend those beyond the list that, that actually Vince went through in the script and as is described in our slides. So I won’t iterate those again. I would just say as we think internally and our focus on the portfolio, obviously we continue to strengthen the moats in the core businesses in which we participate. And we're very focused on continuing to shift our portfolio into higher growth sectors and we look to combine really the focus in those two areas as to how we direct our investments going forward.
Rick Wise:
Just again thinking about the guidance for this next year -- I don't want to overdwell on the flu season, but obviously, this year was kind of tough comp, the year just ended. Any early thoughts on flu season assumptions? And what's in your model at this point? And would that -- if that’s also potentially depending on the severity of the season, maybe potentially some upside to the numbers?
Vince Forlenza:
Sure, Rick. So the assumption is for a normal flu season, which is essentially what we had this past year in 2019. So we don't expect the same unfavorable compare we had in 2019. So that's our assumption. It's really way too early to tell as it is always this time of year. Some indication of some severity of flu season in Australia, et cetera. But that doesn't always play out here. So it's way too early to tell. And within the guidance range, yes, if it's a severe flu season, that would bump us up in the guidance range. And if it was significantly weaker than a normal flu season, it could take you down. And we're talking probably 30 basis points of revenue on either side of that, 20 basis points to 30 basis points at this point. And so that's kind of the way we think about it. And very similar to the way we think about it in the first quarter every year.
Operator:
Our next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar:
Vince, congrats on a successful career. Wish you the best in your next phase of life. And maybe starting with the quarterly cadence here, Chris. On I guess the Q1 impact on MMS. I think you mentioned software changes. And I think your main competitor is talking about roll out of new platform. Can you maybe just talk about the competitive dynamics and whether the software rollout, whether that's just first quarter phenomena or -- usually when I hear software, I think about integration issues. So just maybe give some color on what's changing there?
Chris Reidy:
Sure, Vijay. So I'm going to get started on that. We did say that we expect revenue growth to be between 1% and 2%. And one of the drivers of that is the timing of the upgrades in the Alaris Pump software, which I'll have Tom talk about in a moment. But you also have the tough compare on the DCB impact that you get the full brunt in the first quarter. And then a tough compare in Pharm Systems, which grew extremely well in the first quarter of FY '19. So you’ve a little bit of that China MDS impact that we've referred to. We also expect Diabetes Care growth to be flat in the first quarter. And pricing is most acute in Q1. Having said that, despite the 1% to 2% growth in the first quarter, we expect the first half to be relatively close to guidance of within 100 basis points. So you kind of have the similar split between first half and second half that you had in '19, driven by a number of those factors. So for a little bit more color on the Alaris Pump upgrades, I'll turn it over to Tom.
Tom Polen :
Hey, Vijay. So just a note, as you know Alaris is the clear leader and product choice in not only the infusion market but also as part of a broader Medication Management Solution that our customers are investing in. And it's part of our process and our strategy in the business to continually iterate and make enhancements to the platform. And so, you've seen us do that certainly on the hardware side with significant investments such as the new Alaris M2 pump launch which has been extremely well received by our customers. And we've been making those same type of investments in software upgrades over the last couple of years. And this upgrade right here is a continued reflection on those investments and will be forthcoming. Just in terms of momentum, maybe just one other comment there on your question. We saw in FY'19 near or at I’d say record levels of continued share gain, both in the infusion and the dispensing business. So about 200 basis points of gain in infusion and 100 basis points in dispensing. And we see no slowdown in that momentum.
Vijay Kumar:
That's helpful Tom and Chris one quick housekeeping on share count. From my understanding May 1 is when it steps up, the conversion kicks in. It just looks like the 287 million maybe it's a tad higher than that, what the street was expecting. Maybe some comment on share count?
Chris Reidy:
Yes, so that's -- we did give that guidance in the script as the 287 million. We don't think that the conversion of the preferred dividends is going to be that meaningful. And obviously we issue some stock comp that would naturally float it up since we're not in a position to buy back shares at this point. And so you see a natural floating up of that. I think it's a combination of all those things that get to, to the 287 million. But we can certainly talk to you after the call if you have any further questions.
Operator:
Our next question comes from our line of Lawrence Keusch with Raymond James.
John Hsu:
Good morning. This is John Hsu on for Larry. Tom, if we can start maybe, in the prepared comments since you mentioned the strategic and cultural transformation, can you talk about what you're seeing happening from a cultural perspective?
Tom Polen:
Sure, certainly, John good question. From a cultural perspective, we've been very focused on continuing our focus on growth and innovation. And we've been talking about that quite a bit. As we've gotten larger, so quickly, we've also been very focused on agility and removing complexity from the organization and our processes. We think that -- and that fits right aligned with some of the actions that we're also building into our business strategy, as Chris mentioned, our focus on -- and plan not to do another large transformational M&A deal, fits with our focus on continuing to transform our culture from an agility perspective as we simplify and remove complexity from the organization in our next phase. And we will share more about not only those strategies, but our focus on culture and you'll see it actually more in action at the Analyst Day that Monique announced that we’ll have later on in FY '20 in May.
Vince Forlenza:
Yes, I would just add that Tom and I've been working on this. And I think it is a natural next step based on all the things that we've done. And as Tom and Chris and others are really looking at the next step of value creation, as Tom just mentioned, there's a lot of work going on, not just on synergies, but on business process. And that gets to both the agility that Tom was talking about, but empowerment of people with those new systems, aligning with the big efforts that we started year and a half ago around customer experience. So Tom is pulling this together in a really nice way is what I would say. And I think the company is getting very excited about it. So I'm looking forward to see how this rolls out.
John Hsu:
Okay, great. And then just on the Bard synergies, those are tracking to plan. If we look back to CareFusion, you clearly were able to outperform the initial guidance there. Can you just talk about maybe the confidence that you have in the $100 million remaining synergies. And then is there any potential for upside to those numbers?
Chris Reidy:
Well, you're right, we did beat the CareFusion synergies, I think when we learned a lot when we did that and I think we assessed the Bard synergies more accurately. Having said that, we've already seen upside to what we initially announced, and that's on the tax side. So, we didn't promise any tax synergies as part of the deal. And we certainly have seen those. And that's enabled us to offset some other headwinds. As I look at it, we are very confident in this $100 million that I referred to, as the final phase. I don't see too much potential to raise that significantly. We will see that as we go through throughout the year. But executing that I would remind people that when we did the Bart deal, people were saying, how are you going to get any synergies at all, it was a well run company. So I think getting $300 million in the three years is quite an achievement. And then on top of that is the revenue synergies which we're seeing in the business and you're seeing in the results. So when you think about what we're driving on the Bard deal, the top-line growth of 5% to 6%, what we've seen in the last two years is that the combined company drives about 5.8% over those two years, legacy Bard driving 6.2% and legacy BD driving 5.6%. So a lot of revenue growth, some of that coming from the synergies as well. So we really feel good about what we're accomplishing right in line with our expectations.
Operator:
Our next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
And congratulations to Tom and Vince. Two questions from me, one high level for Tom and one on sterilization. So, Tom you're going to step into the CE role in January. I know it's early, but what changes can we expect under your leadership? And then secondly, on sterilization, I'll ask both my questions upfront here. I think the shutdown in Georgia is supposed to end tomorrow. Could you give us an update on where you are with the remediation, your confidence in resuming production? And just lastly, I think, in the press release you put out, you said you expect to operate at a reduced capacity. How long do you expect that process to last?
Tom Polen:
Hey, Larry, this is Tom, thank you for the comments and the questions. So as you know, Vince and I have worked together for quite some time, 15 plus years, and have been on the journey that BD has been on together. And so as we think about the next phase for the company, I would say that while we'll share more of that, of course, in upcoming forums, you can expect very much a continuation of the journey that we're on. There is a natural of course inflection as we come to the end of the Bard integration window, whereas we now realize the full cost synergies. We, of course, will be freeing up capital to create value in other ways, as you heard Chris walk through. And so we will be contemplating what is a natural inflection in our strategic cycle, refreshing that but continuing very much in line with I think what has made BD a attractive place for investors, that bellwether performance, the dynamics of the company, and building off of the new capabilities, technologies and assets that the company has built over particularly the last seven years under Vince's leadership and moving those forward into the next phase of growth.
Vince Forlenza:
So let me just comment on EtO, it's November the 7th that we get back to production. Well, we're producing, we're not sterilizing. And just to make sure you understand it was voluntary, so that they could do some ambient air testing and that will get done and then we'll go back to producing. Going forward, what we're talking about is we've made some process changes to further optimize eliminating fugitive emissions. We think that with those changes, we can meet all customer demand going forward. And we'll just continue to optimize. So we're not sitting here saying that we're not going to be able to meet customer demand. We're very confident that we can do that. So that's the way you should think about it.
Operator:
Our next question comes from the Bill Quirk with Piper Jaffray.
Bill Quirk:
Vince, great ride. And certainly thank you for everything. And Tom congratulations on the new role. So Chris, I hate to come back to China and pricing, but I just want to confirm that the guidance assumes it does continue into '20 kind of beyond what you've already experienced at the city or province level? And then secondly, congrats on the initial BD COR release in EU. When might we see that in the U.S.? Thanks guys.
Vince Forlenza:
So I'll start Bill, and you're right, we do have that baked into our guidance for the year that it would continue. As you might expect, the provinces are very transparent on the kinds of pricing results that they're getting. We do expect that at some point they will experience some issues related to quality and that might change things. But right now it’s very much focused, as Alberto said on pricing as a component of the tenders. So we do expect some of that to continue throughout the year and our guidance has that baked in.
Alberto Mas:
Let me briefly comment on BD COR. As you know, we launched this product mid of 2019 in Europe. It's now CE marked and available in European selected markets. We will continue to extend that into CE marked regions and target towards the end of 2020, maybe beginning of '21. That depends on the regulatory process to make it available in the U.S. as well. So we are really excited about this momentum we’re seeing the customer demand in Europe, and also the customer feedback we're seeing. So we work very diligently on releasing it in the other regions as soon as possible.
Operator:
Our next question comes from the line of Matt Taylor with UBS.
Matt Taylor:
So I just wanted to ask a little bit more about the DCB dynamics. You touched on this a couple times on the call. But have you seen any change since the FDA’s second memo in August in terms of any pickup, there's been some more data has come out? What do you think would have to happen to actually improve the trajectory of the existing core DCB business? That’s my first question.
Simon Campion:
So, good morning, Matt. It’s Simon here. So yes, in relation to the second letter that FDA pushed out in August, I think it's fair to say that we certainly didn't see any initial uptake or decline in DCB utilization. But then in late September, as you may know, the independent analysis of the Lutonix data was published in JACC, I think it was September 28. And the response so far to that data has been quite favorable for us. We’ve obviously trained all our sales forces on that and they've been pushing that message to our customers that Lutonix DCB is not only effective but it's also safe. So, I would say that we are quite pleased with the response the market has shown in that regard, but qualify that it's only one month ago. So it's very early, but we're quite pleased with that. And I think then to your second -- to your more -- maybe more macro question about probably what it will take to really shift this market back to where it is, I think that quite frankly is a resending of the FDA letter, that’s required to get it back to where it was.
Matt Taylor:
And just a clarification on the BTK comments before. You mentioned that you expect you might be able to see a filing at some point next calendar year. Would that be something that could create kind of a normal filing timeline or would it be different given the fact pattern here? Just help us under understand that.
Simon Campion:
It would be a normal filing cadence. It would be a PMA supplement. So it would be probably within the typical 180-day plus range. So that's the usual method FDA would take to assess that.
Operator:
Our next question comes from a line of Robbie Marcus with JP Morgan.
Robbie Marcus:
It's been two years now where you've had great underlying EPS growth, but single-digit reported EPS growth. I was wondering if you could talk philosophically about your commitment to double-digit EPS growth? And are there any levers you can pull throughout the year to get you back up to double-digit?
Chris Reidy:
Sure, Robbie. So I think, when you look at the headwinds that we've had in this past year, we tend to forget that there was 600 basis points of pressure from FX. And to jump over 600 basis points would be not prudent in terms of running a long-term business. Now, we always do try to jump over some portion of the FX and we’ve had a good track record of being able to do that. And so, we -- when we look at the guidance going forward, we would expect to have 100 basis points. But at some point, you would expect that those headwinds from FX to not be 600 basis points or not to be 250 basis points even. So, as we think about it, we'll jump over some of it as we did in the fourth quarter and the second half of the year. As bad as it was, it was worse than we had anticipated. It kept getting worse. The volatility of the yuan, the euro weakness and the dollar strength and then the volatility of the pound, all of those things were driving the strength of the dollar. And so we jumped over that in the second half of this year. And we don't talk too much about that. As we look at the guidance for this year, we have another big issue to deal with and that's a drop off of the Gore royalty, and that's 500 basis points. And so, if you take that and the 250 basis points, we’re jumping over -- we're dealing with 750 basis points of pressure that is not part of the underlying business. And I would say our ability to offset that Gore royalty was better than it would have been on a standalone Bard basis. It would have been very difficult to offset any of that. And we were able to offset a very good portion of that. So we feel good about the ability to jump over headwinds. There have been more than our share of headwinds in the past. We don't see that once we get through the Gore royalty. We don't see a lot of that going forward. It goes kind of back to normal. And we do have a business that is on an underlying basis, very reliable, very predictable. Tom talked about the nature of our business as having the kind of moats around our business, strong product lines, and an excellence in manufacturing. And then we also will have the ability to buy back some shares in the future as we pay down the debt. And we've been dealing with those headwinds without the ability to do that over the last couple of years. And so we have that lever back in our arsenal as we go forward. And that will be very helpful as well. So we're, I believe, coming to a point where some of this will be behind us and we go back to being the predictable BD that we've always been. So, thanks for your questions.
Robbie Marcus:
Understood. And then a quick follow-up. I'm going to sneak two very quick ones in here. One was there any extra selling day in the quarter and two the Urology business continues to exceed expectations. Can you just talk about the drivers and sustainability there? Thanks.
Vince Forlenza:
On the first, we don't make a habit of talking about days, some companies do. It all evens out. So nothing to speak of there. And on Urology, that's a great point. We very rarely talk about things like 9.9% growth in the quarter and so I'll pass that over to Simon.
Simon Campion :
Yes. So again, Urology has been a sustainable performer. This year we've seen sequential growth in a number of our businesses, particularly TTM and the acute Urology business. So it continues to inspire us with confidence. We've got a cadence of new product launches that will come out across the entire Urology business in the next year. So that's just another leg on the legacy BDI stool. So we're very pleased with it.
Operator:
Our final question comes from the line of Richard Newitter with SVB Leerink.
Jaime Morgan:
Hi, this is Jaime on for Rich. Thanks for taking my questions. Just had one quick question since most of them have already been asked. What is your strategy on the Diabetes business going forward? I know last call you had mentioned you were evaluating your strategic options for the T2 Patch Pumps. So I was just looking to see if you could provide an update for us there. Thanks.
Tom Polen:
Hi, Jamie. This is Tom. Thanks for the question. We are continuing to advance the patch pump in our pipeline. We did, as we had mentioned on a prior call withdraw our FDA application after getting feedback from them. That was a bit more comprehensive than what we had anticipated. And so as we also shared on the last call, we are now progressing that primarily with a third party R&D partner with deep expertise in that space, but we are progressing that forward. As that continues to advance in our pipeline, we'll share an update on that as it ends up approaching closer to launch. Thank you.
Operator:
There are no further questions at this time. I will turn the floor back over to Vince Forlenza for closing remarks.
Vince Forlenza:
Thank you very much. Let me start with saying we had strong performance to close our Fiscal Year 2019. It was broad based. It was all three legs of our stool. All three segments performed really, really well with great momentum going into this year. Entering fiscal 2020 in the final year of the Bard deal, we're confident that we will continue to deliver on our commitments. And I think you'll hear more about in May, Tom's vision and the company's vision in terms of how we continue to drive shareholder value. I'm looking forward to that. And then finally, I'd like to say once again thank you to all of you, the investors, the analysts who have been with us on this exciting journey and I'm confident that the company is positioned well for continued success. So thank you very much and greatly appreciate it.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to the BD's Third Fiscal Quarter 2019 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 13, 2019, on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 1475284. I would like to inform all parties that your lines have been placed in a listen-only mode until the question and answer segment.
Monique Dolecki:
Thank you, Lori. Good morning, everyone and thank you for joining us to review our third fiscal quarter results. As we have referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make Forward-Looking Statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Reconciliations to the GAAP measures that include the detail of purchase accounting and other adjustments can be found in our press release and its related financial schedules and in the appendix of the investor relations slides. A copy of the release, including the financial schedules, is posted on the bd.com website. As a reminder to provide additional revenue visibility, we will speak to our fiscal 2019 third quarter revenue results and fiscal 2019 revenue guidance on a comparable currency neutral basis. The comparable basis includes BD and Bard in the current and prior year periods, and excludes intercompany revenues and revenues associated with divestitures among other adjustments. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, President and Chief Operating Officer; Alberto Mas, Executive Vice President and President of the Medical segment; Simon Campion, Executive Vice President and President of the Interventional segment; and Patrick Kaltenbach, Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vince Forlenza:
Thank you, Monique, and good morning, everyone. At BD, our strategy is driven by our purpose advancing the world of health. Our results this quarter demonstrate that our strategy is working and our core remains strong. Our progress with Bard is enabling us to deliver even more impactful comprehensive solutions for our customers. Turning to Slide 5 and our third quarter highlights. Our third quarter performance was strong, revenue growth reflects the plan back half acceleration that we have been discussing with you throughout the year. As expected, growth was broad-based and we drove mid-single-digit growth in all three segments.
Christopher Reidy:
Thanks, Vince and good morning everyone. Moving on to Slide 7, I will review our third quarter revenue and EPS results as well as the key financial highlights. Third quarter revenues grew 5.7% on a comparable currency neutral basis. As Vince mentioned, our strong third quarter revenue growth was broad-based and is a strong indicator of the health of the business. As we have discussed previously, there are a number of drivers across our segments that gave us confidence in our planned second half acceleration. I will provide more color on the third quarter revenue growth in a moment when I take you through the results by segment and geography. EPS is also in-line with our previously communicated expectations for the quarter. Despite significant FX headwinds in the quarter, we delivered adjusted EPS at $3.08 crossing the $3 per share mark for the first time since closing the Bard acquisition. On a currency neutral basis, EPS grew 14.8%. We also continue to delever during the third quarter, paying down approximately $450 million of debt. Gross leverage was 3.7 times as of June 30th and we remain on-track to achieve our commitment to delever to below three times over three years. Moving on to Slide 8. I will review our medical segment revenue growth. BD Medical’s third quarter revenues increased 6%. As expected performance in the medical segment was driven by continued momentum and share gains in Medication Management Solutions and strength and pharmaceutical systems. In addition, growth and medication delivery solutions normalized as anticipated and was driven by our leading vascular access portfolio, which also reflects our revenue synergy investments. Growth in Diabetes Care was aligned with our expectations driven by strength in emerging markets.
Vincent Forlenza:
Thank you, Chris. Turning to Slide 19 in our planned product launches by segment. As we had been discussing with you, we have a very robust pipeline across the Company. There are a number of things we are excited about. I will touch on just a few recent launches here. Starting with the BD medical segments. In May, we launched the BD Pyxis ES System version 1.6, which brings software enhancements achieved through upgrades to the core ES software, as well as through system integration of three technologies. BD Pyxis ES Refrigerator, BD Pyxis Track and Deliver and BD HealthSight Data Manager. These enhancements improve clinical workflow efficiency, pharmacy flexibility and end-to-end medication safety. Regarding our health site platform, feedback from customers continues to be very positive and we are gaining traction across our applications. Before we move on to our Life Science segment, I would like to discuss the Type 2 insulin Patch Pump. As we discussed on our call last quarter, the feedback we received from the FDA was more comprehensive than we had anticipated. Based on this feedback and given the intricacies of this product category, we have decided to withdraw our FDA application and have engaged a third-party R&D partner with expertise in this space, while we work through our strategic options. As a result, our previous timeline has been extended and we will provide you with additional information as we make progress. Moving on to the BD Life Science segment. We are excited by the recent launch of BD COR, our new high throughput molecular diagnostics platform aimed at providing automation of molecular testing in core and other large centralized labs. Early customer interest and placement of our BD COR units are exceeding our expectations. We also continue to see strong growth on the BD MAX platform supported by the commercial success of recently introduced assays such as the BT MAX Vaginal Panel, as well as our Enteric Panel suite.
Operator:
The floor is now open for questions. Our first question comes from the line of Kristen Stewart of Barclays.
KristenStewart:
Hey good morning everybody.
VincentForlenza:
Good morning Kristen.
ChristopherReidy:
KristenStewart:
So I guess, just want to kind of start off with just kind of longer term expectations. I can appreciate that you guys probably don't want to give any specific color around 2020 and guidance in that respect. But having into the call I think 2020 outlook was definitely one of investor's top concerns and given the update on Lutonix below the knee and it not being approvable I think that is only to kind of increase the concerns on the street. So I was wondering, if you could just maybe help provide your thoughts on puts and takes for how we should think about fiscal year 2020. I know that you had talked about the deal model being in kind of mid-teens growth. Obviously, there has been some changes with the Lutonix, but also Gore royalty is just how should we think about that in the year ahead and the puts and takes? Thanks.
VinceForlenza:
So Kristen, thanks very much for the question. I have to say. We are not surprised to get the question on surprises, you have to write off if that. But let's get it on the table. We are making good progress and 2020 is what I want you to know and everyone to know. We are making good progress on the budget. We are a little early on, we are not finished yet. But with knowing that we had a Gore royalty going away, we started this process earlier. And I feel really good about the process that we are running and the progress we are making there. So with that, I'm going to turn it over to Chris, he is going to give you a little more detail. We are not going to completely guide today. But we will give you a good sense of the progress we are making.
ChristopherReidy:
Sure. Thank Vince and good morning Kristen. You know you are right, it's too early to give a level of precision to guidance for the next year, there will be some things that we are watching. But what I would say is that the message essentially remains the same as last quarter with the one exception being BTK. But if you think about it on the revenue side, we still expect to drive 5% to 6% growth for 2020. Despite the DCB status quo and the BTK delay, so we will still be able to drive that 5% to 6%. And then on EPS, at worse the BTK impact even if we don't have it for the full-year is about 1%. And we would intend to mitigate as much of that as possible. A little bit of pressure on FX, but we will watch that. But despite all of this, barring anything that unforeseen changes from here. We are very confident in our ability to deliver double-digit earnings growth next year. Where we are in that double-digit will depend on things that transpire between the next couple of months. So, but we feel good with that floor of double-digits. And we will see where BTK plays out where FX goes. But everything else is pretty consistent with what we have said before.
VinceForlenza:
So all-in-all good progress, and maybe I will just ask Simon to comment. Simon you know, you are having some really good performance on some new products that give us this confidence on the 5% to 6%. So maybe you want to talk about some of the other products that are off setting some of these things in the DCB area.
SimonCampion:
Sure Vice. So I think Chris already on the statements mentioned Venovo and Covera and WavelinQ within the PI business. And I'm sure you will have seen the recent Trump - on kidney disease which will only serve to help the visibility of this ailment. And another great quarter in end stage renal disease domestically and internationally. I think also very significantly to the BDI segment, is our performance globally, as we begin to leverage the scale of BD, particularly in areas where or Bard was only condensing its investment profile. So, for example, biosurgery and infection prevention in Europe had a tremendous quarter. And that was driven by the investments that we made as part of the acquisition. And urology continues to perform terrifically well, driven by home care internationally and new products domestically. And we foresee that the great progress continuing in all three businesses within BDI.
VinceForlenza:
So thanks, Simon. The bottom line of what Simon is saying is we are right on the deal models and mixing new products is a little different. We didn't expect the DCB situation. But as Simon just detailed for you there is a whole series of other new products, including in urology that is going quite well. So that is enabling us to hold that guidance range. So thanks, Kristen, for the. We appreciate it.
Operator:
Your next question comes from a line of David Lewis of Morgan Stanley.
DavidLewis:
Good morning just two quick once for me. One for Chris and one for Simon. Chris just thinking about the fourth quarter, you obviously maintain 25%, 26% margins, but it sort of implies 28% fourth quarter margins to get to the midpoint. So should we think about the low end of the range for the year on margins and how do you get that 2.5 point step up? And same question on growth Chris, you talked about acceleration into the fourth quarter. But it's a pretty significant momentum step up into the fourth quarter just to get to the low end of the five to six. So maybe your confidence top and bottom for the fourth quarter? And just a quick one for Simon. Post the panel and now with the BTK update. Have you made any commercial decisions about the DCB commercial organization in terms of a size, is it right size to the opportunity, and then the level of growth? Thank so much guys.
ChristopherReidy:
Sure I will start. So clearly, we have been saying that the revenue is going to accelerate in the second half of the year. You saw that starting to happen in Q3, we see that accelerating even further in Q4. Again, it's the continuous strength in UCC and surgery, the MMS momentum that we have. MDS is accelerating and strong growth in biosciences and DS which is essentially across the business. So we have strong confidence in that. And then on operating margins, we do see acceleration in the operating margins in the fourth quarter. Don't forget we don't have the FX drag that goes away in the quarter. We continue to see revenue synergies - cost synergies and CI continuing to build. And again, FX abates there. So we have a lot of confidence and being able to get solidly within that 25% to 26% range that we gave guidance on. Simon.
SimonCampion:
Hi, David it's Simon. So certainly we have been preparing for all eventualities with respect to the DCBs and BTK as well. While we won't provide you any details here, I think it's important to recognize that the territory managers for example wouldn't prefer intervention that business, they sell far more than DCBs. And we have seen your positive uptake in stents and other areas. So to begin to affect those, I think would be not a great move. But obviously as part of this process, we have sought to offset as much of this as possible without impacting the commercial performance of the organizations.
VincentForlenza:
And we are still waiting to see where the FDA comes out, the course on labeling changes and it’s the letter to physicians. So we will stay tuned for how that works out. Thanks for the question.
Operator:
Your next question comes from the line of Bob Hopkins of Bank of America Merrill Lynch.
RobertHopkins:
Yes, thank you and good morning.
VincentForlenza:
Good morning Bob.
RobertHopkins:
Just a lot of questions one could ask. But I can't help but just one more on paclitaxel. Just curious if you could elaborate, just in however you can on kind of what you heard from FDA after the panel meeting. Do you have a sense at this point, whether you think you might need a whole new trial or just longer term data or any incremental senses as to what you heard from there would be helpful.
VincentForlenza:
You are asking on BTK.
RobertHopkins:
Yes.
VincentForlenza:
Yes, that is what I thought.
SimonCampion:
On BTK, well, Bob its Simon. I don't think we would provide the specific information here. We did provide the six month data and interim 12-month data in the PMA that we filed. And we continue to cooperate and work with FDA as we work through this. But to provide any specifics about it, I think would confer a competitive advantage on others and I'm low to do that. So it remains a very active PMA, our teams are collaborating with FDA and we expect to have face-to-face meetings here with them in the not too distant future.
VincentForlenza:
To really nail down what that data requirement will be. And we have more data to bring to the table too. So we continue to work on it. Thanks for the question Bob.
Operator:
Your next question comes from the line of Robbie Marcus with JP Morgan.
RobbieMarcus:
Great. Thanks for taking the question. I was hoping you could talk about your strategy around M&A in general. You are down at three, seven times leverage, we saw you not wait until you got all the way to your target last time with the Bard deal. Just how you are thinking about where to add, what to add valuations in the space? And then also, if you could just touch on maybe your thoughts on M&A specifically in diabetes. This is an area, I think back to the last Analysts Day. There was a long list of product innovations you were hoping to bring to market. I don't think it probably turned out as positive as you hoped. Just your thoughts on diabetes and your plans for the future there? Thanks a lot.
VincentForlenza:
Yes, sure. And happy to answer the question. First, just a little bit of a correction. We did hit our deleverage target on the CareFusion deal before we did the Bard deal. And listen your are very politic in the way you have rest of the question. So no problem at all. But anyway, so we are really focused on meeting our leverage target as we go forward. Now, what we have been saying and remain committed to is that, must do plug-in M&A is an important part of the strategy. And as we put the deal model together we made allowance for that and you have seen us do stuff like WavelinQ, because it's an important part of the growth strategy. You should expect, over the next year that we will continue doing that, as we move forward towards deleveraging and getting down below three times. And then, as we look forward, we have tremendous capability in terms of our ability to do M&A. But, we are not a serial acquirer, we are a strategically driven Company. And you should expect us to be thinking about plugging M&A and then looking at the dividends and share repurchase as we move forward. So, Chris, anything else you want to add to that?
ChristopherReidy:
I would just point you back to the presentation, I made at your conference back in January, Robbie, where we talked about future cash flow considerations and the bottom line of that is we throw up a lot of cash. We happened to be using it to pay down $6 billion of debt, but at the same time, when that is done, which is, within the next year, we will have a lot of cash to allocate. And we started getting some sense of that, we will be talking more about that as we move on. But again, it gets back to what Vince said is, we are not going to let it build up in the balance sheet, we are going to be more active in tuck-in M&A on a strategic level across the whole portfolio and likely to start going back to share buybacks, once we start building up the cash balances and have gotten down to that three times leverage. And we made that correction, because we are very proud about the fact that we live up to our commitments, we committed that we would get down to three times leverage in the CareFusion deal. And we did that before moving into the Bard transaction and we are going to get down to the three times leverage this time as well.
VincentForlenza:
So, as Chris said, plug-in M&A across the entire portfolio and that could include diabetes, obviously, any other business here. In the short run, we remained committed to the Patch Pump. You heard the comment that we have taken on a development partner for doing that and we will continue to work on that as the number one priority as well as investing in the core of that business where we see some nice opportunities. But thanks for the question.
Operator:
Your next question comes from line of Vijay Kumar of Evercore ISI.
VijayKumar:
Hey guys, thanks for taking my question. I have a housekeeping questions first. One on in Q4, the imply at the lower end of the 5% or 6% of the annual rate and you are going to place Q4 6% organic, where is the acceleration coming from just given the tougher comps, if you can walk us through that. And the second on 3Q, the MDR regulation, incremental cost, is that sort of an ongoing implementation costs, are we annualizing during the Q4? Thank you.
ChristopherReidy:
Yes. So it was a little hard to hear you, Vijay, but at the same time, I think I got it. You were looking for a little bit more on Q4 revenue and we are not talking about accelerating much more from the five to seven. It's a little bit and, I went through before where we are seeing strength in some of the new products that we have brought to market. Venovo to Covera, WavelinQ are very helpful, continued strength in UCC. We are seeing great momentum in MMS, as you saw from the results this quarter. MDS is accelerating as we expected it to and we see strong growth in biosciences and diagnostic systems. Don't forget, we have some revenue synergies that kick in towards the back end of this year, particularly in the fourth quarter. So that is where we are seeing it come from. And I think, I talked about the margins, gross profit. As I mentioned in my prepared remarks, we saw some one-time kind of timing items that go away in the fourth quarter and rebound. Not to mention FX, not being a headwind, both on gross profit and operating margin. We see CI and synergies ramping. So we are very comfortable with the direction and very similar message to what I said last quarter, you saw that moving that direction and the third quarter and we expect that to continue in the fourth quarter.
VincentForlenza:
So Vijay, the only thing I would add to that is the emerging markets growth is going to continue to be strong. I mentioned already that in China, we were double-digits, we expect to be double-digits for the rest of the year. We have a great business there, a great team there and a strong partnership with the Ministry of Health. That is all going extremely well. We don't expect this environment with tariffs on retail products and stuff to be impacting that business. So we expect that to do double-digits for the entire year. And feel good about that. We feel good about the rest of Asia. And of course, EMEA, you saw, it was very strong this quarter. We expect that to continue too. So there is a lot of drivers both in the business side and from the geography side.
ChristopherReidy:
I think just for clarity, I would add two other points, Vijay. We do expect lower interest other to be about 450 million, as we mentioned in our prepared remarks. And then I would expect tax to be closer to the middle of the range. There is a lot of intricacies and tax, but you saw it was lower in this quarter at 12.8%. That will rebound upwards in the fourth quarter, putting us right towards the middle of the guidance range that we gave.
VincentForlenza:
Thanks for the question.
Operator:
Your next question comes from the line of Larry Biegelsen of Wells Fargo.
LarryBiegelsen:
Good morning, thanks for taking the question. Just one on Lutonix, one on China. So on Lutonix there have been a lot of questions on BTK. But my question is on the current indications and kind of what you are seeing since the FDA panel and your expectation once the updated FDA guidance comes out? And just Vince, I heard your comments on China and your confidence there. But there we are getting questions from investors about potential backlash in China against U.S. products given all the rhetoric here. Maybe you could help us understand why you are confident in that growth continuing and why some of this noise won't have any impact domestically? Thanks for taking the question.
VincentForlenza:
Yes. Sure. I will handle that. And then Simon can handle the intricacies of what is going on DCBs. So on China, as I was mentioning just a minute ago, our experience through this whole situation with what is going on with trade has been that they have been keeping very separate what is happening in healthcare versus what is happening on the trade side. And I think that reflects number one, a strategic priority to continue to develop the health care system in this environment. And that is what we hear from the Ministry of Health and in fact, more recently over the past six months. We have had conversations, where they have explicitly told us that. So that is the first part of it. The second part of it is, we had our team in here and the China Healthcare System is now better funded than it was a year ago or three years ago. And so there is some positive momentum going on in China, as the rest of the economy slows down that I think is important to them. And then thirdly, we are really well positioned with the portfolio and the organizations that we have in China and it's not just the fact of our commercial organization. But it's what we do in terms of investing in China. We have four plants in China, we continue to invest behind that, we continue to invest in innovation for China as well. And I know Tom is excited about the portfolio, he is been working very closely with John DeFord and our team in Asia. So, we have built a partnership over 25-years there. And so we do think that different aspects of the environment will be difficult, and we are ready for that. But we also expect that with what we have done to fully invest in China and not just a commercial organization, we are very, very well positioned there. And that is what we hear and Tom has got another one or two things he would like to add.
ThomasPolen:
Larry, this is Tom, good morning. Maybe just one small thing to add to Vince's good overview there is that those investments that we have made over the last 25-years, particularly in that localized, highly automated manufacturing, today the majority of the high volume disposable medical devices that we sell in China, we make in China locally. So we are actually importing, relatively low percentage, particularly of our high volume disposable devices, where there can be local competition, we are actually behaving as a local in that. Employing local associates, acquiring raw materials locally, et cetera, and engaging in those local communities. So much more on the some of the unique areas where there is actually not a local competition. In area such as BD,BDS, et cetera or BDI, where we would be doing importing and we are actually moving somewhat of that manufacturing into China as well.
VincentForlenza:
Yes. Okay, so Simon on DCBs and the intricacies there.
SimonCampion:
So good morning Larry it's Simon. So, I think, as you obviously know the panel happened in June and I think industry really did put the best foot forward here and in a collaborative nature. I think many of the main physicians that spoke was speaking on behalf of the role of paclitaxel, not only within PAD, but also these are paclitaxel in other areas and not seeing a signal associated with that. And everyone continues to work with FDA, as they look to refine their due doctor letter. What we have seen is approximately 50% reduction, I think we communicate that on the last call, it has remained at about that point in the last quarter and barring any unforeseen upsized I think we should expect that to continue as we roll forward here. But once again, DCBs are just about 1% of the total BDX business as Chris has spoken to and I have spoken to with new products in PI with new products in surgery that are just launched and with the outstanding performance and funnel within urology. I think we are well placed to offset as much of the headwinds as we can moving forward.
LarryBiegelsen:
Thanks, guys.
VincentForlenza:
Sure, thanks.
Operator:
Your next question comes from the line of Bill Quirk with Piper Jaffray.
WilliamQuirk:
Great. Thanks, good morning everyone.
VincentForlenza:
Hey Bill.
WilliamQuirk:
A couple of questions for Chris. Just, can you maybe just elaborate on the lower interest expense. Doesn't like should be additives to earnings for the full-year. So I'm just trying to figure out where the offset is, just given that the overall earnings guidance didn't change? And then secondly, would you care to elaborate on, I guess the durability of the BD MAX growth you have seen several very strong quarters now? Thank you.
ChristopherReidy:
Sure. So you already saw some of the interest reduction in the third quarter. And that was actually used to offset the additional pressure, we saw about $0.05 of pressure more than we expected to in FX. We thought it would be about $0.20, it was more like $0.25 of pressure. So you have already seen some of that and that is why I pointed you to the fact that the tax rate goes back up in the fourth quarter to get to the middle of the range for the year. It's now 13.3 year-to-date through the third quarter and we expect it to be closer to the 15% for the year. So obviously, that is an offset that you see and it was much lower. So when you put all that together and you model, I think you get back to right where we are. And there is no question that the FX has put pressure, it was real in the third quarter. But we are holding our range for the year despite that pressure.
VincentForlenza:
Okay. Patrick.
PatrickKaltenbach:
Let me comment quickly on the BD MAX. And as we said in the quarters before, we saw growth north of 20% and again, this quarter it was north of 20% and it's driven by the strong access we have the Enteric Panel to NDP Panel et cetera. So we are pretty confident that this has a long runway, building out more panels on BD MAX. And, again, there is strong demand, and we have pretty high growth in the business.
VincentForlenza:
Patrick, anything you want to add on BD COR, I mentioned it as one of the new product launches, maybe a little more color on that.
PatrickKaltenbach:
Yes. So we just launched BD COR in Europe. And we are really, really happy with the initial demand we are seeing and interest, we are seeing from our customers in Europe. It's still early days, because we have just one assay so far on it, but we are building out the panel. And we think, we have a very competitive platform on hand that will drive the future growth within our business here. And we will have the same as I said, we have from BD MAX report and BD COR build out a complete platform approach. So we can cover both the acute and the COR lab. So it has a very strong driver for business.
VincentForlenza:
Okay thanks Patrick. And thanks for the question.
Operator:
Your next question comes from the line of Rick Wise of Stifel.
FrederickWise:
Hi good morning Vince and hi Chris how are you doing?
VincentForlenza:
Good morning, we are doing great.
FrederickWise:
One quick one and one guidance. And just Vince, as always, I'm curious to hear your thoughts about the politics and med tech tax. I always like to hear your thoughts like that. But I would like to ask a guidance question. I think you are making it abundantly clear and for multiple reasons why fourth quarter - fiscal fourth quarter is going to look good and accelerated and sort of sounds like a minimum look a lot like the growth that we saw in the fiscal third quarter. But you do have your dramatically most challenging comp of the year. Maybe help us understand how you had hit the upper end or get towards the upper end of guidance. What has to happen and it would seem to me, to get to that full-year guidance more toward 6% you would have to post an upward single-digit fourth quarter. Is that remotely possible or are there some variables that I'm not understanding. Any color would be much appreciated.
VincentForlenza:
We have provided guidance in the past calls that because of DCB, because of the flu season as it played out, those are the biggest drivers that we would be towards the lower end of our guidance range of five to six in spite of those pressures. So the guidance for Q4 really implies the low end of that 5% to 6% range. So, as you have just mentioned, it would take a real blow out to get up to the top, but the businesses are performing strongly. But as you said, with the content that makes it really difficult.
ChristopherReidy:
Yes, I mean, we feel really good about the fact that the businesses are delivering well. We talked about BDI and the performance in this quarter with would have been well over 6% less for the DCB impact. And as I said even with the DCB impact and the potential BTK impact, we feel strongly about the ability to drive 5% to 6% next year as well. So we are feeling good about that momentum. In order to get the high ends of the range, we would have had to have a blowout flu season and because we know that was a tough compare against last year's flu season and DCB was incredible.
VincentForlenza:
Yes. Tom.
ThomasPolen:
Frederick, this is Tom good morning. Maybe just one other comments that to add there. You mentioned the comp being last year's Q4 and you are right, as Chris mentioned, we feel really good about the momentum from Q3 going into Q4 and one of the biggest comp area is last year I believe was in MMS we saw very strong growth. And I think one of the things I'm surprised you haven't got the question of a really strong number in MMS this quarter, as well, which is reflecting the continued momentum that we see in that business. And unless Alberto has any other comments to add there. But I think we are continue to be pleased at growing significantly above market in the MMS business, which we expected to continue. So.
AlbertoMas:
Yes, very good quarter for MMS clearly growing 9% plus, and it just reflects an ongoing momentum for this business. Yes we have been favorably impacted by some timing of installations, like here we - be on the last side in the pump side. But that will normalize overtime. We had a very strong quarter last year in Q4 we will jump over that and we won’t grow up to 9% growth rate clearly, but we are expecting good performance given the high quarter. And the drivers are the ones that we had mentioned in the past in terms of our core platforms into Alaris, Pyxis. The health side analytics to this really driving the integrated platform approach to the - and interoperability where we already have 475 sites live. And it just shows that momentum and that acceptance by the market of what we are offering as an integrated platform.
VinceForlenza:
Yes, the business is performing great, really, really well. Thanks Alberto. And thanks for the question.
Operator:
Your next question comes from the line of Richard Newitter of SVB Leerink.
RichardNewitter:
Hi, thanks for the questions. I have two here. One on molecular, the double-digit growth trend is very strong. You also had some competitive and continue to put up strong double-digit growth rate. I guess my question here is how much of the performance and the momentum in that business is something happening in terms of improvement, the underlying market versus share? And then the second question would just be on drug-coated balloons, I would love to just hear following the FDA panel, what are your customers and doctors saying in terms of what it’s going to take to kind of either get back to levels, or close to the levels of utilization and implementation where they were pre-panel and the study. And where do they think that level is? It's half of what it used to be. What are your customers saying with respect to that view post panel? Thanks.
VincentForlenza:
Alright. So let's do molecular first, and then we will come back to DCB.
PatrickKaltenbach:
Thanks Richard for the question. So on molecular, as you said, our growth is pretty strong, not only driven by BD MAX. But it's probably one of the big contributors there. If you look at our growth very competitive market growth. I would say clearly indicates that we are taking some share right now. Given the strong growth that we have, and we are again confident on our, in our assays that they are hitting the right market segments and it's also - if you look for example on Enteric, we are not using multiplex as is we are using a more target approach and that is also in terms of reimbursement model very beneficial for us. So I would say definitely points to taking market share for us.
VincentForlenza:
Okay. Simon on DCB.
SimonCampion:
So with respect to DCBs. I think the FDA needs to come out with a statement to - and says that the benefits outweigh the risks in summary for the market to begin to begin to rebound. I think our customers feel like their hands are tied right now with the Dear Dr. Letter from March 15th and that is reflected in the current 50% there about a decline in business, not just with us, but with others too. So I think in one sentence, benefits need to outweigh the risks and the benchmark for recovery profile is if you reflect back on drug eluting stents in the coronary system, you can see the recovery profile that they experience over prolonged period of time.
VincentForlenza:
Yes, which took a few years, right Sam to come back.
SimonCampion:
Which took a few years. But we saw the way to see what the contents of this letter holds for us. And more importantly, for the patients that we serve. These remains the same way then patients that we serve will not have the treatment options available to the scale it was before the Dear Dr. Letter.
VincentForlenza:
So just to answer that a little bit. This is probably not a black and white situation. There is a lot of degrees of gray and what the FDA can say here and so we don't know exactly where that will come out. Simon mentioned before industry has given a lot of input, we expect to KLLs are also giving input on that. And we think very shortly, we will get an updated letter, the FDA, I should say will be coming forth with an updated letter in terms of exactly what Simon was talking about. So we are waiting to see where that comes out. And I would agree with Simon, industry more so the healthcare providers have made some great arguments as to why this product is important for patients. And so we will see how that plays out over the next couple of days. Thanks for the question.
Operator:
Your next question comes from a line of Matt Taylor of UBS.
MatthewTaylor:
Hi, thanks for taking the question. So I just had a clarification question on your commentary on DCBs and next year at synergy. So it sounds like when you are talking about being able to grow 5% to 6%. That is not predicated on any real snap back in the core DCB business, is that correct? And then also, when you reiterated the Bard revenue synergies, you are right on-track, there is no major impact or un-surmountable impact from DCBs. Is that right?
ChristopherReidy:
Yes. So you are right. As we think about 2020, we are assuming that 50% holds through 2020. So no snap back in that. Okay. On the synergies, the cost synergies were right on target. We did mention that, we will do $100 million this year. And we are well on our way to 300. I think from a revenue synergies we are on-track as well. So.
ThomasPolen:
So Matt, this is Tom, just to give a little bit more color on the revenue synergy. So we are seeing the three areas that we have shared before, we are seeing very good momentum across both the vascular access area, we brought the Bard pick and midline business in and integrated with our catheter team. I would say in the last two quarters, we are really seeing an increase in the number of competitive conversions, which was exactly our strategy. And that gives us confidence going forward and that continuing to the fuel performance, particularly in the MDS business, so you see that now in the back half of this year, going into next year. We are seeing the benefits in our surgery business. You are seeing some of that play out actually this quarter, that the investments that we made in the combined Biosurgery and chloro prep infection prevention salesforce in Europe. We are seeing Biosurgery and infection prevention now growing strong double-digits in Europe because of those synergy investments that we have made. And then, of course, the third area of just geographic expansion in markets, particularly beyond China that Bart had invested in significantly, we are seeing strong growth in BDI in those other geographies as well. And so, we feel very confident our revenue synergies being on-track for this year and continuing that momentum in 2020.
MatthewTaylor:
Okay. And then just one follow up, it sounds like the BD COR product could be a really interesting drivers. You have had some comments on it today, but they are a little general. Could you talk a little bit more about how big you think that product could be overtime as it builds on your successes with MAX?
PatrickKaltenbach:
Yes, I can take that. Look at again , current revenues are still, it's early days, right. We are ramping the product. We are just ramping it in Europe with the HPV panel on it. As I said, this is for as a revenue driver in 202,1 2022. I think we will see lots of revenue contributions coming from this platform, when we also have it available worldwide. We think it's a very attractive platform, given the automation capabilities it has, especially also taking care of the pre-analytical step within the platform. So we think we will see a very nice revenue contribution and growth contribution in our diagnostic services business. And in the years 2021 and 2022. This year, it's definitely - making a huge contribution.
VinceForlenza:
Okay. Right. Thanks. Thanks, Patrick.
Operator:
Your final question will come from the line of Josh Jennings of Cowen.
JoshuaJennings:
Hi, good morning. Thanks for taking the questions. Just two questions. First on the peripheral business, just in terms of attempting to leverage the salesforce even more on the DCB pullback. I was wondering about your views on the need for an atherectomy platform. I think prior to the acquisition, there was a rumblings that Bard had a system in development in the pipeline and just wanted to hear is that still the case within back to its pipeline? And secondarily, just wanted to hear some of the thoughts on the hernia businesses, Phasix seems to be doing very well. There is some controversy around synthetic non-receivable mash. And just wanted to hear your views on the market and in Phasix positioning? Thanks for taking the questions.
SimonCampion:
So its Simon here. I wouldn't comment specifically in what is in our NPD funnel until we are ready to actually give a commercial launch date. As you know, PI plays and in every category within the PAD space, with the exception of atherectomy. So it's obviously something we keep a close eye on internally and externally. But Company further on that I wouldn't do so. And then with respect hernia, at long last, I can stop referring to the hurricane, because Q3 so the last comp again versus the hurricane that happened actually two years ago. So we had a very strong underlying quarter in Q3. We continue to grow above the market. And your Phasix performance with our context of Bard business continue to do really well. We have just released three-year data on Phasix, which continue to do really well. We just released another version of Phasix. As Vince mentioned, Phasix ST OVHR, which incorporates a new positioning system. And that is off to a great start. And again, we just recently released a new articulating fixation system that thus far has got tremendous feedback from our customers. So hernia continues to do very well and we continue to look for other ways that we can leverage that sales in team that we have domestically and internationally. So we should expect to see that continue in that vein.
VinceForlenza:
Okay Josh, thanks for those questions.
End ofQ&A:
Operator:
Thank you. I will now return the call to Vincent Forlenza for any closing comments.
Vincent Forlenza:
Okay. So let me wrap this up. A couple of thoughts, our revenues were strong across all the businesses and regions in-line with the second half plan acceleration we are very excited about that. We expect our momentum to continue and have reaffirmed our fiscal year 2019 revenue and EPS guidance. And as we approach the final year at the Bard deal model, I'm confident that we will continue to deliver on our commitments, and create more value for our customers or patients and our shareholders. Once again, thank you for your questions. We look forward to updating you again around this exciting business that we have built. Thanks very much.
Christopher Reidy:
Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Operator:
Hello, and welcome to the BD's Second Fiscal Quarter 2019 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through May 16, 2019, on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 1284128. [Operator Instructions] Beginning today's call is Ms. Monique Dolecki, Senior Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Darla. Good morning, everyone. And thank you for joining us to review our second fiscal quarter results. As we've referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our second fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Reconciliations to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. Our second quarter results include a non-cash charge in the period related to product liability matters of $331 million pertaining to certain legacy Bard surgical products. In addition, in April, we notified customers of the recall expansion of the Alaris pump to include all pumps with a certain molded component that was manufactured between April 2011 and June 2017. We have recorded a cumulative charge of $65 million related to the recall to reflect the estimated costs of the remediation efforts that will occur over the next three years. We are working closely with our customers and the FDA and our remediation actions are guided by our proactive commitment to patient safety and minimizing the disruption of patient care. These items along with the details of purchase accounting and other adjustments can be found in the reconciliations to GAAP measures in the financial schedules and our press release or the appendix of the investor relations slides. As a reminder to provide additional revenue visibility, we will speak to our fiscal 2019 second quarter revenue results and fiscal 2019 revenue guidance on a comparable currency neutral basis. The comparable basis includes BD and Bard in the current and prior year periods, and excludes intercompany revenues, revenues associated with divestitures and an adjustment to the prior year related to customer rebates and incentives, as detailed in the financial schedules and our press release. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, President and Chief Operating Officer; Alberto Mas, Executive Vice President and President of the Medical segment; Simon Campion, Executive Vice President and President of the Interventional segment; and Patrick Kaltenbach, Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vince Forlenza:
Thank you, Monique, and good morning, everyone. At BD, our strategy is driven by our purpose advancing the world of health. We are confident that our strategy is working, our core remains strong and we continue to invest in innovation to deliver even more impactful comprehensive solutions for our customers. Turning to Slide 5 and our second quarter highlights. Our performance in the second quarter was broadly in line with our previously communicated expectations. Strong performance in our core combined with our continued focus on driving operational efficiencies and Bard cost synergies drove revenue growth the 3.4% and earnings per share value -- their earnings per share in line with our guidance range for the second quarter. Our results through the first half are right where we expected them to be. As we've been discussing with you, we plan for revenue growth in the second quarter to be below our full year guidance range. This was driven by our expectations for strong underlying core business growth, partially offset by a tough flu comparison and timing within the year in pharmaceutical systems. There were two additional items that impacted our growth this quarter, the market reaction to the FDA letter regarding DCBs and timing in the medication delivery solutions business in the U.S. When we factor in these items, underlying revenue growth was in line with our expectations year-to-date. In addition, we remain pleased with the integration of Bard. We are on track for our costs and revenue synergy capture targets, and we have gained momentum on the investments that we made last year. In addition, notable progress has been made on IT systems integration and in planning for supply chain initiatives. We are reaffirming our full fiscal year 2019 currency neutral revenue guidance despite near-term pressure to our DCB business. Our updated EPS guidance reflects strong underlying performance, partially offset by the headwind to our DCB business as well as additional foreign currency pressure due to broad strengthening of the U.S. dollar. Looking forward to the remainder of fiscal year 2019. We have confidence in our planned back half acceleration. There are a number of growth drivers across our segments, which we will review later in the presentation in addition to easing comparisons. I'll now turn things over to Chris for more detailed discussion of our second quarter fiscal performance and our fiscal year 2019 guidance.
Chris Reidy:
Thanks, Vince, and good morning, everyone. Moving on to Slide 7, I'll review our second quarter revenue and EPS results as well as the key financial highlights. Second quarter revenues grew 3.4% on a comparable currency neutral basis. As Vince mentioned, our second quarter performance was broadly in line with our expectations, driven by strong underlying core business growth. There were two items in the quarter that brought the revenues slightly below our expectations. First in our Medication Delivery Solutions business in the U.S., our results reflect the impact of distributor inventory adjustments in our hypodermic business. Inventory levels are now normalized, and we expect strong demand for the remainder of the year. Second, our results this quarter also reflect an impact to our DCB business. The FDA's mid-March update regarding the use of all paclitaxel-coated devices has negatively impacted companies that manufacture and sell these products. I'll provide more color on revenue growth in the quarter in a moment when I take you through the results by segment and geography. Adjusted EPS of $2.59 grew 7.2% on a currency neutral basis. This was in line with our previously communicated expectations for the quarter. We also continued to deleverage during the second quarter, paying down approximately $500 million of debt. We remain on track to achieve our commitment to deliver to below three times over three years. Moving on to Slide 8, I'll review the Medical segment revenue growth. BD Medical second quarter revenues increased 3.8%. Revenues in Medication Delivery Solutions or MDS grew 1.3%. As expected, our second quarter results reflect a tough comparison to the prior year in the U.S. The inventory adjustments previously discussed also impacted growth in the quarter. However, we expect strong demand and growth in this business in the second half of the fiscal year. Outside the U.S. growth in MDS was driven by strength in Europe across vascular access management and vascular access devices. Revenues in Medication Management Solutions or MMS grew 7.3%. Growth in MMS was driven by strong performance and infusion and strength and retail dispensing. Diabetes Care revenues grew 4.7%. As expected, revenue growth rebounded from lower growth in the first quarter with strengths in both the U.S. and international businesses, aided by timing of orders. Revenues in Pharmaceutical Systems grew 3.9%. Performance in farm systems reflects the timing of customer ordering patterns, which benefited the first quarter and negatively impacted growth in the second quarter as we expected. Now turning to Slide 9, and the BD Life Sciences segment. Revenues increased 2.7% in the second quarter. As expected, this growth reflects a headwind of over 200 basis points related to the strength of last year's flu season in comparison to a more typical flu season this year. As you're aware, the timing and severity of the flu season can impact our year-over-year comparisons. As a result, revenues in Diagnostic Systems declined 1.6%, reflecting a headwind of approximately 550 basis points from the tough flu comparison. Underlying performance was solid and driven by double-digit growth and IDAST and our BD MAX molecular platform. Preanalytical Systems revenues grew 3.5%. Growth continues to be aided by recent capacity additions that have improved the supply of push button collection sets. As expected, partially offsetting this growth was the timing of distributor orders that benefited the strong first quarter. Biosciences revenues grew 7.9%. Growth was driven by research reagents our FACSymphony and FACSLyric platforms and strengths in emerging markets. Now turning to Slide 10, and the BD Interventional segment. Second quarter revenues increased 3.5%. This reflects an unfavorable impact of 170 basis points from the hurricane and DCBs. On an underlying basis, growth was approximately 5.2%. Revenues in Peripheral Intervention or PI grew 3.8%. Our results this quarter reflect the previously mentioned impact to our DCB business. On an underlying basis, PI revenues grew approximately 6%, driven by strong global growth in end stage renal disease and growth across the entirety of the business in emerging markets. I'll provide our updated assumptions for DCB growth over the remainder of the fiscal year later in my remarks. Second quarter revenue growth and surgery was 1.2%. As expected, this reflects a tough comparison to the prior year in our hernia business when we released supply for back orders following Hurricane Maria. Growth in the surgery unit includes strong performance in biosurgery and infection prevention, where we continue to see the benefits from our revenue synergy investments. Revenues in Urology and Critical Care, or UCC, grew 6%. Performance in UCC continues to be driven by products and acute Urology as well as continued strength in our home care and targeted temperature management businesses. Now moving on to Slide 11. I'll walk you through our geographic revenues for the second quarter. U.S. revenues grew 2.2%. This is below our normal growth rate and reflects the impact of DCBs and the distributor inventory adjustments within MDS. In addition, this reflects a tough flu comparison as expected. Moving on to international. Revenues grew 4.9%. This reflects solid performance from all three segments with strength and emerging markets and across the medical segment in Europe as previously discussed. Developed market revenues grew 2.4%, driven by solid performance in Europe, partially offset by lower growth in the U.S. Revenues in emerging markets grew 9.2%. Performance was driven by growth of 11.8% in China, which reflects strong performance across all three segments. In addition, emerging markets benefited from double-digit growth in EMA. Turning to Slide 12, which recaps the second quarter income statement. As discussed revenues, grew 3.4% in the quarter on a comparable basis. Moving down the P&L, gross profit grew 2% year-over-year, excluding the impact of currency. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenues was 25.9%. This reflects additional deferred compensation expense due to stock market performance in the quarter. For your reference, deferred compensation expenses fully offset than other income expense. SSG&A was also impacted by unfavorable timing from the harmonization of Bard's compensation and benefit plans, as expected. On an underlying basis expenses are growing slower than sales and reflect our ongoing focus on discipline spending, and the achievement of Bard cost synergies. R&D as a percentage of revenue was 5.8%, which reflects our continued commitment to invest in innovation. As a result, operating margins decreased to 150 basis points, or 50 basis points on a currency neutral basis, which was in line with our expectations. Our tax rate was 16% in the quarter, which was also in line with our expectations at the high-end of our full year guidance range. As expected, we paid preferred dividends of $38 million in the quarter. As we have been discussing the preferred shares are not included in the shares outstanding calculation. In the quarter, adjusted earnings per share were $2.59, which is a decline of 2.3% versus the prior year or an increase of 7.2% on a currency neutral basis. Now turning to Slide 13 and our gross profit and operating margins for the second quarter. Gross profit margin was 55.3% in the quarter. On a performance basis, gross profit margin was flat year-over-year in line with our expectations. This reflects margin improvement driven by our continuous improvement initiatives and cost synergies, while offset by unfavorable mix driven by lower flu and DCB revenues, as well as headwinds from raw materials and pricing. Currency had a negative impact of 90 basis points on gross profit margin, which was greater than anticipated due to the broad strengthening of the U.S. dollar against other currencies. Operating margins declined 150 basis points in the quarter, or 50 basis points on a currency neutral basis. The decrease in operating margin was driven by increased SSG&A in the quarter as previously discussed. Moving on to Slide 15 and our full fiscal year 2019 revenue guidance. As we discussed, our underlying performance is strong. Through the first half, we are right where we expected to be. Looking to the second half of the fiscal year beyond these in comparison such as the flu there are a number of drivers across our segments that give us confidence in our planned acceleration. Within the Medical segment, these include continued momentum in share gain and MMS and revenue synergy capturing MDS driven by our leading vascular access portfolio. In Life Sciences, we expect continued strong growth in BD MAX MDS and the timing of instrument sales and reagents the benefit growth in BD. Within BD Interventional, we've recently launched several new products such as the 4 French WavelinQ, Covera and Venovo, which are performing as anticipated and are being well received in the market. And we anticipate several more product launches across BDI in the second half. We also expect continued double-digit growth in China in the second half of the year. While we now expect revenue growth of 4.5% to 5.5% to the BD Interventional segment, due to anticipated DCB headwinds, we have reaffirmed our total company revenue growth guidance of 5% to 6%. Our updated guidance reflects a reduction in DCB sales of approximately 50% over the remainder of the year. We continue to expect BD Medical revenue growth of 5% to 6% and BD Life Sciences growth of 4% to 5%. We also continue to anticipate developed market growth of 4% to 5% and growth of about 10% in emerging markets, driven by a diversified base with low-double-digit growth in China and strengths in EMEA and Latin America. Now moving on to Slide 16 and our full fiscal year 2019 EPS guidance. Our EPS guidance reflects our expectation for continued strong underlying performance, driven by revenue growth and solid operating performance, partially offset by near-term headwinds. On a currency neutral basis, we expect adjusted EPS growth of about 12%. This reflects a headwind of approximately 150 basis points related to DCBs. Based on current rates, we expect currency will result an additional headwind of approximately 200 basis points. This is driven by a broad strengthening of the U.S. dollar against other currencies. Our current forecast reflects the euro to dollar exchange rate of $1.12 versus our original expectation of $1.16. In addition our updated forecast also reflects incremental pressure attributable to profit in inventory. All-in, we expected to deliver adjusted EPS of $11.65 to $11.75. Now, before we move on, I'd like to take a moment to walk you through the additional information we've provided on Slide 16 this quarter. In response to questions we've received this fiscal year, we thought it was prudent to provide investors with a snapshot of our ability to offset headwinds to the business. This year, the magnitude of the headwinds we are facing is significantly greater than the headwinds we've encountered in recent years. The total headwinds this year amount to approximately $400 million. We have the ability to offset approximately $150 million this year, which is 50% more than we've offset in each of the past few years. To summarize, this chart demonstrates that our core is strong. The integration of the Bard deal was very much on track. And together, we have an even greater ability to offset headwinds by driving robust operating performance. Turning to Slide 17, we have also updated our detailed P&L guidance to reflect the headwinds from DCBs and FX. We now expect reported revenue growth of 8% to 9% as a result of approximately 50 basis points of incremental FX pressure. Gross margins are expected to be between 56% and 57%, and operating margins between 25% and 26%. Our margin guidance is approximately 50 basis points lower than our previous guidance as a result of both DCB and FX headwinds. We expect operating cash flow to be approximately $4.1 billion. The balance of our guidance expectations for the full fiscal year 2019 remain unchanged. In addition, we continue to expect to achieve approximately $100 million in cost synergies in fiscal year 2019. We are on track to fully realizing $300 million in annualized cost synergies over the three year deal period. We feel good about the momentum we have across our businesses. While we're facing some near-term headwinds, we are confident that will deliver on our commitments in fiscal year 2019 and beyond. Now, I'd like to turn the call back over to Vince, who'll provide you with an update on our product portfolio.
Vince Forlenza:
Thank you, Chris. Turning to Slide 19 and our planned product launches by segment. As you can see, by this slide, we continue to have a rich pipeline. There are a number of things we continue to be excited about. I'll touch on just a few of the recent launches here starting with the BD Medical segment. We are excited about the consistent cadence of innovation within BD Medical and are seeing strong uptake from recent launches. Notably, adoption of our new Alaris M2 pump is aiding the strong growth and infusion. Also, the recent additions of our health side platform have continued to gain great interest and positive feedback from customers. Another good example is in our Diabetes Care business, where we are seeing good uptake of our new best-in-class pen needle Nano Pro. Within BD -- within MDS, we also launched two new products during the second quarter that strengthen our vascular access product family, the PowerGlide Cue and BD Provena PICC. Regarding the Type 2 insulin Patch Pump, we recently received feedback from the FDA in our 510(k) submission. We're in the process of evaluating and responding to the agency's feedback, which was more comprehensive than we expected. Given the FDA's comments, we are considering a variety of options and strategies, but do expect a launch delay. We plan to provide you with an update on our August conference call. In the BD Life Sciences segment, we recently launched the BD FACSDuet, a new automated flow cytometry sample preparation instrument with CVD IVD certification. The BD FACSDuet system raises the bar on flow cytometry automation, offering a fully integrated sample to answer dilution with a BD FACSLyric clinical flow cytometry. This is a new fully automated sample preparation instrument enables clinical laboratories to improve their efficiency by reducing errors and limiting the manual user interactions required to run assays under BD FACSLyric. We also started shipping the new 12-color FACSLyric further enhancing the capabilities of this platform. In the BD Interventional segment, we received 510(k) clearance from the FDA for the BD WavelinQ 4 French Endovascular AV Fistula System. We're excited to add the 4F system to our portfolio of technologies that create, restore and/or maintain AV access for patients on hemodialysis. With its slim profile, the 4F system increases the fistula location options by enabling risk access points to be created. This provides increased procedural flexibility for clinicians, while reducing the risk of scarring or arm disfigurement for patients compared to open surgical AV Fistula creation. We also received approval from the FDA for the Venovo venous stent, which is the first venous stent indicated to treat obstructed or narrowed blood flow specific to the iliac and femoral veins located near the growing. Most importantly, it is engineered to address the special challenges of venous lesions that are very different than those posed by arterial narrowing. As you can see, we have a very rich pipeline of new products across our businesses. And we look forward to sharing additional updates with you along the way. Before I move on, I would like to remind you that we have, again included a slide in the appendix of today's presentation that provides an update on our sustainability initiatives. We hope you find this information useful and understanding BD's commitment to these important initiatives. Moving to Slide 20, I would like to reiterate the key messages from our presentation today. Solid revenue and EPS growth this quarter was driven by strong underlying growth in our core across our businesses and regions. Through the first half, our results are right where we expected them to be. The integration of Bard is on track, and we are confident in our ability to achieve our costs and revenue synergy commitments. Looking forward to the remainder of fiscal year 2019, there are a number of drivers across our segments that give us confidence in our planned back half acceleration. In summary, we are confident that our strategy is working, our core remains strong, and we have a significant opportunity to continue to deliver even more impactful, comprehensive solutions for our customers and their patients around the world. So thank you. We will now open the call to questions.
Operator:
The floor is now open for questions. [Operator Instructions] Your first question is coming from David Lewis with Morgan Stanley.
David Lewis:
Just two for me, one on revenue and one on currency. Just if you could just -- starting with revenue for a second, our sense is the DCB update probably reflects a 50% reduction in that business in the back half. I just guess the question is, is that worse than the existing trend or how risk adjusted is that for the disease panel. And just given the quarter and DCB within that 5% to 6% range, should we be thinking toward the lower half of that range? And then I have a quick follow-up.
Chris Reidy:
Yes, David. This is Chris, you got that right. 50% is what we're projecting for the remainder of the year. And that is in fact what we're seeing through the month of April and late March. So we're calling it as continuing along those lines. Obviously, we'll see what happens when the FDA talks at the end of June. But right now, we're calling it as we're experiencing it. What we are also assuming is that BTK, while we continue to talk to the FDA about BTK, but we would expect that launch to be in the next fiscal year as well. So it's a combination of those two impacts. And when you take that impact against our original guidance range of 5% to 6%, it does bring us down to the low end of the guidance range.
Operator:
Your next question is from Kristen Stewart with Barclays.
Kristen Stewart:
Just in terms of, Chris, you had mentioned the ability to kind of offset some of this, what are some of the actions that you have generally taken year-to-year, as you think about kind of offsetting some of these headwinds, there's obviously concerns out there just with next year with the Gore royalties coming off, and then some questions I guess on how to think about DCBs going forward, with BTK, maybe being a potential offset, I guess, mixture to a degree helping the trend, if we get approval. Just -- how should we just think about this flexibility that you have and the levers that you can pull?
Chris Reidy:
Sure. So I'm going to start, just to put things in perspective. Then I'll turn it over to Tom. As we showed on the waterfall chart, we're driving 19% to 20% underlying growth and that -- clearly, 3% of that comes from the year-over-year tax rate. But we're driving 16% to 17% growth as well. And we've been able to do that kind of growth in the past. And so that -- I would point you to the fact that 12% FXN despite the $400 million of pressure that I'm talking about is evidence of our ability to still drive good strong FXN growth despite that kind of pressure. And so, Tom is going to talk a little bit about the kinds of things we did to get there.
Tom Polen:
As we think about in FY'19, I'd say all the businesses are very tightly managing expenses. So if you look at our underlying SSG&A growth, we're 3% or less year-to-date in the core businesses that reflects that level of discipline that we're driving across the organization. And, of course, as we planned for '20, and we're deep into planning there. Of course, we're way ahead of where we normally would be given the situation with the Gore royalty. I'd say, again very, very disciplined expense management across the Board, both G&A, and obviously the selling and marketing as well as continued management of our R&D lines. We continue to drive a number of efficiency programs across all of those organizations, where appropriate, moving, for example sustained engineering to lower cost locations where we can be doing that. That's a trend that we've been accelerating actually within the Bard organization, substantial progress this year. And when it comes to paclitaxel, specifically, of course, and we can comment on this later through Simon, but, of course, as we dig further in, all we see is becoming more and more confident in our data on paclitaxel that we do not have -- we're very, very confident in the safety of Lutonix. And again we can comment on that further later on. So we're looking forward to the FDA discussion in June. We're not doing any restructuring of that organization at this point in time. We're going to be hiring for the launch of BTK. And so, one thing that we'll be monitoring very closely is how we come out of the FDA session and then making a decision after that and as was mentioned before, we are still in active discussions with the FDA on the BTK product, right. It's a very unique, new solution in the marketplace. There are no valid treatment options other than amputation for patients suffering with below the knee blockages. And so, right, we are still hopeful that while that won't occur in FY'19 that it will occur later on and we'll get a better sense of that, we think after the June meeting as well too, so more to come. We're planning behind the scenes, but we think it's prudent to see where that evolves too.
Vince Forlenza:
So, Kristen, you can get a strong sense there, we're doing everything we can, as Chris said, to offset those headwinds. We're being prudent around the DCB situation and then 2020 is a whole different work stream in line with what we have been communicating all along in terms of how we will offset that. We're making good progress in all of these things. We'll see how the DCB situation comes out. One thing that I would add is that we have done -- we've taken our data to a third party and have them take a look and actually do the analysis for us, we're feeling very good about those results and the safety results that they show and Simon and his team are looking to get that published. So we look forward to getting our data out there. So thanks for the question.
Operator:
Your next question is from Larry Biegelsen with Wells Fargo.
Larry Biegelsen:
One on FX, and then one on the P&L guidance. So starting with FX, I think initially, it was a 2% top line hit, with about a 3.5% EPS impact from currency. And now, I think it's 2.5% at the top line, but 5.5% EPS hit. So could you just help us understand why it seems like the ratio from the top line hit to the EPS hit is greater now? And now I'll ask my second question on the P&L guidance right now. Chris, can you help us bridge kind of from the first half operating margin of about 24% to the implied second half operating margin of about 27%? Hopefully, I'm doing the math right at the midpoint there. Thanks for taking the questions guys.
Chris Reidy:
Great, Larry. Two good questions. So let me step back on FX a little bit and as you pointed out, we had estimated about a 3.5% EPS impact or about $0.40, thereabouts. Our new guidance is 5.5%. And we have certainly seen since November a broad strengthening of the US dollar against the Euro, but also more directly against all other currencies around the world. Through the first half, we are already experiencing the $0.40 or 3.5% of FX pressure, and Q2 was slightly worse than we had expected. We had thought it would be $0.20 to $0.22 and we saw a $0.25. As far as the remainder of the year goes, we had expected FX pressure in Q3, but we are now expecting that to be worse than anticipated as the dollar continues to strengthen. And as we looked at Q4, we had originally thought that that turned around and offset the impact of Q3 to essentially be neutral in the second half. That doesn't look like it's going to happen now as the dollar continues to strengthen and the Q4 is neutral, but certainly not an offset to Q3. So when you put all that together, it drops about $0.20 more in the third quarter and then the fourth quarter would be relatively flat. And some of what's making that happen as well as the profit and inventory that as the dollar continues to strengthen, that come back from profit and inventory that we expected in the fourth quarter is lessened. And so that's what makes the fourth quarter neutral. One thing to consider in terms of the drop through is as we've seen in past years, when the pressure comes from currencies other than euro. And of the $0.60 pressure that we're seeing this year, only $0.15 of that is from the euro, so the rest is all other currencies. When the pressure comes from other currencies, the drop through tends to be greater than it was in prior years. So that's the story on FX. In terms of your other question, in terms of the way to think about margin from where we are, the first-half margin is, as you said, about 24%. We're guiding 25% to 26%, which implies about a 27% second half. And a number of things go into that very much consistent with what we said on the call last quarter. FX does abate in Q4, as we annualize headwinds, the cost synergies that we have ramped in the second half, particularly on a year-over-year basis. We also have additional SSG&A leverage on higher second half sales. And we feel very good about the acceleration of revenues in the second half that generate that as we went through in the script. So we feel real good about our ability to get to that 25% to 26% operating margin improvement despite the headwinds.
Operator:
Your next question is from the line of Bob Hopkins with Bank of America.
Bob Hopkins:
So just, I wanted to start out maybe with a little bit of a longer-term question and on the upcoming paclitaxel panel, if we just hypothetically say that doesn't go well, are you guys still comfortable with that 5% to 6% that you've talked about is still doable, even if paclitaxel panel goes poorly and you have to kind of really draw down your thoughts on what the below the knee opportunity might look like?
Vince Forlenza:
So, we think that, by the time the panel meets, there is not much time for the substantial impact in this year. And so if it doesn't go well, then we would have to take a look at this business and look at the expense structure and how we would manage that. We actually believe that the industry from talking to other companies that all of us have good data. As I mentioned, we want to get ours out there and published. So we're actually looking forward to that June meeting, we wish it was coming sooner. Simon, anything else you would add to that?
Simon Campion:
No. Just once more, as Vince said, we have reaffirmed the safety profile of our product with an independent group of physicians involved. All the interventions that would use our product and oncologists, and we said we do that back in the Q1 earnings call. We've done that, we've reaffirmed it, and we're going through the publication process. The other thing to note, while DCB is undoubtedly a headwind for us, there are many other -- many other legs to the Peripheral Intervention stool and indeed the BDI stool that can help mitigate some of those headwinds. So as we break down our business, we can see a good growth in the other segments on a global basis, the other parts of PI on a global basis. So DCB is very important, but it's not the only positive story that we have to express as we serve patients globally.
Operator:
Our next question is from the line of Robbie Marcus with JPMorgan.
Robbie Marcus:
Maybe just a follow-up on Kristen's question a little bit. I think a lot of us are sitting here looking at some of the headwinds, some of them going into fiscal '20, some of them not. I know it's still pretty early in the year and we won't get full '20 guidance here, but maybe if you could just help us think about three times 13% EPS growth going into fiscal '20, is that still something that's achievable off these new lowered numbers? And any puts and takes you could help with that with early in the year here with all the headwinds? Thanks.
Vince Forlenza:
Sure, Robbie. So you're right, we're not going to give guidance for 2020 this early in the year, but I would say that the deal model is very intact. Obviously, we have to keep our eye on the DCBs and the impact next year. But we still have strong performance and momentum across the business and continued synergy capture. And so everything we talked about and offsetting the Gore royalty, clearly, is still in place. Now the Gore royalty as is clear is running a little harder than the original deal model. And so that's something we're clearly working toward to getting too. So as we look at the -- as we look at these significant headwinds that we have in the short term, clearly, there is some -- like you wouldn't expect the kind of pressure we are getting in FX, if the FX, if the dollar stays right where it is, there would be about a push next year, so no 5.5% kind of headwinds. And so that is great. And obviously the divestiture was a one-time item and you wouldn't have that again. Flu kind of normalizes. We had a normal flu season this year. We would plan for a normal flu season. So you don't have that headwind going forward. Resins, we had a spike in resins just before we gave guidance last year. That's gotten slightly favorable and it's kind of held right there. So we'll have to watch that. Oil prices are going up, but it seems like the pricing there has more to do with supply right now than oil prices, as it had in the past. So we'll certainly watch that, but no indication that there is additional pressure there. And your guess is as good as mine on tariffs. And so we'll see. We'll do everything we can to offset tariffs and do what we can to move sources et cetera. But that remains to be seen whether that's a headwind going forward or not. So it's clearly an indication that the level of headwinds that we had this year tend to abate. And so we'll address more of that going forward as we go throughout the year.
Operator:
Your next question is from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Just wanted to talk about the DCB reduction here, the $57 million, it seems like the EPS impact is greater than what we would have expected there. Can you talk about the margins on that business? And am I right to think that nearly 100% of that is falling through the bottom line. And if so, why would that be? Thanks.
Vince Forlenza:
Well, first, the margins in that business are very high. It's a very attractive product line, one. Two, we're continuing to manufacture the product. And so, but, of course, had significantly lower volume. So then we have the variances that go along with that. And Chris can give you more detail.
Chris Reidy:
Yes. So it's clearly not 100%, but they're really good margins, and we don't like for competitive reasons to give the specifics, but it's very strong. I think what you might be missing in your model is our assumption on below the knee. So you're right about the $57 million at strong margins, but then you got below the knee coming out of our numbers as well, which certainly has an impact of about $20 million to revenue or thereabout. So that would get you in the ballpark.
Operator:
And our next question is from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar:
So just a couple of -- on guidance, I roll it into one question. When you think about the back half step up, it looks like a couple of 100 basis points on the revenues. I just want to make sure that step-up in the back half, there's nothing changed versus three months ago. And then we know it looks like it's a first-in-class product, right, maybe some color on what it means. And then a follow-up on margins, gross margin is down sequentially. Is this all FX or maybe just some comments on what happened on gross margins? Thank you.
Chris Reidy:
Sure. So a couple of comments in there. So first of all, on the confidence on the second half revenue, it is exactly as we called it last quarter as well. And the things that go in there are the tough flu comp in the first half. So if you look at Life Sciences year-to-date is 3.7. Clearly, we're calling it much higher than that in the second half. And so you've got that benefit sticking in Life Sciences, you've got the EMA tender timing and Biosciences that we talked about. We continue to see strong performance in BD MAX. So we're very confident on that acceleration. On BDI, you mentioned Venovo. We also have the 4 French WavelinQ. You saw that we got approval for 4 French. So we have that, and Covera. And as I mentioned in my prepared remarks, a number of other product launches in the second half. And then, moving to surgery within Interventional, we have Progel back and that's accelerating nicely. So -- and surgery essentially won't have the impact of the hurricane that we were fighting in the first half of this year. So that returns to normal. And then on the medical side, we mentioned that we expect MDS to accelerate based on the strong hypo demand that we're seeing, and that was a supply issue in the past. And so that's writing itself. And so, we expect strong demand there. And then MMS, as you see, the performance at MMS, we continue to see that performing well in the second half of the year. Don't forget revenue synergies also build. The timing is we haven't seen too much revenue synergy in the first half. We've seen some, but we have strong confidence in seeing that build in the second half. So we're very, very confident on the revenue build in the second half. And so when you think about it, we're about 4.3 year-to-date, which is about where we expect it to be for the first half of the year, even though, Q2 is a little lighter. We are actually a little bit better in Q1 as you might remember. And so the back half of the year implies kind of a 5.5% to 6% growth, which we feel very, very comfortable with. In terms of your comment on margins, most of that is the FX impact. And so that's what's driving that. On an underlying basis, FX and the margin was right where we expected to be. The bigger driver of that is SSG&A, as you can see, was a little bit harder in the second quarter. That's just a timing issue. When you normalize for the integration of Bard, so, Bard wasn't in the first quarter, so you saw a big -- first quarter last year. So in the first quarter, you saw a big change. In the second quarter, that comes back in. What you see happening is things like comp and benefit plan, you're taking two companies that are on different year-ends -- fiscal year-ends and normalizing that. So you're getting some hits in the second quarter that normalizes over the course of the year. Those benefit plans aren't incremental there. They are the same as they were. It's just out of quarter. The best indication of that is something that Tom mentioned is that for the first half of the year, on a comparable basis, SSG&A is running about 2.9%. That's about where we expected to be for the year, which is showing that we are able to drive down costs through synergies and continuous improvement. So we feel good about the gross margin. And that will improve through the second half of about 57% on average to get us to the 56% to 57% guidance range we mentioned.
Operator:
Our next question is from Larry Keusch with Raymond James.
Larry Keusch:
I was just hoping that you guys could talk a little bit about the pump market. Obviously, competition is certainly set to increase over the next 12 months or so. So just wanted to get a sense for sort of what you're seeing out there in the market? Thoughts around your market share gains and what really is the differentiator that you think that you have for the Alaris system at this point as the competitors come in?
Vince Forlenza:
So Tom is going to kick that off. And then we'll go from there.
Tom Polen:
Hey, Larry, this is Tom, and I'll make a couple of comments and then turn it over to Alberto for anything further there. So we feel really good about our position in infusion pumps, of course, another great quarter from MMS here, and certainly very strong year-to-date performance. Customers continue -- we continue to gain share in that one to two points. We're on that exact same trajectory this year as we have been for the last several years and certainly the power of the system is not just in the pump itself, obviously, the integration of the LVP, the syringe, the PCA, the interoperability. We're at over 400 interoperable sites, which is a multiple higher than I think all the rest of the market combined. And now, the power of HealthSight, in particular as well where we're leveraging data across, not just the infusion platform, but across dispensing and our other solutions around compounding and inventory management to help provide outcomes for the customer leveraging that data to do things such as reducing inventory costs or preventing diversion of drugs, improving patient safety and those are things that we alone are uniquely positioned to provide because of the breadth of our portfolio and we see a lot of excitement from customers there. The majority of our deals, north of 50% of our deals, when we close them today, are not just pump deals, they're deals that include multiple elements of our portfolio and again that's quite unique to us and not something that those who are in this space can offer. So Alberto, anything else to add to that?
Alberto Mas:
No, I think you summarized it well. So we continue to develop our core platforms nicely and Pyxis side adding, for example, Pyxis Logistics IV Prep. So we continue to invest in our core platforms and the interoperability on the Alaris is really a significant differentiator for us. And then the wraparound for really the integration of our core platforms to provide really unique analytics for our customers is really that -- where we're seeing the big winners. We do, obviously, have visibility into the future and some of these upcoming contracts and we feel very confident that we'll continue that category share gain consistent to what we've always said and that Tom as highlighted.
Operator:
Our next question is from the line of Rick Wise with Stifel.
Rick Wise:
Two quick questions, maybe Vince at a high level, your emerging market business continues to do well, you called out China specifically. Maybe talk to us about how sustainable it is, given the trade issues, economic uncertainties, the back and forth and just more specifically on the Type 2 diabetes pump delay because of complex feedback and you're reflecting on options. Does this diminish your confidence in the product to make it to the market the next year or so, how quickly would you hope to work it through and make a go-no go kind of decision. Thanks so much.
Vince Forlenza:
Right. So let me start out on emerging markets, and thanks for the questions, Rick. So you're right. We saw very strong performance in China, good performance in Asia, good performance around EMA as well too. So we're actually confident that we're going to continue to see that. I would tell you my experience with the China team is that the trade situation is being kept very separate from what's happening in our business. And it just remains so important to China to continue to develop that healthcare system. It's foundational to their strategy and the stability of course that they're always seeking. So we are seeing strong performance across all three of our business segments and as we look forward, we continue to see that. One of the reasons why is that, the funding of the Chinese healthcare system is actually improving over time and most people don't know and understand that, but our team walked us through that about a month ago or so. So we're feeling very good on that side. On the Diabetes pump, we did get the feedback from the FDA, and we're in a situation where we're really assessing the options that we have, the technical pathways that we have in responding to them, some can be simple, some can be longer term. And so that's why we said, hey, listen, we've got to call that out for you. We've got to do that work before we can assess exactly where we end up in terms of launch date with that. And so that's where we stand and that's why we think it's going to take us another quarter or so to really understand how those potential solutions play out. Tom, is there anything else you want to add to that?
Tom Polen:
No. I think you did very well.
Vince Forlenza:
Okay. So that's where we stand and we'll talk to you later in the summer about it.
Operator:
Your next question is from the line of Dan Leonard with Deutsche Bank.
Dan Leonard:
So first question on Slide 16, appreciate all the heavy lifting to offset the headwinds. But can you clarify -- have you taken incremental actions to offset the incremental worsening foreign currency in DCB troubles? That's my first question. And then my second, just a housekeeping, did you quantify the distributor inventory adjustments in medical delivery and if not, is it possible to quantify those. Thank you.
Chris Reidy:
So this is Chris. On the first question, what I would say is the incremental FX impact, we are already driving 19% to 20% underlying growth and we're not going to offset FX by cutting into muscle at that point. And that was the point of saying, we're already driving $150 million of offsets. As it relates to DCB, we're not assuming any offsets at this point, as we talked about, but if things went negatively, which we don't expect in June, but if they did, we would clearly take actions to offset the impact of that. So the actions that we're talking about are things like sales, comp incentives or whatever, and we're not going to take short-term action to hurt the sales force that we need, when things come back. But if things got materially worse after June, we certainly would look at that and manufacturing, et cetera.
Tom Polen:
And maybe Dan, this is Tom. Just to add to Chris's comments, I would say, so as you heard from Vince and Chris, of course, our core business is very much on track, is on budget for the year across the board. With that said, we have taken above budget actions to manage expenses. So we have done things such as there are hiring freezes on non-manufacturing non-sales related roles. We have launched initiatives to more aggressively manage, particularly indirect spend as an example, right. And so every one of the businesses and parts of the organization are driving expense initiatives to reduce expenses below budget, and we are implementing those very actively, I would say. So again, that's driving that base 19%, 20% number that you heard Chris talk about.
Operator:
Your next question is from Rich Newitter with SEB Leerink.
Unidentified Analyst:
Hi, this is Jaime on for Rich. I was just wondering if we could go back to kind of the Bard cost synergies, any additional progress that you guys made in the second quarter. And how we should be thinking about some of the things that you've highlighted in the past around the surgery sales force expansion as well as geographic expansion in the back half contributing? And then just the second part of that question, relative to the deal model, is it still fair to assume that if upside were to materialize that would primarily be from the revenue synergies? Thanks for taking my question.
Vince Forlenza:
Okay. So there is a bunch in there. Let me start with the cost synergies. So we're right on track with the cost synergies. As we said, the most recent achievements we pointed to are kind of in the IT infrastructure space as well as in the supply chain. And so some of those things are like moving data centers and collapsing data centers and moving off of older IT systems like MFG Pro and beginning to move those kinds of items. We did close down the Murray Hill office, including the data center and moved it out. So those are the kind of synergies that you start achieving. This is on top of last year's achievements, which included duplicate public company costs and some of the procurement savings. As we look out into 2020, we would be looking at more of the operational kind of synergies like plants and distribution centers and that kind of thing. So we're right on track where we expected to be from a cost standpoint. The same is true on the revenue synergies, as we said, we invested to get some revenue synergies. And I'll pass it over to Simon to talk a little bit about the surgery component of that.
Simon Campion:
Yes, good morning. It's Simon here. So I think we mentioned again last time on the biosurgery and infection prevention, sales organization within Europe. We invested heavily there and that sales force is performing as expected and actually above our plan. Now we did something similar in the U.S. where we combined the same two sales forces. And we're getting good leverage between the legacy Bard, biosurgery sales force and the legacy BD infection prevention sales force. The other point I think is important to note here is that the investment profile and the investment agenda that Bard had set forth has been fully supported by BD. Example of that is acquisition of TVA Medical to fill out our end-stage renal disease portfolio and that acquisition has gone to plan. As Chris noted earlier, we got FDA clearance for the 4 French. We've rolled that out, and the progress in that business continues to be very good. And then on a global basis across all three businesses, we continue to do very well, particularly in the emerging markets in China. So overall, all the investment plans are on track and the investment agenda that we set forth has been fulfilled by BD.
Operator:
Your next question is from Matthew Mishan with KeyBanc.
Matthew Mishan:
I'm going to ask my first one, and then I'm going to have a follow-up. On the surgery side in Interventional, you guys talked about a tough comp, especially in hernia. But maybe talk a little bit about the biosurgery piece of that, you'd have a -- you probably have a very easy comp around the Progel ramp? And I'm also just curious about the performance of the Hemostat Arista powder where there is increasing competition?
Simon Campion:
Simon again. Indeed, yes. Progel, we reintroduced back to the market. I think it was in the October-November timeframe. And we're really pleased with how that has performed. We are -- I would say, we're slightly ahead of where we thought we would be with that. As you rightly mentioned, we have seen increased competition on the Hemostat side and the evaluations have certainly eaten in a little bit into our business there. But I think from a clinical perspective, we feel really comfortable with where we stand with the performance of Arista versus some of the competitors that have entered the market. So I think while there's some short-term pain as their products are evaluated, a lot of institutions and the clinicians have come back around to Arista. And then the final point I'd like to make about that business is, as you may have seen, we have received approval for sterile ChloraPrep, which further differentiates us in the infection prevention business. And we are getting ready to roll that out over the summer months. And we've seen great growth on that in the past two quarters. We expect that profile to continue as we roll out a further differentiated product in that category.
Matthew Mishan:
Okay. And then on to this continued strength that you're expecting in MMS, you're running up against some very serious back half comps. I'm just trying to understand how much visibility you have there to new placements or maybe there is a lag from the increase in placements to the benefit you're going to get on the consumables part of that business.
Vince Forlenza:
Go ahead, Alberto.
Alberto Mas:
Okay. So yes, we do, obviously have visibility of some of the contracts that are coming up. There are two variables used, contracts and then installation or placement timing. And we have a sense for -- the placement can sometimes change because it's not depending on us, and we had to accommodate the customer as well. But we feel fairly more than confident that we're going to see the same similar type of trajectory in the second half than in the first half. So we're -- and the dynamics, as Tom mentioned, and I mentioned before, are basically the same, because we're not trying to compete like with like, but more a comprehensive approach to our portfolio and putting in front place some of the differentiators such as interoperability and some other, the HealthSight Analytics and so on.
Operator:
And there are no further questions at this time. I would now like to turn the floor back over to Vince Forlenza for closing remarks.
Vince Forlenza:
Well, thanks to all of you for joining us today on the call. Let me make a couple of remarks here. Our performance year-to-date with some puts and takes is right in line with our expectations. We expect a strong back half and have confidence we will deliver it, consistent with our proven track record and historical performance. Even in the phase of significant headwinds, we continue to weather the storm. Our core remains strong. The deal model is tracking in line with our plan. Yes, we have to handle DCBs, and we will do that. And together, BD and Bard have the ability to deliver robust operating performance. So having said all that, we look forward to updating you again next time. Thanks very much.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time. And have a wonderful day.
Operator:
Hello, and welcome to BD's First Fiscal Quarter 2019 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through February 12, 2019, on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 7064558. [Operator Instructions]. Beginning today's call is Ms. Monique Dolecki, Senior Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our first fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our first fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Reconciliations to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. As a reminder, to provide additional revenue visibility into the new BD, inclusive of Bard, we will speak to our fiscal 2019 first quarter revenue results and fiscal 2019 revenue guidance on a comparable currency-neutral basis. The comparable basis includes BD and Bard in the current and prior year periods and excludes intercompany revenues and revenues associated with divestitures as detailed in the financial schedules and our press release. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, President and Chief Operating Officer; Alberto Mas, Executive Vice President and President of the Medical segment; Simon Campion, Executive Vice President and President of the Interventional segment; and Patrick Kaltenbach, Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vincent Forlenza:
Thank you, Monique, and good morning, everyone. As many of you already know, in December, we celebrated the one year anniversary of the closing of the Bard transaction. Together with Bard, we accelerated our strategy to provide our customers and their patients with leading medical technologies and innovative solutions. We are extremely proud of our achievements over the past year. It is evident that the combination of BD and Bard is delivering value to our customers, patients and shareholders. Turning to Slide 5 and our first quarter highlights. We are very pleased with the strong start to fiscal 2019. As we stated in our pre-announcement in mid-January, our first quarter results were ahead of our previous expectations, largely driven by the timing of certain tax items as well as better-than-expected performance across all three segments. Our results reflect continued momentum across our businesses and regions and strong margin expansion after a very strong Q4 in 2018. Our integration of Bard is on track, and we are continuing to realize cost and revenue synergies as expected. During the quarter, we held our first combined sales training meetings. In every region of the world, there was tremendous energy and excitement about the opportunity we have to make a difference in the lives of others. We are already seeing traction with our combined biosurgery and infection prevention sales force in Europe, which is evident in our financial results. We are also making good progress integrating and simplifying our systems and processes, which delivers cost savings and helps associates work more efficiently. We are leveraging BD shared service centers and the infrastructure investments we made during the CareFusion integration by bringing legacy Bard associates onto our IT, finance and HR operating systems and technologies. We've also made progress with supply chain efficiencies and also with our real estate footprint, combining BD and Bard sites in several key locations, including our New Jersey headquarters. Looking forward to the total year, we expect continued momentum and are reaffirming our fiscal 2019 revenue and EPS guidance. I will now turn things over to Chris for more detailed discussion of our first quarter financial performance and our fiscal year 2019 guidance.
Christopher Reidy:
Thanks, Vince, and good morning, everyone. Moving on to Slide 7, I'll review our first quarter revenue and EPS results as well as the key financial highlights. As Vince mentioned, we are off to a strong start in fiscal 2019. First quarter revenues grew 5.2% on a comparable currency-neutral basis. This includes a pricing decline of about 20 basis points, which was in line with our expectations. First quarter revenue growth was driven by mid-single digit growth across all three segments. At the business unit level, there are some puts and takes, which are driven by year-over-year comparisons, along with timing within this fiscal year. When we adjust for these items, we still drove total company revenue growth of over 5% on an underlying basis. I'll provide more color on revenue growth in the quarter in a moment when I take you through the results by segment and geography. Adjusted EPS of $2.70 grew 8.9% or 14.9% on a currency-neutral basis. As we stated in our pre-announcement, this was ahead of our previous expectations, as the quarter benefited from some timing within the year related to certain tax items. In addition, performance was better than expected across all three segments. We also continued to delever during the first quarter, paying down approximately $400 million of debt. As a result, our gross leverage ratio declined to 3.8x as of December 31. We continued to be on target to achieve our commitment to deleverage to below 3x over three years. Now moving on to Slide 8. I'll review our Medical segment revenue growth. BD Medical first quarter revenues increased 5.2%. Revenues in Medication Delivery Solutions, or MDS, grew 2.9%, driven by strength in vascular assess and infusion disposables. Performance in MDS reflected tough comparison to the prior year in the U.S. Revenues in Medication Management Solutions, or MMS, grew 6.7%. Growth in MMS was driven by stronger-than-expected capital placements in infusion. Diabetes Care revenues grew 0.6%. Revenue growth was impacted by the timing of distributor orders in the U.S. and the timing of tenders in EMA. Orders that were anticipated to occur in the first quarter are now expected to occur over the second and third fiscal quarters. Revenues in Pharmaceutical Systems grew 15.7%, driven by strong demand for core products and continued growth in SAIS. Performance also reflects the favorable timing of customer ordering patterns, which benefited the first quarter and is expected to negatively impact growth in the second quarter. Turning to Slide 9 and the BD Life Sciences segment. First quarter revenues increased 4.7%. This includes a headwind of approximately 50 basis points related to the strength of last year's flu season as expected. As you're aware, the timing and severity of the flu season can impact our year-over-year comparisons. Revenues in Diagnostic Systems grew 2.7%. Performance was driven by our instrumented microbiology platforms, including blood culture and IDAST and our BD MAX molecular platform. Performance in Diagnostic Systems reflects a tough comparison to the prior year for Kiestra installations as well as a headwind of approximately 130 basis points related to the flu grow over. Preanalytical Systems revenues grew 7.6%. Growth was aided by recent capacity additions that have eased constraints on the supply of push-button collection sets as well as the timing of distributor orders. Biosciences revenues grew 3.6%. Growth was driven by research reagents as well as growth in newer instruments, such as the FACSLyric. Performance in Biosciences reflects the unfavorable timing of tenders in EMA. Now turning to Slide 10 and the BD Interventional segment. First quarter revenues increased 5.7%. Revenues in Peripheral Intervention, or PI, grew 0.6% as we expected. This reflects a tough comparison to the prior year, which included sales related to a distribution agreement that has since ended. On an underlying basis, growth remained strong and in line with our full year expectations. In terms of DCBs, performance was in line with our expectations, and we did not see a negative impact as a result of the paclitaxel study released in December. Performance in PI also reflects strong growth in oncology products, particularly in emerging markets and China. First quarter revenue growth in Surgery was 10%. This reflects a favorable comparison to the prior year related to Progel. We continue to receive a very positive response to Progel being reintroduced in the market. Performance in Surgery also reflects a favorable comparison to the prior year in our hernia business related to Hurricane Maria, which partially reverses in the second quarter. We're also pleased that our hernia business has regained almost all of its shared following the hurricane. Growth in the Surgery unit also includes strong performance in infection prevention in Europe, where we expanded our direct sales presence as part of our revenue synergy investment. Revenues in Urology and Critical Care, or UCC, grew 7.3%. Performance in UCC was driven by new products in acute care urology as well as strength in our home care and targeted temperature management businesses. Now moving on to Slide 11. I'll walk you through our geographic revenues for the first quarter. U.S. revenues grew 6%. This is above our normal growth rate and primarily reflects strong growth in MMS and Pharmaceutical Systems within the BD Medical segment, Preanalytical Systems and BD Life Sciences segment, and Surgery and UCC in the BD Interventional segment as discussed previously. Moving on to international. Revenues grew 4.1%. Strong performance in Asia Pac and Latin America was partially offset by lower growth in Europe due to Kiestra and Pharmaceutical Systems order timing as well as a tough comparison to the prior year and timing of tenders in EMA as previously discussed. Developed market revenues grew 4.7%, driven by strong performance in the U.S. Revenues in emerging markets grew 7.8%. Performance was driven by growth of 13.3% in China and double-digit growth in Latin America, partially offset by EMA as previously discussed. Growth in China reflects strength across the Life Science and Interventional segments as expected. Performance in the Medical segment in China was slightly ahead of our expectations due to the geography of orders in Pharmaceutical Systems. Turning to Slide 12, which recaps the first quarter income statement. As discussed, revenues grew 5.2% in the quarter on a comparable basis and 37.1% as reported. Moving down the P&L. Gross profit improved during the quarter, increasing 42.8% year-over-year. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenues was 25.7%, which reflects Bard's higher SSG&A spend profile, partially offset by the achievement of synergies. R&D as a percent of revenues was 6.1%, which reflects our continued commitment to invest in innovation. Operating margins increased 80 basis points or 170 basis points on a currency-neutral basis. We continued to deliver significant operating margin expansion, which reflects strong P&L leverage as the new BD. Our tax rate was 11.2% in the quarter, which is significantly below our full year guidance range due to the timing of some discrete items. As expected, we paid preferred dividends of $38 million in the quarter. As we have been discussing, the preferred shares are not included in the shares outstanding calculation. In the quarter, adjusted earnings per share were $2.70, which is an 8.9% increase versus the prior year or 14.9% [Technical Difficulty] basis. Now turning to Slide 13 and our gross profit and operating margins for the first quarter. Gross profit margin was a strong 56.3% in the quarter. On a performance basis, gross profit margin improved by 230 basis points. This reflects the inclusion of Bard's more robust gross margin profile as well as our continuous improvement initiatives, cost synergies and favorable mix. These items were partially offset by headwinds from raw materials and pricing. Currency had a negative impact of 90 basis points on gross profit margin as expected. Operating margin grew 80 basis points in the quarter or 170 basis points on a currency-neutral basis. Margin expansion was driven primarily by gross margin improvement combined with synergy capture. Currency had a negative impact of 90 basis points on operating margin in the quarter. I'll take you through our fiscal 2019 guidance over the next several slides, but while we're discussing margins, I'd like to point out that we continue to expect to deliver margin expansion of 100 to 150 basis points on a currency-neutral basis. This is in addition to significant margin expansion of approximately 750 basis points over the last 5 years. Now moving on to Slide 15 and our full fiscal year 2019 guidance. As we discussed, while there are a number of moving pieces within the year, our underlying performance is strong, and we have reaffirmed our revenue guidance. We continue to expect total company revenue growth of 5% to 6% on a comparable currency-neutral basis. By segment, we expect BD Medical revenues to grow between 5% and 6%; BD Life Sciences to grow between 4% and 5%, which includes a headwind of approximately 90 basis points reflected to the flu -- related to the flu; and BD Interventional to grow between 6% and 7%. We continue to anticipate developed market growth of 4% to 5% and growth of about 10% in emerging markets, driven by a diversified base with low-double digit growth in China and strengthen in EMA and Latin America. Now moving on to Slide 16 and our full fiscal year 2019 EPS guidance. We have also reaffirmed our adjusted EPS guidance. On the left side of the chart, you see that we continue to expect strong underlying growth, driven by revenue growth and robust operating performance as well as the benefit from a lower tax rate due, in part, to the achievement of tax synergies. Partially offsetting this growth, there are a number of headwinds. First, while the pressure from raw materials has eased slightly, we continue to expect a headwind of about 2%. In addition, we continue to expect an impact of about 1% from tariffs, which includes the postponement of the increase from the 10% rate to a 25% rate. We continue to work with our partners to minimize the unfavorable impact to the company going forward. Our guidance also continues to assume a normal flu season, in contrast to the severe flu in fiscal 2018, which results in a headwind of about 1% in fiscal 2019, the majority of which will occur in the second fiscal quarter. The divestiture of Advanced Bioprocessing at the beginning of fiscal 2019 and the annualization of the divestitures to merit Medical will also impact our EPS growth in fiscal 2019. On a currency-neutral basis, our strong underlying performance is expected to drive adjusted EPS growth of 13% to 14% despite the pressure from headwinds and divestitures. Based on current rates, we continue to expect currency will be a sizable headwind of about 3.5% in fiscal 2019. This assumes a euro-to-dollar exchange rate of $1.14. All in, we continue to expect to deliver adjusted EPS of $12.05 to $12.15, which represents growth of approximately 10%. Now from a phasing perspective, we continue to expect revenue and EPS growth to be weighted towards the back half of the year. And as a result, the timing of a few items within the year that are impacting growth, we are providing explicit guidance for the second fiscal quarter. Starting with the top line, we expect revenue growth to be below our full year guidance range by about 100 basis points, driven primarily by the flu comparison. On the bottom line, in addition to the unfavorable impact from raw materials and tariffs, we now expect the headwind from FX will be most pronounced in the second quarter due to profit and inventory. We also assume a tax rate at or above our full year guidance range. However, as we saw this quarter, the tax rate can fluctuate depending on a number of items, including the possibility of special items arising in the quarter. Based on these variables, we expect EPS to be between $2.50 and $2.60 in the second quarter. Now turning to Slide 17. The balance of our guidance expectations for the full fiscal year 2019 remain unchanged. We continue to expect to achieve approximately $100 million in cost synergies in fiscal year 2019, and we're committed to fully realizing $300 million in annualized cost synergies over the three year deal period. We're excited about the momentum we have across our businesses and are confident that we will deliver on our commitments in fiscal year 2019 and beyond. Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio.
Vincent Forlenza:
Thank you, Chris. Turning to Slide 19 and our planned product launches by segment. As you can see, on this slide, we have a rich pipeline of planned product launches in fiscal 2019 across our segments. There are a number of things we continue to be excited about. I'll touch on just a few of the recent launches here. Starting with the BD Medical segment. We recently launched two new cloud-based applications, BD HealthSight Data Manager and BD HealthSight Diversion Analytics. Both are part of the BD HealthSight platform that enables an enterprise-wide connected medication management system. The data manager application simplifies the management of drug formularies for customers by allowing for a consistent understanding of every drug's identity across all BD devices and customer sites. The diversion analytics application is designed to help hospitals and health systems identify potential narcotic drug diversion through the use of augmented intelligence and integrated workflows. We are pleased with the strong customer interest in HealthSight, as the number of customer sites adopting the platform continues to accelerate. These newest applications are attracting even stronger demand and are already getting traction in the marketplace. Regarding our Type two Patch Pump, as expected, we submitted our regulatory approval applications for the U.S. and Europe and continue to anticipate our early access launch will occur late in calendar year 2019. We continue to be excited about bringing this differentiated solution to the market for people living with type 2 diabetes. In the BD Life Science segment, we recently received U.S. FDA clearance of the BD Phoenix CPO Detect test and the BD MAX Enteric Viral Panel. BD MAX continues to perform very well and drive growth in this segment, growing over 30% this past quarter. The BD Phoenix CPO Detect test expands BD's portfolio of solutions for identification and antimicrobial susceptibility testing of infections caused by CPOs. CPOs or superbugs, as they're more commonly called, represent a prominent threat to public health because these dangerous microbes are often resistant to nearly all available antibiotics. This new test gives laboratories an accurate and cost-effective method to rapidly identify CPOs and support patient management and is another example of the company's commitment to providing solutions to help address the global burden of AMR. With the approval of the BD MAX Enteric Viral Panel, BD now offers a broad suite of solutions for the detection of intestinal conditions of bacterial, viral and parasitic origin in clinically relevant targeted panels. With this launch, BD suite of assays for diagnosing gastrointestinal conditions will provide clinicians with greater flexibility for more efficient and cost-effective patient management. In the BD Interventional segment, as expected, WavelinQ, our solution that provides a minimally invasive nonsurgical option for creating critical AV fistulas for hemodialysis procedures, launched in the U.S. in the first quarter. We are pleased with the early results and feedback and look forward to introducing our next-generation product later in the year. Regarding Lutonix BTK, as you are aware, the first releases of our IDE trial data for our Lutonix 014 Drug Coated Balloon with a below-the-knee indication were provided at the VIVA and VEITH meetings in late 2018. The data has been well received and continues to generate interest and excitement in the marketplace. We have also continued to work with the FDA towards regulatory approval, and our projected time lines remain on track for commercialization by the end of fiscal year 2019. In addition to Lutonix BTK, we also continue to look forward to several new product launches later this year that will enhance growth in the interventional segment, including Venovo venous stent and Covera stent graft fistula indication. As you can see, we have a rich pipeline of new products across our businesses, and we look forward to sharing additional updates with you along the way. Before I move on, I would like to remind you that we have again included a slide in the appendix of today's presentation that provides an update on our sustainability initiatives. We hope you find the information useful in understanding BD's commitment to this important topic. Moving on to Slide 20. I would like to reiterate the key messages from our presentation today. We are very pleased with the strong start to fiscal year 2019. Our results reflect continued momentum across our businesses and regions, strong margin expansion and excellent execution by our BD associates. I want to thank all of our BD associates for their tremendous efforts on behalf of our customers, their patients and our shareholders. You've done an outstanding job. The integration of Bard is on track, and we are confident in our ability to achieve our cost and revenue synergy commitments. New product innovation is continuing to fuel growth, and we are excited about the robust pipeline across our businesses. In summary, we have a significant opportunity to deliver innovative health care solutions to our customers and their patients around the world. Looking forward, I am confident that we will deliver on our commitments in fiscal year 2019 and beyond. Thank you. We will now open our call to questions.
Operator:
[Operator Instructions]. Your first question comes from the line of Brian Weinstein with William Blair.
Brian Weinstein:
I thought we could just start with the phasing throughout the year just trying to understand that a little bit better, first half versus second half. Is this any different than what you originally thought? And can you talk about your confidence on the acceleration that's needed? It looks like you have to do kind of mid- to high 6s in the back half of the year here to get to the midpoint of the revenue guidance. So can you talk about your confidence on the acceleration there and dig into the drivers a bit more, both on the top line as well as on the bottom line?
Vincent Forlenza:
Yes. So I'll start and then I'll turn it over to Chris for some more detail. Yes, we feel good about it. This is how we expected the year to play out with the exception, of course, of the tax item that occurred in the fourth quarter. But if I go to operating results, this is pretty much what we thought would happen. Of course, we knew we had the large flu coming up that we had to jump over in the second quarter. We did a little better in the first quarter than expected as you heard in our remarks, but we always knew that the back end of the year, the second half of the year, we were going to see higher growth and accelerating EPS. And that's driven by actually all three segments and improving performance across each. There was a bunch of timing things that happened in the first quarter that Chris will walk you through, but you're going to see strong performance across all three segments, the phasing of the cost synergies in the second half and then FX turns around as well. So Chris, those are your high-level comments...
Christopher Reidy:
Sure. And I think Vince covered most of the points. I think it is in line with what we expected, with a couple of adjustments in terms of timing for Q1 to Q2. So for example, the higher tax rate in Q2 is to be expected considering 11% tax rate in Q1. So there will be some catch-up there. FX will be a little bit worse in Q2 than we had originally expected, and we know there are some other offsets to that. But that will hit us mostly in the second quarter. And then Pharm Systems growing nearly 16% in the first quarter. There will be some bounce-back on that in the second quarter, but the first half of the year just about where we would have expected. In terms of the rest of the year ramping, we did expect that, and we're very confident in that. On the revenues side, we've got a lot of new product launches in the pipeline across the business. You've got WavelinQ product that we talked about from the TVA acquisition, Venovo, Covera and Lutonix 018 and even some BTK upside potential. Progel, as we said, is doing very well, and our reintroduction of that product is going very well. As you know, we have revenue synergies ramping in the back half of the year, and then on the P&L side, FX abates in the second half and you start getting the cost synergies ramping. And so all those things give us great confidence in the second half of the year, and we're very comfortable with the full year guidance. It is a little bit lumpy, and that's what we had expected.
Vincent Forlenza:
Brian, just to add 1 or 2 more comments on the Life Science side. What you saw in the first quarter is a bunch of CD4 tenders that got shifted to later in the year, that's going to improve Life Sciences' growth. It also negatively impacted EMA in the first quarter. That's going to come back in the second part of the year as well. And then you saw some Kiestra timing that's going to help. So there's a whole bunch of things across the segments you're playing out that way. And then lastly on the Medical side, we're expecting continued strong growth in MMS as we do well, both in dispensing, but in -- particularly on the pump side of things. And Pharm Systems is going to continue to be strong for the year. It will be a lumpy next quarter, but then bounce back. So those are a whole bunch of things that are going on. And maybe, Alberto, you want to comment on what's happening in the pump space.
Alberto Mas:
Yes, thanks. This is Alberto. Yes, we are feeling very pleased about the performance and very confident on the MMS side this quarter, in particular, and for the rest of the year. On the infusion side, we're seeing continued above-market growth. We do feel very confident that we are gaining category share in the infusion in the U.S. A lot of that has to do with great acceptance of our refreshed Alaris M2 pump with our complete focus on interoperability, where we are seeing now 350 live sites in interoperability, and that's not -- that is a very difficult operational thing to pull off as we know by experience, and I think we've dialed in the process. And we're expanding interoperability beyond Cerner and Epic to new platforms as well, Meditech and Allscripts. And the last element that, I think, is driving the business as well is what I would call more horizontal interoperability as we've put into play all our platforms, and our HealthSight Analytics platform that leverages all our platforms together, not only the pumps, but gives really a lot of visibility across the different platforms is really engaging our customers and providing us nice wins in the marketplace. So very pleased with the performance of that business.
Vincent Forlenza:
Yes, thanks, Alberto, and of course, we grew 6.7% after we had such a strong quarter in the business. So last year, we were $50 million moved ahead and a bunch of that was pumps. So I think, overall, that should give you a good sense across the segments. Chris, do you have anything else you want to...
Christopher Reidy:
No, I think that covers it.
Operator:
Your next question comes from the line of Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen:
One question on emerging markets, one question on -- one follow-up question on MMS. So on emerging market, Vince, growth was 7.8% this quarter, little -- slightly softer versus recent quarters. The outlook is still 10% for fiscal 2019. Why the confidence there? And then just a follow-up on MMS, obviously, very strong this quarter after 23% growth in the U.S. in Q4. So maybe could you give us a little bit more color on share gain that you expect this year versus last year in pumps and Pyxis?
Vincent Forlenza:
Yes, sure. I'll talk to emerging markets. Yes, we're confident in emerging markets and what you actually saw was a decrease in EMA, which was actually two things, a strong comp, but also these tenders which have moved from the first quarter into the second, third and fourth. And so we're going to see a very strong bounce-back in EMA. We have the orders. That's why I am so confident. It's a matter, of course, setting up the financing, which is something that takes a bit of time to do. So you look at that. Latin America was strong right at double digits and, of course, China was strong and did extremely well. So it was really just EMA, and it bounced back. We have visibility to do gives me the confidence. So I bet a little bit more on share gains and also how we're doing with Pyxis too. You've been talking about the pumps.
Alberto Mas:
Yes. In terms of the category shares, it's very consistent with what we've said before, which is slightly accelerating share gains, more toward 200 basis points in infusion and closer to the 100 basis points on the Pyxis side, on dispensing side. And in dispensing and Pyxis, we really are supporting our core platform with a lot of new launches, Pyxis Logistics, Pyxis IV Prep for the pharmacy and Pyxis Supply as well that happened in the last quarter. So there's a lot of things, together with our overall platform. Again, HealthSight is the overall envelop, if you like, that really helps us in some of the conversion. So also a good performance on the Pyxis side.
Vincent Forlenza:
Okay. Great. So you get a sense that our new business model that we've put in place a year ago is really working for us. And Larry, thanks for the questions.
Operator:
Your next question comes from the line of David Lewis with Morgan Stanley.
David Lewis:
Just two questions for me. Vince, I appreciate the comments on the peripheral business this morning. But given the investor focus there, it sounds like most of the momentum deceleration there is really the distributor dynamic. But maybe just sort of talk about your confidence in sustaining growth in that business prior to the BTK launch and why you're convinced that there's been no sort of clinical response to the recent paclitaxel toxicity concerns. And then maybe for Chris, maybe just a little bit more detail, I think, we think about the earnings dynamics for this year, you laid out a lot of headwinds and tailwinds. I guess, some of those headwinds in our mind look a little less significant, just given where you came in here in the first quarter, your confidence in the back half of the year. I guess, in our -- by our math, I think there could have been a little more upside to the earnings guide, potentially this early in the year, but you held your earnings guidance. But maybe just talk about the pacing of earnings and your confidence in that earnings number and the headwinds and tailwinds into the back half.
Vincent Forlenza:
So Chris will talk first and then Simon will talk about the business question.
Christopher Reidy:
Okay, sure. Thanks, David. So in terms of the headwinds, I would say that the headwinds for resin costs, as we said, are getting a little bit better, as is the tariffs. But both of those have to flow through the inventory. So you're really not picking up all that much this year. And we would expect that to be offset by a little bit worse on the FX side as you see the dollar continue to strengthen, not only against the euro. The $1.16 versus $1.14 metric there doesn't seem to be too much, but it's pretty much against every other currency around the world. And so that's a little bit worse. So on balance, that evens out. And in terms of the guidance, it's still very early in the year, and we still have the flu season, which is a big variable that we're watching as well. So it feels like the headwinds and tailwinds are balancing each other, and it's a bit early to call the flu season.
Vincent Forlenza:
Okay. Simon?
Simon Campion:
Good morning, David. Simon here. So just at a macro level, we do have a lot of confidence in our projections going forward for PI. We have several new product launches that are coming up, not least BTK, but also Venovo and the Covera Fisher indication. So we're coming in just where we thought for Q1, notwithstanding some of the comments that Chris made earlier on. So our confidence is high, as we move through the rest of the year. In relation to the paclitaxel study that came out in December, we didn't see any impact in December or in Q1 rather clearly, there's been a lot of talk about it. And I think you have noted that on January 17, FDA came out and said that the benefits continue to outweigh the risks and some customers that we'd seen moderate their behavior as a result of the paper have now turned back on as a result of that paper -- as a result of the publication. And in addition, we released data at link, we continue to work with regulatory agencies domestically and globally. And we continue to have data that supports our position that we have -- we do not have any safety concerns with any of our Lutonix products.
Vincent Forlenza:
So I just wanted to add a little bit too on the 0.6%. So obviously, the takeaway is that it had nothing to do with the paclitaxel. It was a tough compare to last year. We had 11% growth and that is, as you refer to the Boston Scientific distribution agreement, which is now ended. Basically that was a loading of the channel that we have to jump over. There's also some timing when you're closing out the year with the transaction. Don't forget it was the last quarter for Bard and that's always a big quarter from a sales comp standpoint, so that made it a tougher compare as well. And there was even a little bit of drag from revenue recognition, we talk about that being immaterial at the BDX level, but it did have a data 100 basis points drag to the PI business. So a tough comp that had nothing to do with that paper, and we do expect that to be rebounding in Q2, the PI business. And we're still calling it to be high single digits for the full year.
Operator:
Your next question comes from the line of Kristen Stewart with Barclays.
Kristen Stewart:
I was wondering if you could just provide a little bit more color on Swatch, on the insulin kind of patch technology, just in terms of how you expect to approach the market? Does this require you guys to build up a sales force or just kind of any color in terms of kind of market activities that you may be looking to do as this year progresses, and then I have a follow up request.
Vincent Forlenza:
Yes, sure. I think Alberto is going to take that.
Alberto Mas:
Yes. We're obviously in the process of defining that, as was mentioned before. The early access units will be available towards the end of the calendar year first quarter of next fiscal year. So we have some time to -- but we're beginning to -- it has to do with obviously, typical evidence generation, it has to do with engaging the payers, it has to do with what channels do we use, in what way do we use in each of the channels. And yes, some additional focus resources that will be paced with our sales and our revenue generation appropriately. So we are looking at all these factors. It's a little bit too early to define these things because -- but we've started the process, certainly in terms of engagement of outside parties. And we're still defining our own channel strategies in detail, so stay tuned on that.
Kristen Stewart:
Will there be any clinical -- any of the clinical experience presented at ADA? Or any other meetings?
Alberto Mas:
I don't think so, but maybe on follow up, we can define that better.
Operator:
Your next question comes from the line of Bob Hopkins with Bank of America.
Robert Hopkins:
So just two quick questions. And I apologize, if I missed this but just on the FX headwinds for the second quarter and really the first quarter. Can you just quantify the headwind to EPS that's implied in that Q2 guidance and then also what the specific EPS headwind was in Q1? Just so we can get a sense for the -- FX state in the first half versus the second half?
Vincent Forlenza:
Sure. So as we had called out in the first quarter, there was about $0.15 of headwinds. We see that accelerating to about $0.22 in Q2. Again, the dollar's moved, strengthened a little bit. We have visibility into the profit and inventory coming through in the second quarter. And then the second half of the year, you basically lapped the strong dollar year-over-year, so those FX headwinds abate. So it's really a first half story but accelerating drag in the second quarter for about $0.22.
Robert Hopkins:
Right. Okay, perfect. Makes for easy math in the back half. And then the other thing I just wanted to discuss really quickly on the MMS side was, obviously you had a fantastic last quarter and a strong quarter this quarter, but obviously very different growth rates from the low 20s down to where we are today. And I was wondering if you could just kind of help us understand the moving pieces driving those big swings and what the cadence looks like for the division over the course of the rest of the year.
Vincent Forlenza:
Okay. So Alberto can talk to that.
Alberto Mas:
Yes. This is Alberto. This -- most of the business on the infusion side is cash sales if you like as we sell the product. So it has to do a lot of with -- a lot of times when we place the instruments, when we install the instruments and that is defined by, obviously, the contracting process but also when the customer is ready for that implementation. So there's a bulk -- a bit of a bulky sales quarter-to-quarter, depending on the disposition of the customer to actually install the resources there, and we can't always control it -- the quarter-on-quarter. Obviously, that normalizes on a yearly basis. On the Pyxis side, most of that now is, given our trace methodology. 75% of that business is very predictable so there's less variability there. But 25% continues to be what we call cash business and that depends on what the timing of the contracts and installations and things like that so that's what's driving that. And we do have some visibility on these things, but ultimately it's when you schedule some of these installations and placements with the customer that drives the quarterly revenues. But we're -- we have some visibility obviously in the coming quarters, and we feel confident that overall, in the year, we'll have the expected results and if not -- we're confident about the overall results for the year.
Vincent Forlenza:
Yes. And Bob, I would add that yes, we had 20% growth in the fourth quarter, which was particularly strong but that's really not indicative of what we would expect for the year. But having said that, MMS is very strong and a 6.7% growth rate in Q1, following up that pull forward of quarters into the fourth quarter is really very strong growth. We see that continuing in the second quarter as well with high single-digit growth. So clearly, MMS is growing very strong, it has got a lot of great momentum based on some of the things that Alberto has been talking about. So we really feel good about that part of the business.
Operator:
Your next question comes from the line of Isaac Ro with Goldman Sachs.
Isaac Ro:
Chris, I wanted to come back to the comment on fiscal 2Q EPS guidance. The [indiscernible] like -- more like $2.92 so clearly the FX dynamic, we miss modeled, you gave us the bottom line FX I think $0.20. Could you maybe go a little further up the pineal, and give us a little bit more detail on what the FX means for gross margin and net margin just so that we get the quarterly trend proper there?
Vincent Forlenza:
Sure, let me go through each step. So obviously, we talked about revenue growth being down around 100 basis points from low end, so think about 4% and that's really primarily two big things. It's the tough flu compare of about 70 basis points and then you've got farm systems, which grew 16% in the first quarter and you know that's a lumpy business. So that moderates in the second quarter and that's a drag of about 50 basis points year-over-year. Then there's a bunch of other puts and takes in biosciences and a tough PI compare. Those kinds of things will be another 30 basis points or so. So about 150 basis points of drag on the topline that obviously flows down. Then you've got the drag on from FX, which is most pronounced in Q2 as we talked about and that will have a greater impact on the gross margin. You also got the rollout of some of the raw material and resin cost and tariff cost that we talked about, that really hit us more in the second quarter than it did in the first quarter. And then another point I'd make is on a year-over-year basis. We started to ramp the investments to get revenue synergies in the second half of last year and those are ramping, and we continue to spend that or make those investments. And so in the second quarter, the year-over-year impact is a headwind as well. Now it's positive in terms of those investments at driving revenue synergies that show up in the second half of the year, so there's unfavorable timing of spending on things like that. And then lastly, obviously you have the tax rate being 11% in the first quarter, and that's going to moderate somewhat to get to our 14% to 16% for the remainder of the year. You put all those things together. We didn't want anybody guessing. We put out the number of $2.50 to $2.60 just to get everybody aligned with that.
Isaac Ro:
Really helpful. And then maybe Vince, a follow-up question for you on end markets, specifically China. If I look at the Life Science part of the franchise and listen to what your peers have had to say, it seems like the outlook there remains pretty healthy, anywhere from high singles to low double digits for the rest of the year. Can you just comment on what's baked into your expectations there and just kind of your visibility as to the pace of spend. We're obviously all looking at macro data points to try and get a sense of the economic effect as we enter 2020 and that region seems the most sensitive towards changing the cycle. So I appreciate your view.
Vincent Forlenza:
Yes. Let me take you to the high level, and then I'll turn it over to Patrick to talk about Life Sciences in China, which is doing quite well. And so we actually had the leader of China in here about a week ago, and we see -- even though with the economic slowdown, we could see continued spending on health care and neither real change in the cost control mentality that was there a year ago. So kind of steady on that sense and not doing big capital projects building hospitals but they are funding continuing care. And so we had a good first quarter across all of our businesses. And as I mentioned, a little better on the medical side, including Life Sciences. And so as we look at, not just over the base, the rest of this year, but even in the next couple of years that seems to be the pattern that we're going to expect continued funding of the health care system. It drives stability in the country so that's the way we're looking at, that's where our China team is looking at. So Patrick, maybe you want to talk a little bit about Life Sciences and what you're seeing there.
Patrick Kaltenbach:
Sure. I'm happy to. Yes, definitely -- I mean, if you look at Q1, we grew about 14.7 -- close to 15% in China. In Life Sciences, they've very, very strong underlying growth. And also, for the full year, we continue to project double-digit growth for sure. And as Vince said, there's a lot of investments, not only in health care, there's a lot of investment in pharma and also a lot of investment in life science research, where we played a lot of our B2B products. So we are very confident that the underlying growth and demand in China will continue for the remainder of the year and also next year. There's, as you know, the current five year plan in China really is focused on providing better health care to the population in China, and it will drive a lot of the underlying growth.
Operator:
Your next question comes from the line of Robbie Marcus with JPMorgan.
Robert Marcus:
Two for me. One, can you talk about where you stand in terms of sales and operational synergies with the Bard business? We've seen now a one plus one equals more than two from the combination. And then maybe just spend a minute on the Urology Business. One that was growing low single digits with Bard but since the deal it has been in the mid- to high single digits. Just help us understand what's going on there.
Vincent Forlenza:
Sure. So first Tom will talk to you about the Bard synergies and where we're going with that and then Simon can talk about the really strong performance in the Urology.
Thomas Polen:
Robbie, this is Tom. So I can touch base very briefly on, certainly, the cost synergies but that will really focus on the revenue synergies. Obviously, cost synergies are going as planned, as you've heard earlier, and we expect that to continue to ramp up through the back half of the year. I think, probably the more interest to you is on the revenue synergy side. And so as we think about that overall, we still expect Bard revenue synergies of about $250 million by FY '22 that's greater than the CareFusion revenue synergies of $150 million to $175 million by the end of this year, which is well on track. And of course, both of those are five year targets. So in FY '19, we see revenue synergies to be -- think about it in the 10s of bps. Relatively -- minimal to no profit impact in our EPS benefit in FY '19 because we're investing behind getting those initiatives. We started seeing EPS benefits of the revenue synergy starting next year, more meaningfully. So as you think about what the drivers of those are, as we've said in the past, we invested about $15 million in FY '18 towards revenue synergies. Most of those in selling, particularly around our vascular access portfolio, bring together the PICC, the midline, the catheter sales team as well as investing in a new surgery sales force in Europe. And so, the three areas that we've talked about historically on revenue synergies are all progressing to our plans. Those three are vascular access, where we've got the broadest portfolio of vascular access devices, again, from PICCs to central lines to catheters. And we've integrated our sales forces in the U.S. and Europe so that they're all selling now the entire portfolio. And we're seeing really positive customer feedback, again, we just did that this past summer. But as we look at our pipeline in those categories, I'd say it's certainly stronger than it ever has been, pre BD and Bard coming together. So we really feel good about the momentum there, and we expect some benefits in the back half of the year. Second on surgery, again, we've just put in -- also late last year, the biosurgery sales force in Europe, and we're seeing some early positive signs there. So we're seeing infection prevention growth rate in Europe went up this past quarter. We're feeling good about the next quarter. And so that momentum is heading in the right direction. We put in -- just to know, we went from 0 to about 50 reps in biosurgery, in Europe, as part of that investment strategy, so it's a meaningful number. And then second -- I'm sorry, third was the geographic expansion. And so right there, we had talked that legacy Bard has invested heavily in China, and saw a strong growth there but had relatively limited penetration in Latin America, EMA, rest of Asia outside China. And so we've started registering -- I'm sorry, we started expanding the channels in some of those markets as well to get after some growth opportunities that we see. So I think that sums up hopefully on -- where we stand on synergies, but we feel good about it. And I'll turn it over to Simon to talk about Urology.
Vincent Forlenza:
Maybe just before Simon starts, a little bit more data on the cost side. Chris?
Christopher Reidy:
Sure. So just to kind of talk about the phasing a bit. As you know, we drove about $75 million of cost synergies last year, in fiscal year '18. We'll do a $100 million and the rest flow into another $100 million in the following year and then the last $25 million. So if you think about what we said, $300 million, essentially $100 million, $100 million, $100 million per year, but because we only had three quarters last year, some of that flows into '21. I would say that what we're seeing is great traction in terms of supply chain and procurement synergies. And as Vince had mentioned in the prepared remarks, we're really leveraging our platforms and the infrastructure investments that we made during the CareFusion integration, by bringing Bard on to our IT, Finance and HR operating systems. And then notably, some efficiencies in our real estate footprint, think of that as sales offices at this point, those kinds of things, as well as the headquarters here in New Jersey. So we've made good move in getting all the Bard associates up here to Franklin Lakes and closing down the Murray Hill facility, so good traction on all of those points. And then as we think through the remainder of the synergies, think distribution centers and manufacturing plant synergies, those kinds of things, continuing some of the infrastructure as well into '20. And -- so really feel good about the visibility that we have and the traction that we have on cost synergies.
Simon Campion:
Robbie, its Simon here. Listen, as you know, in UCC, there are three legs to that stool
Operator:
[Operator Instructions]. Your next question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Just maybe on the guidance here. Chris, if I understand what you're saying -- are you saying gross margins are going to be down sequentially and OpEx up just for us to get to that guide? And given your revenue commentary, some of it implies back half of 6%, but you do have tough comps back half. So I'm just trying to understand the back half cadence.
Christopher Reidy:
Sure. So what you'll see is, in Q2, the gross margins, for example -- actually a slightly favorable year-over-year, but it should be around the 56% level and then those ramp considerably in the second half of the year and that flows down to operating margin as well. So you really get the pressure in the second quarter and then as synergies and continuous improvement and FX abates in the second half, we see that building. So think about the low end of -- below the guidance range of 56.5% to 57.5% on gross margin, kind of in that 56% range in the second quarter. And so there is a bit of lumpiness but strong rebound in the second half.
Operator:
Your next question comes from the line of Brandon Couillard with Jefferies.
Brandon Couillard:
Quick one for Chris, just curious if you could quantify the impact of that tender timing, whether it's in Life Sciences or biosciences, either one in the first quarter?
Christopher Reidy:
So this is -- in EMA, I think you're referring to, and it is a big drag in the first quarter. It rebounds considerably for the remainder of the year and that is Biosciences. It's in a little bit in other areas as well, Diabetes Care, we referred to in our prepared remarks. So primarily, in those areas. And as we talked about, if you look at the emerging market growth of 7.8%, you've got China growing over 13%, you've got a double-digit on Latin America. So you can see EMA was a significant drag to get you down to 7.8% and that's just a timing of orders. And as Vince said, we have the orders in hand, we feel we're confident that, that bounces back for the remainder of the year. And we close out EMA for the full year with a double-digit growth rate. So just an anomaly in the first quarter.
Operator:
Your next question comes from the line of Larry Keusch with Raymond James.
Lawrence Keusch:
Chris, just on the synergies, again, the cost synergies. Clearly get the sense that they are built through the year, but cause again, just help us think about that second half. Is this really more of a fourth quarter event? Or do you start to see some rebound in the third quarter? And then also just, Vince, any quick comments on just sort of the environment in Europe as a whole?
Christopher Reidy:
Yes. So Larry, you do see it's starting in the third quarter, so think there and fourth quarter, probably a little bit more in the fourth quarter than the third quarter but still very strong in the third quarter as well.
Vincent Forlenza:
And the environment in Europe, I would call it stable from our business standpoint, we really didn't see any major changes in demand or pricing or anything.
Operator:
Your next question comes from the line of Bill Quirk with Piper Jaffray.
William Quirk:
Two quick ones for me. Vince and Tom, I know, you don't break it out anymore, but any comment on safety adoption and some of the major geographies and I'm thinking specifically kind of emerging markets in Europe? And then, secondly, Patrick, just a comment regarding the reimbursement shifts in infectious disease panel. You guys are obviously doing very, very well in that space, and it looks like that it may get more attractive as some of the prior payers follow CMS.
Vincent Forlenza:
So on safety, Alberto, you going to take that?
Alberto Mas:
Yes. On the health care worker safety, which is some of our traditional like year, I think obviously in the U.S. that is mostly behind us. In Europe, the big push is there's still more to do, but I think, it'll be a slow, a slow gain in terms of the penetration safety. The big push also is probably behind us, but there'll be steady growth there. And the opportunity still remains in the emerging markets as the standards of livings and the availability of funds happen, there will be -- it'll be adopted more. So that's probably where the upside to it is. We're also not pivoting more to patient safety, a more comprehensive view of safety, and I think there, we're seeing -- we're putting in place some pilots that really can -- we think that can begin to move the needle beyond just the health care worker's safety and more centered around the patient. And there's this other components like a hazardous drug safety as well, which is related then also to more health care. But it's not from a needles and syringes and catheter perspective, but more protecting the pharmacist doing the preps against oncology-type drugs that are hazardous to health.
Vincent Forlenza:
Yes. Just to support what Alberto was saying. You step back and you look at our safety, how we're focused in safety, remember, once we've done, we did the Bard transaction, we now cover 75% of the HAIs. And so as Alberto was indicating, we have a broad infection prevention program, that is more of the growth driver than a needlestick safety at this point in time, and we think that's where the real legs are.
Operator:
Your next question comes from the line of Rick Wise with Stifel.
Frederick Wise:
Chris, maybe just picking up on your early comments about the accelerated debt paydown. I think you said, you paid down over $400 million in the quarter. I mean, clearly, you're on track to get below three, but just remind us why you need to get below three, it sounds like the debt paydown could even accelerate as the year unfolds and maybe evolving use or cash priorities or balance sheet priorities or options over the next 12 to 18 months as you get toward obviously a very much delevered position? Congrats on all that.
Christopher Reidy:
Thank you. Well, we did pay down $400 million in Q1, and we paid down $1.6 billion since the transaction closed. And we're down to 3.8x leverage at this point on a path to 3x leverage by December of 2020, and you can think about that as ratable. So you mentioned accelerated, this is pretty much in line with what we had anticipated. Now when we committed to 3x leverage, we also left ourselves some room to do tuck-in acquisitions and to continue to invest in the business. And so we've continued to do that. You saw the TVA Medical acquisition as an example of that. So we're not feeling constrained in terms of doing tuck-in acquisitions. And I think it's important that we get back to our commitment levels because when you flex your leverage like that, you're committing to the rating agencies that you're coming back to a more normal leverage level. And we did that on CareFusion, we got back down to the 3x leverage. And so we're very focused on living to that commitment again, and well on our way to do that.
Operator:
Your next question comes from the line of Matt Taylor with UBS.
Matthew Taylor:
I wanted to ask one about Medication Management Solutions. You continue to do well and you've talked about above-market growth there for infusion and Pyxis seems to be doing well as well. So with the new HealthSight platform and with this outperformance that you've driven now for years, I was hoping you could give us an understanding of how long you think you can drive the above market performance? Where are the enhancements that we could see going forward? And where are you gaining share from? Is it new sites or you're actually taking competitive share?
Alberto Mas:
Well, I'll start -- this is the Alberto. And I'll start with the last portion of the question. I think there's two aspects to that. One is that we're expanding the market with new capabilities and HealthSight is an example of that, that we're not there before, and we're doing that fairly uniquely. So that obviously affects our share of the other part, if you like. And then we -- in terms of what the visibility that we have, we think that the current environment and competitive environment will continue in the sense that we anticipate to continue to do that in the foreseeable future. Beyond that, it's more difficult to say, but we could continue to invest in our platforms, in our capabilities and mostly, this comes as better as one. All our platforms are unified in terms of the tax stack, in terms of the analytics and we think that's a big, big driver in the medium term and the long term.
Thomas Polen:
Matt, this is Tom. Maybe just to compliment Alberto's comments. So we don't comment on specific competitors by, let's say, we were taking share across most everyone in both the pump-end and the dispensing space at this point. And so we do feel good about that momentum and as you've heard from Alberto as well, we've been continually shifting since BD and CareFusion came together. We certainly continue to invest in the platform itself, let's call it the hardware, which has been traditionally, where a lot of investments are gone. We do have and we've recently released NexGen pump, of course, with the M2. We've got NexGen pumps beyond that as well deep in our -- deep and well underway in our pipeline. And we have the same thing for Pyxis, of course, we launched Pyxis ES, we have got NexGen versions also in our pipeline as well. But we have very purposely shifted a chunk of that investment increasingly into the software solutions. And you saw that with HealthSight, you saw that with the narcotic division, analytics, et cetera. And we see that's -- right when customers look at our solutions versus what may be available from others in the marketplace, it's that software connectivity across the platforms that really allows someone to manage the medication management process in a unique way that we think, we become a very preferred and unique offering in the marketplace because of the solutions that we've been able to bring together. That's in the hardware, but through the software that connects everything and eliminates the inefficiencies in the process and eliminates the opportunities for medication errors in a way that, again, is very unique in the marketplace.
Alberto Mas:
This is Alberto, I just compliment one data point to give you a sense of how HealthSight is getting traction. HealthSight Viewer which is something that we -- it's a product that we launched in fiscal '18, already has over 140 sites that are live, for example. There's obviously some others like Diversion, and we've been through optimizations and a little bit too early to say, we do certainly see some contracts flowing through but the 140 sites for HealthSight Viewer are live.
Operator:
Your next question comes from the line of Richard Newitter with SEB Leerink.
Richard Newitter:
Just a follow up on MMS. With respect to the capital spend environment in the U.S., we've seen number of competitors and companies in the space that have put up some strong capital numbers. The environment seems pretty robust and they're like also -- I would imagine just confusion for some of your confidence in the outlook for this division. So I guess, how much of the robust outlook is underlying capital investment? We're already in the cycle under review and again, how much of a lift or the optimistic outlook is underlying spend versus the market share gain that you can allude to that?
Vincent Forlenza:
I think there's a couple of things going on here. One is hospitals in terms of capital spending are doing well, and we don't see any significant change in that in the short run. The other thing that's going on is that, we've seen remarkable concentration of our customer base and starting to see a shift in governance. And let me call it improved governance across large systems. And as that happens, they want the standardize care, they want to standardize their systems, and I think what you're seeing is, early on in that conversion with that mentality, in the marketplace and the kind of approach that we are taking with HealthSight, and the informatics tying us across the entire system. Alberto just gave you a quick update on the fact -- the number of accounts and whatnot, we think we're very early on in that story and the winners in the marketplace are going to have to run that way.
Thomas Polen:
And this is Tom. And maybe just one other comment as well just to keep in perspective. Obviously, we get very focused on what's happening in the U.S. with the Pyxis and Alaris and the software solutions we've talked about. But I would say that we're also getting strong performance in the other areas of MMS as well and that includes our CME acquisition that we did the other year, which is for the alternate site home infusion market, primarily outside of the U.S. And also our roll-up platform, which is for retail pharmacy dispensing. We've begun having some sales in the U.S., but that's still as primarily an ex-U.S. business, and it's also growing very nicely double digits. And it's getting of increasing size because we've been growing it double digits for the last few years. So areas we don't speak as much about, but certainly are helping to fill the MMS growth rate as well.
Operator:
Your next question comes from the line of Amit Hazan with Citigroup.
Amit Hazan:
I want to come back to the interventional and peripheral segment, and just ask it looks regionally that the slowdown was both in the U.S. and outside the U.S. So just a clarification, if you can help us understand if in the Boston Scientific distribution agreement impacted both regions and then, just given the focus on DCBs here, a little bit increased focus. If you can just give us a reminder of how DCBs grew in your fiscal '18 and what you expect for fiscal '19 for DCB growth?
Thomas Polen:
So Amit, this is Thomas. So with respect to outside the U.S. we -- as Chris said earlier on to -- there were some tender issues here in Q1 on a global basis that we're coming back from in Q2 and beyond. And with respect to DCBs, across the board, we expect mid- to high single-digit growth in DCBs across the SFA and AV platforms. But I think it's very important that we don't isolate the DCBs when we have a full complement of solutions. So DCBs, PTAs stent grafts, we have the whole bag whether it's SFA intervention or AV intervention. So to focus on one aspect of that is not doing the kind of the leadership of the position that we've worked out to generate any favor. So we look at it as a total solution here.
Vincent Forlenza:
And so great new products coming out there. Thanks, thanks for the question.
Operator:
And presenters, there are no further questions. Do you have any closing remarks?
Vincent Forlenza:
Yes, thank you very much, and thanks to everyone for their questions and a really great dialogue. So let me just go -- move my closing remarks. In December, we celebrated the one-year anniversary of the closing of the Bard transactions, and I have to say, we're really proud of our achievements over the past year as a combined company. It's just off to a great start. Secondly, fiscal 2019 is off to a strong start with continued momentum across our businesses and regions after a strong finish to the year in '18 and looking ahead, I'm confident that we will continue to deliver on our commitments. So thank you very much. We look forward to updating you next time.
Christopher Reidy:
Thanks, everyone.
Vincent Forlenza:
Have a great day.
Operator:
This concludes today's conference call. You may now disconnect.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co. Patrick Kaltenbach - Becton, Dickinson & Co. Simon Campion - Becton, Dickinson & Co.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Brian David Weinstein - William Blair & Co. LLC Isaac Ro - Goldman Sachs & Co. LLC Robbie J. Marcus - JPMorgan Securities LLC Bob Hopkins - Bank of America Merrill Lynch Lawrence Biegelsen - Wells Fargo Securities LLC Kristen Stewart - Barclays Investment Bank Vijay Kumar - Evercore ISI Richard Newitter - Leerink Partners LLC William R. Quirk - Piper Jaffray & Co. Amit Hazan - Citigroup Global Markets, Inc.
Operator:
Hello, and welcome to BD's Fourth Fiscal Quarter and Full Fiscal Year 2018 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through November 13, 2018 on the Investors page of bd.com, or by phone using 800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 3197559. I would like to inform all parties that your lines have been placed on a listen-only mode until the question-and-answer segment. Beginning today's call is Monique Dolecki, Senior Vice President of Investor Relations. Ms. Dolecki, you may begin the conference.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our fourth fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our fourth fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Reconciliations to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. In the fourth quarter, the company recorded $58 million in non-cash charges to write down the carrying value of assets primarily within our Diabetes Care business. Following a limited launch of our insulin infusion sets in fiscal 2017, and a product redesign in early FY 2018, the product did not deliver the differentiation we were seeking. As a result, we made the decision to discontinue the sets and focus on accelerating other key innovations. During the quarter, we also wrote off other investments related to a production facility in our Diabetes Care business. These items, along with the details of purchase accounting and other adjustments can be found in the reconciliations to GAAP measures, in the financial schedules, in our press release, or the appendix of the Investor Relations slides. As a reminder, to provide additional revenue visibility into the new BD, inclusive of Bard, we will speak to our fiscal 2018 revenue results and fiscal 2019 revenue guidance on a comparable currency-neutral basis. The comparable basis includes BD and Bard in the current and prior-year periods and excludes the revenues associated with divestitures as detailed in the financial schedules in our press release. Our fiscal 2019 guidance also includes an estimate of the impact of adopting ASU 2014-09, Revenue from Contracts with Customers, as of October 1, 2018. Before I turn the call over to Vince, we would like to comment on the leadership change that we just announced last month. We are very pleased to have promoted Tom Polen effective October 1 to Chief Operating Officer of BD. As President and COO, Tom's responsibility has been expanded to include global operations and supply chain in addition to his current oversight of BD's three global operating segments
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. Before we discuss the company's performance, I would like to comment briefly on the organizational change Monique just mentioned. Tom's promotion to COO reflects the leadership role he has played developing and implementing BD's strategy and vision over the past 18 months. Since Tom was named President in April 2017, BD has made great progress on the Bard integration, named three strong leaders to the segment President roles, and appointed a dedicated Chief Technology Officer. These key leadership appointments position the company well and increase Tom's capacity to focus on driving our strategy, advancing our culture, and accelerating BD's growth and impact. I look forward to continuing to partner closely with Tom, as we take BD to the next level and fulfill our potential as the partner of choice for the global healthcare industry. Now, turning to slide 4, the combination of BD and Bard has significantly accelerated our strategy and has already delivered measurable results, which we will speak to throughout the presentation. Turning to slide 5, I'd like to highlight some of our key achievements in fiscal year 2018. As I look back on last year, I feel incredibly proud of what our organization was able to accomplish. As you already know, earlier this year, we brought C. R. Bard into the BD family. As we exit 2018 and enter fiscal year 2019, it's evident to me that we are truly better together. As expected, we finished the year with a very strong performance and momentum across our businesses. We saw this in both our core legacy BD and Bard portfolios. For the full year, we grew revenues 5.8%, we also drove approximately 210 basis points of margin expansion, and delivered double digit EPS growth. And we achieved all of this while overcoming significant headwinds and making strategic business investments. Our organization has demonstrated just how agile we can be, concurrently executing on both the CareFusion and Bard acquisitions while continuing to drive our strategy forward and simultaneously delivering strong performance. Fiscal 2018 marked the third year of the CareFusion deal, and as we previously announced, we achieved our targeted $350 million in annualized CareFusion cost synergies. At the same time, we are delivering on our Bard commitments. The integration and synergy capture are on track, and we are well on our way to reducing our leverage to below 3 times in three years. Also, our new product innovation is continuing to fuel growth, from the new Alaris Pump and Pyxis ES in our Medical segment, to BD MAX, BD FACSLyric and continued expansion of our BD Horizon Brilliant dyes in Life Sciences, and Lutonix AV and Covera in the Interventional segment, just to name a few. There are also a number of things in the pipeline that we are equally as excited about, and I'll touch on those later in the presentation. And as we have shared with you previously, we successfully completed the transformation of the U.S. Dispensing business model, delivering more value to our customers as evidenced by our share gains. In fiscal 2018, we continued to strategically focus our portfolio, and we divested several assets, including our remaining interest in the Vyaire Medical joint venture, and select product lines related to the regulatory approval of the Bard transaction. We also announced the divestiture of our Advanced Bioprocessing Business, which closed late last month. On the acquisition front, we were very excited to announce the acquisition of TVA Medical. This is a great example of our continued strategy to pursue tuck-in acquisitions to advance our category leadership and enter into additional high-growth segments. All-in, we feel really good about our business performance and strong execution. Moving to slide 6, you will see our initial guidance for fiscal year 2019, which reflects continued momentum across our businesses and strong revenue growth of 5% to 6% in line with the Bard deal model. On the bottom line, we expect to deliver adjusted EPS between $12.05 and $12.15. We expect to drive strong underlying currency-neutral earnings in excess of our deal model of 16% to 17%, which will partially mitigate the macro headwinds that can continue from fiscal 2018. All-in, we expect to drive earnings growth of about 10%. Our outlook is based on our current view of the environment. As is normally the case, there are a number of items that could bring us to the top or bottom end of our guidance range, including
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. I'm also extremely proud of what our organization achieved in 2018 and the strong momentum we carry into 2019. On slide 8, I will review our fourth quarter revenue and EPS results, as well as the key financial highlights for the quarter and the total year. Fourth quarter revenues grew 8.4% on a comparable currency-neutral basis, driven by broad-based strength across all three segments. As we communicated to you last quarter, our confidence in achieving our increased full year fiscal 2018 revenue outlook was based on continued momentum in the fourth quarter with particular strength in our MMS and Pharmaceutical Systems units, and some re-acceleration in Surgery, all of which we achieved. I'll provide more color on revenue growth in the quarter in a moment when I take you through the results by segment and geography. Fourth quarter adjusted EPS was $2.93, growing 22.1% over the prior year, or 24.6% on a currency-neutral basis. For the total year, revenues grew 5.8% on a comparable currency-neutral basis. As a reminder, our full-year results include the impact in the first half of the year from the U.S. Dispensing change, as well as the impact from the hurricane in our first fiscal quarter, which lowered total company revenue growth approximately 60 basis points. Excluding these impacts, we drove full-year revenue growth of approximately 6.5%. This includes approximately 1% of growth related to acquisitions, flu revenues, and timing that benefited the fourth quarter. We also significantly expanded our margins in fiscal 2018. As we previously disclosed, we achieved our targeted $350 million in cumulative annualized CareFusion cost synergies. In addition, we realized approximately $75 million in Bard cost synergies in fiscal 2018. Full year adjusted EPS of $11.01 grew 16.1% or 12.3% on a currency-neutral basis. Growth was driven by strong performance from both legacy BD and Bard businesses, which helped to offset notable headwinds in fiscal 2018. I'll provide more color on fiscal 2018 EPS growth later in my remarks. We also continued to delever during the fourth quarter, paying down approximately $700 million of debt. For the full fiscal year, we paid down a total of $1.2 billion, slightly ahead of our initial expectations. As a result, our gross leverage ratio declined to 3.9 times as of September 30. We continue to be on target to achieve our commitment to deleverage to below 3 times over three years. Additionally, we are also very pleased to have continued our long-standing record of delivering an increasing dividend. Fiscal 2018 marked our 46th year of consecutive dividend increases. Moving on to slide 9, I'll review our Medical segment revenue growth on a comparable currency-neutral basis. BD Medical fourth quarter revenues increased 10.1%. For the full fiscal year, Medical revenues grew 5.6%, which includes an estimated 80 basis point headwind from the U.S. Dispensing change. Revenues in Medication Delivery Solutions, or MDS, grew 5.9% in the fourth quarter, driven by strength in vascular access and infusion disposables. For the full fiscal year, MDS revenues grew 5.6%. Revenues in Medication Management Solutions, or MMS, grew 21.3% in the fourth quarter. Growth in MMS was driven by strong capital placements in both infusion and dispensing, as expected. Additionally, growth in the quarter was aided by placements that occurred earlier than originally anticipated. For the full fiscal year, MMS revenues grew 6.6% including a headwind of approximately 280 basis points from the U.S. Dispensing change. Fiscal 2018 was another year of strong performance in MMS, driven by new product launches and continued share gains in both dispensing and infusion. Diabetes Care revenues grew 1.7% in the fourth quarter. Strength in pen needles in the U.S. was partially offset by a tough comparison to the prior year. For the full fiscal year, Diabetes Care revenues grew 2.9%. Revenues in Pharmaceutical Systems grew 9.4% in the fourth quarter, as expected, driven by strong demand for core products and continued growth in SAIS. For the full fiscal year, Pharmaceutical Systems revenues grew 6.4%. As we move forward, we are well positioned to take advantage of market trends towards biologics and prefilled vaccines. Now, turning to slide 10 and the BD Life Sciences segment, fourth quarter revenues increased 6.9%, with strong performance across the segment. For the full fiscal year, BD Life Sciences revenues grew 6.8%, including approximately 90 basis points of growth related to flu revenues. Revenue in Diagnostic Systems grew 8.2% in the quarter. Performance was driven by our instrumented microbiology platforms, including blood culture, TB, and IDAST, strong Kiestra installations and our BD MAX molecular platform. For the full fiscal year, Diagnostic Systems grew 9.6%, which includes approximately 270 basis points of growth related to flu. Preanalytical Systems revenues grew 6.1% in the quarter, driven by push button collection sets, where recent capacity additions have eased constraints on supply. For the full fiscal year, PAS grew 4.1%. Biosciences revenues grew 6.4% in the quarter. Growth was driven by research reagents as well as growth in new instruments, such as the FACSymphony and FACSLyric. For the full fiscal year, Biosciences grew 6.8%. Turning to slide 11, I'll review our Interventional segment revenues growth on a comparable currency-neutral basis. Fourth quarter revenues increased 6%. For the full fiscal year, revenues grew 5.2%, which includes an estimated 90 basis point headwind from the impact of the hurricane in Puerto Rico in our first fiscal quarter. Revenues in Peripheral Intervention, or PI, grew 7.6% in the quarter. Performance reflects strong growth in oncology products, particularly in emerging markets and China, as well as continued strength in ESRD. For the full fiscal year, revenues in PI grew 9.3%, reflecting our cadence in new products and geographic expansion. Fourth quarter growth of 3.3% in Surgery reflects an acceleration from last quarter's growth rate, as the business continues to regain share following the hurricane. For the full fiscal year, Surgery grew 1.3%, which includes an impact of 240 basis points from the hurricane, and 120 basis points from the hold on Progel. Excluding these items, we estimate Surgery would have grown approximately 5% for the full year. We relaunched Progel last month and are pleased with our early results. Urology and Critical Care, or UCC, revenues grew 7.4% in the quarter, driven by new products and strong performance across the Acute Urology portfolio. For the full fiscal year, UCC revenues grew 5.3%. Moving to slide 12, I'll walk you through the geographic revenues for the fourth quarter on a comparable currency-neutral basis. U.S. revenues grew 8.7% in the fourth quarter. This was above our normal growth rate, and primarily reflects very strong growth in the MMS and Pharmaceutical Systems units within the BD Medical segment, as previously discussed. For the full fiscal year, U.S. revenues grew a strong 5%, which includes an estimated 100 basis point headwind from the U.S. Dispensing change and the hurricane. Moving on to International, revenues grew 7.9% in the fourth quarter. Growth was driven by strong performance in all three business segments, particularly in Asia Pac, Latin America and EMA. For the full fiscal year, International revenues grew 7%. Developed Market revenues grew 7.7% in the fourth quarter. Growth in Developed Markets was driven by strong performance in the U.S. For the full fiscal year, revenues in Developed Markets grew 4.8%, which includes an estimated 70 basis point headwind from the U.S. Dispensing change and the hurricane. Fourth quarter Emerging Markets revenues grew 11.8% currency-neutral, bringing our full year growth to 11.6%. Growth in China was a strong 13.6% in the fourth quarter, bringing the total year growth rate to 13.2%. This was driven by double-digit growth across all three segments. Turning to slide 13, which recaps the fourth quarter income statement, as discussed, revenues were strong, growing 8.4% in the quarter on a comparable basis. Moving down the P&L, gross profit improved during the quarter, increasing 47.6% year-over-year, and gross profit margin was a strong 56.5%. SSG&A as a percentage of revenues was 25%, which reflects Bard's higher SSG&A spend profile, partially offset by the achievement of synergies. In addition, strong revenue growth resulted in additional selling commission expenses in the fourth quarter. R&D as a percentage of revenues was 6.2%, which reflects our continued commitment to invest in innovation. Operating margins increased 350 basis points or 380 basis points on a currency-neutral basis. We continue to deliver significant operating margin expansion, which reflects strong P&L leverage as the new BD. Our tax rate was 15.3% in the quarter, bringing our full year tax rate to 16.7%, which is just below our guidance range. As expected, we paid preferred dividends of $38 million in the quarter. As we discussed last quarter, the preferred shares are not included in the shares outstanding calculation. In the quarter, adjusted earnings per share were $2.93, which is a 22.1% increase versus the prior year, or 24.6% on a currency-neutral basis. Very strong revenues were partially offset by the headwind by currency, increased raw material costs, and increased selling commission expenses. Turning to slide 14 and our gross profit and operating margins for the fourth quarter, gross profit margin was a strong 56.5% in the fourth quarter. On a performance basis, gross profit margin improved 360 basis points. This reflects the inclusion of Bard's more robust gross margin profile, as well as our continuous improvement initiatives and cost synergies. These items were partially offset by headwinds from raw materials. Currency had a negative impact of 30 basis points on gross profit margin. Operating margin grew 350 basis points in the quarter, or 380 basis points on a currency-neutral basis. Margin expansion was driven primarily by gross margin improvement, combined with synergy capture. For the full fiscal year, we delivered significant margin expansion of 210 basis points on a currency-neutral basis. We're very pleased to have delivered approximately 700 basis points of underlying operating margin expansion over the past four fiscal years, which highlights our strong execution and also demonstrates that our strategy is sound. Moving to slide 15, I'd like to walk you through our fiscal 2018 EPS growth. All-in, we delivered EPS growth of 16.1%, 12.3% on a currency-neutral basis. This reflects EPS growth which was in line with the deal model. EPS also benefited from stronger revenue performance, was partially offset by a number of macroeconomic headwinds and business investments. Currency had a positive impact on fiscal year 2018. Now, moving on to slide 17 and our full year fiscal 2019 revenue guidance, we expect currency-neutral revenue growth of 5% to 6% on a comparable basis. This is in line with the expectations we have been communicating since the deal announcement. From a phasing perspective, we expect fiscal year 2019 to align with fiscal year 2018 with revenue and EPS growth weighted towards the back half of the year. In addition, the headwind from FX will be most pronounced in the first quarter. By segment, we expect BD Medical revenues to grow between 5% and 6%, we expect BD Life Sciences revenues to grow between 4% and 5% which includes a headwind of approximately 90 basis points related to the flu, and we expect the BD Interventional revenues to grow between 6% and 7%. Similar to fiscal 2018, we expect revenue growth to be driven by recent product launches across all three segments and strength in both Developed and Emerging Markets. We anticipate Developed Market growth of around 4% to 5% in fiscal 2019. In Emerging Markets, we expect growth of about 10%, driven by a diversified base with low-double digit growth in China and strength in EMA and Latin America. Now moving on to slide 18 and our full fiscal 2019 EPS guidance, as there are a number of moving parts that impact earnings per share in fiscal 2019, I would like to provide more color on our EPS guidance. Starting on the left-side of the chart with our fiscal 2018 adjusted EPS of $11.01, we expect strong underlying growth of approximately 16% to 17% on a currency-neutral basis. This is in excess of our deal model and is driven by revenue growth and robust operating performance. Moving to the right on the slide, we expect a lower effective tax rate to contribute approximately 3% to EPS growth, bringing our total underlying EPS growth to approximately 20%. We expect an effective tax rate of 14% to 16% in fiscal 2019. Continuing to the right on the slide, you will see, we are facing a number of headwinds in fiscal 2019. On the macro front, raw material pressures increased throughout 2018 and accelerated into fiscal 2019, primarily due to additional resin price increases driven by a supply-constrained market. In addition, the round of tariffs that was enacted in late September will result in an incremental headwind to the round one impact we previously discussed with you. We are actively working with our partners to minimize the unfavorable impact to the company going forward. Our guidance also assumes a normal flu season in contrast to the severe flu in fiscal 2018, which results in a headwind in fiscal 2019. We also have a headwind related to the sale of Advanced Bioprocessing that closed last month and the annualization of the divestitures to Merit Medical. On a currency-neutral basis, our strong underlying performance is expected to drive adjusted EPS growth of 13% to 14% despite these headwinds and divestitures. While currency was a benefit for the first nine months of fiscal 2018, it became a headwind in the fourth quarter. And based on current rates will be a sizable headwind of about 3.5% in fiscal 2019. This assumes a euro to dollar exchange rate of $1.16. All-in, we expect to deliver adjusted EPS of $12.05 to $12.15, which represents reported growth of approximately 10%. From a phasing perspective, we expect to achieve approximately $100 million in cost synergies in fiscal year 2019. We are committed to fully realizing $300 million in annualized cost synergies over the three-year deal period. Now turning to slide 19, I'd like to walk you through the balance of our guidance expectations for the full fiscal year 2019. On a reported basis, revenue growth for the total year is expected to be between 8.5% and 9.5%. This reflects a currency headwind of approximately 200 basis points. Adjusted gross profit as a percentage of revenue is expected to be approximately 56.5% to 57.5%. This is an increase of up to 100 basis points from fiscal 2018, and is due to strong underlying performance, partially offset by higher resin costs and the impact of tariffs. Adjusted SSG&A is expected to be 24.5% to 25.5% of sales. This is about flat when compared to fiscal 2018, and is primarily due to cost synergy achievements, partially offset by Bard's higher SSG&A profile. We expect our R&D investments to be in line with fiscal year 2018 at about 6% of revenues, and reflects our continued commitment to invest in new products and platforms. As a result of the items I just detailed, operating margin is expected to be between 25.5% and 26.5% of revenues. On a currency-neutral basis, operating margins are expected to grow 100 basis points to 150 basis points. This represents strong underlying margin expansion, partially offset by the impact of the fiscal 2019 headwinds we just discussed on the previously slide. As we also just discussed, we expect our tax rate to be 14% to 16%. For fiscal 2019, we anticipate our adjusted average fully diluted share count to be approximately 275 million shares. For modeling purposes, I would like to remind you that net income reflects the deduction of approximately $152 million of preferred dividends. The preferred shares are excluded from the adjusted diluted shares outstanding. Cash flow is expected to be strong, with operating cash flow of about $4.2 billion in fiscal year 2019. Capital expenditures are expected to be approximately $900 million. In summary, I'm excited about the strong momentum we have across our businesses, and I'm confident that we'll deliver our commitments in fiscal year 2019 and beyond. Now, I'd like to turn the call back over to Vince, who will provide you with an update on our Bard revenue synergies and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. Moving on to slide 21 and Bard revenue synergies, as we have been discussing with you since the deal announcement, we expect measurable revenue synergies from Bard starting in fiscal 2019. Our investment toward achieving these revenue synergies began in fiscal 2018, and we are pleased to announce that over the five-year deal period, we expect to drive total revenue synergies of approximately $250 million. As we expected, this is significantly larger than our CareFusion revenue synergy target of $150 million to $175 million, given the hundreds of products already in the registration process. There continue to be three key areas where we expect to achieve synergies
Operator:
Thank you. Our first question is coming from the line of David Lewis with Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. Just two quick ones for me. I'll start with Chris or Vince. So, guys, the headwinds are consistent with our model, but clearly the magnitude of each is a little greater. So I think from our emails this morning, the questions that I think investors want to get answered is does fiscal 2019 earnings reflect any change in the underlying fundamentals of the business with a rate of progression of the Bard deal model? Or is this just a perfect storm of macro headwinds? And then I have a quick follow-up.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure, David. And this is Chris. Thanks for the question. I think you look at the momentum that we had in fiscal year 2018, we were driving 6.5% revenue growth and 16% earnings per share growth, and that momentum actually accelerated in the fourth quarter with 8.4% revenue growth, 25% increase in EPS, and 350 basis points of gross margin improvement. So clearly the fundamentals of the business are very strong, and we carry that forward into 2019. If you refer to the waterfall chart that we went through, you can see that we're driving 16% to 17% underlying into 2019. And then on top of that, we're adding another 3% from tax synergies that we had talked about potentially developing, and we now see our way clear to get those from tax synergies and some geographical mix. So the combination of those two are driving underlying improvements of around 20%. Now, when you issued your note a couple of weeks ago, you had rightfully called out some significant headwinds of around 800 basis points. It turns out that it's closer to 1,000 basis points, so the magnitude, as you mentioned, is stronger. And the new news there is all around macro items, and I'd start with resins. In the fourth quarter, we saw a double-digit growth in the price of resins. And we had talked about resin prices going up last year, and the impact was about $35 million in 2018 or about 1% of EPS. That doubles to over $60 million of impact based on that double-digit growth in the fourth quarter of the price increases, primarily driven by supply constraints. Typically, it's impacted by oil prices, but it's mostly supply constraints at this point. In addition, after your conference, I think it was a day after your conference, the second round of tariffs hit. And the impact of that, we had said it was about $15 million in round one. In total now, we're looking at about $45 million of impact from round one and round two. We can offset about $10 million of that in-year through working with our suppliers and other things, so the impact we expect to be about 1% or about $35 million. Between those two items, resins and tariffs, we have just about $100 million of pressure. Then on top of that, we have FX going the wrong way, and basically reversing what you saw in the benefit that we got from FX this year. And so we expect it to be about 350 basis points of pressure. I would note that most of those pressures are one-time in nature. We wouldn't expect resins to continue at that same pace in terms of headwinds. Tariffs, we're going to be working with our suppliers to resource the base. Now, that takes a while. We wouldn't expect to see much more impact in 2018, but that would help mitigate the impact in 2019 and, perhaps, whatever we can mitigate actually becomes a tailwind for us. Flu is the flu, divestitures go away, and FX could flip next year, just like this year flipped from last year, so more one-time in nature. So, all-in all-in, we're offsetting about half of these significant pressures, and I would point out that we're still going up on an FXN basis from 12% in 2018 to 13% to 14% in 2019. So that's still an increase, despite the headwinds we laid out. So the fundamentals are really strong, to your point, and we feel extremely good about the underlying business and the momentum. And if anything, the deal model, we're exceeding the deal model.
Vincent A. Forlenza - Becton, Dickinson & Co.:
The only thing I would add, David, is, from a geographic perspective, we had strong performance across all regions. And as you know, looking back a couple of years, that wasn't always the case. But this year, we've seen it across all geographies and all businesses. So we feel really good about it.
Christopher R. Reidy - Becton, Dickinson & Co.:
David, you said you had a two-part question, so we'll go back to you.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Oh, sorry. That was very, very detailed. So, I'll make this one quick. Vince, people expected 7% this quarter. You did closer to 8%. So momentum in the business, we saw several hundred basis points of acceleration. So the question is, look, it would not have been prudent to guide anything different than 5% to 6%, and that's what investors expected. Can you just talk about how good you're feeling about the 5% to 6% number for 2019? And I'll jump back in queue. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, I'm feeling very good about the 5% to 6% number. And yes, we had a very strong fourth quarter. You saw real strong performance out of Pharm Systems. And if you look back across the year, Pharm Systems, it's not just a one-quarter issue for them (46:57). We've seen some fundamental changes in that marketplace on the vaccine side and more of a longer-term shift to prefills. That's something we've been working out for years. It's going well. I think while in MMS, you saw tremendous performance, and, yes, some, as Chris mentioned, was customers requiring installation a little earlier than we expected, but fundamentally, we're gaining share in both the pump side and on the Pyxis side. And I talked about some of the new products that are going there. So I think we're going to see good, strong, continued performance across the entire BD portfolio. I walked you through all of the new products. I won't repeat all of that. And then from a geography standpoint, as I was saying, we feel good about the geographies. Feel good about what's going on in Asia. I mentioned a slight moderation in China, and that's just the continued cost controls. But we expect to have good performance across all of our business segments in China, so feel good about that. Where we've seen some improvement in 2018, certainly with India, much, much better performance than historically, but strong across the board. What we're going to have to jump over, quite frankly, is the flu. And we'll just have to take what happens in flu up and down. So I feel good about the 5% to 6% guidance range that we gave you.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Great. Thanks, guys.
Operator:
Our next question comes from the line of Brian Weinstein with William Blair.
Brian David Weinstein - William Blair & Co. LLC:
Hey, guys. Thanks for taking the question.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Brian David Weinstein - William Blair & Co. LLC:
Just a follow-up on David's question there, obviously, a very strong year-end with the 8.4% growth, but maybe, Tom, can you talk about the sustainability of the trends that you're seeing, and specifically the drivers. Vince, you mentioned a little bit in Medical, but specifically maybe the Interventional and Life Sciences side as we head into 2019?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, I'll let Tom do that. I kind of overviewed that in the remarks, but Tom, maybe you can get into a little more detail.
Thomas Polen - Becton, Dickinson & Co.:
Sure. Hey, Brian, this is Tom. So, I think, as you heard from Vince, what we were most pleased about is, is that there was strong growth across all three segments, and it was both in the core across all three segments as well as what you saw where new products starting to fire in each of the three segments. And so as we think about Medical, again, we've got core strong underlying businesses with Pyxis ES as a new product really gaining traction and share this year. We saw the new Alaris Pump M2 (49:44) really be widely positively received in the marketplace. We expect about 2 points of share gain in FY 2018 on the pump side, and that continuing into 2019. And then the momentum in Pharm Systems, as you heard Vince mention, driven by both the trend in vial to prefill, but also around biologic and self-injection and some of the portfolio investments we've made over the last couple of years really positioning us well as a strategic partner of choice with top pharma. There is a trend that we expect to continue the growth going forward, and we're adding capacity very actively actually in that space to make sure that we're in a position to continue to capitalize on that. Same thing in Life Sciences, right? So, we look at core businesses are strong. DS, we see – BD MAX continuing to grow north of 20% for the year. Kiestra really taking off now in the U.S. It's been strong internationally over the past few years. I'd say, we're seeing a really nice trajectory uptake in the U.S. and that trend is just starting. And, of course, Veritor had a great year. And one thing I'd point out is that while we expect we're modeled a lighter flu season, we did pick up share in the Veritor space and for flu, and so we've got a larger footprint of instruments. Regardless of what flu season happens, we'll be able to capitalize on it further given the penetration that happened in 2018. And then in PAS, we've got new capacity coming online. For Push Button, which is a bit of the driver of the uplift you saw there, that's only going to benefit us as we go into 2019. And Bioscience, a lot of growth driven by new high-end instruments and reagents. And then finally, just on Interventional, you had every business there grew north of 6%, obviously led by the Peripheral Intervention business, but – I'm sorry, the segment grew at 6% with two of the three businesses growing north of 6%. Obviously, WavelinQ, we're positive about and are very positive on the reimbursement, which will be a momentum as we go into 2019. Clearly the BTK data will come out tomorrow, I think just overall reflecting the depth of the portfolio there. And Progel is another thing that we really saw limited impact of in 2018. But as we've gone even just this month – last month in October and as we go into November, customers are ordering Progel. We're seeing sales start to ramp up. And we're seeing good momentum very much in line with our expectations. So, overall across the businesses, we're feeling well about both the core business as well as the value of the portfolio starting to really take off.
Brian David Weinstein - William Blair & Co. LLC:
Okay.
Vincent A. Forlenza - Becton, Dickinson & Co.:
One piece of information I might add, we get asked this question a lot, and we probably won't do this going forward anymore. But going back to legacy Bard, legacy BD, legacy Bard we see grew in 2018 by about 7% and legacy BD grew over 6%.
Brian David Weinstein - William Blair & Co. LLC:
Great.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay, thanks, Brian.
Brian David Weinstein - William Blair & Co. LLC:
Thanks.
Operator:
Our next question comes from the line of Isaac Ro with Goldman Sachs.
Isaac Ro - Goldman Sachs & Co. LLC:
Good morning, guys. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Isaac Ro - Goldman Sachs & Co. LLC:
Hey, guys. So, just a question on a couple of key pipeline items, maybe on the Medical side. Vince, you mentioned a little bit about status on the T2 Patch Pump. Can you give us a little bit more detail as to the initial strategy for rollout at the end of 2019? And then secondly, for Patrick on the Life Sciences business, BD MAX has been doing pretty well for a while now. Can you give us a sense of where we are in the life cycle for that product? I think competition in molecular is getting a little bit thicker, so I'd be interested in where you go from here.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Alberto will take the first one and then Patrick will do the second.
Alberto Mas - Becton, Dickinson & Co.:
Yeah. Well, on the Type 2 Patch Pump, we are – continue to be very excited about the potential of the product. We are making good progress on the program. We are learning through our clinical trials and the interactions with our customers. And we expect to be preparing for a submission in the next few months both in U.S. and Europe. Our production lines are getting up to speed, and we are working our evidence generation programs as well. So the program is progressing well, and we're expecting – depending obviously on the FDA approval process and timing we expect towards the end of the calendar year to be able to launch in the U.S., so good news to report there.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And Patrick?
Patrick Kaltenbach - Becton, Dickinson & Co.:
Yes. Hi, Isaac. This is Patrick. Well, let me first report a little bit on BD MAX, and as you've heard, we've really had very strong growth in the year, we grew about 35% worldwide with BD MAX, and a lot of that is driven, of course, by the new panels we rolled out. We will continue to roll out new panels next year like the Enteric Viral Panel here in the U.S., so that will give us continued momentum. So I'm very, very positive on BD MAX as a molecular solution moving forward. That said, on the slide for new products we had BD COR for next year, which is a higher throughput molecular platform as we go through an early access launch towards the end of next year, and moving forward, I think that will accelerate our growth in molecular as well. So, overall, very positive on the growth opportunities in this space.
Isaac Ro - Goldman Sachs & Co. LLC:
Great. And just a follow up with Chris on the CapEx, I think in the past you guys had talked about doing about $3 billion over the 2016 to 2019 period. If I look at the guide for next year, it looks like you're going to come in a little bit above that number, if not much, but I'm curious kind of in the capital budgeting, what's going on there? Are there items that maybe roll off if we look over the next few years that could release a little more free cash flow growth? Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure, Isaac. It really is more about capacity which comes from the stronger revenue growth in reality. So that's what's driving the CapEx up.
Isaac Ro - Goldman Sachs & Co. LLC:
Okay. Thanks.
Operator:
Our next question comes from the line of Robbie Marcus with JPMorgan.
Robbie J. Marcus - JPMorgan Securities LLC:
Great. Thanks for taking the question. Chris, just to follow up on the capital allocation question there, you've hit your payback targets. You're now less than 4 times as of September.
Christopher R. Reidy - Becton, Dickinson & Co.:
Right.
Robbie J. Marcus - JPMorgan Securities LLC:
In a year where there are a number of headwinds, how do you balance maybe using some of the money allocated for debt paydown to help cover some of the macro headwinds? And in that, are there any other rooms, levers or ways that you can offset some of those macro headwinds that maybe isn't built into guidance here?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, I don't see it being a cash-driven issue in terms of offsetting the headwinds. I think we're investing significant cash in the business in a number of ways, as we just talked about, CapEx for capacity purposes. And so, we feel good about that, and we're generating a lot of cash, as you see. So we think we can do both. We think we can invest in the business to continue to grow the business, as you would expect, and to still make our commitments on the debt paydown. And so we've got about 1 point left or 1 times left, and I would expect that to be ratable over the next two years. So another 0.5 point this year and another 0.5 point next year, and we'll be down below 3 times. So we think we can do both of those items.
Robbie J. Marcus - JPMorgan Securities LLC:
Okay, great. And maybe to stay in that vein, I don't want to jump the gun, but you've now had a fairly successful CareFusion integration. Bard looks to be going ahead of plan. How do you think about now with the very broad hospital platform that you have, how do you think about continued M&A? And are there any areas that stand out to you that you think need the most adding to, or could be bulked up here?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, thanks for the question. And we're really focused on integrating what we have right now. We're just finishing up. As we said, pretty much just finished CareFusion. We're focused on the Bard integration. And we know from a strategic standpoint that we have an excellent portfolio. We're going to continue to do small plug-ins. It's the nature of the business. You saw it with TVA. So you should expect that our focus is going to be debt paydown and continuing to enhance the portfolio in ways that really build up what we'll call category management. We think we've positioned ourselves to be one of the strategic partners of choice within the industry. That doesn't require us to get much, much bigger and broader. It's about playing out what we have and becoming the partner of choice as we drive – as we're driving these synergies, you should think about this as also driving the customer experience. We're going after simplification, making BD easier to do business with, that's the phase we're in right now. In the long run, we know we'll have the capability if we ever desired to make another larger move, but it's great to have strategic flexibility. But as Tom and Chris and I are always discussing, that's not what you want to base your strategy on. It's great to have capability. We're going to drive our innovation system, do our plug-in acquisitions. That's what we're focused on – and process simplification – getting our synergies. And thanks for the question.
Operator:
Our next question comes from the link of Bob Hopkins with Bank of America.
Bob Hopkins - Bank of America Merrill Lynch:
Oh, thank you, and good morning. Just two quick questions. First, just to clarify on resin costs, can you just talk a little bit more about the supply constraints and when do those ease, and when they ease, do the cost come down? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. So the issue is the supply constraint on propylene which is actually a byproduct of ethylene, and ethylene production has significantly reduced. So it's a byproduct of that. And we saw that happening just from a supply standpoint. We are seeing a little bit of capacity coming in from outside the U.S. You may recall, there was a supplier that went bankrupt in the propylene area. We had some hurricane issues over the last year or so. So the combination of all those factors are what's driving the capacity constraints. There is some positives of capacity coming in from international sources, but at the same time you have oil price impacts as well. So we think that the impact that we're seeing in the fourth quarter of that double-digit increase will kind of hold for this year. But we don't see that continuing to go up in the future. We think it will be fairly stable over the course of the year.
Bob Hopkins - Bank of America Merrill Lynch:
Okay, great. And then the follow up, I just wanted to ask a question on MMS because that's obviously very exceptional growth in that business this particular quarter. So maybe if you could just kind of quantify where you are in terms of pump market share, how much share you think you're gaining. And then I'd just be curious as to – if you could explain a little bit more about your comment that you're seeing placements earlier than expected. What are the dynamics around that? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Alberto will take that.
Alberto Mas - Becton, Dickinson & Co.:
Yes. Well, obviously, great performance in the quarter. We saw 20%-plus growth rate in both sides of the business, both dispensing and infusion. A lot of these dynamics – well, in terms of the actual timing, it's timing of infusion pump placements and installations. But also on the Pyxis side, on the dispensing side, the variability especially after trades comes more – (01:02:00) there's a component of our business that continues to be capital purchases, cash purchases, if you like. This is affected by timing. And in terms of the timing, it's a combination of customer expectations and when they're ready and readiness, as well as our own preparedness, availability of service and installation, and resources at the same time. So that combination drives some of the timing. What I would emphasize is more of the underlying growth rate of the business overall, which we – we expect the momentum to continue. The market share is – we estimate around 2 percentage point share gain on the infusion side, and 1% on the dispensing. A lot of that – and then Tom mentioned some of the investments in the core, or our anchor products like the M2 (01:02:53), like Pyxis ES and so on. But what really is driving a lot of these conversions and momentum in the business is our integrated and connected strategy through our interoperability capabilities. We now have over 350 sites that are now live there as well as our HealthSight platform, analytics that really enables that integration and capability that is unique from our perspective.
Bob Hopkins - Bank of America Merrill Lynch:
Great. Very helpful. Thank you.
Alberto Mas - Becton, Dickinson & Co.:
Okay.
Operator:
Our next question comes from the line of Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen - Wells Fargo Securities LLC:
Oh, good morning. Thanks for taking the question.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Larry.
Lawrence Biegelsen - Wells Fargo Securities LLC:
One on the fiscal 2019 revenue guidance and one on Lutonix, and I'll start with the revenue guidance. So you exited the year growing 8.4%, and as someone mentioned earlier, it's prudent I think to guide to 5% to 6%. But my question is, Chris, you talked about it being more back-end loaded. So just trying to understand why that would be the case. Q1 is the easiest comp I think in the year. That's my first question, and then I had a follow-up.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, so there's two things. The flu grow over (64:12) is in the first half of the year, and then as we talked about MMS, that 23% growth in MMS in the fourth quarter with these earlier placements that – some of that's going to come out of the first quarter, and that's on the revenue side. And as I mentioned in the prepared remarks, FX will hit us on the bottom line in the first quarter. So that's the reason for the comments on phasing.
Lawrence Biegelsen - Wells Fargo Securities LLC:
Thank you. And then on Lutonix, assuming a positive outcome tomorrow, I think Bard estimated that the BTK opportunity was about $250 million. So my question is, assuming a positive outcome tomorrow, do you agree with that? And is reimbursement in place and sufficient to kind of drive that opportunity? Thanks for taking the questions.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Simon?
Simon Campion - Becton, Dickinson & Co.:
Yeah. So nothing has materially changed from the Bard projections with respect to the market opportunity for BTK, and it's going to – the expectation is it will be continued to be reimbursed as any traditional DCB.
Lawrence Biegelsen - Wells Fargo Securities LLC:
Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So, very much in line with what we expected. Okay, thanks for the questions.
Operator:
Our next question comes from the line of Kristen Stewart with Barclays.
Kristen Stewart - Barclays Investment Bank:
Hi. I have two questions. The first one, I know you touched a little bit on this, but I was wondering if you could just go in a little bit more in terms of the opportunity relative to the Patch Pump. I know you discontinued the sets. How did you frame that opportunity relative to the Patch Pump? And then I have a second question for Chris.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Tom?
Thomas Polen - Becton, Dickinson & Co.:
Hey, Kristen. This is Tom.
Kristen Stewart - Barclays Investment Bank:
Hey, Tom.
Thomas Polen - Becton, Dickinson & Co.:
So, first off, just to speak to FlowSmart a little bit more, certainly the type 1 insulin pump market, it's continued to evolve over the last few years. And as was mentioned earlier on the call, the latest product redesign for FlowSmart didn't deliver the level of differentiation that we were seeking. And so, look, we could have continued to invest in FlowSmart. If you would ask us that, yes, we could have continued to invest in that. But given the economics of that as more of an OEM product and the number of more attractive investment opportunities we now have in our R&D pipeline, as part of our portfolio process we made a decision to stop that product and redirect the investments into more attractive opportunities both within DC and outside of DC. And certainly within DC, the number one product there that we're investing behind and put some further funding behind is Swatch (66:37). And as you heard from Alberto, we continue to be – very positive outlook on that product. It's gone through and continues to go through clinical trials. We continue to get additional patient and physician feedback on it which is all at or above our expectations. And so, we're doubling-down on the final stage of bringing this to market this year.
Kristen Stewart - Barclays Investment Bank:
Perfect. And then not to jump too, too far ahead, but it looks like the Gore royalty has been running a lot higher than where it was trending with Bard. And I was just wondering if you could kind of just give us your perspective on ability to grow through that. I know that's not really a big impact for fiscal 2019, just given the timing of when the royalty ends, but how should we just think about longer term? Clearly, this year, you had mentioned it sounds like you're running a little bit ahead of the deal model. Does that give you increased confidence to offset some of those headwinds, or just how should we think about kind of Gore? I know that's a little bit out, but...
Christopher R. Reidy - Becton, Dickinson & Co.:
So, yeah, Kristen, this is Chris. And you're right that the Gore royalty is running a little bit hotter. But fundamentally, it's no change from what we talked about when we announced the deal, that the biggest impacts in reducing that is the paydown of the debt and the corresponding decrease in interest expense, coupled with now we talk about revenue synergies, and they start in 2019 and ramp-up a little bit more in 2020. So, that helps. The cost synergies again mitigate that, and then the conversion of the preferred dividend helps a little bit as well. So, fundamentally, it's the same offsets, and so that's what we would expect to see.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks for the questions, Kristen.
Kristen Stewart - Barclays Investment Bank:
Thank you.
Operator:
Our next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore ISI:
Hey, guys.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning, Vijay.
Vijay Kumar - Evercore ISI:
Thanks for taking the questions. Morning, Chris. Just maybe back on that margin question, so if you look at the deal model, Chris, that we had, 200 basis points of annual margin expansion right through 2020. I'm just looking at the guidance here. What would cause this to get to low end of the operating margin guidance for the year? Because I can understand some of the headwinds getting to the high end of the margin guidance, maybe even at the midpoint, but the low end, I'm having a tough time. So, can you just walk us through versus the deal model...?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So, you're talking about 2019?
Vijay Kumar - Evercore ISI:
Yes.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. So, on an underlying basis, the operating margin expansion would be over 200 basis points, which is right in line with what we expected. You get about a 80 basis point, somewhere in there, 50 to 100 basis point drag from the raw materials, resins, tariffs and the divestitures. So, all-in all-in, we've got about 100 to 150 basis points of margin expansion, which is right in line with what we had originally announced. And just as a reminder, I mean, we say this. We're really proud of the fact that we've driven 700 basis points through to-date from FY 2015. And then with 100 to 150 next year and more than likely the same kind of amount in 2020, over a five-year period, we'll have driven about 1,000 basis points of margin expansion. So, we really feel good about margin expansion, including next year.
Vijay Kumar - Evercore ISI:
Got you. And then one on tax rate, so it's down year-on-year. Is this now sustainable, Chris, or were there any one-off assumptions for the tax guide for 2019?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, so it's not one-off. It's really driven by the normal geographical mix and the synergies of bringing BD and Bard together and the tax structures we talked about. And we said that would take the better part of a year to sort through, and the 14% to 16% is a reflection of that.
Vijay Kumar - Evercore ISI:
Thank you, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thank you.
Operator:
Our next question comes from the line of Richard Newitter with Leerink Partners.
Richard Newitter - Leerink Partners LLC:
Hi. Thanks for taking the questions. Vince, my first one, just on the $250 million Bard revenue synergies by 2022, I might have missed it, but can you just talk through how to think about the cadence there over that time period, and if you can talk to the different buckets, which ones materialize at which times?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. So, I'll start and then Tom can add a little bit more color to it. But first thing to think about is the vascular access portfolio. We've put the sales forces together in the U.S. We've got that as one business in MDS. And that we're able to go in and starting right now sell an optimized portfolio of products, including the PICCs. And so we think that when you look at 2019, we're talking about tens of basis points for fiscal year 2019 and then things ramping up from there. The other thing that's contributing to that in the short run is, we've hired the sales force in Europe, and on the Surgery side, and that's around biosurgery and ChloraPrep. And so we've brought them on. We're activating those sells reps. So those are two good things that are going on. And the third piece is the geographic expansion piece. China, they already have the organization in place. We're continuing doing that. But in places like Latin America and Asia, they come on stream and then they accelerate the growth once you get past 2019. Tom, you want to add anything else to that?
Thomas Polen - Becton, Dickinson & Co.:
That was a great summary. The only maybe two things to mention from the other third pillar, so Vince talked about vascular access, the channel expansion in Europe, as you know, Bard had really invested heavily in China, and we're also continuing to invest now in areas where they hadn't got to invest yet, like Latin America, EMA, and the rest of Asia. From a timing and phasing over the five-year window that we've talked about, we think about obviously very limited synergies this last year; 2019, it does step up. And then 2020, it kind of doubles off of where we were in 2019 and then it stays relatively at that level, maybe modest increases of those additional gains for the next two years after that. So, certainly, 2019 is a step-up, but then 2020 continues to step up more ratably.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Richard Newitter - Leerink Partners LLC:
Okay. That's really helpful. Thank you very much. And then if I could just ask, I think I heard a comment earlier on in the call that China growth moderated, and maybe I'm just looking at the wrong numbers. But it looked like 13% growth constant currency for China this quarter, last quarter, roughly the same. What was that comment about specifically?
Vincent A. Forlenza - Becton, Dickinson & Co.:
That was me. Yeah, I actually said it grew 13% in the quarter. But looking forward, I said we expected it to be low-double digits next year. And all I mentioned was that we had very strong performance across the board. We expected that to continue, that the whole industry had seen a little bit of cost control that was put in place. This is no new news. We had exceptional performance in our Life Sciences side of the business. So we expect basically the same performance, maybe a tick lower, that's all.
Richard Newitter - Leerink Partners LLC:
Okay.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, I would say, most of that tick lower was related to math because we're growing about the same amount of revenue dollars off a bigger base. And so it steps down a point or two from that alone.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. But thanks for the chance to clarify that.
Richard Newitter - Leerink Partners LLC:
Okay. Thank you.
Operator:
Our next question comes from the line of Doug Schenkel with Cowen.
Unknown Speaker:
Hey. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Unknown Speaker:
This is Chris (74:49) on for Doug today. Thanks for taking my questions. As a follow up to your previous question, could you just provide a breakdown of the key drivers to margin expansion in 2019? Now, how do cost synergies, core execution and the inclusion of Bard contribute to the 100 to 150 bps of target expansion?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Hold on one second.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. So, the base plan initiatives are up about 150 basis points. The synergies add about 50 and then the Bard portfolio is about another 10 or 20 basis points. That gets you up to about 200 basis points. And then, as I mentioned, the resins, tariffs, flus and the divestiture pressures are in the 80 to 100 kind of range, which brings you to total of about 100 to 150 basis points.
Unknown Speaker:
Great. Thank you. Then maybe just a unrelated follow-up. You ended 2018 with about 7% growth in Life Sciences business, guidance for next year is 4% to 5%. I think you called out flu as being 90 basis points headwind, so guidance for next year still implies a moderation in growth beyond just difficult flu comparisons. I mean, with that in mind, what else is impacting Life Sciences' growth next year? And can you just comment on the underlying sustainable revenue growth rate for that business? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, Patrick will take that.
Patrick Kaltenbach - Becton, Dickinson & Co.:
Yes. I'm happy to take that. First and foremost, if you look at this year's growth rate, of course, we had also a tailwind from the flu. So if you take flu out, we had been growing between 5% and 6% as well this year, so that's my first point. And forward-looking, I think what we are looking at is an underlying market growth somewhere between 4% to 5% in overall Life Sciences. If you take the flu headwind this year out and say we will grow between 5% and 6%, we will actually achieve that goal to grow at the high end, if not above the market with our product portfolio. I'm very confident that with the product portfolio we will roll out next year and what we did this year, we have a strong momentum in the Life Sciences market. We see a lot of opportunity in the immunology space, diagnostics base, and new solutions we have in the Preanalytical portfolio as well. So, again, the fundamentals are strong and I think we are positioned well. The 4% to 5% are really based on the fact that we account for the 90 basis points in flu.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. Yeah, the only other thing I'd point out is we had the FlowJo acquisition in the current year, and that was worth probably 40 basis points.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, so that kind of tricks up the comparison a little bit.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah.
Unknown Speaker:
Okay. Great. Thank for taking my questions.
Operator:
Our next question comes from the line of Bill Quirk with Piper Jaffray.
William R. Quirk - Piper Jaffray & Co.:
Great. Thanks, and good morning, everyone.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
William R. Quirk - Piper Jaffray & Co.:
Two questions, I guess, first, Vince, just following up on Rich's question about the pacing of revenue synergies, can you speak to the pacing for CareFusion kind of – or maybe, Tom, in the next couple of years? And then, secondly, for Patrick, regarding the changes to Medicare reimbursement around the respiratory and GI panels, it strikes us that BD is in a pretty good position here given how you've set your panels up, so I would just love a comment on that changing dynamic and I suppose the potential for commercial payers to follow Medicare? Thanks, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
All right. So, Tom is going to talk to the CareFusion.
Thomas Polen - Becton, Dickinson & Co.:
Okay. Hey, Bill. This is Tom. So, on CareFusion, we continue to be very much on track to realize the $175 million in cumulative CareFusion synergies by FY 2019. And so we're coming to the tail end of that process of course now. As we've talked about before, we've seen the tens of bps impact, and I think you're seeing that across the Medical segment, which is where that's all focused, and it's specifically within the MDS International business and MMS, which I think you've seen really the acceleration from what – remember when we started the journey there, was an underlying CareFusion growth rate of 3% to 3.5% growth that obviously based on what you saw in 2018 we're exiting and going into 2019 at a number well north of 5%. And so, we see that clearly contributed to the revenue synergy impact that we've seen and look forward to bringing that home in a strong way in 2019. Maybe a comment from Alberto as well.
Alberto Mas - Becton, Dickinson & Co.:
Yeah. I also want to emphasize that our international product registration efforts has really continued and we registered a total of 300 product registrations in new markets as we expected. And just to give a little bit more color on the Medical segment, a lot of it's driven by CME, infusion pumps and Rowa dispensing solutions, ChloraPrep and the Pyxis IV Prep are some of the items that are driving some of these revenue synergies.
Thomas Polen - Becton, Dickinson & Co.:
Maybe Patrick on MAX?
Patrick Kaltenbach - Becton, Dickinson & Co.:
Yeah. I can answer that. I mean, referring to Tom on (79:54) Medicare changes, I think we do not really expect it to have a big impact on our portfolio overall. As you know, we have some exposure, but most of our tests are not paid according to CFLS (80:07) because they fall outside of the Medicare population. So, we don't really expect a big impact there.
Vincent A. Forlenza - Becton, Dickinson & Co.:
It hasn't been a big impact. We don't expect it to.
Operator:
Our final question comes from the line of Amit Hazan with Citigroup.
Amit Hazan - Citigroup Global Markets, Inc.:
Oh, hey. Good morning. Thanks. Hey. Good morning. Thanks. Let me ask my first one on the Bard synergies on the cost side. Just wondering, now we're kind of nearing almost a year since the close, what's your visibility now versus the year ago as to whether your cost synergy target has room to improve over the original guide?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. So, thanks for the question, Amit. I think one thing I would point to is the tax synergies, which were not included in the initial amount. We typically don't show them, but did come to fruition. We did about $75 million in 2018 and those were the types of synergies that you get from the duplication of public company costs and some procurement. So the visibility to those typically is very high. The next bucket that you would think of the next $100 million is the integration of systems and processes and functions. And we are in the execution stage of that. I feel really good about it, but you want to see that. And then, the third bucket is distribution centers and plants, et cetera, and that takes a while. So, we're just coming into the phase where we'll see the execution of those two buckets, which are really the ones that are the more difficult to get and takes a lot of execution. So, nothing that we see at this point would enable us to call an increase to that $300 million beyond the tax, but that's something that we're right in the middle of execution on, so a while longer before we can predict it for 2020.
Amit Hazan - Citigroup Global Markets, Inc.:
Thanks. And just last one, then on Interventional business and Surgery and actually hernia in particular, even if I exclude Progel and the hurricane, it seems to be trending slower than what Bard was doing pre the acquisition. Obviously, a big part of Bard's success in recent years was coming from share gains in hernia, so I'm just wondering if you can give us some color on growth trends in your hernia platform and what you expect there in the coming year.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Simon will do that for you.
Simon Campion - Becton, Dickinson & Co.:
So, I think, as you said, we've just come off the hurricane and Progel and we're in the process of regaining some of the share that we've lost. You saw a reacceleration in Q4 for us. We do expect that to continue, but clearly there remains work to be done. So that's what we're looking at moving forward. And then, as Vince said earlier on, we are looking at geographic expansion here now as well, and we expect to – for that to be able to accelerate our momentum moving forward too. So, we're pretty happy with where we sit right now, and we're looking forward to executing on the synergies that we've rolled up.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. All in all, the overall Interventional segment is doing very, very well. And the recovery program from the hurricane was not just getting the production back in place, but of course, there was a lot of competitive inventory in the channel that we had to go and deal with. The team has done a fantastic job on that in getting that back. And we expect that to continue in 2019, but the overall business is doing well. So, we expect that recovery to continue in 2019, but thanks for the question.
Operator:
At this time, there are no further questions. I will now turn the floor back over to Vince Forlenza for closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So, thank you very much for your participation and your questions. Let me just finish with some final thoughts. We had a very strong finish to the year, and I feel incredibly proud of our performance and what this team has done. The combination of BD and Bard continues to deliver exceptional value to our customers and our shareholders. And lastly, we have good momentum going into fiscal year 2019, and we look forward to updating you next time. Thank you very much.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Operator:
Thank you. This concludes today's conference call. You may now disconnect, and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Vijay Kumar - Evercore ISI Bob Hopkins - Bank of America Merrill Lynch Isaac Ro - Goldman Sachs & Co. LLC Larry Biegelsen - Wells Fargo Securities LLC Robert J. Marcus - JPMorgan Securities LLC Doug Schenkel - Cowen and Company William R. Quirk - Piper Jaffray & Co. Jaime L. Morgan - Leerink Partners LLC
Operator:
Hello, and welcome to BD's Third Fiscal Quarter 2018 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 9, 2018, on the Investors page of the bd.com website or by phone at 1-800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 278 8137. I would like to inform all parties that your lines have been placed in a listen only mode until the question-and-answer segment. And beginning today's call is Ms. Monique Dolecki, Senior Vice President of Investor Relations. Ms. Dolecki, you may begin your conference.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our third fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Reconciliations to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. As previously disclosed in April 2018, the company divested its remaining interest in the Vyaire Medical joint venture. The company received gross cash proceeds of approximately $435 million and recognized a pre-tax gain on the sale of approximately $308 million. In addition, in the third quarter the company recorded an $81 million non-cash charge to write down the carrying value of intangible assets related to the retiring of the BD CLiC system within our Biosciences business. We have redeployed select resources within our Biosciences business to allow us to better focus our genomic strategy on continued innovation and immunology research. These items, along with the details of purchase accounting and other adjustments, can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the Investor Relations slides. As a reminder, our third quarter P&L results reflect the new BD, which includes the results of C.R. Bard for the full quarter. To provide additional revenue visibility into the new BD, we will speak to our revenue results and fiscal 2018 revenue guidance on a comparable currency neutral basis. The comparable basis includes BD and Bard in the current and prior year periods and excludes the revenues associated with our soft tissue core needle biopsy and Aspira drainage product lines that were divested in February. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer, and Chief Administrative Officer; Tom Polen, President; and Alberto Mas, Executive Vice President and President of the Medical segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. Turning to slide 4. At BD, our strategy is driven by our purpose
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. Moving on to slide 7, I'll review our third quarter revenue and EPS results as well as key financial highlights. As Vince mentioned, our performance as the new BD continues to be strong. Third quarter revenue growth was in line with our expectations and was driven by strong mid-single digit growth across all three segments. On a comparable basis, revenues grew 5.5%. Our strong revenue performance includes a pricing decline of about 40 basis points in the third quarter, which was in line with our expectations. Year-to-date, pricing declined 35 basis points. I'll provide more color on revenue growth in the quarter in a moment when I take you through the results by segment and by geography. Adjusted EPS of $2.91 grew 18.3% or 11% on a currency neutral basis. Growth was driven by strong performance from both the legacy BD and Bard businesses. Despite the more recent strengthening of the U.S. dollar, FX was again a tailwind this quarter. All in, we continue to be very pleased with our performance as a combined entity. In addition to strong year-to-date revenue growth of 5.8% on an underlying basis, we expect revenue growth to accelerate in the fourth quarter, which I'll speak to when I discuss our updated guidance. Before we move on, I'll also point out that as of June 30 our gross leverage ratio declined to 4.2 times, reflecting the paydown of approximately $400 million of debt. We are on target to achieve our commitment to deleverage to below 3 times over three years. Now moving on to slide 8, I'll review our Medical segment revenue growth on a comparable currency neutral basis. BD Medical third quarter revenues increased 5.7%. Revenues in Medication Delivery Solutions, or MDS, grew 5.8% in the third quarter, driven by strength in vascular access and vascular care. Revenues in Medication Management Solutions, or MMS, grew 8.3%. As a reminder, at the end of the second fiscal quarter we reached the one-year anniversary of the change in the U.S. dispensing business model. As we anticipated and communicated to you last year, the financial impact of this change lasted four quarters and is now behind us. Customer response has been overwhelmingly positive to the successful transformation, as evidenced by the continued strong adoption of Pyxis ES in the quarter. Beyond dispensing, growth in MMS in the third quarter was also driven by strong performance in infusion. Diabetes Care revenues grew 2.4%, driven by growth in pen needles in the U.S., partially offset by the timing of tenders in emerging markets that occurred in the second quarter as previously communicated. Year-to-date, Diabetes Care grew 3.4%. Revenues in Pharmaceutical Systems grew 3.8%. Results for the third quarter were impacted by the timing of customer orders. Year-to-date, Pharmaceutical Systems grew 5.2%. Now turning to slide 9 and the BD Life Sciences segment. Third quarter revenues increased 5.6% with strong performance across the segment. Revenues in Diagnostic Systems grew 5% in the quarter. Performance was driven by core microbiology and continued growth in our BD MAX molecular platform. Preanalytical Systems growth of 5.2% was driven by global strength in core products. Biosciences revenues grew 6.8% in the quarter, driven by performance in research reagents and advanced bioprocessing, as well as growth in newer instruments, such as the FACSMelody and FACSLyric. Turning to slide 10 and the BD Interventional segment. Third quarter revenues increased 5.1%. Year-to-date, revenues grew 4.9%, or 6.1% on an underlying basis, adjusted for the impact of the hurricane in Puerto Rico in our first fiscal quarter. Revenues in Peripheral Intervention grew 8.1% in the quarter. Performance reflects strength in drug-coated balloons, driven by the AV indication and strong international growth in biopsy products, particularly in China. Growth of 1.7% in Surgery reflects strong international growth in infection prevention, partially offset by a continued hold on Progel that adversely impacted growth in Surgery in the quarter by approximately 170 basis points. We remain on track to relaunch Progel by the end of this calendar year. Urology & Critical Care revenues grew 5.6% in the quarter, driven by strong performance in our acute care Urology portfolio. Moving on to slide 11. I'll walk you through our geographic revenues for the third quarter on a comparable, currency neutral basis. U.S. revenues grew 5.9% in the third quarter. Performance was strong across the Medical and Life Sciences segments. Within the BD Interventional segment in the U.S., strong performance in Peripheral Intervention and Urology & Critical Care units was partially offset by a decline in the Surgery unit that was driven by the continued hold on Progel as previously mentioned. Moving on to International, revenues grew 5.1% in the third quarter. Growth was driven by strong performance in the Life Sciences and Interventional segments. Growth in the Medical segment outside the U.S. reflects strong performance in the MDS and MMS units. Slower growth in the Diabetes Care and Pharmaceutical Systems units outside the U.S. reflects the timing of orders as previously discussed. Developed Markets revenues grew 4.6% in the third quarter. Growth in Developed Markets was driven by strong performance in the U.S. as previously discussed and strength in Europe in the Surgery, MMS, and MDS units. Third quarter Emerging Markets revenues grew 10.5%. Revenues in China grew 13.2%, driven by strong double digit growth in the Life Sciences and Interventional segments. In addition, revenues in Latin America grew in the high single digits. Now turning to slide 12, which recaps the third quarter income statement. As discussed, revenues were in line with our expectations, growing 5.5% in the quarter. Moving down the P&L, as we expected, gross profit improved during the quarter, increasing 46.2% year-over-year. Gross profit margin was a strong 58%. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenue was 25.2%, which reflects Bard's higher SSG&A spend profile, partially offset by the achievement of synergies. R&D as a percentage of revenues was 6%, which reflects our continued commitment to invest in innovation. Operating margin increased 260 basis points or 180 basis points on a currency neutral basis. We continue to deliver significant operating margin expansion, which reflects strong P&L leverage as the new BD. Our tax rate was 18% in the quarter, which is in line with our full year guidance range. And as expected, we paid preferred dividends of $38 million in the quarter. As we discussed last quarter, the preferred shares are not included in the shares outstanding calculation. In the quarter, adjusted earnings per share were $2.91, which is an 18.3% increase versus the prior year or 11% on a currency neutral basis. Now turning to slide 13 and our gross profit and operating margins for the third quarter. As expected, gross profit margin was a strong 58% in the third quarter. On a performance basis, gross profit margin improved by 340 basis points. This reflects the inclusion of Bard's more robust gross margin profile as well as our continuous improvement initiatives and cost synergies. These items were partially offset by headwinds from raw materials such as resins. Currency had a positive impact of 70 basis points on gross profit margin. Operating margin grew 260 basis points in the quarter or 180 basis points on a currency neutral basis. This was driven by gross margin improvement, partially offset by the higher combined company SSG&A profile, as previously discussed. I'll take you through our fiscal 2018 guidance over the next several slides. But while we're discussing margins, I'd like to point out that we're well on our way towards delivering significant margin expansion of 200 basis points to 250 basis points this fiscal year on a currency neutral basis. Moving on to slide 15 and our full fiscal year 2018 revenue guidance. For the total company, based on strong performance across our businesses, we are increasing our revenue guidance. We now expect revenue growth to be above the high end of our previous guidance ranges with total company revenue growth of over 5.5% on a comparable currency neutral basis. This represents strong growth of over 6% on an underlying basis, excluding the estimated impact from the U.S. dispensing change and the hurricane in our first fiscal quarter. As a reminder, this also includes approximately 25 basis points of benefit from this year's severe flu season. We are also increasing our Medical and Life Sciences segment revenue guidance. We now expect both segments to grow above the high end of our previous guidance ranges with growth in the Medical segment of over 5% and growth in the Life Science segment of over 6%. We are also reaffirming our guidance of 5.5% to 6.5% growth in the Interventional segment. We continue to expect revenue growth to be driven by recent product launches across all three segments and strength in both developed and emerging markets. Our updated revenue guidance reflects developed market growth of over 4.5% in fiscal 2018 or over 5% excluding the estimated 50 basis points impact from the U.S. dispensing change and the hurricane. In Emerging Markets, we continue to expect low-double digit growth, driven by a diversified base with mid-teens growth in China and strength in EMA and Latin America. Now moving on to slide 16 and our full fiscal year 2018 EPS guidance. We continue to expect strong earnings performance in fiscal 2018 and are narrowing our EPS guidance. As there are a number of moving parts that impact earnings per share in fiscal year 2018, for modeling purposes and to ensure consistency I'd like to provide more color on EPS guidance. Starting on the left of the chart with our guidance as of last earnings call in May. We expected currency neutral EPS growth of approximately 12%, driven by strong growth in operating income. This represented 14% to 15% growth on an underlying basis, excluding headwinds of 2% to 3% from the U.S. dispensing change. We also expected currency would provide an approximate 4% tailwind to earnings growth in fiscal 2018, which is now a smaller benefit than we initially anticipated. Moving to the right half of the slide in our updated guidance, you will see that the impact of our increased revenue guidance is expected to be largely offset by a reduced currency benefit as I just mentioned. In addition, we also have an impact from the acquisition of TVA Medical. Our FX assumptions assume a euro to dollar exchange rate of $1.17, down from $1.23 at the time of our May guidance. As a result, we are narrowing our adjusted EPS guidance range to a range of $10.95 to $11.05, which represents growth of approximately 15.5% to 16.5%. We continue to expect the Bard acquisition to deliver low single digit accretion in fiscal year 2018 and high single digit accretion in fiscal year 2019. We are committed to fully realizing $300 million in annualized cost synergies as we exit fiscal year 2020. Turning to slide 17. I'd like to walk you through the balance of our guidance expectations for the full fiscal year 2018. As a reminder, this guidance includes the results of Bard as of January 1, 2018, which is the beginning of our second fiscal quarter. On a reported basis, revenue growth for the total year is expected to be over 31.5%, which is above the high end of our previous guidance range. This reflects a currency tailwind of approximately 250 basis points. For fiscal year 2018, we continue to anticipate our adjusted average fully diluted share count to be approximately 261 million shares. For modeling purposes, I'd like to remind you that net income reflects the deduction of approximately $114 million of preferred dividends. The preferred shares are excluded from the adjusted diluted shares outstanding. Beyond revenues and EPS, all other P&L guidance from May remains unchanged. In summary, I'm really excited about our continued strong momentum as the new BD. And I'm confident that we'll deliver on our commitments in fiscal year 2018 and beyond. Now I'd like to turn the call back over to Vince, who will provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris, and moving on to slide 19. As we have been discussing with you, our integration of CareFusion is largely complete. We have already achieved our cost synergy commitment of $350 million and are on track to realize our revenue synergy commitment. At the same time, as I mentioned in my opening remarks, we're very pleased with the progress we are making with the Bard integration. As previously communicated, we have started to realize our year one cost savings and remain confident in achieving our target of approximately $300 million in annualized savings by fiscal year 2020. We're also continuing to make progress with our investment in revenue synergies that we discussed with you previously. We recently completed cross-training of the sales force in MDS, where we brought together the BD and Bard vascular access portfolios. And we have also trained and activated the new surgical sales hires in Europe that we discussed with you last quarter. We look forward to sharing future updates with you as we make additional progress across our initiatives. Turning to slide 20 and our planned product launches by segment. Starting with our Medical segment, recently we released the first BD-branded Alaris PC unit and large volume pump. This is the first new pump enhancement in more than 10 years. The BD Alaris offers customers three key areas of value. First, customers will see improved quality and reliability through enhanced connectivity and cybersecurity. They will also benefit from clinical enhancements, such as a new alarm and loading features and various clinical efficiencies. Additionally, this new pump is helping us to continue to expand enterprise interoperability through the BD HealthSight platform. So far, we've been very pleased with the customer adoption. And feedback has been positive. With respect to our type 2 patch pump for diabetes, we remain on track for our initial limited launch in late FY 2019. We have completed multiple clinical trials, which have allowed us to gather insights that are critical as we prepare for our initial limited launch and beyond. Our production preparedness continues to be on schedule to support the expected commercial demand. And we anticipate submitting our regulatory approvals for the U.S. and EU later this year. We continue to be excited about bringing this differentiated solution to the market for people living with type 2 diabetes. In our Life Science segment, we have seen continued strong performance on our BD MAX platform, driven by Enterics CT/GT (sic) [Enteric CT/GC] (26:19), as well as the recently launched MAX Vaginal Panel. We have seen strong customer adoption of our Vaginal Panel, a unique assay capable of directly detecting the three most common infections known to cause vaginitis. In addition, we will be expanding the assay menu further with the launch of MAX TV assay in the coming months. We also continue to expand our digital capabilities in support of our BD Kiestra lab automation solutions platform with instrument cup connectivity through our Synapsys informatics software. We have also released Synapsys version 2.1 in the U.S., which expands the ability of the software to establish secure connectivity across multiple instruments. Moving on to the Interventional segment. As I discussed in my opening remarks, we recently acquired TVA Medical. The addition of TVA Medical expands our leading ESRD access portfolio with a new technology that will further improve our ability to serve physicians and their patients by providing a minimally invasive nonsurgical option for creating critical AV fistulas for hemodialysis procedures. Both BD and Bard have a rich history of commercializing innovative technologies. And we will leverage that skill set and our leading position in the ESRD access space to bring this new technology to our customers and their patients. We are currently in the process of training our sales reps and clinical teams and started hiring some additional salespeople in preparation for a Q1 fiscal 2019 launch in the U.S. In addition, we recently launched the Echo 2, our next generation positioning system within our hernia business. Echo 2 is a technology that works very well on robotics in laparoscopic surgery and expands our Echo first generation technology. As you can see, we have a very rich pipeline of new products across our businesses. And we look forward to sharing additional updates with you along the way. Before I move on, I would like to speak for a moment about our commitment to sustainability, which is a key component of our strategy. We're pleased to have recently published an update on our progress towards achieving our 2020 sustainability goals. These goals provide the framework for how we manage and make an impact on the most relevant social and environmental issues for our company. We remain focused on supporting priority health needs that are aligned with the UN Sustainability Goals (sic) [UN Sustainable Development Goals] (29:04), or SDGs. And we contribute to the SDGs through our collaboration with the public and nonprofit sectors across the four key areas that comprise our 2020 goals, innovation, access, efficiency, and empowerment. We just recently joined PEPFAR to celebrate their 15th year anniversary and the global impact they've had on 14 million men, women, and children with HIV AIDS. Building strong health systems is essential for control of the HIV AIDS epidemic. And BD is proud to be in the 11th year of its public/private partnership with PEPFAR, which focuses on strengthening laboratories and improving clinical practice in several countries across sub-Saharan Africa and Asia. As much as BD has been able to affect positive change in health care for the past 120 years, we continue to strengthen our ability and leadership in our industry. With this leadership comes even greater responsibility. Our integration with Bard will bring a renewed look at our key sustainability issues and goals. And we will communicate more about how sustainability at BD will evolve in future reports. We look forward to our progress with you along the way. We have also included a slide in the appendix of today's presentation that provides you with some details on our sustainability initiatives. We hope you find the information useful in understanding BD's commitment to this important topic. Now before I move on to my summary, I would like to thank Bill Tozzi for his great work in running the Interventional segment on an interim basis, while continuing his work as leading the integration. Thanks very much, Bill. We really appreciate it, and so do our shareholders and all of our associates. Moving on to slide 21, I would like to reiterate the key messages from our presentation today. First, our strong performance year to date reflects our early progress and momentum as the new BD. Our core remains strong. And our expanded portfolio and complete solutions have further solidified our leadership position in Medtech. This is evidenced by our financial performance across businesses and regions. Second, the integration of Bard is off to a strong start, and we have key leaders in place. We're confident in achieving our costs synergy and accretion commitments. Third, we have increased our revenue guidance and narrowed our EPS guidance as a result of our strong year-to-date performance and our expectation for acceleration in the fourth quarter. Lastly, I have increasing confidence in our outlook as we move forward as the new BD. We will continue to deliver comprehensive solutions for our customers and value to shareholders around the world. Thank you. We will now open the call to questions.
Operator:
Thank you. The floor is now open for your questions Our first question comes from the line of David Lewis with Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. Maybe one for Vince and then one for Tom. Vince, just want to focus on guidance into next quarter. So guidance for the year are very solid. Fourth quarter sort of implies acceleration to sort of 6.5% organic by our math. So are there any just sudden like momentum deceleration this quarter and some acceleration built into next quarter? Any timing issues that you sort of talk about as you roll into this quarter and to next quarter? And really just want to get you to express your confidence in getting to that next quarter number.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. So I'd start out by saying, I'm very confident in our next quarter number. And yes, there were some things in this quarter, some timing issues in this quarter that did affect us. And I'll point them out to you. So number one of course was in the Surgery business, where you've got Progel in that comparison costing us about 25 basis points. Then we have about 25 basis points of Pharm Systems timing. We expect Pharm Systems to be very strong in the fourth quarter. And we expect in the Surgery business that you're going to see an acceleration in the Surgery business also in the fourth quarter. There was a little bit of kind of channel dynamics going on there in terms of the hurricane and what not. We see that reversing itself in the fourth quarter. And then timing of diabetes tenders, so that's about another 10 basis points. So if you do the math on all of that, you're basically at about a 6%, maybe 6.1% underlying. So we actually feel better about this quarter than you would look at it at first pass. But moving on to the next quarter, we feel quite good across all three of the businesses. First, the pipeline that we're seeing in MMS, and strength in both the Pyxis product line, drug administration, and of course on the pump side, too. I mentioned in my remarks the first advancement on the pump side in 10 years. And I mentioned that we're seeing very strong adoption there. Feeling good about that business. I think on the Life Science side, I mentioned BD MAX but also Kiestra is – we're going to see strong growth in Kiestra in the fourth quarter. So we got really good visibility. And then you saw Biosciences doing quite well, expect that continuation. So if I go through each one of the businesses, we're looking good across all three segments. So I feel very good about kind of this guidance that we're giving you at going beyond the top end of the range. Chris has got a couple of other comments he'd like.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. The only thing I would add is that Pharm Systems and MMS, MMS grew 8.3% this quarter. But we expect both Pharm Systems and MMS to be double digits in the fourth quarter. And I would correct one thing, David, that you said. By our math, the fourth quarter implication is over 7% to get to our guidance range. So we feel really good about the revenue and the acceleration into the fourth quarter and the guidance range that we've put out.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. Very helpful and very clear, guys. And then to Tom or Vince, just thinking about the Interventional business. Growth last quarter, 7.8%, to 5.1% this quarter, a little bit of a deceleration. That's the one business – every outlook was raised; that's the one business where you did not raise outlook. Anything you'd call out in how you're feeling about the core Bard growth here? Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Tom will take that.
Thomas Polen - Becton, Dickinson & Co.:
Hey, good morning, David. This is Tom. So we feel very good about the overall core Bard business growth. So as you saw, we had 5.1%, or 5.7% excluding Progel...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Thomas Polen - Becton, Dickinson & Co.:
...for the overall segment, which is right in line with the overall guidance we've given for the year, the 5.5% to 6.5%, and we're 6.1% year to date. So right in the middle of the range. Again, we feel good about that. Obviously quite strong performance out of the Peripheral Interventional (sic) [Intervention] (36:35) business. We continue to see well north of 25% growth in DCBs, driven by that AV fistula launch that we've been talking about. Oncology also doing extremely well. On the Urology/Critical Care side, we see very good growth, 5.6% for the quarter, which is quite strong for that business, driven really by the global acute Urology portfolio, as well as some timing on the temperature management business. But overall, that's been doing very well as well. And then obviously on Surgery as Vince mentioned, it was a 1.7% in the quarter, or a 3.5% excluding Progel. And we expect some rebound to that as we go into Q4 with some timing as people had kind of balanced inventory pickup in the prior quarter with this quarter, as they're stabilizing post-hurricane. But we expect that to start really stabilizing on a go forward basis as we go into Q4.
Christopher R. Reidy - Becton, Dickinson & Co.:
I would just add as well that if you looked at things on a legacy basis, legacy Bard, our full year guidance would imply about 7% growth. And legacy BD nearly 6% growth, and that's at the high end of the range as we would've anticipated. So good momentum.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks for the questions, David.
Operator:
Our next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore ISI:
Hey, guys. Congratulations on a really nice quarter here and thanks for taking my questions. So maybe I'll start off on that guidance question once. A really strong Q4. And it looks like most of this was strength in underlying business. Right? And I think most of us, the question is when you look at FY 2019, how should we be thinking about underlying trends in some of the business segments? Right? Are there any areas where you see some new products gaining momentum? Or any areas where comps might be an issue? Just any color on 2019 I think would be helpful.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, I think you've got to look at 2018 and how we're doing across the entire company. It's very difficult for me to point to anything specifically. I think I just walked through good momentum across all three of the segments at the top line. That's the way I'm thinking about that. From a demand side, if I think about it from a regional standpoint, I think all the regions are doing well, whether it's Asia. We haven't talked about China yet, but China had a good quarter. Asia has done well. Latin America is doing well. Europe is strong. You're seeing strong momentum in both, in the developed markets. So it's difficult for me to call out anything in particular at this point in time. I'll refine that obviously when we get to our guidance. But I think you should look at the strength this year and use that as the basis.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. I would just add that we do obviously have a little bit of a headwind from the flu, because that was such a strong season for us. But we also have a little bit of a tailwind compare from the hurricane, which is a little bit smaller than that headwind, but roughly offset one another.
Vijay Kumar - Evercore ISI:
That's helpful, Chris. And just maybe one on margin. I think back, when you look back at when the Bard deal was announced, we had expected 500 basis points to 600 basis points of margin expansion. Given where we are in the cycle now, close to 300 bps of margin expansion, when you look at 2019 and 2020, we're still expecting 250 basis points to 300 basis points of margin expansion. One, is that correct? And second, when you think about your comments on FX benefiting margins this year, now how should we think about the interplay between FX and synergies for 2019? Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So you're absolutely right. We are delivering on the first piece of the margin improvement. Really the deal model assumptions that we laid out don't change. And so we're right in line with that, we're executing on that and delivering in 2018. And we would expect 2019 to be in line, as you laid that out. So that 500 basis points of improvement is what we had laid out. And we're delivering on that. If you look at the results this year, we were getting some benefit from FX. But it was above and beyond. So we delivered 410 basis points this quarter, for example, 340 basis points underlying and the rest coming from FX. So that's kind of like the icing on the cake was the FX piece. Going forward, obviously, we won't get that tailwind from FX. We'll have to watch the dollar, the euro, and some other currencies to see. So it might be a slight headwind going forward. We'll see how that plays out.
Vijay Kumar - Evercore ISI:
Thank you, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Thanks, Vijay.
Operator:
Our next question comes from the line of Bob Hopkins with Bank of America.
Bob Hopkins - Bank of America Merrill Lynch:
Hello. Thanks very much for taking the question. Just wanted to address a couple quick things. First, and this is really big picture, but I was just wondering if you could talk a little bit about the global trade rhetoric that's going on over the last couple of months today? And how BD is positioned relative to what you know today about the numbers that are out there? Just I think a little bit of an update there would be welcome. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So I'll start out and maybe Chris will want to add a few things. Of course we, like everyone, are concerned about the global trade rhetoric of course, especially with China. Things with Europe seems to be calming down a bit. Tariffs for us this year are not material. It's a small number. It'll be a little bit of a headwind going into next year, as long as we stay where we are in terms of what's happening with China. Do you want to add anything else?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. So just to be specific on that. In the fourth quarter, we got about $0.01 of impact from the tariffs as enacted now. And that's typically some electronic parts particularly related to our MMS and Biosciences businesses. So really de minimis, but about $0.01. That annualizes next year, so I think $0.04 next year or thereabouts, but not particularly meaningful. As it relates now, if you look at the next set of rounds, I think it's about the same. And we'll see if that happens at all. And they – constantly changing, so we'll watch that. But not particularly significant.
Thomas Polen - Becton, Dickinson & Co.:
Bob, this is Tom. Just maybe to add to the events in Chris's comments.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah.
Thomas Polen - Becton, Dickinson & Co.:
Just one other thing to consider is we've had a very systematic strategy over the last couple years to migrate manufacturing for China in China. And so today over 50% of the BD Medical products that we sell in China are manufactured in China. That obviously is a (43:51) to the tariff. We've been doing that now in the Life Science. We've been very purposely moving products into China for China there. And we're now, as part of our integration work with Bard, we got a number of products already started under way to transition manufacturing again for China in China. So we see that as probably a position that we're maybe more advantaged than other companies within the sector that position us well from a tariff perspective.
Vincent A. Forlenza - Becton, Dickinson & Co.:
It gives us a very balanced global network with a lot of manufacturing in the U.S. but very balanced around the globe.
Thomas Polen - Becton, Dickinson & Co.:
Yeah.
Bob Hopkins - Bank of America Merrill Lynch:
Great. Very helpful. And then just quickly I wanted to kind of come back to something that a couple of people have asked about. But if you're commenting on exiting the year at over 7% growth, which is obviously very robust. And I know it's a little early to be talking about this. But just if you could at least talk qualitatively about the sustainability? Does that strength exiting the year suggest that there may be a little bit of upside to the kind of the LRP that you guys have been talking about? Or just a bunch of things coming together particularly in that fourth quarter? So it's really a question on sustainability.
Vincent A. Forlenza - Becton, Dickinson & Co.:
I'll let you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. I think we feel really good about the way we're exiting the year. But I think there is some timing that we talked about that shows up in the fourth quarter. So it's early to be talking about next year at this point. But we feel like we're going in with strong momentum and executing on the range that we talked about at the time of the deal model. So more to come.
Bob Hopkins - Bank of America Merrill Lynch:
Great. Thanks for taking the questions.
Operator:
Our next question comes from the line of Isaac Ro with Goldman Sachs.
Isaac Ro - Goldman Sachs & Co. LLC:
Good morning, guys. Thanks very much. Just hoping you could talk a little bit more about U.S. surgical volume trend. Kind of curious what you saw in the quarter and what's baked into the guidance for the rest of the year? And the reason I ask is, it does look like across the industry things have gotten a little bit better. But maybe not to the degree you would hope for, given seasonality and just economic backdrop here. So be interested in your take on that dynamic.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. I'll just make an overall comment first and then I'll turn it over to Tom. But I don't think we've seen any real change in the surgical dynamics broadly across the product line, the legacy BD piece or the Bard piece, other than the little bit of confusion from the hurricane, which is kind of clouding things. But, Tom, is there anything else you want to add?
Thomas Polen - Becton, Dickinson & Co.:
Vince, I think you said it well.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks.
Isaac Ro - Goldman Sachs & Co. LLC:
Okay. Helpful. And then just a follow-up on the gross margin dynamic, just to continue on that topic. It'd be helpful if you could maybe deconstruct a little bit more some of the key drivers of improvement. You said to us you had multiple factors at play here. Trying to figure out which of those are likely to sustain on a sort of normalized basis if we put aside FX.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So we obviously get a nice lift from the mix with the Bard gross margins. And so that's about 300 basis points this particular quarter. For example, we had 100 basis points of improvement from synergies. And that was partially offset by headwinds from raw materials, about 30 bps, mostly resins, and pricing was about 20 bps thereabouts.
Isaac Ro - Goldman Sachs & Co. LLC:
Got it. Thank you very much.
Operator:
Our next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen - Wells Fargo Securities LLC:
So good morning. Thanks for taking the question. One on Bard, one on some new – some products.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Larry Biegelsen - Wells Fargo Securities LLC:
So first on Bard. Any update on revenue synergies and tax synergies and timing and maybe just qualitatively the potential benefit? And then I had one follow-up.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Tom will talk about the revenue synergies. I think we're feeling pretty good. Tom?
Thomas Polen - Becton, Dickinson & Co.:
Yeah. Hi, Larry. This is Tom. So we do continue to expect revenue synergies are going to be measurable starting in FY 2019 and larger than the CareFusion revenue synergies as we've shared in the past. More to come on specifically what those dollars are. I think we've always hinted that that would come as we give FY 2019 revenue guidance. And we expect that that's still the exact timing that we're on. But maybe the other things I could add is we've shared already that we're investing about $15 million this year towards revenue synergies. Most of that falling in SSG&A expenses as we're ramping up our efforts in a few areas, and those are around vascular access. So driving synergies across that broadened portfolio of PICCs, mid-lines, and catheters. And then that other major area is in Surgery, particularly the U.S. and Europe, where there was opportunities to double down the channel to leverage the biosurgery and the infection prevention platform. So those investments are rolling out. Actually Q3 was kind of the peak of those investments. Q4 will continue at a similar rate and then continue to roll into 2020. But we are seeing positive momentum.
Vincent A. Forlenza - Becton, Dickinson & Co.:
The only other thing I would add is that we have piloted the vascular access value proposition in a few accounts. And the response from the accounts has been excellent. We just saw that in the last couple of weeks. So we think we're on the right track here.
Larry Biegelsen - Wells Fargo Securities LLC:
And, Chris, on the tax synergies? And just I'll ask the product question. So Lutonix BTK, still file by year-end 2018? Any update on the data presentation? And just lastly, TVA, the opportunity seems underappreciated to me. Any color on how big that could be? Thanks for taking the questions.
Christopher R. Reidy - Becton, Dickinson & Co.:
So I'll go with the tax rate first, and then I'll pass it over to Tom. It's still a little bit early on the tax synergies. And the reason for that, first of all, it's complicated. But it's, secondly, complicated by tax reform. And so there's a lot of folks that are helping us dive through that as we speak. So more to come in the future on that. I think we feel good about where the tax rate is now. We're looking at the low end of our range, so in that 17% kind of range of – the original range we gave was 17% to 19%. So we're looking pretty good from that standpoint. The one other point that I'd remind people is you do get a bit of a grow over next year, because of the tax on foreign earnings from tax reform kicks in next year. So we're getting a little benefit this year. And it erodes a little bit next year. But we're pretty confident that we can offset that. So just something to think about. And Tom.
Thomas Polen - Becton, Dickinson & Co.:
So, Larry, this is Tom on BTK and TVA. So BTK is right on track with what we had shared historically. We are right now finishing the six-month follow-up and preparing the submission of the PMA in Q1 of 2019. That's 100% on track. And we expect to be able to talk about the BTK data, just as we've shared before probably at the beginning of the calendar year in some scientific forums. On TVA, I think you're 100% right on. We're really excited about that technology. If you've seen the current methods for creating a fistula and the invasiveness of the surgery versus the minimally invasive nature and what that looks like and the time to having a mature fistula, it's a radical difference versus the current state of care. And so that gives us really the – what we think is going to be an early lead in minimally invasive vascular access solutions for patients with end-stage renal disease. It's really a disruptive innovation that we do think presents a significant opportunity for BD PI [Peripheral Intervention] and is really going to just further add to our full range of solutions for supporting IV access for patients undergoing hemodialysis.
Vincent A. Forlenza - Becton, Dickinson & Co.:
The other exciting thing about this is it enables the creation of new fistula sites.
Thomas Polen - Becton, Dickinson & Co.:
Two.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And so two sites. So from a patient standpoint, this is extremely important. So as Tom was saying, we agree with you that this is a real opportunity to convert the current procedures.
Thomas Polen - Becton, Dickinson & Co.:
I would just add our sales teams are being trained now and we're planning for a launch in Q1.
Larry Biegelsen - Wells Fargo Securities LLC:
Thank you.
Operator:
Our next question comes from the line of Robbie Marcus with JPMorgan.
Robert J. Marcus - JPMorgan Securities LLC:
Great. Thanks for taking the question. Vince, I was hoping you could talk about your Emerging Markets growth. 15% to 20% of the business, still growing pretty strong double digits there. How much of that is from the addition of the Bard business? How did Bard do versus Becton? And any color on the sustainability there?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. And so I would say it was very much where we expected it to be. So kind of if you backed up underlying Bard and underlying BD, we're very much in line with historical trends. China I think was around – all-in, around 13% or so. And the BD and Bard pieces were pretty much in line with what we expected. For me, the big bounce back has been in EMA year to date doing quite well. And then very good growth in Latin America. So I would say that from a revenue synergy standpoint, we're really in very, very early days. We're only two quarters into this, just training folks on that. So you're not seeing the revenue synergy piece of that yet. That's to come. Now the one place we're moving ahead that's not Emerging Markets, as Tom mentioned of course, is in Europe. We do have the sales force now in place on the Surgery side of things. So just getting started there basically this quarter. So more to come next year on revenue synergies.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. And, Robbie, this is Chris. I would add when you think about Emerging Markets growth, I would say Bard adds about 2% to Emerging Markets, which is in line with what we would've expected.
Robert J. Marcus - JPMorgan Securities LLC:
Great. Maybe as a follow-up for Tom, on the type 2 diabetes patch pump and the cannula, the infusion set with Medtronic. These are two that have significant potential. Can you give us any more in terms of the go-to-market strategy with the type 2 pump? Any details around the product or how it compares to some of the other patch pumps out there? And is there any ability or willingness to take this into the type 1 market? Thanks.
Thomas Polen - Becton, Dickinson & Co.:
Okay. Okay. Robbie. This is Tom. So for Swatch, we continue to be very excited about the potential of that product. And we continue to make good progress. We are progressing our clinical trials as we had shared in the past, including the – we've just completed the analysis of an in-human insulin fusion trial. And that went exactly to plan for us. It was very positive response from patients on its ease of use and overall performance. So right now we're actually preparing to start-up our next in-home safety trial, again using insulin. And we're making good progress overall, gearing up our manufacturing. We've moved that to our Ireland location, where that's going to be the permanent manufacturing location. And we're building our commercial plans at this point in time. So it has been designed specifically for type 2 patients, both from a feature set and extreme ease-of-use. Right? What really differentiates this product from other types of patch pumps we think are the extreme simplicity of the user interface on the digital side and on the hardware side. And so that we've designed to not necessarily have all the bells and whistles that someone with type 1 would want, but that's also allowed us to have a cost position that is very specifically targeted for type 2 patients. So think about a cost position that's much more at parity with pen therapy than a significant premium that's typically associated with pump therapy. And that's one of the core value propositions that we hear a lot of excitement from payers on as well. So...
Alberto Mas - Becton, Dickinson & Co.:
So this is Alberto. I just wanted to complement the fact that we are really advancing very well. Our production preparedness is on track. And we'll be ready to go with a good ramp up for the product from a production perspective. And that we are expecting to submit our submission for type 2 patch pump later this year, around that time.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So and going towards type 1 would make no sense, as Tom said, with the features that we have. And that's key actually to the regulatory strategy that we have, that this is focused on type 2 patients. But longer term, think about this as maybe with other drugs for the home, not in the short run, but that's where there's possible market expansion. We're already talking to pharma companies about that.
Thomas Polen - Becton, Dickinson & Co.:
Yeah. I would just add so we do have of course our Pharmaceutical Systems business, which does take devices from other business units and applies them for other disease states by selling those to other pharma companies. And so we have signed our first deals on a B2B basis with that product. And we think there's more opportunities there ahead. So we really see an opportunity to leverage the platform, not only through our Diabetes Care business, but also through our Pharmaceutical Systems business unit, where we have relationships with essentially all of the top pharma companies.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks for your questions.
Robert J. Marcus - JPMorgan Securities LLC:
That's great, thanks a lot.
Operator:
Our next question comes from the line of Doug Schenkel with Cowen.
Doug Schenkel - Cowen and Company:
Hi. Good morning and thank you for taking my questions.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, Doug.
Doug Schenkel - Cowen and Company:
I want to ask a pricing question of Chris. But before we get there, a couple pump questions, different types of pumps.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Doug Schenkel - Cowen and Company:
So, Tom, maybe as a follow-up to just that last question. On the diabetes side, would you ever consider collaborating with a CGM company to automate insulin dependent – I'm sorry, insulin delivery in intensively managed patients who potentially could be using your pump?
Thomas Polen - Becton, Dickinson & Co.:
Yeah, Doug, this is Tom. So yes, we would over time certainly look at CGM being integrated into the algorithms and collaborating with those types of organizations. Yes.
Doug Schenkel - Cowen and Company:
Okay. Thank you for that. And then on the new Alaris pump, just want to talk about the sales strategy there. Is this largely replacing existing BD units? Or do you think with this you can get even more aggressive targeting competitive conversions? You've done an excellent job gaining share. I'm just wondering if this actually positions you even better?
Thomas Polen - Becton, Dickinson & Co.:
Yeah, Doug, let me turn that over to Alberto Mas, who has obviously taken over the Medical.
Doug Schenkel - Cowen and Company:
Okay. Yeah. That would be great.
Alberto Mas - Becton, Dickinson & Co.:
It certainly positions us better with the customer, because there's an enhanced connectivity, cybersecurity, alarms, and so on. So the features are more advanced. Where we're seeing most of our gains, if you like, in the marketplace is when we put together our complete portfolio around the – our HealthSight capabilities in data and analytics. And together – when we put together our Alaris platform together with our Pyxis and from dispensing all the way to med management. The other driver here is interoperability. It's a very important component of our strategy. We think that we're ahead from that perspective from the competition. And we have a track record of actually getting it implemented, which is a key component of interoperability.
Doug Schenkel - Cowen and Company:
Okay. Thank you for that, Alberto. And, Chris, just last one on pricing. You guys have done a great job over the last few years maintaining price. It does look like you've come under a little more pressure recently. I'm just wondering if there's anything more to talk about there? And looking ahead, how do we think about tariffs in the context of pricing moving forward?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So I would say that it's pretty much in line with what we expected. We went into this year, we mentioned we expected to see pressure. And we're seeing a little bit of pressure, so tens of basis points. And it's pretty consistent. We're taking some price in certain areas as you know. And in other areas we're bringing the pricing down. So not unlike what we've been doing over the last few years, and we've been holding that fairly steady. So it's very consistent with where we were. And as it relates to tariffs, it's very small for us. So we don't see any implication on pricing at this point.
Doug Schenkel - Cowen and Company:
Okay. Thanks, guys.
Operator:
Our next question comes from the line of Bill Quirk with Piper Jaffray.
William R. Quirk - Piper Jaffray & Co.:
Great, thanks. Good morning, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Morning.
William R. Quirk - Piper Jaffray & Co.:
So, Vince, you highlighted the TVA medical transaction.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
William R. Quirk - Piper Jaffray & Co.:
How should we think about the pacing of capital deployment for additional M&A activity as compared to that reduction?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Sure. So number one, we are focused on debt reduction and meeting our commitment to get down to three times. And so – and we're on track to so far. So we're feeling good about that. But as we did our modeling and our planning, we didn't make allowance for tuck-in acquisitions. And just as we did under CareFusion, we did a few of them. When we tightened the screening and said, they have to be must-dos strategically. And of course we always have rigid criteria. But you should expect that we will continue to do plug-in acquisitions. But also at the same time meet those deleveraging goals. And that's on track so far.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. I feel really good about the fact that we're at 4.2 times already and also did very a very exciting acquisition like TVA and were able to do both. And it goes back to what Vince said, as we had planned to leave some room, because we knew we didn't want to be out of the tuck-in acquisition business. And so we were able to accomplish both.
William R. Quirk - Piper Jaffray & Co.:
Very good. And then, Tom, circling back to an earlier question, can you help us think a little bit about how you're thinking about the TVA Medical contribution here following the 1Q launch?
Thomas Polen - Becton, Dickinson & Co.:
Hey, Bill. This is Tom. So I don't think we certainly are giving any guidance by product line by quarter. But we would expect – obviously it's a new market that we're going to have to develop. And we think it'll over time become a meaningful contributor to the Peripheral Intervention business. But we don't comment much more than that by product line.
William R. Quirk - Piper Jaffray & Co.:
Okay. Got it. Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Just remember the old adage that this is a company built on singles. And so just keep that in perspective.
William R. Quirk - Piper Jaffray & Co.:
Got it. Thanks, Chris.
Christopher R. Reidy - Becton, Dickinson & Co.:
Okay.
Operator:
Our next question comes from the line of Rich Newitter with Leerink Partners.
Jaime L. Morgan - Leerink Partners LLC:
Hi. This is Jaime on for Rich. Thanks for taking my questions. I guess just following up kind of on capital deployment and M&A landscapes.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes.
Jaime L. Morgan - Leerink Partners LLC:
Kind of what (1:03:43) about size-wise for any potential tuck-ins? And (1:03:47) are you most focused on for areas where you feel that it would benefit from such a deal?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, these are smaller transactions. You saw at TVA is kind of, they got the technology developed, they got an FDA approval. It wasn't a science project. It was a complete product. And in the Interventional segment, you see a lot of that. If you look back over our history, you saw us buying companies that were in the $50 million range. That sort of stuff. Smaller things is generally what we are talking about. A good example is FlowJo, a small software company. It enhances the growth rate. It's another single like Chris was saying. But really rounded out our solutions portfolio over there. Those kind of things is what we're talking about here.
Jaime L. Morgan - Leerink Partners LLC:
Okay. Great. And then just a follow-up. I know you guys are commenting on how the Bard acquisition is going on track and progressing very well. Just a question that I had there. Is there any changes that have surprised you kind of either to the positive or negative since the deal has closed? If you could share any color there.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. That's a good question. I think the interesting thing is that I don't think there has been any significant surprises in terms of when we step back and look at the fundamental assumptions that we had driving the acquisition, starting on the strategy side and how these things fit together. And then on the financial side, if there's been an upside it is how similar the cultures have been and how quickly the teams have come together. I'm delighted, as I mentioned in my remarks, to have several members now on my leadership team out of Bard. Not that I didn't think they were great people ahead of time. But the way this has come together, as I mentioned, from a cultural standpoint has been really good. So that has been fine. I think the differences between CareFusion and this one, CareFusion was put together through acquisition. It had a bunch of different cultures. And so we had to integrate a bunch of different cultures. And then you were integrating actually a bunch of different businesses. With Bard, it's one culture. Those run very decentralized. And so the integration challenge, the complexity in that integration challenge comes from the differences in the business units and the business systems across them. And of course, so that's just a different way of having opportunity and getting at the opportunities across the two businesses. But pretty much, that's it. Very happy with the way the integration is going. And thanks for the question.
Jaime L. Morgan - Leerink Partners LLC:
Thanks.
Operator:
At this time, there are no further questions. I will now turn the call back to Mr. Forlenza for closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Thank you very much for your participation. Just some final comments. As you saw in the quarter, the core BD performance is very strong and we see acceleration in the fourth quarter. I just mentioned that the Bard integration, the synergy capture, the base business performance is also right on track. Very, very happy about that. This year has been a very challenging year because of the amount of things that we have had on our plate. Integrating two businesses, as I said. We're in great shape on CareFusion, pretty much done with that. The Bard piece is going well. But of course we threw on top of that the hurricane and having to deal with that across both organizations. And I'm really proud of the way people have stepped up to those challenges. And at the end of the day, this is an organization that's come together quite nicely, that's working extremely hard to meet our own expectations and your expectations. So thank you very much.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Operator:
Thank you. That does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas E. Polen - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Isaac Ro - Goldman Sachs & Co. LLC Brian David Weinstein - William Blair & Co. LLC Vijay Kumar - Evercore Group LLC Larry Biegelsen - Wells Fargo Securities LLC Robert Hopkins - Bank of America Merrill Lynch Robbie J. Marcus - JPMorgan Securities LLC Rick Wise - Stifel, Nicolaus & Co., Inc. Doug Schenkel - Cowen & Co. LLC Jaime L. Morgan - Leerink Partners LLC
Operator:
Hello and welcome to BD's Second Fiscal Quarter 2018 Earnings Conference Call. At the request of BD, today's call is being recorded. It will be available for replay through May 10, 2018 on the Investors page of the BD.com website or by phone at 1-800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 2857189. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Crystal. Good morning everyone and thank you for joining us to review our second fiscal quarter results. As we referenced in our press release we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our second fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. Reconciliations to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release including the financial schedules is posted on the BD.com website. The details of purchase accounting and other adjustments can be found in the reconciliations to GAAP measures, in the financial schedules in our press release or the appendix of the Investor Relations slides. As a reminder, our second quarter P&L results reflect the new BD which includes the results of CR Bard for the full quarter. To provide additional revenue visibility into the new BD, we will speak to our revenue results and fiscal 2018 revenue guidance on a comparable currency neutral basis. The comparable basis includes BD and Bard in the current and prior year periods and excludes the revenues associated with our biopsy and Aspira drainage product lines that were divested in February. Lastly, we have again provided slides that illustrate the new reportable segment and business unit structure of the combined company and the key brand mapping for the units within the Medical and Interventional segments. These slides can also be found in the appendix of the Investor Relations slides. Before I turn the call over to Vince, we would like to comment on some leadership changes that we announced last week. First, we are very pleased to have named Alberto Mas current segment President for Life Sciences as the new segment President for Medical effective May 29. Alberto has successfully served as segment president of Life Sciences for the past two years developing a strong team focused on driving innovation and growth. Alberto previously held president roles as the leader of three major BD business units including Bio Sciences, Diagnostic Systems and what was known as Medical Surgical Systems. With Alberto's move to the Medical segment we are excited to announce that Patrick Kaltenbach will join BD to serve as segment President for Life Sciences also beginning May 29. Patrick comes to us from Agilent Technologies where he most recently served as president of the Life Sciences and Applied Markets Group, Agilent's largest business group, well known and highly regarded throughout the life sciences community, Patrick brings tremendous industry expertise to BD and deep global experience that uniquely prepare him to succeed in this critical role. John Groetelaars, current president of the Interventional segment has decided to leave BD for the position of President and CEO of Hill-Rom. While we are disappointed that John is leaving, we are pleased that Bill Tozzi current BD Bard integration leader has stepped in as interim segment president for Interventional beginning May 1. Throughout his 40 year career with BD, Bill has held a number of key leadership positions. After serving as Company Controller, Bill was worldwide president of the Medication and Procedural Solutions business during the CareFusion integration. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, President; and Alberto Mas, Executive Vice President and currently the President of the Life Sciences Segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique and good morning everyone. Before we discuss the company's performance in the quarter, I would like to comment briefly on the organizational changes, Monique just mentioned. We are happy to name Alberto Mas to the open role of segment president for Medical. Alberto has had an exemplary career with BD making significant lasting contributions in roles spanning the businesses, regions and functions over more than 25 years. We're confident Alberto is the right leader to continue to advance the Medical segment strategy and lead the segment in its next phase of growth. We also look forward to having Patrick Kaltenbach on board as the segment president for Life Sciences to continue to advance our strategy of becoming a transformative partner from discovery to diagnosis. Attracting an industry leader of Patrick's caliber to BD highlights our commitment to the strategy we have for our Life Sciences segment, the progress we've made and the tremendous opportunities that lie ahead. While we take time to confirm the right successor, we are also pleased to have appointed Bill Tozzi as interim segment president for Interventional. With Bill's deep integration experience and the strong segment leadership team continuing to drive the business forward, we're confident we will maintain the Interventional segment momentum. I would also like to thank John Groetelaars for his contribution to Bard. I know that everyone at BD wishes him much success in the next chapter of his career. We are confident our new segment leadership team has the experience, capabilities and drive necessary to continue to execute on our strategy and our transformation into a bigger, better and bolder BD. Now turning to slide 4. This quarter marks an important milestone in BD's history as it is the first time reporting our results as the new BD, which combines the BD and Bard businesses generating over $4 billion in revenues in the quarter. We are committed to providing our customers and their patients with leading medical technologies and innovative solutions that improve the treatment of disease for patients and the process of care for health care providers. We are confident we have the team in place to execute on our strategy and we remain on track to achieve our fiscal 2018 and 2019 accretion commitments. Turning to slide 5 and our second quarter highlights. Our results this quarter clearly demonstrate our early progress as the new BD. Revenue performance exceeded our expectations and was driven by strong growth across all three segments as well as the impact of the flu season. Our results reflect continued momentum, both in BD's core and the Bard businesses. On a legacy basis, Bard revenue grew 8.5% in the second quarter. The integration of Bard is also off to a strong start. We are executing against our detailed plans and have begun to realize our year one cost synergies as expected. In addition, at the end of the second quarter, we reached the one-year anniversary of the U.S. dispensing change. We are proud to be the only company that has been able to execute this business model change within one year and transform our customers' experience. This important initiative was received very positively by our customers and has laid the groundwork for us to execute upon our medication management strategy going forward. In April, we divested our remaining interest in the Vyaire Medical joint venture. As we shared with you at the time of creating the joint venture, the respiratory business was not core to BD's strategy. Our year-to-date performance along with our current outlook gives us confidence to raise our fiscal 2018 revenue guidance to the high-end of our prior range. On the bottom line, we are increasing our fiscal 2018 EPS guidance as a result of more favorable foreign currency. We are maintaining our currency neutral EPS growth expectations, as slight headwinds in the second half of the year from the Vyaire divestiture, some anticipated incremental clinical trial expenses in our pre-analytical systems business and increased material costs are expected to offset our increased revenue outlook. Chris will provide more details on this later in the presentation. In summary, we're very pleased with our performance and are confident in our outlook as we move forward as the new BD. I will now turn things over to Chris for a more detailed discussion of our second quarter fiscal performance and our fiscal year 2018 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. Moving on to slide 7, I'll review our second quarter revenue and EPS results as well as the key financial highlights. As Vince mentioned, our performance as the new BD is strong. Second quarter revenue growth was ahead of our expectations and was driven by strong growth across all three segments, a stronger than expected flu season and favorable foreign currency. On a comparable basis, revenues grew 5.7%, driven by strength across all three segments. Our second quarter results included the adverse impact from the U.S. dispensing change, which lowered revenue growth by approximately 80 basis points. As Vince mentioned, we have annualized this change, and accordingly, the second quarter was the final quarter with the year-over-year comparison issue related to the U.S. dispensing change. Offsetting the headwinds in the quarter from the dispensing change were flu revenues that contributed approximately 80 basis points to total company revenue growth. Excluding both of these items, underlying revenues also grew 5.7%. Pricing declined about 50 basis points in the second quarter, in line with our expectations. I will provide more color on revenue growth in the quarter in a moment when I take you through the results by segment and geography. Adjusted EPS of $2.65 grew 15.2% or 7.8% on a currency neutral basis. This includes the adverse impact of approximately 500 basis points from the U.S. dispensing change as expected. Adjusting for this, currency neutral EPS growth was in the low teens. Growth was driven by strong performance of both the legacy BD and Bard businesses. In addition, FX was a tailwind this quarter due to the year-over-year weakening of the U.S. dollar. As Vince mentioned earlier, we are very pleased with our first quarter as a combined entity. Our current outlook reflects our second quarter revenue outperformance and continued momentum over the second half of the year. As a result, we are raising our revenue guidance to the high end of our previous range. We are also raising our adjusted EPS guidance to reflect a more favorable benefit from foreign currency. We are maintaining our currency-neutral EPS guidance, as we anticipate some incremental expenses in the second half of the year. I'll provide more detailed guidance commentary later in my remarks. Before we move on, I also want to point out that as of March 31, our gross leverage ratio declined to 4.5 times, driven by growth in EBITDA and the pay-down of $100 million of debt. We are on target with our commitment to deleverage to below 3 times over three years. Moving on to slide 8, I'll review the revenue growth by segment on a comparable currency-neutral basis. BD Medical second quarter revenues increased 4.2%, which includes a headwind of approximately 160 basis points from the U.S. dispensing change. Revenues in Medication Delivery Solutions or MDS grew 4.9% in the second quarter. Growth was driven by strength in vascular access and vascular care, which includes our prefilled flush devices. Revenues in Medication Management Solutions or MMS grew 0.5%. Revenue growth was impacted by a headwind of approximately 580 basis points from the U.S. dispensing change. Underlying MMS revenue growth was driven by strong adoption of Pyxis ES in the U.S. as well as international growth in infusion. Diabetes Care revenues grew 5.7% driven by growth in pen needles in the U.S. and strength in emerging markets that was aided by the timing of tenders that we had initially anticipated in the third quarter. Diabetes Care revenue growth also reflects a favorable comparison to the prior year. In Pharmaceutical Systems, revenues grew 7.9%. This reflects incremental market demand for our large pharmaceutical and biotech customers, for our Hypak and other prefillable drug delivery devices. Turning to slide 9 and the BD Life Sciences segment. Second quarter revenues increased 7.3%. Revenue growth was driven by strong performance in Biosciences and Diagnostic Systems, which was aided by a stronger flu season in comparison to last year and contributed an estimated 300 basis points to Life Sciences growth. On a year-to-date basis, the flu contributed approximately 170 basis points to Life Sciences revenue growth of 7.3%. Revenues in Diagnostic Systems grew 12.6% in the quarter. Performance was driven by strength in core microbiology and continued strong growth in our BD MAX molecular platform, partially offset by the timing of Kiestra installations in the U.S. In addition, the flu season contributed over 800 basis points to Diagnostic Systems growth in the quarter. Preanalytical Systems growth of 1% reflects a tough comparison to the prior year and the impact of a production issue in one of our product lines, which was resolved during the quarter. Biosciences revenues grew 8.9% in the quarter. This reflects growth in our newer research instruments, such as the FACSMelody and FACSymphony analyzer, as well as continued strength in research reagents. Growth was also aided by a favorable comparison to the prior year. Now turning to slide 10 and the BD Interventional segment. Second quarter revenues increased 7.1%. Revenues in Peripheral Intervention grew 10.9% in the quarter. Performance reflects strength in drug-coated balloons driven by AV indication, strong international growth in biopsy products, particularly in China, and the continued strong growth in LIFESTREAM stents that were launched in May 2017. Growth of 4.2% in Surgery was driven by our diverse leading hernia platform as well as strong international growth in infection prevention, partially offset by a continued hold on Progel that adversely impacted growth in Surgery in the quarter by approximately 70 basis points. Urology and Critical Care revenues grew 6.5% in the quarter. This reflects growth in our global urology portfolio, including our acute and non-acute products. Growth also benefited from the timing of capital orders in our temperature management business from the first quarter to the second quarter. Moving to slide 11, I'll walk you through our geographic revenues for the second quarter on a comparable, currency neutral basis. U.S. revenues grew 4% in the second quarter which includes an estimated headwind of 150 basis points from the U.S. dispensing change. Growth in the U.S. was driven by strength across multiple businesses and the impact of the flu season. Within the BD Medical segment in the U.S., growth was driven by the Medication Delivery Solutions and Pharmaceutical Systems units. BD Life Sciences segment results in the U.S. reflects strength in the Diagnostic Systems and Biosciences units. Revenues in the Preanalytical Systems units were adversely impacted by the previously mentioned production issue in one of our product lines. Within the BD Interventional segment in the U.S., growth was driven by performance across all three businesses. Moving on to international, revenues grew 7.9% in the second quarter. Growth was driven by broad strength across Medical, Life Sciences and Interventional segments. Developed Markets grew 4.6% in the second quarter including an estimated headwind from the U.S. dispensing change of 90 basis points. Growth in Developed Markets was driven by strong performance in the U.S. as previously discussed, and strength in Europe in the Surgery, Urology and Critical Care, Diagnostics Systems and Biosciences unit. Second quarter emerging markets revenues grew 12.4%. Revenues in China grew 13.3%, with double digit growth across all three segments. Double digit revenue growth in EMA was driven by infusion disposables and Medication Delivery Solutions and also reflects the Diabetes Care tender timing as previously discussed. Revenues in Latin America grew high-single digits driven by strength across core microbiology and Diagnostic systems and research instruments and reagents in Biosciences as well as strong performance across the Interventional segment. Turning to slide 12 which recaps the second quarter income statement and highlights our currency neutral results. As discussed, revenues were ahead of our expectations growing 5.7% in the quarter including approximately 80 basis points negative impact from the U.S. dispensing change. Moving down the P&L starting with gross profit. Gross profit increased 45.9% year-over-year. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenue was 25.0% which reflects Bard's higher SSG&A spend profile. R&D as a percentage of revenues were 6.2% which reflects our continued commitment to invest in innovation. Both SSG&A and R&D reflect spending in a few key programs that was accelerated into the quarter from later in the fiscal year and offset some of our second quarter revenue outperformance on the bottom line. Our tax rate was 16.9% in the quarter which is in line with our full year guidance range. Operating margins increased 290 basis points reflecting strong P&L leverage as the new BD. As expected, we paid preferred dividends of $38 million in the quarter. The preferred dividend is more dilutive to EPS than the additional preferred shares and as a result preferred shares are excluded from the adjusted diluted shares outstanding calculation. In the quarter, adjusted earnings per share were $2.65 which is a 15.2% increase versus the prior year, or 7.8% on a currency neutral basis. Both operating income and EPS include approximately 500 basis points of negative impact from the U.S. dispensing change. Adjusting for the impact of the U.S. dispensing change, currency neutral EPS growth was in the low teens. Earnings were ahead of our expectations due to strong revenue growth and more favorable FX partially offset by our decision to accelerate investments in SSG&A and R&D in the quarter as previously discussed. Now turning to slide 13 and our gross profit and operating margins for the second quarter. Gross profit margin was a strong 56.1% in the second quarter. On a performance basis, gross profit margin improved 340 basis points. This reflects the inclusion of Bard's more robust gross margin profile as well as our continuous improvement initiatives, cost synergies and favorable mix. These items were partially offset by a headwind of 80 basis points from a combination of the U.S. dispensing change, raw materials and pricing. Currency had a positive impact of 10 basis points on gross profit margin. Operating margin grew 290 basis points in the quarter. This was driven by gross margin improvement partially offset by the increase in SSG&A and R&D as previously discussed. Currency had a positive impact of 30 basis points on operating margin in the quarter. I'll take you through our fiscal 2018 guidance over the next several slides, but while we are discussing margins, I'd like to point out that we continue to expect to deliver significant underlying margin expansion of 200 basis points to 250 basis points this fiscal year which is in addition to approximately 500 basis points of margin expansion over the last three years. Moving on to slide 15 and our full fiscal year 2018 revenue guidance. As previously discussed, we are raising our currency-neutral revenue guidance for the total company to 5% to 5.5% growth on a comparable basis which is the high-end of our previous range. This represents strong underlying growth of 5.5% to 6% excluding the estimated impact from U.S. dispensing change and the Bard impact from Hurricane Maria in Puerto Rico in the quarter that ended December 31, 2017. While we are maintaining our Medical and Interventional segment revenue guidance ranges, based on our strong year-to-date performance and current outlook, we expect to be higher in those ranges than previously anticipated. As a reminder, our Interventional segment guidance also excludes the first quarter impact from Hurricane Maria. We are increasing our guidance for our Life Sciences segment to 5% to 6% growth primarily as a result of the stronger than expected flu season. We continue to expect revenue growth to be driven by recent product launches across all three segments and strength in both developed and emerging markets. Our increased revenue guidance reflects developed market growth of around 4% to 4.5% in fiscal 2018 or around 4.5% to 5% excluding the estimated 50 basis point impact from the U.S. dispensing change and the hurricane in Puerto Rico. In emerging markets, we continue to expect low-double digit growth driven by a diversified base with mid-teens growth in China and strength in EMA and Latin America. Moving on to slide 16 and our full fiscal 2018 EPS guidance. There are a number of moving parts that impact earnings per share in fiscal 2018. For modeling purposes and to ensure consistency, I'd like to provide more color on EPS guidance. Starting on the left half of the chart with the guidance we provided on our February earnings call, we expected adjusted EPS of $10.85 to $11. This reflected currency-neutral growth of approximately 12% or 14% to 15% on an underlying basis driven by strong growth in operating income excluding headwinds of 2% to 3% from the U.S. dispensing change. Assuming foreign currency rates in place at that time we expected currency would provide a 3.5% tailwind in fiscal 2018 resulting in an expected EPS growth of approximately 15% to 16%. Our current guidance reflects our strong year-to-date performance and our updated revenue outlook as well as more favorable FX. Partially offsetting these increases are costs associated with additional clinical trials and investments in our quality systems in PAS that we anticipate occurring in the second half of the year as well as increased material costs. In addition, the divestiture of the Vyaire joint venture results in approximately $0.03 of pressure. All in, this results in a $0.05 increase to our adjusted EPS guidance to a range of $10.90 to $11.05 which represents growth of 15% to 16.5%. On a currency-neutral basis we continue to expect approximately 12% adjusted EPS growth in fiscal 2018. Our FX assumptions assume a euro to dollar exchange rate of $1.23. Even with today's euro at $1.20, our full year outlook remains unchanged. We continue to expect to deliver low-single digit accretion in fiscal year 2018 and high-single digit accretion in fiscal year 2019. We are committed to fully realizing $300 million in annualized cost synergies as we exit fiscal year 2020. Now turning to slide 17, I'd like to walk you through the balance of our guidance expectations for the full fiscal year 2018. As a reminder, this guidance includes the results of Bard as of January 1, 2018, which is the beginning of our second fiscal quarter. On a reported basis, revenue growth for the total year is expected to be between 31% and 31.5% which reflects a currency tailwind of about 250 basis points, an improvement from our prior guidance of about 200 basis points of tailwinds. For fiscal year 2018, we continue to anticipate our adjusted average fully diluted share count to be approximately 261 million shares. For modeling purposes, I would like to point out that the net income reflects the deduction of approximately $114 million of preferred dividends. And the preferred shares are excluded from the adjusted diluted shares outstanding. Beyond revenues and EPS, all other P&L guidance from February remained unchanged. In summary, I'm excited about the strong momentum we have across both the BD and Bard businesses and I'm highly confident that we will deliver on our commitments in fiscal year 2018 and beyond. Now I'd like to turn the call back over to Vince who will provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. Moving on to slide 19, as we have been discussing with you, our integration of CareFusion is largely complete and we are on track to achieve our cost and revenue synergy commitments. At the same time, as I mentioned in my opening remarks, we are making excellent progress with Bard. Our organizational design and integration plan are in place and we are pivoting from planning to execution. As previously communicated, our initial focus is on public company costs and procurement savings. We have already begun to realize some of those savings and we have comprehensive work streams in place with assigned accountability for the future realization of operational cost synergies. We have also begun our investment in revenue synergies that we discussed with you last quarter. We have started hiring salespeople in Europe for our Biosurgery and ChloraPrep platforms and also have started cross-training our strategic account management group. We look forward share updates with you as we make additional progress across our initiatives. Turning to slide 20 and our planned product launches by segment, let's start with our Medical segment. Our new BD HealthSight platform for enterprise medication management that was introduced at the American Society of Health-System Pharmacists meeting in December is being well received by our customers. This new platform offers a unique combination of connective technologies, analytics and expert services to help close the communication gap across disparate solutions and drive a safer, more efficient medication management process. In our Life Sciences segment, as anticipated, we continue the targeted expansion of our BD MAX menu and are starting to gain traction in the EU with our Enteric Viral Panel that we launched at the end of the second quarter. In addition, as expected, we received FDA approval of our BD Onclarity HPV assay which further differentiates our women's health offering. The BD Onclarity HPV assay detects and identifies HPV genotypes that put women at high risk for cervical cancer and provides information to guide physician decision-making. Moving on to the Interventional segment. As we discussed last quarter, our new low-profile 5Fr. ProSeries Life Stent platform that launched in the EU mid-year 2017, received FDA approval in the first quarter of fiscal year 2018. In the second quarter, we launched this new platform in the U.S. as expected. This new stent family provides the lowest profile, longest lengths and broadest indications for any peripheral arterial stent. In mesh fixation, we launched a new resorbable-tack fixation device named OptiFix Open. This new family is designed to aid in open hernia repair and will deliver resorbable tacks through a curved distal tip. And in Urology and Critical Care, we recently launched our new Magic3 GO Male intermittent catheter family. This new product incorporates our proprietary silicon technology of the Magic3 family with our new low friction coating technology that doesn't require the use of a water sachet or the need to lubricate the catheter prior to use. As you can see, we have a very rich pipeline of new products across our businesses, and we look forward to sharing additional updates with you along the way. Before I move on, I would like to remind you that we have again included a slide in the appendix of today's presentation that provides an update on our sustainability initiatives. We hope you find the information useful in understanding BD's commitment to this important topic. Moving on to slide 21. I would like to reiterate the key messages from our presentation today. Our strong performance reflects our early progress as the new BD and the momentum across both the BD and Bard businesses. The integration of Bard is also off to a strong start. We remain committed to achieving our cost synergy commitments and have begun our investment in revenue synergies. We increased our revenue and EPS guidance as a result of our strong year-to-date performance and our expectation for continued momentum over the second half of the year. In summary, we are very pleased with our performance and are confident in our outlook for fiscal year 2018 and beyond as we move forward as the new BD. Before we open the call for questions, we'd like to take a moment to congratulate Mike Weinstein on his retirement from JPMorgan. Mike is an influential thought leader and has made a significant impact on shaping the sell-side coverage of the med tech industry. Mike, we wish you all the best in the future and hope that our paths will cross again. And, Robbie, we look forward to working with you. So thank you, and we will now open the call to questions.
Operator:
Thank you. Our first question comes from the line of David Lewis with Morgan Stanley.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning, guys, a very solid quarter. Vince, one for you and then maybe one for Tom. Just, Vince, discussing the outlook in the back half of the year, if I back out the flu benefit this quarter, I think maybe it was 75 bps. Momentum was very stable first and second quarter. At the high-end of your range guidance for the back half of the year seems to bet rough stability, maybe slight momentum deceleration. How do you see momentum into the back half of the year relative to the guidance range?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, we see momentum continuing in the back half of the year. The only change I really see from momentum standpoint is really the flu, as you just mentioned. But we're feeling very good across all three segments. And we raised the Life Sciences guidance, but we think that we're going to see good momentum in the other two segments as well towards the upper end of the range.
David Ryan Lewis - Morgan Stanley & Co. LLC:
And, Tom, the big change this quarter for Bard, obviously, underlying Bard was up about 1 to 2 points, kind of 8.5% versus 7% last quarter. Can you just discuss some of the drivers behind that reacceleration here in the second quarter? And how you see the Bard outlook for the remainder of the year? Thanks so much.
Thomas E. Polen - Becton, Dickinson & Co.:
Yeah. Hi, David. So I think as you saw strong performance across all three of the Bard businesses, Peripheral Intervention, Surgery, and Urology/Critical Care driven by a lot of new product launches in each of those areas. As we think about the back half of the year as you noted, we do expect growth in the back half to continue strong, and we're very confident in our full year range. We did benefit from some timing in the first half, some orders in temperature management in Urology. And we're going to begin to lap several key product launches in the back half, specifically the Lutonix AV and LIFESTREAM covered stent in the back half. So we may see the back half slightly lower than the first half, but that's just due to that timing topic and the lapping those key product launches. But very solidly within the range, feel very confident about that.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, David.
Operator:
Our next question comes from the line of Isaac Ro with Goldman Sachs.
Isaac Ro - Goldman Sachs & Co. LLC:
Good morning, guys. Thank you. Just on the Bard integration process, it looked like you guys reiterated your synergy goals. Just hoping to get a little more color on where the integration team is currently focused, kind of key initiatives over the next 12 months just from a step-by-step process? Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure, Isaac. So as we have said before, the initial focus on synergies is the public company costs, which are pretty much behind us, as well as then the initial procurement savings, and that's typically the first bucket of synergy savings that you get. I talk about this kind of as three separate buckets of $300 million, think about it as $100 million, $100 million, $100 million. In the current year we'll get something like – because it's only three quarters – $70 million to $80 million and then you can think about it as ratable over the next two years. But in the third year, let's say, that's when you start getting your manufacturing and operational synergies. They take a little bit longer to plan, so that's why it takes that long. And then in the second bucket, in the second year, you can think about getting some of the process kind of improvements, things like shared service centers, integration of IT and the like, and the integration of functions. That's kind of a general sense of how to think about that.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And this is Vince. So in addition to that, as I mentioned in my remarks, we've started to work on the revenue synergies. And so we're doing the detailed account planning in the U.S., we've got the key account group involved in that, so that's off to an excellent start. And then in Europe, in the Surgery business, we started to build out the sales force for that area for both ChloraPrep and Biosurgery. So those are the two real short-term initiatives.
Isaac Ro - Goldman Sachs & Co. LLC:
Got it. And then maybe just a follow up on BD Life Sciences, with Patrick taking over, obviously, he brings a nice track record from Agilent. I was hoping you could maybe give us a little color as to how the strategic direction there might evolve under his leadership? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, I'm very excited to have him coming on board May 29, and I think he brings a broad view and a very deep view of the industry. I think what's attracted him is the programs that we have that are ongoing, both on, I'll call it the Life Sciences research side broadly and the opportunities we have around BD Biosciences, and we've been talking to you about some of them, the different markets that we can take flow into, including cell therapy, single-cell genomics. And he brings really in-depth knowledge of, I'll call them, companion spaces for you. Also for him, I think, which is exciting is the opportunities we have on the diagnostics side of the business and how we can drive that. So what you should expect is that it will be about implementation around those opportunities in the short run, and then creating a more expansive strategy as we move forward.
Isaac Ro - Goldman Sachs & Co. LLC:
Got it. Thank you.
Operator:
Our next question comes from the line of Brian Weinstein with William Blair.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Brian.
Brian David Weinstein - William Blair & Co. LLC:
Talk a little bit about flu real quickly. Can you talk about success with Veritor, where you are in terms of placements at this point? And also is there anything going on with new menu there or any other feature sets that you're going to be adding to Veritor as we get ready for the next flu season?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Alberto, would you like to take that?
Alberto Mas - Becton, Dickinson & Co.:
Yes, we've continued to put more and more placements out there in terms of the flu. We're up to approximately 30,000 units out there that are currently working. We are taking share primarily from the manual segment, so we're doing well from that perspective and we launched our connected version of Veritor, if you like, recently as well, which has enabled us to penetrate more on the retail segment as well. Due to the broader menu, we are working on additional assays, but I think it's a little bit too early to be specific about it at this point.
Brian David Weinstein - William Blair & Co. LLC:
Okay. And then as a follow up, we talked a lot about overall BD and kind of where you guys are going, but I'm curious within your entire portfolio where do you see the best chance of the next 12 months for meaningful share gains, if anywhere? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, there's a number of businesses that are doing quite well, Brian, and in the Medication Management Space, you really saw a turnaround over the last, I'm going to call it 18 to 24 months and I think we feel exceptionally good with the launch HealthSight. It was probably the first place that I would point to, whether it's a share gain or not what's going on with the Lutonix clones, quite frankly. In the Interventional segment, we had some excellent growth because of the AV claim there and we're just starting on that piece as well. Temperature management is going well in that segment. I'm excited about what's happening in Biosciences with the new instrumentation, we just showed we've got both the Symphony analyzer and sorter now, Melody is doing great and BD MAX, quite frankly, is doing quite well, an area that I know you follow closely. So for us, it's never one thing, it's a whole series of things that's happening. And Alberto, what were you saying?
Alberto Mas - Becton, Dickinson & Co.:
No, and I think we are very excited about Kiestra as well, that will allow us to really advance in the automated and connected segment out there with....
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. I think if you look at this growth, it's a good model. It's balanced growth across all three segments is the way I would sum it up. Thanks for the questions, Brian.
Operator:
Our next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore Group LLC:
Hey, guys. Congratulations on a nice quarter here. And maybe I'll start with a high-level question, Vince. When you look at the strength in the quarter, right, obviously I think people are looking at next year in a sustainability of strength. So Bard is coming in better, your dispensing impact goes away, Biosciences, it looks like that business is inflecting. It looks like one of your supply chain peers this morning had a little bit of disruption in their supplies business. So is there some share gains going on, and what's the visibility confidence that we have on the sustainability of strength we are seeing now flowing through for fiscal 2019?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, I think we feel good about fiscal 2019. There are some additional share gains going on even in our core business, if you look at MDS, certainly in the hypodermic area we have also been taking share. We continue to do really well with our flush product line. So it goes back to the question that was just asked, I'd come back to that answer which is, across the portfolio, across all three segments we're feeling good with the product launches that we have just started with that we've been talking about today, but also the products that are coming behind them. So we continue to expect in line with the way we have been talking over the last 12 to 18 months in terms of good momentum from both the BD core and the Bard core, so across all three segments.
Vijay Kumar - Evercore Group LLC:
And just may be one on the guidance. First, when you look at the guidance, gross margin, that has to step up meaningfully in the back half, and I am assuming that's because of your dispensing impact goes away. It looks like tax rate is coming down meaningfully in the second half and maybe could you just talk about, because I know you had spoken about synergies on the Bard side and whether that's helping you guys here a little bit?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, so I'll take that last one first on the tax rate. Our guidance is 17% to 19%. You saw the 16.9% quarter. I think you can expect the tax rate to be at the low end – very low end of our guidance range. And then gross profit, we were thrilled with the gross profit performance in the second quarter, 340 basis points expansion versus the prior year and right in line with where we expect it to be. We do expect the gross profit to continue to accelerate in the back half, as you expect – as you mentioned. And there's a couple of things driving that. We have the anniversary-ing of the U.S. dispensing headwind which sometimes gets lost in terms of the impact that it has on margins as well is the top and bottom line. We have the synergies beginning to ramp, the Bard synergies, the conclusion of the CareFusion ones obviously, but the Bard synergies continue to ramp. And then you've got the full second half of rich Bard margins. We've only had one quarter in the first half, and so we'll have the full half of that. So we expect those margins to grow very nicely, and that flows down to operating margins as well. So we're feeling very comfortable about our guidance range on both gross profit as well as operating margin. As I said my script, 200 basis points, 250 basis points this year on top of 500 basis points over the last three years; we're feeling pretty good about our margin performance.
Vijay Kumar - Evercore Group LLC:
Thank you, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Thanks, Vijay.
Operator:
Our next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen - Wells Fargo Securities LLC:
Good morning. Thanks for taking the question. One on Bard, one on Life Sciences. So on Bard, Vince, where do you think you are in the integration process? Do you think you're past the time when you would see disruption or dis-synergies? Could you talk a little bit about how PICCs and midlines did? I think that's in MDS now. And when you expect Progel to return? And I just had one follow-up on Life Sciences.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Sure. So let's start with the integration process. We have the organization set up, and so we feel good from that standpoint. And so people are implementing. They're in that mode. So I think I'd feel pretty confident about we're not in disruptive phase. You're always doing new things over three years, but as long as we have them well-planned and understood, then we can avoid that and that's been the history on CareFusion. We expect it to be the history on Bard as well. But in terms of the specifics you were asking on Interventional, Tom, do you want to take that?
Thomas E. Polen - Becton, Dickinson & Co.:
Yeah, hi, Larry. This is Tom. So first on the PICCs and midlines, we continue to see very strong growth in both of those platforms, particularly ex-U.S. in line with prior performance. I'd say we're seeing some very early positive signs of the opportunity and vision that we had set out to be able to offer customers a more integrated vascular access solutions, combining not only short-term peripheral access with our peripheral catheters but also with the longer-term value that PICCs and midlines offer in terms of longer-dwell catheterization. And so we're seeing our commercial teams in the U.S., ex-U.S., begin putting those value propositions together, beginning to have discussions with customers and we're hearing very positive receptivity there. So we're quite excited about the future and the opportunities with that combined portfolio. On a Progel perspective, we're making good progress on the relaunch, and we expect relaunch at the end of calendar year 2018.
Larry Biegelsen - Wells Fargo Securities LLC:
Thanks. That's helpful. And then on Life Sciences, I am trying to understand what you expect in the second half versus the first half on an underlying basis. So you did 7.3%, I think, in the first half. But I know you benefited from flu, but you had the headwind from the Preanalytical manufacturing issue. The guidance implies only about 3.5% growth in the second half. So help us understand first and second half in Life Sciences on an underlying basis. Thanks for taking the question.
Christopher R. Reidy - Becton, Dickinson & Co.:
Larry, I'll go first. This is Chris. Your calculation of the implication on the second half is off by a lot. It would imply over 5% growth in the second half. So that's...
Larry Biegelsen - Wells Fargo Securities LLC:
Well, that helps. Sorry about that. Thanks for taking the question.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure.
Vincent A. Forlenza - Becton, Dickinson & Co.:
We can go through the details with you later.
Larry Biegelsen - Wells Fargo Securities LLC:
Thank you.
Operator:
Our next question comes from the line of Bob Hopkins with Bank of America.
Robert Hopkins - Bank of America Merrill Lynch:
Thanks, and good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning.
Robert Hopkins - Bank of America Merrill Lynch:
I just wanted ask a question on the new EPS guidance. It sounds like really the only thing that's changed is an assumption on currency. But I'm asking the question because currency, obviously, has been incredibly volatile from here. So just what do you sort of assume for currency for the rest of the year? And if the dollar continues to strengthen, would that matter to this guidance? Just trying to put that in perspective because, again, the dollars are all over the place lately.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So a couple of things on that, Bob. As we've said in the prepared remarks, our assumption is based on $1.23 to the euro, but as we noted, the $1.20 that it is today does not have a material impact on the rest of our year, and we're very comfortable with what we've seen already flowing through. And you're right that we did flow that $0.05 through on an FX. But there were a couple puts and takes there. Clearly, the performance on the top line is benefiting us in the remainder of the year, and we do have some investments that we need to make in the second part of the year. We talked about some additional clinical trials and investments in quality systems in our PAS business, and we're consciously making those investments. And so when you flow that all in, that keeps FX in neutral and raises the FX. So there's a couple of moving parts there.
Robert Hopkins - Bank of America Merrill Lynch:
Okay. Thank you for that. And then just one other thing I want to quickly ask about is with the leadership change on the Interventional side, just maybe give us some color on the process for coming up with a sort of a full-time solution there. Is that likely to be internal? And just how long will that take? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. We don't think it's going to take all that long. We're talking maybe a couple of months, something like that from a process standpoint. It is likely to be internal, and you certainly want someone who has a background in devices who will understand the business quickly, the differences in the business model, but who also understands BD. And we think we have some excellent candidates.
Thomas E. Polen - Becton, Dickinson & Co.:
Bob, and this is Tom. Just a note. I think one of the things that, as Vince mentioned, we're going to be relatively quick in that over the next couple of months. And in that time, because we have extremely strong leadership teams in each of the individual businesses that are continuing to run those which gives us confidence to – and actually the luxury, particularly with Bill stepping in as the Interim President, to take the time to make sure we appoint the right leader there.
Robert Hopkins - Bank of America Merrill Lynch:
Perfect. Thanks for the color.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Operator:
Our next question comes from the line of Robbie Marcus with JPMorgan.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Robbie.
Robbie J. Marcus - JPMorgan Securities LLC:
Great. Hi, and thanks for taking the question. Vince, I know you touched on in a bit so far, but I was hoping you could just give us your early insights into how the integration is going, areas that you've been surprised by both on the positive and negative and what's been the reception from your customers in terms of the combined portfolio so far?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, let me start on the customer side, because myself and Tom, and Chris, other members of the management team, we've been talking to the key accounts and I would say it's been very positive. And the conversations we're having about how to we now strategically partner with these accounts as they do things like improve their care management teams, that's been very exciting for us. We're in the process of setting up some top-to-top meetings and to follow up on those kind of conversations. So I would say from a customer standpoint, very positive, and that's not just in the U.S., that's in Europe as well that we've done some of those meetings, so feeling very good about it. In terms of surprises, I don't know that there has been any significant surprises. I think on the positive side, we thought the cultures were very similar, and they are more similar than we expected, very, very customer driven and focused and purpose driven and that's been a huge positive, and the way teams have come together even quicker than they did on the CareFusion integration has been a very strong positive. We had this philosophy about taking the best of either company, and we've been modifying some of our processes, some of them come from Bard, some go from BD as we look at running a $16 billion plus company. That has accelerated even faster than we thought. So all in all good, very, very good start. And as you saw this quarter, it was off to an excellent start. Chris, do you have anything else?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, I would just add to the last point you made, Vince, that the key to any integration is maintaining the momentum in the core businesses. And you can see from this quarter and the previous quarter that the momentum is extremely strong on both businesses across all of our segments. And when you look at the performance on a Bard basis before we moved the products around, 8.5% is a killer quarter, and it just demonstrates the kind of momentum. So that's the key to make sure you keep that momentum in a period of a lot of change, we've been able to do that, that's really important. And then the execution on the cost side, we know how to do that. We've got teams in place to do it, and as Vince mentioned earlier, getting that momentum on the revenue synergies, I would tell you when you talk to salespeople on both sides of Interventional now and BD legacy, they're excited about having the portfolio of products. So all of those are great indications of getting off to a good start.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Your second question, Robbie?
Robbie J. Marcus - JPMorgan Securities LLC:
Great. And then, Chris, one more for you, just on some of the onetime items in second quarter, you called out Kiestra placements, you called out timing of tenders in diabetes, flu was 80 bps. Can you just run through the different impacts of what was onetime in nature in second quarter? And then which will be either detracting or adding to third quarter, fourth quarter? Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, so in addition to the ones that you talked about, I would also say that we did have the advancement of some investments in R&D and selling, and so we made that decision consciously to invest earlier in some R&D programs. And so those, that's really more of a timing thing, that helps us in the back end. But then as we pointed out, we had some production issues in PAS, which we resolved within the quarter in the second quarter, so that won't carry forward. But we do want to make some investments in our quality system and add some clinical trials in the back half, again in PAS, so that would – does impact us in the second half as I talked about previously. The only other one kind of items, we talked about resin pressure on the last earnings call. If anything we see that pressure ticking up slightly from what we talked about. So just to refresh everyone's memory, in the beginning of the year we saw about $15 million pressure from resins. On the last earnings call we said it'd probably be about $15 million incremental to that. We're probably looking at another $5 million for the full year, just based on the way oil prices and the market in that area from a supply side. The only other onetime kind of item that you got is we were delighted to consummate the Vyaire joint venture and divestiture. It wasn't core to our strategy, it helps us focus on our core business. But with that comes a little bit of dilution in the back half of about $0.03. I think that's all the onetime items in addition to the ones that you talked about.
Robbie J. Marcus - JPMorgan Securities LLC:
Okay. Thanks very much.
Operator:
Our next question comes from the line of Rick Wise with Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning to you both. Maybe, Chris, just starting off with you, you talked about the accelerated spending, the second half spending moving into first half on the SSG&A and R&D side. Maybe give us if you would be so kind, a little more color on where is this going? Is it U.S., is it OUS, is it Bard, is it Becton? And how should we think about the implications of those stepped-up investments?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, and we saw the opportunity, and it's really in the MMS business, and it's primarily R&D. We're just looking at some next-generation kind of items, too early to talk about. But we saw the opportunity to advance that spending, and we took the opportunity. As we said in the past, as we saw FX becoming a tailwind, we would take the opportunity to invest some of that if we saw that option. And we did, and we felt it was the right thing to do.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And, Rick, the other piece of spending in the quarter was really in the PAS business. We mentioned that in the first half was some manufacturing issue. In the second half, we're doing some clinical trial work to resolve the warning letter. So it's a one-year spend is the way to think about that.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Okay. And two last ones, I'll just say them quickly. First, Chris, for you, you highlighted the 4.5 times gross leverage and the debt paydown and your three-year goal. Any reason that that couldn't happen faster? And maybe just reflect on all that a little bit. And maybe last, Vince, you both talked about some big picture issues. Maybe talk, there's so many big topics, whether it's China, the trade war, the tariff concern. How are you thinking about that as you frame the outlook as well? Thanks to you both.
Christopher R. Reidy - Becton, Dickinson & Co.:
So on the debt paydown, we feel good about the fact that we're right on target. You saw the $100 million paydown. We look to paydown about $1 billion this year, and then $2.5 billion in each of the next two years or thereabouts. Could you accelerate that? Sure we could, but we don't think that's the prudent way to do it. We like to keep some dry powder for M&A deals. Certainly, you want to be able to do some tuck-in acquisitions. That's something that we've always done on the BD side, but clearly the Bard strategy included small tuck-in acquisitions. And we want to make sure we keep the opportunity to do that and don't restrict that too much. And as well as investing in our normal capital investments and what have you, while still increasing the dividend a little bit. So it's a balance of all those things, which is the way we thought about it as we announced the deal. And we're executing just on point.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Rick, from a tariff standpoint, we don't think it's – from an overall basis, it's going to be material. We do make our flu test in China and import it into the U.S. That's not that big a business that's going to have a big impact on the company. Needles and syringes are on that list, but we don't do that, so that's not an issue. We do buy some material from China. Once again, we think we can cover that. So we're looking at it as manageable if it stays the way it is now.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Thank you so much.
Operator:
Our next question comes from the line of Doug Schenkel with Cowen.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, Doug.
Doug Schenkel - Cowen & Co. LLC:
I have a couple topics I want to cover. First, a follow up on PICCs and then a follow up on that last China question. So I'll just start on PICCs. Tom, following up on that earlier question, are your sales reps now fully trained to sell the full suite of catheters and recognizing it's very early, is there any evidence that having a broader product portfolio is already benefiting overall core Medication Delivery Solutions growth?
Thomas E. Polen - Becton, Dickinson & Co.:
Hey, Doug. This is Tom. So we have begun cost training some of our team members in the U.S. specifically. We expect that will continue through, though, the end of the fiscal year, and so we expect both U.S. and European teams to be cross-trained going into FY19. The training really ramps up in the June/July timeframe is our expectation there. So I think it's too early to say you're not seeing the results in this quarter of that combined opportunity, again, as I mentioned, we're seeing very positive feedback from customers, it's intuitive in many ways of course, in the future we'll have the same people talking about peripheral catheters and PICCs and midlines and being able to holistically work with the customer to get the best solution for the patient, right? Often there are questions on what device should I use? And we'll be in a position to be the leader in helping our customers figure that out the right way that's best clinically and economically appropriate for them. So I think more to come in terms of seeing the revenue impact, but we're hearing very good feedback overall and we're confident in our ability to get good value there.
Doug Schenkel - Cowen & Co. LLC:
Okay. Thanks for that, Tom. I think the second one is for you, Chris. China growth comparisons are, as you know, more difficult in the second half than they were in the first half, I think, by roughly 300 basis points. And there's also uncertainty not just about tariffs but the impact of the pricing to invoice changes. Does guidance embed an assumption that second half growth is going to moderate in China due to the tough comp or are you expecting some of the new products and the revenue synergies from various acquisitions to help you power through the comparison and the other dynamics I mentioned?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. So as we gave guidance in China, Doug, the full year we expect to be kind of in the mid-teens, and we see a slight acceleration, actually, in the second half, and that's due to actually easier comparisons in our Life Sciences segment compared to the second half last year. And we don't see any impact of the tariffs on our revenue stream, and as Vince mentioned, we don't see any significant impact on our cost basis either. But it's something that we'll watch.
Doug Schenkel - Cowen & Co. LLC:
Okay. Thank you.
Operator:
Our next question comes from the line of Richard Newitter with Leerink Partners.
Jaime L. Morgan - Leerink Partners LLC:
Hi, Vince. Hi, Chris. This is Jaime on for Richard Newitter.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Jaime L. Morgan - Leerink Partners LLC:
Good morning. A quick question on the Lutonix below the knee trial. I was just looking for an update here. I know you guys in the past have cited end of calendar year 2018 for PMA submission, so is there any update that you can provide where you track on the submission and then how the trial is progressing?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Sure. Tom will take that.
Thomas E. Polen - Becton, Dickinson & Co.:
Hi, Jaime, this is Tom. So as we announced earlier, we did complete enrollment in this past January and we anticipate completing six months follow up and submission of the PMA to the FDA in Q1 of FY19. So all that remains 100% on track.
Jaime L. Morgan - Leerink Partners LLC:
Okay. Great. And then just one additional question with respect to the retail pharmacy initiatives going on, can you talk a little bit about what your expectations are here and potentially if you guys have any thoughts on what Amazon is attempting to do in this space?
Vincent A. Forlenza - Becton, Dickinson & Co.:
So from an Amazon perspective, I'll take that, this is Vince. We continue to have conversations with Amazon and it's kind of unclear what they want to do. Of course they just announced about 10 days ago or so that they were not going to move ahead on the drug side, we do not have – they've tried a few things in the acute-care marketplace, it doesn't look like they're moving ahead there anytime soon either. So we continue to see if there's some ways for us to work with them, but right now I would say there's not much happening in that space. On the retail pharmacy side of things, we continue to grow our Rowa automation business, and that business is growing double digits. We're excited about that, that growth of course is being driven by international, and we're excited about that product line.
Thomas E. Polen - Becton, Dickinson & Co.:
And we continue to have – this is Tom, we continue to have very strong relationships. Obviously on diabetes, we'll look to expand those as we launch Swatch (01:07:01) in the future and we certainly recognize as that marketplace evolves, could be increasing opportunities for us in a number of other ways. Veritor is another product platform, our point-of-care infectious disease platform which is widely used within the retail pharmacies today. And again opportunities as people look to shift care there in greater ways we'd look to partner with those institutions to help do that, so.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And we are talking broadly retail when we say that.
Thomas E. Polen - Becton, Dickinson & Co.:
Yes, yes, yes.
Jaime L. Morgan - Leerink Partners LLC:
Great. Thanks for taking my questions.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Operator:
There are no further questions at this time. I will now turn the conference back to Vince Forlenza for closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So thank you very much for your questions. Just to sum up here, we are proud of our strong performance across the board, all three segments as we discussed. We're very pleased to have raised guidance our first quarter as a combined company with Bard. And lastly the integration has been going smoothly and we look forward to updating you throughout the year. So thanks very much. Have a great day.
Thomas E. Polen - Becton, Dickinson & Co.:
Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co. Thomas E. Polen - Becton, Dickinson & Co.
Analysts:
Bob Hopkins - Bank of America Merrill Lynch David Ryan Lewis - Morgan Stanley & Co. LLC Michael Weinstein - JPMorgan Securities LLC Isaac Ro - Goldman Sachs Kristen Stewart - Deutsche Bank Securities, Inc. Brian D. Weinstein - William Blair & Co. LLC Lawrence Biegelsen - Wells Fargo Securities, LLC Brandon Couillard - Jefferies LLC William R. Quirk - Piper Jaffray & Co. Doug Schenkel - Cowen and Company. LLC Rick Wise - Stifel, Nicolaus & Co., Inc. Lawrence Keusch - Raymond James & Associates, Inc. Vijay Kumar - Evercore ISI Richard Newitter - Leerink Partners LLC Matthew Taylor - Barclays Capital, Inc.
Operator:
Hello and welcome to BD's First Fiscal Quarter 2018 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through February 13, 2018, on the Investors page of the BD.com website or by phone at 1-800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 4282726. I would like to inform all parties that your lines have been placed on a listen-only mode until the question and answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin the conference.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our first fiscal quarter results. As we referenced in press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our first fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release including the financial schedules is posted on the BD.com website. The details of purchase accounting and other adjustments can be found in the reconciliations to GAAP measures, in the financial schedules in our press release or the appendix of the Investor Relations slides. As a reminder, our first quarter results are on a standalone basis and represent only BD. We will report the combined BD plus Bard P&L results beginning with the second quarter of fiscal year 2018. In preparation for the newly combined company or newco reporting, we have also provided slides in the appendix of the earnings presentation which illustrate our new reportable segments and the way we will report our geographies going forward. To align the new segment structure to our go to market strategy, approximately $700 million in annual revenues related to several products such as ChloraPrep and V. Mueller have moved from the legacy BD Medical Segment to the new Interventional Segment. Also, approximately $800 million in annual revenues related to several products such as PICCs and midlines have moved from Bard into the BD Medical Segment. Details of the key product families and brands and our new segment structure can be found in the appendix of today's slide presentation. We would also like to note that as the Gore royalty income stream is set to end in August of 2019, BD has concluded the income stream is non-recurring in nature and not central to the ongoing operations of the company. Therefore, the historical amounts recorded by Bard as revenue have been reclassified to other income to reflect BD's future reporting classification. We've provided pro forma historical revenue information consistent with our new reporting structure which can be found in the schedules posted on the Investor Relations page of our website at BD.com which have been updated to include the first quarter of fiscal 2018. Furthermore, I would also point out that while BD and Bard operated on different fiscal years, the information you will see in our guidance slides is presented on the basis of BD's fiscal year which ends on September 30. Our comparable basis revenue guidance includes Bard's results for the full fiscal 2018 and fiscal 2017 periods. For the purposes of today's call, we will provide revenue guidance for BD and Bard as standalone companies, in addition to the combined BD plus Bard outlook. Going forward, all guidance will be on a combined BD and Bard basis. Lastly, our combined company P&L guidance includes the reclassification of certain Bard items to be consistent with BD's legacy reporting structure. Bard's shipping costs have been reclassified from cost of goods sold to SSG&A and quality and regulatory costs have been reclassified from R&D to cost of goods sold. In addition, our P&L guidance also reflects the reporting of the Gore royalty as other income. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administration (sic) [Administrative] Officer; Tom Polen, President; and Alberto Mas, Executive Vice President and President of the Life Sciences Segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique and good morning to everyone. As most of you are already aware, we are delighted to have closed the acquisition of C.R. Bard on December 29th of 2017. The combination of BD and Bard further accelerates our strategy of providing solutions for our customers. We are committed to providing our customers with products and value-added services all the way through full solutions to enable better, safer care at a lower cost. Together with Bard, the new BD is uniquely positioned to improve both the treatment of disease for patients and the process of care for healthcare providers. Turning to slide 5 and our first quarter highlights. As we stated in our press release, we are proud of our final quarter as the legacy BD. Our results this quarter highlight the continued strength in our core and our reliable, consistent results. We delivered strong underlying revenue growth in both the Medical and Life Science Segments ahead of our initial expectations. And we continue to remain on track with our CareFusion cost and revenue synergy commitments. We are also off to a terrific start with our Bard integration activities which are progressing as planned. In early January, we celebrated Day 1 activities around the globe to welcome Bard and their 16,000 associates. The energy of our associates globally around what we can do as a combined organization to advance the world of health is really incredible. As we come together as the new BD, we have strong momentum across both legacy companies. I'm pleased to report that the Bard's performance in their final standalone quarter was in line with our expectations. Chris will share some high-level details of Bard's results during his commentary this morning. Moving on to slide 6, we are pleased to share our financial outlook today on a combined basis. We anticipate strong revenue and EPS growth consistent with the expectations we communicated upon announcement of the Bard transaction. On a comparable basis, we expect underlying currency-neutral revenue growth of 5% to 6% and mid-teens growth in adjusted earnings per share. I will now turn things over to Chris for a more detailed discussion of our first quarter financial performance and our fiscal year 2018 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. Moving on to slide 8, I'll review our first quarter revenue and EPS results, as well as the key financial highlights. Total first quarter revenues of approximately $3.1 billion grew 3.7% on a currency-neutral basis. As Vince mentioned, our underlying performance is strong. Our first quarter results include the impact from the U.S. dispensing change, which lowered total company revenue growth by approximately 110 basis points. Excluding this impact, we drove revenue growth of approximately 4.8%. Pricing declined about 20 basis points in the first quarter. In addition, as we communicated to you last quarter, we faced the tough comparison this quarter to strong 6.1% growth in the prior year. I'll provide more color on revenue growth in the quarter in a moment when I take you through the results by segment and geography. Adjusted EPS of $2.48 grew 6.4%, or 3.9% on a currency-neutral basis. This reflects the tough comparison to the prior year and the U.S. dispensing change as expected. Adjusting for the U.S. dispensing change, EPS growth was in the high single-digits. At the end of December, upon closing of the Bard transaction, our gross debt leverage was 4.7 times. We expect to begin to delever in the latter half of fiscal 2018. This timing is in line with what we have previously communicated and our commitment to deleverage below 3 times leverage over three years. Moving on to slide 9, I'll review our revenue growth by segment on a currency-neutral basis. BD Medical first quarter revenues increased 1.9%, which includes a headwind of approximately 170 basis points from the U.S. dispensing change. In addition, the Medical Segment in particular faced the tough comparison to the strong revenue growth in the first quarter of the prior year. Adjusting for the combined estimated impact of 340 basis points from the U.S. dispensing change and the tough comparison, the BD Medical Segment grew over 5% on an underlying basis. Medication and Procedural Solutions or MPS revenues grew 5% in the first quarter. Growth was driven by continued strength in our pre-filled flush devices, infection prevention and surgical products. Revenues in Medication Management Solutions or MMS declined 3.4%. Revenue growth was impacted by a headwind of approximately 540 basis points from the U.S. dispensing change. In addition, the timing of capital installations in both dispensing and infusion in the prior year resulted in tough comparison to the prior year where MMS revenues grew 11%. Adjusting for the combined estimated impact of 950 basis points from the U.S. dispensing change and the tough comparison, MMS grew approximately 6%. Diabetes Care revenues grew 2.2%, driven by growth in pen needles. This reflects a tough comparison to the prior year where growth in the U.S. of 7.2% was aided by the timing of customer orders. In Pharmaceutical Systems, revenues grew 3.7% in the first quarter despite a tough comparison in the prior year where growth of 15.5% was aided by the timing of customer orders. Now, turning to slide 10 and the BD Life Sciences Segment. First quarter revenues increased 7.3%. Strength across the segment was aided by an early flu season in comparison to last year, which contributed an estimated 90 basis points to Life Sciences growth. As you're aware, the timing and severity of the flu season can impact our year-over-year comparisons. Revenues in Diagnostic Systems grew 12.5% in the quarter. Performance was driven by strength in core microbiology and continued strong growth in our BD MAX molecular platform as well as timing of Kiestra installations in the U.S., EMA, and Europe. In addition, the earlier flu season contributed an estimated 260 basis points to Diagnostic Systems growth in the quarter. Preanalytical Systems growth of 4% was driven by strength in core products. Biosciences revenues grew 5.3% in the quarter. The strong momentum from the second half of 2017 continued as expected. This reflects growth in our newer research instruments such as the FACSMelody and FACSymphony as well as continued strength in research reagents. Now, moving to slide 11, I'll walk you through our geographic revenues for the first quarter on a currency-neutral basis. U.S. revenues grew 1.6% in the first quarter, which includes an estimated headwind of 200 basis points from the U.S. dispensing change. The previously mentioned tough comparisons to the prior year in MMS and Diabetes Care also impacted revenue growth in the U.S. Growth in the U.S. was driven by strong performance in the MPS unit in the Medical Segment and the Diagnostic Systems and Preanalytical Systems units in the Life Sciences Segment. Growth in MPS reflects strength in infusion-related disposables and infection prevention. Growth in Diagnostic Systems in the U.S. was driven by the earlier flu season in comparison to the prior year as well as continued growth in BD MAX driven by our newer women's health assays. Preanalytical Systems growth was driven by strength across core products. Now, moving on to international, revenues grew 6.3% in the first quarter. Growth was driven by Kiestra installations and strength in core microbiology within Diagnostic Systems and strong sales of our newer research and clinical instruments within our Biosciences unit. Strength in pre-filled flush devices in MPS and strong growth in Pharmaceutical Systems, which was aided by geographic ordering patterns, also contributed to international growth. Developed markets revenues grew 2.5% in the first quarter, including an estimated headwind from the U.S. dispensing change of 130 basis points. Growth in developed markets was driven by strong performance in Europe in Pharmaceutical Systems and Diagnostic Systems. First quarter emerging markets revenues grew 10%, driven by growth of China of 9% and double-digit growth in EMA that was aided by the timing of tenders. Now, turning to slide 12 which recaps the first quarter income statement and highlights our currency-neutral results. As discussed, revenues grew 3.7% in the quarter, which includes approximately 110 basis points negative impact from the U.S. dispensing change. Moving down the P&L, starting with gross profit, despite the loss of gross profit related to the U.S. dispensing change, gross profit margin was a very strong 54.9%, which is an increase of 4.2% year-over-year. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenues was 25.1%. As expected, in the first quarter. we incurred additional shipping costs related to our efforts to scale shipments in late September, as we discussed on our last earnings call. Our results also include the impact of the U.S. dispensing change as well as a tough comparison of the prior year. On an underlying basis, we're very pleased with the leverage we're getting in SSG&A. R&D as a percentage of revenues was 6.2%, which reflects a 5% increase in R&D dollars year-over-year and our continued commitment to invest in innovation. Our tax rate declined to 16.4% in the quarter. Operating income grew 1.2%, and adjusted earnings per share grew 3.9% compared to the prior year. Both operating income and EPS include approximately 500 basis points of negative impact from the U.S. dispensing change. Now, turning to slide 13 and our gross profit and operating margins for the first quarter. As I mentioned, gross profit margin was a very strong 54.9% in the first quarter. On a performance basis, gross profit margin improved by 30 basis points, as continuous improvement initiatives, cost synergies and favorable mix were partially offset by a headwind of 80 basis points from raw materials, pricing, and the U.S. dispensing change. Currency had a positive impact of 30 basis points on gross profit margin. Operating margin declined 30 basis points in the quarter. This was driven by the increase in SSG&A as previously discussed, partially offset by a positive impact of 30 basis points from currency. I'll take you through the combined company guidance inclusive of Bard over the next several slides, but while we're discussing margins, I'd like to point out that for the full year, we expect to deliver significant underlying margin expansion of 200 basis points to 250 basis points. This reflects the inclusion of Bard beginning in the second quarter of fiscal 2018 and is an increase of approximately 100 basis points from our prior guidance of 100 to 150 basis points of margin expansion for legacy BD. Over the four-year period through fiscal year 2018, we expect to deliver approximately 700 basis points of margin expansion. Moving on to slide 15 in our full fiscal year 2018 revenue guidance. Prior to closing the Bard acquisition, on our November earnings call, we provided standalone revenue guidance for BD of 4% to 5% growth on a currency-neutral basis, which represented strong underlying growth of 4.5% to 5.5%, excluding an estimated 50-basis-point impact from the U.S. dispensing change. Now, on a standalone basis, Bard's revenues are expected to grow 5% to 6%. This represents strong growth of 6% to 7% on an underlying basis, which excludes an estimated 100-basis-point adverse impact from Hurricane Maria in Puerto Rico on Bard's results in the quarter that ended December 31 of 2017. Going forward, we do not expect an impact to Bard's revenues related to the hurricane. On the BD side, as you'll recall, the fiscal year 2018 revenue and EPS guidance we provided on our November earnings call did not reflect any potential adverse impact related to Hurricane Maria in Puerto Rico. However, at that time, we had estimated the impact could be up to $40 million in revenues with a corresponding impact of up to 1-percent-point of EPS growth. Subsequent to our November call, thanks to the heroic efforts of many of our associates, we were able to get our plans back online quicker than previously anticipated. As a result, the impact to revenues and EPS has been minimized and our current guidance for fiscal year 2018 now includes a non-material impact related to the hurricane. For the new BD plus Bard, we expect currency-neutral revenue growth of 4.5% to 5.5% on a comparable basis that includes BD and Bard in both the current and prior year periods as if the acquisition had been completed at the beginning of our fiscal 2017 year. This represents strong underlying growth of 5% to 6% and is in line with the expectations we have been communicating since the deal announcement. Turning to slide 16 in our segment revenue guidance, you'll see guidance for our three segments. As a reminder, certain legacy BD Medical and Bard products have been realigned with our go to market strategy. This has resulted in the movement of revenues between the BD Medical and BD Interventional Segments, and as a result, the new BD Interventional Segment is not analogous with legacy Bard. We expect BD Medical to grow between 4% and 5%. We expect our Life Sciences Segment to grow between 4.5% and 5.5%, which is an increase from our prior guidance. And we expect the new BD Interventional Segment to grow between 5.5% and 6.5% excluding the impact from Hurricane Maria in Puerto Rico in the quarter that ended December 31, 2017. We expect revenue growth to be driven by recent product launches across all three segments and strength in both developed and emerging markets. The combination of BD and Bard accelerates our growth profile in both developed and emerging markets and as a result, we now anticipate developed market growth of around 4% in fiscal 2018 or around 4.5% excluding the estimated 50-basis-point impact from the U.S. dispensing change and the hurricane in Puerto Rico. In emerging markets, we now expect low double-digit growth driven by a diversified base with mid-teens growth in China and strength in EMA and Latin America. For transparency, we'd like to take a moment to provide some color on Bard's results for the quarter that ended December 31, which represented the fourth quarter of their fiscal 2017 year. While we do not plan to discuss the results at length, we wanted to share some of the key insights into the business performance in the quarter. Bard's revenues and earnings performance in the December quarter were in line with our expectations and prior Bard guidance. Bard's revenue growth was 3.7% on a currency-neutral basis, which included an adverse impact of approximately 330 basis points from Hurricane Maria in Puerto Rico. Adjusting for the hurricane, Bard's fourth quarter revenues grew 7%, in line with company's prior guidance. Revenue growth was driven by continued strength in China and Latin America and more broadly across emerging markets. In addition, strong high single-digit growth in Peripheral Vascular in the U.S. was aided by the launch of Lutonix AV. As a reminder, these businesses will be reported in BD's new reporting structure going forward. And moving on to slide 17 and our full fiscal year 2018 EPS guidance. There are a number of moving parts that impact earnings per share in fiscal 2018. For modeling purposes and to ensure consistency, I'd like to provide more color on EPS guidance. Starting on the left side of the chart, with the guidance we provided on our November earnings call for legacy BD, we expected adjusted EPS of $10.55 to $10.65. This reflected currency-neutral growth of approximately 10%, driven by strong growth in operating income, partially offset by headwinds of 2% to 3% from the U.S. dispensing change and approximately 3% from an expected increase in our effective tax rate. Assuming foreign currency rates in place at the time, we expected currency would provide a 2% tailwind in fiscal 2018 resulting in expected EPS growth of approximately 12%. Now, continuing to the right in the chart, we expect underlying accretion from the Bard acquisition of 3% to 4%. This is expected to be offset by approximately 2% from a combination of the divestitures of our soft tissue core needle biopsy product line and Bard's Aspira product line of tunneled, home drainage catheters and accessories, as well as the timing of close of the Bard acquisition. The net result is low single-digit accretion, which is in line with what we've been communicating. As you'll see when I take you through our detailed P&L guidance on the next slide, we expect an effective tax rate of 17% to 19% in fiscal 2018. This is a decrease of approximately 1% from the combined effective tax rate of 18% to 20% that we had previously communicated and is driven primarily by U.S. tax reform and results in an increase of approximately 1% to our EPS guidance. From an investment standpoint, consistent with our initial thoughts, we plan to invest approximately $15 million toward Bard revenue synergies and this is dilutive to earnings by approximately 50 basis points. In addition, while our guidance does anticipate an increase related to the flu, we're also seeing increased pressure related to resin pricing that is offsetting the expected flu benefit. The net of these items results in approximately 12% currency-neutral adjusted EPS growth in fiscal 2018 or 14% to 15% on an underlying basis adjusted for the impact from the U.S. dispensing change. This is in line with the mid-teens growth profile we've been communicating to you since the deal announcement. Lastly, we anticipate an incremental currency tailwind of about 150 basis points based on current rates. This assumes a euro to dollar exchange rate of $1.22. All-in, this results in strong newco earnings of $10.85 to $11, which represents 15% to 16% growth. Another important element to note that is while we expect to deliver low single-digit accretion in fiscal year 2018, we are reaffirming our guidance of high single-digit accretion in fiscal year 2019. From a phasing perspective, we expect to achieve $70 million to $80 million in cost synergies in fiscal year 2018, with the balance being fairly ratable over fiscal years 2019 and 2020. We're committed to fully realizing $300 million in annualized cost synergies as we exit fiscal year 2020. Turning to slide 18, I'd like to walk you through the balance of our guidance expectations for the full fiscal year 2018 for the new BD including Bard. This guidance includes the results of Bard as of January 1, 2018, which is the beginning of our second fiscal quarter. We expect reported revenue growth for newco of 30% to 31%, which includes a currency tailwind of approximately 200 basis points. Adjusted gross profit as a percentage of revenue is expected to be approximately 56% to 57%. This is an increase of approximately 200 basis points from our prior standalone BD guidance and is due to the inclusion of Bard's robust gross margin profile. Adjusted SSG&A is expected to be 24.5% to 25.5% of sales. This is an increase compared to our November guidance for standalone BD and is primarily due to Bard's higher SSG&A spend profile which is driven by the direct sales approach, partially offset by anticipated G&A related cost synergies. We expect our R&D investments to be in line with fiscal year 2017 at 6% to 7% of revenues. As a new company, we will continue to invest in new products and platforms. As a result of the items I just detailed, operating margin is expected to be between 25% and 26% of revenues. On a currency-neutral basis, we expect our underlying operating margin to improve by 200 basis points to 250 basis points for the total fiscal year. As we discussed, we expect our tax rate to be between 17% and 19%. For fiscal year 2018, we anticipate our adjusted average fully diluted share count to be approximately 261 million shares. Cash flow is expected to be strong with operating cash flow of about $3.5 billion in fiscal year 2018. Capital expenditures are expected to be between $850 million and $900 million. So in summary, I'm excited about the strong momentum we have across the BD and Bard businesses and I'm confident that we'll be able to deliver on our commitments in fiscal year 2018, which are consistent with what we've been communicating to you since the announcement of the transaction. Now, I'd like to turn the call back over to Vince who'll provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. And moving on to slide 20. As we have been discussing with you, our integration of CareFusion is largely complete and we are on track to achieve our cost and revenue synergy commitments. At the same time, we're making excellent progress with the integration of Bard. As I discussed in my opening remarks, we have hosted very successful Day 1 activities globally. We are entering 2018 with great momentum across both companies. Our integration plans are well underway and as Chris discussed earlier, we are committed to fully realizing $300 million in annualized cost synergies, as we exit fiscal year 2020. In addition, as Chris mentioned, we've begun our initial investment in revenue synergies. We're continuing to build out our revenue synergy plans at a very detailed level and we look forward to sharing updates with you along the way. Turning to slide 21 and our planned product launches by segment. As we've been discussing with you, we have a very robust product pipeline across the company. I will not review all of the items on slide 21 in detail, but we will share some comments on a few items. Within our Medical Segment, we have recently begun shipping IV solutions to our customers through our partnership with Fresenius. As saline remains limited in supply, the addition of sodium chloride to our Medication Management portfolio will benefit our customers and their patients. Beyond sodium chloride and 5% dextrose, we expect to add additional compounds to our offering this fiscal year, but contingent on our partner's FDA approval. Before we move on to our Life Sciences Segment, I would like to provide an update on a program we've been working on in our Diabetes Care business relating to enabling dose capture for insulin pens. We've made a decision to stop this program due to the reassessment of the near-term commercial opportunity. We've redeployed these resources into our smart Type 2 patch pump and are funding additional clinical trials in anticipation of launch. Including our first in human insulin infusion trial running now, we're very excited about our progress on this transformative initiative, and we'll come back to the pen program later on. Moving on to our Life Sciences Segment, we recently obtained the CE Mark for the BD MAX Check-Points CPO assay. This next generation molecular screening test for antibiotic resistant CPOs provides detection of the five most common carbapenemase genes in less than 2.5 hours as compared to traditional methods that can take up to 24 hours. Together with our plated media and the BD Phoenix CPO detect panels, BD provides comprehensive solutions for screening and infection management to support clinical microbiology laboratories in their AMR programs. We also expect to continue targeted expansion of our BD MAX menu this fiscal year with the launch of our Enteric viral panel and our TB assay. In addition, we anticipate approval of our BD Onclarity HPV assay, which will further differentiate our women's health offering. Moving on to the Interventional Segment, to help bridge the time from Bard's last public update in January 2017 to date, we have provided a list of Bard's product launches for fiscal 2017 in the appendix to today's slide presentation. Focusing now on the list on slide 21, I will highlight a few of the fiscal 2018 items in the Interventional Segment. The AV access drug coated balloon, which launched at the beginning of BD's first quarter, is changing the treatment pathway for the hemodialysis patients suffering from a stenotic fistula. This launch makes a significant new treatment option for the highly vulnerable patient population and is the only DCB approved for this indication in the U.S. Also related to DCB, as most of you are aware, in January, we announced the completed enrollment in our Lutonix below-the-knee trial, which is a significant milestone. This study has enrolled over 450 patients over four-and-a-half years – four-plus years I should say, and it is more important to note that there have been 14 safety monitoring reviews over this time with no safety issues. This speaks highly to the safety of the product. The Lutonix BTK trial is the only ongoing DCB trial for BTK arteries in the U.S. and we anticipate completing six-month follow-up and submission of the PMA to the FDA by the end of calendar year 2018. We look forward to being the first company to have the below-the-knee indication in the U.S. Moving on to some fiscal 2018 anticipated launches, with the Interventional Segment. Our new low profile 5French ProSeries LifeStent platform launched in the EU mid-year 2017 and just received PMA approval. We are building inventory and anticipate launching the product in the U.S. over the next few months. This new stent family built on the LifeStent platform will provide the lowest profile, longest lengths and broadest indications of any peripheral arterial stent. This new launch also expands our 5French ProSeries of chronic total occlusion, percutaneous transluminal angioplasty and drug coated balloon products to a full suite of peripheral arterial disease tools that are 5French compatible. We're also anticipating PMA approval and preparing for the launch of our Covera family of next generation AV access circuit stent grafts. We completed enrollment in IDE studies for both the treatment of AV fistulas and AV access grafts in 2017. Our graft study enrolled a little faster with follow-up completed last fall and PMA submission in December. We currently anticipate a U.S. launch of Covera with the AV access graft indication towards the end of fiscal year 2018, with PMA submission for the fistula indication anticipated about the same time. As you can see, we have a very rich pipeline of new products across our businesses and we look forward to sharing updates with you along the way. Before I move on, I would like to point out that we have included a new slide in the appendix of today's presentation that provides an update on our sustainability initiatives. While we have always been focused on ESG in creating shared value, we have received feedback from the investor community about its increasing relevance to investment decisions. We hope you find the information useful in understanding BD's commitment to this important topic. Moving on to slide 21 (sic) [22], I would like to reiterate the key messages from our presentation today. We delivered strong underlying revenue growth in both the Medical and Life Sciences Segments in our final quarter as legacy BD. Our performance highlights the continued strength in our core and our reliable, consistent results. Looking ahead, we are confident in our fiscal 2018 outlook which is consistent with the expectations we communicated upon the announcement of the Bard transaction. I would like to thank all of the BD and Bard associates for their dedication and hard work that made this combination possible. We have great momentum across both companies as we welcome C.R. Bard to BD, and we are excited about the opportunity we have as a combined company to advance the world of health for our customers and their patients around the world. Thank you. We will now open the call to questions.
Operator:
The floor is now open for your questions. . Thank you. Our first question comes from the line of Bob Hopkins with Bank of America.
Bob Hopkins - Bank of America Merrill Lynch:
Hello. Thanks very much for taking the questions. I appreciate it.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Bob Hopkins - Bank of America Merrill Lynch:
Good morning. So the first question I have is just really a clarification on the guidance and some of the information you provided yesterday. So for the 2018 pro forma guide of 5% to 6%, is ex-dispensing changes and the hurricanes, what number is that compared to for 2017? I saw that 5.2% yesterday, but is that also ex-dispensing changes and hurricanes?
Christopher R. Reidy - Becton, Dickinson & Co.:
No. I think the way to think about it is 5.6% ex-dispensing.
Bob Hopkins - Bank of America Merrill Lynch:
Okay. That's for 2017?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes.
Bob Hopkins - Bank of America Merrill Lynch:
Okay. So that compares to the 5% to 6% free (39:21)?
Christopher R. Reidy - Becton, Dickinson & Co.:
That's right. That's right.
Bob Hopkins - Bank of America Merrill Lynch:
Thanks for that clarification.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure.
Bob Hopkins - Bank of America Merrill Lynch:
And then, just one other thing I wanted to ask about is just you mentioned resin cost going up, could you just quantify that for 2018?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, so we're looking at an incremental $15 million or so. Now – you have more clarity around that in the upcoming quarter, it gets a little bit murkier in the second half of the year. But our best guess right now based on what we're seeing in that market, oil prices certainly have an impact, but the market itself is a difficult market in terms of supply and demand. And so, we're estimating right now about $15 million impact. What we are saying, we're also assuming a benefit from the flu upside, and the two of those basically offset one another as we see it today.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Bob, thanks for your questions.
Bob Hopkins - Bank of America Merrill Lynch:
Thank you.
Operator:
Your next question comes from the line of David Lewis with Morgan Stanley.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. A couple quick ones for me. One, strategically for – and then, one, actually more financially oriented. So Vince, just on the Gore royalty, this is sort of your first time having to pro forma Bard. Bard had talked about their strategic plans for how they were going to offset the Gore royalty. You've obviously moved that to other income which is the appropriate treatment. But how are you thinking about the opportunity to offset the Gore royalty, either through M&A, SG&A cuts or balance sheet deployment? And I have a quick follow-up for Chris.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, first off, in terms of the Gore royalty, as we've been talking about, we expect to be delevering aggressively. And so, we're going to see a decrease in interest expense. So that's number one on the list and the timing kind of works out very nicely from that standpoint, David. The second thing is, yes, you will also see the rollout of the cost synergies. And third, as we get to that timeframe, we're going to expect the benefit of revenue synergies starting to impact. So when you put that all together, I think we're in good shape.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. The only thing I would add then as well is you've got the conversion of the mandatory preferred at that timeframe, which helps to offset a little bit as well...
Vincent A. Forlenza - Becton, Dickinson & Co.:
(41:27)
Christopher R. Reidy - Becton, Dickinson & Co.:
...the factors. Yes. The interest goes down.
David Ryan Lewis - Morgan Stanley & Co. LLC:
So generally, you think you can offset the Gore royalty through a lot of operating and non-op dynamics without deploying material balance sheet.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. We think we're in good shape with that, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. Very clear. And then, Chris, just a few dynamics of earnings here. Thinking about the earnings guidance. To us, currency, based on your euro/dollar assumptions, looks a little conservative. Are there any currency headwinds that we're not thinking about in terms of different pieces there? And your tax rate, another piece there where that number seems conservative based on this quarter's rate going forward. So does that reflect your full appreciation of all the tax dynamics, or does that also look a little conservative here as we start the beginning of the year? So your currency and tax and do those look conservative...
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure.
David Ryan Lewis - Morgan Stanley & Co. LLC:
...are the things we're missing? (42:18) Thanks so much.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. Great. Well, as you know, we do the 30-day moving average on FX, and the quote we have today is at $1.22 to the euro. So there's no other basket of currency impact or whatever. They're all moving consistent with the euro. And obviously, we're at $1.235 I think today, so there is a little bit of upside there. We'll see how that goes. We remain consistent with the 30-day average just to smooth out the bumps and the benefits along the way. But if we do see some currency upside, that will flow through in the future. We would also look, though, to see if there is more investments. We're making the initial investment of the $15 million to drive Bard synergies, and if there's significant amount of FX upside going forward, we might invest some of that. But that's to come. And then, on the tax rate, there's an awful lot of complexity around the tax rate. As you might imagine, they institute the tax reform at the end of December, and it's right on top of a very large transaction with BD and Bard. So there's a lot of things going into that. As we had previously mentioned, we see the benefit of tax reform to our tax rate as being a slight benefit. There's a lot of things that go into that. But that's what's manifested in the impact down from the 18% to 20% that we had announced upon the deal announcement, down about a full percentage point down to the 17% to 19%. There are some impacts in 2019 that would be headwinds, as some pieces of the tax reform act go into effect in 2019 that don't affect us in 2018. But we think that some of the combination with Bard and those kinds of things, we should be able to offset that going forward. So we feel good about the 17% to 19% rate as we get that benefit from tax reform.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Great. Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks, David.
Operator:
Your next question comes from the line of Mike Weinstein with JPMorgan.
Michael Weinstein - JPMorgan Securities LLC:
Thank you. My questions are primarily around the guidance as well. So if I think about Bard, that kind of net 1% to 2%, call it, year one accretion, that's before the benefit of – the dollar's moved since you announced the transaction and before the benefit of tax, you're separating those and putting them in the other other (44:57) columns? Is that right?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes, that's the right way to think about it, Mike.
Michael Weinstein - JPMorgan Securities LLC:
So if we really thought about Bard just as a standalone, Bard would be year one much more accretive than that 1% to 2%, because again, the movement of dollar since the time you announced the transaction and the benefit of tax reform?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes. Absolutely.
Michael Weinstein - JPMorgan Securities LLC:
Okay. The $0.07 (45:19) beat this quarter relatively Street expectations, you didn't let that flow through. Could you maybe just comment on why? And then, I don't think you've given us what the incremental tax liability is going to be from reform and is that in your 4.7 times gross debt number?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So let me take that last piece first. That's important in terms of the tax. We will, as part of the press release, I think in the attachments you'll see, that we lay out the impact of the unremitted earnings. So we took a charge on the BD side of $561 million related to that toll charge. And then, that was offset, though, by a $290 million benefit that relates to the write-down of the net deferred tax liability. But the right one to focus on from a cash standpoint is the $561 million. Now, on the Bard side, in their opening balance sheet, they recorded a charge of $220 million related to the toll charge. So in total, it's $781 million. Now, the good news is that we don't start paying that until next fiscal year, and the way it's allocated, it's back-end loaded, so it's really only 8% a year in the first five years. The reason that's important is it really doesn't have a big impact on our three-year period where we're paying down the debt to the 3 times leverage, so really no material impact on that. And then, as we look forward, you see that our cash this year, we're generating $3.5 billion, that's with only three quarters of Bard included, so that will go up next year and the year after. So we generate a lot of cash. So while I'm not thrilled about paying this $781 million over the next eight years, we have more than enough cash generation going forward to cover that. So those are the details around that. And then, in terms of the first question, we beat the revenue that drove Q1 EPS earnings, and that's still within our 5% to 6% overall revenue guidance that will flow down. So the range I think we've captured within our range the benefit in the first quarter. And frankly, it's still early, so we'll see how it goes going forward.
Michael Weinstein - JPMorgan Securities LLC:
Okay. Thank you, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks, Mike.
Operator:
Our next question comes from the line of Isaac Ro with Goldman Sachs.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Isaac.
Isaac Ro - Goldman Sachs:
Good morning, guys. Thanks. Hi. How are you?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good.
Isaac Ro - Goldman Sachs:
Question for you on the Diagnostics business. There's some changes in reimbursement going through in the U.S. marketplace. Curious what you're seeing so far. You said that labs are facing low reimbursement for some of the more commodity categories that you serve.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So I'll turn it over to Alberto. Alberto, do you want to get that?
Alberto Mas - Becton, Dickinson & Co.:
Yes. Hello. Good morning. It's too early to see any impact at this point. We've always seen this as a relatively limited impact to us directly. There will be some overall pressure on pricing we anticipate, but it's not significant. We're told it's U.S. only. Secondly, it's capped every year 10% maximum decrease. It's only for CMS and a lot of our customers are obviously private. And it only impacts the last schedule (48:59) versus the hospital and the DRG. So we're not anticipating this to be a significant impact on us.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks.
Isaac Ro - Goldman Sachs:
And then, maybe...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, go ahead, Isaac.
Isaac Ro - Goldman Sachs:
Thanks. So Chris, maybe second item on just the expense side, if I think about the long-term with regard to the Bard integration, could you maybe outline some of the longer-term projects that come into play, as you think about back-end operational stuff, because you've done a couple of larger deals for the last two years? I'm curious you said to us (49:32) there are some longer-term projects in the works?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes, absolutely. So what I've said is that there's really you think about this in three buckets. So the $300 million, the first year, you're really talking about public company costs as well as procurement kind of savings. So that's what you would expect the first third to be. In the third year, you would expect the more long-term projects that you're referring to which is looking at manufacturing facilities and distribution centers. And obviously, that takes a lot of planning. You want to get that right. And that's what you would see showing up in year three. In year two, you would be looking at some of the functional systems and transformations, putting the two companies on the same kind of systems integrations, going to Workday, for example, those kinds of things and that shows up in year two. So the only other thing I'd say is because it's not a perfect year, we're looking at about $70 million to $80 million of impact in the three quarters this year, and then, pretty much ratable over the next two years.
Isaac Ro - Goldman Sachs:
Thanks, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks very much.
Operator:
Our next question comes from the line of Kristen Stewart with Deutsche Bank.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Hi. Good morning. Thanks for taking my question.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning, Kristen.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Kristen Stewart - Deutsche Bank Securities, Inc.:
I was just wondering with, I guess, now having the acquisition closed for I guess a little over a month now with operating and just seeing the revenue synergies with having the ability now to spend, what sort of spending, where are you targeting it? Is it more for U.S. spend, international spend? Can you maybe just give a little bit of detail what gives you the confidence to spend on revenues and what sort of synergies are you looking at? And I've one follow-up.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. I'll ask Tom to talk to that. But it's very much in line with our original thinking on the deals. Tom, do you want to just take that?
Thomas E. Polen - Becton, Dickinson & Co.:
Sure. Hi, Kristen. This is Tom. So from a regional perspective, actually, the U.S. and Europe are the two areas that we're most heavily investing in and about a little less than a third would be in emerging markets, so two-thirds in U.S. and Europe and a little less than a third in emerging markets. From a business unit perspective, those investments are also heavily concentrated within our MDS business unit and the surgery area. And that, as you can imagine, is expected. That's where we see synergies of portfolios coming together. So the PICCs coming in, MDS from Bard in with our catheter and other drug delivery technology, so that's an epicenter of synergies we see. And then, in surgery, where we're moving our ChloraPrep business and V. Mueller business, Interventional Specialties from BD into that area, obviously, ChloraPrep now having channel access, for example, in Europe via the biosurgery team and opportunities for us to further accelerate growth, for example, even in biosurgery channel expansion ex-U.S. So those are the two businesses and two major regions that we're investing in. Thanks for the question.
Kristen Stewart - Deutsche Bank Securities, Inc.:
And what do you think in terms of the payback on these investments? Do you think that you'll get those back in 2020? And then, just a follow-up on the patch pump. Could you just remind us on the timeline to market then and do you think that taking the resources away from the insulin pen can help accelerate that? Thanks.
Thomas E. Polen - Becton, Dickinson & Co.:
Yes. So Kristen, we see, from a payback period, actually, this first tranche of investments have a relatively short payback period. And so, we won't see – the revenue will start to ramp in the very – really see it come through in 2019, not necessarily notable where it will be visible across the new $16 billion company. But we expect the pay back relatively to break even within a year on the first $15 million of investment. And then, there's other tranches of investments that we'll be making in the future as was alluded to earlier on the call. When it comes to the patch pump, again, it continues to go very well and our targeted launch is at the very end of FY 2019. And I wouldn't say we see an acceleration from the investments that we're making in a faster way there. It's more of we're adding in clinical trials and that's some learnings that we've had, particularly in the diabetes space where we want to do more patient testing prelaunch, and so, we've added in a number of patient trials. You heard Vince mentioned actually an active patient trial that's underway right now. It's actually our first use of Swatch in patients with insulin underway, and all of that's been funded incrementally versus some of our original thinking and plans.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Just get more customer data earlier on.
Thomas E. Polen - Becton, Dickinson & Co.:
Absolutely.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Kristen, thanks for the questions.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Thank you.
Operator:
Our next question comes from the line of Brian Weinstein with William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Yes. Good morning. Thanks for taking the questions. Moving away from Bard for a second, have you guys seen any improvements in business operations from the business model change in dispensing? And related to that, we keep getting questions on market share between you and your competitor there. So can you talk a little bit about what you see for growth in dispensing on a normalized accounting basis versus the market? And then, I have a follow-up as well. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes, we can do that. We have some good data on that that Tom can walk you through. We're feeling very good about that business.
Thomas E. Polen - Becton, Dickinson & Co.:
Hi, Brian. This is Tom. So we actually continue to see fantastic customer feedback to the new model. We see our Net Promoter Score actually approximately doubling. Since we've made that change, the feedback from customers has been very positive, particularly along with some of the investments that we've made in clinical consultants who are supporting wider use of the features of Pyxis ES. We've always said that folks only were using about a third of the power of the platform, and now, with some of the consultants that we've been able to fund through this new approach, we're really seeing customers being able to adopt and get more value out of the platform. If you look actually at last year, the U.S. dispensing, excluding trace, was about 10% growth for the year, so very, very strong underlying performance. And while we certainly don't make statements about peers or competition, specifically, I would say that we continue to gain momentum in our customer base. As you know, we have a very significant market leadership position, and we continue to expand that position through integration of our Med Management continuum including our IV compounding platform, what we're now calling Pyxis IV Prep, our inventory management system, which we now call Pyxis Logistics, and the new BD Health site platform that we launched at ASHP this year. So overall, really positive feedback from customers and we're seeing very good momentum going forward.
Brian D. Weinstein - William Blair & Co. LLC:
Great. And then, a quick follow-up on flu. I would have thought the impact potentially could be bigger in Q2. Did I hear you right that you thought that that would potentially just be about $15 million? And are you still producing flu kits for Veritor? There were some rumor that you may have stopped production after you hit some target volumes for the year. Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
I think what you have to remember, Brian, is that last year, the flu was fairly strong in the second quarter. So although we had a nice benefit in the first quarter compared to last year, it's not absolute that it will be higher for the year. But in January, we really did see and it clearly is a strong flu season. That's why as we look out – you don't know what's going to happen, it could drop off, so we'll see. But based on January, we're thinking that there is more flu upside in the remainder of the year. And roughly, it's offset by that $15 million increase in resin prices. So that's the way we currently see it.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And, Alberto, from production standpoint?
Alberto Mas - Becton, Dickinson & Co.:
Well, not only have we not stopped it, we have increased it. We are at full capacity, adding shifts, anything that we can do to try to increase production, as we see the demand being very, very high. And as of today, we haven't seen any unusual (57:22) back order, although it is continuing be a very, very high level, so we are a little bit of hand to mouth. But we're doing everything possible to crank up production.
Brian D. Weinstein - William Blair & Co. LLC:
Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks, Brian. Great to hear from you.
Operator:
Our next question comes from the line of Larry Biegelsen with Wells Fargo.
Lawrence Biegelsen - Wells Fargo Securities, LLC:
Good morning, guys. Thanks for taking the questions.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Lawrence Biegelsen - Wells Fargo Securities, LLC:
Two product-related questions for me. I'll ask them both upfront. First, Vince, you highlighted IV solutions. That was the first product you highlighted in the initiatives for fiscal 2018. Could you help quantify the benefit to BD in fiscal 2018 and beyond? And then second, Lutonix is obviously an important product for Bard, but there are a lot of moving parts or changes in that market from a reimbursement and competition standpoint. But you, obviously, have new indications of geography. So can you talk about your high level expectations for Lutonix over the next few years? Thanks for taking the questions.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, sure. So I'm going to turn those over to Tom. In the quarter, the IV solutions was not meaningful. But we do expect to ramp up in the second part of the year. And how far that goes is also going to depend on how much capacity our partner has and do we get new FDA approvals. But Tom, do you want to add anything else to that and then just jump on the drug coated balloons?
Thomas E. Polen - Becton, Dickinson & Co.:
Hi, Larry. I would just say for IV solutions, think about it in tens of basis points for the MDS business specifically, and then, obviously, that dilutes out further when you take it to the BDX level. Specifically, on Lutonix, I would just say, obviously, the change in reimbursement that you referenced, it's not something that we like, but it's also something that we expect will have only minimal impact on our growth trajectory this year and going forward. We didn't see fundamentally a change year-on-year in growth, think about 2018 growth for Lutonix and DCBs overall being very much in line with growth that was seen in prior years and we expect that to go forward and that's really driven by the very robust pipeline that the business has. Obviously, we've got the new AV indication, we have BTK coming that's going to help that whole category grow for us, and we expect drug coated balloons are going to continue to grow in line with prior year in 2018 and in the years ahead.
Lawrence Biegelsen - Wells Fargo Securities, LLC:
Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Next question.
Operator:
Our next question comes from the line of Brandon Couillard with Jefferies.
Brandon Couillard - Jefferies LLC:
Thanks. Just two quick ones for Chris. Can you tell us what you're penciling in for ASPs for fiscal 2018? And then, for newco, can you remind us how big resins are as a percent of COGS?
Vincent A. Forlenza - Becton, Dickinson & Co.:
I'm sorry. Can you ask the question again? There was some static there (01:00:11) Brandon ASPs.
Brandon Couillard - Jefferies LLC:
Yeah. What you're penciling in for ASPs for the year, and then, secondly, what resins are as a percent of COGS for newco?
Christopher R. Reidy - Becton, Dickinson & Co.:
Okay. On the ASPs, what we have said is that we expect pricing across the business to be slightly down. So I think tens of basis points across the business. And then, the percentage of resin, resin across BD is about $250 million. I think that's just the BD side. So that gives you something to work with.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Partly yes, (01:00:46) it'll be a little bit more...
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, it'll be a little bit more with Bard.
Vincent A. Forlenza - Becton, Dickinson & Co.:
With Bard, I guess, $300 million or so.
Brandon Couillard - Jefferies LLC:
Super. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Great. Sure.
Operator:
Our next question comes from the line of Bill Quirk with Piper Jaffray.
William R. Quirk - Piper Jaffray & Co.:
Great. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Bill.
William R. Quirk - Piper Jaffray & Co.:
Good morning, everybody. So recognizing it's a little more difficult to pull up, any way to help us think about the impact of the flu season on some of the ancillary medical products just given the higher rate of hospitalization? And so, I guess what I'm asking about is kind of ex the actual direct flu products themselves.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes, so there is a correlation, of course, with folks ending up in the hospital and having other conditions. Now, how to quantify that, that's extremely difficult. But historically, if we look back, we do see a little bit of a positive impact across multiple product lines. We see it on the Diagnostic side with blood culture and you may see, of course, in catheters and those sorts of things. And there is an increase in cardiac events. As I said, it's not big enough that we can measure it, but it is certainly there.
William R. Quirk - Piper Jaffray & Co.:
Okay. Got it. Thanks, Vince. And then, Tom, just a quick update on the O.U.S. CareFusion revenue synergies from new product launches and how should we think about that going forward. Thank you.
Thomas E. Polen - Becton, Dickinson & Co.:
Sure. Hi, Bill. So we're now over 250 active or in-process registrations when it comes to focusing on revenue synergies, so we're continuing to make very good progress there. And while we don't quantify those revenue synergies each quarter, we continue to expect to see growth contributions in the range of tens of basis points as we've shared in the past. We also expect to see those most visible in the international MDS and MMS businesses. And if you'll notice, you'll see those, if you look at the last couple of quarters, those continuing to go very, very strongly, MDS and MMS international.
William R. Quirk - Piper Jaffray & Co.:
Got it. Thank you.
Thomas E. Polen - Becton, Dickinson & Co.:
Yes.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Thanks a lot.
Operator:
Our next question comes from the line of Doug Schenkel with Cowen.
Doug Schenkel - Cowen and Company. LLC:
Hey. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Doug Schenkel - Cowen and Company. LLC:
First, starting on the product realignments, what has been the initial feedback from your sales force and customers? Could you help quantify how this might accelerate the revenue growth outlook for the impacted segments? And should we be contemplating any initial dissynergies related to the realignments? And then, I guess the second thing I just wanted to quickly talk about is Bard's M&A history. As you guys know, strategic tuck-ins have helped boost Bard core growth over time. This was arguably a pretty important part of their strategy. Could you just provide us an update on how much capacity you have to keep that going given where the gross leverage ratio is today? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Okay. So I'll start on the M&A side. And there's always part of our modeling that we would leave room for strategic M&A. And of course, the way we think about that is more must do. And the conversation we're having with the Interventional Segment is, give us your pipeline so that we can plan that in. And as you said, that's tuck-in M&A, and we take that as kind of the base of what we have to do. The second thing is going on in the other two segments, so we're creating that list right now. And as we have to do it, we will do it. But we think we've got enough capacity planned that we can do that plus get down to the 3 times leverage that we're talking about. So we're in pretty good shape with that. Tom, do you want to pick up the other piece?
Thomas E. Polen - Becton, Dickinson & Co.:
Yes. Hi, Bill. So on the realignment, the feedback from both the sales team and our customers have been very positive. Obviously, our customers really were excited by the opportunity, particularly on the vascular access side where they saw the power of those two portfolios really helping to meet their needs from one partner, right, the ability to provide short and long-term vascular access, be it peripheral catheters, midlines or PICCs. And so, putting those in one business, we have a program what we call optimal vascular access where we help and we're developing more tools and we'll be working on evidence generation around the power of our portfolio to help prevent bloodstream infections, to help optimize length of stay for the patient and for the caregivers that are inserting that and managing that. It can be quite costly. From a side effect, obviously, bloodstream infections, but also just the longer you can keep that site active and dwelling is very important, particularly in some of the longer care patients like those undergoing cancer treatment. Same thing holds true on the surgery side. Our teams are very excited about that realignment. Of course, we had a surgery group come in from CareFusion who was put in our Med Management business, and so, they felt a little bit out of home. They actually feel very much at home now moving into a group that wakes up and thinks surgery every day of the week. And so, there's efficiencies and effectiveness opportunities from that combination. A good example of it would be the ChloraPrep team who primarily goes into ORs and calls on surgeons now in the surgery group, great opportunity ex-U.S. where Bard has had teams calling on surgeons in Europe. BD never had that in the past. They're now – as part of one of the first areas of revenue synergies that we're investing in is getting those products into more surgery reps in Europe now and starting to expand the use of those products to prevent surgical site infections as an example. So overall, we're hearing very positive feedback. But we're also being very staged in the way that we do that integration, right? We're not looking to just suddenly push the portfolios together through one common sales team everywhere. We're being very staged in the way that we plan and think that through so that we prevent any dissynergies.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks, Tom.
Operator:
Our next question comes from the line of Rick Wise with Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, everybody. Two questions. First for Chris, and then, a bigger picture one for you, Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Chris, I just want to make sure that I'm not missing anything on gross margin or I'm understanding the guidance. On gross margin, just a couple aspects (01:06:58). You talked about the 80 bps of drag in the guidance from currency. A couple things, included in that was dispensing, how much was the dispensing? And then, just looking at it, I'm sure I'm not thinking about it correctly. I know there are a lot of moving pieces, but if I just over-simplistically take the Bard gross margin and the BD gross margin and weight them, annualized basis, that looks like 58%, 59% kind of gross margin range. You're guiding to 56%, 57%. Okay, you only have nine months, that's not a full year. But that feels extra conservative. Am I thinking about this correctly? Is it the Gore royalty? Just a little more color if you would on the right way to think about it.
Christopher R. Reidy - Becton, Dickinson & Co.:
So your point there was that Gore royalty does have an impact. The impact of dispensing is about 40 basis points. The Gore royalty hits you by about 30 basis points on top of that. And don't forget you only have Bard only for the three quarters, so that doesn't give you the full benefit. So we won't get that. Initially, what we were saying is that Bard would impact us by 300 basis points or so for a full year. So you have to discount that back to three quarters. So when you have all those ins and outs, that's what you come up to with the guidance that we gave you. As we talk about that flowing down, that flows down to operating margin as well, and we're looking at 200 to 250 basis points in FY 2018 and that will basically give us about 700 basis points over the last several years. And then, going back to our initial guidance, we talked about 200 basis points a year in the next two years, so another 400 basis points through 2020. So when you add all that up, it's about 1,100 basis points from the period beginning back in, I guess, 2015 through 2020, so in five years, 1,100 basis points. So we feel good about that.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Great. And Vince, I hate to ask you already where the upside drivers might come from. I mean I think you've given us realistic even perhaps conservative guidance, but do the upside drivers as you work hard to make all this happen over the next year or three come from faster debt paydown, more cost cutting, pipeline upside? I know you're excited about the Bard pipeline, the benefits of the now even larger portfolio as you meet with customers. How are you thinking about it? Thank you so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes, and thanks, Rick. I'm going to start back with both cores on both businesses look strong. We came into this year with a good pipeline, and we're making good progress on that pipeline on the BD side. And I just walk you through the Bard side. So I feel very good about that. As Tom walked through the revenue synergies, I think we've got a good plan there. The second piece in terms of taking this into more geographies, I think, could be a further upside for us. That's not where we're starting – that's not our primary focus, but there are geographies, Latin America and other parts of Asia where we think it'll take a little longer to get it going, but we see nice upside there. And then, we're looking to come back to some of those product launches that we have talked about such as Barricor and whatnot, where we're actually starting to learn. We've got the product out in Europe. So I think there are some upsides there. So those are the kind of things I'm comfortable with. The cost synergy piece, I think, is really well planned at this point in time. So I don't think it comes from more rapid deleveraging. I think it comes from operational effectiveness and implementing what we're talking about here.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Thanks so much.
Operator:
Our next question comes from the line of Larry Keusch with Raymond James.
Lawrence Keusch - Raymond James & Associates, Inc.:
Hey, good morning, everyone.
Christopher R. Reidy - Becton, Dickinson & Co.:
Hey, Larry.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Hey, Larry.
Lawrence Keusch - Raymond James & Associates, Inc.:
Hey. Vince, could you just give some thoughts on sort of how you're thinking about the backdrop for the U.S. market now that you've been through the end of the year in 2017 and looking into 2018?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure, Larry. So I think it's a really interesting question that you're asking. We started last year talking about this, and we basically said that we see this as a stable marketplace, number one. Number two that maybe there's a little bit of cyclicality now built into the marketplace because of high deductible plans. I think that's going on. But in addition, of course, we had the flu. But when I look at the U.S. market, I don't see any big negative impacts from the changes that have been made in terms of healthcare reform and whatnot, the Affordable Care Act, impacting a very small piece of the population. We'll have to see what they're doing in terms of going forward. But on the capital side, we're seeing continued focus on spending the capital that has actually got a real return for them in terms of improving productivity in the hospitals, which is what we're doing. So at the end of the day, I would say U.S., stable, and for us, strong from a capital standpoint. We don't see any real issues there. We've seen Europe come back and bounce back nicely, especially on the Life Sciences side of the business in the Diagnostic area. The focus on funding in automation and those sorts of things has been good. The two places that I would comment on, China was strong this quarter and we expect it to continue to be strong and, of course, that's both sides of the business. The one big change from last year is EMA. Where EMA has come back, it's a little stronger than we normally would expect just from the timing of tenders this year, but it is once again growing for us. So all-in-all, good from a market standpoint; Latin America, pretty stable like it was last year.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. And then, perhaps just for Tom, I just wanted to come back to IV solutions and really the two parts of the question are, is Fresenius continuing to expand its manufacturing capacity for IV solutions that can be imported into the U.S.? And then, I guess the second part of the question is if you have to sort of look at what capacity they have today and ability to supply you, is that sort of in line with where we were at the start of the fiscal year? Better? Worse? Just trying to calibrate that a little bit.
Thomas E. Polen - Becton, Dickinson & Co.:
Yeah, thanks, Larry. So we obviously don't comment on Fresenius' specific capacity nor their capacity plans. But I would say that we're very pleased with the relationship. The capacity that – and our supply as part of our partnership is very much in line with our expectations, and we continue to work with them very collaboratively on the long-term capacity planning to serve the U.S. market.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. Thanks, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Great. Thanks.
Operator:
Our next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore ISI:
Hey, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Hey, Vijay.
Vijay Kumar - Evercore ISI:
Thanks for squeezing me in. So maybe one on pipeline and one clarification. So the pipeline question, I think I heard you say the pen program on the Diabetes side was stopped and you're investing on the patch pump side. So maybe could you talk about sort of how the decision was made or why stopping the pen? And I thought on the BTK side, the DCB, below-the-knee trial, we were supposed to have an interim look. Did we have that interim look or any thoughts on that would be helpful?
Vincent A. Forlenza - Becton, Dickinson & Co.:
So Tom will take both of those.
Thomas E. Polen - Becton, Dickinson & Co.:
Right.
Vincent A. Forlenza - Becton, Dickinson & Co.:
I think we've got some pretty good rationale on the pen side of things.
Thomas E. Polen - Becton, Dickinson & Co.:
Yes. Hi, Vijay, this is Tom. So on the pen side, as you know, we've been working on that program, and as we just routinely look at all of our projects in our portfolio, we made a decision that due to the nearer term commercial opportunity for that first generation product that we wanted to redeploy those resources to really double down on the smart Swatch. And by the way, when we had originally shown Swatch, it was not necessarily smart at launch, we can also accelerate (01:15:41) work, so the product that we're launching is smart and will have well over 10,000 patient days now of Swatch worn by patients delivering insulin by the time of launch. So that's a significant acceleration in terms of real world data that we'll have versus some of the original plans. When it comes to BTK, so of course, it is a blinded study, so we personally, of course, do not look at that data until the study is completed. I would say that just to give a little bit more insight there, so we stopped the enrollment in the trial, but there still will be six-month follow-up as part of the trial that's planned. So think about by the end of August, the last patients would be completed for their follow-up. And then, we would end up preparing for submission at the very end of the calendar year. But because of it is a blinded, we do not – management does not see the data. As you think about when we might be able to present some interim data, obviously, because it's blinded, we're not going to see the data until the follow-up is completed. But we do anticipate the results will be presented after the PMA submission, but at this time, the study remains ongoing and in follow-up.
Vijay Kumar - Evercore ISI:
That's helpful, Tom. And Chris, maybe one quick one on the divestitures. Can you quantify what the magnitude was?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Divestitures.
Christopher R. Reidy - Becton, Dickinson & Co.:
In the divestitures?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes.
Vijay Kumar - Evercore ISI:
Yes.
Christopher R. Reidy - Becton, Dickinson & Co.:
The two are about $50 million in total.
Vijay Kumar - Evercore ISI:
Thank you, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
In revenue.
Christopher R. Reidy - Becton, Dickinson & Co.:
In revenues.
Vijay Kumar - Evercore ISI:
Yes. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Thanks, Vijay.
Operator:
Our next question comes from the line of Richard Newitter with Leerink Partners.
Richard Newitter - Leerink Partners LLC:
Hi. Thanks for taking the question. Just going back to China and in the context of your revenue synergy discussion, you're guiding to I think you said 15% growth which is above the 11% that you did for Becton standalone in the fiscal first quarter.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes.
Richard Newitter - Leerink Partners LLC:
Is that just the combination of the two companies and the strong momentum and, obviously, Bard, a little bit faster? Or is there any early revenue synergy baked into that?
Vincent A. Forlenza - Becton, Dickinson & Co.:
No, that's pretty much straight forward.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes. That's straight math. No revenue synergies on top of that to get to the mid-teens.
Richard Newitter - Leerink Partners LLC:
Okay. And then, the second question that I had was on the AV access market opportunity. I think Bard had talked about a $250 million kind of market opportunity there. Is that how you see it now that you have a little bit of time with the launch commercial?
Thomas E. Polen - Becton, Dickinson & Co.:
We still see it as that same view from Bard. Actually, the uptake in the first few quarters post-launch has been very much in line with expectations. It's off to a great start and no change in that perspective in terms of the long-term opportunity.
Richard Newitter - Leerink Partners LLC:
Okay. Thanks.
Operator:
Our next question comes from the line of Matt Taylor with Barclays.
Matthew Taylor - Barclays Capital, Inc.:
Hi. Thanks for taking the question.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure, Matt.
Matthew Taylor - Barclays Capital, Inc.:
Thank you. I was hoping to follow up on that kind of same line of thinking. With the combination of Bard, in the past, you had talked about the potential for a lot of those revenue synergies to come from geographic expansion in the future. So I guess the core of my question is I want to understand what you think the sustainability of that kind of emerging market growth is in the kind of the three-year plan of the Bard-Becton combo.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. We feel very good about it is what I would say. I think what you heard us talk about is there is some immediate things that we can go after with fast payback. So we're starting there. And then, Tom mentioned as he went through this some more money going into other geographies. And so, we still see it that way. In China, of course, it's – Bard has been focused on, I'll call it, the leading hospitals, the top tier. We see the opportunity to accelerate driving into Tier 2. We think we've got more work to do to plan that out, but we haven't changed our opinion on that. And so, that would be one of the highest priorities, then, the rest of Asia, and then, Latin America. That's the way we're thinking about it. So the answer to that question is absolutely yes.
Matthew Taylor - Barclays Capital, Inc.:
Okay. Thanks. And then, I wanted to ask about CareFusion versus Bard. It struck me that...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Matthew Taylor - Barclays Capital, Inc.:
...CareFusion deal has worked out really well for you guys and...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes.
Matthew Taylor - Barclays Capital, Inc.:
...now, you're guiding to $350 million in synergies.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes.
Matthew Taylor - Barclays Capital, Inc.:
It's a similar size to Bard in terms of revenue, but can you compare and contrast kind of the synergy opportunities between the two, and then, what we've learned from CareFusion that could apply to Bard?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. I think in many ways, they are similar synergy opportunities as I talked about before. The public company costs and the procurement initiatives are very similar. And you could say that the manufacturing and the distribution would be the same kind of effort. What I would say, though, is we have the benefit of having the infrastructure in place that just is coming to the conclusion of integrating CareFusion. Know how to do this. We hit the ground running. So it's – we're not trying to build the team to go after it. It's already been done. And that second bucket that I talked about is based upon a lot of the infrastructure we put in as part of CareFusion and took the opportunity to do that. So that's helpful as well.
Matthew Taylor - Barclays Capital, Inc.:
Thank you.
Operator:
Our next question comes from the line of Kristen Stewart with Deutsche Bank.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Hi. Thanks for taking the follow-up. Just on the guidance, last quarter, I think you had mentioned that there could be a potential impact from Puerto Rico that could hit later in the year. I was just wondering if you were still anticipating any sort of impact from Puerto Rico from a cost perspective.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. Sure, Kristen. So as I said in my prepared remarks, we did – just to remind everybody, last time, we didn't include it in our guidance, but we said it could be as much as $40 million of revenue and flow down to as much as 1% on EPS. If you remember the timing of when we did that, we were still running on generators. The plants weren't backed up yet. So because of the efforts of a lot of folks, particularly our associates in Puerto Rico and as well as a number of other associates around the world, we got those plants back up and running. They're off generator, although intermittent still, but we don't see the impact. Although on the BD side, we will see some impact. It's smaller and included in our guidance as just one of the many puts and takes, so nowhere near the amounts that we had quantified. And then, on the Bard side, a little bit different. They felt the impact immediately, and they felt it in their fourth quarter. It was right in line with what they had guided to, which was about $30 million of revenue impact, and it came in just a tad higher than that, but right in line with what they had expected, and now, that's behind us. So as we combine as the new company, there is no impact from Puerto Rico in the Bard side going forward.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Okay. And then, they were also having some supply disruptions within their biosurgery business. Is that still ongoing or is that expected to be resolved in I think their latest guidance (01:23:16)?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes. So we still have some impact for the next couple of quarters this year. That's built into the guidance that we have, and then, we lap that I think in the fourth quarter.
Thomas E. Polen - Becton, Dickinson & Co.:
Yes, Kristen, this is Tom. We expect to begin shipping, that's Progel that you're referring to, at the end of 2018. Think about it Q4 2018 we resume shipping (01:23:36).
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. BD's quarter.
Thomas E. Polen - Becton, Dickinson & Co.:
Yes.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Okay. And that 7% underlying growth rate that I assume was not (01:23:44)...
Christopher R. Reidy - Becton, Dickinson & Co.:
What was the last part of your question? You broke up.
Vincent A. Forlenza - Becton, Dickinson & Co.:
You broke up, yes.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Sorry. The 7% underlying growth rate for Bard, that was only adjusted for the hurricane impact, correct?
Vincent A. Forlenza - Becton, Dickinson & Co.:
You got it.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes, that's right.
Vincent A. Forlenza - Becton, Dickinson & Co.:
That's right.
Christopher R. Reidy - Becton, Dickinson & Co.:
That's right.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Okay. Perfect.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks a lot.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Thanks very much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Those were good clarifications. Okay.
Operator:
At this time, there are no further questions. I will now turn the conference back to Mr. Forlenza for closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, first off, thank you, all, for your participation and your questions. Let me just say we're really happy to have closed the deal and brought together two companies with an opportunity for a tremendous impact on improving healthcare around the world. We're off to a strong start as you saw, and we're really excited about the prospects of the combined company going forward. So thank you very much. We look forward to updating you next quarter.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks a lot.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Michael Weinstein - JPMorgan Securities LLC Brian D. Weinstein - William Blair & Co. LLC Larry Biegelsen - Wells Fargo Securities LLC Isaac Ro - Goldman Sachs & Co. LLC William R. Quirk - Piper Jaffray & Co. Derik de Bruin - Bank of America Merrill Lynch Doug Schenkel - Cowen & Co. LLC
Operator:
Hello and welcome to BD's fourth fiscal quarter and full fiscal year 2017 earnings call. As the request of BD, today's call is being recorded. It will be available for replay through November 9, 2017, on the investor's page of the BD.com website or by phone at 1-800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 92540524. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our fourth fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our fourth fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release including the financial schedules is posted on the BD.com website. The fourth quarter and full fiscal year comparable revenue growth rates provided today exclude the revenues of divestitures, most notably the Respiratory Solutions business that was divested in October of 2016, just after our 2016 fiscal year end. As a reminder, this is the last quarter in which we will have a year-over-year impact due to the Respiratory Solutions divestiture as we reach the anniversary of the divestiture with the start of the new fiscal year. The details of purchase accounting and other adjustments and a comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedule in our press release or the appendix of the investor relations slides. Please note that all fiscal year 2018 guidance provided today is on a BD stand-alone basis. Regarding the acquisition of C. R. Bard, all the strategic and financial parameters remain unchanged from the deal announcement. After the transaction closes, we'll provide more detailed guidance for the combined company. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, President; and Alberto Mas, Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. Turning to slide 4, as you read in this morning's press release, we are very pleased with our performance for the year. I'm extremely proud of all of our accomplishments this year and how hard our organization worked to achieve them. Our core remains strong and we continue to execute on our CareFusion commitments. At the same time, we announced another transformational acquisition and are making excellent progress towards a successful closing. We achieved all of this while overcoming multiple headwinds. Despite the impact from the transformation of our U.S. dispensing business model, lost earnings from the divestiture of the Respiratory business, the impact from the severe hurricane season and continued currency pressure, we grew revenues 4.5%, drove approximately 180 basis points of margin expansion and delivered double digit EPS growth. The bottom line is our business continued to deliver solid consistent results. Before I highlight some achievements in fiscal year 2017, I'd like to take a moment to comment on the severe storms that occurred in the fourth quarter. We are grateful that all of our associates are safe and accounted for. As an organization, we are working to support our associates in Puerto Rico by delivering much-needed food water and power supplies as well as by setting up an employee relief fund. I'm proud of response by our global associates to personally contribute and help their peers in need. I'm also impressed by the fortitude of our associates in Puerto Rico who are enduring continued hardship and yet find a way to come to work so that we can continue to meet the needs of our customers and their patients. Chris will provide commentary on the business impacts from the hurricane in a few moments. Moving along to our key achievements this year, first, the strategic transformation of the U.S. dispensing business model was successfully implemented and our strategy for end-to-end medication management is resonating with our customers. We are continuing to see sales pull-through as customers understand the benefits of our integrated offering. Second, emerging markets continue to be a key growth driver for the company. Our momentum in China and the broader emerging markets is reflected in our strong fiscal 2017 performance in both segments. Third, we're extremely pleased with the excellent progress we continue to make with our CareFusion cost synergies. We expect approximately $350 million in total CareFusion cost synergies as we exit fiscal year 2018. For the three years ending fiscal 2017, on a cumulative basis, we achieved underlying margin expansion of approximately 500 basis points. And fourth, we are making excellent progress in preparing for the integration of Bard and BD. We are excited by the opportunities the new company will have to bring more comprehensive clinically relevant solutions to customers and patients around the globe. Moving on to slide 5, we have achieved several significant milestones towards the Bard closing in the six months that have followed the acquisition announcement. This past spring, we went to market shortly after the deal announcement and successfully issued approximately $5 billion in common and preferred shares. We also launched nearly $10 billion in senior notes. All offerings were oversubscribed by a multiple of over 3 times, clearly a positive indicator of investor sentiment about the transaction. In early August, Bard shareholders approved the merger with approximately 99% of the share votes cast in favor of the proposed merger. More recently, conditional clearance was received from the European Commission. As expected, we have committed to divesting certain assets associated with our soft tissue core needle biopsy product line, which we acquired with CareFusion, to satisfy the conditions to the Bard closing requested by the European Commission. From an integration standpoint, once we receive all regulatory approvals, we will be ready. Our teams have been engaged in extensive integration planning, including day-one readiness. We continue to expect that the BD and Bard transaction will close in the fourth calendar quarter of 2017, subject to customary closing conditions and additional regulatory approvals, including the U.S. Federal Trade Commission and other regulatory bodies. Moving to slide 6. You will see the guidance for fiscal year 2018 on a stand-alone, currency-neutral basis that excludes any expected impact from the Bard acquisition. For fiscal year 2018, we expect currency-neutral revenue growth of 4% to 5% based on our current view of the environment and various macroeconomic factors. As a reminder, the U.S. dispensing change will continue to impact our year-over-year growth by 100 basis points in both the first and second quarters of fiscal 2018, resulting in an estimated headwind of approximately 50 basis points for the full fiscal year. Of course, there are a number of items that could bring us to the top or bottom end of our guidance range, including a stronger or weaker flu season than expected, the performance of new product launches, emerging market growth and pricing. On the bottom line, we will continue to deliver high-quality earnings growth. For fiscal year 2018, we expect adjusted EPS of $10.55 to $10.65, which reflects currency-neutral growth of approximately 10%. As Monique stated earlier, we will provide guidance for DB plus Bard after the transaction closes. I will now turn things over to Chris for a more detailed discussion of our fourth quarter financial performance and our fiscal year 2018 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. I'm also extremely proud of our achievements this year as well as the extraordinary efforts made by our organization in the fourth quarter. Moving on to slide 8, I'll review our fourth quarter revenue and EPS results as well as the key financial highlights for the quarter and the total year. Total fourth quarter revenues of $3.2 billion grew 4.4% on a comparable currency-neutral basis. For the total year, revenues of $12.1 billion grew 4.5%, in line with our previously communicated expectations. The fourth quarter and full-year results include the impact from the U.S. dispensing change, which lowered total company revenue growth by approximately 100 basis points in the fourth quarter and 50 basis points for the full year. Excluding this impact, we drove full-year revenue growth of approximately 5%, which is the high end of our full-year guidance range. As Vince mentioned, our underlying performance is strong. As we communicated to you last quarter, our confidence in achieving our outlook was based on strong fourth quarter performance in MMS and Diabetes Care and across the Life Sciences segment, combined with continued strength in emerging markets, all of which we achieved. In addition, through the excellent efforts of our associates and our distribution and logistics partner as well as strength across the business, we overcame the logistics-related issues we described to you in mid-September. I'll provide more color on revenue growth in the quarter in a moment when I take you through the results by segment and geography. We significantly expanded our margins and captured an additional $80 million in annualized synergy cost savings related to CareFusion, reaching $250 million in annualized cost savings on a cumulative basis through the end of fiscal 2017. We are on track to achieve approximately $350 million in total annualized cost synergies by the end of fiscal 2018, which is the high end of our previously communicated range. Adjusted EPS growth of 13.2% in both the fourth quarter and the full year reflects our ability to overcome the dilution from the Respiratory divestiture and the U.S. dispensing change. Combined, these headwinds impacted EPS growth by approximately 700 basis points in the fourth quarter and 400 basis points for the full year. We are also very pleased to have continued our longstanding record of delivering an increasing dividend. Fiscal 2017 marked our 45th year of consecutive dividend increases. Now moving on to slide 9, I'll review our revenue growth by segment on a comparable currency-neutral basis. As discussed, fourth quarter revenue growth was 4.4% for the total company, including an estimated headwind of 100 basis points from the U.S. dispensing change. Pricing declined about 10 basis points in both the fourth quarter and the full fiscal year. Due to the timing of Hurricane Maria late in our fourth quarter, there was very little impact to our fourth quarter results. BD Medical fourth quarter revenues increased 3.9% which includes a headwind of 160 basis points from the U.S. dispensing change. For the full fiscal year, Medical revenues grew a strong 4.3% which includes an estimated 80 basis points headwind from the U.S. dispensing change. Medication and Procedural Solutions, or MPS, fourth quarter growth was 1.5%. Broad strength in infusion-related disposables was partially offset by a tough comparison to the prior year. For the full fiscal year, MPS revenues grew 3.8%. Revenues in Medication Management Solutions, or MMS, grew 6.7% in the fourth quarter including a headwind of approximately 600 basis points from the U.S. dispensing change. Growth in MMS was driven by our international dispensing business and by global strength in infusion. For the full fiscal year, MMS revenues grew 4.9% including a headwind of approximately 300 basis points from the U.S. dispensing change. Diabetes Care revenues grew 6.4%, driven by strong growth of 8.7% in the U.S. and double-digit growth in emerging markets, as expected. International growth continued to be impacted by some softness in Europe, primarily in the UK. For the full fiscal year, Diabetes Care revenues grew 3.6%. Pharmaceutical Systems revenues grew 3.4% in the fourth quarter. Strong growth in Safety and SAIS were partially offset by the impact of timing of customer orders that benefited growth earlier in the fiscal year. For the full fiscal year, Pharmaceutical Systems grew 5.3%. BD Life Sciences fourth quarter revenues increased 5.4%. Growth was driven by strength across the segment. For the full fiscal year, BD Life Sciences revenues grew 4.8%. Revenues in Diagnostic Systems grew 5.2% in the fourth quarter. Strength in core microbiology was driven by blood culture and IDAST. In addition, we saw continued strong growth in our BD MAX molecular platform. For the full fiscal year, Diagnostic Systems grew 6.4%. Preanalytical Systems growth of 5.3% in the fourth quarter was driven by strength in core products. For the full fiscal year, PAS grew 5.2%. Biosciences revenues grew 5.8% in the fourth quarter. This reflects growth in our newer research instruments such as the FACSMelody and FACSymphony as well as continued strength in research reagents. In addition, FACSLyric, our more recently launched next-generation clinical flow cytometer for HIV and leukemia and lymphoma applications, also contributed to growth in the quarter. For the full fiscal year, Biosciences grew 2.4%. This was driven by strong momentum in the second half of the year, which we expect to continue in fiscal year 2018. Moving to slide 10, I'll walk you through our geographic revenues for the fourth quarter on a comparable currency-neutral basis. U.S. revenues grew 2.1% in the fourth quarter, which includes an estimated headwind of 200 basis points from the U.S. dispensing change. BD Medical revenues grew 2.2% including an estimated headwind of 280 basis points from the dispensing change. BD Life Sciences revenues grew 2% in the U.S. For the fourth quarter, growth in BD Medical in the U.S. was driven by performance in Pharmaceutical Systems, Diabetes Care and the infusion business within MMS. Within MPS, continued strength in prefilled flush devices was offset by a tough comparison to a strong performance in the prior year across the portfolio. For the fourth quarter, BD Life Sciences growth in the U.S. reflects strength in core products in Preanalytical Systems and in Research Instruments and Reagents in Biosciences. Growth in our U.S. Diagnostics business was driven by continued strength in BD MAX, offset by a tough comparison to significant Kiestra installations in the prior year. For the full fiscal year, U.S. revenues were strong, growing 3% despite an estimated headwind of 100 basis points from the U.S. dispensing change. Moving on to International, revenues grew 6.9% in the fourth quarter. Growth of 6% in the Medical segment was driven by performance from infusion-related disposables in the MPS unit and from both the infusion and dispensing businesses in MMS. Within our international dispensing business, strength in emerging markets and strong performance in our retail business in Europe contributed to MMS growth in the quarter. Diabetes Care revenues reflect strength in emerging markets, partially offset by continued softness in Europe, as previously discussed. Growth in the Life Sciences segment of 8.3% was driven by performance across the Diagnostic Systems, Biosciences and PAS. Diagnostic Systems growth reflects strength in core microbiology including IDAST and Kiestra and in BD MAX. Biosciences revenues reflect strong sales of our newer research and clinical instruments. Growth in PAS was driven by strong demand for core products in emerging markets. For the full fiscal year, international revenues grew 6.2%. On slide 11, developed markets revenues were strong, growing 2.8% in the fourth quarter and 3.4% for the full fiscal year, despite estimated headwinds from the U.S. dispensing change of 130 basis points and 60 basis points respectively. Fourth quarter emerging markets revenue grew a strong 12.7% currency neutral, bringing our full-year growth to 10.1%, which exceeded our expectations. China growth for the fourth quarter was strong at 13.4%, bringing the total year growth to 11.6%. The fourth quarter growth rate in emerging markets reflects broad strength across both segments. By geography, greater Asia, including China and EMA grew double digits and sales in Latin America were up high-single digits. Moving on to global safety on slide 12. Fourth quarter currency-neutral sales increased 3.9% year-over-year. By geography, safety revenues in the U.S. grew 30 basis points while international sales grew 9.1% currency neutral. By segment, fourth quarter Medical safety sales grew 2.7% and Life Sciences safety sales grew 5.9%. In the U.S., growth in Preanalytical Systems and infusion disposables in MMS was offset by a tough comparison to the prior year. International performance was driven by strong growth in Pharmaceutical Systems in China and solid growth in Europe in our Medical segment and strength in China and EMA in Preanalytical Systems. Safety revenues grew 16% in emerging markets in the fourth quarter and 11.5% for the full fiscal year. Slide 13 recaps the fourth quarter income statement and highlights our currency-neutral results. As discussed, revenues grew 4.4% in the quarter on a comparable currency-neutral basis, which includes approximately 100 basis points negative impact from the U.S. dispensing change. As we move down the P&L, I would like to point out that, similar to our prior quarters, our results in the prior year period include the Respiratory Solutions business while the current period does not, as the business was divested in October 2016. Starting with gross profit, the decline of 50 basis points year-over-year includes approximately 600 basis points of negative impact from the loss of gross profit related to Respiratory Solutions divestiture and the U.S. dispensing change. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenues was 24.4%. In the fourth quarter, we incurred additional selling and shipping costs related to our efforts to scale shipments in the month of September, as previously discussed. As a result for the full year, SSG&A as a percentage of revenues was slightly above our guidance range. Accounting for the impact from the Respiratory divestiture and the U.S. dispensing change, we are pleased with the leverage we have achieved on an underlying basis, with SSG&A dollars growing slower than revenues. R&D as a percentage of revenues was 7%. The decline in R&D dollars spent year-over-year is due to the divestiture of the Respiratory Solutions business as well as the comparison to the prior year where we increased R&D spend in the fourth quarter as a result of the medical device tax suspension. Our tax rate declined to 14.6% in the quarter, resulting in a full year effective tax rate below our guidance range of 15.2%. As you are aware, we expected a lower tax rate in fiscal year 2017 as an offset to the impact of U.S. dispensing change. Looking ahead to fiscal 2018, as you will see when I take you through our adjusted EPS guidance, we expect an increase in our effective tax rate. This is largely the result of discrete items in fiscal 2017 that are not expected to recur. In the quarter, operating income grew 6.3% and adjusted earnings per share grew 13.2% compared to the prior year. Both operating income and EPS include approximately 700 basis points of negative impact from the Respiratory Solutions divestiture and the U.S. dispensing change. Turning to slide 14 and our gross profit and operating margins for the fourth quarter, as you can see, currency did not have an impact on gross profit margin or operating margin in the quarter. On a performance basis, gross profit margin improved by 100 basis points as continuous improvement initiatives, cost synergies and favorable mix which includes the positive impact of divestitures were partially offset by slight headwinds from pension and raw materials. As expected, operating margin improved significantly in the fourth quarter, increasing 180 basis points. This was largely driven by the comparison to the high level of R&D spend in the prior year. For the full year, we are extremely pleased to have delivered approximately 180 basis points of underlying margin expansion. As Vince said earlier, over a three-year period we achieved approximately 500 basis points of margin expansion. Moving to slide 15, I'd like to highlight our EPS growth which was in line with our expectations for the total year. Starting with fiscal 2016 EPS of $8.59, we are extremely pleased that we were able to deliver currency neutral EPS growth of 13.2% while overcoming notable headwinds. The strength of our performance as well as the tax benefit from stock comp accounting and other discrete items drove our ability to offset significant headwinds from the Respiratory Solutions divestiture, the U.S. dispensing change, pension and unfavorable currency. All in, we delivered earnings growth of 10.4%. Moving on to slide 17 and our full fiscal year 2018 revenue guidance for stand-alone BD, at a high-level, we expect revenue growth of 4% to 5% on a currency-neutral basis which represents strong underlying growth of 4.5% to 5.5% excluding the impact of the U.S. dispensing change. On a reported basis, revenue growth is expected to be between 5% and 6%, reflecting a currency tailwind of approximately 100 basis points. This assumes a euro to dollar exchange rate of $1.18. From a phasing perspective, as a reminder, in the first quarter we have a very tough comparison to 6.1% revenue growth in the prior year in addition to the impact from the U.S. dispensing change. Moving on to the segments, we expect BD Medical to grow between 4% and 5%, and we also expect our Life Sciences segment to grow between 4% and 5%. Revenue growth contemplates a small amount of pricing pressure. We expect revenue growth to continue to be driven by recent product launches across both segments and continued strength in both developed and emerging markets. We expect high single digit growth in emerging markets driven by a diversified base, with China growing low-double digits and continued strength in Latin America. And in terms of developed markets, we believe the stability we have seen in the market over the past 18 to 24 months will continue, yielding a growth rate of around 4% in fiscal 2018. Now moving on to slide 18 and our full fiscal year 2018 EPS guidance for stand-alone BD, in fiscal year 2018, we expect another year of very strong earnings with 15% to 16% growth on an underlying basis. This includes additional CareFusion cost synergies and aggressive continuous improvement initiatives which will help offset notable headwinds from the U.S. dispensing change and the expected increase in our effective tax rate, resulting in currency neutral earnings growth of approximately 10%. Assuming current spot rates, we expect currency will provide a tailwind in fiscal 2018, the first time in seven years, resulting in expected EPS growth of approximately 12%. Now from a phasing perspective, beyond the tough compare for revenues in the first fiscal quarter and the impact of the U.S. dispensing change, there are a few additional items to consider. The additional cost base initiatives are not expected to ramp until the second fiscal quarter and the tailwind from foreign currency is not expected to be ratable across the year, but rather disproportionately larger in the second quarter. Regarding Puerto Rico, our current fiscal 2018 revenue and EPS guidance does not contemplate any potential impact related to Hurricane Maria. We are still evaluating the impact and estimate it could be as much as $40 million to revenues, with a corresponding impact that could be as much as 1 percentage point of EPS growth. The products manufactured in our three plants in Puerto Rico represent approximately 5% to 6% of total company revenues. All three of our plants are suffering from the destruction of the infrastructure of Puerto Rico, which, as you are aware, has interrupted the supply of power, water and raw materials. Our two plants in Cayey are currently back in production. However, we are still working to scale them to full productivity. Our third plant, which is located in Juncos, experienced more damage than the plants in Cayey and is not operational today. With that said, we expect to resume production in Juncos by the end of the first quarter. While we feel good about our ability to return to full productivity during the fiscal year, this is dependent on several factors that are outside of our control. Before I move on, I'd like to echo Vince in thanking our associates in Puerto Rico, who over the last six weeks have demonstrated great dedication and perseverance. Now turning to slide 19, I'd like to walk through the balance of our guidance expectations for the full fiscal year 2018. We expect gross profit margin to be between 54% and 55%. SSG&A as a percent of sales is expected to be between 23% and 24%. We expect our R&D investment to be in line with fiscal year 2017 at 6% to 7% of revenues, as we continue to invest in new products and platforms. As a result of the items I just detailed, operating margin is expected to be between 24% and 25% of revenues, up from 22.9% in fiscal year 2017. Excluding the favorable impact of foreign currency, we expect our underlying operating margin to improve 100 basis points to 150 basis points, bringing our cumulative margin improvement over four years to 600 basis points to 650 basis points. We expect our tax rate to be between 17% and 19%. This is higher than our fiscal 2017 tax rate, which included a number of discrete items. For fiscal year 2018, we anticipate our adjusted average fully-diluted share count to be approximately 219 million shares. Cash flow is expected to remain strong with operating cash flow of about $2.9 billion in fiscal year 2018. Capital expenditures are expected to be between $800 million and $850 million. With respect to our anticipated acquisition of Bard, things are progressing well. The financial parameters we described when we announced the deal have not changed. We will provide guidance for BD plus Bard after the transaction closes. In summary, we have good momentum exiting fiscal 2017, and I'm confident that the fiscal year 2018 will be another strong year of performance. We look forward to the closing of the Bard acquisition. We believe that the combination of BD and Bard will create an even more powerful healthcare company, enhancing value for our customers, patients and shareholders globally. Now I'd like to turn the call back over to Vince, who'll provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. Moving on to slide 21, I will walk you through our updates on new product innovation and strategic and business initiatives. Starting with the new product innovations within our Medical segment, we're pleased that we will soon be able to provide sodium chloride saline to our customers through our partnership with Fresenius. As saline remains limited in supply, the addition of sodium chloride to our Medication Management portfolio will benefit our customers and, of course, their patients. Within our Diabetes Care business, as you are aware, we temporarily paused shipments of our insulin infusion sets. This was due to a moderately-higher-than-anticipated rate of complaints associated with insertion that occurred during the pilot launch. We have conducted a clinical trial to gather further insights and to ensure that patients ultimately realize the full benefits of BD FlowSmart technology. We are continuing to work closely with Medtronic toward full commercialization. In Life Sciences, while we continue to receive very positive feedback from customers on the overall benefits of our Barricor blood collection tubes, a few customers have reported issues unrelated to test results. As a result, we have voluntarily recalled Barricor in the U.S. and are actively working with the FDA to get back on the market. We anticipate relaunching in fiscal year 2018. Importantly, there is no change in the value proposition of the product. While there are delays in these two products, we're quite pleased that numerous new products that we talked with you about at our Analyst Day last November are on track and are doing quite well. These include our UltraTouch push-button blood collection set, Veritor Plus, new BD MAX assays and the new research in Clinical Instruments within Life Sciences that we talked about as well as Pyxis ES and Neopak in our Medical business, just to name a few. Within our Genomics business, we recently expanded our portfolio through the launch of BD Rhapsody, a new single cell platform for RNA expression analysis. Previously in limited release as BD Resolve, the BD Rhapsody is a complete segment of reagents, instruments and software for targeted gene expression analysis of tens of thousands of individual cells. Also in our Life Sciences business within strategic and business initiatives, we completed a small tuck-in acquisition of a leading provider of informatics software that enables BD to offer full sample to discovery flow cytometry and single cell genomics solutions. We also recently announced that Tim Ring and David Melcher will join the BD Board of Directors upon the closing of the Bard acquisition. We look forward to the experience and guidance they will bring to the new combined company. And lastly, I would like to congratulate our MMS team on the one-millionth installation of the Alaris Pump module. The Alaris Pump is helping health care providers to safely administer medication to their patients, reduce medication errors and improve patient safety. Moving on to our operational efficiency update on slide 22, we continue to make progress with our CareFusion cost synergy capture. Through the end of fiscal year 2017, we've achieved $250 million in annualized synergies. We expect approximately $350 million in total cost synergies related to the CareFusion acquisition as we exit fiscal year 2018. Turning to operating margin expansion, as you can see, we continue to drive significant operating margin expansion over a multiyear period. The consistent performance of our businesses combined with operating efficiencies, cost leverage and cost synergy capture is driving continued underlying operating margin expansion. Over the three-year period through fiscal year 2017, we delivered approximately 500 basis points of cumulative margin expansion. Moving on to slide 23, I'd like to reiterate the key messages from our presentation today. First, our core remains strong across both segments. We're pleased with our fiscal 2017 performance and our ability to offset notable headwinds from the Respiratory divestiture, the U.S. dispensing change, and foreign currency headwinds. Second, we're extremely pleased with the excellent progress we continue to make with our CareFusion synergies and our ability to drive continued margin expansion. Third, we continue to make excellent progress executing against our integration plan and towards closing the Bard transaction. And finally, we look to fiscal year 2018 and beyond with confidence as we continue to pursue our mission to address some of the world's most pressing health care needs and advance the world of health. So thank you. We will now open the call to questions.
Operator:
Thank you. Our first question comes from the line of David Lewis with Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. Vince and Chris, I'll give you kind of a two-part question, all really focused on top line growth fiscal 2018. So Vince, the 4.5% to 5.5% underlying growth for 2018 is obviously better than most investors anticipated. It's actually much more consistent with the outlook you provided in November at the November 16 Analyst Day where you talked about 2018 acceleration above that 5%. So I know you talked about some of the drivers. Bf you just think about the pipeline, Vince, that you talked about in November of 2016 versus where you sit now heading into 2018, I wonder if you could bridge that gap and provide people the sense of why you're so confident that 5%-plus number is achievable. And then, Chris, just to avoid some of the communication dynamics across quarters for this year, obviously first quarter's going to be the weakest. As we move forward to quarters two through four, should we think about stable underlying growth in two, three and four? Or is the back half going to be more polarized than the first half excluding that first quarter? Just wanted to get a sense of after that first quarter how people should think about the modeling. Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. So, David, at a very high level I think what we've seen is strong growth in developed markets, driven by new products and then improving growth in the emerging markets. Especially if I go back a year, it's really China has changed. And if you look at the last four quarters, it improved every single quarter. The biggest change there of course was the rebound on the Life Sciences side, but you also started to see some of the synergies that we were getting from CareFusion as Rowa (39:27) has started to take off and some of the disposable growth has been quite good. The other thing that has happened from an environmental standpoint is our sales growth in EMA has rebounded. And so that started to help us. You especially saw that in this quarter, and we expect that to continue. So from a geography standpoint, we are well balanced. From a new product standpoint, first, I would point out what's happened in Biosciences and the really nice turnaround that you have seen there, driven by all the new product launches that I listed
Christopher R. Reidy - Becton, Dickinson & Co.:
So to the second part of that question on the phasing as we look into 2018. As we said, the toughest compare is in the first quarter, as you know. Second quarter stabilizes a little bit. You still got the overhang from the 100 basis points of dispensing and that stabilizes a little bit. And then you make up for the first quarter for the most part in the second half of the year. Remember, the third quarter will be a bit of an easier compare because we had a low growth quarter this year in the third quarter. And then fourth quarter is pretty much an average compare. So think about it as a tough compare first quarter, which drives a lower than average first half, made up for in the second half.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Great. Thanks so much.
Operator:
Our next question comes from the line of Mike Weinstein with J.P. Morgan.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Mike.
Christopher R. Reidy - Becton, Dickinson & Co.:
Morning.
Michael Weinstein - JPMorgan Securities LLC:
Morning. I'm going to try and sneak in three questions if I can, so here we go, here. (43:00). Number one, I know you're not updating on Bard today, but have your thoughts on year one accretion from Bard changed at all since the time of the deal announcement? Number two, I was interested in just kind of the update you were running through there on some of the pipeline. One product you didn't touch on was the type 2 basal-bolus pump. Can you update us on the status of the development and launch plans there? And then third and last, I promise, is China. And as you're aware, China is moving towards national reimbursement for some devices and really started, what I would call, at the high end of the medical-technology curve. Can you just give us your thoughts on where China is headed and as you think about your exposure or lack of exposure to your business as well as Bard's business, because obviously China has been a big growth driver for you and for Bard over the last several years?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Since they were such good questions, we'll allow you to do three, okay?
Michael Weinstein - JPMorgan Securities LLC:
Much appreciated.
Christopher R. Reidy - Becton, Dickinson & Co.:
And I'll take the first one on the year one accretion. So as we said in our prepared remarks, we feel good about the Bard transaction and the financial parameters are in line with what we had articulated at the time of the deal announcement. Specifically, related to year one accretion, we had said low-single-digit accretion and that still stands. Bear in mind that was for a full year, we'll probably get nine months, but we still see low-single digit per share accretion.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. On the pump, Tom, you want to comment on that?
Thomas Polen - Becton, Dickinson & Co.:
Hi, Mike. This is Tom. Yes. The type 2 patch pump continues to progress very well in our funnel. One thing is you do see if you look in the appendix that we had said before we were expecting to launch that at the very end of FY 2018. Based on some learnings actually from other product launches, we did add in an additional patient clinical trial there, and so we now expect that to launch in 2019. So we don't see revenue in our guidance within the Diabetes Care business for 2018, but the project's progressing very well from a development perspective. We actually just finished final acceptance testing on the manufacturing line this week and are installing that in our plant in Ireland this month.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. And I'll take China. For us, Mike, the issue that you mentioned is not really all that relevant. What we've been working on has been the two invoice evolution in China in two provinces. And we've successfully implemented a program within those two provinces, and net-net it's neutral to positive for us, the way that we have done this. And so we think we're in very good shape if that moves ahead. They have slowed it down, and so we don't see a big impact in this year. Over time, I think they will come back to it. So that piece of it is fine, and we think we'll be able to apply it on the Bard side as well as we move forward. In terms of the pricing, we've been very effective in getting the right pricing in the Green Book. And so as I look out over the next couple of years, I don't see a big issue, Mike.
Michael Weinstein - JPMorgan Securities LLC:
I appreciate it. Thanks for taking the questions, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Operator:
Our next question comes from the line of Brian Weinstein with William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Hey, guys. Thanks for taking the questions.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure, Brian.
Brian D. Weinstein - William Blair & Co. LLC:
You guys talked about getting some benefit from the end-to-end solutions in MMS. I was hoping you guys could expand on that a little bit and talk about how customers are receiving kind of the entire solution at this point and talk specifically, if you could, about some share gains that you are expecting within the various segments there.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Tom will take that.
Thomas Polen - Becton, Dickinson & Co.:
Hey, Brian. This is Tom. So I think if you look at obviously MMS's performance in the quarter, which was 6.7%, and that includes a 600 basis points of headwind just from the accounting change, so if you take that into account, it's north of 10%. That's driven, as you mentioned, by very strong growth on both the dispensing and the infusion side. We do expect our infusion category share to have gone up between 1% and 2% this year, in line with prior year, so we are continuing very good progress there. As you heard from Vince earlier, we've actually just installed our one-millionth Alaris Pump this past quarter, which was a major milestone for us. And on the dispensing side, several years ago we were talking about the stabilization of Pyxis ES. At this point, Pyxis ES is really humming. We've got over 1,700 sites live now across the U.S., and we feel very good. We actually had a record level of new business closes on Pyxis ES since the platform has been in the marketplace and certainly a record level for Pyxis in the last five or six years. So we're feeling good about that. The other thing is one of the metrics that we look at is pull-through of other products, so how often are customers choosing to buy Pyxis plus Alaris plus our software solutions, products like Cato and Pharmogistics? And as we look at those metrics, we see ratable quarter-on-quarter improvement in the value of people buying that end-to-end offering. And so all of that gives us confidence as we go into FY 2018 that that solution is working. We'll be unveiling some new particularly informatics solutions at the ASHP coming up in December that are just going to further the offering that we have in that space.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So hopefully we'll see you there, Brian.
Thomas Polen - Becton, Dickinson & Co.:
Yes.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Next question, please.
Operator:
Yes, sir. And your next question comes from the line of Larry Biegelsen with Wells Fargo.
Larry Biegelsen - Wells Fargo Securities LLC:
Good morning, guys. Thanks for taking the question. First, just to clarify the low-single digit accretion in 2018, should we prorate that for nine months? And then two product related questions. Tom, earlier this year you talked about an interim analysis for the Lutonix (49:34) trial. Should we still expect that before the end of 2017? And are you still confident in that indication? And then second, the flu season is expected to be severe this year. Can you talk about your exposure to the flu and how a severe flu season could impact BD? Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
So on the year one accretion, as I said, the most important thing is all the financial parameters on this deal are consistent with what we had said. We did give guidance for the full year, to your point, but the interesting thing is it's low-single digits. It's low-single digits whether you do it over a year or nine months, and so you have the nine months. We also have the divestiture of what we have to do on the needle biopsy, but we'll give more precise information on that along with multiple other parameters and inputs related to the transaction when we give the full guidance for the transaction in February. But it's consistent low-single digits.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So from a flu perspective, we budget kind of an average flu season, and so if it ends up in North America being stronger, which is where most of the market is, then it would drive us more towards our upper end of our range. That would be one of the positive factors. There has been some strong flu in other parts of the world, so we'll see how that plays out. Our expectation is that you budget that in the second quarter of the year not the first quarter. Last year, it was a very unusual year and came in in the first quarter. So that's how we're thinking about it. We'll see.
Thomas Polen - Becton, Dickinson & Co.:
And Larry, this is Tom. On your question on Lutonix, no change from obviously what Bard management guidance was prior on the timing of that. I'd say we continue to be optimistic around the ability to get that claim over the longer term, though. So no change versus what they had shared previously.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Right. Okay. Thanks very much. Next question, please?
Operator:
Our next question comes from the line of Isaac Ro with Goldman Sachs.
Isaac Ro - Goldman Sachs & Co. LLC:
Good morning, guys. Thank you. I had a question on the Diagnostics part of the business, in particular the outlook here as we digest the PAMA legislation. I know it's early, but it does seem like the custom Medicare reimbursement are going to have a pretty protracted impact on a variety of labs that you guys serve. So I'm curious how you're game planning the way in which they spend, how that's going to change, and how you guys can make sure that you continue to get your share of the business?
Alberto Mas - Becton, Dickinson & Co.:
Yes. Hi. This is Alberto. The PAMA proposals on CMS – first of all, I want to mention that they're in the comment period. They're not definitive. And we have commented in the direction of supporting the AdvaMed rationale, which is that probably they took a relatively small sample of labs, mostly bigger labs, and we are proposing that we take a little bit of a timeout and extend that polling of pricing to more smaller, independent labs. But just to put it into context, obviously there's – most of our business is private insurance. This only affects the lab schedule. So we think that the direct impact potential in our businesses of this PAMA legislation is at worst, if you like, it's in the single digits that we're talking about. Single digit millions of dollars, and probably mostly on the low end because the amount of our business affected by this is relatively small and it's also capped by the proposal any one year in terms of how much the impact is.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. So not a big impact for us.
Alberto Mas - Becton, Dickinson & Co.:
No.
Vincent A. Forlenza - Becton, Dickinson & Co.:
But thanks for the question.
Operator:
Our next question comes from the line of Bill Quirk with Piper Jaffray.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Bill. Are you there, Bill?
William R. Quirk - Piper Jaffray & Co.:
Yes. Hello. Can you hear me?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes. We can hear you now.
William R. Quirk - Piper Jaffray & Co.:
Good morning. Sorry about that. User error, I guess, on this end. So first off, Vince or Tom, can you talk a little bit about the ongoing adoption of new guidelines around handling certain oncology drugs and maybe how that might flow through to the domestic Medical business? And then I have a follow-up as well.
Thomas Polen - Becton, Dickinson & Co.:
Sure. This is Tom, Bill. So obviously, we have been part of helping to shape those legislations around closed system transfer devices and the adoption of those. We obviously have our product PhaSeal, which is growing very nicely, at or near double digits, and we expect that trend to continue as that legislation continues to expand to new states. In both the U.S. but also ex-U.S., we see very, very strong growth around the world for that platform. So I'd say no fundamental inflection difference that we expect in 2018 or 2019 but continuing to grow very strongly as it has been in recent years.
William R. Quirk - Piper Jaffray & Co.:
Okay. Great. Thanks. And then, Chris, just a housekeeping question. The fourth quarter adjusted earnings number, are you backing out the Bard debt interest expense as well as the cash interest income? It just wasn't clear when we were looking through the adjustment.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes, and that's consistent with what we did last quarter as well.
William R. Quirk - Piper Jaffray & Co.:
Okay. Perfect. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Next question, please?
Operator:
Our next question comes from the line of Derik de Bruin with Bank of America.
Derik de Bruin - Bank of America Merrill Lynch:
Hi. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Derik de Bruin - Bank of America Merrill Lynch:
Hey. Just a couple of quick ones. One, and the impact to Bard from Puerto Rico and just some of their operations, just an update if there's going to be any read-through on that one. And then I just wanted to follow up on – just going back to your Analyst Day last year, just wanted to know if there's an update on your next-gen molecular system that you have in the works.
Christopher R. Reidy - Becton, Dickinson & Co.:
So on the first piece, we really can't say much about Bard at this point. But what we would say is they were fairly straightforward in the impact from Puerto Rico on their side. They did have an impact in their last quarter, and they anticipate having an impact in the next quarter. But they're back up operating, much like our Cayey plants and are subject to the same power issues that we are. But they don't have the same level of issue that we have at our Juncos plant. They're more like our Cayey plants, which are further along.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Which are scaling up. Okay. And then Alberto will brief you on next gen. Thank you.
Alberto Mas - Becton, Dickinson & Co.:
Yes. On the next gen molecular, we are – the program progresses, is continuing. We are very focused on a very reliable instrument and ultimately that's going to be guiding our launch cadence. But the program is ongoing and tracking as expected. One thing that's worth mentioning as well is that we have filed for HPV with the FDA a few months ago, and we expect approval of that towards the end of this calendar year. So December, January type.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. So making good progress.
Alberto Mas - Becton, Dickinson & Co.:
Good progress, yes.
Vincent A. Forlenza - Becton, Dickinson & Co.:
End of the day. Okay. Thanks very much. Next question?
Operator:
Our final question comes from the line of Doug Schenkel with Cowen & Company.
Doug Schenkel - Cowen & Co. LLC:
Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Doug Schenkel - Cowen & Co. LLC:
I think just a couple quick questions for Chris. It doesn't appear 2018 stand-alone free cash flow guidance assumes much of a year-over-year increase. Could you just walk us through why that is? And then second question for Chris. You noted you incurred additional selling and shipping cost in Q4. I'm just wondering if you'd quantify that, so we could get to what margins would've been excluding those? And, kind of along the same lines, you stepped up R&D in a big way sequentially, Q3 to Q4. Just wondered if you'd comment on what drove that. Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So on cash, we actually do have a nice step-up and we've seen that step-up over the last couple years. We're going from $2.8 billion to $2.9 billion. Most of that is the flow-through of net income. There is a payment of nearly $100 million related to pension payments, that kind of thing, that will have been made. You'll see that in the 10-K when we file, but a nice drop-through from net income. SSG&A, you're right. We did have some additional costs to drive the logistic issues, and we thought that was the right thing to do to drive the revenue and keep our customers happy, and so there was a step-up there. All in, with that, there were about $20 million or so of cost. And the R&D question that you asked was?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Just sequentially, what drove it up quarter-on-quarter?
Christopher R. Reidy - Becton, Dickinson & Co.:
Well, you have the fact that we're scaling, and it's more of the growth is relating to the spending in the prior year, which was lumpy, which had to do with the repeal of the medical device tax.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Device tax. Yes. So it wasn't starting any new major programs or anything. We're really focused on delivering what we talked to you about at Analyst Day. And, of course, the other thing I would mention coming back to the cost question in the fourth quarter was we overcame $5 million of incremental costs in Puerto Rico, and you saw that on that line, too. So that's things like write-offs...
Christopher R. Reidy - Becton, Dickinson & Co.:
... of inventory and the like that occurred.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Exactly.
Christopher R. Reidy - Becton, Dickinson & Co.:
So we did overcome that as well.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Okay?
Operator:
At this time, there are no further questions. I will now turn the call back to Vince Forlenza for closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thank you very much, operator. So just a couple of thoughts. First, we delivered on our commitments this year with really strong performance demonstrating the consistent and I'd call it reliable nature of our business despite various headwinds throughout the year, which we detailed on the call. Our core business remains strong, and we're confident in our outlook for next year. And, lastly, of course, we look forward to the upcoming close of the Bard transaction and the opportunity to create meaningful, long-term value and continue to improve healthcare globally. So thank you very much for your participation today.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co.
Analysts:
Michael Weinstein - JPMorgan Securities LLC David Ryan Lewis - Morgan Stanley & Co. LLC Isaac Ro - Goldman Sachs & Co. LLC Rick Wise - Stifel, Nicolaus & Co., Inc. Vijay Kumar - Evercore ISI Doug Schenkel - Cowen & Co. LLC Matthew Taylor - Barclays Capital, Inc. Richard Newitter - Leerink Partners LLC Derik de Bruin - Bank of America Merrill Lynch
Operator:
Hello and welcome to BD's Third Fiscal Quarter 2017 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 10th, 2017, on the Investor's page of the bd.com website or by phone at 800-585-8367 for domestic, and area code 404-537-3406 for international calls using confirmation number 50820826. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our third fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. The third quarter comparable revenue growth rates and fiscal year 2017 comparable revenue guidance provided today excludes the revenues of divestitures, most notably, the Respiratory Solutions business that was divested in October of 2016, just after our 2016 fiscal year-end. The details of purchase accounting and other smaller adjustments, and the comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the investor relations slides. As a result of previously communicated changes related to the transformation of our U.S. dispensing business model, we recorded a one-time non-cash charge of approximately $495 million net of tax during the third fiscal quarter of 2017. We continue to expect the impact of the change to be a headwind of approximately $50 million to $60 million to revenues, and 2% to 3% to EPS in fiscal year 2017. The impact to revenues and EPS is ratable across the third and fourth fiscal quarters of 2017. As a reminder, this change results in a difficult comparison which is limited to the second half of this fiscal year and the first half of fiscal year 2018, but it creates a more predictable revenue stream going forward. More complete details can be found in our 10Q, which will be filed later today. Please note that all fiscal year 2017 guidance provided is on a BD stand-alone basis. Regarding the Bard transaction, all strategic and financial parameters remain unchanged from the deal announcement. After closing, we will provide more explicit guidance for the combined company. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administration Officer; Tom Polen, President; and Alberto Mas, Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. As you read in this morning's press release, we are pleased with our performance this quarter. Our core remains strong and we continued to deliver consistent solid results. As we take you through the results, there are a number of puts and takes within the year, but the sum of it is that our performance is strong. Year-to-date, adjusting for the Respiratory Solutions divestiture, we are growing 4.5% on the top line, with high-single digit operating income growth and strong mid-teens EPS growth as we are overcoming the impact of the U.S. dispensing change with strong underlying performance. In the quarter, China and the broader emerging markets posted strong double-digit growth reflecting our momentum in these important markets. Total revenue growth was slightly lower than expected, which Chris will touch upon in just a few moments. We continue to make excellent progress and are on track to achieve our CareFusion cost and revenue synergies. Our fiscal 2017 revenue synergies are being driven by international registrations of consumable products in MPS, along with dispensing in MMS. We now have 225 approved or in-process product registrations in new markets, with an ultimate target of over 250 registrations. The strategic transformation of the U.S. dispensing business model that we communicated last quarter has been successfully implemented, and customer reception has been overwhelmingly positive. As we look to the total year, we are very confident in our outlook. The strength of our year-to-date performance allows us to reaffirm our currency-neutral revenue and earnings guidance. Also, as a result of favorable foreign currency movement, we are raising our adjusted earnings guidance. Turning to slide 5, our pending acquisition of C.R. Bard remains on track, with an expected closing date in the fourth calendar quarter of 2017, subject to regulatory and Bard shareholder approvals. Upon announcement, we communicated a fall 2017 closing timeframe. That remains unchanged, and our continued expectation is that we will close in the November to December 2017 timeframe. Overall, things are progressing quite nicely. We are also pleased that Bard's business performance to date is strong and in-line with our expectations, as evidenced by their recently-recorded quarterly earnings. From an integration standpoint, we should receive regulatory approval sooner – if we receive regulatory approval sooner, we'll be ready. We have been able to leverage our experience from the CareFusion acquisition to lay the plans for another successful integration, and we have made excellent progress to date. We've created a detailed execution plan that builds upon our CareFusion experience, and are very pleased that we are well ahead of where we were at this time with CareFusion. In terms of talent, we have retained key Bard leadership, including John Groetelaars, who will serve as President of the new Interventional segment; John DeFord, who has been named SVP Research and Development for the Interventional segment; and Betty Larson, who has been named SVP, Human Resources for the new segment. In addition, John Groetelaars' full leadership team has been established, with all regional and business presidents in place. We're thrilled with the number of exceptional Bard leaders dedicated to making the combined company a success as we move forward together. We will share more information about the new company structure as we progress towards the closing. As you are aware, shortly after announcing the Bard acquisition, we went to market and successfully issued approximately $5 billion dollars in common and preferred shares. We also launched nearly $10 billion dollars in senior notes. All offerings were over-subscribed by a multiple of over three times. As a combined company, we believe we will further accelerate and broaden our strategy, create new growth opportunities for both companies, and deliver meaningful long-term value for shareholders. Together, we will be uniquely positioned to deliver innovative healthcare solutions that improve both the process of care and the treatment of disease. So now I'll turn things over to Chris for a more detailed discussion of our third quarter financial performance and our fiscal year 2017 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning everyone. Like Vince, I'm also pleased by the progress we are making with our integration planning for the Bard acquisition, and the value the combination will create for our customers, patients, and shareholders globally. Moving on to slide 7, I'll review our third quarter revenue and EPS results, which I'll speak to on a currency-neutral basis. Total third quarter revenues of approximately $3 billion dollars grew 2.4% on a comparable basis, which was slightly below our expectations. We estimate that the U.S. dispensing change lowered total company revenue growth by approximately 100 basis points, in line with our previously-communicated expectations. As Vince mentioned, our underlying performance is strong. Accounting for the dispensing change and the timing of items within the year, our third quarter results would have been in the low end of our full-year guidance range of 4.5% to 5%. I'll provide more color on revenue growth in the quarter in a moment, when I take you through the results by segment and geography. Adjusted EPS of $2.46 grew 7.7%. As expected, EPS was impacted by the divestiture of the Respiratory Solutions business, as well as the U.S. Dispensing business model change, which resulted in a combined headwind of approximately 600 basis points to EPS growth. We're very pleased with our performance year-to-date. Revenue growth is strong at 4.5%. Accounting for the approximate 40-basis-point impact from the U.S. dispensing change, we estimate that the revenue growth year-to-date would have been near the high end of our 4.5%-to-5% guidance range. Year-to-date EPS growth of 13.1% reflects our ability to grow over the dilution from the Respiratory divestiture and the U.S. dispensing change. Moving on to slide 8, I'll review our revenue growth by segment on a comparable currency-neutral basis. In the quarter, pricing declined about 20 basis points. BD Medical third quarter revenues increased 1.3%. Revenues in the Medical segment was slightly below our expectations in the quarter. Year-to-date, Medical revenues grew a strong 4.5%, which includes an estimated 50-basis-point headwind from the U.S. Dispensing change. Medication and Procedural Solutions, or MPS, growth was 3.7%, which reflects strength in infusion-related disposables and infection prevention. Growth in MPS in the U.S. was below our expectations, due to the normalization of inventory levels across several major distributors. Revenues in Medication Management Solutions, or MMS, declined 4.2%. We estimate that the U.S. dispensing change lowered MMS revenue growth by approximately 550 basis points. MMS revenue growth was also impacted by strong capital insulations in dispensing in the first half of the fiscal year, as previously communicated. In addition, within our International Infusion business, certain customer orders planned for the third quarter are now expected to occur in the fourth fiscal quarter. On an underlying basis that accounts for these items, we estimate that MMS would have grown in the mid-single digits. We continue to be pleased as we gain momentum in the market in our MMS business. Diabetes Care revenue growth of 2.7% was driven by 4.2% growth in the U.S. and double-digit growth in emerging markets. International growth was impacted by some softness in Europe, primarily in the U.K., where we are seeing increasing pressure from government payers as part of austerity measures. Pharmaceutical Systems revenues grew 3.9%. Results were impacted by the timing of customer orders that benefited growth in the first quarter. Year-to-date, Pharmaceutical Systems grew 6.1%. BD Life Sciences third quarter revenues grew – increased 4.8%. Growth was driven by strong performance in Biosciences and solid growth in Diagnostic Systems and Preanalytical Systems. Revenues in Diagnostics Systems grew 3.8%. Strength in Core Microbiology was driven by blood culture and IDAST partially offset by the timing of BD Kiestra installations which we expect to occur in the fourth quarter. In addition, we saw strong accelerated growth in our BD MAX molecular platform driven by the recent introduction of new enteric's and women's health assays. Preanalytical Systems growth of 3.9% was driven by strength in wing sets, including the recently-introduced BD UltraTouch. Biosciences revenues grew a strong 7.1%. This reflects continued strength in research reagents driven by our Sirigen dyes and growth from new recently-launched research instruments such as the FACSMelody. Moving on to slide nine I'll walk you through our geographic revenues for the third quarter on a comparable currency-neutral basis. U.S. growth was about flat with BD Life Sciences growing at 5.2% and BD Medical declining 1.3%. We estimate the U.S. dispensing change lowered BD Medical U.S. revenue growth by approximately 270 basis points and total company U.S. growth by approximately 200 basis points. Performance in BD Medical in the U.S. reflects growth in the MPS and Diabetes Care units. This growth was offset by the timing and geography of orders in Pharmaceutical Systems and the U.S. dispensing change. Performance in the Medication Management Solution unit also reflects the timing of capital placements that occurred earlier in the fiscal year, revenues in MPS were driven by strength across a wide range of infusion disposables and infection prevention, partially offset by the normalization of inventory levels. BD Life Sciences growth reflects strong performance in Biosciences and Preanalytical Systems. Growth in our U.S. Diagnostics business was driven by strong core Microbiology and BD MAX partially offset by the timing of revenues in some platforms. Revenues in Preanalytical Systems were driven by growth in wing sets and also reflect strong performance across all product platforms. Revenues in our Biosciences business in the U.S. were driven by strength in research reagents and growth from research instruments such as the FACSMelody and the FACSymphony. Moving on to International, revenues grew 4.7%. The Medical segment grew 4.9%. Growth was driven by customer ordering patterns in Pharmaceutical Systems and by performance from infusion-related disposables in the MPS business. Diabetes care revenues reflect strength in emerging markets partially offset by softness in Europe, as previously discussed. Performance in MMS reflects the impact of strong capital insulations in the first half of the fiscal year as well as certain customer orders planned for the third quarter within our infusion business that are now expected to occur in the fourth fiscal quarter. Growth in the Life Sciences segment of 4.4% was driven by performance in Diagnostic Systems and Biosciences. The Diagnostic Systems growth reflects strong sales in Core Microbiology including IDAST where we continue to see demand from the recently-launched Phoenix M50 and strength in BD MAX. Biosciences revenues reflect strong research instrument sales that partially benefited from an easy comparison due to the prior-year funding delays in certain geographies. On slide 10, developed markets revenues grew 0.9% and emerging markets revenues grew 10.9%. We estimate the U.S. dispensing change lowered developed markets revenue growth by approximately 130 basis points. The third quarter growth rate in emerging markets reflects double-digit growth across the Medical segment and also in Diagnostic Systems. By geography, China, greater Asia and EMA grew double-digits and sales in Eastern Europe and Latin America were up high-single digits. China growth for the third quarter was strong at 12%. Revenue growth was driven by continued strong demand for consumables in both segments as well as the Phoenix M50 and MALDI-IDAST instruments and diagnostic systems, and research instruments in Biosciences. For the total year, we continue to expect China to grow in the low double-digit range. With year-to-date growth of 9.1%, we are confident in our high single-digit emerging market growth outlook for the full fiscal year. Now, moving on to Global Safety on slide 11. Currency-neutral sales were flat year-over-year. Tough comparisons to the prior year in both segments and across all geographies were the primary driver of lower Safety growth across the portfolio. By geography, Safety revenues in the U.S. grew 1.5% and international sales declined 2% currency-neutral. Emerging Market Safety revenues were about flat due to a tough comparison to the prior year in which EM Safety grew approximately 20%. By segment, Medical Safety sales declined 2.1% and Life Sciences grew 3.7%. In addition to the tough comparisons to the prior year, U.S. and Medical Safety growth this quarter was impacted by distributor inventory levels in MPS as discussed earlier. International and Medical growth were also impacted by customer orders, planned for the third quarter within our infusion business that are now expected to occur in the fourth fiscal quarter as mentioned previously. Slide 12 recaps the third quarter income statement and highlights our currency-neutral results. As discussed, revenues grew 2.4% in the quarter on a comparable currency-neutral basis, including approximately 100 basis points negative impact from the U.S. dispensing change. As we move down the P&L, I'd like to point out that similar to prior quarters our results in the prior-year period include the Respiratory Solutions business, while the current period does not as the business was divested in October of 2016. Starting with gross profit, the decline of 1.3% year-over-year reflects the loss of gross profit from the Respiratory Solutions business and the U.S. dispensing business model change. On a comparable basis that accounts for these items, gross profit would have grown over 100 basis points faster than revenue growth. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenues was 23.7%, and we are very pleased with the leverage we are getting year-to-date. R&D as a percentage of revenues was 6.1% as we continue to invest in innovation to drive future growth. The decline in R&D spending year-over-year is due to the divestiture of Respiratory Solutions business, as well as the comparison to prior year where we ramped R&D spend in the third quarter as a result of the medical device tax suspension. Our tax rate declined to 16.5% in the quarter, which is in line with our full-year guidance. In the quarter, operating income was flat and adjusted earnings per share grew 7.7% compared to the prior year. Both operating income and EPS include 600 basis points of negative impact from the Respiratory Solutions divestiture and the U.S. dispensing change. Now, turning to slide 13 and our gross profit and operating margins for the third quarter. On a performance basis, gross profit margin improved by 150 basis points as continuous improvement initiatives, cost synergies and favorable mix, which includes the positive impact of divestitures, were partially offset by a slight decline in pricing. On an operating margin basis, we delivered 100 basis points of margin expansion. Year-to-date, we have achieved approximately 160 basis points of underlying margin expansion. We expect the fourth quarter margin performance to significantly improve, largely driven by the comparison to the high level of R&D spend in the prior year. We remain confident in our ability to drive 200 to 225 basis points of margin expansion for fiscal year 2017. Moving on to slide 15 and our full fiscal year 2017 EPS guidance. We are particularly pleased that the strength of our performance year-to-date is driving our ability to offset headwinds from the Respiratory Solutions divestiture, the U.S. dispensing change, and FX pressure. As a result, we are reaffirming our full-year fiscal 2017 currency-neutral adjusted EPS guidance of $9.70 to $9.80, which represents underlying growth of 15% to 17% and a 2% to 3% headwind from the U.S. dispensing change. As you're aware, foreign exchange rates have moved since we last provided guidance in May, and the foreign currency headwind has moderated slightly with one quarter to go. As such, we are raising our adjusted EPS guidance to $9.42 to $9.47. Our guidance assumes a euro-to-dollar exchange rate of $1.15. Turning to slide 16, I'd like to walk through the balance of our guidance expectations for the full fiscal year 2017. As we discussed, there are a number of puts and takes within the year, but our underlying performance is strong. Despite a headwind of approximately 50 basis points from the U.S. dispensing change, we continue to expect total company revenue growth of 4.5% to 5% on a comparable currency-neutral basis. This was comprised of growth of 4.5% to 5% in BD Medical and 4% to 5% in Life Sciences. Based on our current view of the environment, we continue to expect a small amount of pricing pressure for the year. All other P&L guidance from May remains unchanged. Now I'd like to turn the call back over to Vince, who will provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you Chris. Moving on to slide 18, I will walk you through our updates on new product innovation and strategic and business initiatives. Starting with the new production innovations within our Life Science business, we continued to expand the BD MAX system menu of unique, clinically-relevant panels. We recently received 510(k) clearance from the U.S. FDA for our newly-developed molecular test for detecting harmful intestinal bacteria. The BD MAX Extended Enteric Bacterial Panel is the latest offering in the suite of BD MAX Enteric assays. We also recently received 510(k) clearance from the U.S. FDA for the BD FACSLyric flow cytometer system. The BD FACSLyric system strengthens BD's portfolio of clinical flow cytometry solutions available in the U.S. with an easy-to-use in vitro diagnostic system for use with assays for immunological assessment of individuals and patients having or suspected of having immune deficiency. Within strategic and business initiatives, we recently released our 2016 sustainability report. One full year after announcing our 2020 sustainability goals, we are already making notable progress across our four focus areas of innovation, access, efficiency and empowerment. We believe that aligning our relevant environmental, social and governance factors with our capabilities will help BD continue to generate differentiated results for all of our stakeholders from shareholders to society. Moving on to our business update on slide 19. We continued to make progress with our cost synergy capture through our G&A functional transformation. We continued to remain focused on our functional transformations as we leverage our shared service centers and continued to build out our Centers of Excellence. In addition, our manufacturing-related synergies remain on track and we continue to expect the majority of these to be achieved in fiscal year 2018. We also continue to expect $325 million to $350 million in total cost synergies related to the CareFusion acquisition as we exit fiscal year 2018. Turning to operating margin expansion. As you can see, we continue to drive significant operating margin expansion over a multi-year period. The consistent performance of our businesses, combined with operating efficiencies, cost leverage, and cost synergy capture, is driving continued underlying operating margin expansion. We continue to expect to deliver over 500 basis points of cumulative margin expansion over the three-year period through fiscal year 2017. Moving on to slide 20, I would like to reiterate the key messages from our presentation today. First, while there were some timing items within the year that impacted the quarter, our core business remains strong across both segments. We're pleased with our continued solid performance year-to-date and our ability to drive performance to offset divestitures, the U.S. dispensing change, and foreign-currency headwinds year-to-date. Second, our operating performance, cost leverage, and cost synergy capture continued to generate operating margin improvement and drive double-digit earnings growth. Third, as we look to the total year, we're confident in our increased outlook for the full fiscal year. Finally, we're very excited about the powerful combination of BD and Bard, and our ability to deliver innovative solutions that position us to improve both the process of care and the treatment of disease. We're very pleased with the excellent progress we are making with the Bard integration, and look forward to the future with confidence. Thank you. We will now open the call to questions.
Operator:
The floor is now open for your questions. Our first question is coming from the line of Mike Weinstein with JPMorgan.
Michael Weinstein - JPMorgan Securities LLC:
Thank you, and good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, Mike.
Michael Weinstein - JPMorgan Securities LLC:
Chris, could you start by maybe providing us a bit of a bridge for this quarter? It's clear from your commentary that there were a number of timing items that impacted the organic performance this quarter, some of which you called as effectively timing of tenders, more contracts falling from the third quarter to fourth quarter. Could you just call those out in the different businesses and what the impact was, and how much of that we will see recaptured in 4Q?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure, Mike, be happy to do that. So, if you think about the 2.4%, the underlying growth is 4.5%, and the way to get there is about 100 basis points related to the U.S. dispensing business we had articulated on the last call. Then we had timing factors. If you think about the first half of this year, we were running 5.6% year-to-date, and so we said that wasn't indicative. There was a lot of timing in there, and what was in there, particularly was, in MMS, they had a very strong first half, and so did Pharm Systems. Pharm systems grew over 7% in the first half, and we knew that is a lumpy business. Then on top of that, we saw some timing this quarter. In MMS International, we saw some orders that we expected to see in the third quarter that we now expect to see in the fourth quarter. And there was some Kiestra installations that moved from the third quarter to the fourth quarter. So when you normalize for all those items, you get to the 4.5% underlying growth. Now we did say we saw some softness in MPS related to normalization of inventory levels and a little bit of softness in Diabetes care in the U.K. But if you added those back, that would have brought us more to the 5% kind of level in the quarter. So that's where we saw a little bit of softness, going from 5% down to 4.5%.
Michael Weinstein - JPMorgan Securities LLC:
And do you think, do you have a read on whether inventory levels are now at an appropriate level, or whether you see any bounce back in the fourth quarter? And then, can you just clarify maybe, just so we're all on the same page, what you're implying for fourth quarter organic growth?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So, since we're at 4.5% year-to-date through the third quarter, we're implying in the 4.5% kind of range for the fourth quarter, and we do think that the inventory levels was a one-time adjustment within the third quarter, so we don't expect to see any hangover from that in the fourth quarter. We do see emerging market strength across the board. If you look at what we did in emerging markets this quarter, 9% year-to-date, 11% in the quarter, that's the best quarter in two years. China grew 12%, 11% year-to-date. So we're seeing – emerging market growth is very strong, so we see that continuing. Life Sciences, we see strength across (31:26 – 31:31) quarter bounce back. Until (31:33) we see strength in the fourth quarter, we see Diabetes Care rebounding, primarily driven by the U.S., as we do think that the U.K. pressure will continue. MMS has the International Q3/Q4 timing, so we'll get a little benefit from that. MPS will actually have a tough compare in the fourth quarter, but we already had that baked in to our guidance. So that's how we get to a good solid fourth quarter, and to the 4.5% to 5% for the year.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So then, Chris, if you take that and you add back in the dispensing, you get up really to 5%.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes. So that's why, as we said at the second quarter, we felt we were at the high end of our guidance range, and the pressure from the dispensing brought us down to the lower end of our – but still within our guidance range.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And that's what we continue to see.
Michael Weinstein - JPMorgan Securities LLC:
Understood. Let me just follow up on one more financial question. So, we thought the FX swing from $1.07, which was where your last guidance was set on the euro, to $1.15, which is where you now set guidance, would be more of an impact on the second half or full-year guidance than what you announced today. So could you shed some light on that? And then, if you have any early indication of what you think the FX impact will be on FY 2018, that would be appreciated.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. Absolutely. So, as you said, when we gave guidance the last time, we were at $1.07. We use the 30-day running average, as you know, so that would be $1.15. Today, we are sitting at $1.18. So the $0.08 between the $1.07 and $1.15, if you think back to the rule of thumb that we've given in the past, 1 point of euro move is worth about $0.02. So the $0.08 move is worth about $0.16 cents for a full year, but we just have one quarter to go. And, really, where you saw the move was in the month of July, so it's truly an impact of just one quarter. So that'd be about $0.04 for the quarter. Then when you look at all other FX currencies, we actually are still seeing pressure from the pound, the yen, and the yuan, which really haven't moved at all in the past quarter, and so we still see pressures. All other currencies, there's about $0.01 of benefit since May, and so that's the $0.01 there and $0.04, so we see about $0.05 running through, and that's how much we increased the guidance by. In terms of your comment around next year, we use the 30-day average because the volatility in FX has been dramatic over the last year or so, and we like the direction it's going. So if it stays at $1.18, we certainly will see a benefit. The average for this year, if it holds at $1.18 for the rest of the year, the average for this year will be about $1.10. So $1.18 for full next year would be about $0.08. If you use the rule of thumb, that's about $0.16 of benefit. And then, you would expect to see a little bit of benefit from all other foreign currencies, where there was a little bit of pressure this year. So that's a way to think about next year, if things hold at $1.18, and we hope they do.
Michael Weinstein - JPMorgan Securities LLC:
That's helpful. Thank you, guys. I appreciate it.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Yes. Thanks, Mike.
Operator:
Your next question comes from the line of David Lewis with Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. Just a quick follow up on Mike's question. Just looking at the fourth quarter, I was under the impression back half of the year was going to be sort of 4%, 4.5%, so sort of implies the fourth quarter has to be closer to the 5% or a little higher. It's also the hardest comp of the year, so I just want to make sure that just given the hardest comp of the year you're still sort of confident you can get back to that number in the fourth quarter.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes. So, David, as we said, the impact of the dispensing change would bring us from the high end of our guidance range of 4.5% to 5% for the year, down to the low end. So year-to-date, we're at 4.5%. So what that really implies for the fourth quarter is 4.5%. We do have some timing within the third and the fourth quarter, as I mentioned. The MMS International orders have slipped. We got some Kiestra installations that slip into the fourth quarter. So the combination of those things give us the confidence, and we see good strength across the rest of the business. The core is strong. Emerging markets growth, as I said, is looking very good, and Life Sciences is looking solid as well. So we feel good about the fourth quarter.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. And then, Vince – maybe, Tom, a quick question for Tom and a quick question for Vince. On Pyxis, I just want to get a sense of is the transition sort of progressing as expected? Has there been any underlying business disruption based on Pyxis? One of your competitors actually had a decent quarter. And then, Vince, for you, on Bard integration, dynamics that are kind of more encouraging as the pre-integration planning has been going on, and any additional thoughts on what business could move in or out of the Interventional segment? Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good. Okay. Tom, you can take that.
Thomas Polen - Becton, Dickinson & Co.:
Hey, David. This is Tom. Actually no, we see very positive feedback on the Pyxis ES business model conversion and actually positive momentum in terms of share gain in that space. So actually customers have been very satisfied with the new model. Feedback has been very positive in terms of it aligning with their needs and flexibility interests going forward, as well as being able to capitalize on the new software solutions that we're coming out with today and ongoing in the future. I'll turn it over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So, as we said, we are making some really good progress in terms of the integration planning, what the portfolio looks like. We haven't announced to the organization yet the answer to the question that you're asking, so I don't want to get ahead of that. We're doing work, of course, in the catheter area in terms of how that will come together. We know that we have to maintain focus on both the Pyxs and, of course, the IV catheter franchise and the structure that we're contemplating will continue to do that. But we are also looking at how we create this overall benefit in terms of enabling the customer base to optimize. And we think we've got great ideas there. And then we are looking at the surgical area and the various puts and takes there. So that's where we're at, but we'll be in great shape on those issues very, very quickly.
Christopher R. Reidy - Becton, Dickinson & Co.:
I should just add, too, that as we preliminarily look at the work on cost synergies, we feel real good about the $300 million of cost synergies that we articulated and we also feel equally as confident in having revenue synergies that are measurable in fiscal year 2019. So we're really reaffirming everything we said at the time of the transaction that we feel good about the cost synergies, the revenue synergies and the potential for those. So we've made good headway in the last couple of months on those issues.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Great. Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay.
Operator:
Your next question comes from the line of Isaac Ro with Goldman Sachs.
Isaac Ro - Goldman Sachs & Co. LLC:
Good morning, guys. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Isaac Ro - Goldman Sachs & Co. LLC:
Just two questions end-market questions for you. One on Life Sciences. If I look across some of the peers this quarter there does seem to have been a little bit of a slowdown in the drug industry kind of spending rate and there are probably a wide range of reasons for that. But I'm curious if you could comment on what you're seeing in terms of activity from drug companies? What's baked into your outlook for the rest of the year?
Alberto Mas - Becton, Dickinson & Co.:
Yes. Hi. This is Alberto. Good morning. We haven't seen any material change in the demand from the pharma companies. Now, a lot of these are driven by negotiations and discussions with us for a long period of time where the funding is secured. So we'll monitor that, but at the moment we are not seeing any big impact.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Advanced Bioprocessing is also a very small piece of our overall business. It tends to be lumpy, orders based, as Alberto was saying, and so we wouldn't see a big impact from that.
Christopher R. Reidy - Becton, Dickinson & Co.:
And certainly Pharm Systems year-to-date is 6.1% growth so we feel good about that, so.
Isaac Ro - Goldman Sachs & Co. LLC:
Great. And then just a follow up on the hospital spending environment. Appreciate you guys don't necessarily have a lot of exposure to major CapEx-type debates or what not, but interested in just this purchasing behavior. We've obviously seen a little bit of uncertainty around the policy side of hospital spending in the U.S., what that might mean for them. So I'm interested in how you're thinking about the evolution of hospital spending in the current environment.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, you know I've had multiple discussions on that point with the customer base in the U.S. And, basically, what I've heard back from the customer base is, listen, we all believe this is still going to population-based health and there are things that we have to do from a capital perspective, and those things are multiyear programs. And so we are not changing the way we are going about things. Are we being careful? Yes, we are being careful. But those commitments, most of those larger capital commitments have been made in their multi year. So we're not really seeing anything from our standpoint. Now when you step back and look at BD, we have small exposure to that, getting smaller with the move that we just made in terms of the change in the business model in MMS. And on the diagnostic side, most of what we do is reagent rental. So not a huge issue for us, but I would say over the next couple of years, we're expecting stability unless there is some major discontinuity in terms of where Congress ultimately goes, and so far Congress hasn't gone anywhere.
Isaac Ro - Goldman Sachs & Co. LLC:
Makes sense. Thank you, guys.
Operator:
Your next question comes from the line of Rick Wise with Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, Vince. Hi, Chris.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Rick.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Maybe just starting with your comments on the CareFusion cost synergies. You reaffirmed the $325 million, $350 million. Just wondering, is there a lot more to go? Is the bulk of it in the fiscal – the next 12 months? Just how do we think about that? And just as part of that, recently you've seemed a lot more concretely optimistic about seeing some CareFusion sales synergies. Not to be obsessed by it, but are you more optimistic about that as we look ahead as well?
Christopher R. Reidy - Becton, Dickinson & Co.:
So let me take the cost synergies. As you remember, we talked about those being relatively ratable over the three-year period, and that's what's playing out. So through 2016, we had about $170 million. We run about $80 million more per year on top of that. So that's what you would expect by the end of this year, and then the balance to the $325 million to $350 million would be in 2018. So that's pretty much on track, and you can see the benefit of that as we look at the margin growth. As we talked about in our prepared remarks, we expect this year to drive 200 basis points to 225 basis points of operating margin improvement. That brings us to over 500 basis points of margin improvement in the last three years through 2017. And then, as you think about it, we're talking about the Bard transaction driving an average of 200 basis points over the next three years. That's a lot of basis points of operating margin improvement over a five-to-six-year period. So we feel real good about that, and that's what we're seeing. The first part of that is driven by the CareFusion synergies.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So coming to the revenue synergies, Rick, I think we're feeling very good about what we talked to you about when we signed the deal. And if you remember, the way this works is we can only do so much in that planning, where we are before close. But where we are in that process is, we've had teams meeting together and we had a hypothesis in terms of where those were going to occur; which product lines, which geographies. We feel very good about that hypothesis having worked with the Bard team in terms of these are the focus areas, this is where we're going, this is where we're going to go after and get these things. Of course, we can't do the account level detailed planning yet, that comes later. But net-net, we feel very good about what we told you. In addition ... (44:38)
Thomas Polen - Becton, Dickinson & Co.:
Yes. Hi, Rick. This is Tom. Maybe just to add and update some of the commentary, the details that we've shared in the past is, we do remain on track towards actually an ultimate target of now about 250 products registered ex-U.S. from CareFusion. We actually have about 150 of those approved already and are promoting and selling those. There's another 75 products that has been submitted to regulatory agencies that are pending approval. And then, we're working on getting the final group of submissions made. So we're making really great progress there. We are seeing what I'll call kind of tens of bps of benefit in the overall Medical segment and company numbers. And as we've always said, those revenue synergies have always been expected ex-U.S. and specifically focused on the International MPS and MMS businesses. And if you look at International MMS and MPS, you can see we're up about 7% growth year-to-date in both of those businesses internationally, and that's reflecting those revenue synergies.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. And, Rick, I thought you were asking me about Bard, and I was answering that. And Tom, of course, answered about CareFusion, but we're a great team.
Thomas Polen - Becton, Dickinson & Co.:
We got lots of revenue synergies on both sides. Yes.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Thank you. And just quickly, Vince, just you highlighted a couple of things in the pipeline. Thinking back to the Analyst Day, a part of the 5%-plus growth story pre-Bard was the exciting pipeline. Any updates on some of the exciting diabetes products, Kiestra, Barricor? You talked about BD MAX. Any updates that we should be paying attention to or thinking about? Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Well, I'll ask Alberto to do that on the Life Science side, and then Tom can pick it up on Medical, because there's a lot of good things to talk about.
Alberto Mas - Becton, Dickinson & Co.:
So just on the Life Sciences, I'll highlight three launches or approvals this quarter, and Chris mentioned them. The FACSLyric, which is our next-generation clinical flow cytometry. We are very excited by that. It'll be much easier to use. Clinical software standardization across the different sites really will enable our customers to do very nicely. Second one is in Kiestra, our urine application, which uses imaging to essentially automatically discard no-growth plates, which really will lighten the workload and concentrate the limited amount of resources our customers have to a more valuable tests basically. And the third one is Lyric, one more that I'm – the extended bacterial panel that was also that was also previously highlighted. That is the third element out of four of our Enteric series of panels overall. And the last one to be approved now is the viral panel.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And I'll just add a couple of longer-term comments on the Life Science side. So remain excited about the Resolve platform from the cellular research technology that we have. That's on track. And I think you've have been doing, Alberto, some customer testing with that.
Alberto Mas - Becton, Dickinson & Co.:
Right.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And excited about that.
Alberto Mas - Becton, Dickinson & Co.:
And just to complete the picture, MAX, we expect the 20-plus percent growth rate – normally we have this quarter, but for the year. Kiestra in the double digits, and our Core Microbiology franchise grew over 5% year-to-date as well. So we're very confident about our Core products.
Christopher R. Reidy - Becton, Dickinson & Co.:
And I also mentioned in the prepared remarks the UltraTouch showed some benefit this quarter.
Alberto Mas - Becton, Dickinson & Co.:
It's being very well received in the market.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. So on the Life Science side, we are feeling very good about it. If there's one thing, Rick, that's been a little slow, it's been the Barricor launch, and it's just taken longer. We've got a good pipeline, but it's taking longer to convert the customer base and we've got to improve that process. But everything else we were showing you is on track. So, Tom, do you want to do the other side.
Thomas Polen - Becton, Dickinson & Co.:
Sure. Hi, Rick. This is Tom. On the Medical side, maybe just to hit a couple highlights across the businesses. First, is we have launched in the last few quarters some new enterprise software for our Cato and Pharmogistics platforms in MMS. That's doing extremely well. We've seen really positive customer uptake as those products are letting them manage compounding, as well as their inventory for pharmaceutical products across multiple hospitals within their network. Within MPS, we're continuing a launch of our Medication Management consumables there. We've actually just launched a new infusion set for Asia as part of our revenue synergy strategy. That's off to a good start. And at Analyst Day, we had shared we have plans to launch two new infection prevention products per year going forward, and that's very much on track for 2018, those products, and you'll hear more about those as we move ahead. And then on Swatch, as you mentioned, in diabetes care, no changes. We remain on track for end of fiscal year FY2018 for our launch in the U.S. of Swatch. Maybe one other area that we often get questions on is IV Solutions. As you know, there's a number of different formulations and bag sizes that customers need to run their institution. And we have our partner, Fresenius, that we've been working with to bring that broad portfolio of products to the U.S. market. To date, our partner's gotten FDA approval for the 5% dextrose, and we've begun marketing and selling that to customers. And additional formulations, including kind of the large volume saline product, we're still expecting approval in the coming months. Hopefully by the end of the calendar year.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Thanks so much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Okay. Thanks a lot.
Operator:
Your next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore ISI:
Hey, guys. Thanks for taking my questions. So maybe I'll start one on – the first one on the revenue guidance. Chris, obviously the stock is indicating off here in the pre-market. And I (50:28) think people are nervous, investors are nervous, on the set-up heading into back half and the implied fourth-quarter guidance. I mean, if I take a step back to the picture laid out at the Analyst Day, right. So we were looking for north of 5% organic during the 17th and 19th year. So if you look at where we are today, (51:03) organic, we are looking at a stock with a story of – accelerating organic into 4Q and a step into 4.5% and then possibly 5%, or north of 5%, for 2018. Can you talk us, one, what degree of confidence we have for the fourth quarter ramp up? And then, what's the delta between 2017 and 2018, right? Where is that incremental growth coming from?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure, Vijay. So, as we mentioned before, if you really peel back the on the underlying performance for the year, year-to-date we're 4.5%, but that's in the face of significant headwinds from this U.S. dispensing change that we had of about 50 basis points. That puts you right at the 5% level, so we feel really good about that. Clearly, the headline is depressed by the dispensing model. We knew that was the risk. We tried to communicate that, that that would be a pressure in the second half of this year. You're going to see that same kind of pressure year-over-year in the first half of next year. And that's to be expected. It's the right thing to do. It positions us extremely well competitively in that business. And it actually helps us better focus on our customers and their needs. So, we're doing it for all the right reasons, but it clearly is going to depress the headline. We knew that. We also knew that the timing was going to be a headwind in the second half of the year, because of the fact that we were running so hot in the first half of the year, 5.6%. So that had an impact as well. So, as I said earlier, the underlying for the quarter was 4.5%. It would have been 5%, except for the little bit of pressure we saw in MPS in normalization of inventories in the diabetes piece. So that would have been a strong 5% in the quarter as well. As we look out into the fourth quarter, we're very confident by a number of things that we see; the timing coming back to us a little bit on some of the things that moved from the third to the fourth quarter, but the strength of the core business is the most important. And look at the emerging market growth; that's the strongest it's been in a couple of years. We really feel good about that. The rest of the business is solid. So we really feel good about that as well, so it really hasn't changed from what we were talking about, in terms of the momentum of the business and the underlying business, when we talked at Analyst Day. And then, going forward into next year, we feel that same strength continuing again, albeit with the pressure of the headwinds of the dispensing change in the first half of the year. But for the full-year, that will normalize, because it'll be six months versus six months this year. So on the top line, we feel very good about the momentum that we have. And then, the ability to take that up to the 5%-to-6% level with the Bard transaction as that occurs. So, from a top-line basis, we're feeling like the momentum is there. And then, we haven't really talked about the EPS line, but when you look at that chart 15, we're driving 15% to 17% underlying EPS, FX and growth, and that's overcoming the Respiratory dilution of about 1.5%. That's really strong growth. Then you got the headwinds from the dispensing change that we have, which is real. That $60 million dollars of revenue that drops to the bottom line, there's some cost related to that as well. We're overcoming that. We're overcoming the headwinds that we saw in FX this year, which, although it's abated a little bit, that's still 3.5% of headwinds from year-over-year FX pressure. Hopefully, that turns around next year. So from a bottom line, we're feeling really good going forward as well. So, hopefully that addressed your question.
Vijay Kumar - Evercore ISI:
That does, and that was very helpful. And then, maybe one for Vince. Looks like the confidence on the Bard deal closure, it just sounded – I'm trying to piece everything together, right? So you mentioned the November-to-December timeframe, the FTC's second request. And then also, I think you mentioned about integration being ahead of where we were in a comparable timeframe on the CareFusion. Can you just put all of those together? What's the incremental confidence we have that this may not slip out to January? Or what's the key gating factors in terms of deal closing? I think that would be helpful.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Sure. And so, we never thought that the U.S. was going to be the gating factor in terms of getting the deal closed. We always thought that China was the long pole in the tent, and that remains exactly the way we saw it. So, we expected a second request in the U.S. It was no surprise to us. We're dealing with the issues that they raised, and we expect to deal with them quickly. So our view in terms of the closing time really hasn't changed at all, because of those two factors.
Vijay Kumar - Evercore ISI:
Thanks, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Operator:
Your next question comes from the line of Doug Schenkel with Cowen & Co.
Doug Schenkel - Cowen & Co. LLC:
Hi. Good morning. There's three topics I'd like to cover. First, on revenue guidance. Our math suggests that around 100 basis points of fourth quarter revenue growth is a function of revenue that moved out of Q3 into Q4. I just want to see if we're in the right neighborhood there. Secondly, on margins. Gross margin was solid this quarter. It doesn't seem like there was anything abnormal there. How should we think about the sustainability? And moving lower in the P&L, third quarter operating margin was above the full-year guidance target. I'm just wondering if we should be contemplating a pick-up in investment in our fourth-quarter model? And on the same topic, I just want to make sure that some of the Bioscience issues in the second quarter that impacted margins are now fully resolved. And the last topic is just on the pipeline. What's the status of the diabetes infusion set rollout? Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Well, let me see if I can get some of those questions. I think your timing is about right in terms of Q3 to Q4; that feels about right. And we feel good about the ability to hit the 200 basis points to 225 basis points of margin improvement, you mentioned abnormal. The only thing abnormal is that we are driving 200 basis points to 225 basis points of margin improvement this year, and 500 basis points over the last 3 years. So, we feel really good about that. There is say a little bit of easier compare in the fourth-quarter as I think I mentioned, because R&D ramped so much in the fourth-quarter of last year as a result of the medical device tax repeal. And so that makes it a little bit easier. The operating margins this quarter are a little misleading because of the fact that Respiratory really had an impact in there. When you peel back the Respiratory piece, you see really good margin growth. The gross profit margin in the quarter was 100 basis points faster than revenue growth. And both OIBT and EPS were very strong in the quarter when you back out the overhang from respiratory. So feel real good about that.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Bioscience is back to normal, right, Alberto?
Alberto Mas - Becton, Dickinson & Co.:
Absolutely back to normal, minimal impact this quarter and 100% back to into stocked position.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. You saw the growth of over 7% in the quarter. So we feel good about that.
Thomas Polen - Becton, Dickinson & Co.:
And Bill (sic) [Doug] this is Tom. On the infusion set, so we are in the process of, as I think we had shared in the past, we've gotten some complaints during the initial launch. We were in the process of running a clinical trial to confirm that some of the new training tools that we've included in the packaging optimized the patient's ability to start using this set. That clinical trial is going exactly as planned and our guidance assumes we resume the launch in FY 2018.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks for your question.
Operator:
Your next question comes from the line of Matt Taylor with Barclays.
Matthew Taylor - Barclays Capital, Inc.:
Hi. Thank you for taking the question. I guess I was just wondering if you could update us on kind of the outlook for emerging markets for Becton as you think about it organically and with Bard. You had a little bit better performance this quarter. So just curious if you could give us some insight into the moving parts there, and then how you think about the next year or two?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, I'll kick it off and then if Chris wants to add some more detail. What you saw in the quarter was of course strong performance in emerging markets, strong performance in China. The Middle East bounced back, and the rest of Asia. So, and then good performance in Latin America. So I would characterize it this way, Latin America has been stable through all of this, even with all the political stuff that has been going on. And they continue to prioritize health care down there in terms of spending and modernization and access. So with all of that, we see that continuing. If I go back to Asia for you, what's changed China for us is the rebound on the capital equipment side. We had good performance through some difficult times in China on the device side of things, on the disposable side, but on the Life Sciences side has really come back. We're seeing strong performance with multiple platforms in China, and we expect them to continue to ramp there. So, we feel very good about China looking forward. The rest of Asia continues to do well and had strong performance. India is a little bit more of a question mark from the standpoint of just things like tariffs and what not. But we think we'll be okay from a revenue growth standpoint. And then lastly, just coming back to the Middle East, what we saw was the stabilization in Saudi Arabia. And where that was a big drag, that is no longer a big drag for us. And where we had in Africa a drag from CD4 testing, that's not a significant drag anymore. And in fact, some new guidance came out just recently Alberto, I think, from the WHO on continuing using CD4. So all of that, we are feeling good about our guidance for the year in terms of high-single digits. And continued success moving on from there.
Christopher R. Reidy - Becton, Dickinson & Co.:
I have nothing to add. The year-to-date is 9.1%. That is a very high-single digits, and the momentum continues. And as I mentioned earlier, it was our best performance in two years in emerging markets. So we feel good about the momentum there.
Operator:
Our next question comes from the line of Richard Newitter Leerink Swann – or Leerink Partners.
Richard Newitter - Leerink Partners LLC:
Hi. Thanks for taking the question. I just wanted to follow up on the comment, I think you said that pricing got a little bit worse or the headwinds intensified a touch. Can you elaborate on that specifically, and was there a specific division? Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yes. So there was about 20 bps of pressure in the quarter. Year-to-date, it's about 20 bps in total after the first quarter being flat, and the second quarter, actually, was down about 30 bps, so it's actually moderated a little bit from that. That's the kind of plus and minus we have seen for a while now, is 20 bps to 30 bps, up, flat, down, somewhere in that range. We did mention that we are seeing pricing pressure in the U.K. in diabetes care from the austerity measures and the government payers. So that's continued, but pretty much in that range.
Richard Newitter - Leerink Partners LLC:
Okay. Thanks. That's helpful. And then maybe on just your Safety business outside the U.S. Can you just talk about where you are on the conversion opportunity across the various geographies? I know that you were up against tough comps. The growth rate reflects that. But how should we think about the sustainability of kind of penetration from that ...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes. Tom can walk you through that and Alberto can pick up on the diagnostic side, so.
Thomas Polen - Becton, Dickinson & Co.:
Hi, Richard. This is Tom. Yes. As you mentioned, within the quarter, we did see – there's a very tough compare because last year in the quarter, Safety revenues grew 9% overall, and that was including 20% growth in emerging markets, driven – and that was particularly concentrated in the Medical segment, that difficult compare where there was timing of tenders in Asia and EMEA in that quarter that aided that high growth rate. As you think about the outlook though for Safety, no fundamental changes to what we had shared in prior quarters. We still see about 50% of the way through the safety conversion in Europe, and so certainly, a runway remains there for the next several years. And in emerging markets, we are still certainly sub 20% conversion as you think about markets like China, the rest of emerging markets even less than that, less than 15% or 10% conversion and so still a long runway to go there. Obviously, the key to success in driving that is driving the legislative changes that really start mandating health-care institutions to convert to safety products. You saw that happen in Europe, and we continue to work with governments around the world, particularly, again, in emerging markets to help shape that policy and marketplace.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Anything you'd like to add, Alberto?
Alberto Mas - Becton, Dickinson & Co.:
Yes. For (65:22) for the quarter, we did have a very difficult compare last year, grew over 10%. So that was – and then it's mostly just timing of tenders outside the U.S. is mostly what affected it, but otherwise no big change.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And you continue to have a long runway in emerging markets?
Alberto Mas - Becton, Dickinson & Co.:
In emerging markets for sure. Yes.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Great. Okay. Thanks.
Operator:
Our final question comes from the line of Derik De Bruin with Bank of America Merrill Lynch.
Derik de Bruin - Bank of America Merrill Lynch:
Hi. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Derik.
Derik de Bruin - Bank of America Merrill Lynch:
Hey. A lot of my questions have been asked, but just one follow up to something going on in this market. We've seen so many other suppliers of safety syringes and pre-fillables and injectable drug packaging sort of comment on generic de-stocking and sort of some issues with their customer and slowing (66:13). Any of that sort of impacting you, are you noticing any change in buying patterns or buying behaviors from those customers?
Thomas Polen - Becton, Dickinson & Co.:
This is Tom. No. I mean, if you look at – now, keep in perspective, most of our drug delivery devices are probably not as much used for the generic space because a large portion are in the biologics. Obviously, that's still relatively early in biosimilars. And if you look at our Pharm Systems business, I think we're up 6.7% year-to-date there, so very strong performance.
Derik de Bruin - Bank of America Merrill Lynch:
Okay. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks for the question.
Operator:
There are no further questions at this time. I will turn the conference over to Vince Forlenza.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Well, thank you very much. Maybe to sum up here, we're really excited about Bard and the progress so far is exceeding our expectations. As we said, we're ahead of where we expected to be in the integration planning and getting more and more confident around the business model. We're confident and feel good about our outlook for the remainder of the year. And lastly, we're really pleased we're able to jump over significant headwinds that we mentioned on the call. And I think we're doing this because of really excellent execution by the folks in the businesses around the world. So thank you very much, and I look forward to briefing you next quarter. Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Michael Weinstein - JPMorgan Securities LLC Lawrence Keusch - Raymond James & Associates, Inc. Derik de Bruin - Bank of America Merrill Lynch Brandon Couillard - Jefferies LLC Doug Schenkel - Cowen & Co. LLC Vijay Kumar - Evercore Group LLC William R. Quirk - Piper Jaffray & Co. Richard S. Newitter - Leerink Partners LLC Brian David Weinstein - William Blair & Co. LLC Ian Mahmud - Barclays Capital, Inc.
Operator:
Hello and welcome to BD's Second Fiscal Quarter 2017 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through May 9, 2017, on the Investor's page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 3838563. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Christie. Good morning, everyone, and thank you for joining us to review our second fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our second fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in the press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. The second quarter comparable revenue growth rates and fiscal year 2017 comparable revenue guidance provided today excludes the revenues of divestitures, most notably, the Respiratory Solutions business that was divested in October of 2016, just after our 2016 fiscal year-end. The details of the purchase accounting and other smaller adjustments and the comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the investor relations slides. As a result of the changes related to the transformation of our U.S. dispensing business model, we expect to record a onetime non-cash charge of approximately $400 million during the third fiscal quarter of 2017. More complete details can be found in our 10-Q, which will be filed later today. Please note that all fiscal year 2017 guidance provided is on a BD stand-alone basis. As we move closer to our anticipated closing of the C. R. Bard acquisition, we will provide more explicit guidance on the pro forma financials for the combined company. Leading the call this morning is Vince Forlenza, Chairman and Chief Executive Officer. Also, joining us are Chris Reidy, Executive Vice President, Chief Financial Officer, and Chief Administration Officer; Tom Polen, President; and Alberto Mas, Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
I thank you, Monique, and good morning, everyone. Turning to slide 4; as many of you know – already know, last week was a very exciting time for us and a pivotal moment in BD's history as we announced the acquisition of C. R. Bard. The combination of BD and Bard represents another major milestone in the strategic transformation of our company. As a combined company, we believe we will further accelerate and broaden our strategy, create new growth opportunities for both companies, and deliver meaningful long-term value for shareholders. Together we will be uniquely positioned to deliver innovative healthcare solutions that improve both the process of care and the treatment of disease. We continue to expect the transaction to close in the fall of 2017 and we look forward to updating you along the way as we prepare to welcome Bard's team of talented associates to BD. Last week, we had the opportunity to meet with many of the Bard associates at some of their major locations and we were impressed by the collaborative spirit of Bard's leadership team, who is already generating ideas for what we could accomplish as a combined company. Turning to slide 5 and the second quarter highlights; we entered the Bard transaction with very strong momentum. Performance from both the Medical and Life Science segments contributed to strong revenue growth over the first half of fiscal year 2017. Our results continued to demonstrate the benefit of our diverse product and geographic portfolio and our ability to drive strong underlying margin expansion through the achievement of synergies, operational efficiencies, and continuous improvement. In addition, we achieved our commitment of 3 times gross leverage within two years of close, exactly as we planned and originally stated. We continue to make excellent progress and remain on track to achieve our CareFusion cost and revenue synergies. The integration of CareFusion has laid the foundation for the integration of Bard, providing a road map for the creation of a detailed execution plan. As I just mentioned, we expect this transaction to close in the fall of 2017, subject to regulatory and Bard shareholder approvals. Later in the presentation, Chris will update you on some changes we are making to our dispensing business, as we reinvent the Medication Management process. We will transform the dispensing business model from capital placements to a value-based software and solutions model, and we believe this further demonstrates our ability to execute on our vision to create a more robust and customer-focused business. As we look to the total year, we are very confident in our outlook. The strength of our year-to-date performance allows us to reaffirm our fiscal year 2017 revenue and adjusted earnings guidance, which includes the impact of the accounting change from this new business model. Of course, with this accounting change, there is minimal change to cash flow. I will now turn things over to Chris for a more detailed discussion of our second quarter financial performance and our fiscal year 2017 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. Like Vince, I'm also very excited about the combination of BD and Bard and the value created for our customers, patients, and shareholders globally. We are very pleased with our performance in the first half of fiscal 2017, with revenues growing 5.6% and EPS growing 16.2%. You can see, we are entering the Bard transaction with strong momentum. Moving on to slide 7, I'll review our second quarter revenue and EPS results, which I'll speak to on a currency-neutral basis. Total second quarter revenues of approximately $3 billion grew 5.2% on a comparable basis, which was ahead of our expectations. Adjusted EPS of $2.30 also exceeded our expectations, growing at 12.8% over the prior year. We're also pleased that we continued to de-lever and reduce the debt associated with the acquisition of CareFusion. We paid down approximately $3.5 billion in debt in the two years since the acquisition, including approximately $700 million in the second quarter of this fiscal year. We are very pleased that we achieved our commitment of 3 times gross leverage by the end of this past March, as we had anticipated. Moving on to slide 8, I'll review our revenue growth by segment on a comparable currency-neutral basis. Performance from both segments drove second quarter revenue growth of 5.2%. Growth was ahead of our expectations, driven by strength in Medication Management Solutions, Diagnostic Systems, including a stronger than expected flu season, and Preanalytical Systems. In the quarter, pricing declined slightly. Moving on to revenues growth by segment, BD Medical's second quarter revenues increased 4.8%. Medication and Procedural Solutions, or MPS, growth was 5.6%, which reflects strength in infusion disposables. Revenue growth in Medication Management Solutions, or MMS, up 7%, was driven by strong capital installations in dispensing in the U.S. and Europe. Growth was positively impacted by increased installation efficiency and the timing of placements that occurred in the second fiscal quarter earlier than originally anticipated. Diabetes Care revenues were about flat. Revenue growth was impacted by the timing of customer orders in the U.S. which occurred in the first quarter, earlier than initially anticipated, as well as the timing of tenders in emerging markets that we now expect to occur later in the fiscal year. Pharmaceutical Systems revenues grew 2.6%. Results were impacted by the timing of customer orders in Europe that occurred in the first quarter, earlier than originally anticipated, in addition to a tough comparison to the prior year in the U.S. due to the geography of customer ordering patterns. BD Life Sciences' second quarter revenues increased 5.8%. Growth was driven by strong performance in Preanalytical Systems and Diagnostic Systems. Revenues in Diagnostic Systems grew 10.5%. This reflects a strong quarter for flu-related sales, as well as the continued strength of core microbiology, including blood culture and Kiestra. In addition, we saw solid growth in BD MAX, driven by the recent introductions of new enterics and other assays. Preanalytical Systems growth of 7.5% was driven by safety-engineered products in both the U.S. and emerging markets. Biosciences revenues declined slightly due to the timing of instrument installations, as well as the impact of temporary fulfillment delays related to certain research reagents as a result of damaged inventory. In addition, we recorded a charge primarily related to the write-off of the inventory, which you will see in a few moments when I take you through the second quarter income statement. Moving on to slide 9, I'll walk you through our geographic revenues for the second quarter on a comparable currency-neutral basis. U.S. growth was strong at 4.0%. This was comprised of BD Medical growing at 3.2% and BD Life Sciences growing at 6%. Performance in BD Medical reflects strong growth in capital placements in our dispensing business and MMS and a wide range of infusion disposal products in our MPS business.BD Medical growth in the U.S. was impacted by the aforementioned customer ordering patterns in our Diabetes Care business and a tough comparison to the prior year in our Pharmaceutical Systems business, as previously mentioned. BD Life Sciences growth reflects strong performance in Diagnostic Systems and Preanalytical Systems. Growth in our U.S. Diagnostics business was driven by a strong flu season, continued strength in blood culture, Kiestra, and BD MAX. Revenues in Preanalytical Systems were driven by safety-engineered products across all platforms. Revenues in our Biosciences business in the U.S. were about flat, as strength in our Advanced Bioprocessing business was offset by the impact of the aforementioned research reagent fulfillment delays. Moving on to internationals; international revenues grew 6.5%. The Medical segment grew 7.1%. Growth was driven by performance from infusion disposables and the MPS business and strong capital instillations in our dispensing business and MMS. Pharmaceutical Systems revenue growth reflects the timing of customer orders, as previously mentioned. Growth in Diabetes Care reflects the timing of tenders in emerging markets, as previously mentioned. The growth in Life Science segment was 5.6%, driven by sales of safety-engineered products in emerging markets and strong sales in our Core Microbiology and BD MAX in Diagnostic Systems. Within Core Microbiology, we saw continued strength in blood culture as well as growth in ID/AST that was driven in part by the recent introduction of the Phoenix M50. Biosciences revenues declined due to timing of instrument sales in certain geographies that are now expected to occur later this fiscal year. On slide 10, developed market revenues grew a strong 4.5%, and emerging markets revenues markets grew 8.7%. The second quarter growth rate in emerging markets reflect strength in sales of safety-engineered products as well as core products in Diagnostic Systems in EMA and Latin America; and strength in MPS, particularly in China. China growth for the second quarter was ahead of our expectations at 11.9%. Revenue growth was driven by continued strong demand for consumables in both segments. For the total year, we continue to expect China to grow in the low double-digit range. We continue to anticipate emerging markets growth of high-single digits. Now, moving on to global safety on slide 11, currency-neutral sales increased 6.3%. Safety revenues in the U.S. grew 3.7%. International sales grew 10.3% currency-neutral, driven by strength across emerging markets, which grew 13.4%. Medical safety sales grew 4.7%, driven by a range of infusion disposables. Life Sciences safety sales, which are driven by Preanalytical Systems unit, grew 9% in the quarter, with strong growth across emerging markets as well as in the U.S. Slide 12 recaps the second quarter income statement and highlights our currency-neutral results. As discussed, revenues grew a strong 5.2% in the quarter on a comparable currency-neutral basis. As we move down the P&L, I'd like to point out, similar to last quarter, that our results in the prior-year period include the Respiratory Solutions business, while the current period does not as the business was divested in October 2016. BD's ownership interest in the Vyaire joint venture is recorded within other income in our second fiscal quarter results. Starting with gross profit, the decline of 0.8% year-over-year reflects the loss of gross profit related to the Respiratory Solutions business and the impact of the aforementioned damaged research reagent inventory. On a comparable currency-neutral basis that adjusts for these items, gross profit would have grown in excess of revenue growth. I'll provide additional details on gross profit in just a moment. SSG&A as a percentage of revenue was 24.3%. We're very pleased with the continued leverage we are getting as SSG&A continues to grow at a slower pace than revenues when adjusting for Respiratory Solutions in the prior year. R&D as a percentage of revenue was 6.3% as we continue to invest in innovation to drive future growth. As you'll recall, with the suspension in the medical device tax last year, our ability to ramp R&D spending did not occur until after the second fiscal quarter. With a more normalized level of R&D spend than the prior year and also adjusting for Respiratory Solutions, R&D would have grown in line with revenue growth in the second quarter. Operating income grew 0.9%. As I just mentioned, there are a few one-time puts and takes this quarter. On an underlying basis, P&L leverage remains strong with estimated double-digit growth in operating income. Our tax rate declined to 12.5% in the quarter, which is below our full-year expectations of 17% to 19%. The effective tax rate in the second quarter was lower than expectations, largely due to an incremental benefit from the stock compensation accounting rule change and other discrete items. In the quarter, adjusted earnings per share were $2.30. This represents a 12.8% increase versus the prior year, which reflects our solid growth profile, strong underlying margin expansion, and a lower tax rate that offset approximately $0.06 of the pressure in the quarter related to the inventory write-off in Biosciences. Now, turning to slide 13 and our gross profit and operating margins for the second quarter; on a performance basis, gross profit margin improved by 90 basis points. Gross margin includes the impact related to the damaged reagent inventory and a slight decline in pricing, offset by growth that was driven by continuous improvement initiatives, cost synergies, and favorable mix, which includes the positive impact of divestitures. On an operating margin basis, we are pleased to have delivered 80 basis points of margin expansion. We continue to drive cost synergies, which were partially offset by the timing of the R&D spend in comparison to prior year. Year-to-date, we have achieved approximately 180 basis points of underlying margin expansion and remain confident in our ability to drive 200 basis points to 225 basis points of margin expansion for fiscal year 2017. Now, moving on to slide 15, I'd like to take a few minutes to provide an update on our progress in transforming our U.S. dispensing business. As you may recall, discussions regarding this change have been ongoing since prior to BD's acquisition of CareFusion, and we have been actively working on this for the past two years. Over that same time horizon, we have been successful in stabilizing and improving the installation process of the Pyxis ES system. We believe our success is evident by the continued robust growth we have seen in the U.S. dispensing business. As we better align with customer goals, we see a strategic opportunity to change the way we engage with our customers. The business is evolving from one-time hardware installations towards providing lifetime solutions, software, and ultimately, value. With Pyxis ES, the business is shifting towards smart, connected dispensing devices with incremental software enhancements over time. This results in reducing medication errors and drug waste while improving drug availability and hospital cash flow. This also enables customers to benchmark their Medication Management performance versus other hospitals across the country. From a financial perspective, this requires us to match our accounting with the new business model by moving from capital leases to operating leases, which results in recording revenues ratably over the contract term versus recognizing the entire contract value upfront. The impact of the change will be determined by customer acceptance and finalized by the end of this month. We anticipate a headwind of approximately $50 million to $60 million to revenues and $0.20 to $0.25 to EPS in this fiscal year. This accounting change results in a difficult comparison, which will be limited to the second half of this fiscal year and the first half of fiscal year 2018, but it creates a more predictable recurring revenue stream going forward. Now, due to the strong momentum we have seen across the company and the over-performance we have delivered year-to-date, we are pleased that we're able to offset this accounting change and maintain our previously communicated revenue and earnings guidance. This business model change creates substantial value for our customers and we will keep you updated as we make progress with this transformation. Moving on to slide 16 and our full fiscal year 2017 guidance; with strong performance year-to-date, we are reaffirming our full fiscal year 2017 adjusted EPS guidance of $9.70 to $9.80, or 13% to 14% growth on a currency-neutral basis. Foreign exchange rates have not moved meaningfully since we last provided guidance in February, and as such, we continue to expect achieving earnings of $9.35 to $9.45, including the impact of currency, which represents growth of 9% to 10%. Our guidance assumes a euro to dollar exchange rate of $1.07, and as a reminder, includes dilution of approximately 1.5% from the Respiratory divestiture. Turning to slide 17, I'd like to walk through the balance of our guidance expectations for the full fiscal year. We continue to expect total company revenue growth to 4.5% to 5% on a comparable currency-neutral basis with growth of 4.5% to 5% in BD Medical and 4% to 5% in Life Sciences. Based on our current view of the environment, we continue to expect a small amount of pricing pressure for the year. We now expect our tax rate to be between 16% and 18%. All other P&L guidance from February remains unchanged. Now, I would like to turn the call back over to Vince, who will provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
I thank you, Chris. Moving on to slide 19, I will walk you through our updates on new product innovation and strategic and business initiatives. Starting with new product innovations, within our Medical business, we recently launched BD Enterprise Pharmogistics 1.0, which is a pharmacy inventory management software that integrates with the Pyxis ES platform to provide enhanced medication availability and patient safety across even the largest multifacility healthcare networks. Within our Life Science business, we received 510(k) clearance for the new BD FACSVia flow cytometry system, which provides blood banks and clinical laboratories with an easy-to-use cell analysis solution to help determine and quantify the presence of residual white blood cells in their blood products. The addition of the BD FACSVia system follows our larger strategy of making flow cytometry easier to use with improved efficiency, simplified sample analysis, and higher quality diagnostic results. Within strategic and business initiatives, we recently completed the acquisition of CME, a manufacturer of ambulatory infusion pumps. The acquisition of CME further strengthens our strategy and portfolio of Medication Management Solutions across the healthcare continuum and enables an even broader impact on patient outcomes. Moving on to our business update on slide 20, we continue to make progress with our cost synergy capture through our G&A functional transformation. We continue to remain focused on ongoing supply chain optimization in our distribution network. In addition, our manufacturing-related synergies remain on track and we continue to expect the majority of these to be achieved over the remainder of the deal horizon through fiscal year 2018. We continue to expect $325 million to $350 million in total cost synergies related to the CareFusion acquisition as we exit fiscal year 2018. Turning to operating margin, as you can see here, we are continuing to drive significant operating margin expansion over a multi-year period. The consistent performance of our businesses combined with operating efficiencies, cost leverage, and cost synergy capture is driving continued underlying operating margin expansion. We move forward with strong momentum and continue to expect to deliver over 500 basis points of cumulative margin expansion over the three-year period through fiscal year 2017. Moving on to slide 21, I would like to reiterate the key messages from our presentation today. First, we are very excited about the powerful combination of BD and Bard and our ability to deliver innovative solutions that position us to improve both the process of care and the treatment of disease. Second, both segments continue to perform ahead of our expectations and our results highlight the benefit of our diverse portfolio, both from a product and geographic standpoint. We continue to execute on our strategy and the progress we are making in transforming Medication Management is a good example of this. Third, operating efficiencies, cost leverage, and cost synergy capture continue to generate significant operating margin improvement. And finally, we are moving forward with strong momentum, are confident in our outlook for the full fiscal year, and in our ability to drive revenue and earnings growth. We are very optimistic about BD's prospects for the future and our ability to continue to drive shareholder return. Thank you. We will now open the call to questions.
Operator:
Thank you. The floor is now open for questions. In order to allow for broad participation, please limit your question to one. Thank you. Your first question is coming from David Lewis with Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Just a couple questions this morning, if I could; just first for Chris then maybe a follow-up for Vince. So, Chris, this accounting change for Pyxis transitioning from capital to operating type leases, we've talked about this for years. Maybe just kind of walk through, we know it's neutral to cash flow, but in terms of why do this now, the advantages it poses to the business, and the magnitude of a revenue or EPS hit for 2018 relative to 2017. And then I have a quick one for Vince. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure, Vince will start it out, David. Thanks a lot for the question. As you mentioned, this is something we've been working on for two years. And the first phase was improving the base software, the Pyxis ES, the installation process. And you can see in our results we've made great progress there. We're now moving into a different phase where we're adding new capability to Pyxis. And as we do that, we have to make sure that we're organized in the field to support this new business model. The last thing we want to be doing is putting new capability into a system and not bringing the customer along with us. This is a matter of customer satisfaction. And so, while there's more complexity, there's a tremendous ability to optimize Medication Management. Tom will give you a little more details on that, but this is really about a tremendous advantage for the customer base and utilizing the capability. Tom will mention that he has to change kind of how we support in the field and what people are doing there. So, Tom, maybe you want to make a few comments, then we'll come back to the financial aspect.
Thomas Polen - Becton, Dickinson & Co.:
Sure, Vince, and good morning, David. I think, as Vince mentioned, obviously, you have been asking us about this change from pretty much I think the first week of the CareFusion acquisition and when we came together, and we've basically saw the same opportunity that you had described and have been working on this for the past two years, and then all of that preparation has led to this point where we're ready to transform the business model. I think, as Vince described, Pyxis ES is really the catalyst, because it's now this smart, connected dispensing system where we're shifting from a onetime installation event and then really the touch point with the customer was five years later, when there was another capital requirement, to where there needs to be a much more ongoing consultative related relationship with the customer where the focus is all on delivering outcomes for improving Medication Management, right, every month, every quarter, every year. And so, this change in the – what is a accounting or business model change, right, really shifts us more to be able to deliver that business model, which I just described. As part of and in tandem with this accounting change, we are concurrently increasing, actually, the number of resources in the field that are working as consultants with our customers to maximize their use of Pyxis ES and to drive benefits from all of the features, particularly, really around how to use data to improve outcomes. As Vince mentioned, we've been concurrently investing in the new software modules which can help our customers do things like optimize inventory, reduce med errors or drug waste, benchmark themselves versus peers. And this change also tees us up to be able to not only better deliver and engage customers in those solutions, but also allows us flexibility going forward to be able to capture value from innovations delivered via software. And so, we see all of these things coming together. We recognize, obviously, the timing never necessarily a good timing at all, but we thought now is the right time from the business perspective as well as it's the right time for our customers. And all the feedback that we've gotten from customers as we've begun discussing this with them has been extremely, extremely positive.
Christopher R. Reidy - Becton, Dickinson & Co.:
So, this is Chris. And so, for all the reasons that Tom and Vince mentioned, this makes all the sense in the world from a customer standpoint and really positions us well going forward. But as you know, the trick when companies – other companies have done this, is how do you keep it from being death by a thousand cuts, because other companies did this in a way that you waited for the contract to come due and that could take three years for it to be a headwind. We've been able to do this in one fell swoop across substantially all of our customer contracts, and that limits the impact to a year, a one-year impact. The other positive is we're – because of the business momentum that we currently have, we're going to cover the impact of that, both on the top and the bottom line, which really mutes the impact of this. And the fact that we're able to do it six months in really helps to compare year-over-year that you were talking to from a fiscal year 2018 versus 2017, because we'll have six months this year and six months next year. So, the timing actually feels really good and we're able to accomplish this, get it behind us. As you mentioned, it has no impact on cash flow because now the revenue will be recognized as the cash is received. So, the timing seems to work out for a lot of reasons, particularly because we can cover it. And so, that felt like the right timing to us.
David Ryan Lewis - Morgan Stanley & Co. LLC:
And then – that's very, very clear, guys. Thanks for the color. And then, Vince, just for you; there's a lot of moving parts in the quarter, but based on your guidance versus consensus, it seems like underlying growth coming up about 50 basis points and maybe earnings coming up something close to $0.12. So, just real quickly, where is the underlying strength coming from you this year so far in, kind of, a broad perspective? And given the strength in the business and where the equity capital markets sit, how should we think about the equity-linked capital raise for Bard consideration? I'm assuming we should think about that as coming very, very soon. Thanks so much. I'll jump back in queue.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Sure. Thanks, David. We're seeing strength in both segments and we've seen the stabilization in emerging markets as well, and stabilization in developed markets. So, where geography was an issue last year, it's not an issue this year; strong performance you saw in China, good performance in Latin America, and then stabilization in Saudi and that sort of thing. So, we're feeling very good about emerging markets now. We continue to guide in the high single-digits. So, that is looking good and China is looking at double-digits. Both Medical and Life Sciences are performing well. I think you saw MMS doing extremely well; MPS doing well. Pharm Systems had a good first half. There's just some timing for the first half. And Diabetes Care we expect to be more robust in the second. So, Medical is doing well; Diagnostics is knocking it out of the park, quite frankly, with what they're doing with Kiestra, the launch of the Falcon 50 this quarter. That's going extremely well. And, of course, flu was a positive. And so, the only piece that has been a little soft has been Biosciences. They're doing well in the high end of the marketplace. They had this inventory situation this quarter and we expect to get that behind us quickly.
Christopher R. Reidy - Becton, Dickinson & Co.:
And to the second part of that question around the equity offering, as we said last week, we intend to move quickly on that. The process would be filing our Q, which should happen today. Then we have to file pro forma financial statements. You can expect us to move on that quickly. Once those are filed, we can really address the timing. But as we said last week, we expect to move very quickly on that, so don't blink or you'll miss it.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay. Thank you very much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Thanks, David.
Operator:
Thank you. Your next question comes from Mike Weinstein of JPMorgan.
Michael Weinstein - JPMorgan Securities LLC:
Thanks. Kind of clarify a couple financial items related to the accounting change. So, the $50 million to $60 million in revenues tied to the $0.20 to $0.25 in EPS, $50 million to $60 million of lost revenues isn't $0.20 to $0.25. So, is there some additional costs to doing this that we should understand? And then, second, if I just focus on slide 17, which is the fiscal 2017 guidance change. The only item that's changing is the tax rate moving down 100 basis points. Is there an offset that we're missing that EPS doesn't move up for the year with the tax rate moving down 100 bps? Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So, just a little bit of color on what creates the revenue drag. It's really, over the next six months, we're going to be recognizing just this year's amount of revenue, whereas in prior years, we would have done a full five years of revenue as you book the contract. The impact of that is about $50 million to $60 million. That goes entirely down to the bottom line. There's no margin impact, or whatever. It flows directly through. So, the $50 million to $60 million is $0.20 to $0.25 on the bottom line that we're covering. Then, as you think about the change in the tax rate, as one of the slides showed, I think it's slide 16, that change down is one of the ways that will offset some of that $0.25. I think that's like an $0.08 to $0.09 benefit by moving down to the 16% to 18% kind of range. So, we're overcoming the remainder of that $0.20 to $0.25 operationally. So, we just want to be clear that we're jumping over the accounting change in 2018 as well, partly because of the six months this year versus the six months next year. So, we set the base and go from there.
Michael Weinstein - JPMorgan Securities LLC:
And so, what is it you have to go to your customers for existing installed systems and do? So, if you have an installed system, you've already recognized the revenue. What is it you're going to those existing customers and doing?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, Tom will tell you.
Thomas Polen - Becton, Dickinson & Co.:
Yeah, again, (36:38) this is Tom. We literally just communicate via a letter and they have the opportunity to opt out or automatically are opted in. There's nothing specifically that has to happen at the customer's site. And then, of course, as I described before, concurrently we are deploying, as part of our business model transformation, all the other parts of that transformation including additional resources in the field to provide consultative services to help optimize the use of the software with the platform and generate outcomes. And so those things are happening concurrently. But there's nothing hardware change or from a service implementation that has to occur.
Christopher R. Reidy - Becton, Dickinson & Co.:
And those letters went out earlier this year.
Thomas Polen - Becton, Dickinson & Co.:
Correct.
Michael Weinstein - JPMorgan Securities LLC:
And what about, Tom, the compensation for the reps. Reps were getting paid on the installs before. How does their compensation change?
Thomas Polen - Becton, Dickinson & Co.:
No changes this fiscal year, and obviously, we'll be evaluating how to best continue to align our sales force compensation with creating customer value as we go into FY 2018.
Michael Weinstein - JPMorgan Securities LLC:
Okay. Perfect. Can I ask one? Yeah, Vince, I want to ask one last, just a Bard question.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Michael Weinstein - JPMorgan Securities LLC:
One of the kind of questions that came up a lot last week from people was just the difference in the pace of product iteration at Bard versus other companies, include Becton, Dickinson. And as much as it and people asking, how do you maintain that model at Bard with this kind of very accelerated rate of what I would call modest iteration at Bard over the last several years that they've gotten this model down correct and that's been successful for them? How do you keep that – as you pull the company into Becton, Dickinson, how do you maintain that model and that culture?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, Mike. Sure. I think that as we traveled around, we got a strong sense of that. And by setting this up as a separate segment, number one, and number two, keeping that system in place, and we've made that very clear. In fact, we're interested in taking that system to other BD businesses where it could apply. We were excited because, as we got together with their teams, as I mentioned in my remarks, they were already talking about things that we could do together. And so, we're going to resource it. We're not going after any synergies in terms of R&D and that – so, we'll maintain that system, is basically what I'm going to tell you
Michael Weinstein - JPMorgan Securities LLC:
Understood. Thanks, Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Operator:
Thank you. Your next question comes from Larry Keusch of Raymond James.
Lawrence Keusch - Raymond James & Associates, Inc.:
Thanks. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning.
Lawrence Keusch - Raymond James & Associates, Inc.:
So, I just want to circle back and make sure I'm understanding some of the mechanics here on the change here in the dispensing strategy.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Lawrence Keusch - Raymond James & Associates, Inc.:
So, maybe, Tom, if you could just touch on this. So, if you're an existing customer, as you indicated, you get a letter suggesting that you're moving to this new business model. They've already paid upfront for their installation and they've got some modest back-end stuff that I think comes through. So, it sounds like they don't have to do anything. So, again, is this really in terms of the accounting associated with the new installations?
Christopher R. Reidy - Becton, Dickinson & Co.:
Larry, this is Chris. Just to be clear, the way the contracts currently work is they have not paid. They pay – let's say, you're doing a five-year contract, 60 months. They're going to pay a little bit every month for 60 months. The accounting was that we recognized revenue upfront for the entire five years under capital lease accounting. Now, what we'll do is we'll just match the revenue growth – the revenue that we book to the actual collection of the cash. So, it matches the cash. It's actually a very positive way of accounting from a recurring revenue standpoint because once you book – once you get the contracts that now you've got 60 months of revenue that's just basically contractual as opposed to the lumpiness of the capital lease model where everything would have been booked upfront.
Thomas Polen - Becton, Dickinson & Co.:
So, no change to the customer in terms of how they're paying.
Christopher R. Reidy - Becton, Dickinson & Co.:
That's right.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Perfect. That's very clear. And then just, I was hoping to just get a quick update on two of the sort of newer products. Any thoughts around the infusion set, the diabetes infusion sets and some of those kinking issues that were going on? And then separately, any update on the progress for the insulin patch pump?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Sure. Tom can take both of those questions.
Thomas Polen - Becton, Dickinson & Co.:
Yeah, hi. So, we are continuing – we do have, as you mentioned, the temporary pause on shipments of the new infusion set and we're working on bringing that product back to market in collaboration with our partner, Medtronic. As you mentioned, and as we've discussed, we've had feedback on the set that was overall extremely strong. We had some complaints during launch and we're – the heavy focus is now working on optimizing the on-boarding process for patients, so that they properly learn how to use the set and can do so safely and optimally. So, we're in the process of actually running a – starting a trial to confirm that that training will help make sure that we get the right outcomes and then move forward in relaunching that. And so, that's progressing as planned. On the pump, nothing to comment other than it remains on track with the date for the second half of FY 2018 that we had shared at the Analyst Day meeting, but we're seeing very good progress on that price development initiative.
Lawrence Keusch - Raymond James & Associates, Inc.:
Okay. Terrific. Thanks, guys.
Operator:
Thank you. Your next question is from Derik de Bruin of Bank of America Merrill Lynch.
Derik de Bruin - Bank of America Merrill Lynch:
Hi. Good morning. A couple of questions. So, can you talk a little more about the Bioscience issues with the reagents this quarter? Just a little bit more clarity on that. And also, how do you think about sort of like the implications for the stock-based accounting tax changes for the rest of the year? I mean, is there any good – I know it's going to be variable from quarter-to-quarter, even a full-year basis, but is there any way to sort of help figure that out, (42:48) a little better?
Christopher R. Reidy - Becton, Dickinson & Co.:
I can take the last part of that first and then we'll move to damaged inventory.
Derik de Bruin - Bank of America Merrill Lynch:
Yeah.
Christopher R. Reidy - Becton, Dickinson & Co.:
So, in calculating this at the beginning of the year, we got a little more benefit in this quarter than we had anticipated. That really shouldn't affect the rest of the year. Now clearly, stock-based compensation is kind of a mark-to-market kind of thing going forward, depending on the stock price. So, it adds a little volatility for every company, but I think we're very comfortable with the guidance that we have for the rest of the year, and that 16% to 18%, which takes into consideration the favorability that we saw in the second quarter. Okay, and Alberto?
Alberto Mas - Becton, Dickinson & Co.:
And in terms of the – we did have some damage to inventory. The damage was caused when we relocated Resurge reagents to new a warehouse as part of a network optimization. And we conducted a full investigation and determined that we needed to initiate a field action and write-off the affected inventory.
Christopher R. Reidy - Becton, Dickinson & Co.:
So, it was exposed to some conditions that were outside of what normally it should be exposed to. Anyway, you'll be back...
Alberto Mas - Becton, Dickinson & Co.:
And we'll be back – we expect to restore supply – complete supply by...
Christopher R. Reidy - Becton, Dickinson & Co.:
This quarter.
Alberto Mas - Becton, Dickinson & Co.:
...during the quarter; in Q3.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah.
Derik de Bruin - Bank of America Merrill Lynch:
And did I catch that you that that was a $0.06 hit, you said, on the quarter?
Alberto Mas - Becton, Dickinson & Co.:
$0.06.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. It's a $0.06 impact to the quarter.
Derik de Bruin - Bank of America Merrill Lynch:
Great. Thank you very much.
Operator:
Thank you. Your next question comes from Brandon Couillard with Jefferies.
Brandon Couillard - Jefferies LLC:
Thanks. Good morning. Just curious if you could quantify the flu impact in the quarter, and as well on the Biosciences side, the impact to revenues from that inventory disruption.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay.
Christopher R. Reidy - Becton, Dickinson & Co.:
So, the first is about 30 bps of...
Vincent A. Forlenza - Becton, Dickinson & Co.:
I'm sorry, 30 bps of revenue growth in the quarter from the flu. And do we have a revenue impact or we have to do some work? Do you have that?
Alberto Mas - Becton, Dickinson & Co.:
Yes. The revenue impact from the reagents is $6 million in revenue for the quarter.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Alberto.
Brandon Couillard - Jefferies LLC:
Thanks.
Operator:
Thank you. Your next question is from Doug Schenkel of Cowen.
Doug Schenkel - Cowen & Co. LLC:
Good morning and thank you for taking the questions. Actually, just quick follow-ups on that last question. Was that 30 bps for flu across the entire business? And what does that $6 million impact translate into in terms of gross margin impact across the business?
Christopher R. Reidy - Becton, Dickinson & Co.:
So, the first is right, that's 30 bps across the business in the quarter, so at the BD level. And at the second, it's about 40 bps or so of gross margin headwind from that impact on the damaged inventory.
Doug Schenkel - Cowen & Co. LLC:
Okay.
Christopher R. Reidy - Becton, Dickinson & Co.:
And it's more than just the $6 million, it's the write-off as well.
Doug Schenkel - Cowen & Co. LLC:
Okay. Got it. That's very helpful. And then, I guess, a broader follow-up on Biosciences. Recognizing the impact of the fulfillment delay that we've talked about a bit here, it did still look like Biosciences came up a little bit light of expectations. I'm just wondering if you saw anything that surprised you during the quarter more broadly, either in the pharmaceutical end market or in the academic end market. The latter I mentioned because of NIH funding uncertainty in the U.S. and because some of your peers have commented that European academic was a bit weaker relative to expectations. And, you've also had some tender challenges within Biosciences, I think, related to CD4 in Africa. Was that still an issue in the quarter and any insight on when that will headwind will subside? Thank you.
Alberto Mas - Becton, Dickinson & Co.:
No, we don't see any underlying change in the market or basic change in the market. It's actually pretty much as we expected and no major changes. We don't see any changing behaviors from our customers because of the NIH budgeting. In fact, obviously, as has happened during the weekend, if anything, the NIH budget was increased by $2 billion. So, that was actually good news. And in terms of the CD4, that has stabilized. We're seeing about half the impact that we saw last year and that's beginning to stabilize. We'll see some erosion of that over time, but at a much more paced approach. The impact on the quarter, if anything, was mostly a timing of instrumentation in Asia and Europe but we expect – we have visibility and we expect that to be regained in the second half.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. If you had normalized for that timing issue and a little bit of the impact of the fulfillment delay, it should be in the 4% range of growth.
Doug Schenkel - Cowen & Co. LLC:
Okay. Super helpful, guys. Thank you.
Operator:
Thank you. Your next question is from Vijay Kumar of Evercore ISI.
Vijay Kumar - Evercore Group LLC:
Hey, guys. Thanks for taking my question. And maybe, Chris, a couple of ones for you and I had one follow-up for Vince. So, just maybe on the gross margins, right, so I think you mentioned 40 bps on the reagent impact. It looks like margins missed consensus by about 100 basis points. So, I'm wondering, one, did the accounting rule adoption have any impact in the quarter, or did Alaris pump, I know you had some charges for the center recall, did that have any impact in the Q?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, no, not at all. There's no impact from the accounting change until next quarter. But what you're seeing is the impact of FX. So, most analysts, I think, modeled the impact of FX to gross margins ratably over the year. Half of the impact of the FX hits you in the second quarter or hits us in the second quarter. And so, that was the difference that flowed through to the gross margin.
Vijay Kumar - Evercore Group LLC:
That was helpful, Chris. And then, on the EPS side, it's interesting. So, the accounting rule, was a $0.20, $0.25 hit on the EPS, but we maintain the EPS guidance, right. And the math I'm doing here, you get about $0.12 to $0.13 benefit from the lower tax rate, and revenues coming in better as maybe another $0.05 to $0.06. It implies an underlying benefit of $0.05 to $0.06. Where is that coming from? Is that better margin pull-through in the back half?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah. Thanks. So, you did the math pretty correctly. I think the tax impact is probably a little lighter than what you said in terms of coming down. But it really is just the performance of the business in the first half of the year that we see continuing. I think when you look at 5.6% revenue growth year-to-date and the kind of EPS growth that we see year-to-date, as well, up 16% or thereabouts, that is flowing through and will flow through to the second half of the year, enabling us to offset between that and the tax rate coming down that $0.20 to $0.25. So, we feel really good about that.
Vijay Kumar - Evercore Group LLC:
Got you. And then one quick one for Vince or maybe Tom. A lot of questions here on Bard acquisition and maybe potential revenue synergies. I guess, maybe can you walk us through on the kind of due diligence you guys did on Bard and why you felt so comfortable that that is the right asset? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, Tom can walk you through that. And, as you know from our previous conversation, we started way back in June on some really deep diligence across the entire product portfolio. But, Tom, why don't you give them some color on that?
Thomas Polen - Becton, Dickinson & Co.:
Yeah. Hi, Vijay. Good morning, this is Tom. I think as we discussed, obviously, our diligence, like with the CareFusion acquisition, included not only deep dives into each of the markets but also that includes primary research with end users and customers as well as those who are innovating in the space. And so, we performed that diligence across actually several hundred end user customers to understand the opportunity, not only of the base business momentum, but also the opportunity for new innovations and the dynamics of those innovations versus competition and the likelihood of – and the trajectory of those being successful. And obviously, as a result of that analysis, we became very comfortable. Obviously, some of those areas we knew very well already because they're close to home, like the vascular access space, PICCs and midlines, urology also not that distant, and then other areas like DCBs, which are newer to us. You can imagine, we even took additional time and did even more thorough end-user research and evaluations to get comfortable with. And, of course, then we also had exposure to other information during the diligence process. So, yeah, we're excited and see opportunities certainly on revenue synergies as we move forward and I think as we've noted, as Chris and Vince have identified, we think that they'll be sooner than what we saw with CareFusion, just given the very strong momentum of Bard in registering products internationally over the last couple of years.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. So, as we did our own due diligence, and we were seeing 500 registrations and a really strong pipeline. So, at the end of the day, we were even more comfortable when we finished up. But thanks for your question.
Operator:
Thank you. Your next question comes from Bill Quirk with Piper Jaffray.
William R. Quirk - Piper Jaffray & Co.:
Great. Thanks. Good morning, everybody
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning.
William R. Quirk - Piper Jaffray & Co.:
So, I guess, last question, a little segue way from there on the CareFusion, product registration o-U.S....
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
William R. Quirk - Piper Jaffray & Co.:
...can you give us an update there? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Happy to do that. Tom will do that.
Thomas Polen - Becton, Dickinson & Co.:
Hey, Bill. This is Tom. Good morning. So, we're seeing great progress across our product registration efforts and we're continuing to see actually revenue synergies this year. I think you can see that in both our MMS and MPS performance year-to-date. We're on track with about 190 active or in-process product registrations in new markets. And that's towards an ultimate target of a little over 200 registrations. So, we're making really good progress there and we're starting to see the impacts of that come through on the revenue side.
Christopher R. Reidy - Becton, Dickinson & Co.:
Okay. Thanks very much.
Operator:
Thank you. Your next question comes from Richard Newitter with Leerink Partners.
Richard S. Newitter - Leerink Partners LLC:
Hi, thanks for taking the question. Wanted to follow-up on the capital operating lease situation. I'm just wondering, does this allow you to innovate and then to change the model through which you, kind of, bring additional software updates to Pyxis and to sell that to the customer? Is there any change there, and should we expect any, kind of, more iterative kind of innovation on that front?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, the answer to that is yes. This is foundational that allows us to do that over time. Absolutely.
Operator:
Thank you. Your next question comes from Brian Weinstein with William Blair.
Brian David Weinstein - William Blair & Co. LLC:
Hey, guys, good morning. Question for you on Microbiology. Can you talk about what was the Core Microbiology growth in the quarter? And also, bioMérieux put up some very strong core micro growth as well. What's going on in the underlying microbiology markets that we're seeing nice acceleration from both companies lately? Thanks.
Alberto Mas - Becton, Dickinson & Co.:
So, we're carrying a lot of momentum on Core Microbiology, primarily on our vac tech (54:44) business where we think we have a very strong value proposition in terms of recovery rates and time to detection. Kiestra continues to be a growth – a significant growth factor for us, which also allows us to provide complete solutions to customers. And outside the Core Microbiology, we talked about the M50 from an ID/AST perspective. The launch was very successful, very well received, especially in emerging markets where it's the ideal throughput and size for that. And finally, BD MAX is really doing well for us, especially as we see the momentum for enterics gaining ground.
Operator:
Thank you. Our final question is coming from Matt Taylor with Barclays.
Ian Mahmud - Barclays Capital, Inc.:
Hi. This is Ian Mahmud on for Matt. Good morning. Can you hear me okay?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. Yes, we can. Good morning.
Ian Mahmud - Barclays Capital, Inc.:
Okay, great. Great. Good morning. So, on the acquisition of Bard, you haven't – or you didn't include tax synergies in your synergy estimates, but Bard does have a meaningfully higher tax rate. How quickly do you think you could bring that down?
Christopher R. Reidy - Becton, Dickinson & Co.:
So, we – just to give you kind of a background on that, their tax rate is about 21.5% to 22% and ours is now the 16% to 18%. On a combined basis, we said 18% to 20%. That takes into account both those tax rates as well as some of the shield – the tax shield from the additional debt that we're offering, plus some other puts and takes. So, there's a bunch of things that go in there that kind of net out so that it's their rate plus our rate. Having said that, we did say that we do see the potential for tax synergies going forward beyond that. Obviously, we've got to get the two companies together, but – and really, there's a lot of blocking and tackling that goes on in looking at legal entities in their structure and our structure. But based on the due diligence that we did, we're very comfortable that some of the structures that we have in place for a long time we'll be able to take advantage of, as well as some of the things that they have in place we should be able to leverage as well. So, on a combined basis, we think we will be seeing tax synergies above and beyond what we've put in the model. And we probably need – the rest of this year, we'll start to have some conversations, but really, once we close, which is very similar to what happened on the CareFusion transaction, once we close, we can really get our arms around that and get all of our tax advisors looking at the various puts and takes and then more to come. So, I would say sometime right after we close, which would be the fall of this year, so about a few months after that we'll have a better understanding of that. And you can look to us to start quantifying that at that point.
Operator:
Thank you. I will now turn the floor back over to Vince Forlenza for any closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, operator, and thank you, all, for participating on the call this morning. We look forward to updating you on the rest of the year. We feel really good about the momentum as we go into the second half of the year, and we look forward to updating you on the progress with C. R. Bard. And together, as we put this together, we do believe we're uniquely positioned to deliver innovative healthcare solutions that improve both the process of care and the treatment of disease and that's going to be unique in this industry. Thanks very, very much.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Executive:
Monique Dolecki - VP, IR Vince Forlenza - Chairman, CEO and President Chris Reidy - CFO and EVP, Administration Tom Polen - EVP and President, Medical Alberto Mas - EVP and President, Life Sciences
Analyst:
David Lewis - Morgan Stanley Andrew Hanover - JP Morgan Brian Weinstein - William Blair Larry Keusch - Raymond James Vijay Kumar - Evercore ISI Doug Schenkel - Cowen Jonathan Gorberg - UBS Derik de Bruin - Bank of America Bill Quirk - Piper Jaffray Brandon Couillard - Jeffries Rich Newitter - Leerink Partners
Operator:
Hello and welcome to BD's first fiscal quarter 2017 earnings call. At the request of BD, today's call is being recorded. It will be available for replay through February 09, 2017, on the Investors page of the BD.com website or by dialing 1800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 51388884. [Operator Instructions]. Beginning today's call is Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our first fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our first fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedule is posted on the BD.com website. The first quarter comparable revenue growth rate and fiscal 2017 comparable revenue guidance provided today excludes the revenues of divestitures, most notably the respiratory solutions business that was divested in October of 2016 just after our 2016 fiscal year end. In the first quarter, the company recorded a reversal of certain reserves related to a court decision which among other things reversed an unfavorable anti-trust judgment in the RTI case This item along with the details of purchase accounting and other smaller adjustment in the comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedule in our press release or the appendix of the investor relations slide. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Tom Polen, Executive Vice President and President of the Medical Segment; and Alberto Mas, Executive Vice President and President of the Life Sciences Segment. It is now my pleasure to turn the call over to Vince.
Vince Forlenza:
Thank you, Monique, and good morning, everyone and Happy Groundhog Day. Let’s get started on slide 4, most of you participating on today’s call attended our analyst day back in November and more recently the JP Morgan Healthcare Conference. At these events you heard us detail our strategy for sustainable growth with a pathway to a target of 5% plus revenue growth and 10% plus earnings growth. At analyst day, you were also able to see first-hand, many of the exciting products and solutions that we believe will help us drive more sustainable healthcare globally. As we partner with healthcare systems to address their key priorities, we are broadening our served markets through our focus on major healthcare challenges, where we believe we can have the greatest impact. To achieve our objectives, we laid out a comprehensive plan centered on three key components. First, it’s the broad array of new products that we are either launching now or we plan to launch over the next two years. Second, it’s our move to solutions. As we do that and move in to adjacencies, we are becoming more impactful across our businesses on these major healthcare issues. And third, is our geographic expansion including revenue centered synergies from CareFusion. I’m pleased to say that we’re on track with that plan that we laid and we are off to a strong start in fiscal year 2017. Moving to the first quarter highlights, performance from both the medical and life science segments contributed to revenue growth that was ahead of our initial expectations. Our results this quarter continued to demonstrate the benefit of our diverse product and geographic portfolio. We continue to drive strong underlying margin expansion with the achievement of synergies, operational efficiencies and continuous improvement. Looking forward to the total year, we are reaffirming our fiscal 2017 currency-neutral revenue guidance. Our first quarter performance along with our current outlook for the total year, gives us confidence to raise our currency neutral EPS guidance. Since we provided guidance in November, the dollar has strengthened broadly relative to the euro and other currencies and a negative impact from foreign exchange is now more pronounced. Chris will give you more details on this in just a moment. In summary, we are delighted with our strong start to fiscal year 2017 and are confident in our outlook for the full fiscal year. I’ll now turn things over to Chris for a more detailed discussion of our first quarter financial performance and our updated fiscal year 2017 guidance.
Chris Reidy:
Thanks Vince and good morning everyone. As Vince said we are off to an excellent start to fiscal year 2017. Moving on to slide 6, I’ll review our first quarter revenue on EPS results, which I will speak on a currency-neutral basis. Total first quarter revenues of approximately $2.9 billion grew 6.1% on a comparable basis which was ahead of our expectations. Adjusted EPS of $2.33 also exceeded our expectations, growing at 19.4% over the prior year. EPS growth was driven by revenue outperformance, coupled with strong operating performance. We are also pleased that we have continued to de-lever as we reduce the debt associated with the acquisition of CareFusion. During the first quarter, we paid down a $500 million debt maturity and are currently at approximately 3.1 times gross leverage. We remain on track to achieve our commitment 3.0 times gross leverage by March of this year. Looking forward to the total year as Vince mentioned, we are reaffirming our fiscal 2017 currency neutral revenue guidance. Our first quarter performance along with our current outlook for the total year gives us confidence to raise our currency neutral EPS guidance to a range of $9.70 to $9.80, which represents growth of 13% to 14%. Since we’ve provided guidance in November, the dollar has strengthened broadly relative to the euro and other currencies and a negative impact from foreign exchange is now more pronounced. We expect to be able offset about half of the increased currency pressure and now expect adjusted EPS to be in the range of $9.35 to $9.45 which represents growth of 9% to 10%. Moving on to slide 7, I will review our revenue growth by segment on a comparable currency-neutral basis. Performance from both segments drew first quarter revenue growth of 6.1% which was ahead of our initial expectations. Growth was positively impacted by the timing of certain revenues that occurred in the first quarter, which we originally anticipated would occur later in the fiscal year. I’ll discuss this as I take you through the business results. Adjusting for these timing related items, revenue growth was in line with our full year guidance range of 4.5% to 5%, which exceeded our expectations for the quarter. In the quarter, pricing was about flat. Moving on to revenue growth by segment, BD Medical first quarter revenues increased 7.5%. Medication and Procedural Solutions or MPS growth was 4.3%, which reflects strength in Flush and continued growth in infection prevention. Revenue growth in Medication Management Solutions or MMS of 11% was driven by capital installation in both dispensing and infusion. Growth was positively impacted by increased installation efficiency and the timing of placements that occurred in the first fiscal quarter earlier than originally anticipated. Diabetes care grew 4.5%; this reflects strength in pen needles which was aided by the timing of customer orders in the US, which occurred in the first quarter earlier than initially anticipated. Pharmaceutical systems growth of 15.5% was driven by strong performance in Europe, which was favorably impacted by the timing of customer orders that occurred earlier than anticipated. In addition, we experienced continued strength in our self-injection platform. Adjusting for the timing related items, BD Medical revenue growth in the first quarter was at the high end of our full year guidance range. BD Life Sciences first quarter revenues increased 3.2%. Growth was driven by performance in pre-analytical systems and diagnostic systems. Biosciences revenue declined slightly as growth from favorable customer ordering patterns and advanced bioprocessing and strength and research instrument sales in the United States was offset by a difficult comparison for the prior year and other geographies. Revenues in diagnostic systems grew 6.4%; this reflects continued strength in core microbiology including Kiestra, BD Max and an increase in flu-related sales. Pre-analytical systems growth of 4.2% was driven by safety engineered products, primarily in emerging markets. Moving on to slide 8, I’ll walk you through our geographic revenues for the first quarter on a comparable currency neutral basis. US growth was very strong at 5.5%. This was comprised of BD Medical growing 6.5% and BD Life Sciences growing at 2.8%. Performance at BD Medical reflects strong growth in capital placements in our dispensing and infusion businesses in MMS and a wide range of infusion disposable products in our MPS business. Growth was also driven by our diabetes care business. BD Medical growth in the US was aided in part by the timing of capital installation in MMS and customer ordering patterns in diabetes care as previously mentioned. BD Life Sciences growth reflect strong performance in our Biosciences business, driven by favorable customer ordering patterns in our advanced bioprocessing business and sales of research instruments and reagents. Growth in our US diagnostics business was driven by core microbiology including Kiestra and an increase in flu related sales. Revenues in (inaudible) medical system declined slightly due to limited US availability in one of our product lines. Moving on to international, revenues grew 6.8%. Medical segment grew 9.1%. Growth was driven by our pharmaceutical systems business which was favorably impacted by the timing of customer orders as previously mentioned and performance from infusion disposable and infection prevention products in the MPS business. Capital installation in our dispensing in MMS also contributed to growth in the quarter. Growth in the Life Science segment was 3.5% driven by sales of safety engineered products in emerging markets, as well as strength in Latin America and Asia Pac in diagnostic systems, which included a favorable comparison the prior year in China. An increase in flu-related sales also contributed to growth in diagnostic systems. Biosciences revenues declined due to a difficult comparison to the prior year, related to instrument sales in certain geographies. On slide 9, developed market revenues grew a strong 5.8% and emerging markets grew 7.7%. The first quarter growth rate in emerging markets reflects a strong performance in China and Latin America, partially offsetting this growth are declines in the Middle East and in our Biosciences business in Africa, as we anticipated and communicated in our last quarters’ earnings call. And Middle and Africa had a negative impact of approximately 200 basis points on growth in the quarter. Excluding these regions emerging markets grew approximately 10%. China growth for the first quarter was in line with our expectations at 9.1%. Revenue growth was driven by capital equipment purchases and higher reagent sales and diagnostic systems, as well as continued strong demand for consumables in both segments. Growth was partially offset by a difficult comparison to the prior year in Biosciences as expected. For the total year, we continue to expect China to grow in the low double-digit range. We continue to anticipate emerging markets growth of high single digits. Now moving on to global safety on slide 10, currency neutral sales increased 4%. Safety revenues in the US grew 1.6%. This is below our normal growth rate and reflects a decline in pre-analytical systems as previously mentioned. International sales grew 7.6% currency-neutral, driven by strength across emerging markets, which grew 18.1%. Medical safety sales grew 3.7%, driven infusion disposables and diabetes care. This growth was partially offset by a decline in the Middle East as anticipated and a tough comparison to the prior year and Asia-Pac. Life Sciences safety sales which are driven by our pre-analytical systems unit grew 4.4% in the quarter, as strong growth across emerging markets more than offset developed market revenues that were about flat. Slide 11 recaps the first quarter income statement and highlights our currency neutral results. As discussed, revenues grew a strong 6.1% in the quarter on a comparable currency-neutral basis. As we move down the P&L, I’d like to point out that our result from the prior year include the respiratory solutions business, while the current period does not, as the business was divested in October 2016. BD’s ownership interest in the Vyaire joint venture will be recorded with another income beginning in our second fiscal quarter. Gross profit was strong growing 1.7% despite the loss of gross profit related to the Respiratory Solutions business. On a comparable basis, gross profit would have grown in excess of revenue growth as the divestiture of respiratory business resulted in an estimated 6% headwind to gross profit growth. I’ll provide more details on gross profit in just a moment. SSG&A as a percentage of revenue was 24.3%; we’re very pleased with the continued leverage we’re getting in SSG&A. R&D as a percentage of revenues was 6.2% as we continue to invest in innovation to drive future growth. Operating income grew 9.8% reflecting strong P&L leverage. Our tax rate declined to 17% in the quarter, which is in line with our full year expectation of 17% to 19%. In the quarter adjusted earnings per share were $2.33. This represents a 19.4% increase versus the prior year which is very strong growth even after the dilution impact from respiratory solutions. The impact of currency in the quarter was a headwind to EPS of about one penny. Turning to slide 12 in our gross profit and operating margins for the first quarter. As we just discussed, the impact of currency was not meaningful in the first quarter though we do expect currency headwinds for the balance of the year. On a performance basis, gross profit margin improved by a 190 basis points. This growth was driven by a continuous improvement initiatives, cost synergies and favorable mix, which includes the positive impact of divestitures. On an operating margin basis, we are extremely pleased to have delivered about 250 basis points of margin expansion, as we continue to drive cost synergies. In addition, margin expansion was positively impacted by the divestiture of the respiratory solutions business. Moving on to slide 14, our strong performance in the first quarter and our full year outlet, gives us the confidence to raise our currency neutral adjusted EPS guidance for fiscal 2017 by 1 percentage point to a range of 970 to 980. Offsetting this increase performance, our incremental currency headwinds of approximately 2 percentage points that resulted from the US dollar strengthening relative to the euro and other currencies since we’ve provided guidance in November. Our guidance assumes a euro to dollar exchange rate of $1.06. On an adjusted basis, we expect to achieve of $9.35 to $9.45, which represents growth of 9% to 10%, which as a reminder include dilution of approximately 1.5% from the respiratory divestiture. Turning to slide 15, I’d like to walk you through the balance of our guidance expectations for the full fiscal year of 2017. We continue to expect total company revenue growth of 4.5% to 5% on a comparable currency neutral basis with growth of 4.5% to 5% in BD Medical and 4% to 5% in Life Sciences. Based on our current view of the environment, we continue to expect a small amount of pricing pressure for the year. As a result of our strong first quarter performance and outlook for the year, we now expect underlying operating margin to improve by 200 basis points to 225 basis points. This excludes the unfavorable impact of foreign currency and also excludes slight pension headwinds. Beyond revenues, EPS and underlying operating margin, all other P&L guidance from November remains unchanged. Now I’d like to turn the call back over to Vince, who will provide you with an update on our key initiatives and product portfolio.
Vince Forlenza:
Thank you Chris. Moving on to slide 17, I’ll walk you through updates on new product innovation and strategic and business initiatives, starting with a few quick updates in our recent product launches. Some of you already know that as part of our pilot launch, we temporarily paused shipments for our insulin infusion sets. The customers who have already received the product have been told they can continue to use it. During our initial pilot, we received a moderately higher than anticipated rate of complaints associated with insertion. If you recall, we initiated a limited launch to gather customer insights prior to broad commercialization and to detect opportunities for improvements like this. These early learning’s which are not unusual are invaluable to ensure that patients ultimately realize the full benefits of BD FlowSmart technology. We are continuing to work closely with Medtronic towards full commercialization. In Life Sciences, we have received very positive feedback from customers on our Barricor blood collection tubes since launching in September this past year. We’re also pleased that we continue to see strong growth in BD Max across our portfolio of assays including CT, GCTV and our extended Enteric Bacterial Panel in Europe, both of which launched in the fourth quarter of fiscal year 2016. Our menu expansion continued in the first quarter with a MAX vaginal assay launch in the US. The vaginitus panel is the first FDA cleared PCR based panel in the US. We have over a dozen accounts in various stages of validating the new assay. We also anticipate the launch of extended Enteric Bacterial Panel in the US later this fiscal year. Moving on to our more recent new product launches, within our medical business, we recently launched the BD Neopak 2.25 ml pre-filled glass syringe. This syringe is specifically designed for high value and sensitive biologic drugs that require higher quality levels and performance. This new syringe enables the development of drug-syringe combination products with extended injection intervals which will provide patients with more time between injections and decrease the frequency of injections. Within our Life Science business, we recently announced the commercial availability of the new BD Precise WTA kits that provide an easier method to identify and quantify genetic information in individual cells for genomic based research. These kits provide researchers with more accurate and easy to use genomic tools to enable more efficient identification of genetic markers for disease. The combination of our reagents, sales orders and data analytics enables BD to support researchers from sample preparation to any data analysis. We’re also pleased that BD was recently named the 2016 Top Global Innovator by Clarivate Analytics, a distinction that honors the most innovative corporations and institutions in the world. Within strategic and business initiatives, we’re pleased with the successful launch of Vyaire Medical, a respiratory solutions joint venture. Vyaire will enable more strategic focus and investment to build a leading global respiratory company. We’re also pleased that we continue to make strong progress achieving revenue synergies related to CareFusion. We now have over 160 product registrations either approved or in process. Moving on to our business update on slide 18; we continue to make progress with our cross synergy capture. Our G&A functional transformation continued in the first quarter. We are pleased to have implemented a new global HR and payroll systems in January. We also remained focused on ongoing supply chain optimization in our distribution centers. Our manufacturing related synergies remain on track and we continue to expect a majority of these to be achieved in the later part of our deal of Horizon. We continue to expect 325 million to 350 million in total cost synergies related to the CareFusion acquisition, as we exit fiscal year 2018. Starting with operating margin expansion, we have driven significant operating margin expansion on a multi-year trajectory. Starting with fiscal year 2015, we delivered 100 basis points of operating margin expansion followed by another 200 basis points in fiscal year 2016. In fiscal year 2017, we expect to deliver another 200 basis points to 225 basis points of margin improvement. The consistent performance of our business, combined with operating efficiencies, cost leverage and cost synergy capture is driving continued, underlying operating margin expansion, which will result in over 500 basis points of cumulative margin expansion over the three year period. Moving on to slide 19, I would like to reiterate the key messages from our presentation today. First, we remain on track with a comprehensive plan we laid out at our recent analyst day and we are very pleased with our strong start to fiscal year 2017. Second, both segments performed ahead of our initial expectations and our results highlight the benefit of our diverse portfolio, both from a product and a geographic standpoint. Third, operating efficiencies, cost leverage and cost synergy capture are generating significant operating margin improvement, as evidenced by our increased guidance for the total year. Finally, we are confident in our outlook for the full fiscal year and our ability to drive currency neutral revenue and earnings growth. We remain very optimistic about BD’s prospect for the future and our ability to continue to drive shareholder returns. Thank you, we will now open the call to questions.
Operator:
[Operator Instructions] Your first question is coming from the line of David Lewis with Morgan Stanley.
David Lewis:
Vince and Chris, I wonder if we could just start with the outlook for the year. I think there’s two elements people are focused on, your strong first quarter revenues, but maintaining currency neutral revenue guidance and lowering earnings by $0.10 despite much stronger quarter, better underlying margin strength. So can you walk us through these two dynamics and your confidence in the remainder of the year? Thank you
Vince Forlenza:
So I’ll start-off David. From a revenue standpoint, we are delighted with the start that we had and we feel very good about the outlook for the year. We just thought it was a little early to take up the revenue guidance. Now looking at the underlying markets, they do seem to have stabilized, so we’re feeling good about that. We just think that from a much broader perspective we are in to an uncertain environment. So, it was the first quarter, we feel good about it, we have confidence in the year, and we’ll come back in the second quarter and take another look. Now in terms of the impact of currency and what now, I’ll turn that over to Chris.
Chris Reidy:
So looking at our EPS guidance, we feel really good about the performance in the first quarter as well, and we think a portion of that is going to flow through to the year. As you see we raised the FX and guidance which is what we control and we feel really good about where that stands. We don’t control the currency. Now we did do all of this based on a 30 day average which is what we’ve always done and that was $1.06. As you saw over the last couple of days, it’s moved up to a $1.08. It’s been very volatile, we haven’t adjusted for that so clearly there’s some upside effect continues and it would be a pleasant surprise to see currency finally moving in the other direction and being at our back instead of in our face. So, our guidance does not take that in to consideration, because whatever it is its going to flow through. So we feel good about the fact that we raised the FX and guidance and then currency is going to be what currency is and we’ll walk through that as we go forward, as we it settle out. But wasn’t too long ago that people thought the dollar was going to go to parity, now it seems to be heading the other direction. Who knows, we hope for the best.
Operator:
Your next question comes from the line of Michael Weinstein with JP Morgan.
Andrew Hanover:
Hey this is Andrew Hanover in for Mike, thanks for taking the question. I just wanted to follow-up on that specific question just to understand the cadence based on what guidance is today. And obviously you had the one-time items in this quarter that were pulled further, came in earlier than expected. But anything that would change what you were expecting for the rest of the year, and how should we think about the cadence for the second to fourth quarter? And the as a follow-up I just wanted to get an idea on the status of the Barricor launch and how that is going?
Chris Reidy:
On the first piece of that I would say, clearly ahead of expectations in the first quarter. If you remember we said that going to have a little bit more of a difficulty comparing the first quarter primarily because they grow over in the Middle Eastern and Africa. Middle East was about what we expect; Africa was just actually a little bit better because of the timing of some contracts. But clearly we blew that 4% kind of guidance in the first quarter out of the water. I’d say about two-thirds of the revenue over achievement was timing related. You can look at pharm systems growing 15.5%, that’s a lumpy business, it’s not a 15% grower, but it’s a good grower, but it’s mostly timing or a chunk of that is timing. So we about two-thirds, one-third breakout at this point. So clearly revenue is moving up in the range, and as Vince said it’s a little bit up early in the year we still have things like flu ahead of us, it’s still not clear where that’s going to go, although it’s somewhat encouraging but that could turn on a dime. So we’ll see where that goes, pricing is still a bit ahead of us. So it’s early in the year, but clearly feel a lot better about our revenue guidance and a lot more confident in that guidance range. So we’ll see how it goes, but we’re off to a great start.
Andrew Hanover:
And for Barricor?
Alberto Mas:
Yes, as Vince mentioned we do feel very positive about the feedback that we’re getting from our customers. We’ve seen some early wins around 30 accounts have now converted to Barricor. We have a healthy pipeline of just over 150 accounts; they are validating and evaluating the product. It is a product that takes quite a long time to validate between three and five months. So although all the signs are positive, this is going to be a slow conversion process that we’re going to see.
Operator:
Your next question comes from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Just coming back in to FX a little bit, last year you guys were very successful at offsetting all of the FX headwind that you had. It sounds like you’re thinking you can offset about 50% of them this year. Can you be a little more specific on where you’re able to offset those FX headwinds this year and did you sort of fully exhaust some of those options last year. And I guess as part of that, can you just talk about where we are specifically in the 325 million to 350 million in cost synergies that you guys are targeting from CareFusion, thank you?
Vince Forlenza:
If I take you back 12 months ago, we were getting the same kind of questions in terms of had we exhausted what we could do at the end of the first quarter, you can’t do anymore and then of course we actually exceeded and overcame the FX. So this is early in the year. We were expecting some volatility in FX, we were very careful in our expense in terms of how we role that out in the first quarter and I think we did an excellent of managing. But we’re feeling very good about the P&L as we look across the rest of the year. Chris anything else you’d add to it?
Chris Reidy:
Yeah I just did on that before I get to the second part of your question. That it’s our job to offset as much of that FX headwind as we can, and I think we’ve done a great job with that last year. We continue that with our first quarter guidance raising the FX and neutral. So that’s our job to do that, and its - basically the cost synergies, the continuous improvement, all of those things go in to our ability to do that. We feel really good about where we are in cost synergy. We have the 325 to 350, we feel very good and confident with that. As you know some of the cost synergies come towards the backend and as we get increasing visibility towards that we’ll address where the total cost is going come out. But the traction that we have is terrific and it’s still a little bit early to give any more specificity to where we’ll ultimately end up, but we feel really good about the synergy progress that we’ve made and continue to expect that to be strong.
Operator:
Your next question comes from the line of Larry Keusch from Raymond James.
Larry Keusch:
Chris perhaps for you, the 3.1 times gross leverage obviously impressive in tracking right to the three times that you were targeting by the end of March. I guess the question is, and I sort of will wrap in the billion dollars of stranded cash that you have overseas. To the extent that you to get that money back and you leverage comes down to that three times target, how do we think about the cadence of broadly capital deployment and specifically share repurchase and dividend. And then the second question is and it’s sort of been touched on, but given the outperformance in the first quarter on sales on a constant currency basis, how we specifically think about the cadence of the remaining quarters, given some of that timing pull forward. Does that imply that the 2Q would not be below the 4.5% to 5% outlook for the year?
Chris Reidy:
On that last point, I think in terms of the cadence I think somebody else asked that too. As we look out, it’s going to be pretty ratable. I don’t think there’s going to be any spikes in the second, third, or fourth quarter, and so it will be within the range that we had provided for the year. And obviously because of the timing, it’s probably towards the low-end of that range to keep us within the 4.5 as you do the math. The other part of the question capital deployment, sure, my favorite. So the way to think about that, one of the things you said Larry was the billion dollars of stranded cash. Remember that a company our size needs certain amount of working capital, so I don’t see all of that as a billion dollar, some of that is just normal working capital needs. As we pay down to the 3.0, we’re going to get down to vey historically low levels of cash. It will take a little while to kind of go back up to normal working capital levels. And then a little while longer to actually start accumulating the cash that you need for further deployment. So as I look out, the impact this year of any share buybacks would be de-minimus because of what I just subscribed in building back up the cash balances. But clearly we’re not going to let cash build upon the balance sheet and we will deploy that as that cash starts building up again. But the way you should think about it for this year is that the impact of any share buybacks which would occur later in the year would be de-minimus to the year.
Operator:
Your next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar:
So maybe just one housekeeping question on the guidance here. It looks like FX was an incremental $0.17- $0.18 headwind, but the reported EPS was only lowered by $0.10. So could you maybe just walk me through on where you’re getting the offset from, I think that would be helpful.
Chris Reidy:
Yeah, we’re actually seeing a little bit strength in the revenue side, and our margins as you can see were very strong in the first quarter as well. So the combination of those two things, the beat in the first quarter some of that’s going to flow through. So we see about a third of the revenue, about a third of the bottom line flowing through and that’s where we’re seeing it.
Vijay Kumar:
And maybe one more for Chris. What is the net impact of corporate tax reform and border tax? Is that a net neutral, net positive?
Chris Reidy:
Well on the border tax we certainly - we are a net exporter. So that’s positive, certainly as the lowering of the US rate would be positive. It all depends on all of the other factors that go in it, and that’s very volatile in terms of what other factors there might be such as the interest expense and the price of repatriation of unremitted foreign earnings. So it’s too quick and too soon to know because it’s anybody’s guess as to what will actually end up in the ultimate rules, and we still got a way to go. But there’s some positive, there’s some negative, we’ll see where they come out. But the one thing that I would want you to take away is that we are a net exporter. We do have over 30 plants in the US, so we feel good about that aspect of it.
Operator:
Your next question comes from the line of Doug Schenkel with Cowen.
Doug Schenkel:
My first question is on China and I just want to have a quick circle back to Brian’s question from a couple of minutes ago. So first on China, you grew over 9% in the quarter against a difficult compare. You didn’t call out CareFusion contribution specifically. So with that in mind, I was just hoping you could comment on how much products that have completed the registration process contributed to growth and what’s the right way to think about ramping over the coming quarters. And then just to go back to Brian’s question, one area of clear focus today seems to be the concern that you may be reaching a limit on your ability to keep offsetting FX with operating discipline without cutting into bone over the next several quarters. I’d say it’s a bit more pronounced that I would have expected largely because you didn’t reiterate reported EPS and I think a lot of folks thought that you maybe could have. Could you just comment more directly on how you feel about how much dry powder is left and kind of back that up with some data that tells us that there is or there isn’t a lot of operating discipline left to be had in offsetting some of the FX headwind thank you?
Vince Forlenza:
Okay, lets start with China first. And we did have a strong performance in China and a lot of it was on the medical side. So Tom why don’t you talk about a little bit about that and the CareFusion impact?
Tom Polen:
Sure. Hey Doug, this is Tom. As Vince mentioned earlier we have made really good progress on the registration as we were after revenue synergies up to 160 plus either approved or under active review. As we had always shared, of course China has one of the longest registration time, and so as we think about our synergies, we do have synergies coming in China but that’s certainly not the main source of them at this point. We’ll see those coming in over the next couple of years. As you think about revenue synergies overall, it was a good contributor to the segment in the quarter. Think about it in tens of basis points impact on BD Medical revenue growth in the quarter on a global basis.
Vince Forlenza:
Okay. So we’ll come back to this question about where do we get potential offset as we look forward through the P&L? And you’ve mentioned operating discipline and of course we will continue that. But Chris we have other levers that we can fall to?
Chris Reidy:
We do, certainly as we talked about the synergies. In our ability to drive more synergies, we’ve gotten a lot of traction on that, there’s still a lot to come and so there’s potential to continue to drive more synergies and that would be a potential. We feel good about the fact that we are able to offset a good chunk of the FX headwinds in our guidance. As we go down to 106, its now 108, there’s certainly some upside there as well. It’s somewhat out of our control where FX goes, but our job as I said before is to offset as much of that as we possibly can and I think we have some options and opportunities particularly around synergy acceleration and those kinds of things that we would be pushing up.
Vince Forlenza:
And the only other thing I would add Chris is that, if we continue with a strong revenue, we saw a very good margin on that incremental revenue. So we have that as a looking forward as well. So those are the elements.
Operator:
Your next question comes from the line of Jonathan Gorberg with UBS.
Jonathan Gorberg:
Can you give us, Vince I know one of the things from a new product standpoint investors had been anticipating was that insulin infusion set, and just maybe a little bit more color on what should investors be expecting given early feedback that you’ve gotten either from a timing or what you’re going to do from a product standpoint?
Vince Forlenza:
Yeah Tom can talk to that.
Tom Polen:
Hi Jonathan, this is Tom. So as Vince mentioned in October we began the initial pilot launch with Medtronic in the US to collect customer insights and inform about the rollout. As we said, we did put out a safety notification a few weeks ago and it stated that although the majority of customers are using the product successfully and we’re getting great feedback on that, there was a small percent that had reported some issues. And so we had an agreement with Medtronic temporarily pause the shipment so we could review that customer feedback. We also indicated that any customers who have the product, it’s okay to continue to use it. Again we’re getting overall very good feedback, and we recognize that it’s a new and different technology and we need to make sure that we’re rolling out the right training so that we’re getting our customers the right instructions for use a 100% are having that right experience. So we’ve been analyzing that feedback, we’re finding some of the training practices etcetera. Obviously we’re disappointed with the shipment pause, but as Vince also mentioned, we view this as part of a learning critical to maximize the potential of this over both the near and long term. It doesn’t change at all our outlook for the product. We continue to be very positive on the opportunity and extremely positive on the benefit of the flow-smart technology. We also don’t see any impact of this on the guidance for the medical segment of the company.
Vince Forlenza:
So we’re still working towards full commercial launch changing some of the training materials. Thanks Tom. Thanks John.
Operator:
Your next question comes from the line of Derik de Bruin with Bank of America.
Derik de Bruin:
A couple of question, first, when you look at the respiratory JV on that other income line, how should we think about that for the rest of the year. And going forward on that is a low single digit sort of growth estimate for that a reasonable assumption on that business or in that contribution?
Chris Reidy:
It’s not going to be very material and we’re not counting on it being very material for the rest of the year. And its’ on a lag just because of the reporting piece which is not unusual. So I wouldn’t expect too much there. I don’t think it’s going to really be a driver.
Derik de Bruin:
And then just one follow-up, you call that flu several times and historically flu has been anywhere if I think what 12 million to 15 million in a good flu season for you. Could you call up the contribution in Q1 and then sort of expectations for Q2?
Vince Forlenza:
Yeah, I don’t know that we can give you an expectation for Q2, but Alberto can comment on what we’ve seen so far and what happened in this quarter. Alberto?
Alberto Mas:
Yes, flu seasons specifically in Asia. So Japan and Korea were earlier than last year as well as in the US, the last year’s flu season was late. So we saw strong demand in Asia in Q1, and very, very late in December. There was a little bit of a spike in the order from distributors in anticipation of what we’ve seen an increase in flu for the last three weeks or so. We don’t know exactly obviously how that’s going to, going forward how that’s going to evolve. But there was a very late buy-in of inventory by distributors in the US moderate still. It contributed about just over 1.5% growth rate to the DS growth rate for the quarter.
Operator:
Your next question comes from the line of Bill Quirk with Piper Jaffray.
Bill Quirk:
Couple of question I guess for Vince or Tom, just curious as there was a broadening of an EU sharps directive that might get expanded in scope to some non-healthcare workers like police and lab workers and such. Just kind of thinking about the potential size of this opportunity, I’m guessing this is more of an ’18-’19 sort of event, but would love any colors there. And then just a quick one for Chris share count, you got it to 219 for the year. We’re comfortably under that at this point, so just kind of help us think about some of the puts and takes there?
Vince Forlenza:
Tom do you want to comment?
Tom Polen:
Yeah, this is Tom. Certainly we see Europe is about 50% of the way through their safety legislation. I think the add-on that you’re talking about is not something that we see as fundamentally being a significant scale to move the needle beyond kind of the current trajectory. So we will continue to be very positive overall on safety growth in Europe and as well as in emerging markets.
Chris Reidy:
And on the share count, so that assumes - and we’ve seen since we’re not buying back any shares we got a little bit of a lift from conversion of options, and we’ve seen that over the last several quarters. So it’s just a continuation of that and no assumption of share buybacks for the remainder of the year.
Operator:
The next question comes from the Brandon Couillard from Jeffries.
Brandon Couillard:
Just curious if you could elaborate on the US safety weakness in the first quarter and whether or not that we should think that’s about the normalizing in 2Q, and then secondly, curious if the International Biosciences experience was actually in line with plan?
Vince Forlenza:
So first safety, and in the US there was a little bit of an impact on the Life Science side because we had some capacity constraints on one particular product in PAS and we’re working to add that capacity. So that’s what you saw there. We’re adding some capacity and we’re going to be tight for the balance of the year. But Tom?
Tom Polen:
We saw a pretty solid performance from a medical perspective in the US in the quarter, no change in that. I think as we think about safety overall in the quarter, we recognize that at the BDX level it was maybe a bit more of an impact from international safety, so also some headwinds in the Middle East and Asia, but we see those basically moderating as we go forward for the year as those annualize and overall see a positive outlook for safety to the balance in FY’17.
Vince Forlenza:
And Alberto international safety I think you did pretty well too.
Alberto Mas:
Yes, and we did particularly well and above average because some of the supply in some of the constrained product and push-button recollection went outside the US. So we saw particularly high safety numbers.
Vince Forlenza:
So little less growth in the US, but more international. Okay, great.
Chris Reidy:
And emerging markets over 18% growth asset.
Operator:
Your last question comes from the line Rich Newitter from Leerink Partners.
Unidentified Analyst:
This is Robby in for Rich. Just one on price, you mentioned the pricing environment a couple of times. How should we think about and how you are thinking about that. It sounds like you’re taking a little bit more of an incremental cautious approach there? And just a follow-up, could you just highlight what US growth would have been X the order pull through thank you?
Chris Reidy:
So on the pricing piece, I think it’s very consistent with the way we always approach pricing. There’s no question that there is pricing pressure in different parts of the business. We tend to be able to offset a lot of that, and so we started this year opening guidance with tens of basis points of pressure. The first quarter was about flat as I mentioned and so we’re still having our guidance, the tens of basis points coming from the remainder of the year, that’s got some room for upside. If we’re able to outperform, but right now it contains that tens of basis points of pricing pressure.
Vince Forlenza:
Well thank you very much. May be to then go on and just wrap up the call. We are very pleased with the strong start to the year. We’re implementing our strategy that we laid out for you at analyst day. That whole plan is on track, we’re excited about the new product launches. You saw the increased performance on the margin as well. So when we step back and look at this in totality we’re viewing very good across the continuum of the entire P&L. So thank you very much for your questions and look forward to updating you next quarter. Thanks everyone.
Operator:
Thank you. This does conclude today’s teleconference. Please disconnect your lines at this time and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Alberto Mas - Becton, Dickinson & Co.
Analysts:
Michael Weinstein - JPMorgan Securities LLC David Ryan Lewis - Morgan Stanley & Co. LLC Kristen Stewart - Deutsche Bank Securities, Inc. Rick Wise - Stifel, Nicolaus & Co., Inc. Lawrence Keusch - Raymond James & Associates, Inc. Vijay Kumar - Evercore ISI Brian D. Weinstein - William Blair & Co. LLC Jonathan Groberg - UBS Securities LLC William R. Quirk - Piper Jaffray & Co. Derik de Bruin - Bank of America Merrill Lynch Doug Schenkel - Cowen & Co. LLC Matthew Taylor - Barclays Capital, Inc. Richard Newitter - Leerink Partners LLC
Operator:
Hello and welcome to BD's fourth fiscal quarter and full fiscal year 2016 earnings call. At the request of BD today's call is being recorded. It will be available for replay through November 10, 2016, on the Investors page of the BD.com web site or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 94169710. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Christy. Good morning, everyone, and thank you for joining us to review our fourth fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our fourth fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the BD.com website. As a reminder, we annualized the acquisition of CareFusion in March, and as such, our fourth quarter results reflect the new BD in both the current and prior year periods. In addition, comparable prior year revenues are adjusted to exclude the sales related to the terminated agreement with CareFusion for the sale of SMP's respiratory care products. The impact to the bottom line was not material. Comparable organic revenues are adjusted to further exclude the impact of non-annualized acquisitions and closed divestitures. The fiscal 2017 comparable revenue guidance provided today will exclude revenues of closed divestitures, most notably the Respiratory Solutions business that was divested in October of 2016, just after our fiscal year end. In the fourth quarter the company recorded a non-cash impairment charge for capitalized internal use IT software assets. This charge, along with the details of the purchase accounting and other smaller adjustments and the comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the Investor Relations slides. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Chief Administrative Officer; Tom Polen, Executive Vice President and President of the Medical Segment; and Alberto Mas, Executive Vice President and President of the Life Sciences Segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. First, congratulations to the Cub fans out there, especially the BD associates in Chicago. In the words of Brian Weinstein, go Cubs! Moving on to my presentation. As we stated in our press release, we are extremely proud of our accomplishments in our first full fiscal year as the new BD. As you already know, the acquisition of CareFusion 18 months ago significantly accelerated our strategy. And the powerful combination of BD and CareFusion continues to deliver positive results. We've seen significant benefits as a result of this transaction from a customer, employee, and shareholder standpoint. And we think there's more to come. Turning to Slide 4, I'd like to highlight some key achievements in fiscal year 2016. First, our results reflect our consistent performance and the benefit of our diverse geographic and product portfolio. Legacy BD remains solid. And the CareFusion portfolio has performed in line with our expectations. Second, emerging markets continue to be a key growth driver for the company. We experienced some headwinds this year, particularly in the Middle East and Africa, but remain confident that emerging markets are well positioned for continued growth. We also continue to create new growth opportunities for CareFusion products in these markets and expand their global reach by leveraging BD's international infrastructure. We're on track with our new product approval and submission plans and look forward to providing more color at our analyst meeting later this month. Developed markets continued to show stabilization. And growth has accelerated over the past year. Third, we made key strategic decisions to optimize our portfolio. This included the divestitures of BD Rx and the Spine business in conjunction with the joint venture for the Respiratory business, which we just completed in October. These actions further enable the organization to prioritize and invest in the most important opportunities for future growth. We were deliberate in increasing our R&D investment in targeted high growth areas and fully utilized the benefit of the medical device tax suspension. Fourth, we remain focused on our operating effectiveness and efficiency initiatives, which have generated significant margin expansion. This year, we drove approximately 200 basis points of underlying margin expansion, which includes approximately $120 million in cost synergies. We also delivered robust earnings growth of almost 30%, which is greater than our initial expectations. Lastly, we closed our first full year as the new BD, having achieved all important milestones. And also demonstrated that we are successfully executing on our acquisition of CareFusion. As we look forward, we continue to build on our solid foundation and look to fiscal year 2017 and beyond with confidence. Moving to Slide 5, you will see the guidance for fiscal year 2017 on a currency neutral basis. For the fiscal year 2017, we expect currency neutral revenue growth of 4.5% to 5%, based on our current view of the environment and various macroeconomic factors. There are a number of items that could bring us to the top or bottom end of that range, including a stronger or weaker flu season than expected, the performance of new product launches, emerging market growth, and pricing. On the bottom line we will continue to deliver high quality earnings growth. For fiscal year 2017 we expect EPS of $9.45 to $9.55, or $9.62 to $9.72 currency neutral, which reflects growth of 12% to 13%. Now I'd like to turn the call over to Chris who will walk you through our financial performance in the fourth quarter and full year, along with the additional details about our fiscal year 2017 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. Moving on to Slide 7, I'd like to begin by discussing our fourth quarter revenue and EPS results, as well as the key financial highlights for the quarter and the total year. Total fourth quarter revenues of approximately $3.2 billion grew 6.4% on a comparable basis. Fully diluted adjusted EPS came in ahead of our expectations at $2.12, growing at 16.5% over the prior year. As Vince mentioned earlier, we are very pleased with our solid finish to the year, as the first full year as a combined entity with CareFusion. For the total year revenues grew 4.3%. We significantly expanded our margins and captured approximately $120 million in synergy cost savings. Adjusted EPS of $8.59 exceeded our expectations, driven by solid revenues, margin expansion, and an improved tax rate. In addition to the cost synergies, tax synergies have materialized sooner and have exceeded the benefits we anticipated in the early days of the transaction. We are also pleased to announce that we have continued to delever, as we reduce the debt associated with the acquisition of CareFusion. We are currently at 3.3 times gross leverage and remain on track to achieve our commitment of 3 times gross leverage by March of 2017. On Slide 8 I'll review our revenue growth by segment on a currency neutral basis. Fourth quarter revenue growth was 6.4% for the total company. In the quarter pricing was about flat. BD Medical fourth quarter revenues increased 7.9%. Medication and Procedural Solutions growth was 6.6%, which reflects strength in Flush [PosiFlush], ChloraPrep, and safety engineered products. Revenues in Medication Management Solutions, or MMS, grew 12.8%. This was driven by double digit growth in both dispensing and infusion sales. Respiratory Solution revenues increased 12.7%, as expected. This reflects strong capital installations and a favorable comparison to the prior year period. Growth in Diabetes Care was 3.6%. This reflects solid growth in pen needles which was partially offset by an unfavorable comparison to the prior year period. Pharmaceutical Systems growth of 5.1% reflects strength in our self-injection platform. For the total year, BD Medical grew 4.7%. BD Life Sciences fourth quarter revenues increased 2.7%, primarily driven by growth in Preanalytical Systems and Biosciences. Diagnostic System revenues were about flat compared to the prior year. This reflects continued strength in core microbiology in BD MAX, which grew double-digits in the quarter. This growth was offset by the timing of Kiestra installations outside the U.S., which I will speak to in just a moment. For the total year we are extremely pleased with our Microbiology business with Kiestra growing at about 19%. Preanalytical Systems growth of 4% was driven by safety engineered products and growth in the U.S. and emerging markets. BD Biosciences growth of 4% was driven by continued strong research instrument placements in the U.S., and reagent sales. For the total year Life Sciences grew 3.4%. The headwinds we experienced in Africa negatively impacted segment results by 60 basis points, bringing underlying growth to 4% for the total year. Moving to slide 9, I'll walk you through our geographic revenues for the fourth quarter on a currency neutral basis. U.S. growth was very strong at 7.2%. This was comprised of BD Medical growing at 7.7% and BD Life Sciences growing at 5.8%. BD Medical's performance reflects strong growth in capital placements and a wide range of infusion disposable products in our Medication and Procedural Solutions business. Growth was also driven by our Pharmaceutical Systems business. BD Life Sciences growth reflects strong performance across the segment in the U.S. The growth in our Biosciences business was driven by high parameter research instruments, including FACSymphony, our FACSCelesta midlevel analyzer and the launch of the FACSMelody. Our U.S. Diagnostics business saw continued growth in Microbiology, including Kiestra and the BD MAX molecular platform. The Preanalytical Systems business grew 5%, driven by safety engineered products. Moving on to international, revenues grew 5.2%. This is below our normal growth rate, which is primarily related to the Life Sciences segment. The Medical segment grew 8.2%. This was driven by strong performance from infusion disposable products in the MPS business and strong performance in China. Growth was also driven by medication management, reflecting double-digit growth in both dispensing and infusion. Growth in the Life Science segment was about flat compared to the prior year. We experienced a decline in Diagnostic Systems due to the timing of Kiestra installations. Increased installations in the third fiscal quarter negatively impacted the fourth fiscal quarter in conjunction with a tough comparison to the prior year fourth quarter. Biosciences growth was slower in the quarter due to continued declines in Africa, as we anticipated. The Preanalytical Systems business grew 2.9%, driven by strength in China, which was partially offset by a tough comparison to the prior year period. On slide 10, Developed Markets grew a healthy 5.8%, bringing the total year growth to 4.1%. Emerging Market revenues grew 8.5%, currency neutral, bringing our year-to-date growth rate to 5.3%. China growth for the fourth quarter was 17.7%, bringing the total year growth rate to 10.1%. Growth in Emerging Markets this fiscal year was slower than initially expected in the Middle East and Africa. And we believe those challenges are largely behind us after we exit the first quarter of fiscal year 2017. Emerging Markets remain an important growth driver. And given our robust international footprint, we are well positioned to drive growth well into the future. Looking into fiscal year 2017, we expect Emerging Markets to grow high single digits, driven by a diversified base, with China growing low double digits, continued strength in Latin America, and fewer headwinds in EMA and Africa. In terms of Developed Markets we believe the stability we have seen in the market over the past 12 to 18 months will continue, yielding a growth rate of about 4%. Moving to Global Safety on slide 11. Currency neutral sales increased 5.9% and grew to $783 million in the quarter. Safety revenues in the U.S. grew 5.7%. This reflects continued strength of safety catheters, as well as a benefit from the timing of orders across our hypodermic products. International sales grew 6.2% currency neutral. International performance in the Medical segment was driven by continued strength in China. And safety revenues grew 13.8% in emerging markets. Medical Safety sales grew 7%, driven by infusion disposables, catheters, and a range of safety engineered products. Life Sciences Safety sales, which were driven by our Preanalytical Systems unit, grew 4% in the quarter. Slide 12 recaps the fourth quarter income statement and highlights our currency neutral results. Revenues grew a strong 6.4% in the quarter. Gross profit was strong, growing faster than revenues at 7.9%. And I'll provide more details on gross profit in just a moment. SSG&A as a percentage of revenue was 24.4%. We are very pleased with the leverage we are getting, which is masked in this quarter by key strategic investments in product launches in both segments. R&D as a percentage of revenues was 7.8%, which is higher than normal due to the timing of spend, as anticipated. As a result of the medical device tax suspension, we were able to make additional investments in a number of high growth areas. After normalizing for the significant additional investment in R&D, underlying operating income would have grown about 10% in the quarter. Our tax rate declined to 16.2% in the quarter, due to the reinstatement of the R&D tax credit, tax synergies materializing earlier than expected, and continued favorable geographic mix. In the quarter adjusted earnings per share were $2.12, which is a 16.5% increase versus the prior year. Turning to slide 13 and our gross profit and operating margins for the fourth quarter. On a performance basis gross profit margin improved by 90 basis points, driven by continuous improvement initiatives. This was more than offset by significant currency headwinds of 110 basis points. On an operating margin basis we're extremely pleased to have delivered about 100 basis points of underlying margin expansion. As I mentioned on the previous slide, the leverage we are getting in SSG&A as we continue to drive cost synergies is being masked in the quarter by investments in key product launches. In addition, margin expansion was partially offset by significant R&D investments, as expected, and unfavorable currency. I'd like to take a moment on slide 14 to highlight some of our key operational achievements for fiscal year 2016. The acquisition of CareFusion provided BD a unique opportunity to leverage the transaction to optimize the combined organization through functional transformations. And we have made significant progress in this area. All of our efforts have yielded results, and we are on track to deliver continued synergies. In aggregate we have achieved over $170 million in total cost synergies to date. We have also driven significant margin expansion on a multi-year trajectory. Starting with fiscal year 2015, we delivered 100 basis points of operating margin expansion. This year we achieved another 200 basis points. And we believe we are well positioned to deliver another 175 to 225 basis points in fiscal year 2017. Over those 3 years we will have driven over 500 basis points of cumulative margin expansion. And I believe that we continue to drive robust performance with additional synergies in conjunction with continuous improvement going forward. We are extremely proud of the organization's ability to continue improving on our skills and expertise by executing against our synergy commitment initiatives through these transformations. Moving on to slide 15. I'd like to highlight our robust EPS growth, which exceeded our expectations this year. Starting with 2015 EPS of $7.16, we had communicated last November that we would grow EPS 22% to 23% on a currency neutral basis. Beyond our initial expectations, we delivered an incremental 400 basis points from margin improvement. We also realized incremental benefits from our tax rate improvement, which yielded 300 basis points, bringing EPS to $9.24. Unfavorable currency headwinds impacted earnings per share by 900 basis points. Despite that significant headwind, we were still able to deliver $8.59 of earnings. On a currency neutral basis earnings grew 29.1%, which we believe demonstrates our ability to deliver on our commitments. Moving on to slide 17. There are a number of factors to consider when discussing our earnings per share in fiscal year 2017. For modeling purposes and to ensure consistency, I'd like to provide more color on our EPS guidance. First, as I mentioned, we are extremely pleased with strong EPS growth this year. Looking forward, we expect currency neutral EPS to grow between 12% and 13%. This is partially muted by the impact of the Respiratory JV, as we have previously communicated. Pension also presents a headwind next year of approximately 100 basis points. Contributing to EPS growth is approximately 200 basis points from the adoption of a new accounting standard related to the tax accounting on our stock compensation programs. In addition, we estimate that currency will once again present a headwind. Our guidance assumes a euro to dollar exchange rate of $1.10. On an adjusted basis we expect to achieve very strong earnings of $9.45 to $9.55. Turning to slide 18, I'd like to walk you through the balance of our guidance expectations for the full fiscal year 2017. As Vince mentioned earlier in the presentation, we expect revenue growth of 4.5% to 5%, with BD Medical growing 4.5% to 5% and Life Sciences growing between 4% to 5%. Growth in both segments contemplates a small amount of pricing pressure. From a phasing perspective we expect currency neutral revenue growth in the first quarter to be below this range. This is primarily due to some lingering softness in the EMA region and the timing of tenders in our Biosciences business. This will result in a currency neutral revenue growth of about 4% in the first fiscal quarter. We expect revenue growth to return back to our guidance range in the second fiscal quarter with continued acceleration over the back half of the year. We expect gross profit margin to be between 53% and 54%, which is a significant milestone for BD. SSG&A as a percentage of sales is expected to be between 23.5% and 24%. Our guidance also reflects continued investments in emerging markets as well as costs related to new product launches and registration cost. We expect our R&D investments to be in line with fiscal year 2016, at about 6% to 6.5% of revenues, as we continue to invest in new products and platforms. As a result of the items I just detailed, operating margin is expected to be between 23% and 24% of revenues, up from 20.8% (sic) [21.8%] this year. Excluding the unfavorable impact of foreign currency, we expect our underlying operating margin to improve by 175 to 225 basis points. This also excludes slight pension headwinds. We expect our tax rate to be between 17% and 19%, driven by tax synergies, favorable geographic mix, and a benefit from accounting change in our stock compensation program. For fiscal year 2017 we anticipate our average fully diluted share count to be approximately 219 million. Cash flow is expected to remain strong with operating cash flow of about $2.7 billion in fiscal year 2017. Capital expenditures are expected to be about $700 million. In summary, we have good momentum exiting this fiscal year. And looking forward into 2017 we are building off a solid foundation. I'm confident that fiscal year 2017 will be another strong year of performance, positioning us well for continued success. Now I'd like to turn the call back over to Vince, who will provide you with our concluding remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. Moving on to slide 20. We are pleased with the progress we continue to make on our pipeline and believe we have the most robust pipeline in the company's history. We have recently obtained a number of approvals. I'll touch on just a few. On the Medical side of the business we are pleased that our partner, Fresenius, received their first FDA approval for IV solution products. Additional approvals are expected. And we are on track to start shipping these products late in the first half of the year. Last quarter we received our first orders for FlowSmart, our new insulin infusion set, where Medtronic serves as our distribution partner. Early patient feedback has been extremely positive. On the Life Science side of the business, we are pleased that the FDA has approved the BD MAX vaginal panel and also the GC/CT/TV [CT/GC/TV] assay. We launched our new Phoenix ID/AST instrument. We launched the FACSMelody and received approval for Barricor in the U.S. We plan to share more about our pipeline on November 17 at our upcoming analyst day. Also on analyst day we will discuss the company's strategy and vision for the future and how we are helping to address healthcare's most pressing challenges. The segment leaders will do a deep dive into our business units, which will include some key product launches that we will be unveiling for the first time. We will conclude the day with a financial framework that will outline our plans for sustainable revenue growth, continued margin expansion, strong cash flow generation, and capital deployment. And ultimately demonstrate how all of those things will drive long-term value not only for our customers and patients they serve, but also for our employees and our shareholders. Moving on to slide 21, I would like to reiterate the key messages from our presentation today. First, we're extremely pleased with our first fiscal year as the new BD. We believe that we have demonstrated that we can successfully execute on the integration of our – of the largest transaction in the company's history. Second, the diversity of our portfolio from a product and geographic perspective provides consistent and reliable earnings growth. Third, we continue to invest in key strategic areas and at the same time deliver significant margin expansion and double digit earnings growth. We're looking forward to sharing more details about our pipeline at our analyst day in 2 weeks. We believe we have the most robust pipeline in the company's history. And we look to fiscal year 2017 and beyond with confidence. Finally, I would like to say thank you to all of our associates around the world for our successful first full fiscal year as a combined company with CareFusion. It's a testament to the hard work of all of our employees that we delivered on our commitments. I believe we have a tremendous opportunity to create a true industry leader, as we continue to advance the world of health. So with that, thank you. We will now open the call to questions.
Unknown Speaker:
Operator. Thank you. Our first question is coming from Mike Weinstein with JPMorgan.
Michael Weinstein - JPMorgan Securities LLC:
Good morning, guys, and thanks for taking the question. So as a starting point, Vince, I'd love to hear your thoughts, just as you looked at FY 2017 about some of your end markets. And some of the businesses, as I look over the quarter and the full year 2016, did a little bit better. Some businesses were a bit more challenged. And so maybe just focusing a bit on the more challenged businesses first, can you just talk a little bit about some of the headwinds that you saw? Particularly internationally in the Life Sciences business this quarter, this year? And how you think about some of those end markets in FY 2017? And then if you think about that in aggregate, that 4.5% to 5% revenue growth target for FY 2017, what gets you to the higher end of that range? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Yeah, Mike, sure. Happy to do that. I feel good about the 4.5% to 5%. And let me walk through the markets, and I'll hit the Bioscience issue which you brought up, which was really the real drag, along with, quite frankly, the flu early on in the year. So from a market perspective, let me just start with the developed markets. The developed markets certainly have stabilized. And you've seen that our growth rate going up in the developed markets, in the U.S. The U.S. was very strong by the way, including Biosciences. Europe was good. Japan was good. So we feel good about our position in developed markets and the product pipeline we have for those marketplaces. If I come to emerging markets, the issue really this year was, number one, Saudi Arabia, where we saw the government do a 35% cut of all types of expenses, not just healthcare. And that will annualize during the year. We already saw stabilization in Saudi Arabia. In terms of Africa, Africa was basically CD4 testing. And CD4 testing was driven by, one, some conversion to viral load, and two, actually confusion over a change in the purchasing organization for CD4 and viral load. And we think we have one more quarter of that. We did start to see some CD4 orders come in in the fourth quarter and a little bit of a rebound. But we know we have that in the first quarter, and then that annualizes and improves. Coming back to opportunities on China. You saw the strong growth in China in the fourth quarter. If you actually go back and look at China, after the first quarter, where we had some inventory takedown, China was strong for the other three quarters. We expect that to continue. It was especially strong this year on the Medical side of the business. And we think we're well positioned with the work that Tom and the regulatory team have been doing with the CareFusion product lines there. And as I've mentioned on previous calls, we've started with some of those product lines, kind of the simpler disposables. And I'm sure Tom will talk more about that later on in the call. If there was any softness in China this year from a true demand standpoint, it was on the Life Science side. And it was related to those anticorruption campaign. And what we saw was stabilization starting in the third quarter and continuing into the fourth quarter. And Alberto can mention to you, he's starting to get ramped up. The Bruker deal in China as well, which was a whole new thing for us. We had to learn how to do that and work our way through some issues. So we feel good about China. The rest of Asia has been good. Latin America has performed well this year, in spite of all those issues in Brazil. It's been the rest of the geography that has done fine. Come back to the 4.5% to 5%. Then the other element that you have to think about is two other things. One is we will not have Respiratory anymore. And that has been a bit of a headwind for the company. And then we think in the back half of the year you'll start to see more traction with our product launches. Things like Barricor, they have to do the validation first. So that takes a little while to get going. Customer feedback has been excellent. Alberto can talk about the product launches that you heard for BD MAX. Those are really critical assays to that program. We're excited about them. And so there's a whole list of these things. And we'll show you more about that as we do the analyst day. So that's the way we're thinking about it.
Christopher R. Reidy - Becton, Dickinson & Co.:
One way to sum that up – this is Chris – is that if you back out the light flu season and the headwinds from Africa and Saudi, the rest of the business was at the high end of the 4.5% to 5% this year alone. We see those headwinds abating after the first quarter. Because it really came up in the second quarter – second, third, and fourth of this year. So we still have a little bit of a tough compare in the first quarter that we talked about, particularly in Saudi and Africa. But once we get through that with the new product launches that we're seeing, the strength of the rest of the business, we feel real good about our prospects for 2017.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So what takes you to the top end of the range? Obviously, if those product launches, we get faster traction on them, number one. Two, with flu, flu was very mild last year. It's hard to believe that it would be milder. So if we got a strong flu season, that would take us up, too. Those are probably the two factors that I see. So thanks, Mike, for the question.
Operator:
Thank you. Your next question comes from David Lewis of Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Two quick questions. I'll just – I'll throw them both at you here and jump back in queue. So I guess first off, hats off to Antoinette and the tax team in reaching your target here at least 2 years early from our model. So, Chris, is this a structural kind of new low? Can you do better? And obviously, you're reinvesting these savings both in the fourth quarter and next year. Can you give us a sense of where the 2017 reinvestment is going? And can you do better than these levels long term? And then for Vince or Tom, o-U.S., Pyxis, and Alaris, very strong this particular quarter. Can you talk about the drivers? And sort of update us on how those numbers relate to progress on the CareFusion cross sell? Thanks so much.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure, David, thanks for the question, and thanks for the call-out to Antoinette and team. We've been talking about taking the tax rate down to the high teens for some time now. And we've been making great progress against that. As we mentioned on the last call, the tax synergies coming from CareFusion happened faster and greater than we ever expected. And so we're seeing the benefit of that. So as we look out into next year, we see that bringing us to the high teens. Then we've got the benefit of the stock comp accounting adjustment. That brings us down to the 17% to 19% range. So this move down is part of the march down in the tax rate that we have been seeing, coupled with the benefits that we're getting from the synergies from CareFusion. And so we really feel good about that. We've also closed out a lot of tax exams in multiple jurisdictions. We're part of the IRS's CAP program, so they're auditing us on a real-time basis. So the sustainability of this tax rate is extremely strong. And we feel real good about it.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay, thanks, Chris. Tom, you want to pick up on the second part?
Thomas Polen - Becton, Dickinson & Co.:
Hi, David. So as you mentioned, MMS had a very strong quarter, a little under 13% growth in the quarter, about 7% growth for the full year. And maybe just to touch base on the two areas that you mentioned, Pyxis and Alaris. Certainly, Pyxis ES continues to go very well. We had talked earlier in the year about some of the process improvements we had made to accelerate the installation process. I think you're seeing the results of that work come to fruition now with faster installations, getting those systems in. We now have over 1,100 sites live on ES or about a third of our install base is now upgraded to the ES platform. And the receptivity is very solid. And we expect strong demand on that going forward. Alaris, we continued to gain about 2 to 3 points of category share this past year in FY 2016. And we're looking at kind of a similar progress outlook for FY 2017 as well. And so we certainly do have organizations that are cross selling those as an integrated offering. You'll see at analyst day us talk about some new informatic capabilities and other new products coming out that will further strengthen the integration and the value that we can deliver to customers who are using that complete end-to-end offering. And so we'll look forward to talking to you about that very shortly.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Tom.
Operator:
Thank you. Your next question comes from Kristen Stewart of Deutsche Bank.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, Kris.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Hi, good morning, thanks for taking the question. I was just wondering, as you're approaching your I guess targeted debt levels, how you guys are thinking about M&A kind of beyond that? Are you guys looking at doing some strategic tuck-ins? Or just given the success that you've had with CareFusion, whether or not you'd be willing to do another larger deal? Or would it be back to doing more share repurchase activity?
Vincent A. Forlenza - Becton, Dickinson & Co.:
So, Kristen, thanks for the question. When we think about M&A, we are strategy driven and shareholder value driven. And so the size of the transaction actually follows from the strategy. As Chris mentioned, we're about 3.3 [times] right now. By the time we get to March, we're pretty sure that we're going to be meeting our requirements to the rating agencies. What I would say is that gives us more flexibility around those strategic imperatives. And so we believe we now have the capability to do large. And of course continue to have that capability to do tuck-ins. And a little bit more flexibility to do the tuck-ins in the short run than we've had over last 2 years. And so I'm not sitting here saying we're going back to do a large one. We'll be strategy driven around this, with increased flexibility and capability that we have built over the last couple years. Chris, you want to talk about share buybacks?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, sure. So what I would say though is in addition to that, the continued strong cash flow is terrific. So we have a lot of flexibility. And as Vince mentioned, the balance sheet will be very strong. It is strong now at the 3 times 3 (sic) [3.3 times], but when we get to 3 times leverage, we get a lot of increased flexibility. So as we think about the use of that cash flow, we'll probably do something on the dividend rate. You know that the payout ratio has come down a little bit. We increased 10% a year for the last couple years. The good news is our EPS has gone up over 20%. So the payout ratio has come down a little bit. And we will have to address that going forward. I think CapEx, as you think about it, will be in the $700 million range. That's pretty consistent with where it has been. So that leaves a lot of cash left over. We'll allocate some of that for tuck-in acquisitions. And that will still leave a lot of cash left over. And we're not going to let that cash build up on the balance sheet. So we'll return to doing some share buybacks. You'll hear more about that at analyst day. And certainly as we approach the March period of getting to the 3 times leverage, we'll be giving a little bit more specificity on where we're going. But the good news is, really strong cash flow and a really solid balance sheet with a lot of flexibility.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Okay. Great. And then just one other question. You had mentioned building in a little bit more pricing pressure into the forecast. Can you maybe comment on where you're seeing a little bit more pricing pressure, or expecting that to occur?
Vincent A. Forlenza - Becton, Dickinson & Co.:
So we haven't really seen the environment change all that much. We know that there's going to be pricing pressure. We've talked a lot about it being in Europe. And of course over the last few years we continue to see consolidation in the U.S. marketplace. So I think we're being prudent in terms of how we're thinking about this. And we'll continue to work as we have in the past to offset it.
Christopher R. Reidy - Becton, Dickinson & Co.:
And it's already built into the range of guidance that we're giving.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Right.
Christopher R. Reidy - Becton, Dickinson & Co.:
So it's kind of the part of the range is the pricing.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Kristen.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Thanks very much, guys. Thank you.
Operator:
Thank you. Your next question comes from Rick Wise of Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, Vince. Hi, Chris.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Maybe I'll start off with the gross margin. Chris, you emphasized, underscored the excellent gross margins and hitting significant milestones. I'd just be curious to hear your thoughts on your aspirational goals from here over the next 2 to 4 [years], 3 to 5 years. And maybe talk about the drivers, volume cost, mix. I mean what gets us to those higher levels I have no doubt you aspire to?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. Thank you, Rick. We are really pleased with what we've seen this year. The FXN growth rate was 140 basis points. That's a little bit of synergy from CareFusion. But more it's just the continuous improvement that we've demonstrated that we can execute on within our operations group over the last few years. And as we look forward, the guidance that we gave of 53% to 54%, and that would be inclusive of FX headwinds and pricing headwinds, et cetera, is extremely strong. It's a significant milestone for us to hit that 53% to 54%. We do see a little bit of more synergies coming, because as we execute on the synergies that affect gross profit and the cost of goods sold, which we said would come towards the latter end of our synergies, and that is the way that it's playing out. But again continued continuous improvement in that area. So feel really good about the gross profit margin. Also that flows down to the operating margin. So as we mentioned, this year 200 basis points, last year 100 basis points, next year in that 200 basis points kind of range. 500 basis points in total, again driven both from execution of the synergies as well as continuous improvement initiatives. So feel real good about that. And as we look forward even past next year, 2018 will have continued cost synergies. And you'll see some benefits from that. So all in all, really strong margin improvement. And we feel real good about it
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Rick.
Operator:
Thank you. Your next question come is from Larry Keusch of Raymond James.
Lawrence Keusch - Raymond James & Associates, Inc.:
Thanks, good morning, everyone. I was just wondering if we could go back and expand a little bit on – I know Tom talked a little bit about Alaris. But I was wondering if you could weave in some thoughts around the Fresenius IV solution that was approved, a little bit about what you do anticipate launching with towards the end of the first half, and what drives that share gain for the year that you're sort of suggesting of 200 to 300 basis points.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Thomas Polen - Becton, Dickinson & Co.:
Hey, Larry, this is Tom. So that share gain that we saw this year is actually relatively consistent with the share trajectory that we've seen over the last, let's call it 4 to 5 years within the Alaris platform. I think what customers certainly value in the platform around the power of one, the ability to do not just large volume but also syringe based and narcotic infusions off the same platform, as well as its leading interoperability position with electronic medical records are some of the key reasons why people have been choosing it at a higher rate and continue to do so going forward. Again we do have some new technologies being added to the platform, which we'll share also at the upcoming analyst meeting. So we're very positive on the outlook there. I think we think about IV solutions, and we've mentioned before, that you're going to see a – I would expect a rolling series of approvals on that platform. This is the first. Of course, there is a number of different formulations of IV solutions as well as bag sizes when you think about building out a portfolio that customers really need to run their institution. And so what you just saw get approved was the first in a series of products. And we would expect additional products to be coming out over the months ahead. And that leads us up to where we'll have an early critical, kind of mass of a portfolio for a launch at the end of the first half of the year. Thank you.
Operator:
Thank you. Your next question comes from Vijay Kumar of Evercore ISI.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, Vijay.
Vijay Kumar - Evercore ISI:
Hey, guys. Hey, morning, guys. It looks like the numbers were actually a lot better than what it seemed like at first blush there. Just maybe a couple of questions from the guidance, Chris or Vince. What does the guidance assume from a pricing assumption for next year? And can you just talk about the quarterly cadence, Chris? Because obviously this year was a back half loaded on the revenue front. And given the flat share count and your comments on free cash generation, it looks like maybe there's some upside from cap deployment potentially. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, pricing is just slightly negative in the plan. And as Chris said, it's already in the guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, which is no different than the beginning of just about any year. You got to look at that. The pricing environment, as Vince said, hasn't really changed. And so then I think the next part of your question came to the phasing of revenue going forward. And as we said, we do see some headwinds continuing as we annualize the headwinds from Saudi and Africa. That'll bring us down in the area of about 4% in the first quarter, plus or minus 20 basis points, particularly as that's a high quarter for the flu. So it could go one way or the other on us. But then the ramp in the second quarter brings us back well within the range, the high end of range. And the ramping of new products we see in the second half of the year brings us back to a strong 4.5% to 5% range. So that feels real good. In terms of capital deployment, the share buybacks, we were committed to not buy back any shares, other than what we've already done for Respiratory, which we've talked about. But we're not looking to do anything until we get to the 3 times leverage. We want to hit that commitment that we had. And that brings us through March, so halfway through the year. And then from that point on, you're right. There could be some. But you don't get the full year impact of that at that point. So more to come on that. But there is some potential as we buy back shares to have a little bit of impact on 2017, but probably more likely the impact would be on 2018.
Operator:
Thank you. Your next question comes from Brian Weinstein of William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Hey, guys. Thanks for taking the question. You'll obviously excuse the crackly voice this morning. It was a late night for us in Chicago, and a good one, a very good one.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Congrats on that.
Christopher R. Reidy - Becton, Dickinson & Co.:
Congratulations.
Brian D. Weinstein - William Blair & Co. LLC:
Thank you. Wanted to ask about kind of U.S. headwinds that we've heard about from others, specifically flu year over year was a tough comp for a lot of people. Utilization seems to be a little weaker. We're hearing about things taking longer to get through committees on capital projects and worked out of inventory distributors. So how do you guys think about those? And how do you think about kind of the U.S. market going forward? What are the positive offsets that you're seeing to those? And are you guys seeing any of those same headwinds that I described? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well we're generally not procedural driven. An Alaris conversion to make the hospital safer and more effective, they're not being driven by this on the margin procedures. And in fact Tom was talking about interoperability before. And just to give an example, Brian, we were at one account, and we were saving 5 million keystrokes a year. It's a kind of thing that you want to do in this environment. And it was a very intentional part of our strategy. So what I would say is generally across the board, we're seeing pretty good stability and some increase. We're just getting started with Kiestra , for example, in the U.S., which is a major cost saving, whether it's in the hospital market or in the clinical lab market. And so we don't have a lot of exposure to the kind of headwinds that you were mentioning.
Christopher R. Reidy - Becton, Dickinson & Co.:
I think what demonstrates that, Brian, is the 7.2% growth we saw in the U.S. across the company, which was strong in both segments, 7.7% in Medical and 5.8% in Life Science. And I'd also point to Biosciences growing in the U.S. around 8% for the quarter and for the year. A lot of that was new product introductions, the Symphony [FACSymphony], Celesta [FACSCelesta], the new Melody [FACSMelody] introduction, whatever. So U.S. is feeling particularly strong for our business.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Brian.
Operator:
Thank you. Your next question comes from Jon Groberg of UBS.
Jonathan Groberg - UBS Securities LLC:
Hey, thanks a million. So Vince, it's the first analyst day coming up since – in November here since 2011. And I know you don't want to give away all the details. But just kind of big picture, maybe you can help us understand what you hope people take away from the meeting?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. I hope that they take away a true understanding of when we are talking about this move to complete solutions for the customer based on anchor products and then value-added services, all the way to complete solutions, what that means from a portfolio standpoint. And when I'm saying that we have the most robust pipeline in the history of the company, I want you to understand what that all means. And we will lay that out for you in a lot of detail. So that's number one on the list, that you understand why we have that confidence going forward. And I think it's going to be fun, quite frankly. It was fun doing this 5 years ago. So I'm looking forward to it. And then we're going to take that, and Chris is going to kind of give you a financial model of how this all holds together. And lastly, we're going to talk about the capabilities that it's going to require to do all this. And we're going to show you how we built the capabilities foundationally over the last 5 years. And then how we build upon them. Tom mentioned informatics, for example. But we'll also get into how we approach emerging markets, what's different about our strategy, and why we see that continuing to work. And some of the other capabilities that we will be bringing to bear, which all is an extension of the work we've done over the 5 years. So that's the kind of day and look forward to seeing you there, Jon.
Jonathan Groberg - UBS Securities LLC:
Great. Look forward to it. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Operator:
Thank you. Your next question comes from Bill Quirk of Piper Jaffray.
William R. Quirk - Piper Jaffray & Co.:
Great. Thanks. Good morning, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning.
William R. Quirk - Piper Jaffray & Co.:
Couple of questions here. First off, international safety, Vince, you mentioned China in particular as the standout. Just remind us where we are on the ongoing European conversion. And then secondly, the Life Sciences business, at least relative to Medical, has been a little less predictable. And we certainly appreciate all the new product launches, both in launch as well as the near term development. But do you think this can improve the predictability of the business? Or do you think we may have to look at some tuck-in deals to improve the consistency? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well let me just take Life Sciences first. And the lumpiness that we've seen on Life Sciences, there's two elements. One is just Kiestra, which is a positive thing. These are big installations. They're $2 million. And so you're seeing some quarterly jump arounds as customers are ready for us to install. And because there's some major changes that they have to make to the laboratory, number one. Number two, and we've had this issue with Africa, and that's been a bit of a problem. We think that's going to annualize. Are we interested in tuck-in acquisitions there? Absolutely, as we are on the Medical side. I'm just going to ask Alberto to comment on Kiestra. And kind of what you're seeing from a pipeline standpoint. And how you see the U.S. market evolving, because we just got started there.
Alberto Mas - Becton, Dickinson & Co.:
Yes, good morning. Where we're seeing the most growth and positive growth is in the U.S. market. Traditionally this has been an acquisition that was based in Europe and that market was most developed there. But we're beginning to see some significant traction here in the U.S. In fact the sales this last year doubled versus the previous one, admittedly on a small base. But we're seeing a lot of positive momentum, especially as we build the platform. And you'll hear the capabilities of the platform that you'll hear about in the analyst day. So we would continue to build on those capabilities. And that gets the customers very excited about the future of the platform, not only the present of the platform.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Great. And so the second part of the question was on where are we in Europe from a Safety conversion standpoint. And if I remember right, Tom Polen gave you a baseball analogy last quarter. So what inning are we in, Tom?
Thomas Polen - Becton, Dickinson & Co.:
Yeah. Hey, Bill. Tom. So we're in the middle innings when it comes to E.U. Safety. And maybe it'll be an overtime as well, like there was last night. But overall, we see Safety continuing to perform well in Europe. Compliance with the regulation certainly is fueling that. We see implementation strongest in the conventional hospital settings, a little weaker in the alternate settings. That's true in most markets where individual doctor compliance may be less than a large, governed hospital setting. Strongest conversion rates we see in infusion therapy and blood collection, a little bit lagging in injection. That's also the exact same trend that we saw in the U.S. So still good growth prospects there. And we're in the middle innings. You also mentioned China. Overall, in Emerging Markets we see Safety in the very early innings at less than 15% conversion, so still quite a ways to go.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay, thanks very much.
Operator:
Thank you. Your next question comes from Derik de Bruin of Bank of America.
Derik de Bruin - Bank of America Merrill Lynch:
Hi, good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Morning, Derik.
Derik de Bruin - Bank of America Merrill Lynch:
A lot of the questions been answered. But just wanted a little bit more color on sort of your emerging market expectations. I mean there was a number of reductions in terms of the outlook and the growth over the year – or during 2016. And I realize a lot of that was sort of due to the Africa and the Middle East situation. But what sort of gives you confidence that that's going to reaccelerate this year, other than tougher comps, or easier comps? What are you sort of seeing right now that gives you confidence that that's going – you're not going to have to face another slower year?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well I think you have to start with Saudi Arabia, which was a major impact to our emerging market growth this year. And as I said, government policy was, cut all expenses by 35%. Now if you're going to run your healthcare system, you can't just stop buying product, number one. So our expectation was they were running down their inventories, and then – and they would start to buy. What we've seen in this quarter was stabilization there. And so it didn't come all the way back to positive growth, but there was significant improvement. So that gives us a sense that our hypothesis in this case is right, number one. Number two, it's really Africa and the annualization of Africa. It was still negative. But we started to see, and Alberto could give you more detail, some CD4 orders starting to come in, which we did not see. So, and then we saw good performance across Asia, as I was mentioning before. I expect that to keep happening. I expect Latin America, that Brazil is going to remain status quo. And we're going to continue to see strong growth in the other marketplaces. But, Alberto, any other comments on CD4?
Alberto Mas - Becton, Dickinson & Co.:
Yeah. I just want to go back to a comment that you said before, in terms of the change in the supply chain.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, yeah.
Alberto Mas - Becton, Dickinson & Co.:
That created a little bit of instability in the ordering process and the delivering. And that created a little bit more variance than we had anticipated too.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, where people didn't know how to order.
Alberto Mas - Becton, Dickinson & Co.:
Yeah.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And that's behind them. Then, Chris?
Christopher R. Reidy - Becton, Dickinson & Co.:
I think the other point is that China, we saw a little bit of inventory adjustments in the first quarter of last year. But since then, as Vince mentioned earlier, it's been growing very nicely. And you see the fourth quarter grew extremely nicely. A little bit of an easier compare there, but still very strong. Vince and I and Tom just got back from China. I can tell you that there's a lot of enthusiasm for the – some of the newer products that we're bringing in. So we see a lot of good stability. And as we mentioned, we're looking at low double digits on China in the next year.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And then the last piece is that we do expect to start getting some traction with the CareFusion products. And that's tens of basis points for the corporation, but it's more than that obviously for the Emerging Markets.
Operator:
Thank you. Your next question comes from Doug Schenkel of Cowen & Company.
Doug Schenkel - Cowen & Co. LLC:
Hi, good morning. Just a couple topics. First, could you provide a bridge for 2017 operating margin guidance? I guess I'm just trying to get at how much of this is synergies, removal of respiratory, mix, et cetera. And then second, on the topic of new products, what was new product contribution to 2016 revenue growth? And looking ahead to 2017, it seems like new product contribution to organic growth should account for a bigger part of overall growth, as you accelerate revenue synergies and some important launches, such as the infusion sets. Could you comment on that? Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
So this is Chris on the first part of that question. As we look at the margin next year, the roughly 200 basis points of operating margin, about 50 basis points of that from the normal continuous improvement kind of stuff, another 50 basis points coming from cost synergies, and about 100 basis points coming from the Respiratory JV coming off our income statement. So we get a benefit there. And on the gross profit, it's roughly the same kind of area. There's a benefit from Respiratory. About half of it coming from Respiratory, about half of it coming from CI and synergy.
Vincent A. Forlenza - Becton, Dickinson & Co.:
In terms of new products, the growth that you're seeing in Biosciences is really driven by the new product instrumentation. So I can point you directly to that. But in terms of the other major new product launches that we are talking about, they really haven't gotten traction yet. Barricor, people are just starting to validate Barricor. The approvals on BD MAX we just got in the last month or so. So they really haven't hit. And then you're talking about tens of basis points in terms of the CareFusion products in the emerging markets at this point in time. We haven't done the – we haven't completed the work, let me say it that way – in terms of trying to get a really good analysis around breaking out new product from the entire company. As we're going through the CareFusion integration, we haven't counted the geographic extension of those products as new products. But we're working our way through that. And you'll have a better sense after the analyst day of how this is coming together.
Operator:
Thank you. Your next question comes from Matt Taylor of Barclays.
Matthew Taylor - Barclays Capital, Inc.:
Hi. Thanks for taking the question. I was wondering if you could comment, given that you do have some bigger product cycles here coming up in the fiscal year, and one of the more robust pipelines at the company. Could you comment on some of the bigger opportunities, like fluids, diabetes, and some of the diagnostic launches, in terms of how we should expect the revenue contributions from those to flow? Help us size them? And just give us some thoughts on timing?
Vincent A. Forlenza - Becton, Dickinson & Co.:
So I'll ask Tom to start with talking about diabetes and FlowSmart. Okay?
Thomas Polen - Becton, Dickinson & Co.:
Okay. Hi, Matt, this is Tom. So certainly we're excited about the upcoming launch or the recent launch of the infusion set. In September we did make our first shipments to Medtronic on the MiniMed Pro-set with our FlowSmart technology. Medtronic has begun shipping that to patients. And the feedback that we're hearing is very positive. And there's been a number of bloggers actually write their experience. You can look that up online. But it's very, very good feedback as that's moved into the marketplace just over the last couple months. We do expect that that pilot will expand to a broader full launch in early Q2. And that's well on track. So I think back to one of the earlier questions, as we think about within the Diabetes Care business, we do expect – and obviously we don't give guidance by business unit. But we expect an uptick in 2017 in Diabetes Care, driven by that FlowSmart launch. And that's on track, proceeding as planned.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. So Alberto, why don't you comment on BD MAX and Barricor as well, in terms of kind of phasing on those things?
Alberto Mas - Becton, Dickinson & Co.:
Yes. So for the BD MAX, the two approvals that we got in the U.S., FDA approvals, we're very excited about, because they're very unique assays. They're very differentiated assays that will bring a lot of value to the market. The CT/GC/TV assay is the first one that is integrated, which is a guideline from the CDC to do the three tests all in one. And we're the only ones that will have it in the same assay. The vaginal panel will be a significant improvement versus the only approved assay, the Affirm assay that we have out there will be better accuracy, more targets, and much improved performance from that side. That will take a little bit of time to be built into the sales, as people evaluate and accounts evaluate and convert to these. But we are very, very optimistic. And all the interest has been very high in both accounts. And on Barricor, similar thing. The evaluations are beginning to happen. There's more than 50 accounts currently evaluating the Barricor products. And that momentum we anticipate to continue in the rest of the year.
Vincent A. Forlenza - Becton, Dickinson & Co.:
So if you think about it, Alberto, from a cycle standpoint, an evaluation of a new assay takes about how long generally? 90 days? Customer...
Alberto Mas - Becton, Dickinson & Co.:
Yeah, between – yeah. I would say between – the quickest 45 [days] to it can be up to 100 days. So somewhere in there.
Vincent A. Forlenza - Becton, Dickinson & Co.:
To 100 days.
Alberto Mas - Becton, Dickinson & Co.:
Yeah.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. And then you have to – they got to work off their old inventory and whatnot.
Alberto Mas - Becton, Dickinson & Co.:
Correct.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Now the last piece we haven't mentioned at all, and we will talk to you about it at the analyst day, of course is Genomics. And Genomics, where we stand there is for BD CLIC, we are putting our first instruments as early access into customer accounts. So they will just start to do their validations as well. And so I don't expect that to be a big contributor this year. I expect since it's such new technology, it's going to take a little longer. But we're also starting to get good feedback there. Anything else you want to add?
Alberto Mas - Becton, Dickinson & Co.:
And we will be issuing and launching new protocols as well, new assay protocols...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Alberto Mas - Becton, Dickinson & Co.:
...as we go along the year.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Alberto Mas - Becton, Dickinson & Co.:
And that will build up momentum at the same time.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. It's really coming into I think 2018 with those protocols.
Alberto Mas - Becton, Dickinson & Co.:
Yeah.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks very much for the question.
Christopher R. Reidy - Becton, Dickinson & Co.:
Christy, do we have any other questions?
Operator:
Yes, your final question is coming from Richard Newitter with Leerink Partners.
Richard Newitter - Leerink Partners LLC:
Hi, guys. Thanks for squeezing me in.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, no problem.
Richard Newitter - Leerink Partners LLC:
Just you've now had some time to kind of digest all the opportunities that maybe you had in front of you, that CareFusion had in front of it, but didn't have the means to exploit. And I'm thinking a little bit more about the dispensing business in Europe. And I know the business model in that part of the world is just different, and it hasn't historically lent itself well. But I do believe you had begun to talk a little bit about Rowa and leveraging that technology.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Richard Newitter - Leerink Partners LLC:
I'm just wondering if that's going to factor in in 2017 in the cross sell or the synergy phase of the acquisition integration? And any kind of thoughts there? And is that something that we could hear more about at the analyst day? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yes, you will hear more about it at the analyst day. It's not so much a cross selling opportunity, but an additional opportunity is the way that I would think about that. And we will share that, because we haven't kind of detailed what that product line looks like for you. And there's multiple aspects to that. So, yeah, we'll be happy to talk about that. Thanks for the question.
Operator:
Thank you. I will now turn the floor back over to Vince Forlenza for closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well thank you all for your participation on the call today. It was a pleasure going through, which was a strong year for BD, to talk about 2017. And we're looking forward to getting together with you at the analyst day in 2 weeks. So thanks very much, and we'll see you there.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Linda Tharby - Becton, Dickinson & Co.
Analysts:
Rick Wise - Stifel, Nicolaus & Co., Inc. David Ryan Lewis - Morgan Stanley & Co. LLC Lawrence S. Keusch - Raymond James & Associates, Inc. Brian D. Weinstein - William Blair & Co. LLC Vijay Kumar - Evercore ISI Derik De Bruin - Bank of America Merrill Lynch Jonathan Groberg - UBS Securities LLC Justin Jordan - Jefferies International Ltd. Robbie J. Marcus - JPMorgan Securities LLC William R. Quirk - Piper Jaffray & Co. Doug Schenkel - Cowen & Co. LLC Matthew Taylor - Barclays Capital, Inc. Ravi Misra - Leerink Partners LLC Kristen Stewart - Deutsche Bank Securities, Inc.
Operator:
Hello, and welcome to BD's Third Fiscal Quarter 2016 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 11, 2016 on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 44231624. I would like to inform all parties that your lines have been placed on a listen-only mode until the question-and-answer segment. Beginning this call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Crystal. Good morning, everyone, and thank you for joining us to review our third fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. As a reminder, we annualized the acquisition of CareFusion in March. And as such, our third quarter results reflect the new BD in both the current and prior-year period. In addition, comparable prior-year revenues are adjusted to exclude sales related to the terminated agreement with CareFusion for the sale of Fisher & Paykel's respiratory care products. The fiscal year 2016 comparable revenue guidance provided today will also exclude the year-over-year impact of this contract termination. The impact to the bottom line is not material and is included in our EPS guidance. Comparable organic revenues are adjusted to further exclude the impact of non-annualized acquisitions and closed divestitures. Details of the purchase accounting and other smaller adjustments and the comparable basis revenue results can be found in the reconciliation to GAAP measures in the financial schedules, in our press release or the appendix of the Investor Relations slides. At this time, we would like to announce some leadership changes, which will take place on October 1. Jerry Hurwitz, Executive Vice President of HR and Chief Human Resources Officer, has announced his intention to retire from the company. We thank Jerry for his many contributions and his 24 years of service to BD. We are also very pleased to announce that Linda Tharby will be our next Executive Vice President of HR and Chief Human Resources Officer, effective with Jerry's retirement. We are confident that Linda's drive for performance, combined with her strong strategic agility and passion for people development, will make her well suited to lead HR. Linda's appointment helps the company meet a unique business need and enables Linda to gain personal development on the functional leadership side. We are also pleased to announce that Alberto Mas, currently the Worldwide President of Diagnostic Systems, will succeed Linda as Executive Vice President and President of the Life Sciences segment. Having served as president of three major business units during his 24-year career at BD, Alberto is uniquely positioned for this next step. Since assuming his position of Worldwide President of Diagnostic Systems in 2013, Alberto has focused the business on reinventing the lab through automation and standardization and advancing our position in molecular diagnostics through differentiated assays. We are confident that both of these leaders will make major contributions to our future success as we build a bigger, better, bolder BD. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, Executive Vice President and President of the Medical Segment; and Linda Tharby in her current role as Executive Vice President and President of the Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. Before we discuss the company's performance in the quarter, I would like to comment briefly on the organizational changes Monique just mentioned. Over the past several years, we have continued to strengthen our leadership team through a diversity of experiences and perspectives to form a global team that helps ensure our future success and the continued development of our senior leaders. Our leadership team is designed to support the company's strategy and increased focus on growth, as we develop more impactful solutions for our customers. We're extremely pleased to announce Linda and Alberto's new roles, as they help lead the company through our next phase of growth. Now, turning to slide four and the company's results. We're pleased with our third quarter growth profile. Performance from both the Medical and Life Sciences segments contributed to solid organic revenue growth that was in line with our expectations. Our results this quarter continue to highlight our consistent performance and the benefit of our diverse portfolio. We continue to drive strong underlying margin expansion through the achievement of synergies, operational efficiencies and continuous improvement. We're also increasing our R&D investment in key strategic opportunities and expect to fully utilize the benefit of the medical device tax suspension. As we've shared with you, we have a robust pipeline and look forward to sharing new opportunities with you in the near future. Looking ahead, I feel good about the business and our performance year-to-date gives us confidence in our full year outlook. Moving to slide five. I will review our third quarter revenue and EPS results, which I will speak to on a currency neutral basis. Total company organic revenues grew 4%, in line with our expectations. Adjusted EPS of $2.35 was ahead of our expectations. As I just mentioned, this was driven by strong operating performance, which enables us to invest incremental dollars in R&D. Chris will provide more details on this later in his remarks Now, I'd like to turn things over to Chris for a more detailed discussion of our third quarter financial performance and our updated fiscal year 2016 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. As Vince just mentioned, the breadth and geographic diversity of our portfolio contributed to solid third quarter results. Total third quarter revenues of $3.2 billion grew 4% on a comparable organic basis. This was in line with the growth expectations we had outlined on last quarter's earnings call. As a reminder, the second fiscal quarter had benefited by about 50 basis points from the timing of revenues, which occurred earlier than originally anticipated. In turn, this negatively impacted the third quarter by about 50 basis points. I'll discuss this further as I take you through the business results. BD Medical third quarter revenues increased 3%, reflecting strong performance in Medication Management Solutions and Diabetes Care units and solid growth in the Medication and Procedural Solutions unit. As anticipated, performance in the Pharmaceutical Systems and Respiratory Solutions units were negatively impacted, in part, by customer ordering patterns and the timing of capital placements. These items occurred earlier than originally anticipated, benefiting the second fiscal quarter as communicated on last quarter's earnings call. Medication and Procedural Solutions growth was 2.1%, which reflects strength in infusion therapy and safety-engineered products, but was negatively impacted by the divestiture of our Spine business and a tough comparison to the prior year. Medication Management Solutions revenues grew 6.2%, driven by strong dispensing capital installations with our Pyxis platform. We also saw solid growth in the infusion business. Growth in Diabetes Care was 6.6%, driven by pen needles and a favorable comparison to the prior year. Pharmaceutical Systems growth of 1.5% reflects strong growth in SAIS and safety-engineered products, partially offset by the aforementioned timing of customer orders. Respiratory Solutions revenues decreased 3.3%, reflecting the aforementioned timing of capital placements. Respiratory Solutions had a negative impact of 60 basis points to the third quarter organic growth. Excluding the Respiratory Solutions business, total company organic growth was 4.6%. BD Life Sciences third quarter revenues increased 6%, primarily driven by strong growth in the Preanalytical Systems and Diagnostic Systems units. Preanalytical Systems growth of 6.6% was driven by international markets and safety-engineered products in the U.S. Diagnostic Systems growth of 9.5% was the result of strong growth in microbiology, led by the timing of BD Kiestra installations, as well as continued strength in blood culture and growth in BD MAX. Biosciences revenues grew 1.2% in the third quarter. We are seeing additional pressure in Africa related to our clinical HIV business, and we continue to monitor this situation. In the U.S., Biosciences had double-digit growth, driven by sales of research instruments. In addition, we experienced strong sales in research reagents globally. Growth was partially offset by funding delays, primarily in Western Europe and Japan. Moving to slide eight. I'll walk you through our geographic revenues for the third quarter on a currency neutral basis. U.S. revenues increased 3.4%, reflecting strength in both the Medical and Life Sciences segments. BD Medical's performance reflects strength in dispensing capital installations, which includes the benefit of a large customer installation, as well as strong performance in infusion systems, which include a double-digit growth in our disposables business. SAIS and safety-engineered products also contributed to growth in the quarter. BD Life Sciences growth in the U.S. reflects continued strength in our research business in Biosciences, led by the recently-launched FACSymphony and FACSCelesta instruments and a growing research reagent and Sirigen dye portfolio, including our new OptiBuild platform for customized reagents. Diagnostic Systems was driven by strong growth in molecular, including BD MAX; and growth in core blood culture. Preanalytical Systems also had solid performance across all core platforms during the quarter. Moving on to international, revenues grew 4.6%. This is below our normal growth rate and primarily reflects some unfavorable timing events within the Medical segment. The Medical segment grew 2.6%. This reflects strength in China and sales of safety-engineered products and strong dispensing installations and Medication Management Solutions. This growth was partially offset by the timing events in Pharmaceutical Systems and Respiratory Solutions and softness in the Middle East, as we expected. The Life Sciences segment grew 8.1%. Preanalytical Systems growth was very strong across all regions, primarily due to continued expansion of safety-engineered products. Diagnostic Systems had strong growth in Western Europe, driven by Kiestra installations in the quarter. Overall strength in core microbiology and cervical cancer-related sales also contributed to growth in Diagnostic Systems. The Biosciences business was negatively impacted by the aforementioned declines in the HIV business and funding delays. Now, turning to slide nine, developed markets revenues grew 3.7%, and emerging markets revenues grew 5.2%. The third quarter growth rate in emerging markets reflects solid growth in China and Latin America, partially offset by declines in the Middle East and Africa, as communicated on last quarter's earnings call. The Middle East and Africa had a negative impact of approximately 400 basis points. Excluding these regions, emerging markets grew approximately 9% in the quarter. China growth for the third quarter was 9.5%. Revenue growth across the Medical and Life Sciences segments was driven by continued strong demand for consumables. For the total year, we continue to expect China to grow in the low-double digit range. We now anticipate total emerging markets to grow in the mid-single digit range. We expect that, as we exit fiscal year 2016, these headwinds in the Middle East and Africa will largely be behind us. It's important to note that we anticipate emerging markets growth of high-single digits as we move forward. Moving to global safety on slide 10. Currency neutral sales increased 8.9%. Safety revenues in the U.S. grew 5.3% and international sales grew 13.9%, currency neutral, driven by strength in Asia-Pacific and Europe. Safety revenues grew 19.6% in emerging markets. Medical safety sales grew 9.6%, driven by a range of safety-engineered products including safety catheters and strength in Pharmaceutical Systems. The benefits from E.U. safety legislation continued to aid growth in the quarter. Life Sciences safety sales, which are driven by our Preanalytical Systems unit, grew 7.6% in the quarter. Slide 11 recaps the third quarter income statement and highlights our currency neutral results. As I mentioned a few moments ago, revenues grew 4% on a comparable organic currency neutral basis. Pricing was slightly positive in the quarter. Gross profit improved 6.3%. I'll provide more color on gross profit on the next slide, when we look at the underlying performance and the impact of currency. SSG&A as a percentage of revenues was 22.7%. We're very pleased with the leverage we're getting, which includes the benefit of cost synergy capture. The suspension of the medical device tax also had a positive impact on SSG&A. So, as we've previously communicated, we intend to reinvest the savings in R&D, which you're beginning to see on the R&D line. R&D as a percentage of revenues was 6.5%. We continue to invest in new products and innovation and expect to incrementally reinvest approximately $25 million of the medical device tax in the fourth quarter. As a result, we expect R&D as a percentage of revenues in the fourth quarter to be above our full year guidance range. This brings our total year R&D dollars as a percentage of revenue closer to 6.5%. Operating income grew 12.8%, reflecting strong P&L leverage. Our tax rate declined 350 basis points to 21.3%, which is in line with our full year expectations of 21% to 22%. As Vince discussed earlier, adjusted earnings per share were $2.35, which is a 19.5% increase versus the prior year. This reflects our solid growth profile, strong underlying margin expansion and our lower tax rate. I'd also like to highlight that, year-to-date, we have driven very strong earnings growth of 33.9%. Slide 12 illustrates our gross profit and operating margin for the third quarter. Foreign currency had an unfavorable impact of about 50 basis points on our gross profit margin in the quarter. On a performance basis, strong gross margin expansion of 160 basis points was primarily driven by operational performance and continuous improvement initiatives and, to a lesser extent, from favorable raw material prices. Strong operating margin performance of 210 basis points was primarily driven by gross margin expansion, combined with the achievement of operational efficiencies and the positive impact of cost synergies. These contributions were partially offset by increased R&D expenses we incurred following the medical device tax suspension. Foreign currency had an unfavorable impact of 60 basis points on operating margin in the quarter. Year-to-date, we have driven approximately 280 basis points of underlying operating margin expansion. This strong performance gives us the ability to raise our guidance for the year to a range of 200 basis points to 210 basis points of underlying operating margin expansion. Moving on to slide 14. To ensure consistency and clarity, I'd like to provide more color on revenue growth guidance. Last quarter, we noted there was approximately a 50 basis point benefit from the timing of revenues that occurred earlier than we anticipated. We expected that timing to bring down the third quarter growth rate a bit, and we had guided this quarter to be below our revenue growth range for the total year. The key to understanding our second half revenue growth trajectory is to focus on the absolute dollars we're achieving this year versus last year. We are up against a tough comparison this quarter because, in terms of absolute dollars, that was our highest quarter last year. As you model out the total fiscal year, we have been steadily improving sequential revenue dollars every quarter. While our year-to-date performance implies a revenue growth rate of about 7% in the fourth quarter, you will see that, in terms of absolute dollars, it's reasonable and achievable as illustrated on slide 14. Moving on to slide 15. We are maintaining our adjusted EPS guidance range of $8.50 to $8.57. Our strong performance in the third quarter and our full year outlook give us the confidence to raise our currency neutral adjusted EPS guidance for fiscal 2016 by 1 percentage point to a range of $9.08 to $9.15, while increasing our investment in R&D. Offsetting this increased performance are incremental currency headwinds of approximately 1 percentage point that have resulted from the U.S. dollar strengthening relative to the euro and other currencies since we provided guidance in May. We remain extremely pleased with our performance and our ability to execute and deliver on our commitments. Turning to slide 16. I'd like to walk through additional elements of our guidance for the full fiscal year 2016. We continue to expect growth of 4.5% to 5% in BD Medical. Due to the aforementioned challenges in Africa in our Biosciences business, we now expect revenues in BD Life Sciences to grow between 3.5% and 4%. This brings total BD to the bottom end of our revenue growth guidance range of 4.5% to 5% for the total year. On a reported basis, revenue growth for the total year is expected to be between 21% and 21.5%, which reflects a currency headwind of about 350 basis points, which is an incremental 50 basis point headwind compared to our prior guidance of about 300 basis points of currency headwinds. Based on our current view of the environment, we continue to expect pricing to be flat to slightly positive for the year. Our guidance assumes a euro-to-dollar exchange rate of $1.11 for the rest of the year. We see some remaining FX headwinds over the fourth quarter, as non-euro currencies are also expected to be unfavorable year-over-year. Before I turn the call back over to Vince, I'd like to note that, in June, we continued to deleverage as we paid down a $750 million debt maturity associated with the CareFusion acquisition. At the end of the third quarter, our leverage ratio was 3.4 times and we remain on track to achieve our commitment of 3 times gross debt leverage within 24 months of close or March of 2017. Now, I'd like to turn the call back over to Vince, who will provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. Moving on to slide 18. I will walk through our updates on product innovation, strategic and business initiatives and partnerships and collaborations. Starting with new product innovation. Within our Medical business, we reached over 100 hospitals with Alaris infusion pump interoperability. Bi-directional interoperability to a hospital's electronic medical records improves patient safety and care by reducing manual input of data and programming errors, while also improving staff efficiency. Within our Life Science business, we are seeing strong performance from our recently-launched research instruments, FACSymphony and FACSCelesta. In addition, to complement the portfolio, we recently introduced the unique, mid-level cell sorter, the FACSMelody, which has received positive customer feedback. The FACSMelody will have a full scale commercial launch in the fourth quarter. All of these instruments are complemented by our Sirigen dyes and recently-launched OptiBuild-customized reagents. In the area of women's health, we have continued to make good progress. We have already submitted our vaginitis and GC/CT assays and are now in the process of submitting our HPV assay to the FDA for approval. This assay is designed to provide physicians access to broader, high-risk HPV genotype information beyond types 16 and 18 to guide informed treatment decisions for their patients. This is an important milestone for the company and is complementary to our current portfolio. As part of our menu extension on BD MAX, we have completed an agreement with Check-Points BD, a Netherlands-based company, which is focused on the development of rapid molecular tests for the detection of carbapenem-resistant organisms. Check-Points currently has a CE-marked product optimized for the BD MAX that incorporates our open system reagents. Within strategic and business initiatives, we're pleased with the progress towards the creation of the Respiratory Solutions joint venture and remain on track to close late in fiscal year 2016 or early in fiscal 2017. As we told you last quarter, we have also continued to make good progress with our CareFusion product registration process. We remain on track with our plans to achieve revenue synergies and continue to expect them to begin to materialize in fiscal year 2017 in our Medication and Procedural Solutions business. And in the areas of partnerships and collaborations, we recently completed an in-depth launch planning meeting with Medtronic to integrate our commercial plans and operations, as we anticipate the launch of our insulin infusion set. We remain on track for broad commercial release in early fiscal year 2017. As you can see, we are executing on our strategy and continue to have strong opportunities to drive growth and innovation. We look forward to updating you further at our Analyst Day in New York City in November. Moving on to our business update on slide 19. We continued to make progress with our cost synergy capture. Our G&A functional transformation continued in the third quarter. We're making progress, expanding and leveraging global shared services and centers of excellence. We also continued to focus on implementing lean and efficient end-to-end processes with our corporate functions. During the quarter, we also announced plans to close two plants as we made progress with our footprint optimization. We continue to expect the majority of manufacturing-related synergies to be achieved in the latter part of our deal horizon. We remain on track to achieve our FY 2016 cost synergies and continue to expect $325 million to $350 million in total cost synergies related to the CareFusion acquisition as we exit fiscal year 2018. Turning to operating margin expansion. The consistent solid performance of our businesses, combined with operating efficiencies, cost leveraging and cost synergy capture, is driving continued underlying operating margin expansion. In addition to the 100 basis points of operating margin expansion we achieved last year, we expect another 200 basis points to 210 basis points of expansion this fiscal year. Now, I'd like to reiterate the key messages from our presentation today. First, this was a solid third quarter. Both segments performed well, and our results highlight the benefit of our diverse portfolio, both from a product and geographic standpoint. Second, we are delivering strong operating performance. Also, with respect to our operating efficiencies, cost leverage and cost synergy capture are generating significant operating margin improvement, as evidenced by our increased guidance for the total year. Also, we have many exciting opportunities in the pipeline, and we are incrementally investing in R&D to fund those strategic opportunities. Finally, we are confident in our outlook for the full fiscal year. We remain very optimistic about BD's prospects for the future and our ability to continue to deliver strong returns to shareholders over time. Thank you. We will now open the call to questions.
Operator:
The floor is now open for your questions. [Operator Instruction] Thank you. Your first question comes from the line of Rick Wise with Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, Vince. Good morning, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Rick.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
I guess, I'll start off with the operating margin expansion. I mean, you really are generating extraordinary margin expansion this year for multiple reasons. Maybe, just stepping back, how much – actually, I'll start it differently. Becton has consistently, for a long time, every year, done a good job of expanding margins and reducing costs. But this kind of performance we've seen in fiscal 2015 and 2016, how do we think about the next few years? What are the opportunities that are remaining? And, I mean, do you have a lot more to go in terms of consolidating plant manufacturing? Just give us some larger perspective to think about the future.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure, Rick. I'll take that. It's Chris. Thanks. Yeah, we're really happy with the margins that we're driving. Operating margins this year will be 200 basis points to 210 basis points up, and I'll remind you that that's on top of 100 basis points last year. And so, it's good continuous improvement, and that's coming from two things. Obviously, the synergies are helping us on the operating margins, SSG&A and that type of thing. But we're also seeing very good performance on the gross profit line, and a lot of that is really coming from continuous improvement-type initiatives that we've had in place. So, we feel good about that. And the good news is that that continues going forward, particularly on the synergy piece, so you would expect to see – on top of the normal 40 basis points to 50 basis points that we drive every year, you would expect to see an incremental 40 basis points to 50 basis points just coming from the natural synergies that you get over the life of the deal horizon. On top of that, you would also think about the fact that, with the Respiratory going away and with that joint venture, you'll get a benefit on margins as well because, as we've mentioned, the Respiratory margins really were headwinds to the overall margin. So, we feel good about the margin profile going out into the future over the next couple of years.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And you were asking about manufacturing, and what I was trying to indicate in my remarks – this is Vince, Rick, is that the manufacturing piece of the synergies in the $325 million to $350 million really starts to hit towards the back end, and we've been giving that timeframe of, kind of, late 2017 into 2018. So, we're really early on in kind of the footprint adjustment. We did mention the two plants, but there's a lot more work to be done, but I feel very good about the way the team has this organized. Tom and I have met with them, and I think we really have a solid plan.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Great. And just as a follow-up. Just thinking about two growth drivers, maybe you can give us some more color. You talked about the 50 CareFusion products registered, 25 more on track. Maybe talk about the growth implications there and where you're investing in R&D and how we think about that potentially being incremental growth driver as well. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. So, I'll start with the R&D, then I'll ask Tom to talk about the revenue synergies. So, I really do think that this is a great opportunity for us with the suspension of the medical device tax to, Rick, accelerate our strategy is what this is really about. This is not about going after new areas. This is really about fortifying what we are doing. And so, it's spread over both the Medication Management strategy and over to the Life Science side of things. So, I'll give you one example on the Life Sciences side
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Sure.
Thomas Polen - Becton, Dickinson & Co.:
Hey, Rick. This is Tom. And just to answer your question on revenue synergies, we continue to make good progress on our new product registrations. As you said, last quarter, we shared that we had gained regulatory approval for more than 50 products in over 20 countries and we had another 25 registrations submitted and awaiting approval. And since then, over the last quarter, we've gained a number of new approvals. We've gained – we've actually submitted a number of additional registrations. And so, as we shared before, we're on track with our expectations to begin seeing the initial signs of some of those synergies coming through in FY 2017. And as we shared in the past, we expect those initial synergies to show up in our consumable Medication Management business, which is MPS.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks for your questions, Rick.
Operator:
Your next question comes from the line of David Lewis with Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Just two quick questions, guys. I guess, the first thing for Chris. I'm thinking about 2016, Chris. And so, obviously, the underlying earnings growth this year has been extremely strong. It sets up more of a difficult comparison for 2017. So, I know it's early, but I wonder if you're willing to comment on sort of the comfort with consensus next year, which is sort of low-double digits, sort of low-teens and some of the factors that get you that comfort, if you're willing to provide it. And then, just maybe for – a second one for Chris. Just the capital deployment priorities. You mentioned deleveraging here into this year, into next year. How are we thinking about capital priorities? Maybe it's also a question for Vince in terms of future M&A, share repurchase activity or further deleverage. Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
Great. David, thanks for those questions. Absolutely, as I think through fiscal year 2017, I would take you back to our normal model, which is mid-single digits, 5 percentage on the top and 10 percentage on the bottom. On top of that, you get a couple of hundred basis points coming from the synergies that we've talked about. And then, I think you just have to take into consideration – and I'm not sure everybody's model shows this yet, the $0.10 to $0.14 that come from the Respiratory dilution. So, that gets you to a number that is clearly in the low-double digits, as you said. So, I have a lot of confidence in that. What I'd also point to though is the variables of the headwinds and tailwinds, which generally come from FX and pension, and it's too early to call either of those. And we'll certainly give more guidance on that in November as we provide specific guidance. But right now, neither one of those seem too bad. If FX stayed where it is, it'd be pretty neutral. Pension right now with interest rates are probably a slight negative, but that could change between now and September when it gets measured. So, bottom line is we're really feeling good about that. On to your second question, in terms of capital allocation, you see that we are making great progress towards our 3 times leverage. We're already down to 3.4 times. So, we're well on our way. So, thinking about the second half of next year, we will certainly be in a position where we can – our cash flow is good. We'll be in a position to start on redirecting some of that cash away from debt pay-down and back to the more traditional capital allocation methods that we have. I think what you could expect us to do is go back to a similar model that we had pre CareFusion acquisition, where we look at tuck-in acquisitions. We make sure we're invested in the business, clearly, first. We have always been increasing our dividend, and we continue to increase the dividend, obviously, as we did the CareFusion transaction and we've been increasing 10%. But because the bottom line is growing more than 10%, the payout ratios come down. So, I think we've got to bring that more in the line and do a little bit of catch-up there. And then, obviously, that still leaves a lot of cash leftover. We would rather not have that build-up on the balance sheet. And so, we would likely go back to some share buybacks. Having said that, I intend to go through that in November. We do have some time. I'm actually thinking of getting all of your input between now and March to let us know what you think. And so, I'd encourage that. And as you know, we've been already beginning that kind of dialogue. And so, the good news is I think we have a lot of cash and some positive things that we can do in terms of allocating that. So, that's a way to think about it.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And, David, we haven't changed our philosophy on M&A. We're going to be very strategically driven, number one. We're not size driven or – it's really about what is the strategy and how does that create shareholder value. And so, just as you've seen us do that in the past, that's the way we're going to approach it in the future. Thanks for your questions, David.
Operator:
Your next question comes from the line of Larry Keusch with Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Well, hi. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Larry.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Two questions for you. I'm wondering if you could perhaps help us think a little bit about the agenda, if you will, for the November Analyst Meeting, just on a high level, just trying to figure out what you guys are thinking about covering there.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, we have a lot of new things in the pipeline. We've integrated a lot of things, but I don't think you've had the opportunity that the market hasn't had the opportunity to really see. And so, we're thinking that we have to cover both segments for you. We have to get into in-depth on Medication Management, kind of, across the care continuum for you. We really haven't had that in-depth discussion. And so, that will be a major focus. And then, on the Life Science side, we have a lot to talk about in the core businesses and then the ramp-up of things such as genomics. So, we're going to make sure that you really understand these things. We know that we're a little difficult to understand because there's so much to cover. So, we're going to try to be concise about it. And then, hopefully, we can give you a little sense of the capabilities we have been building at the same time to drive this new wave of innovation. So, those are what we're really looking at. And then, around the same time, as Chris talked to you, we're going to focus on capital allocation. Maybe not in that meeting, but as we do the earnings call. So, those are the big things that we want to talk to you about.
Operator:
Your next question comes from the line of Brian Weinstein with William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Hi, guys. Thanks for taking the question.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Brian.
Brian D. Weinstein - William Blair & Co. LLC:
So, a question on Africa, Middle East, the headwinds that you have there. Can you describe some of that in more detail? In Africa, specifically, you said you're monitoring the CD4 and viral load situation there. But what can you actually do proactively there? And how meaningful of a headwind is this for you, guys, right now?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. So, Linda can address that question.
Linda Tharby - Becton, Dickinson & Co.:
Hi, Brian. It's Linda here. So, as we discussed on our last call, the decline in the Africa HIV business is largely associated with, now, the regional health systems in Africa starting to implement the HIV viral load testing based on WHO guidelines. So, what we are seeing is two things occurring. Number one is tenders that have been previously issued, the amount of volume against those tenders, we're seeing come down, and then the actual tenders themselves being cancelled. So, the impact on our quarter was roughly 200 basis points. And as we exit 2016, we believe that the headwinds are largely behind us. The size of this business in Africa now, think of as being under the – around the $30 million range.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And, Linda, the 200 basis points you were talking about was on...
Linda Tharby - Becton, Dickinson & Co.:
Yeah, the 200...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Life Sciences...
Linda Tharby - Becton, Dickinson & Co.:
Was on the Biosciences growth within the...
Thomas Polen - Becton, Dickinson & Co.:
Biosciences growth.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. And on Life Science, as you saw, we took the guidance down. That was reflective of what was happening in Africa, and that was about 50 basis points – talking about a $20 million kind of hit. And that – we see that as largely behind us. So, we don't carry that going into next year, and it's behind us.
Thomas Polen - Becton, Dickinson & Co.:
Yeah.
Operator:
Your next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore ISI:
Congrats on the nice quarter.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Vijay.
Vijay Kumar - Evercore ISI:
Maybe just one housekeeping question on – I know, on the last call, you guys spoke about the comp metrics, the triggers for comp being changed from the June to September fiscal end. I'm just wondering, how is that, as we're modeling 4Q, right, because it looks like the EPS guidance is a little light relative to what the Street is modeling. Is this just because of how this comp moved from 3Q to 4Q (42:04) the Street was modeling?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, I know, Vijay, so you're pointing to slide 14 and I think we gave that to give you a sense that the revenue growth in the quarter just increases a little bit in the fourth quarter, but the growth rate is significantly different and that's all about last year. So, if you remember last quarter, I mentioned this, this time, we thought we'd actually give you a chart that kind of demonstrates it because I think, if you really study that chart, you can see that the growth rate is moving around, but the dollars have nice, sequential increases every quarter. And so, that gives us the confidence that we can achieve that in the fourth quarter. To your point on EPS, it's really all about the fact that we let the over-performance in the third quarter, we let half of that flow through and then the other half is what we're investing. If you do the math on that investment of R&D, that's about $25 million. That takes you up close to 7.5% of revenue in the fourth quarter. And so, that's the other half of the overachievement in the third quarter that we're going spend. And when you think about that, it's really – we couldn't really spend it in the second quarter. We just couldn't get the programs in place fast enough. We've spent the fair share in the third quarter at 6.5% of revenue, so we started getting some traction on reinvesting in medical devices there and fourth quarter is really a catch-up. So, when you look at how much we're spending this year on R&D related to medical device tax, it's the entire amount of the medical device tax that we get in benefit. So, think about that more as a catch-up. Now, in addition to that, on EPS, we talked about headwinds from FX and that's certainly the other piece of it. We get a little bit of a headwind from the euro going from $1.13 down to $1.11, but the bigger portion is the other currencies. And those other currencies are – there's really three that are driving that impact. The Yuan in China has significantly weakened against the dollar since May, about 3% weakness. The Mexican peso has weakened about 6% versus the dollar. And obviously, the British pound, we all know, from Brexit, impacted by about 9% from our May call. And those are the three that are driving the preponderance of the headwinds on FX in the fourth quarter. Thanks very much.
Operator:
Your next question comes from the line of Derik De Bruin with Bank of America.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Derik.
Derik De Bruin - Bank of America Merrill Lynch:
Good morning. So, I've got one housekeeping question and just a broader one. The housekeeping question is what's the overall impact of the Spine divestiture? Can you give us a run rate? And then, the follow-up on that is – and since you mentioned BREXIT, I guess, you talked about some weakness in Eastern Europe. Can you just, sort of, elaborate on what you're seeing in those market trends and sort of how do we think about the impact to the – some of the uncertainty in Europe going forward? Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
Okay. So, I'll take the first piece. The Spine business is about a $25 million business. So, that should help you in terms of getting the sense of the size that.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And then, for Brexit, we don't see any significant impact to the business. It's very difficult to say exactly how this is going to play out. It's going to take years to play out. No one knows exactly which model they are going to follow. But I think the UK business for us is around $250 million, but we expect the NHS is going to continue to buy product to support the country. So, we don't see a big impact.
Operator:
Your next question comes from the line of Jon Groberg with UBS.
Jonathan Groberg - UBS Securities LLC:
Great. Thanks a million, and congratulations. So, just an end market question for you, Vince or whoever you want to hand it off to. One, can you just give us an update on China on kind of where you are in terms of some of those inventory issues that you called out earlier in the year and just what you're seeing generally in China? And then, in the U.S., I think a lot of people are a little bit perplexed, given what you see hospitals are reporting and MLR ratios. Can you maybe just talk about what you're seeing from a utilization standpoint in the U.S.? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. Well, starting on China, we had a strong quarter in China. So, we think those inventory issues are behind us. And so, we're not seeing a lot of change in the environment from quarter-to-quarter. What we did see was a little bit of strengthening on the Life Science side of things and some of the tenders that we had seen postponed are starting, so it gives us a little bit more confidence on that side, but we continued to see strong performance on the Medical side of the business, consistent with what we've been saying. So, pretty stable there and optimistic as we look towards next year. And then, what was the second piece that you were asking about?
Monique N. Dolecki - Becton, Dickinson & Co.:
(47:26) U.S.
Vincent A. Forlenza - Becton, Dickinson & Co.:
U.S.? So, U.S. utilization seems to be stable to maybe up a tick. I can't give you any real specific data on that. But just in talking to the organization, the U.S. organization, we're feeling quite good. That's the clinical market I'm talking about. The U.S. research market is doing quite well and you saw that, of course, in the Bioscience business.
Operator:
Your next question comes from the line of Brandon Couillard with Jefferies.
Justin Jordan - Jefferies International Ltd.:
Hi. Good morning. It's Justin in for Brandon.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning.
Justin Jordan - Jefferies International Ltd.:
Could you just provide some color surrounding the strength in emerging market safety? And how much longer can the segment grow in the double digits?
Vincent A. Forlenza - Becton, Dickinson & Co.:
We think we still have a long runway there in the emerging markets, and Tom can give you a little bit of color. But a lot of what we saw of this in core products was the catheter area. But, Tom, maybe you want to talk about China and where they are. In Brazil and Latin America, they're real drivers for this.
Thomas Polen - Becton, Dickinson & Co.:
Sure. Hi, Justin This is Tom. So, as Chris had mentioned, specific to the Medical segment, we grew 9.6% in the quarter. As Vince just alluded to, safety catheters were a major contributor to that growth, particularly in Europe and China. Within the U.S., we saw growth in the third quarter really driven by safety connectors on our infusion set. I know you didn't specifically ask about Europe. It's a common question as well. And so, we do see safety continuing to also perform well in Europe. Compliance with the regulation is continuing, and it's the major driver of that safety growth. We've shared in the past that we really see stronger conversion in the infusion therapy and still more of infusion therapy as well as blood collection with less conversion in injection. So, that's more room to go there. And overall, as you think about it, in terms of what we still have ahead, we're still in the middle innings in European safety conversions, let's say, in that start of the fifth.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, and earlier in emerging markets.
Thomas Polen - Becton, Dickinson & Co.:
And earlier in emerging...
Vincent A. Forlenza - Becton, Dickinson & Co.:
(49:31) just starting in the first and second inning in emerging markets.
Thomas Polen - Becton, Dickinson & Co.:
Yeah.
Operator:
Your next question comes from the line of Michael Weinstein with JPMorgan.
Robbie J. Marcus - JPMorgan Securities LLC:
Great. This is Robbie Marcus in for Mike. I just wanted...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Hi, Robbie.
Robbie J. Marcus - JPMorgan Securities LLC:
To follow up – oh, hey. I just wanted to follow up on the fiscal year 2017 outlook, maybe focusing on revenue growth. So, with some of the upcoming launches, like infusion set early next year and some of the early CareFusion approvals in China, are you expecting the top line to accelerate next year and how should we be thinking of that? And if not, what are maybe some of the other puts and takes we should be considering?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Let me take a shot at that, Robbie. Yes, we do expect acceleration next year from where we are in 2016. And what contributes to that is we begin to see some acceleration in terms of revenue synergies from CareFusion. Think about that in tens of basis points. You'll also get a lift from Respiratory going away. And to size that, the impact of Respiratory this year for the full year and it's choppy, as we said, it was about 60 basis points in the third quarter. But over the course of the whole year, it's worth about 10 basis points. And so, you get a little bit of a lift from that naturally, and we feel good about the rest of business. As we talked about emerging markets, we see getting back to the high-single digits kind of range, which is really where we were this year, if you exclude the issues in the Middle East, which was both Africa and in Saudi Arabia, which we talked about on the last call. And so, we feel good about that, and developed markets are continuing to do very nicely. So, we feel really good about our revenue guidance for next year. We'll clearly give you a lot more details as we get into the November call and give you a little bit more about the specific products that we have in the pipeline and the Analyst Meeting in November.
Christopher R. Reidy - Becton, Dickinson & Co.:
And the only other thing I would add is, as we think about it, Saudi Arabia, we're expecting it to be stable. Going forward, we don't expect any major change there. And then, on the Life Sciences side, as we talked about the situation in Africa, we think it's going to stabilize as well, too. So, that's how we're thinking about it.
Operator:
Your next question comes from the line of Bill Quirk with Piper Jaffray.
William R. Quirk - Piper Jaffray & Co.:
Great. Thanks. Good morning, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning.
William R. Quirk - Piper Jaffray & Co.:
So, I guess, two questions, guys. First off, at AACC this week, you had a new Vacutainer. I was hoping you could maybe elaborate a little bit on that in terms of, I guess, some price specifications, kind of, what that could possibly do incrementally for margin structure, et cetera. And then, also, just want to highlight on the microbiology comment that you made. I would be curious as to, kind of, what you're seeing bigger picture there. There does appear to be, I guess, more interest in the category from an investment standpoint than a lot in both domestic as well as European hospitals. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Linda?
Linda Tharby - Becton, Dickinson & Co.:
All right. So, thanks so much. Yes, the technology you're referring to in PAS is called a Barricor technology. So, if you think about blood collection, we created a blood collection tube with our gel about 25-plus years ago. So, this is the next generation. It uses no gel. It's a mechanical separator. So, we're really looking forward. If you think about what this drives for the lab, it really drives so much higher quality, cleaner sample. Just think about all the breakdowns due to the gel in the clinical diagnostic systems, think about that going away and then just driving better workflow efficiency and lower cost. So, we've now rolled that product out outside of the U.S. We're seeing a lot of activity in terms of numbers of accounts that are validating this. So, the validation cycles will take some time, so really start to see the impact of this in 2017. And then, we expect our U.S. launch to occur in 2016. So, really excited about that one. Moving on to microbiology. Broadly, of course, we saw a lot of share gains over the course of the last year in our BACTEC. But if we think about what we're trying to do in the microbiology lab, it's really about our Kiestra system and doing two things. So, the first thing we've done with Kiestra acquisition a few years back is really focus on the full automation. So, moving that plate right from the start of streaking that plate right through to IDAST. Kiestra links all of those systems completely together. And then, over the course of the last year, we worked on our Infostratus (54:29) program, which will now drive informatics around that platform. And of course, the first thing that we will do on that informatics side is launch our Veritor Plus, which is our flu. It will be the next-generation Veritor for us, which will link in to that system which will launch in Q4 of this year. So, hopefully, that gives you a good picture about on the PAS side. We're really excited about the innovation. I talked about the tube side. We also have innovation on the needle side and then what we're doing in the microbiology labs.
Christopher R. Reidy - Becton, Dickinson & Co.:
And from your question in terms of margin on – the product will have attractive margins. There's no big impact in terms of start-up costs next year; it's kind of in the regular course of things.
Operator:
Your next question comes from the line of Doug Schenkel with Cowen.
Doug Schenkel - Cowen & Co. LLC:
Hey. Good morning, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Doug Schenkel - Cowen & Co. LLC:
I guess, my first question is for Vince. My second is for, I think, Linda or Chris. Vince, we appreciate all the detail on operating investment in Q4. Could you share any detail on areas of prioritization associated with the increased R&D investment? And should we think about this as a pull-forward or more of the new normal or maybe a bit of both? And then, again, for Linda or Chris, regarding the cut in Life Science revenue growth guidance for the year, I think you only called out Africa and Middle East weakness as specific reasons for the cut. I think the reduction translates into about $200 million. Assuming my math is right, on the surface, it seems like this is a lot to attribute all to geographic weakness, especially at this point in the year. I'm just wondering if there's other dynamics worth calling out. Thank you.
Christopher R. Reidy - Becton, Dickinson & Co.:
Let me address that one first before we get into the other piece. Your math is off by a decimal. It's about a $20 million impact on a $4 billion business. It's about 50 basis points.
Doug Schenkel - Cowen & Co. LLC:
Okay. That makes more sense. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
There you go. In terms of the R&D spend, you should assume that we will continue to spend the medical device tax as it is suspended and think about that going into next year. And you don't start a program and finish it in one quarter. These things will continue. As I was mentioning, this is an acceleration of the strategy that we have, and we've seen some really attractive opportunities to accelerate that strategy, both on the Life Sciences and on the Medical side. You were mentioning microbiology in your question. We said that is one of the areas in terms of the automation that we felt, with the opportunity that we're seeing for that platform globally, that we could extend that platform. We had finished the technology feasibility, so we felt really good about it. And so, Linda took the opportunity to do that. Now, on the other side, Tom had a series of opportunities in the Medication Management area, where he could accelerate his programs around Medication Management, including the informatics piece of that strategy and there was some opportunity to get some technology from the outside, which we took advantage of. And so, we were very happy that these things came together in that way. We think it positions us well going forward.
Christopher R. Reidy - Becton, Dickinson & Co.:
And I just want to be clear, Doug. I referenced the fourth quarter margin or the investment as about 7.5%. That's not the new normal. I think, going forward, you would still think about R&D as a percentage of revenue in the 6% to 6.5% percent. But fourth quarter is a bit of an anomaly that it's a bit of a catch-up. It's a bit of a catch-up and there's a little bit of onetime, and that's what I was indicating with my opportunistic comment.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Right.
Operator:
Your next question comes from the line of Matt Taylor with Barclays.
Matthew Taylor - Barclays Capital, Inc.:
Hi. Thanks for taking the question. I just wanted to ask an emerging market follow-up question. You talked about expecting high-single digit growth going forward. When you looked through some of the, kind of, near-term temporary headwinds...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah?
Matthew Taylor - Barclays Capital, Inc.:
You've had better growth than that in the past. I guess, can you just talk a little bit about how you developed that forecast, the factors that go into it and what could be sources of upside or downside to that number?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. When we think about emerging markets, obviously, we start with Asia. And within Asia, we start with China, and we're looking at healthcare spending in China and how that is unfolding. And what we're seeing is consistent spending in China. We break that down then to look at business by business, what's happening on kind of the capital side of things as they're purchasing. That's more of an impact obviously on the Life Science side than on the Medical side. And then, we go back and look at the Medical piece in two ways. Of course, what's the opportunity for core growth and then, as Tom was talking about earlier, all the product registrations that we have for China and other marketplaces from the CareFusion acquisition. So, that's China, number one. Number two, we're looking at India as a growth driver and that has – in the last two years, that has picked up and have been a good growth driver for us. Now, there's pluses and minuses in India. We're seeing good fundamental demand there with the burgeoning middle class. We're expanding our distribution in India, so we will take that into account. There are some headwinds in India in terms of tariffs that have been put in place. So, we make sure that that's not any significant impact, but – so, I would say we still find it as a very attractive marketplace for us. In Middle East and Africa, of course, we're much more careful about what's going on in Saudi Arabia. We follow what the government funding is. In this case, of course, the funding was not just in healthcare, but it was a significant change, linked to the price of oil that we saw. And so, the way we're thinking about that is, kind of, the price of oil staying where it is, which means on the low side, which says that they're going to fund their healthcare, but it's not a big expansion of healthcare. That was going on in the first half of the year. That's not happening now. But they have to continue to provide care. That's what we're thinking about there. In Africa, we talked about the CD4 business and some of the shift in the guidelines. We've seen – we believe we've seen the majority of that impact that's really driven by PEPFAR, not the entire marketplace. So, it's a segment of that market. So, we'll watch how that evolves, as Linda said. Then, Latin America is a mixture for us. Mexico is doing well. Brazil is doing okay is what we would say and we watch the economy there and what's happening from an inflationary standpoint. And of course, funding – but the other countries in Latin America are contributing quite nicely. That's how we build it up.
Operator:
Your next question comes from the line of Richard Newitter with Leerink Partners.
Ravi Misra - Leerink Partners LLC:
Hi. This is Ravi in for Rich. Thank you for taking the questions. Just wanted to build on some of the other questions that have been asked. Just in terms of the CareFusion, the growth registrations that you're going through right now, could you maybe just give us a look into what's the denominator behind that? I mean, is this sort of the bolus of all the registrations that you're doing or is there a lot more products that remains to go to that pathway? And then, I have a few follow-ups. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Tom will take that.
Thomas Polen - Becton, Dickinson & Co.:
Yeah. Hi, Ravi. This is Tom. So, I wouldn't say this is the bolus of them. The numbers that we've cited are certainly less than half of the products that we intend to have registered outside. We obviously started with those products that we have the data available for that didn't need to have additional data generated, and we're in existing formats that those markets would accept, take, for example, as we would think about pumps. In some cases, we need to do translation and get the language done first. That's an R&D program to get that ready. Some of the markets require infusion sets to be adapted a bit for local practices. And so, what you saw come through first are obviously those products that meet the needs of specific geographies, we the data ready and we'll move forward and submit right away. And so, most of those also tend to be on the consumables side I shared earlier, which is why, as we think about FY 2017, we would expect those synergies to really be focused within our MPS business because that's where those more simple medical devices that are more universal in nature in terms of how they fit in with the healthcare system that's (01:03:42) to be focused.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Great. Thanks, Tom.
Operator:
Your next question comes from the line of Kristen Stewart with Deutsche Bank.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Hi, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Hi, there.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning, Kristen.
Kristen Stewart - Deutsche Bank Securities, Inc.:
Just as a follow-up to that, I was wondering, Tom, if you could just give us a sense for just how much of an acceleration we should expect to see from some of these filings and how fast can some of this ramp up or how meaningful are these registrations?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. As Chris mentioned, we think about it in tens of bps, not dramatically higher than that. And again, just to put things in perspective, we're really pleased with the performance and outlook even that we've gotten as early as in FY 2016. Of course, as we have said, CareFusion was 3%, 3.5% at best, growth business as a standalone. We're holding at our 4.5% to 5% growth for the segment overall. And as you know, when you take a 3% grow and a nearly 5% grow, you don't get within the range that we're sharing. And so, we're already. We see some good performance this year already as a result of the two companies coming together. We think some incremental improvements on that, in FY 2017, specifically within the MPS business in that 10s of bps as Chris described. The other thing also to keep in mind is that some geographies take a lot longer. So, China, although it's a market that we are filing registrations in, once you file a registration in China, it's a three-year process. So, you can't get into certain markets that fast. Typically, more of the European, Latin America, Southeast Asia markets are those geographies that you can actually get into within an 18-month window. And so, that's where you'll see us enter in first. Those aren't necessarily as large as some of the markets like China, which will be later on in our three-year and outlook horizon. Okay. All right. Thank you.
Operator:
At this time, there are no further questions. I will now turn the conference back over to Mr. Vince Forlenza.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. This is Vince. Listen, thank you for your questions and comments on the call. We look forward to briefing you at the end of next quarter. Thanks very much.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Thomas Polen - Becton, Dickinson & Co.:
Thank you.
Operator:
And this concludes today's conference call. You may now disconnect.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Linda Tharby - Becton, Dickinson & Co.
Analysts:
David R. Lewis - Morgan Stanley & Co. LLC Michael Weinstein - JPMorgan Securities LLC David Harrison Roman - Goldman Sachs & Co. Lawrence S. Keusch - Raymond James & Associates, Inc. William R. Quirk - Piper Jaffray & Co Rick Wise - Stifel, Nicolaus & Co., Inc. Derik De Bruin - Bank of America Merrill Lynch Jonathan Groberg - UBS Securities LLC Brian D. Weinstein - William Blair & Co. LLC Richard Newitter - Leerink Partners LLC Doug Schenkel - Cowen & Co. LLC Vijay Kumar - Evercore ISI Matthew Taylor - Barclays Capital, Inc.
Operator:
Hello and welcome to BD's Second Fiscal Quarter 2016 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through May 12, 2016, on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls using confirmation number 83710101. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Christie. Good morning, everyone, and thank you for joining us to review our second fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our second fiscal quarter press release and in the MD&A section of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release including the financial schedule is posted on the bd.com website. As a reminder, until we annualize the acquisition of CareFusion in the third quarter of fiscal year 2016, we will speak to our revenue results on a comparable currency-neutral basis, which includes BD and CareFusion in the current and prior year periods. We believe this provides additional visibility into the new BD. The comparable current period revenues are adjusted to exclude a small impact related to a purchase accounting adjustment to record CareFusion's deferred revenues at fair value as of the acquisition date. In addition, comparable prior year revenues are adjusted to exclude sales related to the terminated agreement with CareFusion for the sale of Fisher & Paykel's respiratory care products. The fiscal year 2016 comparable revenue guidance provided today will also exclude the year-over-year impact of this contract termination. The impact to the bottom line is not material and is included in our EPS guidance. Details of the purchase accounting and other smaller adjustments and the comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedule, in our press release or the Appendix of the Investor Relations slides. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Tom Polen, Executive Vice President and President of the Medical Segment and Linda Tharby, Executive Vice President and President of the Life Sciences Segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we are very pleased with our second quarter growth profile. Our results this quarter highlight our consistent performance and the benefit of our diverse geographic and product portfolio, with both segments contributing to revenue growth. We continue to drive strong underlying margin expansion through the achievement of operational efficiencies and continuous improvements, coupled with the positive impact of cost synergies. As many of you already know, in March, we celebrated the one-year anniversary of the closing of CareFusion, and we are extremely proud of our achievements over the past year. We have been acutely focused on the integration and a significant amount of work driven by the integration teams across the businesses. In terms of talent retention, we have a strong team that's in place that's comprised of both legacy CareFusion and legacy BD associates. They've been helping drive the company to our next phase of growth as a combined entity. In terms of our customers, we are becoming increasingly more relevant, as they're looking for providers that can really help them improve the quality, efficiency and safety of processes. We have made good progress on this front 12 months post close and feedback from our customers has been extremely positive. Also, we have been actively working to create new growth opportunities for CareFusion products and expanding their global reach by leveraging BD's global infrastructure. We are well into the registration process with dozens of products across multiple geographies. I will provide more details on this later in the presentation. Lastly, we are seeing strong productivity as we are over-delivering on our initial cost synergy capture commitments. As you already know, we've increased our total cost synergy target by about $100 million over the deal's horizon. We are clearly advancing our strategy to improve medication management. The value we bring to customers around the world has become increasingly evident as we make progress integrating these two great companies. We're also pleased to inform you that the annual strategic review of our portfolio is now complete. In March, we announced BD and Apax Partners, a private equity firm, will form a joint venture with Respiratory Solutions business. Apax will establish and stand up a newco, enabling more strategic focus and investment to build a leading global respiratory company. And more recently, we announced the divestiture of our vertebral augmentation solutions business. This product line was not aligned with our strategy and we believe it can see more robust investment in growth under a different owner. The completion of our current strategic review process enables the company to remain focused on the areas, we believe, are high-growth and aligned with our core capabilities. In addition, during our last call, we let you know about our intent to reinvest the savings from the suspension of the medical device tax that went into effect in January. Since that time, we have already allocated increased R&D dollars to highly strategic initiatives. Not only will this help to fund – drive future growth for the company, but it will also enable better outcomes for our customers and their patients. Looking forward to the total year, we are confident in our outlook and are maintaining our fiscal 2016 currency-neutral revenue and EPS guidance. We are also increasing our adjusted guidance to reflect lower currency headwinds due to the weakening of the U.S. dollar relative to the euro and other currencies. Moving to slide five, I will review our second quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Total company revenues grew 5.3% or 5.2% on a combined organic basis. Adjusted EPS of $2.18 was ahead of our expectations, as the quarter benefited in part from some timing within the year. Now, I'd like to turn things over to Chris, for a more detailed discussion of our second quarter financial performance and our updated fiscal year 2016 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning, everyone. As Vince just mentioned, the breadth and geographic diversity of our portfolio contributed to a very solid second quarter results. Total second quarter revenues of approximately $3.1 billion grew 5.3% on a comparable basis or 5.2% on a combined organic basis. This was slightly ahead of our expectations as the quarter benefited by about 50 basis points from the timing of revenues which occurred earlier than expected. I'll discuss this as I take you through the business results. BD Medical's second quarter revenues increased 6.1%, reflecting solid growth across the segment. Medication and Procedural Solutions growth was 4%, which reflects strength in infusion therapy, safety engineered products and infection prevention. Medication Management Solutions revenues grew 6%, driven by strong dispensing capital installation. ES demand was strong in the quarter driven by several large customer conversions, and we saw a positive impact from our efforts to simplify the installation process. We also saw solid growth in the infusion business where we continue to expand our leadership position. Growth in Diabetes Care was 3.6%, driven by pen needles and syringes. Pharmaceutical Systems growth of 11% reflects the strong growth in SAIS. Performance in this business also reflected the favorable timing of customer orders that occurred one quarter earlier than we initially anticipated. Respiratory Solutions revenues increased 10.9%, reflecting the timing of capital placements, which similarly benefited the quarter, as the placements were expected to occur later in the fiscal year. BD Life Sciences' second quarter revenues increased 3.4%, driven by solid growth in pre-analytical systems and diagnostic systems units. Preanalytical Systems growth of 5.7% was driven by safety engineered products in the U.S. and solid growth in Europe and emerging markets. Diagnostic Systems growth of 4.6% was a result of strong growth in core microbiology, including ID/AST and BD MAX assays. Growth was also aided in part by an increase in flu activity in the U.S. While the flu season is still mild in comparison to the prior year, the timing of the late flu season had a positive benefit year-over-year in the quarter of 10 basis points. Biosciences revenues were about flat when compared with last year's second quarter. Strong double-digit growth in the U.S. was driven by continued increased demand for high-parameter instruments and growth in the research reagents. This was offset by a 7% decline in Europe due to a difficult comparison related to timing of orders in the prior year. In addition, growth was negatively impacted by clinical tender delays in Africa associated with our HIV monitoring business related to the World Health Organization guidelines. Moving to slide eight, I'll walk you through our geographic revenues for the second quarter on a currency-neutral basis. U.S. revenues increased 5.7%. This was primarily driven by strength in Medication Management Solutions, Medication and Procedural Solutions, Biosciences and Diagnostics and was aided in part by the aforementioned timing of revenues. BD Medical's performance reflects strong dispensing capital installations and solid growth in the infusion business, as well as strength in infection prevention and interventional specialties. BD Life Sciences growth reflects continued strong performance in the Biosciences business, driven by demand for high-parameter research instruments and reagent sales. Diagnostic Systems had strong growth in microbiology, including Kiestra and blood culture, BD MAX, as well as the benefit from the increase in flu activity during the quarter. Moving onto international, revenues grew 4.8%. This is below our normal growth rate and primarily reflects the aforementioned clinical tender delays in Africa. I'll provide more details on this in a moment. The Medical segment grew 6.9%. This reflects solid performance in Medication and Procedural Solutions, driven by sales of safety engineered products, particularly in China, and strong dispensing installations in Medication Management Solutions. Growth was aided in part by the aforementioned timing of customer ordering patterns and capital placements. The Life Sciences segment grew 1.4%. This reflects strong growth in Preanalytical Systems in Western Europe and Asia Pacific, and strong growth in Western Europe and Latin America in Diagnostic Systems driven by core microbiology. This was partially offset by the aforementioned tender delays in Africa and a difficult comparison in Europe in Biosciences. On slide nine, emerging market revenues grew 5.1% currency-neutral, with developed markets growing 5.3%. The second quarter growth rate in emerging markets reflects solid growth in China and Latin America, partially offset by a decline in EMEA. China growth for the second quarter was 9.4%. Double-digit revenue growth in our Medical segment was driven by continued strong demand for consumables across all of our businesses in the segment. Within our Life Sciences segment, strength in Preanalytical Systems was offset by the slowdown of capital spending in Diagnostic Systems as communicated on our call last quarter. For the total year, we continue to expect China to grow in the low double-digit range. We now expect total emerging markets to grow in the high single-digit range compared to our previous guidance of 9% to 10% growth. This is offset by stronger performance in developed markets growing between 4% and 4.5% for the second half of the year. Our revised guidance for emerging markets reflects the aforementioned impact in Africa to our Biosciences unit from the WHO guidelines. In addition, since we last provided guidance in February, the government of Saudi Arabia announced the new austerity measures, which affect the healthcare industry. This has begun to impact our business in that particular region and we saw a small impact in the second quarter. We view the situation in Saudi Arabia as temporary, though the timing of reversal may not occur within this fiscal year. Our new guidance range contemplates emerging markets growing between 10% and 12% for the second half of the year. Moving to global safety on slide 10, currency-neutral sales increased 6.7%. Safety revenues in the U.S. grew 4.5% and international sales also grew 9.9% currency-neutral, with continued strength in Europe, as compliance with safety legislation continues. Safety revenues grew 15.6% in emerging markets. Medical safety sales grew 8%, primarily driven by safety catheters. Life Sciences safety sales, which are driven by our Preanalytical Systems unit, grew 4.6% in the quarter. Slide 11 recaps the second quarter income statement and highlights our currency-neutral results. As I mentioned a few moments ago, revenues grew 5.3% on a comparable currency-neutral basis. Pricing was slightly positive in the quarter. Moving down the P&L, I will focus on the comparable basis figures, which include CareFusion's results from the prior year, in order to give a better indication of our performance. Gross profit improved by 7.9%. I'll provide more color on gross profit on the next slide when we look at the underlying performance and the impact of currency. SSG&A as a percentage of revenue was 24.5%. We are very pleased with the leverage we're getting, which includes the benefit of cost synergy capture. R&D as a percentage of revenue was 5.9%. Our expenditures in the quarter were slightly lower than our full year expectation of 6% to 6.5% of revenues due to the timing of spending. We continue to invest in new products and innovation and expect to further reinvest the benefit from the medical device tax suspension in the back half of the year. Operating income grew 24.8% reflecting strong P&L leverage. In addition, as we've previously discussed, there were a number of items that negatively impacted operating margin in the prior year in the CareFusion business. I'll address the underlying growth and operating profit in more detail on the next slide. Our tax rate declined 70 basis points to 20.6%, below our full year expectation of 21% to 22% as the quarter included some timing benefits. As Vince discussed earlier, adjusted earnings per share were $2.18 which is a 44.7% increase versus the prior year. This reflects our solid growth profile and strong underlying margin expansion. In addition, growth benefited from the timing of revenues earlier in the year than expected as well as timing within the year related to R&D expenditures and tax as we just discussed. Slide 12 illustrates our gross profit and operating margin for the second quarter presented on a comparable basis. Strong gross profit margin performance of 170 basis points was primarily driven by robust operational performance and continuous improvement initiatives and to a lesser extent from favorable raw material prices. Strong operating margin performance of 370 basis points was primarily driven by gross margin expansion, combined with the achievement of operational efficiencies and the positive impact of cost synergies. In addition, timing of R&D expenses and the benefit of the medical device tax suspension aided operating margin in the quarter. Also you will recall several items drove lower second quarter operating margin for CareFusion in the prior year. Currency had a slightly negative impact on both gross profit margin and operating margins. Moving onto slide 14, since we provided guidance in February, the U.S. dollar has weakened against the euro and other currencies. As a result, we are raising our adjusted EPS guidance by 2 percentage points or $0.13 from a range of $8.37 to $8.44 to a range of $8.50 to $8.57. We are maintaining our currency-neutral adjusted EPS guidance of $9.01 to $9.08, as we expect the second quarter tax timing to reverse and R&D spend to ramp over the back half of the year, which includes reinvestment of the medical device tax. We remain extremely pleased with our performance and our ability to execute and deliver on our commitments. Turning to slide 15, I'd like to walk you through the additional elements of our guidance for the full fiscal year 2016. In summary, we continue to expect comparable organic revenue growth of 4.5% to 5% on a currency-neutral basis, with the back half of the year growing between 5.5% and 6.5%. This contemplates the third quarter growth rate to be slightly lower than our full year guidance range and the fourth quarter to be well above the full year guidance range. On a reported basis, revenue growth for the total year is expected to be between 21.5% and 22%, which reflects the currency headwind of about 300 basis points, an improvement from our prior guidance of about 450 basis points of currency headwinds. The U.S. dollar has weakened against the euro and most currencies since we last provided guidance in February. While our guidance assumes a euro to dollar exchange rate of $1.13 for the rest of the year, which is better than the actual rates in the second half of last year, we see some remaining FX headwinds over the second half as non-euro currencies remain unfavorable year-over-year. We continue to expect growth of 4.5% to 5% in BD Medical and 4% to 4.5% in our Life Sciences segment. Based on our current view of the environment, we continue to expect pricing to be about flat for the year. Beyond revenue and EPS, all other P&L guidance from February remains unchanged. Now, I'd like to turn the call back over to Vince who'll provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. Moving onto slide 17 and our updates on new product innovation, strategic and business initiatives and partnerships and collaborations. Starting with new product innovation, within our Life Sciences business, our Preanalytical Systems business launched two new products this quarter. The UltraTouch Push Button Blood Collection Sets will deliver significant improvements in patient outcomes and lab efficiency. The BD Barricor tubes use gel free technology, which significantly improves sample quality and lab turnaround time. The initial market feedback on both these products has been extremely positive. In our Biosciences business, as evidenced by our U.S. growth rate this quarter, we've seen very positive market uptake of our high-parameter instrumentation, the FACSymphony X-50 and X-20. In our genomics business, we anticipate launching our GenCell CLiC library preparation platform and our FACSseq cell sorter designed specifically for genomics applications later this fiscal year. Within strategic and business initiatives, as we discussed earlier, we have completed our current portfolio review having recently announced the Respiratory Solutions joint venture and sale of the vertebral augmentation solutions business. We remain focused on the areas we believe are high-growth and aligned with our core capabilities. We've also made progress with our product registrations having successfully registered more than 50 CareFusion products in over 20 countries. In addition, we have submitted registrations and are awaiting approval for an additional 25 products. This is consistent with our plans to achieve revenue synergies and we remain on track for them to begin to materialize in fiscal year 2017. And in the areas of partnerships and collaborations, we remain excited for the launch of our infusion sets, which we expect will move to broad commercial release with Medtronic in early fiscal year 2017. We believe this product will improve the consistency of insulin delivery by significantly reducing flow interruptions, simplify the users' experience and increase the patients' overall satisfaction with insulin pumping. We recently entered into a strategic partnership with the Parker Institute for Cancer Immunotherapy and will play a part in the Institute's vision of reducing cancer to a manageable disease. Support from the Parker Institute will help us advance our new cell sorter program, while bringing our high-parameter cell analysis solutions to these researchers, as they work to discover the next breakthrough in Cancer Immunotherapy. As you can see, we are executing on our strategy and continue to have strong opportunities there to drive growth and innovation. We look forward to updating you as we continue to make progress. Moving on to our business update on slide 18, we continue to make progress with our cost synergy capture. Our G&A functional transformation continued in the second quarter, and we made progress with our back-office functions and with harmonizing our IT infrastructure. We remain on track to achieve our FY 2016 cost synergies and continue to expect $325 million to $350 million in total cost synergies as we exit fiscal year 2018. Contributing to our operational efficiencies is the benefit of sustained lower oil prices on raw material costs as we discussed earlier. The consistent solid performance of our businesses, combined with operating efficiencies, cost leverage and cost synergy capture, is driving continued underlying operating margin expansion. In addition to the 100 basis points of operating margin expansion we achieved last year, we expect another 170 basis points to 190 basis points of expansion this fiscal year. Now, I'd like to reiterate the key messages from our presentation today. First, this was a solid second quarter. Both segments performed well and our performance highlights the benefits of our diverse portfolio, both from a product and geographic standpoint. Second, we have made significant progress on the acquisition of CareFusion. The value we can bring to customers around the world has become increasingly evident as we integrate these two great companies. Third, we have taken steps to optimize our portfolio. In doing so, we are positioning ourselves in higher growth areas which are aligned with our core capabilities. By taking these actions, we are delivering the most value to our customers. Finally, we are confident in our outlook for the full fiscal year. We're maintaining our currency-neutral revenue guidance and raising our adjusted EPS. We believe we are well-positioned to continue our track record of delivering value to our customers and shareholders. I look to the future with optimism. Thank you. We will now open the call to questions.
Operator:
Thank you. The floor is now open for questions Thank you. Your first question is coming from David Lewis of Morgan Stanley.
David R. Lewis - Morgan Stanley & Co. LLC:
Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning, David.
David R. Lewis - Morgan Stanley & Co. LLC:
Vince, two questions for you, one for you and one for Chris. I guess, the first one is the theme that you're showing the last several quarters is one that the whole device industry is showing this quarter, which is this polarization between better U.S. performance and slightly softer ex-U.S. performance, specifically emerging markets. Talk to us about how much of this, in your mind, is the quarter or just the trend that BD has been seeing for several quarters. And what's driving that strength in the U.S. in your opinion?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, I think there's a couple of things driving the strength in the U.S. Number one is, I think you have seen a stabilization in the U.S. marketplace in terms of healthcare and I think there's a benefit out there from the people that do have healthcare coverage, especially the expansion of Medicaid. But the other thing that you are seeing is that our businesses are performing quite well. You heard us talk about in the Biosciences business, the launch of those new products. We have a whole series of new products coming out, and I mentioned and specifically the high-parameter work that's going on. So yeah, that showed up in this quarter right now, but that's going to continue as we move through the year. You also saw good performance in Diagnostics, because we're getting some traction, blood culture and Kiestra, that is moving forward, Kiestra moving forward in the U.S., and then good performance across the Medical businesses where we're improving our competitive position in MMS. And so, you see all of that coming together. Europe, I think, once again, I think has stabilized. And this really – of course, you have to drop out the CareFusion factors, but there was negative timing in Biosciences, but you've got the same product launches that are occurring there. And quite frankly, Japan is performing better for us as well. Now, on the other side of the coin, the situation in China seems to have stabilized. We're seeing good performance on the medical device side of the business. And the situation really hasn't changed all that much on Diagnostics on the capital side, but it had stabilized. And so, we're getting good growth in China. We didn't mention it. We continue to get good growth in India. We're getting good growth in Latin America. There were some one-time events this quarter, which you heard in terms of Africa and Saudi Arabia. And Saudi Arabia is more of an impact in the back half of the year. So yes, this is slightly less in emerging market share, but the mix is quite good.
Operator:
Thank you. Your next question is coming from Mike Weinstein of JPMorgan.
Michael Weinstein - JPMorgan Securities LLC:
Thank you, and congratulations on the quarter. Let me start if we went back a quarter and the Street was concerned about the performance in the fiscal first quarter, revenues grew 1.8% organic and the Street was worried just about the ability to see the acceleration. Now, we're three months later, and you grew 5.3% organic this quarter, so essentially, what you said would happen happened. Can you just talk a little bit as you go into the back half of the year? I just want to make sure I understand the commentary on the cadence of the quarters. I know the comp in some different respects in the fourth quarter is easier than the third quarter. I just want to understand just the commentary relative to third quarter being a bit below the full year guidance and the fourth quarter being materially above. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, Mike. I'll have Chris walk you through that, because there's some complications here. You got to go back to last year to understand what was happening, but Chris will walk you through.
Michael Weinstein - JPMorgan Securities LLC:
Yeah.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, so the best way to – the key to understanding the second half growth trajectory is really to focus on the absolute dollars of revenue that we're achieving this year versus last year. We're actually up against a tough comparison in the third quarter, because in terms of absolute dollars, that was our highest quarter last year. So you got to really look at those absolute dollars. Looking at growth rates is a little misleading, because the growth rate last year was negative in CareFusion in the third quarter, but that was more about the comparative prior year, but the absolute dollars are the grow over. And then, as you model out the year, based on the guidance that we just gave you in terms of growth rates for the third quarter and fourth quarter, you'll see steadily improving sequential revenue dollars for all four quarters this year. So we really feel good about the trajectory, particularly on a sequential basis this year. It's all about the compared to last year revenue dollars.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Mike, if you think about it, there were two events at CareFusion, two different compensation events that caused the pattern to be highly fluctuate with the first quarter being very high, the third quarter being very high, and then we had the flu. So you got to go back and look at those absolute numbers as Chris was saying. And then, you'll see that our growth this year, actually, as we look at the whole year, is actually quite smooth, but the growth rates jump around because of that. Thanks for your question, Mike.
Operator:
Thank you. Your next question is from David Roman of Goldman Sachs.
David Harrison Roman - Goldman Sachs & Co.:
Thank you, and good morning, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, David.
David Harrison Roman - Goldman Sachs & Co.:
Vincent, I wanted to follow up on your commentary regarding some of the registrations that you're getting outside of the U.S. I guess, firstly, could you maybe give us a little bit more flavor on what those products are, which businesses those fit in, and then, how we should start to evaluate the impact on a go-forward basis? And then, for Chris, can you maybe help us understand why, given the change in currency, there's not a positive impact on the margin profile? Looks like you've just flowed the dollars right down to EPS at the corporate margin guidance that you previously provided, so why wouldn't we see an uplift in profitability associated with the change in rates?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. So let me ask Tom to comment first. I mean we'll give you more transparency in terms of the sales and sales impact next year, but why don't you talk to the products that are getting registered and which geographies we're talking about?
Thomas Polen - Becton, Dickinson & Co.:
Sure. Hi, David. This is Tom. So as Vince mentioned before, we registered more than 50 products over 20 countries, got about 25 additional registrations submitted and awaiting approval. Essentially, all of those products fall within either MPS or MMS, the two businesses that came from legacy CareFusion, and the majority of those products are actually within MPS, so think disposables. And this is right in line with what we had talked about over the last several quarters that, as we think about the first products that would be able to help drive incremental revenue growth, it would be things like infusion sets, ChloraPrep, the consumables that fit very well with BD's traditional sales channels and market approaches and presence in the marketplaces. And those are the products that we focused on getting registrations for first. So I would say we're seeing some early signs of success, as we've been launching these products, which is very consistent with our plans to achieve revenue synergies and really remain on track to start seeing them materialize more in 2017, but we do see sales now, and obviously, on a company the size of BD and a segment of Medical, we'll see those start showing up more materially as we roll into 2017, but they have started. And I would just say that, obviously, we're going to continue those product registration work, we're continuing the sales and marketing investments to support those initiatives, but overall, we're on track.
Christopher R. Reidy - Becton, Dickinson & Co.:
And to your second question, David, we did still see a little bit of a drag in the second quarter on both the gross profit 10 basis points of currency drag and 30 basis points on operating margin and the dynamic there is a couple of things. One is, although the euro hasn't improved, the non-euro currencies, year-over-year, are still providing a bit of a drag and then, secondly, and probably, more importantly, is the phenomenon of the profit and inventory that we've talked about in the past. So didn't quite catch up in the second quarter, certainly, not much of a drag, and it's starting to level off. And that in my prepared remarks was the commentary for the second half of the year, it doesn't really turn positive because of that phenomenon, but it certainly lightens up in terms of headwinds.
Operator:
Thank you. Your next question comes from Larry Keusch of Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Hi, good morning. I guess, for Tom, would you mind talking a little bit about infusion pump sort of the growth, the competitive landscape, kind of where you think you're going for the year, and then, also as alluded to in the prepared comments, it sounds like the installation process for MedStation ES is improving. I know there've been a number of software tweaks for that ES system over the past couple of years, and just also want to understand if you're kind of getting to a point where that system is now stable.
Thomas Polen - Becton, Dickinson & Co.:
Yeah. Sure, Larry. This is Tom. So let me start off with the good Pyxis question, and then, I'll address infusion pumps. So we are actually quite pleased with the progress that we're making on Pyxis. We actually just released another new version of the software, which we think really makes some very significant progress, and actually, addresses – will make a big step forward in terms of installation efficiency. So as we've shared in the past, we were really focused on improving the installation process. We've shared that there was a quite large backlog at the time of the acquisition. And to really address that backlog, we need to improve the installation efficiency process and we've been working on that applying some of our lean expertise, as well as making some adjustments in the software that would automate a lot of that and simplify the workload in the field. So we're seeing a lot of those efforts come to fruition. We did have very strong placements in Q2 that was part of the driver of MMS growth. We continue to see strong demand for the Pyxis ES platform and we're equally looking forward to continued strong growth in the second half of the year in that as Vince alluded to earlier. So on the infusion side, we also are very pleased with the growth that we saw in the quarter here and have similar expectations for the back half of the year. As you know, we are the market leader in that space. We've continued to strengthen our position over the last several years. We expect to continue to strengthen our position in the market by about the same amount this year, as we have over the last couple of years. We do see customers continue to select the BD Alaris pumps in an incremental way, really based on that interoperability and the power of one to be able to do all of their infusion needs across both large-volume infusions, syringes and narcotics, all in one product, the only item that can do that. So we're happy there. I would point out as well that as you look at our safety sales, particularly in the U.S., that was largely driven by growth in some of the connectors that are associated with our dedicated sets in the infusion category, and that's really a reflection of that strong performance in that infusion category and that renewing consumable stream that comes as we place pumps incrementally. Thank you.
Operator:
Thank you. Your next question is from Bill Quirk of Piper Jaffray.
William R. Quirk - Piper Jaffray & Co:
Great. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Bill.
William R. Quirk - Piper Jaffray & Co:
Good morning, everyone.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
William R. Quirk - Piper Jaffray & Co:
Vince, you and the team have done a really nice job in terms of executing on some of the identified cost synergy opportunities with CareFusion. Can you talk a little bit about the pace of identifying new opportunities, either in terms of additional cost synergies or on the revenue side, and obviously, you alluded to some of the products and registration? And then, secondly, just on China, looks like based on the numbers we're going to need about some sort of teens acceleration, easier comps, but can you just elaborate on that? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, okay. So I'll ask Chris to talk about the cost synergies.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So just a reminder that we raise the cost synergies fairly... (38:14-38:50)
Operator:
Ladies and gentlemen, please standby, the conference will resume momentarily.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Is anybody able to hear us?
Operator:
Yes, we can hear you now.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Go ahead.
Christopher R. Reidy - Becton, Dickinson & Co.:
Okay. So let me start again to that question. So in terms of cost synergies, we did, I would remind you, improve cost synergies fairly recently up to the $325 million to $350 million and that was identification of some new synergies from our recent or our original model. I would also remind you that we increased the overall synergies from the standpoint of the tax rate improvements that we saw that we originally didn't contemplate, and that's another 3% accretion that we had mentioned. Really, when you think about the synergies, we get initial synergies of duplicate public company costs, and then, you move into the integration of systems and infrastructure, and we've gotten good traction on that and that led to the last increase and then, towards the end are the more difficult synergies to get, which are the distribution centers and manufacturing plants, and we actually saw some good initial improvements in that area or traction in that area that led to our last increase. So we really feel great about what we're driving. All in, all in, it's significantly higher than our original expectations, particularly when you add the tax synergy. You see this year the EPS quarter-over-quarter was over 44%, I think, is an indication of that. So we really feel good about our ability to drive those synergies and executing on those synergies.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And then, for China, growth is going to be driven by the Medical side of the company. And there are multiple businesses on the Medical side that are doing well in China. And then, in addition, there were several million dollars of inventory that came out of the chain last year. So there is a favorable comparison in the fourth quarter. But Tom, do you want to comment on any of the product lines?
Thomas Polen - Becton, Dickinson & Co.:
I think as you said, we see the consumables across the board are holding in strong. And we do have, again, while it may not be overly material for the company, China is one of the lead markets in which we launched some of those new products from CareFusion into them. We're seeing some good traction in some of those items, particularly as we think about connectors and some of the oncology products coming out from CareFusion.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And we don't talk about it much, but we also have launched flush in China so that's another piece that has been growing quite nicely for us.
Operator:
And thank you. Your next question is from Rick Wise with Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, Vince. Hi, Chris.
Christopher R. Reidy - Becton, Dickinson & Co.:
Hi, Rick.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
I guess, I'll ask sort of a two-part question. Maybe first big picture, Vince, maybe you can talk a little bit about your latest thoughts, evolving thoughts on capital deployment. You're through the post CareFusion portfolio review, maybe what's next and what you're thinking about? And maybe just one for Chris, on operating margin expansion, you've addressed a little bit, but this acceleration in operating margin expansion can't go on forever. How do we think about the – not for guidance, but how do we think about fiscal 2017 and beyond, what's possible in terms of further operating margin expansion, just directionally? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. That's fine. I'll start out and you guys get really good at your single questions. So the two-part is really fantastic. Let me just say from a capital deployment standpoint, of course, short run, we're still working to get down to the three times leverage and we're making excellent progress there. And so, in the short run, we still have the flexibility to do plug-in acquisitions. And then, as we have been stating, we're going to be really strategy-driven, and we challenge both segments to look at their strategies and as we look at our ability to provide solutions to the marketplace and have a broader impact, that's what's going to drive our strategy. It'll be a mix of both internal development and continued looking on the upside and we'll be very balanced there. But ultimately, it's about strategic impact plus value creation for shareholders and that's how we're thinking about it. Chris?
Christopher R. Reidy - Becton, Dickinson & Co.:
On the margins, Rick, to your point, the second quarter was really rich margin performance on operating margins 370 basis points, that was driven again by the very strong gross profit margin, which is really going around operational efficiencies and continuous improvement, a little bit of benefit from raw material prices, as we talked in the past from oil, but then on the operating side, SSG&A really reflective of hitting on the synergies. It was a little bit of an easier compare in the second quarter because of the operating margin challenges in CareFusion in that quarter last year. So you won't expect 370 basis points. In fact, we expect about 170 basis points to 190 basis points for the year on the operating margin basis. I'd remind you that's on top of 100 basis points of margin improvement last year, so really improving the margins as you point out. As we think about going forward, as we execute on synergies, you would expect to see above normal, so we usually think 40 basis points to 50 basis points of margin improvement. You're going to get more of that as we execute on the synergies in 2017 and 2018. You would also get a little bit of a lift from the fact that as we exit Respiratory which had challenging margins, you get a little bit of a lift. So not to give guidance on 2017, but you're absolutely right, directionally, we're going to see improved margins going forward in 2017 and 2018. And then, as you start lapping those synergies, I think somewhere beyond that, you start going back to that 40 basis points to 50 basis points. That's a few years out.
Operator:
Thank you. Your next question is coming from Derik De Bruin of Bank of America.
Derik De Bruin - Bank of America Merrill Lynch:
Hi. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Derik De Bruin - Bank of America Merrill Lynch:
Hey, another long single question, but you've done a number of portfolio reviews lately with Respiratory and the Simplist portfolio. Could you sort of talk about – this is a 2017 organic revenue growth question and sort of like what the impact of all these moving parts are on it, and do you still feel good about a 4% to 5% longer term organic revenue growth rate for the company?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, when we did the deal and we discussed what our revenue aspirations were, we said legacy BD was growing at around 5% and that CareFusion was about 3.5%, and our goal was to bring the entire company up to about 5%. I think we're making excellent progress. I think you see the performance of the CareFusion businesses is quite strong. I think that the portfolio moves that we have made have been the right ones. So that still is our goal and I think we're making excellent progress.
Operator:
Thank you. Your next question comes from Jon Groberg of UBS.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Hi, Jon.
Jonathan Groberg - UBS Securities LLC:
Good morning. Congratulations – can you hear me, (46:23) congratulations on a good quarter. So can I ask you just a timing question on a few items? I guess, one, the infusion set, do you have kind of a specific launch for that, because this is the diabetes infusion set, and then, on the BD Simplist in the Respiratory, I guess, when exactly do you expect all those to close, and if you have any updated views on the EPS and that kind of impact from an EPS (46:51) standpoint for those initiatives? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, so Tom can talk to those things, but Respiratory, I think we're expecting to close at the end of this fiscal year. And then...
Thomas Polen - Becton, Dickinson & Co.:
Simplist is closed.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Simplist is done.
Thomas Polen - Becton, Dickinson & Co.:
Simplist is closed. And as we shared in the past, on Simplist, we don't expect any impact on sales from that at all. It was small and the other opportunities will make up for that. In terms of the infusion set launch, as Vince mentioned, we expect broad commercialization in early FY 2017. We are tracking towards by the end of this fiscal year, within this fiscal year, we will be doing a limited launch and we talked about this in the past in which Medtronic will start providing the product to a set group of patients so that they can really understand the user insight at another level before they do the full-scale launch. And so, we're moving forward preparing to ship out the first product for that limited scale launch, in the back half of this fiscal year. That will occur. And then, it would open up for a full commercial launch we expect at the start of FY 2017.
Christopher R. Reidy - Becton, Dickinson & Co.:
And this is Chris. The only other thing I'd add is, as we said with the Respiratory announcement, the impact is 2017. Because it closes at the end of our fiscal year, there's no impact to 2016. But for 2017, it's $0.10 to $0.14.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks very much.
Operator:
Thank you. Your next question comes from Brian Weinstein with William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Hey, guys. Good morning. Thanks for taking the question. On R&D, it did step down sequentially. You said that, obviously, you're going to get the benefit of the device tax and reinvest that. But can you talk a little bit more specifically about the priorities within R&D? Is it about accelerating kind of current projects? Is it really putting that money to work at new projects? And any specific areas of focus that you would like to focus on with those dollars? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, sure, Brian, and thanks for the question. First off, in this quarter, there was some timing in the R&D spending that we knew was going to happen. And of course, that timing, that money is going to get spent. And I'm talking before the medical device tax in the back half of the year. It's timing of things like clinical trials and whatnot. But in addition, the money that is being spent on the medical device tax is being spent in both segments, and it is a combination of some new things that we are doing. But mostly, it's current strategies where we are accelerating those strategies, where we had platforms where we could push them faster, and part of that which is a bit new for us is moving to informatics side of things quicker. So you can think of major platforms going faster, and then, informatics piece on top of that, both sides of the company.
Operator:
Thank you. Your next question comes from Richard Newitter with Leerink Partners.
Richard Newitter - Leerink Partners LLC:
Hi. Thanks for taking the question. This is kind of like an innings question. What innings are you in for two parts of your business that we frequently talk about? For Pyxis, do you have – just can you update us on where you are with the kind of the opportunity there to kind of get upgrades for that product cycle? And then the second innings question, just the – in your cytology business, your liquid-based Pap testing, can you just tell us what the trend is there? Are we kind of through the interval expansion impact mostly at this point? And just comment on any pricing or volume trends for that business. Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. Let's start with the Pap first, and Linda can talk to you about that.
Linda Tharby - Becton, Dickinson & Co.:
Yeah. So good morning. So if you look at the liquid cytology business in the U.S., as you mentioned, we're really starting to see a flattening of that business. So the interval testing, we think, we're mostly through. Outside the U.S., we're actually seeing strong double-digit performance. And then the entire platform, both in the U.S. and ex-U.S., is being helped by the total automation we're doing across both our focal point and our Totalys system, so complete control of the sample from collection through the result. So that's driving a lot of growth both in the U.S. and ex-U.S. for us.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks, Linda. Okay.
Thomas Polen - Becton, Dickinson & Co.:
And on Pyxis ES, we're – about 25% of our base business has been converted over to ES. And so, we continue to see strong demand there, and we still do have generally quite a wide runway ahead.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah.
Thomas Polen - Becton, Dickinson & Co.:
Yeah.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thanks for the question.
Operator:
Thank you. Your next question comes from Doug Schenkel of Cowen and Company.
Doug Schenkel - Cowen & Co. LLC:
Good morning. So I don't have a multi-part question, but I do have two questions, one for Chris and one for Tom. The good news is I think they're quick follow-ups. So for Chris, you reiterated full year revenue guidance. You reduced expectations for emerging market growth. That would seemingly imply there's a positive offset for developed market growth. I believe this change in mix should benefit operating margin. It doesn't seem like your guidance reflects that margin mix dynamic. Am I wrong? And if not, why? And then, the second question is for Tom. Regarding your plans for the 25 or so additional CareFusion product registrations, what's the timeline for those? And can you walk us through why those products take a bit longer to get registered? I'm just trying to get a better handle on the profile of those products versus the first 50 that are close to or have been registered? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Chris?
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, just you're not wrong, but at this point in the year, the impact that it has is still within the range of guidance that we gave. So we had a fairly broad range and it's still in that range. So arguably, it's the higher end of the range.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. And Tom?
Thomas Polen - Becton, Dickinson & Co.:
And Doug, this is Tom. So the 25 is not a kind of a straightforward answer. In fact, it's really a combination of just think about, of course, we couldn't submit all files simultaneously, so it just takes time to work through those. So think about those just being ones that we submitted more recently and didn't work through certain regulatory processes. In other cases, it's a combination of there are even certain countries that have longer registrations. China has longer registration processes than most of Europe, as an example, and then, the other one is that certain product categories. So ChloraPrep, for example, is registered as a drug in many markets, particularly, let's say, Latin America. It's registered as a drug. Those typically sit in the regulatory process longer than medical devices. So it's kind of a combination of those three items, not one thing specific and not unexpected at all. It's right in line with our projections.
Vincent A. Forlenza - Becton, Dickinson & Co.:
You have to pull together the data for these files, and so, certain product lines that may not have done that kind of clinical trial work for China, so we had to do some pre-work to get them into the file. That's all that is. Okay. Thanks very much.
Operator:
Thank you. Your next question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore ISI:
Hey, guys. Congrats on a nice beat.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Vijay.
Vijay Kumar - Evercore ISI:
Just maybe one housekeeping question on the guidance, Chris. You beat the quarter pretty handily $0.16 and it looks like FX came in better by 150 bps, but the overall guidance sort of up $0.13 by the midpoint. Just want to make sure sort of – is that a little bit of conservatism on the part of management just because FX has been moving all over the place when you think about, I mean, trying to put the Q in context of FX improving in the back half? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure, Vijay. So what I'd say is you really have to look at the EPS guidance in two buckets. One is the FXN side and then the FX impact. So what we did is we did flow through everything on the FX impact and that was the $0.13. On an FXN basis, you're right, we were up around $0.14 to $0.16, but we see that as timing and the timing buckets are the medical device tax spending which we know where we want to spend it, but because of the timing, don't forget, it happened in January, and we couldn't ramp that quickly. So that past quarter, we really got a lift from that, but we fully intend to spend that in the back half of the year. Then you had timing on the tax rate, so the tax rate was lower than our 21% to 22% and that's just lumpy throughout the year. We expect that to fall back within the rest of the year. So you had that piece. And then, we had the pull forward of some of the revenues from the third quarter to the second quarter and the impact of that. So all of that accounts for the bulk of that $0.14 to $0.16 on an FXN basis. The other thing I'd point out is we actually raised the FXN EPS guidance last quarter by $0.28. It was lost from the standpoint that, at that point, FX was getting worse across the world and it offset that, but the FXN was raised prior. So you really got to think about it in those two buckets.
Operator:
Thank you. Our final question is coming from Matt Taylor of Barclays.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Matt.
Matthew Taylor - Barclays Capital, Inc.:
Thanks for taking the question.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Matthew Taylor - Barclays Capital, Inc.:
Good morning. I wanted to see if you could touch on a couple of kind of interesting projects that you've talked about in the last couple of quarters. One is the solutions that you're bringing in with the swap of the Simplist business, and then, the other is the diabetes partnership with Medtronic. Could you talk a little bit about those opportunities and maybe help us quantify the upside there?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. So Tom will address those. Tom, you want to start with diabetes?
Thomas Polen - Becton, Dickinson & Co.:
Sure. This is Tom. So we haven't specifically sized the opportunity on infusion sets, but I think as we said all year, we're expecting to get the product into some early-stage release in a controlled patient group this fiscal year, and then, really see more of the impact in the Diabetes Care business in FY 2017, that remains unchanged. So we remain very excited about that opportunity, and so, of course, our first venture outside of the pen needles and syringes for the Diabetes Care business moving into a fast-growing market with the market leader, Medtronic, and we're I think equally excited about the product technology and what it can do to help patients and the partnership and what the power of us working together can do to make an impact there. So if you think about solutions, as we, of course, shared before, we have announced the solutions partnership with Fresenius. We are looking at launching that, not necessarily now in Q4 of 2016, but more in early FY 2017, just based on regulatory approval timelines there, but that does continue to move forward. And again, we've not shared a specific number there, but we said it would certainly make up for any reduction in BD Rx sales that we had planned over the coming horizon and that remains right on track.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay.
Operator:
Thank you. I'll now turn the floor back over to Vince Forlenza for any closing remarks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay. Thank you very much for your participation on the call today. It was a real pleasure to talk about a very solid quarter and to raise our EPS guidance. It was also a pleasure to talk about the progress we're making on the CareFusion integration and progress with those businesses, the synergies, the teams in place, and then lastly, the strategic partnerships that we're doing including the Parker Institute relationship, the new products that are being launched. We didn't spend a lot of time on the Life Science business today. There weren't that many questions, but with BD MAX, with Kiestra, all of these things happening over there; very, very exciting, and of course, new products on the Medical side. So thank you very much for your time, and we look forward to updating you next quarter.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Executives:
Monique N. Dolecki - Vice President-Investor Relations Vincent A. Forlenza - Chairman, President & Chief Executive Officer Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer Thomas Polen - President-Medical Segment & Executive Vice President Linda Tharby - Executive Vice President & President-Life Sciences Segment
Analysts:
Michael Weinstein - JPMorgan Securities LLC David Ryan Lewis - Morgan Stanley & Co. LLC David Harrison Roman - Goldman Sachs & Co. Rick Wise - Stifel, Nicolaus & Co., Inc. Larry S. Keusch - Raymond James & Associates, Inc. William R. Quirk - Piper Jaffray & Co (Broker) Matthew Taylor - Barclays Capital, Inc. Brian D. Weinstein - William Blair & Co. LLC Jonathan Groberg - UBS Securities LLC Vijay Kumar - Evercore ISI Rich S. Newitter - Leerink Partners LLC Doug Schenkel - Cowen & Co. LLC Derik De Bruin - Bank of America Merrill Lynch Kristen M. Stewart - Deutsche Bank Securities, Inc. Brandon Couillard - Jefferies LLC
Operator:
Hello and welcome to BD's First Fiscal Quarter 2016 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through February 10, 2016 on the Investors page of the BD.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 20775429. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Vice President-Investor Relations:
Thank you, Christie. Good morning, everyone, and thank you for joining to us to review our first fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call, we will make forward-looking statements and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our first fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the BD.com website. As a reminder, until we annualize the acquisition of CareFusion in the third quarter of fiscal year 2016, we will speak to our revenue results on a comparable currency-neutral basis, which includes BD and CareFusion in the current and prior year periods. We believe this provides additional visibility into the new BD. The comparable current period revenues are adjusted to exclude a small impact related to a purchase accounting adjustment to record CareFusion's deferred revenues at fair value as of the acquisition date. In addition, comparable prior year revenues are adjusted to exclude sales related to the terminated agreement with CareFusion for the sale of Fisher & Paykel's respiratory care products. The fiscal year 2016 comparable revenue guidance provided today will also exclude the year-over-year impact of this contract termination. The impact to the bottom line is not material and is included in our EPS guidance. Details of the purchase accounting and other smaller adjustments and the comparable basis revenue results can be found in the reconciliations to GAAP measures in the financial schedule in our press release or the appendix of the Investor Relations slides. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Executive Vice President, Chief Financial Officer and Chief Administrative Officer; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Executive Vice President and President of the Medical Segment; and Linda Tharby, Executive Vice President and President of the Life Sciences Segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we are pleased with our solid start to fiscal year 2016. Performance from both the Medical and Life Science segments contributed to revenue growth that was in line with our expectations. Strong underlying margin expansion was driven by the achievement of operational efficiencies and continuous improvement, coupled with the positive impact of synergies. As we move through the first quarter, we continue to make progress with the strategic review of our portfolio. Many of you already know, we recently announced that Fresenius Kabi has acquired the BD Simplist portfolio. We believe Fresenius is a better owner of the BD Rx business, as it complements their existing products and capabilities in the injectable pharmaceutical industry. In addition, we're excited that we're initiating a long-term collaboration for Fresenius to supply us with a portfolio of competitive IV solutions in the U.S. This transaction is intended to enable BD to be responsive to our customers' needs and is complementary to our end-to-end medication management solutions for our customers and their patients. Since we provided guidance in November, there've been a number of new dynamics that will affect our results this year. As most of you already know, several weeks ago there was a bipartisan agreement to suspend the medical device tax. This critical relief is extremely important to BD, as well as the patients, providers and research communities we serve. While some of the specifics are still being analyzed, we plan to reinvest this tax back into the business, which further supports our innovation strategy. In summary, we're confident in our outlook and are maintaining our currency-neutral revenue guidance. We're also maintaining our adjusted EPS guidance, despite significant currency headwinds and are raising our currency-neutral adjusted EPS guidance for the full fiscal year. Moving on to slide five, I will review our first quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Total company revenues grew 1.8%, which is in line with our prior guidance of 1% to 2% growth that we had anticipated and communicated on our last earnings call. Adjusting for tough comparisons for the prior year, this reflects solid underlying growth in both segments. Adjusted EPS was $1.96, driven by the solid underlying performance of the segments. Earnings were ahead of our expectations, as the quarter also benefited from product mix that was incremental to already strong gross margin performance, and some timing of expenses and below-the-line items. Now, I'd like to turn things over to Chris for a more detailed discussion of our first quarter financial performance and our updated fiscal year 2016 guidance.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Thanks, Vince, and good morning, everyone. As Vince just mentioned, performance in both segments contributed to a solid start to fiscal 2016. Total first quarter revenues of approximately $3 billion grew 1.8% on a comparable basis, which is in line with our previously disclosed guidance. Our growth rate this quarter reflects a tough comparison to strong prior year results of 6.7% organic growth, which includes CareFusion's final quarter as a standalone company, growing at 10% organically. As a reminder, our results last year were driven by robust performance in the legacy CareFusion businesses, the impact of timing of orders in Pharmaceutical Systems, a very strong flu season, timing of tenders and strong emerging market performance. As a result, these items negatively impacted our first quarter growth rate by over 240 basis points. On an underlying basis, we are pleased with the solid performance of our segments and the momentum in our businesses. BD Medical first quarter revenues increased 1.9%, reflecting the aforementioned items. Medication and Procedural Solutions, or MPS, growth was 2.0%, which reflects strength in pharmacy solutions, infusion therapy and safety-engineered products. Very strong results in the prior year negatively impacted the MPS growth rate by approximately 250 basis points. Despite extremely strong results in the prior year in Medication Management Solutions, revenues grew 4.3%, driven by both strong infusion and dispensing capital installations. Respiratory Solutions revenues declined 6.8%, reflecting the tough comparisons to prior year results due to the strong final quarter as part of legacy CareFusion. Growth in Diabetes Care was 3.9%, driven by solid growth in pen needles. Pharmaceutical Systems growth of 2.6% reflects strong growth in SAIS, partially offset by the impact of timing of orders, which we expect to occur later this fiscal year. BD Life Sciences first quarter revenues increased 1.7%, primarily driven by growth in Preanalytical Systems and Biosciences. Preanalytical Systems growth of 4.4% was driven by safety-engineered products in both the U.S. and Europe, and also reflects strong growth in emerging markets. BD Biosciences growth of 1.2% reflects clinical tendered delays in emerging markets and a difficult comparison to the prior year when sequestration ended. This was offset by strong sales that were driven by an increased demand of high-end instruments and growth in research reagents. The Diagnostic Systems decline of 0.8% reflects a mild flu season, which impacted growth by approximately 400 basis points. Growth was also negatively impacted by a slowdown of capital spending in China. Solid microbiology growth as well as growth in molecular, led by BD MAX and international growth in women's health, partially offset the impact from the flu. Moving to slide eight, I'll walk you through our geographic revenues for the first quarter on a currency-neutral basis. U.S. growth of 1.5% reflects the aforementioned prior year comparisons and timing impacts, with BD Medical growing 1.9% and BD Life Sciences growing 0.3%. BD Medical's performance reflects strength in pharmacy solutions, infusion therapy pumps and related consumables and strength in Diabetes Care. This was partially offset by Respiratory Solutions. BD Life Sciences growth reflects the impact of a light flu season this year, and a difficult comparison to the prior year due to a strong flu season and the ending of sequestration. Offsetting these impacts was strong performance in the Biosciences business, driven by research reagent sales, solid performance in our Preanalytical Systems unit, growth in microbiology, and growth from BD MAX. Moving on to international, revenues grew 2.2%. This is below our normal growth rate, which reflects timing of tenders and capital installations. International revenues also reflect the moderation of growth in China in the quarter, and I'll provide more color on China in just a moment. The Medical segment grew 1.9%. This reflects solid performance in Pharmaceutical Systems and Medication Management Solutions, partially offset by a tough comparison due to large tenders in Brazil and EMA in the prior year, as well as timing of capital installations in the dispensing business. The Life Sciences segment grew 2.7%, which reflects strong growth in Diagnostic Systems driven by core microbiology, women's health, and an expanded BD MAX menu in Europe. We also saw strong growth in the Preanalytical Systems unit. This was partially offset by a decline in the Biosciences business due to tender delays in emerging markets. On slide nine, emerging market revenues grew 2.4% currency-neutral, with developed markets growing 1.7%. The first quarter growth rate in emerging markets reflects a very difficult comparison to the prior year period for both the BD and CareFusion legacy businesses and a moderation of growth in China. China growth for the first quarter was 4.5%, compared with growth of over 23% in the first quarter of last year. This difficult comparison was in line with our expectations. Beyond the difficult comparison, we also experienced the continued slowdown of capital spending in diagnostic systems, which resulted in inventory adjustments. Inventory adjustments negatively impacted growth in the quarter by approximately 350 basis points. While there are pockets of pressure, millions of patients are entering the healthcare system and overall, emerging markets continue to be an important growth driver. For the total year, we expect China to grow in the low double-digit range and total emerging markets to grow 9% to 10%. Moving to global safety on slide 10, currency-neutral sales increased 4.9% and grew to $737 million in the quarter. Safety revenues in the U.S. grew 3.8%, while international sales grew 6.5% currency-neutral, with continued strength in Europe as compliance with safety legislation continues. Safety revenues grew 10.9% in emerging markets. Medical safety sales grew 5.4% primarily driven by safety catheters and a range of products in Pharmaceutical Systems. Life Science safety sales, which are driven by our Preanalytical Systems unit, grew 4.1% in the quarter. Slide 11 recaps the first quarter income statement and highlights our currency-neutral results. As I mentioned a few moments ago, revenues grew 1.8% on a comparable currency-neutral basis. Pricing was about flat in the quarter. Moving down the P&L, I will focus on the comparable basis figures, which includes CareFusion results in the prior year in order to give a better indication of our performance. Gross profit improved by 3.6%. I'll provide more color on gross profit on the next slide when we look at underlying performance and the impact of currency. SSG&A as a percentage of revenue was 24.9%. We are very pleased with the leverage we are getting, which includes the benefit of cost synergy capture. R&D as a percentage of revenues was 6.3% as we continue to invest in new products and innovation. Operating income grew 12%, reflecting strong P&L leverage, which I'll also address in more detail on the next slide. Our tax rate increased slightly. However, it continues to improve versus our initial deal model expectations. As discussed earlier, adjusted earnings per share were $1.96, which is a 45.8% increase versus the prior year. This reflects solid underlying performance from the segments, positive product mix that was incremental to our already strong gross margin performance, some timing of expenses, and below-the-line items. Slide 12 illustrates our gross profit and operating margin for the first quarter presented on a comparable basis. Strong gross profit margin performance of 130 basis points was primarily driven by continuous improvement initiatives and product mix, and to a lesser extent, favorable raw material prices. Building off the strong momentum in fiscal year 2015 of 100 basis points of underlying operating margin expansion, operating margins grew 220 basis points year-over-year, driven by gross margin expansion, combined with the achievement of operational efficiencies, continuous improvement, and the positive impact of cost synergies. Currency had a negative impact on both gross profit margin and operating margins. Moving on to slide 14, since we provided guidance in November, there have been a number of new dynamics that we anticipate will affect our results. Some of these items include the sale of BD Rx, the suspension of the medical device tax, the reinstatement of the R&D tax credit, lower oil prices, a milder flu season, and additional FX pressure. As a result of these new dynamics, in combination with our first quarter results, we are raising our currency-neutral adjusted EPS guidance by 4 percentage points from $8.73 to $8.80 to a range of $9.01 to $9.08. The increased currency-neutral guidance is offset by incremental FX pressures of approximately $0.28 due to the continued strengthening of the U.S. dollar. Therefore, we are maintaining our adjusted EPS guidance of $8.37 to $8.44. We're extremely pleased with our performance and our ability to execute and deliver on our commitments. Turning to slide 15, I'd like to walk you through additional elements of our guidance for the full fiscal year 2016. In summary, we continue to expect comparable revenue growth of 4.5% to 5% on a currency-neutral basis. On a reported basis, revenue growth for the total year is expected to be between 20% and 20.5%, which reflects a currency headwind of about 450 basis points. The U.S. dollar has strengthened further against most currencies since we last provided guidance in November. Our guidance assumes a euro to dollar exchange rate of $1.09. We expect this unfavorable impact to be acute again in the second quarter with a revenue headwind of over 400 basis points on a comparable basis. We expect our currency-neutral revenue growth to be back in line with our guidance range of 4.5% to 5%. In the second half of the year, we expect the currency impact on revenue to moderate. We continue to expect growth in BD Medical of 4.5% to 5%. In our Life Sciences segment, we are revising our guidance to 4% to 4.5% to reflect the mild flu season in combination with lower sales in China. Based on the current view of the environment, we continue to expect pricing to be about flat for the year. We continue to expect gross profit margin to be between 52% and 52.5%, as the benefit from operating efficiencies, the sale of BD Rx and lower resin prices are expected to be partially offset by increased currency pressure. SSG&A as a percentage of sales is expected to be between 24% and 24.5%. This is slightly better than our previous forecast as a result of the suspension of the medical device tax, which was recorded within SSG&A. As we reinvest the medical device tax, we now expect R&D investment of about 6% to 6.5% of revenues. The reinvestment will help us to accelerate the strategies in both of our segments. Operating margin is expected to be between 21% and 22% of revenues as a result of the items I just reviewed. Excluding the unfavorable impact of foreign currency, we are raising our underlying operating margin guidance to 170 basis points to 190 basis points. Once again, we're very pleased with our performance in driving margin expansion. We are broadening our tax rate to be between 21% and 22%. Our full year guidance ranges for operating cash flow, capital expenditures, interest/other, and share count remain unchanged from our November guidance. Now, I'd like to turn the call back over to Vince, who will provide you with an update on our key initiatives and product portfolio.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thank you, Chris. Moving on to slide 17, we are presenting a new slide that includes updates on our new product innovation, strategic and business initiatives, and partnerships and collaborations. With this new format, we will provide business updates each quarter. The product update slides that you are accustomed to seeing will remain in the appendix of the presentation for reference. Starting with new product innovation within our Life Sciences business, we're very pleased with the early access customer response to BD FACSSymphony, a novel cell analyzer enabling the simultaneous measurement of up to 50 different characteristics of a single cell. BD FACSSymphony offers high speed analysis that is 20 times faster than other non-flow platforms. When combined with our BD Horizon Brilliant or the Sirigen reagent portfolio, these capabilities will allow researchers improved identification and analysis of rare cell types and events. In early December, we successfully launched our FACSCelesta instrument, a mid-level cell analyzer with a very positive market reception. The new FACSCelesta system offers simultaneous measurement of up to 14 different single cell characteristics. The FACSCelesta system is also designed to leverage our broad BD Horizon Brilliant reagent portfolio. In our Diagnostic Systems business, we continue to focus on menu expansion and anticipate launching new assays on the BD MAX platform in fiscal year 2016, including CT/GC and vaginitis. Within our strategic and business initiatives, as we discussed earlier, we have divested the BD Rx business and are excited to be adding IV solutions to our Medication Management portfolio. We continue to make progress with our portfolio strategic review process and we'll provide you with updates as we move forward. In January, we launched our new BD brand that captures the new BD and our rearticulated purpose, Advancing the World of Health, which is more relevant than ever in a dynamic and ever-changing industry. And in the equally important area of partnerships and collaborations, we remain on track with our collaboration with Medtronic. The insulin infusion sets in our Diabetes Care business have an expected product launch in the middle of the fiscal year 2016, so this year. We believe this product will improve the consistency of insulin delivery by significantly reducing silent occlusions, simplify the user's experience, and increase a patient's overall satisfaction with insulin pumping. We continue to see strong growth and opportunities in our ID/AST business, where we have built a comprehensive solution offering, which includes the BD Bruker MALDI Biotyper. This is a result of the collaboration with Bruker Corporation. We've seen success over the past several years with the BD Bruker MBT instrument, due to its ability to provide rapid and accurate microbial identification and its adoption in new geographic markets. As you can see, we continue to have strong opportunities that drive growth and innovation, and we look forward to updating you as we make progress throughout the year. Moving on to our business update on slide 18. We continue to make progress with our cost synergy capture. Our G&A functional transformation continued in first quarter and we made progress with our back office functions and with harmonizing our IT infrastructure. We remain on track to achieve our FY 2016 cost synergies and continue to expect $325 million to $350 million in total cost synergies as we exit fiscal year 2018. Contributing to our operational efficiencies is the benefit of sustained lower oil prices on raw material costs, as we discussed earlier. The consistent solid performance of our business, combined with operating efficiencies, cost leverage and cost synergy capture, is driving continued underlying operating margin expansion. In addition to the 100 basis points of operating margin expansion in fiscal year 2015, we expect another 170 basis points to 190 basis points of expansion this fiscal year. Now, I'd like to reiterate the key messages from our presentation today. First, this was a solid start to fiscal year 2016. Both segments performed well and we delivered very strong earnings growth. Second, our margin profile has improved significantly. We're driving operational efficiencies and continuous improvement, in addition to delivering on our synergy commitments. This is manifesting in our financial results, with 200 basis points of operating margin expansion this quarter and increased guidance for the total year. Third, we continue to evaluate and optimize our portfolio and focus on the appropriate strategic initiatives. In doing so, we are positioning ourselves in higher growth areas which are aligned with our core capabilities. By taking these actions, we are delivering the most value to our customers. Finally, we are confident in our outlook and are maintaining our currency-neutral revenue guidance. We are also maintaining our adjusted EPS guidance despite significant currency headwinds and are raising our currency-neutral adjusted EPS guidance for the full fiscal year. We believe we're well positioned to continue our track record of delivering value to our customers and shareholders, and I look to the future with enthusiasm. Thank you. We will now open the call to questions.
Operator:
Thank you. The floor is now open for questions. Thank you. Our first question is coming from Kristen Stewart of Deutsche Bank.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Morning, Kristen.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, Kristen. We don't hear you, Kristen, if you're there.
Operator:
Kristen, your line is open.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Not working. Kristen?
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
We'll have to come back to Kristen.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Are you on mute, Kristen?
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Apparently.
Operator:
Your next question is from Mike Weinstein of JPMorgan.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Hey, are you there?
Michael Weinstein - JPMorgan Securities LLC:
Hey, this is Mike. Can you hear me okay?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Now we can, but you sound a little gravelly.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Sounds like you got a cold.
Michael Weinstein - JPMorgan Securities LLC:
Yeah. Exactly. Well, I'm trying to make up for the flu season. So let me ask you a couple of items. So number one, you guys in the last call had guided to 1% to 2% constant currency growth for this quarter with a tougher comp. The Street heard you, but didn't do a good job of reflecting that in the numbers, but you're maintaining your FX-neutral guidance for the year, which effectively implies that over the balance of the year, the next three quarters, you grow the top line 5.5% to 6% FX neutral. So, A, is that correct? And then B, can you just walk us through your confidence in the top line outlook for the rest of the year? Thanks.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Sure, thanks, Mike. Yeah. So we did have results that were right in line in first quarter with what we guided, the 1% to 2%, it came in at 1.8%, which does imply greater growth for the rest of the year. Just to remind everyone that there was very difficult comps, a strong flu season last year. We had CareFusion's last final quarter, and we talked in our prepared remarks about the 6.7% growth that we were jumping over, including the CareFusion 10% growth. And then we had a number of items like in pharmacy solutions where we have the typical timing compares. All of that goes away; in fact it reverses in the second half. So if you remember, the CareFusion businesses actually grew minus 2% in the third quarter. So actually, we expect the second quarter to be back in basically the range that we normally have, the 4.5% to 5%, and you'll start picking up more in the back half of the year against that CareFusion compare. Don't forget we had the AVEA recall in respiratory. So that becomes an easier compare. Emerging markets actually start comparing to more normalized results. You saw China this year – the first quarter of last year was 23% growth we had to jump over. So all of that starts reversing, and so we are confident in our full year guidance.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks, Mike.
Operator:
Your next question is from David Lewis of Morgan Stanley.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Good morning, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Hey, good morning. Vince or Chris, I wanted to talk about emerging markets for a second here. How congested did you see the updated EM guidance? And I guess, just drilling down here, is the pressure largely capital in select businesses? Are you seeing any type of weakness in Tier 1 hospitals in China? And where are inventory levels now for you in some of these broader emerging markets?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Sure. So taking China first, the weakness was really on the capital side. It was in Life Science, and it does not appear to be driven so much by the financial situation as it was driven more by this issue that we brought up last quarter, which is the auditing of large capital purchases. So we're seeing that in China and we expect that to continue for the rest of the year. On the disposable side, we did fine. And these are products that sustain the healthcare system, and so we expect stability in China on that side. That's really the difference as we look around the emerging markets. That's the biggest difference. If I talk about Latin America, Latin America is basically – Brazil is where we said it was and then with stronger performance in the other countries. So in terms of inventory, as you heard, we made inventory adjustments on the medical side last time and coming back to the diagnostic piece, we actually thought that it was more of a timing issue, this audit issue. We're now saying that's not going away. So we came back and we did make the inventory adjustment on the diagnostics side because of the change in the situation. Chris, anything else you would like to add?
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
No, that about nails it. Yeah.
Operator:
Thank you. Your next question is from David Roman of Goldman Sachs.
David Harrison Roman - Goldman Sachs & Co.:
Thank you. Good morning, everybody. I wanted just to follow up on the CareFusion integration. Clearly, the cost synergy side of the equation is progressing at a rate faster than you had initially provided. But can you give us a little bit more clarity on how some of the cross-selling initiatives may be materializing and when you think we could start to see that drive a revenue uptick, particularly in the context of – the 4.5% to 5% is pretty much where the business has been growing the past couple of years and what it takes to sort of accelerate that number?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Well, overall, I would stick with what we said. You're really going to see the revenue synergies starting in 2017. That doesn't mean that we haven't done some work already in terms of aligning our organizations. And Tom can comment on that.
Thomas Polen - President-Medical Segment & Executive Vice President:
Yeah. Sure. Hi, David. This is Tom. So I think, as Vince said, we've always commented that it would take us some time to get products registered for particularly the ex-U.S. markets, to put through our channels. Those registrations are well underway. We have several dozen products actively under regulatory review that we've already submitted. We have taken a few products that were already approved and put those through our channels and markets like China and we're seeing some early positive signs, but we've always said it would take some time to ramp and that we would see that more in FY 2017. And we're right on track to that.
Operator:
Thank you. Your next question is from Rick Wise at Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, Vince. Good morning, everybody.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Let me start off with the margin expansion. Maybe, Chris, if I looked at the slide correctly, your bridging commentary, you had 22% cost synergies last quarter. This quarter you updated it by adding 4%. So we're really talking about 26% cost synergies now with CareFusion. Am I understanding that correctly? And maybe just in general, how much more is there to go? I mean, has it accelerated?
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Well, you're on the right point, Rick. If you look at chart 14, it really lays that out. The one thing that I would say is that 4% additional is things like the sale of BD Rx. Oil prices continue to give us a lift, as the price per barrel went from $50 to $30, and so whether you call those synergies or – it's all good. What I would point to on that chart is that that $9.01 to $9.08 represents a 37% to 38% increase over where we would've been on a BDX legacy guidance basis. And so how you characterize that, whether it's just accretion or synergies, that's somewhat semantics. We were growing over the expectation that we would have grown 9% to 10% anyway. So we've stayed pure on that. But the tax rate improvements, are those synergies? Yeah, they're synergies as well. It's just not what we had originally contemplated in the deal. So we try to keep a very clear and transparent view of what is synergies and what's accretion and that 4%, as I said, I wouldn't call those synergies. We're not raising our synergy guidance as we did last quarter because these are just kind of other things that are benefiting our cost structure and bottom line that hadn't been contemplated in November. So for what we control, we're really executing extremely well, very pleased with it. But obviously, the FX drag is worse in that regard. Since November, the euro has stabilized at $1.09. Of that 4% drag additional in FX, 1% comes from the euro remaining at that $1.09 and then another percent from other major currencies, like Canada for example, it's down 8% or 7% since November. Mexico is down 8%. China is down 3%. So that's another percent of that 4%. The other two is every other currency in the world is weak against the U.S. dollar, compared to where it was in November, and so that's another 2% so additional 4% drag. So we don't really have a lot of control over that. We do everything we can to mitigate that. So what we control, we're really feeling good about, but we are going against significant FX headwinds. But we really feel good about the fact that we were able to still meet our commitment of $8.37 to $8.44, despite those significant FX headwinds.
Operator:
Thank you. Your next question is from Larry Keusch of Raymond James.
Larry S. Keusch - Raymond James & Associates, Inc.:
Hi, good morning. So just two things here. Number one, it sounded like from the prepared comments that the CareFusion large volume infusion pump business did quite well. I was wondering if you could provide a little color on that and some of the dynamics. I think you said capital sales were up and I'm asking in reference to some strong results from a competitor yesterday. And then just on China, I think you also said low double-digit growth for the year. You are obviously starting much lower than that. So you've touched on this, but how do you really accelerate through the course of the year to get to that low double-digit China growth?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Okay. So Tom will start with the infusion.
Thomas Polen - President-Medical Segment & Executive Vice President:
Sure. Hi, this is Tom. So we did have another solid quarter for the overall MMS business and certainly in our infusion business and particularly – and maybe I'll just comment on the U.S., which is by far the largest market. We did have high single digit growth in our infusion business in the U.S., which in a market that's growing low single digits, we certainly see that as reflecting continued strengthening of our position in our Alaris business. So we're very pleased with our results and the momentum that we continue in that business.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Yeah, I think, Tom, we grew last year in MMS was, what, 40 something percent in the first quarter? So the 4% growth was on top of that, right?
Thomas Polen - President-Medical Segment & Executive Vice President:
Exactly.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Chris, do you want to take China?
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Yeah, so for China, if you look at the first quarter growth, we talked about the difficult compare against the 23% and we talked about the inventory adjustments in Diagnostics. If you normalize for both of those, you'd be in double digits in China in the first quarter. As I said on the overall BD revenue growth to come, the comparison to prior year eases in the second half of the year significantly. We have, for example, respiratory wasn't even shipping in China towards the second half of last year, so that makes it an easier compare as well. So that's where we get the low double digits. We are getting a little bit of a lift. We talked about most of the CareFusion synergies coming next year, but there's a little bit in connectors and things like that that help us – actually an easy compare against CareFusion's China performance last year, that gives us a little bit of a lift as well.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks for the question.
Operator:
Thank you. Your next question is from Bill Quirk of Piper Jaffray.
William R. Quirk - Piper Jaffray & Co (Broker):
Great. Thanks and good morning, everybody. I guess first question is just on safety, and I guess specifically around Europe. I guess it's been a couple of quarters since you gave us an update here in terms of kind of how far through that opportunity we are penetrated and how much more does this have to go? Thanks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So I think Tom can talk to that. It's mostly on the medical side. As you may recall that it's fairly highly converted in the PAS business, and they're really moving to second generation products, but there's more opportunity on the medical side and Tom will talk about that.
Thomas Polen - President-Medical Segment & Executive Vice President:
Hey, Bill. This is Tom. So safety does continue to perform well internationally overall and certainly in Europe, as compliance with the regulation continues to support our safety growth. Maybe just to break it into two categories, from a medical perspective as we think about infusion, I'd say we're probably in the fifth inning, let's say, there as that's typically the first area that people convert to. And then in the injection business, which is generally a low – can proceed as a lower risk procedure, we're in even much earlier innings on that side of the business. So overall, we still have a ways to go, certainly several years to go when it comes to the European safety conversion.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks, Tom.
Operator:
Thank you. Your next question is from Matt Taylor of Barclays.
Matthew Taylor - Barclays Capital, Inc.:
Hi, thanks for taking the question. I guess I wanted to just get a sense of your views about flu, and you haven't updated us on your footprint there in a while. Could you speak to that? And interestingly, Abbott bought Alere this week. So does that change your view on point-of-care testing? Sorry for the multi-part question, but I had a few things to get in there.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Well, that's okay. I don't think Abbott's buying Alere changes our view on point-of-care testing, but Linda will be happy to update you on the flu and what's going on out there.
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Sure. So as we have seen on the flu, we had a tough jump over versus a strong flu season last year. And not seeing anything that would indicate we're going to get any sort of a flu season this year. As for our position in point of care, on our Veritor platform, we feel very good about our position, both in terms of accuracy, turnaround time and throughput. This is being reflected in our share position, now over 19,000 instruments placed globally, and we're very excited about the new wireless connectivity we'll introduce this quarter.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks, Linda.
Operator:
Your next question is from the Brian Weinstein of William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Hey, guys. Thanks for taking the question. First one is on new products. Vince, you used to talk about percentage of revenue that new products were driving. Can you kind of update us where the new products are and what your thoughts are going forward for new products, especially in light of putting more money into R&D from the medical device tax reinvestment? Where are you putting that specifically? What types of projects should we be thinking about?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, sure, Brian. We moved from about 8% to up to the 14%, 15% range last year. And that included Nano kind of starting to come out of that calculation. We're trying to get our arms around how we're going to do this calculation going forward with the CareFusion product line coming in, and we're not quite there yet. But if I look at the portfolio and the number of new products, I would say we're in a strong position. And it's across both of the segments, and it's over the next three-year period. And so both portfolios on the Medical side and the Life Science side appear good. As I mentioned on the call, we feel very excited about the launch of the infusion set, the FlowSmart set. We haven't talked much about it lately, but SAIS is making progress with their Microinfusor, and we have signed up a number of customers there. And so we're starting to see some nice momentum in SAIS. I'm not going to try to walk through all of the new products across MPS and MMS, but there is a nice portfolio, and Tom would tell you in addition that the backlog for Pyxis remains very robust and then, Tom, I think it continues to actually get a little larger, right?
Thomas Polen - President-Medical Segment & Executive Vice President:
Correct. It continues. Obviously, Pyxis ES is a major contributor to that percentage of new products sales and certainly continues to keep that number up very high for the company.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, it would increase the number. And then on Linda's side of the business, I went through those new flow products but also the BD MAX menu expanding. You're seeing the impact of that in Europe already and, Linda, we should be getting those other assays out soon in terms of Chlamydia and vaginitis. What's your expectation there?
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Yes. So both products are in process right now at FDA, so we would expect both of those products to be on the market in the U.S. in Q3 or Q4. We're very encouraged by the growth that we're seeing in Europe with the expanded menu.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah. And then, of course, Barricor, which we mentioned on our last call. Now, coming back to the investment on the medical device tax, I think it's an opportunity for us to really accelerate the strategies that we've articulated to you, both in Medication Management and on the Life Science side. I would say, they're both the core business, as we continue to elaborate things like Kiestra and drive that into the marketplace, and drive the genomics stuff that we just started. I think we're in a situation where a lot of these things haven't launched yet, but they launch over the next couple of years. So thanks, Brian, for the question.
Operator:
Thank you. Your next question is from Jon Groberg of UBS.
Jonathan Groberg - UBS Securities LLC:
Great. Thanks a million and congratulations. Can I just maybe – one kind of clarification and then a quick question. So I'll just put them to you here. But one on China, I guess maybe, Vince or Linda, can you maybe talk a little bit more on the Life Sciences weakness on the auditing of large capital purchases? It seems like about 12 months later than what most Life Science companies have been seeing. Most of them saw it a year ago and reported pretty good results in China this year. So I'm just curious why you think you're seeing those delays more significantly than others in the Life Sciences space. And then I just wondered on the new products on Totalys, I think in your presentation you have that's still launching in the U.S. in 2016, and just curious what you're seeing with that in Europe and whether that's still on track for 2016. Thanks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Sure. So, Linda, do you want to take that?
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Yeah. So maybe on your first question on why the delay in China. If you'll recall, we mentioned last year that we signed an exclusive partnership with Bruker on the ID side in China specifically. So as we were putting those instruments into the market, really starting in our first quarter fiscal year 2015, we had expectations on those that, clearly, in the first quarter, we saw that the overall number of tenders being issued were not at the level that we were expecting. So that would explain the delay because of the Bruker exclusivity. We are seeing, though, very good progress, competitively, in that space with now a more expanded solution to offer. And then, as you note, we are seeing great performance ex-U.S. now with the more expanded platform that includes our Totalys and FocalPoint System for a full liquid cytology solution. So we saw this quarter high double-digit growth ex-U.S. on those platforms, and the anticipated launch date for us in the U.S. is in FY 2016. I don't have the exact quarter sitting in front of me but...
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Later in the year, anyway.
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Yeah, Q3 would be a safe bet for us.
Operator:
Thank you. Your next question is from Vijay Kumar of Evercore ISI.
Vijay Kumar - Evercore ISI:
Hey, guys. Thanks for taking my question. Just maybe going back on the guidance, I wanted to make sure sort of we have the math right. So it looks like the reported revenues came down by 300 basis points, but the implicit assumption on the recreation of EPS and I guess the op margins are going to come up at the high end of the guidance range. I wanted to make sure I got that right. And when you look at below the line, I think other income, you had some hedging gains. Why would those sort of gains reverse in the back half? Thank you.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Okay. So I think I got you right. Yes, operating margins have been increased in the back half of the year. When we look at the Q1 compared to expectations, I think what we're seeing is, as you pointed out, favorable gross margin performance in the first quarter, favorable timing of expenses as well, and then below the line, there's a little bit in tax rate. So the 21.5% is a little bit better than expectations, and we see that flowing through to the total year. We were slightly better in interest income and slightly less in interest expense. You put all those things in, and that flows through to the full year. Of course, it's overwhelmed by the items that I talked about with the oil prices being down will benefit the second half of the year, as well as the sale of BD Rx. So you put all that together and we get to the $9.01 to $9.08 and the $8.37 to $8.44 all-in with FX.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Okay, thanks.
Operator:
Thank you. Your next question is from Richard Newitter of Leerink Partners.
Rich S. Newitter - Leerink Partners LLC:
Thanks for taking the question. Just wanted to ask, actually, two quick ones. One, is the full med tech tax reversal benefit getting reinvested, so it's just a swap between SG&A? Are you allowing some flow-through? And then the second question is what would you expect the kind of adjusted China growth rate to be if you kind of looked at it the way you had – you said low teens, I think, in the past two quarters, if you back out the inventory?
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Okay. So on medical device tax, just to put it in perspective, last year we had about – or in our budget, we had about $60 million for the full year. Don't forget, we only pick up three-quarters of that this year. So that's about $45 million. Right now, we have about a third of that being executed against. The other two-thirds, we're still getting the projects in place, and we do fully expect to spend that this year. There might be a little bit of timing issue. Obviously, in the month of January, we're getting the benefit, and we're only executing on the one-third. So we'll probably just naturally pick up a little bit in timing but not a lot. And that's already in the guidance. But we fully expect to reinvest and we want to reinvest, and we're going through that process now. And then the second question was China. I think that I'd bring you back to – if you adjust for the difficult compare in the first quarter and you adjust for the inventory adjustments that we took in Life Sciences, it brings you back up to a double-digit number in China.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
And we said low double digits for the year.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Yeah, the full year is low double digits. And we get the benefit of a little bit of easier compare.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Easier compares and a little bit of momentum out of some CareFusion products.
Operator:
Thank you. Your next question is from Doug Schenkel of Cowen & Company.
Doug Schenkel - Cowen & Co. LLC:
Hey, good morning, guys.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, Doug.
Doug Schenkel - Cowen & Co. LLC:
So the U.S. Bioscience revenue growth moderated sequentially from I think around 15% year-over-year last quarter to around 6% year-over-year this quarter. Recognizing that comparison was a bit more difficult relative to the prior quarter, the moderation seems to be a bit more material than we would've expected, just given what we've seen from Life Science tools peers. Others have talked about academic/government starting to pick up. It sounds like biopharma continues to be strong. So with all that said, two questions. One, can you describe what you saw in the quarter in terms of demand from biopharma and academic/government in the U.S.? And two, what's embedded into your guidance for contributions from new products and the potential benefit associated with a more robust NIH budget? Thank you.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Okay.
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Okay, so that was a multi-part question. Let me see if I can get at this. So, first, let me just comment on the performance of the U.S. business. The U.S. Biosciences business continues to do very well. We did mention that in first quarter 2015, we had a tough jump over. We had high double-digit growth, primarily in our research instrument base. So we still managed to grow off that base, but it was a difficult compare. So for this quarter, we did see very good growth in our biopharma side, particularly in our advanced bioprocessing business, a business we do not talk about a lot, but is doing very, very well for us. So that was a tremendous area of growth. And then, as we've been talking about for the past several quarters, led by the U.S., our total research solutions platform now, we feel very good about the prospects for that business. Of course, this past quarter launching both FACSSymphony and FACSCelesta, we think across the range of low-, mid- and high-end analyzers now, combined with our Sirigen platform, so really, now, starting to work out that full solution between our instrument base and our solutions base. We see the U.S. research market as being an area that has, if you look at our last quarter report – was very strong for us, and an area moving forward that is in our guidance.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
How do you feel about new products, Linda? I know you can't exactly quantify it but...
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Yeah, so new products overall, starting with Biosciences, the research solutions piece, feel very strong about the genomics side, of course, coming with our full launches on both the GenCell side and Cellular Research coming this quarter so excited about that. And then, of course, PAS with their new products and DS with the expansion of the MAX menu, we're really starting to see these kick in.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So we should start to see some traction in the back half of the year, basically. Okay. Thanks.
Operator:
Thank you. Your next question is from Derik De Bruin of Bank of America.
Derik De Bruin - Bank of America Merrill Lynch:
Hi, good morning.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Good morning.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, Derik.
Derik De Bruin - Bank of America Merrill Lynch:
So could you talk a little bit about sort of looking at the overall portfolio? I mean you've trimmed Simplist and there's been some talk about respiratory earlier on in the process of maybe doing something with that. Has that business rebounded to the point now where you feel comfortable with it that it's – you feel it was part of the portfolio and it's not potentially a divestiture candidate?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So what I would tell you about respiratory is we're running it like – we own this business so we run it to optimize the business, like we do with all of our businesses. Having said that, we are proceeding with our strategic analysis of that business. I would tell you we are making some progress on that, but we're not to the finish line yet. There are a couple of other small pieces that we're continuing to work on also, in terms of that strategic review process and you'll hear more from us as we move forward.
Operator:
Thank you. Today's final question is coming from Kristen Stewart of Deutsche Bank.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
They let you back in, Kristen.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Hi, thanks. Sorry to miss you there before. Technical glitch. I was just wondering if you could expand a little bit more upon the relationship with Fresenius over the solutions and also if there's any additional updates on the CME relationship with the pumps, and anything about bringing that in-house to BD and the timing of launch that that could go into emerging markets?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Go ahead, Tom.
Thomas Polen - President-Medical Segment & Executive Vice President:
Hey, Kristen. This is Tom. Let me start off with the Fresenius one then I'll address the CME. So we're very pleased, obviously, with the long-term collaboration that we've entered into with Fresenius for a broad line of IV solutions in the U.S. marketplace. We certainly see that this opportunity is aligned with our customers' feedback to have additional options available to them and how they buy IV solutions. And we expect to begin launching that line in the very back half of FY 2016. So I think that's probably the most to say about that there, but we see it very much in line in supporting and helping to advance our overall Medication Management strategy. And we've gotten very positive feedback from customers after that announcement. Related to CME, we do sell CME products in certain markets today, primarily in Europe. No new news to update in terms of an acquisition or integration of CME into BD. As you know, we already own 40% of CME and we've talked about options of that going forward. No new news to share there. We continue to promote and grow their products though in the markets, particularly in Europe, that we have had since the beginning of the year.
Operator:
Your final question is from Brandon Couillard of Jefferies.
Brandon Couillard - Jefferies LLC:
Thanks for squeezing me in. Just one more for Linda. Any chance you could give us an update on where BD MAX stands in terms of its global installed base and remind us of the number of tests available on the menu and to what extent is the LDT capability contributing to growth?
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Okay. So on the overall MAX platform, in terms of overall numbers of placements, I'm not going to go into the overall number for the quarter, but safe to say that our total overall global systems now are close to 1,000 placements overall on a global basis. In terms of the menu, of course, the expansions that we saw on the menu in both enterics and CT/GC, what we're seeing now in Europe is very strong double-digit growth and very positive feedback from our U.S. customer base, again starting to see very good growth and placements on our MAX System. And of course, when we get the CT/GC and vaginitis, we're anticipating stronger growth there. On the LDT side, in terms of what we see in terms of opportunity for us moving forward, are you speaking about the...
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Open channel.
Linda Tharby - Executive Vice President & President-Life Sciences Segment:
Yeah. So for us, we see that in Europe being a great advantage. European customers are really adapting that as a strong advantage. And in the U.S., again, it's seen as an area for us versus our competition that really differentiates MAX. So great opportunity for us. I would say that the big opportunity that we see is with the differentiated menu that we're already seeing on the enterics and we look forward to on the CT/GC and vaginitis.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks, Linda. Okay.
Operator:
Thank you. With that, I'll turn the floor back to Vince Forlenza for closing remarks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Well, thank you very much for all of your questions. We are very pleased to update you on our quarterly results and to raise our FX-neutral EPS guidance. We look forward to updating you as the year progresses. Thanks very much.
Christopher R. Reidy - Executive Vice President, Chief Financial Officer & Chief Administrative Officer:
Thanks, everyone.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks a lot.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Executives:
Monique N. Dolecki - Head-Investor Relations Vincent A. Forlenza - Chairman, President & Chief Executive Officer Christopher R. Reidy - Chief Financial Officer & EVP-Administration Thomas Polen - President, BD Preanalytical Systems Linda Tharby - Executive Vice President and President - Life Sciences Segment
Analysts:
David Harrison Roman - Goldman Sachs & Co. David R. Lewis - Morgan Stanley & Co. LLC Robbie J. Marcus - JPMorgan Securities LLC Kristen M. Stewart - Deutsche Bank Securities, Inc. Brian D. Weinstein - William Blair & Co. LLC William R. Quirk - Piper Jaffray & Co (Broker) Doug Schenkel - Cowen & Co. LLC Rick Wise - Stifel, Nicolaus & Co., Inc. Matt C. Taylor - Barclays Capital, Inc. Vijay Kumar - Evercore Group LLC Harris Iqbal - UBS Securities LLC
Operator:
Hello, and welcome to BD's fourth fiscal quarter and full fiscal year 2015 earnings call. At the request of BD, today's call is being recorded. It will be available for replay through November 11, 2015, on the Investors page of the BD.com website or by phone at 800-585-8367 for domestic calls, and 404-537-3406 for international calls, using confirmation number 51724857. I would like to inform all parties that your lines have been placed in a listen-only mode until the question and answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Head-Investor Relations:
Thank you, Christy. Good morning, everyone, and thank you for joining us to review our fourth fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our fourth fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the BD.com website. As a reminder, our fourth fiscal quarter results reflect the new BD, which includes the results of CareFusion for the full quarter. To provide additional visibility into the new BD, we will speak to our revenue results this morning on a comparable currency neutral base, which includes BD and CareFusion in the current and prior-year periods. The comparable basis presents current-period revenues on an adjusted basis that excludes a small impact related to a purchase accounting adjustment to record CareFusion's deferred revenues at fair value as of the acquisition date. Details of the purchase accounting and other smaller adjustments, and the comparable basis revenue results, can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the Investor Relations slides. In addition, we would like to note a change in a distribution agreement effective in the fourth quarter of fiscal year 2015. Fisher & Paykel terminated its agreement with CareFusion for the sale of F&P's hospital respiratory care products, which has an unfavorable impact to revenues of approximately $12 million in the fourth quarter of fiscal year 2015 and approximately $90 million in fiscal year 2016. The fiscal year 2016 revenue guidance provided today will exclude the year-over-year impact of this contract. The impact to the bottom line is not material and is included in our EPS guidance. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer, and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Executive Vice President and President of the Medical Segment; and Linda Tharby, Executive Vice President and President of the Life Sciences Segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we are very pleased with our results this quarter and our great finish to the year. Many of you already know that this was a unique year for BD in which we successfully completed the largest acquisition in the company's 118-year history. The powerful combination of BD and CareFusion has already delivered measurable results, which we will speak to throughout this presentation. As we continue to make progress with the integration of these two great companies, I've become increasingly confident in our ability to deliver end-to-end solutions that increase efficiencies, reduce medication errors, and improve patient safety in all healthcare settings. Turning to slide 4, I'd like to highlight some key achievements in fiscal year 2015. First, our results reflect our consistent performance and the benefit of our diverse geographic and product portfolio, with revenues growing at 5.3% this year. Our core remains strong, and our product pipeline continues to drive growth across the portfolio. Second, we moved into two highly strategic areas. Through the acquisition of CareFusion, we significantly expanded our presence and are now the global leader in a $20 billion medication management industry. We also entered into the high-growth area of genomics through our strategic acquisitions of Cellular Research and GenCell. We believe that BD is well-positioned to add long-term value in these spaces by providing researchers and clinicians with leading technologies that are scalable, high-quality, efficient, and cost-effective. Third, we have continued to invest in higher-growth emerging markets. Emerging markets grew over 9% this year and continued to be a key driver of growth for the company. We're also working to create new growth opportunities for CareFusion products in these markets and expanding their global reach by leveraging BD's international infrastructure. We currently have numerous products in the registration process across multiple geographies. Fourth, we have continued to refine our operating effectiveness and efficiency initiatives, which have generated accelerated margin expansion. Together with CareFusion, we drove approximately 100 basis points of underlying margin expansion year over year, which includes approximately $50 million in cost synergies, demonstrating our ability to deliver on our synergy capture commitments. Our synergy cost savings have largely been driven by G&A, and we have already made good progress with our optimization of our manufacturing footprint, with six plant closures this fiscal year. Over the deal horizon, we have detailed plans to continue our plant network optimization and drive increased automation across the network. Lastly, we completed our 43rd consecutive year of dividend increases, in addition to paying off the $1 billion term loan used to partially fund the acquisition, which highlights our effective deployment of capital. As we look back, we closed our first combined year with broad business strength. We exceeded our financial and operating goals, and we are successfully executing on our acquisition of CareFusion. As we look forward, we will continue to build on our strong foundation, and our acquisition of CareFusion helps us significantly accelerate our ability to deliver effective healthcare solutions for customers around the world. Moving to slide 5, you'll see the guidance for fiscal year 2016 on a currency-neutral basis. For fiscal year 2016, we expect currency-neutral revenue growth of 4.5% to 5%, based on our current view of the environment and various macroeconomic factors. Of course, we have contemplated a number of items that could bring us above or below that range, including pricing, a stronger or weaker flu season than expected, the performance of new product launches, and emerging market growth. On the bottom line, we will continue to drive accretive, high-quality earnings growth. For fiscal year 2016, we expect adjusted EPS of $8.73 to $8.80, currency-neutral. On a reported basis, we expect adjusted EPS of $8.37 to $8.44, while overcoming significant FX headwinds. This reflects operational accretion from the CareFusion acquisition of about 22%, an increase from our previously stated deal accretion target of high teens. In addition, we are pleased to announce that we've increased our cost synergy target from $250 million to $325 million to $350 million as we exit fiscal year 2018. Now I'd like to turn the call over to Chris, who will walk you through our financial performance in the fourth quarter and full year, along with additional details about our fiscal year 2016 guidance.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Thanks, Vince, and good morning, everyone. I'd like to begin by discussing our fourth quarter revenue and EPS results, as well as the key financial highlights for the quarter and total year. Total fourth quarter revenues of approximately $3.1 billion grew 49.1%, or 5.1% on a comparable basis. Fully diluted adjusted earnings per share came in ahead of our expectations at $1.94, growing at 21.8% over the prior year. Top and bottom line growth was driven by broad-based overperformance versus our prior expectations from both the BD and CareFusion legacy businesses. As Vince mentioned earlier, we are very pleased with our strong finish to the year as a combined entity. For the total year, revenues grew 5.3%. We significantly expanded our margins and captured approximately $50 million in synergy cost savings. EPS of $7.16 exceeded our expectations, driven by stronger revenues and margin expansion. We were also pleased to announce that we have continued to deleverage as we reduce the debt associated with the acquisition of CareFusion. We have successfully paid off the $1 billion term loan facility and remain on track to achieve our commitment of 3 times gross debt leverage within 24 months of close. On slide 8 I'll review our revenue growth by segment on a currency-neutral basis. Fourth quarter revenue growth was 5.1% for the total company. In the quarter, pricing was about flat on a legacy BD basis. BD Medical fourth quarter revenues increased 5.2%. Medication and Procedural Solutions growth was 5%, which reflects strength in Flush, ChloraPrep, and safety-engineered products. Revenues in Medication Management Solutions, or MMS, grew 11.1%. This was driven by strong infusion capital installations, which can vary quarter to quarter, and disposables. On the dispensing side, we continue to gain traction with the Pyxis ES platform, as we place focus on the continuous improvement of the installation process. Respiratory Solutions revenues declined 12.4%, as expected. This reflects timing of orders that occurred in the third quarter, which negatively impacted the fourth quarter, the loss of the F&P distribution agreement, and the AVEA ship hold. After adjusting for these items, revenues would have been about flat. The AVEA ship hold has been released and we began shipping again last month. Growth in Diabetes Care was 5.8%, driven by solid growth in pen needles. Pharmaceutical Systems growth of 9% reflects favorable timing of ordering patterns as expected, in conjunction with strong safety sales. For the total year, BD Medical grew 5.5%. BD Life Sciences fourth quarter revenues increased 4.8%, primarily driven by growth in Diagnostic Systems and Preanalytical Systems. Diagnostic Systems growth of 5.9% reflects solid core microbiology growth driven by increased installations of our Kiestra Lab Automation system and continued core blood culture strength. We saw continued strength on the BD MAX platform, which grew double digits in the quarter. Preanalytical Systems growth of 5.8% was driven by safety-engineered products and growth in emerging markets and Western Europe. BD Biosciences growth of 2.2% reflects strong research instrument placements and reagent sales in the U.S., partially offset by delays in government funding in Japan and some operational management changes in Japan. For the total year, Life Sciences grew 5%. Moving to slide 9, I'll walk you through our geographic revenues for the fourth quarter on a currency-neutral basis. U.S. growth was strong at 4.6%. This was comprised of BD Medical growing at 5.1% and BD Life Sciences growing at 3.3%. BD Medical's performance reflects broad portfolio strength, including Flush, ChloraPrep, and Infusion Systems. BD Life Sciences growth reflects strong performance in the U.S. Biosciences business driven by research instrument and reagent sales. In our U.S. Diagnostics business, we saw continued growth in our BD MAX molecular platform, as well as seasonal distributor stocking related to the flu offset by continued declines in our ProbeTec/Viper platforms. Moving on to International, revenues grew 5.5%. This is below our normal growth rate, which primarily reflects the aforementioned challenges in our Respiratory business and a moderation of growth in China in the fourth quarter. I'll provide more color on China in just a moment. The Medical segment grew 5.4%, driven by strong performance in Pharmaceutical Systems and safety-engineered products. The Life Sciences segment grew 5.8%, which reflects strong growth in Diagnostic Systems, driven by solid performance in microbiology, including Kiestra installations. Preanalytical Systems was driven by double-digit growth in emerging markets and strength in safety-engineered devices in Europe. On slide 10, emerging market revenues grew 5.9% currency-neutral, bringing our year-to-date growth to 9.2%. The fourth quarter growth rate in emerging markets reflects a tough comparison to the prior year coupled with some moderation in China and Brazil. China growth for the fourth quarter was 8.5%, bringing the total year growth to 15.4%. This was primarily due to longer purchasing cycles and softness in instrumentation sales, consistent with what we shared on our last earnings call. In addition, we took proactive steps to align inventories in our distribution channel. On an underlying basis, China grew about 12% in the quarter. In Brazil, the challenges are largely macroeconomic, which we expect to continue into fiscal year 2016. Despite softness in Brazil, the rest of Latin America was strong, growing double-digits. Looking into fiscal year 2016, we expect emerging markets to grow at about 10% driven by a diversified base, with China growing in the low to mid-teens, continued strength in Latin America outside of Brazil, fewer headwinds in EMA and strength in India. With CareFusion revenues predominantly in developed markets, emerging markets will be a lower percentage of total company revenues on a combined basis at about 16%, with China accounting for about 5% of total revenues. Moving to global safety on slide 11, currency-neutral sales increased 8.2% and grew to $744 million in the quarter. Safety revenues in the U.S. grew 4.4%, while international sales grew 13.4% currency neutral, with continued strength in Europe, which grew double-digits, as compliance with safety legislation continues. Safety revenues grew 10% in emerging markets. Medical safety sales grew 9%, driven by a range of safety-engineered products, including infusion disposables, catheters and a range of products in Pharmaceutical Systems. Life Sciences safety sales, which are driven by our Preanalytical Systems unit, grew 6.8% in the quarter. Turning to slide 12 and our gross profit margin for the fourth quarter. On a performance basis, margin expansion was driven by continuous improvement initiatives and favorable raw material prices. These contributions were slightly offset by higher pension expenses and other items. Currency had a positive impact on gross profit in the quarter. This was driven by a translation adjustments recognized in the quarter due to the timing of inventory movements, otherwise known as profit and inventory. In addition, our gross profit margin reflects the impact of a reclass from SSG&A to cost of goods sold associated with the alignment of accounting policies in connection with the acquisition integration. Slide 13 recaps the fourth quarter income statement and highlights our currency-neutral results. Since we have already discussed revenue and gross profit, I'll move down the income statement to SSG&A. SSG&A as a percentage of revenue was 24.4%. We're very pleased with the leverage we're getting, which includes the benefit of cost synergy capture, as previously discussed. R&D as a percentage of revenue was 6.4%, which is slightly higher than normal due to the timing of spend, as anticipated, while full-year R&D as a percentage of revenue was 6.1%. Operating income grew 52.3% in the quarter on revenue growth of 49.1%, reflecting strong P&L leverage as the new BD. Our tax rate increased by 160 basis points, as expected, due to the inclusion of CareFusion's U.S.-based results. In the quarter, adjusted earnings per share were $1.94, which is a 21.8% increase versus the prior year. This reflects operating profit growth driven primarily by strong revenues and continued margin expansion. Now turning to slide 15, I'd like to walk through our expected revenue guidance for the full fiscal year 2016. In summary, we expect revenue growth of 4.5% to 5% on a currency-neutral basis. This is comprised of legacy CareFusion growing at about 4% and legacy BD growing at about 5% on the top line. This is very consistent with our long-term growth profile of BD growing midsingle digits and our objective of accelerating CareFusion's top line growth profile to reach BD's average over time. From a phasing perspective, we expect currency-neutral revenue growth in the first quarter to be well below this range. This is primarily due to a tough comparison to the prior year period, in which legacy CareFusion grew 9.9% and legacy BD grew 5.3%. This will result in currency-neutral revenue growth of about 1% to 2% in the first fiscal quarter. After adjusting for the tough comparison, as well as the loss of F&P, growth would be roughly in line with revenue guidance for the total year. On a reported basis, revenue growth for the total year is expected to be between 23% and 23.5%, reflecting a currency headwind of about 150 basis points. This assumes a euro-to-dollar exchange rate of $1.13. The depreciation of Brazilian real year over year, as well as other currencies, such as the euro and the Canadian dollar, results in a significant impact to our performance. We expect this unfavorable impact to be the most acute in the first quarter, with a headwind of approximately 450 basis points. We expect the currency impact to moderate through the rest of the year. We expect growth in both BD Medical and BD Life Sciences of 4.5% to 5%, driven by continued growth in the core in conjunction with new products in both segments. BD Medical growth will be driven by dispensing, pen needles, and infusion infection prevention relatable disposables. Life Sciences anticipates continued growth in biosciences instruments and reagents, microbiology, including expansion of the KIESTRA platform, as well as growth in molecular driven by BD MAX. Both segments expect continued growth of safety-engineered devices and solid growth in both developed and emerging markets. Based on our current view of the environment, we expect pricing to be flat to slightly negative for the year. Moving on to slide 16, there are a number of moving parts that impact earnings per share in fiscal year 2016. For modeling purposes and to ensure consistency, I'd like to provide more color on EPS guidance. First, we are very pleased with the strong performance from legacy BD, growing 9% to 10% on an underlying basis. In addition, we now expect to deliver a significantly lower tax rate, which results in 3 percentage points of improvement to the bottom line. We're particularly pleased with our execution on operational synergies and expect to outperform our high teens target by driving accretion of 22%. As Vince mentioned earlier, we have also increased our cost synergy target to a range of $325 million to $350 million over the deal horizon. As a result, we expect to achieve very strong earnings of $8.73 to $8.80. This enables to us overcome an unfavorable impact from pension expense and a significant headwind from foreign exchange. We expect to deliver adjusted earnings per share of $8.37 to $8.44 for fiscal year 2016. Turning to slide 17, I'd like to walk through additional elements of our guidance for the full fiscal year 2016. But first I'd like to make some comments on the phasing of earnings. Similar to revenue, the impact of unfavorable currency will be most acute in the first quarter, and we expect EPS to be between $1.80 and $1.85. This reflects a currency headwind of approximately 1,500 basis points and a euro-to-dollar exchange rate of $1.13 versus $1.26 when compared with the prior-year period. In addition, the Brazilian real has declined 55%, and the Canadian dollar has declined 15%. Moving on to the total year guidance, we have provided comparable fiscal year 2015 results, which include BD and CareFusion for the full year. We expect gross profit margin to be between 52% and 52.5%. Performance improvements are partially offset by negative currency translation and pension. SSG&A as a percentage of sales is expected to be between 24.5% and 25%. Our guidance also reflects continued investments in emerging markets, as well as costs related to new product launches and registration cost. We expect our R&D investment to be in line with fiscal year 2015, at about 6% of revenues, as we continue to invest in new products and platforms. As a result of the items I just detailed, operating margin is expected to be between 21% and 22% of revenues. Excluding the unfavorable impact of foreign currency, we expect our underlying operating margin to improve by 130 to 150 basis points. This also excludes slight pension headwinds. We expect our tax rate to be between 21.5% and 22.5%. For fiscal year 2016, we anticipate our average fully diluted share count to be approximately 217 million. Cash flow is expected to remain strong, with operating cash flow of about $2.6 billion in fiscal year 2016. Capital expenditures are expected to be about $650 million to $700 million. In summary, we have strong momentum exiting fiscal year 2015. And looking forward into 2016, we are building off of a very solid foundation. Our core remains strong, and we've moved into new adjacencies. We're outperforming on our synergy and accretion targets, as well as delivering earlier tax efficiencies. As we continue to execute and deliver on the factors that are under our control, I'm confident that fiscal year 2016 will be another year of strong performance, positioning us well for continued success. Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thank you, Chris. Moving on to slide 19, we have been discussing our pipeline for some time now, and in fiscal year 2015, there were a number of product launches. I'll not review them in detail, but they are highlighted on slide 19. We're committed to the successful ramp up of these products while we also look to the future and continue to expand our portfolio. Moving on to slide 20, we have some new product launches that we would like to share with you. In BD Medical, we continue to make progress with our insulin infusion sets, with an expected product launch in the middle of the fiscal year 2016. This product will improve the consistency of insulin delivery by significantly reducing silent occlusions, simplify the user's experience, and increase a patient's overall satisfaction with insulin pumping. Also launching in 2016 is the new Pyxis Mini tabletop medication management platform. This is a unique system that supports customer needs in non-acute care settings, such as ambulatory care centers, long-term care, and surgery centers. Leveraging the Pyxis ES platform, the Pyxis Mini extends the value of the ES server and the hospital's IT infrastructure by providing safe and secure medication management. We look forward to sharing further details on the newly combined Medical Segment with new product portfolio launches later in fiscal year 2016. While there has been a strong focus on the Medical Segment due to the CareFusion acquisition, I'd like to note that our Life Sciences Segment remains an important growth driver for BD. It was an exciting year for BD Biosciences, which includes our new genomics business. In fourth quarter we acquired Cellular Research and launched the BD FACSseq, a high-throughput cell sorter which targets solving significant unmet needs in single cell analysis. The combination of Cellular Research's molecular indexing technology paired with cell sorting allows researchers to choose which cells to study and enables the correlation of cell surface markers with genetic data. The combination is intended to enable a more simplified workflow, time reduction to isolate cells, and all of this with higher accuracy. Also in the fourth quarter we launched the new X-50 research flow cytometer. The X-50 represents a significant advancement in technology, enabling simultaneous measurement of up to 50 unique characteristics at the single cell level. The X-50 single cell analyzer enables superior resolution of rare cell populations, providing richer scientific insights to advance the understanding of human disease and intervention strategies. In fiscal year 2016, we expect to launch our GenCell library preparation system. This platform will consolidate and automate NGS library preparation workflow at a reduced total cost position. In our Diagnostic Systems business, we anticipate launching four new assays in the next year, including CT/GC and vaginitis, as we continue to drive menu expansion on the BD MAX platform. We're also on track with our launch of the next-generation Veritor point-of-care instrument, which incorporates smart features to enable connectivity. In our Preanalytical Systems business, we anticipate launching two new products during 2016. The UltraTouch push-button blood collection sets will deliver significant improvements in patient outcomes for patients with challenging venous access. The BD Barricor tubes are an innovative technology which will enhance sample quality as well as lab turnaround time. As you can see, we continue to have strong opportunities in our pipeline, and we look forward to sharing our progress with you as we make progress throughout the year. On slide 21, before we conclude and open the call to questions, I would like to take a moment to discuss a leadership change within the organization. BD announced this morning that, after 41 years of outstanding service to BD, Bill Kozy, EVP and Chief Operating Officer, has decided to retire effective April 1, 2016. Bill has had an exemplary career at BD, and his accomplishments are too numerous to mention them all. As we all know, he has spent the past year leading the successful integration of CareFusion and BD. While we believe this process is well under way, and Bill will stay on until March to ensure a successful transition of these duties to Chris Reidy, who will lead the current integration team. I would like to make a special mention of Bill's relentless commitment to operational excellence to our customers and to our associates. They are highly valued and have made a tremendous difference for all of us and for the company. We would like to express our sincere gratitude and also congratulate him on reaching this milestone. Now, I'd like to reiterate the key messages from our presentation today. First, this was a pivotal year for BD in history, and we are pleased with our strong results. We've exceeded our financial and operational goals for this year, and our increased synergy and accretion targets are evidence that we are successfully executing on our acquisition of CareFusion. Second, our core remains strong. Our investments drive robust revenue growth of 5.3%, and we continue to deliver high-quality double digit earnings growth. We expect to deliver a similar growth profile in fiscal year 2016, with top line growth of 4.5% to 5% and earnings accretion of about 22%. We are pleased with our financial performance, and we continue to deliver and believe we have built a strong foundation for future growth. Third, we expanded into new areas of medication management and entered the genomic market. We're excited about the value that CareFusion brings to BD and our customers as we execute our medication management strategy. We're also very pleased with the progress we've made in Life Sciences with our acquisition of GenCell and Cellular Research, which underscore BD's commitment to drive value through our genomic strategy. Finally, I would like to say thank you to all of our associates around the world. It's a testament to the hard work of the BD and CareFusion employees that we are here today, with what I believe is a tremendous opportunity to create a true industry leader. As we embark on this next phase of growth, I look to the future with enthusiasm and confidence. Thank you. We will now open the call to questions.
Operator:
Thank you. The floor is now open for questions. Thank you. Our first question is coming from David Roman of Goldman Sachs.
David Harrison Roman - Goldman Sachs & Co.:
Thank you. And good morning, everybody. Hopefully I can just sneak two in here along the same lines. Vince, maybe you could just start with the pipeline. The list of products that you're laying out for FY 2016 is probably one of the deeper pipeline benches that you've presented in some time. Can you maybe help you think about the contribution from that pipeline and how that squares with the growth rates that you're presenting here in your guidance? Because it would seem like, given that breadth of product launches, we would see an acceleration in the base business. So can you maybe help us think about some of the gives and takes with respect to product launches versus the performance of the base business?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, David, we feel really good about the guidance that we have given on revenue, the 4.5% to 5%. And you are right. There is a strong breadth of products across the entire portfolio. I think the one business you might have noticed in the guidance that we hadn't talked about before was PAS, with the new launches of the Barricor tube in there and the new push-button product. But I think what you haven't taken into account is it's just going to take a while to ramp up those new products as we get the automated manufacturing in place. So not as much of an impact that would take us above the range. Now, if they go faster, as I said in my remarks, okay, there's some potential upside. And I'm not just talking about the PAS products, but the Pyxis Mini and others, the infusion sets, which is in a similar situation. So I think across the board we're feeling good. We're feeling good about the base business as well. There's little puts and takes, as I mentioned, from a geographic standpoint, but we're still going to get about 10% in terms of emerging markets. So when we put all of that together, we're saying, look, developed world up a little bit, emerging markets still a strong growth driver. And when you put it all back together, it gets you to the 4.5% to 5%. So anyway, that was your first question?
David Harrison Roman - Goldman Sachs & Co.:
Yeah, then the second was just on emerging markets. In your prepared remarks, you talked about product registrations on the CareFusion side. Can you maybe just walk us through the steps and timeline associated with product registration to commercialization and then financial impact, just to maybe frame up how we should think about the progression of that opportunity on a go-forward basis?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, sure. Tom Polen will do that for you.
Thomas Polen - President, BD Preanalytical Systems:
Hey, David. This is Tom. So, as we've discussed in the past, we are pursuing a number of opportunities for revenue synergies in the combined portfolio. We have begun investment work on those registrations and actually submitted several dozen registrations in FY 2015. Of course, that process does take some time. And as I've said in the past, we expect it to take about two years to start seeing the benefits of those pull through in sales. So more of an FY 2017 effect than a 2016, and that's right in line with what we've said since the deal announcement.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, and we really haven't changed our view on the revenue synergies from the start of all of this. The geographies may have moved around a little bit, but in total, it's looking like the same opportunity.
Operator:
Thank you. Your next question is coming from David Lewis with Morgan Stanley.
David R. Lewis - Morgan Stanley & Co. LLC:
Good morning.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, David.
David R. Lewis - Morgan Stanley & Co. LLC:
Chris, just one quick question on first quarter guidance and then I had another question for you on tax rate and synergy, if I could. So just on first quarter guidance, just reviewing, the 1% to 2% constant currency. I'm assuming that just reflects CareFusion numbers year on year, which were, I don't know, 11% in dispensing and 8% in Procedural Solutions, so an unexpected CareFusion quarter. Is there anything else going on in the first quarter we should be aware of besides that harder comp?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Yep, you got that piece right in terms of infusion. So, as we pointed to, the overall CareFusion was 9.9%. If you remember, that was a quarter that was their closing quarter, so that comes into play. You also got the F&P contract loss that we talked about. And then on the legacy BD side, we have the normal pharmaceutical sales, timing of orders, and so that tends to be weaker in the first quarter. And then last year you had Diagnostic Systems with a strong flu season. We're just calling a normal flu season this year. So that could vary, but you put all of those things together and it makes for a tough comp in the first quarter.
David R. Lewis - Morgan Stanley & Co. LLC:
Okay. And then maybe two questions about the long-term outlook. One on tax. You signaled the tax rate continuing to move down maybe to the upper teens over time, but the 2016 guidance is coming in stronger than we expected. So do you have greater tax opportunities before 2018 than you thought and can we get down to upper teens maybe quicker than we thought? And then on synergies, just help me understand with the 30% raise, what are the principal drivers, and what's the pacing of synergies across these three years, and any update on revenue synergies? Thank you.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Okay. That's about four questions, David, but they're all good ones. So on the tax, I think we've said from the beginning that we do expect to get tax synergies, but we thought that when you put two big companies like ours together, it'll take a while to get those structures in place and see through that. We've done a lot of that work and we do see those synergies coming sooner than expected and so you're seeing that in 2016. We do say that ultimately we want to be at the high teens, which is where we've been driving for a number of years. But I wouldn't say past 2016, 2016's in that 21.5% to 22.5% range. After that, I wouldn't ramp it much more than 50 basis points a year after that. We'll provide more insight into that going forward, obviously. But that wouldn't get you down to the high teens by 2018. So I wouldn't say it's an acceleration of the ramp to the high teens, but we are getting it earlier than we had originally anticipated and it's showing up in 2016. In terms of the synergies, what's driving the increase from $250 million to $325 million and $350 million is, as we've been saying all along, we needed to see some traction. Initially, you get out-of-the-box synergies early on, so a reduction of public company costs. And we had good visibility to that. What we needed to see is visibility to the next wave, which is things like IT synergies, putting the combination of the two companies together and getting system synergies and system synergies throughout all of the functions. And so we've now seen some of that traction. We've also even seen some traction in the manufacturing area. As we mentioned in the remarks, we've had six plant closures. So we've started to see some visibility and traction along those lines and that's what gives us the confidence to raise it to the $325 million to $350 million. Now, in terms of the timing that you talked about, we mentioned that we had about $50 million in the first six months. We see that turning into about $100 million for next year on a full-year basis. Then you get about an extra $40 million incremental and that turns into a full-year impact the following year of $80 million. We see the about $40 million incremental kind of ratably over the next couple years, and if you roll it out that way, you get to the $325 million to $350 million.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks a lot, David.
Operator:
Your next question comes from Mike Weinstein of JPMorgan.
Robbie J. Marcus - JPMorgan Securities LLC:
Hi, this is actually Robbie Marcus in for Mike. I was wondering if you could talk a little more about your 10% growth target for emerging markets and how you see that rebounding off fourth quarter, particularly in China and Latin America. And then also, if you don't mind touching on hospital budgets for 2016, given how poorly some of the facility reports have been lately, and what you're considering in your guidance for budgets next year. Thanks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Well, I think you're talking about the U.S. from a hospital budgeting standpoint, and we're assuming pretty much status quo in terms of the U.S. marketplace. Not a lot of improvement, but continued, consistent demand. And we feel good about where we are from a capital standpoint and the backlog that we have. So I think we're in good shape there. In terms of emerging markets, as we mentioned in the quarter, in China we did some proactive work with the distributor community. Remember, we don't give credit to the distributors. So we want to make sure we had the right amount of inventory, and so we've completed that work. So underlying growth I think was closer to 11% in the quarter for China.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Actually 12%.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
12% Excuse me, 12%. And so we see China continuing to grow in the low teens. And of course it's become quite large at this point in time. It's about 5% of BD's sales. We expect India to do well, and we saw good performance this year in India. If you look at Latin America, Latin America did well, with the exception of Brazil, and we continue to expect weakness in Brazil this year, but the rest of Latin America has grown quite nicely, and so we're getting good growth out of that. We think EMA is going to be okay as we move forward. And we're projecting Russia to be soft. And when you add all of that up, you get to our guidance.
Operator:
Thank you. Your next question comes from Kristen Stewart of Deutsche Bank.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Hi, thanks for taking the question. I was just wondering if you could I guess talk to the longer-term outlook. I know when you originally did the CareFusion deal, you had talked about CareFusion being about a 3%, maybe 4% growth company. Sounds like it's coming in a little bit better with the cost synergies, talking about like bottom line growth being more around that 10%. It sounds like things are going better on the cost synergies. Certainly the legacy BD business is doing much better. How should we just think about sustaining the growth? Would you let the higher cost synergies kind of flow through? Would you think about reinvesting those? Or just looking to do more acquisitions to kind of further fuel the top line growth?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Well, let me start on the top line. And if I go back to the beginning, what we said was that CareFusion was about a 3.5% grower. BD was growing at about 5%, and our long-term goal was to get CareFusion up to about the 5%. And that would come through both the geographic expansion and new product opportunity as we synergized with CareFusion across the medication management process. And that is still the strategy. And you're right, the base business in both CareFusion and BD is performing well. And we had a strong quarter. It was about 4% underlying, I think Tom was trying to tell me.
Thomas Polen - President, BD Preanalytical Systems:
Correct. And we expect CareFusion, like you said, historically, about 3.5%. We expect them to be about 4% in 2016.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Right, this year. Yes. 4% this year. Long term, we'd like to get them to 5% is what we said.
Thomas Polen - President, BD Preanalytical Systems:
Right.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
That is still our goal, and we still have work to do to get there. But we are pleased at where we are at. Now, in terms of letting this all – how we think about this, Chris has laid out what the financial characteristics are going to be for the next couple years. What Chris has said in the long term was 5% and 10%. And we haven't come off that. Chris may want to add some color to that, but that implies that we will be investing for the future and also returning value to the shareholders. So, Chris, I don't know if you want to add anything to that.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Right, so the only other thing I would add is, as you think about 2017 and 2018, you have that base model of 5% on the top and 10% on the bottom, but then you do get some incremental pickup from the synergies. And as I answered earlier, we see that incremental amount per year to be about $40 million, then annualizing it for the following year. And so if you run that math, you pick up a couple of percentage points on the bottom, on top of that 10%. So that's the way to think about it.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Okay. So you'd be inclined to let that fall through to the bottom line for shareholders and then kind of think about it growing more traditionally 5% to 10%, 5% and 10% thereafter?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Yeah, I think once you get out and you're past the synergies, you kind of go back to that base model.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Past 2018.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Yeah, past 2018.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Okay, perfect. And then just on BD Simplist, are we getting to the point where that's sort of breakeven, or is that still dilutive overall to the P&L?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
BD Simplist is still dilutive at this point in time. It did grow. It's still not all that big. We still haven't gotten the approvals on the two drugs that we have been talking about for some time. Tom, is there any update on those two drugs in the pipeline?
Thomas Polen - President, BD Preanalytical Systems:
Hi, Kristen, this is Tom.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Hey, Tom.
Thomas Polen - President, BD Preanalytical Systems:
I think as we've shared in the past, we've been realigning our portfolio. We are on track for the next two launches in the high-alert drugs; hydromorphone and heparin we do expect to launch in FY 2016. And so as we add those to morphine, which is our current high-risk drug that's doing very well in the marketplace, we expect those sales to continue to accelerate, so.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Okay, Kristen, thanks for the questions.
Operator:
Thank you. Your next question comes from Brian Weinstein with William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Hi, guys, thanks for taking the question. Maybe a question for you on genomics in general. Can you kind of just talk about what the longer-term plan is here? Are you looking to add additional assets? Or are you looking to add things in things like bioinformatics or kind go deeper in next-gen sequencing? Just talk about what the overall strategy looks like in genomics at this point. Thanks.
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
Hi, Brian, this is Linda. So, over the long term, we're focused on building a leading genomics position in next-generation sequencing, from sample preparation to sample collection to sequencer ready. So it'll be platforms that are ubiquitous and can be used with any next-generation sequencer. So today those platforms involve our PAXgene sample collection and stabilization products. They involve our library preparation platforms from GenCell, and of course now the combination of our BD flow cytometry with Cellular Research's molecular indexing technology. So all of these in combination, again, we think we will have technologies that allow researchers and clinicians as we move to the clinic, more scalable, high-quality, efficient, and cost-effective. So you'll see us continue to build franchises in that whole upfront sample collection process.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So, Brian, certainly we will continue to look for assets in the space. We're very excited about the Cellular Research deal that we just concluded, because we think it is such a great fit with the flow cytometry business, and really does give researchers a new process and a better way of understanding cells. I mentioned in my remarks, you can look at the cell surface markers and you can look at the DNA. And this is where we're really enabling that for the first time. So it's pretty exciting. So Linda will continue to build that business. Thanks for your question, Brian.
Operator:
Thank you. Your next question comes from Bill Quirk with Piper Jaffray.
William R. Quirk - Piper Jaffray & Co (Broker):
Great, thanks. Good morning, everyone.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning.
William R. Quirk - Piper Jaffray & Co (Broker):
A couple questions. First off, Chris, the reclass from SSG&A to cost of goods. Should we think about that as a recurring charge, or is this more one-time in nature? And then, secondly, I guess, kind of question on the pricing assumption, the flat to slightly negative for the coming year. I guess could you give us a little more color into some of the underlying assumptions there, given that it generally kind of outperformed on an incremental basis this year? Thanks.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Sure. So, the accounting adjustment. There's nothing unusual; when you put two companies together, you do see sometimes a difference in the way certain expenses are accounted for. So the adjustment kind of brought costs from SSG&A, mostly related to things like quality and up into cost of goods sold. So it doesn't affect the bottom line, it's just within the P&L itself. When you look at our chart 17 and we talk about the guidance, we've kind of done the comparable basis for you. So there's two things going on when we adjust for comparable basis. One is these accounting adjustments. The other is the fact that CareFusion had a half a year before us. So their percentages were different. So we wanted to put it on an apples-to-apples basis, and chart 17 does that. So if you look at, for example, SSG&A or gross profit on chart 17, what we're showing in 2015 actual on a comparable basis is equivalent on an apples-to-apples basis with our 2016 guidance. I forgot what your second question was.
William R. Quirk - Piper Jaffray & Co (Broker):
Second question was -
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Oh, pricing. Pricing, I'm sorry.
William R. Quirk - Piper Jaffray & Co (Broker):
That's all right.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
So pricing, the way to think about that is over the last couple of years, essentially pricing has been relatively flat. Last year it was down slightly in 2014. This year, it's relatively flat. And so that's really indicative of the guidance that we're going forward with. Flat to slightly down. So it's very consistent with what we've seen over the last two years.
Operator:
Thank you. Your next question is coming from Doug Schenkel of Cowen & Company.
Doug Schenkel - Cowen & Co. LLC:
Hi, good morning. Just a couple of quick questions. First on R&D, R&D spend increased notably sequentially, and on an absolute and percentage of sales basis. Would you be willing to share if there are areas where you are proportionally directing more money that we should be thinking about as we look forward and how we think about this in the context of you driving synergies over the next few years? And then my second question is really a – I guess, really just clarification on guidance. Why did you assume $1.13 versus the current spot rate of $1.09 for the euro, and would you be willing to quantify what the assumption is for new product contributions that are factored into revenue growth? Thank you
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, Doug, first, this is Vince. Listen, in terms of R&D, there's nothing unusual going on in R&D at all. We're not shifting funding or anything, and we haven't changed our outlook in terms of 6% of sales. So there's just some timing going on in projects. So nothing to really report there. And, Chris, on the $1.13?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Yeah, the $1.13 is the last-30-day average; it's actually the last-90-day average, too. The euro was at $1.13 about 10 days ago. So there's been a lot of volatility. We've set our budget up at the $1.13. What I would point to, the fact that as we look forward, the euro really had a big impact in the current year, going from the $1.26, for example, in the first quarter, down to $1.13. And that was the biggest impact on FX in the current year. As we look forward to next year, that $1.16 down to the low $1.10 to $1.13 is much less of an impact going forward than some of the other currencies that we pointed to. So if you looked at our prepared remarks, we point to things like the Brazilian real, as well as the Canadian dollar. Those are huge drivers going forward into the 2016 guidance. We did decide we didn't want to mark-to-market, for example, on a euro basis, and we're comfortable with the guidance we gave, given the full basket of FX currencies.
Doug Schenkel - Cowen & Co. LLC:
Thanks, guys.
Operator:
Thanks. Your next question is coming from Rick Weiss of Stifel.
Rick Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, Vince. A couple questions. First, just a general question. Vince, you said early on in your comments that you're increasingly confident about delivering end-to-end solutions. Just curious, what's that mean exactly? What's giving you more confidence? Are you seeing larger contract system wins? Is that what's driving that statement, or just how do we think about that?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Okay, so if I start on the Medication Management side of things, as we have proceeded with the integration, including the product lines, the work that Tom and his team have done with Cato and CRISI is actually expanding the solution set there, and that seems to be well-received by the customer base. I mentioned also in my prepared remarks that the Pyxis Mini, we're in the process of launching that. And we see that as very important as integrated delivery networks start to think about how they coordinate care across the entire network. So we see ourselves doing quite well from a product standpoint to support that solution going forward. And the more conversations Tom and I have with the customer base, that seems to be the right strategy. So that was the reason behind my remark on the Medication side. On the Diagnostics and Life Science side of the business, Linda can speak to this a little bit more, I'll ask her to in a second. But the ramp-up that we are seeing in Kiestra is quite strong. And so a full automation solution on the microbiology side is really coming along, and we've also added to that with Bruker. So, Linda, you might want to mention how we did with Kiestra, especially in the U.S. this year, and how that's ramping.
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
Sure. Thanks. So as Vince mentioned a total solution. And if you look at the microbiology lab today, many of the labs look like they looked 50 years ago. So the opportunity with Kiestra and the opportunity to automate that lab from sample in to full now with our connectivity to MALDI's ID system, and our AST solution, you really see a full solution. So we saw great traction. One of our key growth drivers in the fourth quarter was BD Kiestra. Great traction in Western Europe, but also and very exciting for us is traction we're seeing in now China, Saudi Arabia, Japan, South Africa. And we ended the year with a significant number of new orders for the U.S. market. So this really is a tremendous opportunity for us. And then just maybe one other solution I'll speak about on the Life Sciences side, a great growth driver for us with some research and the research market is the high-parameter research solution that we're offering now in combination with our high-parameter flow cytometers, with our X-30 and X-50, but also our Sirigen platform, so really enabling activity at the cell level an understanding that that has never existed before.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So, Rick, just to add to that and take it up to a different level here, at the 50,000-foot level, the informatics capability as we understand it now and the way we can leverage that capability across the company, not just on the Medication Management side, but we believe also into the Life Science side, we think is going to be a real enabler of solutions going forward. Now, we're not going to get into detail about that today, but as we evolve that strategy, that's something we'll be talking to you about as we go forward.
Operator:
Thank you. Your next question comes from Matt Taylor of Barclays bank.
Matt C. Taylor - Barclays Capital, Inc.:
Hi. Thanks for taking the question. I wanted just to delve into a couple things a little bit deeper that you hadn't talked about earlier on the call. One, I think people definitely focus on emerging markets. And I know you talked a little bit about macro in Brazil. I guess I want to understand what are the macro factors that you're talking about? Is it currency? Are you seeing flagging demand? Could you characterize that a little bit more in more detail? And then I guess in terms of your EM sales, can you talk a little bit about just visibility in terms of working with distributor partners and how you're able to really see the end market demand versus what you're selling into?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Sure. So in terms of Brazil, what we were referring to really is the timing of tenders in Brazil. So that's related to government funding and how aggressively they ramp that up. And so we generally have a good sense of what the timing of those tenders would be as we put together our budget. And so my remarks reflected that knowledge base from the team down in Brazil and also what they're seeing in the other countries in Latin America, where they see government funding continuing to ramp up and a continued build of those systems. And so that's the macroeconomic factors that I'm talking about. It's mostly government funding. Now, if you go over to China, it's a situation where the government is continuing to build out the healthcare system. It is growing somewhat slower, a couple percentage points slower, than it was in the past. And we've reflected that our guidance. It also reflects what we mentioned last quarter and this quarter, which was a slowdown of action on diagnostic instrumentation tenders. And that is driven by a desire of the hospitals not to get audited as part of the anticorruption process that's going on there. Doesn't mean the hospital did anything wrong. It's an added burden on the hospital, and if they can avoid that in the short run, they would like to do that. We've taken all that into account as we guide. Now, in terms of working with our distributors, we work with them very closely on what their inventory levels are. We have our own sales force calling on the accounts. So we have a view to the pipeline. We do not leave that to the distribution community. So those are the factors that we look at as we take this all into account.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
I would just add that we feel real good about the China growth. If you look at this year over 15% and next year low to mid-teens, that's really strong growth, continues to be strong growth and outpaces our peers from a growth standpoint.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, we continue to out-index our peers in emerging markets by a substantial amount, too. And of course it's become so big, even though, if you take something like China, where the growth rate has come down, the actual absolute number is still about where it was. So it's still a big impact and a big growth driver. And if I look out over the long term, we still see a very long ramp there.
Operator:
Thank you. Your next question comes from Derik De Bruin of Bank of America.
Unknown Speaker:
Hi. Hello. Good morning.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning.
Unknown Speaker:
This is (1:02:18) filling in for Derik. I had a couple of questions quick. I was wondering if you could provide a little bit more color on the Diagnostic volumes outside of the United States and competition in Dx in general and also if you could quantify your revenue exposure to Brazil.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Well, we haven't broken out Brazil any time in the past, so I don't think we will do that. All I would say is, as I was mentioning, that we've taken that softness into account and that the rest of Latin America has become a much bigger piece of Latin America. Chris, anything you can add to that?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Just to put it in perspective, though, if you look at China, one thing we have said is a 2% decline in China, for example, in their growth rate is only worth a 0.1 point of growth on the BD level. And Brazil is much smaller than China. So just to put things in perspective.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
That's good. Linda, why don't you talk about Diagnostics?
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
Yeah, just in terms of overall Diagnostic volumes in emerging markets, we continue to see strong growth in those areas, driven primarily by our BACTEC business, SurePath. We also see strong double digit growth in TB. So continuing to see increases in rollout of our platforms in all of our emerging markets.
Operator:
Thank you. Your next question is coming from Vijay Kumar with Evercore ISI.
Vijay Kumar - Evercore Group LLC:
Hey, guys. Congrats on a nice quarter. So maybe a first question on the guidance. So if I look at the operating margin improvements, at the midpoint it looks like about 50 bps. So that's about a $65 million uplift to your EBITDA. You had legacy, as a standalone BDX, you had margin improvements. And I think CFN, they had their annual margin improvement targets. So I'm just trying to think – and plus, you add in about the synergies, it feels like at the midpoint, it should be slightly better, the absolute dollar increase in EBITDA. So I'm wondering if you could sort of help us walk through? Especially given that pricing is kind of flattish.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Yeah, so just – there's a lot of ins and outs because of the fact that CareFusion had lower operating margins for the first half of last year. And so if you look at that, we're giving guidance of 21% to 22% versus the 20.7% last year. That's about 130 to 150 basis points of underlying growth, and we mentioned that in the script. And you have about 40 basis points of FX headwinds in there. So we feel good about the fact that we're driving that operating margin improvement, both next year and gross profit. So you can see that we're up year over year on the GP line. Again, overcoming about 40 basis points of FX. So about 50 basis points of improvement operationally, and we're continuing the SSG&A performance with another 30 to 40 basis points of operating margin improvement. Now, if you look at SSG&A, if you went back to a combined basis in 2014, you're looking at like 25.7% of revenue. And we're now looking at that down over 100 basis points. So we obviously got a lot of synergies in year on the SSG&A line, and we're doing better on top of that going into next year. So the combination of all of those things point to the increase that we had. And if you look back at the chart that we had, chart 16, you can see that the accretion we talked about being 22% versus the high teens. But the thing that I would point to is that, excluding FX, we're driving $8.73 to $8.80 in terms of EPS on an FXN, neutral, basis. So really doing extremely well on the operation accretion. We've got the tax rate efficiencies kicking in and overcoming that FX headwinds, which are significant with about 5% headwinds from FX.
Vijay Kumar - Evercore Group LLC:
Thanks, Chris. So just one quick follow-up on the synergies. Raised their total targets to $3.25 to $3.50. Does that include I guess – legacy CF, then, had about 100 bips of annual expansion. Does that include or exclude – which was about $75 million by my math over a three-year period. And, I guess, Bill Kozy, congratulations to you. A long, successful career. And he was leading the charge on the integrations, and now with him sort of in there transitioning, I'm curious who's going to lead the integration now.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
So as Vince said, that would be me. And I've been working hand in hand with Bill over the last year. And now we're down to the execution phases, as we said. We've seen those synergies, the traction on those, our ability to use shared service centers, some of the end-to-end process improvements that we have, some of the plans that we have in place on manufacturing. So those are well under way, and hopefully in good hands as Bill retires. So we feel real good about our look forward
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
In terms of your math, Chris, he was asking about the 100 basis points that CareFusion had in their plan.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Oh, sure. So, as we've said from the beginning, Vijay, that our synergies are truly incremental. So you can see what we did on slide 16, that those synergies are on top of the 9% to 10% that we would've normally driven on the BD side. And as we said from the beginning, CareFusion had indicated operating margin improvements that we haircutted from 100 to down to about 70 basis points. And what we're driving in these $3.25 to $3.50 are on top of those underlying improvements that they would have done on their own anyway. And so it really, truly is incremental.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So, Vijay, just one other point on the integration. So think about as Bill transitions, Bill is transitioning the manufacturing operations side. He's been working with Steve Sichak, of course, who runs all the reloco and all that. Success is getting it into that process, getting it into the business, and executing on it. And what we were indicating is we're already doing that with the six plants that we started. So we put it into our normal process. The other big bucket is the G&A side, and of course who's been driving that but Chris. So we're well aligned on this. Bill has done just an absolutely fantastic job. And I can tell you, he won't go out the door until he gets this thing buttoned up, because that's just his nature. But, anyway, thanks for the question.
Operator:
Thank you. Today's final question is coming from the line of Jon Groberg of UBS.
Harris Iqbal - UBS Securities LLC:
Hi, good morning. This is actually Harris on behalf of Jon. Appreciate the question. So first one, can you talk about the impact of recent initiatives to accelerate the Pyxis installation process? I think – I know you mentioned recently putting into place the Lean Six Sigma team, so maybe any update on the impact of these moves and how backlog is now trending?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah, sure, Tom Polen can take that as soon as he turns on his mic.
Thomas Polen - President, BD Preanalytical Systems:
Hi, Harris, this is Tom. So, as we have discussed, as you said, we've been working on the process improvements. We're quite pleased at the progress that we've been making there. We are seeing that process improve over the last six months in particular. And so we still have more work to do, but we have been applying some of our operational systems and Lean approaches to make that better. And we will be continuing that over the balance of FY 2016. What I would say, as well, is that while we're improving the installation process, we are continuing to see very strong demand for customers for ES. So we do not expect any change in that going forward.
Operator:
Thank you. I would now like to turn to floor back over to Vince Forlenza for any closing remarks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yeah. So I would like to thank all of you for your participation today on the call. I look forward to reporting on FY 2016. And, once again, I would like to thank all of the BD associates around the globe for their tremendous work in 2015. Thanks very much.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique N. Dolecki - Head-Investor Relations Vincent A. Forlenza - Chairman, President & Chief Executive Officer Christopher R. Reidy - Chief Financial Officer & EVP-Administration Thomas Polen - Executive Vice President and President - Medical Segment Linda Tharby - Executive Vice President and President - Life Sciences Segment
Analysts:
Michael J. Weinstein - JPMorgan David H. Roman - Goldman Sachs & Co. David Ryan Lewis - Morgan Stanley & Co. LLC Lawrence S. Keusch - Raymond James & Associates, Inc. Frederick A. Wise - Stifel, Nicolaus & Co., Inc. Brian D. Weinstein - William Blair & Co. LLC Derik de Bruin - Bank of America Merrill Lynch William R. Quirk - Piper Jaffray & Co (Broker) Jonathan Groberg - UBS Securities LLC Doug A. Schenkel - Cowen & Co. LLC Vijay M. Kumar - Evercore ISI Richard S. Newitter - Leerink Partners LLC
Operator:
Hello and welcome to BD's third fiscal quarter 2015 earnings call. At the request of BD, today's call is being recorded. It will be available for replay through August 13, 2015 on the Investors page of the BD.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 78953246. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Head-Investor Relations:
Thank you, Jackie. Good morning, everyone, and thank you for joining us to review our third fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A section of recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance, as we will speak to our revenue and earnings results on an adjusted basis, which exclude certain items we recorded during the quarter. These items primarily reflect purchase accounting adjustments that include the amortization of acquisition-related intangibles as well as adjustments to reflect CareFusion's inventory, fixed assets, debt, and deferred revenue balances at fair value as of the acquisition date. As a reminder, our third quarter results now reflect the New BD, which includes the results of CareFusion for the full quarter. To provide additional revenue visibility into the New BD, we will speak to our revenue results this morning on a comparable currency neutral basis, which include BD and CareFusion in the current and prior-year periods. The comparable basis presents current period revenues on an adjusted basis that excludes a small impact related to a purchase accounting adjustment to record CareFusion's deferred revenues at fair value as of the acquisition date. Details of the purchase accounting and other smaller adjustments and the comparable-basis revenue results can be found in the reconciliations to GAAP measures in the financial schedules in our press release or the appendix of the Investor Relations slides. Lastly, we have provided slides that illustrate the new reportable segment and business unit structure of the combined company, which can also be found in the appendix of the Investor Relations slides. Copies of the release, including the financial schedules and Investor Relations slides, are posted on the BD.com website. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Executive Vice President of BD Medical; and Linda Tharby, Executive Vice President of the BD Life Sciences segment. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we are very pleased with our performance this quarter, which was ahead of our expectations. This quarter marks an important milestone in BD's history, as it is the first time reporting our results as the New BD, which combines the BD and CareFusion businesses, generating over $3 billion in revenues in the quarter. We continue to be on target with the integration of BD and CareFusion. We've made excellent progress with our leadership assessment across the organization and are confident we have the team in place to execute on our strategy. We remain on track to achieve our fiscal 2015 and 2016 accretion commitments. Our solid results this quarter clearly demonstrate our early progress as the New BD. This performance was driven by continued solid mid-single-digit top line performance from the BD business coupled with better than expected revenue performance across the CareFusion businesses. Once again, our solid results highlight the benefit of our diverse portfolio both on a product and geographic basis. Additionally, the operating leverage in the quarter demonstrates we're making good progress towards delivering on our synergy commitments. Our strong performance to date and full-year outlook gives us the confidence to raise our adjusted diluted EPS guidance despite additional foreign currency headwinds. Now I would like to turn things over to Chris for a more detailed discussion of our third quarter financial performance and our updated fiscal year 2015 guidance.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Thanks, Vince, and good morning, everyone. I'd like to begin by discussing our third quarter revenue and EPS results as well as the key financial highlights for the quarter. Total third quarter revenues of $3.1 billion grew 55.6%. On a comparable basis, revenues grew 2.4%, which is above the 1% to 2% growth we had anticipated and communicated on last quarter's earnings call. This reflects solid growth in line with our expectation of 4.7% in the BD business. The CareFusion business declined 2% in the quarter due to a tough comparison in infusion, which was better than the 5% to 7% decline we had anticipated and communicated last quarter. Fully diluted adjusted earnings per share came in ahead of our expectations at $2.05, growing at 34.3% over the prior year. Growth was driven by continued solid underlying performance of the BD business coupled with the inclusion of CareFusion. As we just discussed, CareFusion's revenue performance exceeded our expectations, and we were able to realize some cost synergy benefits beginning in the third quarter, which is sooner than we had anticipated. However, we continue to see an increasingly negative impact from FX, given the year-over-year strengthening of the U.S. dollar. As Vince mentioned earlier, we are very pleased with our first quarter as a combined entity. Our results year to date combined with our full-year outlook give us the confidence to increase our EPS guidance despite the increased FX headwinds. These financial metrics remain consistent with our expectation for high teens currency neutral earnings accretion in fiscal 2016 from the CareFusion acquisition. I'll provide more detailed guidance commentary later in my remarks. We are also pleased to announce that we have continued to deleverage, as we reduced the debt associated with the acquisition of CareFusion. In addition to the $650 million paydown at the end of April, we paid down an additional $250 million of our $1 billion term loan facility in July. We remain on track to achieve our commitment of three times gross debt leverage within 24 months of close. Moving on to slide seven, I'll review our third quarter revenue growth by segment on a comparable currency neutral basis. In the quarter, pricing was about flat on a legacy BD basis. Year-to-date pricing is better than our expectations. As such, we are revising our full-year guidance for pricing to be about flat year over year. BD Medical third quarter revenues increased 1.6%. Underlying Medical revenue growth was approximately 4%, which includes normalizing for the tough comparison in infusion. Growth in this segment was primarily driven by Medication and Procedural Solutions, or MPS. As a reminder, MPS includes BD's Medical Surgical Systems unit as well as CareFusion's Infection Prevention and Medical Specialties businesses. MPS growth was 5%, which reflects growth across all platforms, including strength in flush, ChloraPrep, and safety engineered products. Revenues in Medication Management Solutions, or MMS, declined 6.1%. The infusion business had a difficult compare to last year's June quarter, which grew 40%. The dispensing business also had a difficult comparison to the prior year. However, we are experiencing continued strong demand for our Pyxis ES product, and it has continued to perform in line with our expectations. Adjusting for the difficult comparisons, underlying MMS revenues grew about 5% in the quarter. Respiratory Solution revenues declined 2%, reflecting the lost revenues associated with the previously announced recall, as anticipated. This was partially offset by favorable timing of other Respiratory Solution products which shifted from the fourth quarter to the third quarter. Growth in Diabetes Care was 3.4%, reflecting some softness in the U.S., due primarily to the slowing of conversion from syringes to pen needles and flattening of price trends. Offsetting this were solid sales in international markets. Pharmaceutical Systems growth of 8% reflects favorable timing of ordering patterns, as expected, with year-to-date growth of 3.6%. BD Life Sciences third quarter revenues increased 4.2%, primarily driven by growth in biosciences and Preanalytical Systems. Biosciences revenue growth was 5.1% in the third quarter, driven by strong performance in research, instruments, and reagents, and the timing of orders in our advanced bioprocessing business. As we expected and communicated to you on our last quarter earnings call, we saw a small favorable impact related to the timing of government funding in Japan. Preanalytical Systems growth of 4.1% was driven by safety engineered products and growth in emerging markets. Diagnostic Systems growth of 3.7% reflects solid core microbiology growth and double-digit growth in our BD MAX molecular platform, partially offset by the impact of extended interval testing in the U.S. and continued pressure in our ProbeTec Viper platforms. Moving on to slide eight, I'll walk you through our geographic revenues for the third quarter on a comparable basis. U.S. revenues declined 1.5%. I'd like to note that our third quarter results in the U.S. are not indicative of our year-to-date results or our go-forward expectations, as we expect growth in the U.S. to normalize next quarter. U.S. Medical revenues declined 2.8% due to the aforementioned tough comparisons in Medication Management Solutions, or MMS. Normalizing for the tough comparison in MMS, U.S. revenues and U.S. Medical segment revenues each grew about 2%. We saw solid growth in our Medication and Procedural Solutions unit, driven by flush and ChloraPrep, partially offset by a tough comparison in Pharmaceutical Systems and the AVEA ship hold impact on Respiratory Solutions. U.S. revenues in Diabetes Care were about flat. The U.S. Life Sciences segment grew 2.9%. This reflects strong growth in our U.S. Biosciences business, driven by research instrument and reagent sales and timing in our advanced bioprocessing business. In our U.S. Diagnostics business, we saw continued strength in our core microbiology business and growth in our BD MAX molecular platform, offset by the extended interval testing impact and continued pressure on our ProbeTec Viper platforms. Moving on to international, revenues grew 6.6%. The Medical segment grew 7.4%, driven by strong performance in Pharmaceutical Systems and international safety sales. The Life Sciences segment grew 5.2%, reflecting strength in Preanalytical Systems and Diagnostics Systems. Moving on to slide nine, before I get into the emerging market results, I'd like to start with some comments on developed markets. U.S. revenues grew about 2% on an underlying basis, as we just discussed. In the non-U.S. developed markets, we saw strong performance, with Europe, Japan, and Canada all growing in the mid-single digits on a currency neutral basis. With the inclusion of CareFusion, developed markets have become a larger and more impactful portion of the total company revenue base. Moving on to emerging market results, you'll see that emerging markets are presented on a legacy BD basis, as this provides a more meaningful comparison to the guidance we have been providing all year. Beginning in fiscal 2016, we will provide a bridge to a new emerging market baseline that combines BD and CareFusion. With CareFusion revenues predominantly in developed marks, emerging markets will clearly be a lower percentage of total company revenues on a combined basis. It's important to note that emerging markets will continue to be a very important growth driver for the company. In the third quarter, emerging market revenues grew 11% currency neutral over the prior year, bringing our total growth year to date to 10.4%. This growth was driven by Latin America and China. As we expected, our growth in Brazil improved slightly compared with last quarter's growth rate. For the total year, we expect growth in the emerging markets in the BD legacy base of about 10%. China growth for the third quarter was 15.4%. We saw some softness in China, and as a result, have revised our growth outlook slightly lower, to 16% to 17% for the total year. Moving to global Safety on slide 10, comparable currency neutral sales increased 6.2%. Safety revenues in the U.S. grew 0.9%, while international sales grew 13.5% currency neutral, with continued strength in Europe which grew double digits, as compliance with safety legislation continues. Safety revenues grew 13.5% in emerging markets. Medical Safety sales grew 7.4%, driven by a range of safety engineered products, including infusion disposables, with strong international growth across Diabetes Care and Pharmaceutical Systems. Life Sciences Safety sales, which are driven by our Preanalytical Systems unit, grew 4.3% in the quarter. Turning to slide 11 and our gross profit margin for the third quarter, foreign currency had an unfavorable impact of about 50 basis points on our gross profit margin in the quarter. On a performance basis, margin expansion was driven by continuous improvement initiatives and favorable raw materials. These contributions were partially offset by higher pension expenses, product mix, and other items. Slide 12 recaps the third quarter income statement and highlights our foreign currency neutral results on an adjusted basis. As we discussed, revenues were ahead of our expectations, while gross profit was in line with our expectations. SSG&A as a percentage of revenue was 24.3%. We are very pleased with the leverage we are getting that includes the accelerated cost synergy capture, as previously discussed. When you look at the results on a comparable basis to what the combined company would have been last year, we achieved 110 basis points of improvement year over year. R&D as a percentage of revenue was 5.7%, which is slightly lower due to the timing of spending with the fourth quarter. We continue to invest in innovation and expect R&D spend to be about 6% for the full year. Operating income grew 62.9% in the quarter on revenue growth of 55.6%, reflecting strong P&L leverage as the New BD. Our tax rate increased by 110 basis points, as expected, due to the inclusion of CareFusion's U.S.-based results. In the quarter, adjusted earnings per share were $2.05, which is a 34.3% increase versus the prior year. This reflects operating profit growth, partially offset by the transaction impact on the tax rate, interest expense, and increased shares outstanding. Earnings were ahead of our expectations due to the underlying strength in the CareFusion business, as well as our ability to achieve some cost synergies and eliminate some costs in the third quarter that we had anticipated would take place in the fourth quarter. On slide 14, I'd like to update you on our organic revenue growth profile and phasing in fiscal 2015. Third quarter performance across the CareFusion business exceeded our expectations. While some of the Respiratory Solutions sales reflect favorable timing in the third quarter, we now expect organic CareFusion growth of about 3.5% for the fiscal year. When combined with our continued expectation of about 5% organic BD growth, we continue to expect about 4.5% growth for the full fiscal year. Moving on to slide 15, there are a number of moving parts that impact earnings per share expectations. For modeling purposes, and to ensure consistency, I'd like to provide more color on EPS guidance. Starting at the top of the slide with legacy BD, the guidance we provided last quarter of $6.43 to $6.50 assumed adjusted earnings per share growth of 9% to 10% on a currency neutral basis and an estimated unfavorable impact from foreign currency headwinds of about 10 percentage points. Since our May update, the dollar has strengthened further against the euro and other major currencies to which we have exposure, such as the yen, the Canadian dollar, and the Brazilian real. The result is that we now expect an additional 50 basis points of FX pressure to legacy BD EPS at today's spot rates. Incremental FX pressure resulted in a reduction of about $0.03 to our estimated BD legacy adjusted earnings per share guidance, to a range of $6.40 to $6.47. The chart at the bottom of the slide presents our total company guidance. As you'll recall, we had expected about 10% currency neutral accretion from the CareFusion acquisition and a currency headwind to CareFusion's earnings of about 100 basis points, which when applied to our May legacy BD base of $6.43 to $6.50, resulted in a May total company earnings guidance of $7.00 to $7.10. Given the stronger than expected performance in the third quarter from the CareFusion business and our ability to realize some cost synergies and eliminate some costs earlier than we had anticipated this year, we expect an additional 100 basis points of currency neutral accretion in fiscal 2015, partially offset by the incremental 50 basis points of headwinds from FX. This gives us the confidence to raise our guidance to a range of $7.08 to $7.12. With the revised BD legacy base for fiscal 2015, we remain comfortable with what we have previously disclosed in terms of our currency neutral legacy BD and CareFusion accretion profile of high teens accretion in fiscal 2016. We will update you for the FX impact in 2016 when we give guidance in November based on rates in effect at that time. Turning to slide 16, I'd like to walk you through the additional elements of our guidance for the full fiscal year 2015. We expect total company currency neutral revenue growth of 28.5% to 29%, with BD Medical growing 48.5% to 49%, both of which are at the higher end of our previous ranges given better than expected CareFusion performance in the third quarter. We continue to expect Life Sciences growth of about 5%. Also to note beyond revenues and EPS, all other P&L guidance for May remains unchanged. We continue to expect gross profit margin of 52% to 52.5% and SSG&A and R&D as a percentage of revenues of about 25% and 6% respectively. Our operating margin and tax rate guidance also remain unchanged. With that, I'd like to turn the call back over to Vince, who will provide a brief update on our progress around our key initiatives.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thank you, Chris. Moving on to slide 18, I would like to go over the Medical & Biosciences segment and the Life Sciences unit. We remain excited about the Intelliport opportunity. Excuse me one second. We remain excited about the Intelliport opportunity, our system for eliminating bolus IV injection errors at the bedside. We're receiving early positive customer interest, and we remain on track for commercial release. We continue to expect to launch our insulin infusion sets in fiscal year 2016. Our collaboration with Medtronic, announced in June, will enable BD FlowSmart technology to be made widely available to as many people living with diabetes as possible. We had presented three different evidence posters at the American Diabetes Association's annual meeting with data on BD FlowSmart technology. This included results showing a 75% reduction in pressure rise events or silent occlusions. We are confident that this product will have a meaningful impact for diabetes patients globally. Within Biosciences, we continue to anticipate the launch of two additional BD Horizon dyes based on the Sirigen technology. As we have been sharing with you, these dyes combined with our high-end research instruments are enabling significant gains in multi-parameter flow cytometry analysis. We also continue to anticipate the launch of two instruments, the X14 high-parameter multicolor research instrument and the BD FACSVia clinical instrument, aimed to enable increased market adoption in emerging markets, particularly in China. Turning to slide 19, you will see the various product launches in our Life Sciences Diagnostic unit. Our BD MAX molecular instrument continues to gain traction with customers in Western Europe, where our expanded menu that includes the CE Marked GC/CT and GC/CT/Trich assays launched last quarter are enabling increased placements. We remain focused on menu expansion on the BD MAX platform and expect the Enteric Parasite assay to launch later this quarter in the U.S., followed in fiscal 2016 by the Extended Enteric Bacterial and Enteric Viral assays in the EU and the U.S. in 2016 and 2017. In 2016, we also expect to launch GC/CT in the U.S. and the Vaginitis/Vaginosis assays in the EU and the U.S. We also expect to launch the BD Totalys system in the U.S. in women's health and cancer for cervical cancer screening automation in the first half of fiscal year 2016. As you can see, we continue to have strong opportunities in our pipeline, and we look forward to sharing our progress with you going forward. On slide 20, before we open the call to questions, I'd like to reiterate the key messages from our presentation today. First, we're very pleased with our results as the New BD. Second, our performance was driven by continued solid mid-single-digit top line performance from the BD business coupled with better than expected revenue performance from the CareFusion businesses. Once again, our solid results highlight the benefits of our diverse portfolio, both on a product and geographic basis. Third, we are making significant progress successfully integrating CareFusion into BD while achieving cost synergies. Fourth, our strong performance in the quarter and our full-year outlook gives us the confidence to raise our guidance for fiscal year 2015. Finally, we look forward to the future with confidence, as we continue to deliver on BD's strategy of providing complete solutions for global health care needs. Thank you, we'll now open the call to questions.
Operator:
The floor is now open for questions. Our first question is coming from the line of Mike Weinstein with JPMorgan.
Michael J. Weinstein - JPMorgan:
Thank you, guys. Good morning. Maybe I'll start with just the question of now that we are a quarter in, anything new or surprising that you found in CareFusion, either positive on the opportunity side or negative that you have to deal with?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So, Mike, I can't think of any significant surprises. What I would tell you is that I think the implementation, it's not a surprise, we planned it out, is going very well. We're very much on track with what we expected. As we think about both the cost synergies and the planning for the revenue synergies, I think all that detailed planning has come together quite nicely. I wouldn't say it's a surprise, but I did mention in my opening remarks that the talent assessment and integration, we feel very good about the team that we now have in place. Now was it a little bit of a surprise in terms of the strong performance in the quarter of the CareFusion businesses? Yes, we had communicated a revenue expectation that was less. And so that was a bit of an upside for the short run, but in the longer-run issues, really nothing – really on-track performance.
Michael J. Weinstein - JPMorgan:
Okay, good. Let's talk about China, because there were a number of reports over the course of the earnings season from companies with issues in China, most of them more consumer-facing companies than Becton-Dickinson. But you did comment that you thought China was a little bit softer and your expectations came in a little bit. So number one, can you talk about that? And then second, I was hoping you could spend a few minutes on the infusion opportunity in China, which infusion pumps are still very very early in China. That isn't a market that has really developed to this point. And I was hoping you could talk a little bit about how you plan on developing that market. I knew there was a product that you acquired from Israel that you thought might be a good fit, and I was hoping you could you spend a few minutes on that. Thanks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Sure, Mike. That's great. So I'll take China in the quarter, and then I'll ask Tom Polen to talk about the exciting opportunity that we have in the infusion business in China going forward. So we did see a little bit of softness in China in the quarter. It was mostly on the diagnostics side, where we saw longer purchasing cycles for equipment. And so that's what impacted the third quarter. We did change the guidance to 16% to 17%. It's down slightly from where we were last quarter. We do expect that there will be some inventory adjustments on the medical side of the business in the fourth quarter, and that's just being proactive with our distribution partners, to make sure that they have the right level of inventory. That's how we get to 16% to 17%. But when we look at it more broadly, it's still a very exciting opportunity for us. We're still outperforming our peers, but what is going on, it's becoming very big. And as it's becoming bigger, just the law of large numbers is starting to come into effect here. And so, at these growth rates, it's still going to be contributing significantly going forward. And as you mentioned, and asked about, we see the opportunity in the core continuing, but on top of that, as we go forward, the opportunity, not just infusion, but in other product lines. But let me turn it over to Tom to talk about the opportunity in infusion.
Thomas Polen - Executive Vice President and President - Medical Segment:
Okay. Hi, Mike. This is Tom. So as we think about the opportunity in infusion, maybe I'll break it into a time horizon approach. And so, across both consumables and capital, we've actually recently just launched CareFusion's IV needleless connectors through our sales channel in China. And so that's a near-term opportunity associated with the infusion process. They're actually getting our first incremental sales from putting that through the BD sales force. So that's actually in the market underway. The next product that we're looking to launch there related to infusion are the infusion sets. And those are actively being prepared for SFDA submission. But those will be the next products to be launched. And following that are the pumps. As you mentioned, the pumps per hospital bed in China are a fraction, less than 10%, of the ratios that you see in the U.S. And we do see opportunities there, confirmed by research we've done directly and in the market space. We see both – and we've confirmed interest from customers for CME pumps broadly across hospital segments, but we also actually see opportunity for Alaris in the very top tier hospital segment. And so we're preparing registration for both of those products now in China, with more to come. But those will take a couple years to get through the SFDA process.
Michael J. Weinstein - JPMorgan:
Tom, I know you were coming up on a potentially new memorandum of understanding in China related to the medication delivery business. Has that gone into place? Is there anything different about the new memorandum versus the prior one?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So, Mike, I'm going next week to China to sign the new memorandum of understanding, and so I'm really looking forward to that. The last one was a couple years ago. This will include infection control products as well, and it will be focused on infusion therapy.
Michael J. Weinstein - JPMorgan:
Perfect, thank you, guys.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Thanks, Mike.
Operator:
Our next question comes from the line of David Roman with Goldman Sachs.
David H. Roman - Goldman Sachs & Co.:
Thank you, good morning, everyone. I just had one question on the business and then one financial follow-up. Maybe first on the business, could you talk a little bit more about the Special Order Research Processing [SORP] franchise, and just remind us how big that is? And one of the things we've seen across the biopharma industry is the resurgence of R&D spending, and to what extent that might influence that business on a go-forward basis? And I had one financial follow-up.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Sure. So our SORP business is over $100 million, and it's been a strong franchise for us for a long time. And I think, Linda, at the high end of the research market, you're now starting to see some real traction with that product line.
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
Hi, it's Linda here, a couple of additional comments to what Vince mentioned. So, with the addition of our Sirigen dyes and our multi-parameter flow analysis, we're really able to drive multi-parameters up above 50 parameters now, which is unheard of in the market, which is fantastic ,and driving double-digit growth across that research platform. The other area that you mentioned is spending. Of course, we're seeing stability in spending, both in the U.S. and Western Europe, which is helping, and also the NIH budget, which just saw an increase recently with the passing of the 21st Century Cures Act. So overall, as we look ahead to our research business, we continue to see strong performance, and with the funding, continue to see a positive outlook as we move forward.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yes, so as Linda says that, it's more than just the SORP product line that I mentioned. Linda is also talking about the standard research products, which we're very excited about.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
David, did you have a follow-up on the financials? Is David still there?
David H. Roman - Goldman Sachs & Co.:
FY 2016, I just want to confirm that you're still comfortable with that, which was taking the base BD earnings for FY 2015, growing that at 10% FX neutral, then adding in a high teens accretion number. And at that point in time, you had talked about being comfortable with a mid-$8 number. Has anything changed with respect to those assumptions, and how should we think about changes in foreign currency in that context?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
You hit it on the head, David. As we said in and I said in my prepared remarks, we have the baseline of what BD would have been in 2015. You grow that 9% to 10%. It's high teens accretion off of that, but obviously currency neutral. And so you've seen the strengthening U.S. dollar impact that it had this year. So that's why I said we'll address that on the next call based on where rates are at that time.
David H. Roman - Goldman Sachs & Co.:
Got it, thank you very much.
Operator:
Our next question comes from the line of David Lewis with Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, David.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Good morning, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Maybe just a couple quick questions. Chris, just coming back to margins for a second here, so they're obviously so far tracking higher than even our expectations, so two things. Where is the strength coming from the core BD? I think you talked about over 100 basis points. So where is that strength coming from? And then as it relates to CareFusion, you talked about some strength there. Is this faster implementation of the synergy plan or, frankly, is the magnitude of some of the opportunities proving to be larger?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
So far what we're seeing is that the savings are coming sooner, so I don't think it's a magnitude issue. But we were able to get some savings right out of the box in the third quarter that we originally thought would have been fourth quarter items. So you actually pick up an extra quarter of that because we'll get those same kind of savings in the fourth quarter as well. So that's a nice little benefit. In terms of the margin improvements core business, as you know, the raw materials, when we laid that out on the gross profit side, is certainly benefiting us. That is offset, as we always expected, by some pension expense and the like. And then on SSG&A, that 110 basis points improvement is fairly significant, and that's certainly driving good operating margins. So it's all of those things contributing to very nice margins.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Okay, and then maybe just two product segment questions. You talked about obviously CareFusion was stronger than expected. Respiratory was much stronger than we would have expected. I know some of that reflects timing, but how much of that is timing? And then can you just update us on the progress on the recall, either revenue impact or earnings impact? And then on the core company, the only business line that looked a little weak to us was Diabetes. Is there anything in particular we should focus on, or is that simply order timing or stocking? Thank you.
Thomas Polen - Executive Vice President and President - Medical Segment:
Sure.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
So before we move to Tom, let me just say on the recall issue, I'll remind you that we gave an estimate last quarter of the impact that would have. That is already contemplated in our guidance, and so we're in good shape from 2015. And in 2016, it's really not material, and I would just point out that this is a product line that's about $35 million in revenue, so not material going forward either. So I think we've got it contemplated both in 2015 and our expectations for 2016.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So, Tom, do you want to take those questions?
Thomas Polen - Executive Vice President and President - Medical Segment:
Sure. Hi, David, this is Tom, so just maybe one or two other comments on respiratory. Some of the better performance we saw this quarter was driven primarily in our respiratory capital business with favorable timing of orders, as one could expect within those capital-type businesses. So that's the one point there. Regarding the AVEA product, as Chris mentioned, it's about a $35 million product line. We have not assumed in our guidance that that returns to the market within this fiscal year. And so we don't see a risk for that from a timing perspective. On diabetes and your question there, as Chris had mentioned earlier, we did see some softness in Diabetes Care growth of about 3.4%, driven essentially exclusively by the U.S., which was 0.3% growth. And we really see that due to flattening of the price trend coupled with a decrease in the conversion rate from syringes to pen needles. As we sell pen needles at higher prices than syringes, slower conversion creates a drag on the revenue growth. Now with that said, more broadly, we remain really excited about the future in Diabetes Care and we're focused on meeting needs of our customers and growth opportunities, both in the core business as well as in new adjacent spaces, such as the new upcoming infusion set launch in FY 2016 that Vince mentioned in detail with Medtronic.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Great, thank you very much.
Thomas Polen - Executive Vice President and President - Medical Segment:
Thanks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Thanks, David.
Operator:
Our next question comes from the line of Larry Keusch with Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Hi, good morning, two questions actually dovetailing on your answers. Stepping back on CareFusion, I understand the comments around the respiratory business and the timing of orders. But could you also speak to perhaps what else did a bit better there, CareFusion broadly? And then separately, on the insulin infusion set opportunity, which I think is a really good opportunity for you guys, could you help us think about either sizing that or putting some parameters around what this might mean to the company?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Okay, Tom?
Thomas Polen - Executive Vice President and President - Medical Segment:
Yes, this is Tom. So in the CareFusion business, across the board we saw good growth, as we mentioned. In MMS underlying, we were about 5% growth for the quarter. So Pyxis ES and infusion are both doing well there. As Chris had mentioned, we had a very large 40% growth in the prior-year quarter in infusion, which made a tough comp. We also saw very good performance, though, in the Medication and Procedural Solutions business, the legacy CareFusion products, with a focus on both the ChloraPrep products but also the infusion consumables, the IV sets, valves, et cetera, so really positive momentum there. As we think about the infusion set in Diabetes Care, we haven't sized that opportunity. But maybe some comments that I can mention is that we have received FDA, CE, and Health Canada approval. At this point, we're really focused on ramping up our manufacturing for that product and preparing for launch in partnership with Medtronic in FY 2016.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Okay, thank you.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Sure. Thanks, Larry.
Operator:
Our next question comes from the line of Rick Wise with Stifel, Nicolaus.
Frederick A. Wise - Stifel, Nicolaus & Co., Inc.:
Hi, Vince. Hi, Chris. Hi, everybody.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, Rick.
Frederick A. Wise - Stifel, Nicolaus & Co., Inc.:
Maybe starting off, if you would, with two product questions. First, on the pump side of the business, Baxter reported that their pump business, their pump system rebounded nicely. And in talking to them after it, I had the sense that one of your other competitor's regulatory and other dislocations are maybe helping out. Are you seeing any benefits on that side of business? I assumed you all gained share in pumps. But is going to be an incremental better number going forward?
Thomas Polen - Executive Vice President and President - Medical Segment:
We do continue to do very well in our pump business. That's probably what we would say there.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yes.
Frederick A. Wise - Stifel, Nicolaus & Co., Inc.:
Okay, that sounds good. Back to CareFusion, on the Pyxis side, just rereading last quarter's transcript, you were saying that you're seeing improved – you're throwing additional resources into the Pyxis install process. Acknowledging the complexity of the installs, are you gaining those efficiencies, are you accelerating the penetration of your existing backlog? What's happening there?
Thomas Polen - Executive Vice President and President - Medical Segment:
This is Tom, good question. We do have significant work underway. As we mentioned before, we've put in some Lean Six Sigma teams to help lean out the Pyxis ES installation process, and the team is making some early positive progress there. With that said, we do continue to experience very strong demand for the Pyxis ES system. And so while we're installing off of the backlog, the backlog does remain essentially at those record high levels still because the pipeline is being filled in with new orders at quite a good rate. And so the process improvements are underway. We have made progress. More to do there, I would say, but we're heading in the right direction.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yes, we're early on, but we think it's a real opportunity for us. And as Tom is saying, we're seeing the initial impacts, but we've got a long way to go.
Thomas Polen - Executive Vice President and President - Medical Segment:
Rick, and maybe just one other comment I could add is to the earlier question on infusion pumps that you're maybe looking for a little bit more color on, one other comment I could add is that we are seeing customers respond very favorable to the medication management end-to-end vision and the connectivity of our solutions across that process, valuing both the pumps and the Pyxis ES being interoperable with one another through the electronic medical record and our SmartWorks platform. So that's resonating very positively with our customers.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Yes, both Tom and I have been out visiting accounts, and we've seen this first-hand. It's a really powerful value proposition that we have now.
Frederick A. Wise - Stifel, Nicolaus & Co., Inc.:
I appreciate that, thank you.
Operator:
Our next question comes from the line of Brian Weinstein with William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Hi, good morning. Thanks for taking the question.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Hi, Brian.
Brian D. Weinstein - William Blair & Co. LLC:
Hey. So you talked about product mix a little bit. One of the things I'm trying to get my arms around is in the New BD, can you talk about within the different sub-segments? Which sub-segments have significantly stronger and significantly weaker growth in operating margins relative to the corporate average so that we can have some idea going forward about where strength is going to come from, one, and what that can potentially mean for margins?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
I'll take that, Brian. I actually don't see anything to point to across the business. I think it's partly, again, what we point to as the diversity of the business. And so there's nothing that I would call out as exceptionally weak or exceptionally strong. I think each of these businesses have the ability to drive the mid-single-digits revenue growth and improving profitability from where they are now. So I don't think there's anything really to call out there.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
They're pretty much clustered around the corporate average. Diagnostics may be a little bit below, but we see the margins there improving. So nothing in terms of modeling and going forward that I would really be pointing to, I think pretty much a cluster.
Brian D. Weinstein - William Blair & Co. LLC:
Okay. And then on BD MAX, you guys talked about, I think you said double-digit growth. Were you looking at new products driving that? Was it an easier comp? What's going on with BD MAX, and should we expect this level of growth going forward? Thanks.
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
It's Linda here. Thanks for the question, Brian. So on BD MAX, we continue to see expansion of the instruments in the U.S. and in EU being driven by the expanded assays. So we launched CT/GC and CT/GC/Trich in Europe and our enteric panels. We expect that to follow in the U.S. And then Vince provided very good commentary on our expected assay launches in 2016 and 2017. So really now starting to see double-digit growth in the MAX platform and positive feedback from our customers.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Linda, maybe you want to comment on what you're seeing in Europe with the expanded menu.
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
So in Europe, what we're seeing there is, again, very high double-digit growth, and in terms of instrument placement, a double-digit growth percentage in terms of the uptake in overall instruments, so very positive in Europe. And as we get our expanded menu, expect great things in the U.S. market as well.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Great. Thanks, Linda. Thanks, Brian.
Operator:
Our next question comes from the line of Derik de Bruin with Bank of America Merrill Lynch.
Derik de Bruin - Bank of America Merrill Lynch:
Hi, good morning.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, Derik.
Derik de Bruin - Bank of America Merrill Lynch:
Just a quick question. The adjusted revenues for this quarter, is that a one-quarter phenomenon, or do we need to think about that $13 million or something similar to that going forward? How do we think about that?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
There's a little bit going forward that will continue to bleed in. It's not significant.
Derik de Bruin - Bank of America Merrill Lynch:
Great, and then just one quick follow-up. On the intervals and on the Viper headwinds, when do those begin to subside? When do you start to annualize those?
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
Hi, it's Linda here. Of course, the guidelines came into effect in late 2012. We put that number today at about 70% to 75% penetration, in terms of doctors who have adopted that new interval testing. So probably over the next year or so, we say – where does that finish out, 85% to 90% of doctors adopting. So we probably have another year or so of the interval testing to get through.
Derik de Bruin - Bank of America Merrill Lynch:
Great, thank you very much.
Operator:
Our next question comes from the line of Bill Quirk with Piper Jaffray.
William R. Quirk - Piper Jaffray & Co (Broker):
Great, thanks and good morning, everybody.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Good morning, Bill.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning.
William R. Quirk - Piper Jaffray & Co (Broker):
I guess first question, Linda, just to follow up on that last response, we saw CMS recently talk about a five-year interval, from three years. And this actually follows up on, if I remember correctly, the additional guideline or recommendations made last year. So I guess, on a long-range basis, should we think at all about intervals potentially going to five years on pap testing?
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
So, I think those guidelines are probably way too early for us to comment on. I can tell you that what's out there publicly from the medical community would say that five years, depending on age bracket, is way too long for screening. So it's something that we continue to monitor, but today, there's no healthcare system on a global basis that has moved to a five-year interval timing. So we'll monitor it. Too early to comment, but nothing that concerns us in the short term on that.
William R. Quirk - Piper Jaffray & Co (Broker):
Okay, got it. And then I guess, staying on a similar diagnostic topic, microbiology in the U.S., can you flesh out for us a little bit how that's performing? I would certainly expect that we should see some pretty good things here, given the pretty updated suite of products that you have into that space.
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
Yes, thank you. Our core microbiology business is doing very, very well in the U.S. and ex-U.S. And it's driven by the strength of our BACTEC platform, driven by the strength of ID/AST and our new partnership with Bruker on the MALDI platform. And really tying all of this together is our new Kiestra lab automation system. So we've now just begun our footprint on that in the U.S. We have less than 2% market penetration. So we see a lot of opportunity, as we move forward, to really reinvent that microbiology lab from the specimen through the ID/AST, really starting with automating the workflow. We'll have papers now globally published that say efficiency with the Kiestra lab automation system installed are 60% to 70% improvements in their workflow efficiency. And the next thing we'll look to do is really introduce smart imaging into that platform. So I'm very excited about our U.S. microbiology business and what we're doing across the entire platform.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
And it really had good growth this quarter.
Linda Tharby - Executive Vice President and President - Life Sciences Segment:
It did, very nice.
William R. Quirk - Piper Jaffray & Co (Broker):
Very good, thanks.
Operator:
Our next question comes from the line of Jon Groberg with UBS.
Jonathan Groberg - UBS Securities LLC:
Hey, good morning, so just two quick questions. One, Vince, can you update us where you are on the strategic review process? Obviously, there were a number of press reports that there could be some businesses that might be divested. And then secondly, I think you maintained your emerging market growth outlook. But China, which is a big part of that, was brought down. I'm just curious where you saw some offsets there to maintain it. And what do you think is a reasonable emerging market growth rate, say, for the next three to five years, just given a lot of the macro noise that you have seen this year? Thanks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
We haven't changed our perspective on emerging markets. We kept it at 10% for the year. I think that's a good way for us to be thinking about it. And you're right, there are moving pieces there. We saw Brazil bounce back, for example. India actually, we don't talk about, has been doing better and better for us. So, we expect Asia to continue to be strong. So it's not just China. And as we said, China is going to – continue to be strong for us. It's not going to be at 20% going forward. So that's the way we think about that. In terms of the strategic review process, we're making good progress on that program, and we're to the point of doing some market checks on appropriate assets. And we'll keep you updated as that moves forward.
Jonathan Groberg - UBS Securities LLC:
Thanks.
Operator:
Our next question comes from the line of Doug Schenkel with Cowen & Company.
Doug A. Schenkel - Cowen & Co. LLC:
Hi, good morning.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Good morning, Doug.
Doug A. Schenkel - Cowen & Co. LLC:
If cost synergies were to continue to track ahead of plan, how do you balance the opportunity to let that flow through, versus accelerating the pace of investment in growth and sales synergy initiatives?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
Clearly, we have some commitments and targets to meet. I would say right now, we're not seeing the acceleration increase in the total amount of synergies, so we're not saying that. And so we're going to meet our commitments of high teens, and that's very important to us. Clearly, there's always a balance, but we feel like we are making the right investments. We're not holding back in investments. You saw us last quarter announce that we were going to do some registrations in China right out of the box because, even though it was a little bit of a drag, we knew that it was the right thing to do. So I don't see anything we're holding back on because of that. So, that's the way I would leave it.
Doug A. Schenkel - Cowen & Co. LLC:
Okay, and I do have a second question, but just to be clear on that, you did pull forward some of the cost synergies into this quarter. I guess really the question is, as we think about the next few quarters that there are opportunities to do more of that. Does that allow you to accelerate investment, or would you actually allow some of the upside to flow through for investment?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
It's a hypothetical question. We're going to do the right thing. If we think there's a benefit to accelerating something, we would accelerate it, keeping in mind, if we were in that position, keeping in mind our commitments that we're making. We talked to you, I think it was last quarter, about the fact that we accelerated the work on registration for China. So those one-off decisions we'd be making; we'll just be rational about it.
Doug A. Schenkel - Cowen & Co. LLC:
Okay. And then I think for Tom, Earlier this year, we had talked about the ability to move some of the CareFusion products in Europe out of distributors and into the BD direct channel. I think that was something that maybe was at least one area of focus within the context of the annual strategic review, any update on that? Thank you.
Thomas Polen - Executive Vice President and President - Medical Segment:
Yes, we haven't been driving that yet. We've been focused in some markets where the products were not necessarily launched yet. It's been our focus, such as ChloraPrep has been a primary area. The other thing I would say perhaps is that we have integrated in our distributor for dispensing in Europe, and so we do now take that. We are taking those products direct. So the entire dispensing business we are now taking direct through Europe.
Doug A. Schenkel - Cowen & Co. LLC:
Okay, thank you.
Operator:
Our next question comes from the line of Vijay Kumar with Evercore ISI.
Vijay M. Kumar - Evercore ISI:
Hey, guys, thanks for squeezing me in here, and maybe one quick housekeeping question. On the guidance for the year, it looks like CareFusion came up a little bit, and you hinted that legacy BDX was around the mid-single-digit range. So I'm wondering. Did the organic for the combined BD, did it just come up versus the prior guidance?
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
As we laid out on that chart, Vijay, we're still at about 4.5%. And so a little bit up on CareFusion, but it's more rounding than anything else. So we've continued to show the 4.5%, and we laid that out on the chart as to where that's coming from, so pretty much in line with what we would have expected.
Vijay M. Kumar - Evercore ISI:
Great, and then one on pricing. It's heartening to see I guess pricing actually coming in flat. I think that's the first time we've had a flattish pricing year in quite a number of years. And I'm just wondering. Is this a market phenomenon? Are you seeing anything on the competitive front? Is that what's going on? I'm just curious. How should we be thinking about pricing on a go-forward basis?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
We'll have to look at that again next year as we get into it. Last year we saw a little bit of negative pricing in the fourth quarter, and I know we're guiding pretty much flat pricing for this year. But it's still a very competitive marketplace. I'm very happy with the way we have managed pricing this year. It's something we're really intensely focused on. But I think we have to stay tuned and do our plan before I say it's going to be – that the market has changed, I wouldn't be making that statement. I think we've done a good job this year, and so we'll revisit it next year.
Christopher R. Reidy - Chief Financial Officer & EVP-Administration:
I would just add that it feels to me pretty much the same as it did last year. We did have a little bit of a blip in the fourth quarter last year, but it was pretty flat up to that point. It feels the same here.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
That's what I think.
Vijay M. Kumar - Evercore ISI:
And the last one, leverage levels, you reaffirmed that 3X within 24 months of deal closure. I'm just curious. Are there any adjacencies that you've reinvested? You're obviously getting into medication management, a lot of EHR, informatics opportunities. And would that be appealing for you?
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
So, Vijay, I wouldn't comment on a particular adjacency, but we do continue to think about plug-in acquisitions as we go forward, and we look forward to having more flexibility as we take those debt levels down.
Vijay M. Kumar - Evercore ISI:
Thanks, guys.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
That was a good question.
Operator:
Our final question comes from the line of Rich Newitter with Leerink Partners.
Richard S. Newitter - Leerink Partners LLC:
Hi, thanks for squeezing me in.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Sure.
Richard S. Newitter - Leerink Partners LLC:
Just on the CareFusion side of things, Pyxis or Pyxis ES, can you just update us on where you are with respect to the installed base, the opportunity, and the upgrade cycle, whether it's in innings or actual quantification? Can you give us a sense of where you are and where you see you can go?
Thomas Polen - Executive Vice President and President - Medical Segment:
Sure, this is Tom. So we're less than 20% converted, our base business, and so we're in the early innings.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
A long way to go.
Richard S. Newitter - Leerink Partners LLC:
Okay, that's very encouraging. And then just maybe higher level, as you engage further with customers with the combined portfolio and the broad complementary nature of the BD and CareFusion full suite of offering across the hospital, are the conversations – or can you characterize where the conversations are going there, anything to suggest that maybe some revenue synergy potential could begin to formulate even faster than expected as we look to 2016 and beyond, anything to increase or decrease your confidence on that front? Thanks a lot.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
No, I think we're pretty much where we said we were going to be. Tom mentioned that the concept in terms of Medication Management is resonating very well. We have some work to do with integrating Cato and CRISI into the system and getting the software aligned. So there's some technical work to be done that gates us a little bit in the short run. But in terms of how we are thinking about it and the timing, I think we're right on track. Tom also mentioned we are making progress, getting products into the market outside of the U.S., as he mentioned, in China, so right where we expect it to be.
Richard S. Newitter - Leerink Partners LLC:
Thank you.
Operator:
That was our final question, and now I'd like to turn the floor back over to Vince Forlenza for any additional or closing remarks.
Vincent A. Forlenza - Chairman, President & Chief Executive Officer:
Okay, thank you very much for your participation today and your thoughtful questions. It's a very exciting time at BD, and we look forward to updating you on the progress of this strategy as we wrap up the year. Thanks very much, thanks a lot.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.
Executives:
Monique N. Dolecki - Becton, Dickinson & Co. Vincent A. Forlenza - Becton, Dickinson & Co. Christopher R. Reidy - Becton, Dickinson & Co. Thomas Polen - Becton, Dickinson & Co. Linda Tharby - Becton, Dickinson & Co.
Analysts:
David Ryan Lewis - Morgan Stanley & Co. LLC Michael J. Weinstein - JPMorgan Securities LLC David Harrison Roman - Goldman Sachs & Co. Brian D. Weinstein - William Blair & Co. LLC S. Brandon Couillard - Jefferies LLC Rick A. Wise - Stifel, Nicolaus & Co., Inc. Kristen M. Stewart - Deutsche Bank Securities, Inc. Vijay M. Kumar - Evercore ISI William R. Quirk - Piper Jaffray & Co Lawrence S. Keusch - Raymond James & Associates, Inc. Rich S. Newitter - Leerink Partners LLC Doug A. Schenkel - Cowen & Co. LLC Derik De Bruin - Bank of America Merrill Lynch Mark Massaro - Canaccord Genuity, Inc.
Operator:
Hello and welcome to BD's second fiscal quarter 2015 earnings call. At the request of BD, today's call is being recorded. It will be available for replay through May 14, 2015 on the Investors page of the BD.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 21629817. I would like to inform all parties that your lines have been placed in a listen-only mode until the question-and-answer segment. Beginning today's call is Miss Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique N. Dolecki - Becton, Dickinson & Co.:
Thank you, Christy. Good morning everyone and thank you for joining us to review our second fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at BD.com. During today's call we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our second fiscal quarter press release and in the MD&A sections of recent SEC filings. We will also discuss the non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release including the financial schedules is posted on the BD.com website. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Executive Vice President of BD Medical; and Linda Tharby, Executive Vice President of BD Life Sciences. This quarter, we recorded certain pre-tax adjustments, which primarily reflect acquisition-related charges and financing charges. Details of these and other smaller charges can be found in press release attachments or the appendix of the Investor Relations slides. As a reminder, our second quarter results are on a standalone basis and represent only BD. We will report combined BD-CareFusion results beginning with the third quarter of fiscal year 2015. In preparation for the newly combined company or new co-reporting, we have also provided slides which illustrate changes to our P&L, our new reportable segments, and the way we will report our geographies going forward. In addition, we have also provided pro forma historical revenue information on a combined basis, consistent with our new reporting structure. They can also be found in the appendix of the Investor Relations slides. Also, for the purposes of today's call, we will provide guidance for BD as a standalone company for the balance of fiscal year 2015 in addition to the combined BD-CareFusion outlook. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we are proud of our final standalone quarter as we welcome CareFusion to BD. Our results this quarter highlight our consistent performance and the benefit of our diverse geographic and product portfolio. We delivered solid revenue and EPS growth, which were in line with our expectations. Year-to-date, we delivered revenue growth of 5.1% and adjusted EPS growth of 11.6%, which reflects a growth profile consistent with our external commitments and long-term goals. As you already know, we officially consummated the acquisition of CareFusion on March 17. This transaction significantly advances our strategy in the Medical segment and accelerates our evolution into a customer-focused provider of complete solutions. Integration activities are progressing as planned, and the CareFusion business performance to date is mostly in line with our expectations. Today, we're pleased to share our financial outlook on a combined basis. We are forecasting solid revenue and EPS growth, consistent with our expectations and with high level qualitative guidance we've provided over the past several months. On an annualized basis, we expect pro forma organic revenue growth of about 4.5%. We expect adjusted earnings per share to be between $7 and $7.10, which represents growth of about 19% to 20%. On slide five, we've outlined the guidance for BD on a standalone basis, the impact of CareFusion for the remainder of our fiscal year, and summarized the total guidance for our combined company. As you can see, we continue to expect BD on a standalone basis to grow at about 5% on the top line and about 9% to 10% on the bottom line. The acquisition of CareFusion will add 23% to 24% accretion to revenues and about 10% accretion to earnings. This results in revenue growth of 28% to 29% and earnings growth of about 19% to 20% for the total fiscal year. On a pro forma annual basis, which sums the organic results of both companies, we estimate BD and CareFusion's organic revenue growth would be about 4.5%. These financial metrics are consistent with our previously communicated high teens earnings accretion in fiscal year 2016. We're also reaffirming our commitment to deliver $250 million of cost synergies, which will be fully realized in fiscal year 2018. We will continue to update you as we make progress. Now, I'd like to turn things over to Chris for a more detailed discussion of our second quarter financial performance and our fiscal year 2015 guidance.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, Vince, and good morning everyone. I'd like to begin by discussing our second quarter revenue and EPS results, as well as the key financial highlights for the quarter. Total company revenues was solid increasing by 4.9%. Fully diluted adjusted EPS came in at $1.61, growing at 8.2% over the prior year, reflecting a difficult comparison to the prior year period as expected. As Vince mentioned earlier, our results this quarter highlight our consistent performance and the benefit of our diverse geographic and product portfolio. We experienced solid growth in both our Medical and Life Science segments. We also saw continued strength in safety-engineered products. We saw some softness in emerging markets mainly due to timing issues. Conversely, growth in the U.S. was strong, and I'll provide more color on these items in just a moment. To summarize, we feel very good about the final standalone quarter and the year-to-date results. Our results year-to-date give us the confidence to reaffirm guidance for BD on a standalone basis. We expect to continue to deliver a very consistent growth profile of 5% on the top line and 9% to 10% on the bottom line. We're also pleased to announce that we've already begun to deleverage the debt associated with the acquisition of CareFusion, paying down $650 million of the term loan at the end of April. I'll provide more explicit guidance details for BD and CareFusion later in my remarks. Moving on to slide eight, I'll review our second quarter revenue growth by segment on a currency-neutral basis. Organic revenue growth was 4.9% for the total company. The impact of price erosion was about 10 basis points in the quarter. Year-to-date pricing is better than our expectations, but we are maintaining our full-year guidance of about 30 basis points of pressure. BD Medical's second quarter revenues increased 5.4%. Growth in this segment was primarily driven by our Medical Surgical Systems unit. Medical Surgical growth was 7.5%, which reflects strong international safety sales. Growth in Diabetes Care was 4.1%, reflecting solid growth of pen needles, partially offset by an unfavorable comparison to the prior year period. Pharmaceutical Systems growth of 2.6% also reflects an unfavorable comparison to the prior year period as expected. BD Life Sciences second quarter revenues increased 4.4%, primarily driven by Diagnostic Systems and growth in Preanalytical Systems. Diagnostics Systems' growth of 7.8% was led by strong, clinical microbiology sales. We also continue to see good traction with the BD MAX platform internationally, where we expanded our menu offering. Preanalytical Systems' growth of 4.5% was driven by safety-engineered products and emerging markets. Biosciences revenue growth was 0.8% in the second quarter, with strong instrument growth in U.S. and Western Europe. This was unfavorably impacted by the timing of government funding in Japan as we expected and communicated to you on our previous earnings call. Funding has been approved, and we expect growth to normalize by the end of the fiscal year. Moving to slide nine, I'll walk you through our geographic revenues for the second quarter. Softer growth in our International business was supplemented by strong growth in the U.S. BD's reported U.S. revenues increased 4.5%, primarily driven by strength in Medical Surgical Systems, Diagnostic Systems and Biosciences. We view the environment in the U.S. as stable to improving slightly. Revenue in our U.S. Medical segment increased by 3%. This was driven by our Medical Surgical Systems business, which benefited from strong growth in our flesh (10:26) product line. The Diabetes Care and Pharmaceutical System units were partly impacted by the aforementioned difficult comparison to the prior year. The U.S. Life Sciences segment grew by 6.1%. This reflects strong growth in Diagnostic Systems of 7.5%, driven by clinical microbiology sales. Biosciences growth of 7.7% was driven by strong research reagent and instrument sales. Moving on to International, revenues grew 5.2% currency-neutral. Medical segment grew 6.9%, reflecting strong growth across the business and in international safety sales. The Life Sciences segment grew 3.2%, reflecting very strong growth in Diagnostic Systems of 8.1%. This was partially offset by the aforementioned impact of the timing of government funding in Japan in Biosciences. On slide 10 you will see that emerging markets accounted for approximately 25.2% of our total revenues. Emerging market revenues grew 7.6% currency-neutral over the prior year, bringing our total growth year-to-date to 10%. In the second quarter, emerging market revenue growth was negatively impacted by the timing of orders in China as well as in EMA. We also experienced a deceleration of growth in Brazil due to a slowing in government orders, as we expected. We indicated to you on our first quarter earnings call that we would keep an eye on Brazil given the macroeconomic conditions there. We expect our growth in that region to improve in the second half of our fiscal year. For the total year, we expect growth in emerging markets of about 10%, with growth in China expected to be in the 18% to 19% range. Safety revenues grew 10.8% in emerging markets, due to the aforementioned items in China and Brazil. Moving to global safety on slide 11. Currency-neutral sales increased 8.7% and grew to $550 million in the quarter. Safety revenues in the U.S. grew 2.2% while International sales grew 16.3% currency-neutral. Medical safety growth was 11.6%, with strong international growth driven by all three businesses. Life Science safety growth was 5.8% in the quarter. Turning to slide 12 and our gross profit margin for the second quarter. On a performance basis, margin expansion was driven by favorable product mix and continuous improvement initiatives. These contributions were slightly offset by higher pension expenses and other items. Raw materials were about flat in the quarter. Also, you will see that currency did not have an impact on gross profit. This was driven by translation adjustments recognized in the quarter due to the timing of inventory movements, otherwise known as profit and inventory. Slide 13 recaps the second quarter income statement and highlights our foreign currency-neutral results on an adjusted basis. As we discussed, revenue and GP were in line with our expectations. SSG&A increased about 4.5%, which reflects increased investments in emerging markets, higher pension expense and an unfavorable comparison to the prior year. R&D increased 3.7%. This remains in line with our expectations at 6.3% of revenues as we continue to invest in new product development and innovation. Operating income grew 6.5% in the quarter, reflecting solid P&L leverage. Our tax rate declined by 90 basis points, which benefited from favorable geographic mix. In the quarter, adjusted earnings per share were $1.61, which is an 8.2% increase versus the prior year, reflecting a difficult comparison to the prior year period. On slide 15, I'd like to provide a little more color on the revenue growth phasing for BD and CareFusion, which operated on different fiscal years. Most of you may already be familiar with CareFusion's publicly disclosed fiscal year 2015 revenue growth guidance of 5% to 7%. As illustrated, the results for CareFusion's fiscal year 2015 are in line with that guidance, which we expect to land at about 6%. We expect a revenue decline in CareFusion's fourth fiscal quarter of 5% to 7% due to a very tough comparison versus the prior year period in the infusion business, which grew at about 40%. Growth is also unfavorably impacted by a voluntary recall on the Respiratory Solutions business, which I'll touch on in just a moment. We expect growth to normalize in CareFusion's first fiscal quarter of 2016 and return to 3% to 5%. This will result in BD's organic revenues growing 1% to 2% in the third quarter and about 4% to 5% in the fourth quarter, driving rateable earnings in the back half of the year. As Vince and I mentioned earlier, BD has maintained a consistent revenue growth profile of about 5%, which we expect to continue for the balance of BD's fiscal year. To summarize and to arrive at BD's NewCo organic revenue growth, we have combined BD's full fiscal year with CareFusion's second quarter and third quarter and our expectations of CareFusion's fourth quarter and for what would have been their first quarter of fiscal year 2016. The result is pro forma organic revenue growth of approximately 4.5%. For transparency, we'd like to take a moment to provide some color on CareFusion's third quarter of fiscal year 2015. Tomorrow we will issue our 10-Q. The filing will show revenues, net income and earnings per share for BD and CareFusion for the period ending March 31. Due to the numerous adjustments for both companies, there will be limited visibility into CareFusion's underlying business performance in their third fiscal quarter. While we do not plan to discuss their third quarter results at length, we wanted to share some of the key insights into the business performance in the quarter. CareFusion's revenue growth was solid at 5.4% currency neutral. Revenue growth was impacted by about 240 basis points from unfavorable currency translation. While CareFusion has a relatively small international presence, FX has been very volatile and has negatively impacted their results. There are a number of items that negatively impacted operating margin in the quarter, which we estimate would have been about 18% to 19% of revenues on an underlying basis, or at about 19.5% year-to-date. Prior to our completion of the acquisition, CareFusion recorded a charge related to a recall in Respiratory Solutions. We are anticipating lost revenues in addition to the remediation costs associated with this recall. This was not contemplated in our original forecast for CareFusion and has an unfavorable impact of about $0.05 to earnings per share for BD's fiscal year. We expect to be able to start shipping again by the end of our fiscal year. On the dispensing side of CareFusion's business, we are pleased with the traction of Pyxis ES. As the CareFusion management team indicated previously, there is a healthy demand for this product which also comes with a lengthier implementation process. This is in line with our expectations. And due to the more complex implementation process, there has been and will continue to be a more significant investment of resources dedicated to Pyxis ES. CareFusion's third quarter results reflect a more significant investment here, in addition to lower revenue growth, which was impacted by a pull-forward into the second quarter. On the infusion side of the business, CareFusion delivered strong results as the team worked to continue to install the record number of committed contracts it had coming into the quarter, as well as to realize the benefit of the strong capital placements it had over last year. As CareFusion's previous management team shared with you, strong capital placements in the infusion business results in pressure on the overall company's margins in the short term. We expect to see higher margin consumables in the long run. Lastly, we are pleased with the performance in the former procedural solutions business, which lacked the vital signs acquisition last quarter and continues to leverage its clinically differentiated product portfolio. As a reminder, these businesses will be reported in BD's new reporting structure going forward. Now moving on to slide 16, there are a number of moving parts that impact earnings per share in fiscal year 2015. For modeling purposes and to ensure consistency, I'd like to provide more color on EPS guidance. Starting with BD's legacy business, adjusted earnings per share for fiscal year 2014 were $6.50. In fiscal year 2015, we expect to grow earnings by about 9% to 10% on an underlying basis. This is very consistent with the earnings growth profile we've communicated for some time. The unfavorable impact of foreign currency is about 10%, which is an incremental 100-basis point headwind to the guidance we provided in February. This contemplates a euro-to-dollar exchange ratio of about $1.11 and brings our current adjusted earnings per share to $6.43 to $6.50. In addition, we expect underlying currency-neutral accretion from the CareFusion acquisition of about 11%. As I just mentioned, we also have an unfavorable impact from the Respiratory recall of about $0.05. From an investment standpoint, we plan to accelerate our product registration process and international markets, and this is dilutive to earnings by $0.02. The net of these items results in 10% accretion. Due to the volatility of FX movements, we anticipate an additional currency headwind to CareFusion's earnings of about 100 basis points. This results in NewCo earnings of $7 to $7.10 or growth of 19% to 20% on a currency-neutral basis. While it's still too premature to talk in detail about fiscal year 2016, we think that it's important to be clear on the new baseline in which to calculate future earnings for BD. As I just mentioned, our new fiscal year 2015 EPS base for BD standalone is $6.43 to $6.50. Starting from this point, you can apply BD's traditional earnings growth profile of about 10%, and then add our guidance of high-teens earnings accretion on top of that. We hope this provides more clarity around the base earnings assumption to help in calculating the accretion from the transaction. Another important element to note is that while we expect to deliver about 10% FX and accretion in fiscal year 2015, we are reaffirming our guidance of high teens accretion of fiscal year 2016. Some of the anticipated accretion benefits have been accelerated into this fiscal year, as we're able to reduce duplicative public company costs quickly. From a phasing perspective, this means that we expect to achieve approximately $40 to $50 million in synergies in fiscal year 2015, with the balance being fairly rateable. We are committed to fully realizing $250 million in cost synergies in fiscal year 2018, but as Vince mentioned earlier, we will update you on our synergy expectations as we make progress. Now turning to slide 17, I'd like to walk you through the additional elements of our guidance for the full fiscal year 2015. We expect revenue growth for NewCo to be 28% to 29%, with BD Medical growing at 48% to 49%, and Life Sciences growing at about 5%. Gross profit as a percentage of revenue is expected to be approximately 52% to 52.5%. BD and CareFusion have similar gross margin profiles when reclassifying certain items consistent with BD's legacy reporting structure. As expected, we do not anticipate material incremental synergy improvement in GP in fiscal year 2015 beyond the operational efficiencies in the company's base plans. SSG&A is expected to be about 25%. The dilutive effect of CareFusion's SSG&A profile is offset by our expected synergies, resulting in a spend profile similar to BD's historical average. As I just mentioned, we continue to see a significant opportunity leveraging our global infrastructure to sell CareFusion's products, and we are accelerating our product registration process in international markets. We expect our R&D investment to be in line with fiscal year 2014 at about 6% of revenues. As a new company, we will continue to invest in new products and platforms, including incremental R&D investments in emerging markets. As a result of the items I just detailed, operating margin is expected to be between 20.5% and 21% of revenues. Similar to SSG&A, the dilutive impact of Carefusion's margin is offset by synergy achievement as we anticipate seeing an acceleration of operating margin expansion in the back half of this fiscal year. Excluding the unfavorable impact of foreign currency and pension expense, we expect our underlying operating margin to improve by about 60 basis points to 80 basis points for the total fiscal year. As you can see, we expect our tax rate to be between 23% and 24%, with a rate of 21.2% in the first half of BD's fiscal year and a higher blended tax rate for the second half of the year. This reflects a new geographical mix of profits. Please keep in mind, this higher tax rate is reflective of the six-month impact from CareFusion. Next, while we normally don't provide guidance for these line items, for clarity and for consistency, we anticipate Interest/Other to be about $250 million, and an average fully diluted share count to be 207 million for fiscal year 2015. In fiscal year 2016, we're expecting an average fully diluted share count of $218 million. In a sizable acquisition like this, the success of the integration is of critical importance. We are very comfortable that we are off to a great start and feel confident in our ability to deliver on the financial guidance we provided. Of course, we'll continue to keep you updated as we move forward. Now I'd like to turn the call back over to Vince, who will provide a brief update on our progress around our key initiatives.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thank you, Chris. Moving on to slide 19, I would like to review the program and product launches in our Medical segment. As we announced in March, we closed our acquisition of CRISI Medical Systems following FDA approval for Intelliport. It gives BD access to the injection safety market with a differentiated platform that we believe, when combined with our new CareFusion portfolio, will significantly enhance our growing end-to-end I.V. medication safety offering. Also, we recently received 510(k) clearance on our Infusion – Insulin Infusion Sets. We continue to expect a product launch in fiscal year 2016. This product will improve the consistency of insulin delivery, simplify the user's experience and it increase a patient's overall satisfaction with insulin pumping. Turning to slide 20, you will see the various product launches in Life Sciences. Within the Diagnostics business, our BD MAX molecular instrument continues to gain traction with customers in Western Europe, where our expanded menu is enabling increased placements. We remain focused on menu expansion on that platform, and in the second quarter, we launched the new CE-marked GC/CT and GC/CT Trich assays on the instrument. Within Biosciences, we continued to anticipate the launch of two additional BD Horizon Dyes based on the Sirigen technology. As we have been sharing with you, these dyes are enabling significant gains in multiparameter flow cytometry analysis. We also anticipate the launch of two instruments, the X-14 high-parameter multi-color research instrument and the BD FACSVia clinical instrument aimed to enable increased market adoption in emerging markets, particularly in China. In addition to these new product launches, we are also focused on successful commercial launches of our many recently launched products. As you can see, we continue to have strong opportunities in our pipeline, and we look forward to sharing our progress with you throughout the year. On slide 21, before we open the call to questions, I would like to reiterate the key messages from our presentation today. First, we're proud of our final stand-alone quarter. We have built a strong foundation for future growth while delivering on our financial and operational goals. Second, we continue to evolve into a customer-focused provider of complete solutions. The combination of the two companies will further enable us to deliver end-to-end solutions from drug preparation through dispensing and administration, that increase efficiencies, reduce medication errors, and improve patient safety in both hospitals and pharmacies. Based on our visits with customers, early feedback has been extremely positive as they see the value we can deliver by improving both cost and outcomes. We very much look forward to growing our business together with CareFusion. Third, we are pleased with our solid NewCo financial performance. Given our proven track record of success, we are confident in our ability to integrate this sizable acquisition. We believe we can continue to deliver on our commitments and further leverage our capabilities as we strengthen this new company. Finally, we are well-positioned for continued success in fiscal year 2015 and beyond. We look forward to the future with confidence. Thank you. We will now open the call to questions.
Operator:
Thank you. The floor is now open for questions. (Operator instructions). Thank you. Our first question is coming from David Lewis of Morgan Stanley.
David Ryan Lewis - Morgan Stanley & Co. LLC:
Good morning. I was trying to -
Unknown Speaker:
Good morning, David.
David Ryan Lewis - Morgan Stanley & Co. LLC:
I'm just trying to slip in two quick ones here. I apologize. The first one, thanks for the earnings bridge you provided into 2016. They're just for clarity, I think, in light of some other competitive reports. If you think about fiscal 2016 and the bridge you provide, it kind of sticks you in sort of the mid-$8s, mid-$8 range for fiscal 2016. I just wondered if you comment on whether that's a reasonable range. And my second question is just digging in deeper, Vince, on CareFusion, you have two specific elements. You talked on the deal announcement about Pyxis and the tailwind of Pyxis. Can you talk about in light of the sequential change in growth rates, how you're thinking about that Pyxis tailwind across multiple quarters and any updated thoughts on the backlog? And then, on the Respiratory recall, are we still talking about NV and (30:21) ReVel? And maybe you could quantify perhaps the impact on revs or growth that that recall is having. Thank you very much.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Well, let's do the CareFusion side first. And what I would say, and then I'll ask Tom to comment is, we really don't have any change in our perspective on the growth rate around Pyxis. We see solid customer demand. We see a continued strong backlog. The thing was quite lumpy as we went through the transition in terms of ownership, but in terms of fundamental demand, I don't think we don't see any changes. Tom?
Thomas Polen - Becton, Dickinson & Co.:
Hi, David. This is Tom Polen. Certainly on Pyxis, we still are at a record high in terms of the backlog itself. And I think as prior management had talked about in CareFusion, the insulation is a more complex insulation than the predecessor product. And now that we own CareFusion, we're very, very focused on driving forward to improve our ability to install the systems in a fast and more efficient manner. And so a lot of those core BD process improvement strengths we actually have now our Lean and Six Sigma teams engaging very deeply with that ES organization to help lean that out and hopefully shorten that cycle time as we move forward.
Vincent A. Forlenza - Becton, Dickinson & Co.:
David, on the 2016, I think that's why on chart 16 we gave the basis of $6.43 to $6.50, and then you would grow that at around the 10% that we normally guide to and then grow that by the high-teens accretion, and it puts you right into that range that you mentioned in the mid-$8s. So I think we're comfortable with that. But what I would point out is that there's still models out there that aren't getting the number of shares right and so that's why we actually gave the 16 shares of the $218 million. I'd also caution on tax rate, the tax rate we're giving for 23% to 24% this year only has the 27% to 29% CareFusion impact for half a year. So when you annualize that next year, you get another tick-up or so of a percent in the tax rate. So I'd caution on that. And then interest expense is always difficult to calculate going forward. So we gave the base for this year, and should be able to use that going forward. So those are the three that I think a number of models out there aren't getting right, but in terms of the general neighborhood, it's right on. So, I'll turn it back over to Tom, and he'll come back to the recall for you, David.
Thomas Polen - Becton, Dickinson & Co.:
Hi, David. This is Tom. So the recall is not on ReVel, it's on AVEA. And just maybe a little bit of comments on that further to those that Chris and Vincent made. So, prior to completion of the acquisition, CareFusion had initiated the process for that AVEA ventilator recall. We've since notified the FDA and applicable customers. We're not aware of any patient injuries resulting from the defect and we're doing this proactively. As Chris mentioned, a liability was recorded on the CareFusion opening balance sheet for the cost to remediate. We have identified the root cause, we're actively handling the remediation. However, during that remediation period, we're going to be unable to ship the new AVEA ventilators for a period of time here in the second half. We do expect to begin re-shipping this summer, and so we'll see some sales growth headwind in that business unit while that product's on hold, which will alleviate as we begin to ship again in the second half of this fiscal year.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay, thanks, Tom. Thanks, David.
Operator:
Thank you. Your next question is from Mike Weinstein of JPMorgan.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning, Mike.
Michael J. Weinstein - JPMorgan Securities LLC:
Can you hear me okay?
Vincent A. Forlenza - Becton, Dickinson & Co.:
We can now.
Thomas Polen - Becton, Dickinson & Co.:
Now we can, yeah, Mike.
Michael J. Weinstein - JPMorgan Securities LLC:
Perfect. I'm sorry. So, I've got a long list of questions, but I'm going to try to narrow it down. So, let me start with the CareFusion portfolio. The ventilator business is giving you – or at least, the Respiratory business is giving you a little bit of a headache with the recall. But can you just talk more broadly how you're thinking about some of those assets, Respiratory and other, some of the lower margin consumable pieces within the CareFusion portfolio and whether those will stay with the company longer term?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure, Mike. So as we previously said, we're going through a strategic review process with those businesses. We've actually tied that process into our normal strategic planning process now, which I think you're familiar with. It goes on basically during the summer and wraps up then. So we're working hard to get to a decision. We want to go through this and look at it both strategically and financially in terms of the value that we can create. And so we want to get to answers over the next few months. We do see some opportunities in those businesses so we want to be thoughtful about this, but we haven't made a decision yet.
Michael J. Weinstein - JPMorgan Securities LLC:
Okay. It sounded like from the BD side that growth actually should get better in the second half of the fiscal year. Japan and the Biosciences business sound like it will start to improve off of what was, obviously, a very difficult quarter for that piece. The Latin American business sounded like it was going to get better, China sounded like it was going to get better. So are there any offsets that we should be aware of relative to what was basically a bunch of positive comments for the second half relative to the second quarter?
Vincent A. Forlenza - Becton, Dickinson & Co.:
I don't think there's any significant negatives, Mike, that we're talking about. We do think that Mexico is going to get a little better. I think that, getting into a little bit more detail, that we're not expecting Brazil to get better. We expect that to be continued softness for the balance of the year. You're right about Japan coming back because we know that the funding has been released in Japan. So we're confident on that piece. And there was, coming back to China, we do expect that was really timing within the quarter and China's gonna grow around, what, 19% or so, Chris, if I remember, 18% to 19%?
Christopher R. Reidy - Becton, Dickinson & Co.:
So, yeah, I would say that's a pretty good picture. For the most part, most of those items that you talked about we contemplated in the last call and pointed towards. I think the only watch-out is still Brazil. We do expect that to rebound a little bit based on timing of orders, but, as you know, the economic environment there is still under a lot of pressure. So that's still a watch-out.
Michael J. Weinstein - JPMorgan Securities LLC:
Okay. And then two more real quick for you, Chris. So, one, the accelerated paydown of some of the debt is positive and it looks like there's the opportunity for the debt load to reduce faster than what we were originally assuming, so could you talk about that? And then second, on the pro forma tax rate, I just want to push back a little bit. The BD's pro forma tax rate was basically running at 22% plus or minus. CareFusion's was coming down through a number of initiatives that they had. But even if we look backward and assume that their rate stayed where it was, you guys shouldn't be at 25% plus. You guys should be probably more in the 24% to 25% range before any tax strategies. So can you just talk a little bit about that and whether there's some conservatism there on the guidance? Thanks.
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So let me address that piece first. That's what I was implying. We gave guidance for the remainder of this year of 23% to 24%. And the point I made that next year they still are at 27% to 29% based on their own previous guidance. And so when you put the full weight of that in next year, you are in that range of 24% to 25%. So I didn't mean to imply we're over 25%, but it's a little bit up from the 2015 guidance that we gave of 23% to 24% just based on the weighting. But that brings you to the zone that you talked about. In terms of the paydown of the debt, this was in line with what our expectations were, as we described if you recall, in 8-K in November we talked about that. And what we were guiding to is committing to be being below 3 times leverage within a couple of years. And so the $650 million of paydown was right in line with that.
Michael J. Weinstein - JPMorgan Securities LLC:
Okay.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Mike.
Operator:
Thank you. Your next question comes from David Roman of Goldman Sachs.
David Harrison Roman - Goldman Sachs & Co.:
Thank you. Good morning, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
David Harrison Roman - Goldman Sachs & Co.:
I wanted to start on the BD Diagnostics business, which showed very strong performance in the quarter, particularly in the U.S. And I was hoping you could go into just a little bit more details into the underlying drivers there and what we're seeing from some of the new product launches that you introduced a number of years ago, whether it's Veritor or BD MAX or something going on in the underlying business.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure. I'll turn it over to Linda Tharby.
Linda Tharby - Becton, Dickinson & Co.:
Good morning, David. So yes, good strength in our business in the U.S. That was driven by our core blood culture business, so a number of placements there and increased share position and the pull-through on that. And also, as you noted on our flu business continued to gain share in both our Veritor platform, and then a strong early flu season, which we saw the tail on that in the second quarter.
Operator:
Thank you. Your next question -
Vincent A. Forlenza - Becton, Dickinson & Co.:
So, it was really core microbiology that drove it. Thank you, David.
Operator:
Thank you. Your next question is from Brian Weinstein of William Blair.
Brian D. Weinstein - William Blair & Co. LLC:
Thanks for taking my question. Vince, you had mentioned some acceleration in spending for product registrations. Maybe Tom can speak a little bit to specific products that you're talking about, and does this change the timing of expected revenue synergies that might come from those products? Thank you.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Tom, you want to talk to that?
Thomas Polen - Becton, Dickinson & Co.:
Yeah. Hey, Brian. This is Tom. We're specifically focused right now on – we've talked a lot about China, obviously being a high area of interest for us from a synergy perspective. And so, that's right now, the primary area that we're focused on registrations in. There are other geographies. So as we have shared in the past, we're looking at -- the revenue synergy opportunities being more in the 2017-plus window. And as you know, registrations in China typically can be up to a two-year process. And so, we don't see that changing, but we see us just getting a jump start on moving forward with what we've already shared.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Thanks, Brian.
Operator:
Thank you. Your next question comes from Brandon Couillard of Jeffries.
S. Brandon Couillard - Jefferies LLC:
Thank you. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
S. Brandon Couillard - Jefferies LLC:
Quick one for Chris. In terms of the operating cash flow outlook for the year, are there any discrete cash outlays related to the acquisition to be aware of, either in the back half or as it relates to next year?
Christopher R. Reidy - Becton, Dickinson & Co.:
I wouldn't say anything specific to point to. Obviously, we have impacts of the cost that we're driving to get synergies, so that's obviously cash, but that's one of the reasons why we wanted to give some guidance on what the combined company was. And that would be about $2.1 billion on that NewCo basis for the remainder of the year. If you remember, we were at about $1.85 billion and about half of the CareFusion operating cash flow runs around $250 million or thereabout. So, on a combined basis, so nothing really to point to there.
S. Brandon Couillard - Jefferies LLC:
Okay, thank you.
Operator:
Thank you. Next question comes from Rick Wise of Stifel.
Rick A. Wise - Stifel, Nicolaus & Co., Inc.:
Good morning, everybody.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Christopher R. Reidy - Becton, Dickinson & Co.:
Good morning, Rick.
Rick A. Wise - Stifel, Nicolaus & Co., Inc.:
Maybe just to start with a bigger picture question, Vince, for you, just reflecting again on the strategic rationale for CareFusion. I know it's early in the process, but, Vince, do you feel like you're seeing any early indications that putting CareFusion in Becton is having, just an impact on the kinds of conversations you're having with hospitals about your concept of continuum of care? I'm asking less about new business one, but is it changing conversations? Do you feel more optimistic that it's going to change your dialogue with these customers?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Rick, absolutely. I had the opportunity to go out in the field, and I visited quite a few customers. In fact, we had a number of people from the management team out with CareFusion and BD sales reps. And I would say it is a – it's a very full and deep conversation around the process. It's not just about the product. It's about the integration of that product into the process and the IT components. And so, it's – it is a very different conversation with the management team at these hospitals. So I was very encouraged by the feedback that I got directly in person from these accounts. So, yeah, I would say so. I feel real good about it. Tom was out there with me. He was on a second team, and we hit quite a few large customers.
Operator:
Thank you. Your next question is from Kristen Stewart of Deutsche Bank.
Kristen M. Stewart - Deutsche Bank Securities, Inc.:
Hi. Thanks for taking the question. Just wanted to, I guess, talk through – I guess for clarification, I guess you mentioned that the U.S. benefited from – in the Diagnostic business a stronger flu season. Any way to quantify that from a broader top-line perspective?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, I think the comment was really back about the previous quarter, not so much in this quarter. Very small in this quarter. I mean, we're talking like $3 million. So, negligible.
Operator:
Thank you. Your next question is from Vijay Kumar of Evercore ISI.
Vijay M. Kumar - Evercore ISI:
Hey, guys.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Vijay M. Kumar - Evercore ISI:
Thanks for taking my question. So, Vince, I just want to go back to the earlier question on sort of having this breadth of product portfolio. I think in your prepared comments, you sort of touched upon it. And we certainly see consolidation being a team within the whole med supplies channel. Now, I'm just curious, do you feel like from an assets perspective, do you have the right mix of assets? Do you have the right breadth as you go after these larger accounts in a changing healthcare environment? Sort of, what are your longer term thoughts on the mix of assets?
Vincent A. Forlenza - Becton, Dickinson & Co.:
So I think in terms of the medication management space, if you go back and look, and remember that chart we showed you about medication management being a $20 billion industry and the breadth that we have across that, I think we feel very good about that breadth. I would say what was new for me in the field was the excitement that combining BD and CareFusion was bringing, as the customers saw both the concept of Intelliport and CRISI added to what CareFusion already had. And so I think with that, we're in very good shape in terms of the portfolio. I think that we're also excited about the small pump from Cesar Medical (46:15). And including that in the portfolio, we see opportunity there. We do think that we will have to do more work in the long run as we think about expansion in emerging markets. And as Tom mentioned earlier, we've started the whole registration processes for the products that fixed. But we do believe over the long run, it's not so much an asset purchase as it is market development and it is strategic marketing to understand the needs in those areas and how we can drive that further. Tom, would that be consistent with your thinking?
Thomas Polen - Becton, Dickinson & Co.:
Absolutely. I think one of the other things is maybe, Vijay, to answer your question around longer term is how we in the longer term leverage now the strength that we have in the hospital and begin to follow that into new care settings that are being driven by payer changes, right, as patients are moving into lower cost settings. So we think we have optionalities going forward that maybe we didn't have in the past.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, I think that's a great point. Thanks, Vijay.
Operator:
Thank you. Your next question comes from Bill Quirk of Piper Jaffray.
William R. Quirk - Piper Jaffray & Co:
Great, thanks. Good morning, everybody.
Christopher R. Reidy - Becton, Dickinson & Co.:
Morning, Bill.
William R. Quirk - Piper Jaffray & Co:
So, on microbiology, we certainly noticed a trend over the past couple of years where we're seeing a relatively dearth of new products coming out of the chemistry and the immunochemistry side of the market. On the other hand, we're seeing a lot of innovation coming out of microbiology, broadly speaking. So, can you comment a little bit on the drivers here for BD. And I guess, specifically, help us think about how sustainable this increase that you saw in the quarter is, maybe over the year and the next couple years. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, I think Linda can talk to that.
Linda Tharby - Becton, Dickinson & Co.:
Sure. So let me maybe handle the second part of the question first, which is the sustainability of the growth. So, certainly for the U.S. market, we have been seeing improvements in that platform broadly on our core blood culture business. bioMérieux had some issues in the front half. We see them coming out of that now in the back half. So, we will see some stabilization back to more normal market growth rates in the back half. But more broadly, for our microbiology business, we have been focused very much on improvements in our ID/AST platforms, and also in our lab automation. So, our KIESTRA platform now, we're very excited. We're really starting to see increased placements now in the U.S., which we'll start to see in the coming year. So, a lot of evolution in the core micro lab that BD is really driving.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah. We're just getting started with KIESTRA in the U. S. We're just making our first placements. We think that we have a long way to go, as Linda was indicating, with lab automation there. As Linda also indicated, we have gained some share in that business because both some competitive difficulties, but some new products and new resins we've had out in the marketplace in blood culture. So we're performing very well in that core business, and, of course, on top of that then, we're looking to continue to drive BD MAX and get that menu done, but I think the business is doing a good job.
Operator:
Thank you. Your next question comes from Larry Keusch of Raymond James.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Hi. Good morning.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Morning.
Lawrence S. Keusch - Raymond James & Associates, Inc.:
Wondering if you could just go back into the emerging markets growth, which is, you pointed out, was slower than we'd been seeing in the past. And I think you called out some timing of orders and some other things. But I'm wondering if you could kind of dive back into that and help us understand why those businesses, particularly China, comes back. And then, also, just so I understand, the gaining of the synergies, are you basically saying what's left over, the $40 million to $50 million that you get this year, what's left over from that out of the $250 million is ratable through fiscal 2018?
Vincent A. Forlenza - Becton, Dickinson & Co.:
Chris, why don't you start?
Christopher R. Reidy - Becton, Dickinson & Co.:
Okay, let me start with that one. So the way I would talk about the synergies, if you think about the $250 million over a three and a half year period, kind of implies $70 million a year and about half of that – and half year would be $35 million. That's why we're saying we really got a little bit more than that from a ratable standpoint in the initial six months. But as we look out, we see that as more of a pull-forward, so the remainder of the next three years kind of gets you to that $250 million on a ratable basis. Moving to your other question, I think that what we were pointing to in the timing, particularly in an area like China, is the fact that it's not an indication of the underlying growth. And China's been growing very nicely now, as you know, for a number of years, and we're not seeing a tick-down that's significant, particularly on the dollar increase. Clearly, the bigger the base that we have, it will have an impact on the growth rate going forward. But right now, we're seeing the China business in that area of 18% to 19%, and we wanted to point to the fact that this quarter was an anomaly of order timing. The same is actually true in EMA where we had some order timing issues and so we wanted to make it clear that that was not systemic. Now, in Brazil, a little bit different story. We had some order timing based on government orders and government tenders, but a little bit more of an issue there in terms of the economic environment. But we do expect that to come back a little bit in our second half of the year, but not as robust as it's been in the last couple of years. So we just wanted to give you that kind of flavor.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And just to add a little bit more detail on China, that was mostly Pharm Systems order timing; we're not talking about the government delaying orders.
Christopher R. Reidy - Becton, Dickinson & Co.:
Right.
Vincent A. Forlenza - Becton, Dickinson & Co.:
This is the normal lumpiness that we have globally in Pharm Systems.
Christopher R. Reidy - Becton, Dickinson & Co.:
Clearing customs.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Yeah, clearing customs. So this was the normal stuff that happens there, not a Chinese-driven situation.
Operator:
Thank you. Your next question comes from Richard Newitter of Leerink Partners.
Rich S. Newitter - Leerink Partners LLC:
Hi. Thanks for taking the questions. Just a quick one on buybacks. Can you just remind us what and when you might resume buybacks?
Christopher R. Reidy - Becton, Dickinson & Co.:
Sure. So we mentioned that we would be committed to paying down the debt, and so that's our first order of priority. And we're committed to getting under 3 times leverage in the next couple of years. That'll be the priority. So we don't envision any share buybacks during that period of time.
Operator:
Thank you. Your next question comes from Doug Schenkel of Cowen & Company.
Doug A. Schenkel - Cowen & Co. LLC:
Hi. Good morning. I guess I have a question for each of you. Vince, in one of the opening lines to your prepared remarks, you indicated that CareFusion was performing largely in line with your expectations. Did you use that language specifically and solely because of the AVEA recall? And then, Tom, what's the criteria you're using to evaluate potential divestitures and what's the associated timeline? Chris, your comments on tax rate for fiscal 2016, just to be clear, that guidance is based on weighting of geographic exposure solely and doesn't seem to incorporate assumptions for further tax optimization efforts. And then, Linda, any update on Viper LT? It's been quiet on that front for a little while. Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
There you go. A good five-part question that you have. It's funny because when I read that line, I was wondering if somebody would ask me that question. But the answer is, yes, it was the AVEA recall that I was referring to specifically when I said that. So that's part number one. Part number two was around I think the timing in terms of the portfolio, if I remember correctly. What we're working on is a process that is integrated with our strategic planning process. So in terms of making the decisions, we said that process is going to continue through the summer. But we're looking to try to get to a real conclusion around that in that kind of timeframe.
Christopher R. Reidy - Becton, Dickinson & Co.:
And with regard to the tax issue, from the very beginning we were saying that tax optimization is something we would expect to be able to get to but was not in our model because it takes a while to do that. That's a lot of pick-and-shovel work. So what I was referring to is that in the early years, it's going to be 27% to 29% of their rate. Our rate of 21.5% to 22.5%, you get some shield for the interest, obviously. That would be in that 50 basis point to 75 basis point range. That's a complicated calculation that has implications on foreign tax credits and a number of other things that offset it. So when you put all that in the mix, you would expect to be in the 23% to 24% this year and 24% to 25% next year, but not contemplating any tax optimization because it won't come that quickly we wouldn't expect. And we would expect that to be something a couple years down the road that we'll be able, as we did with the BD tax rate, to drive that down through optimizing tax structures. We would expect to be able to do that, but it'll take a little while to get there.
Vincent A. Forlenza - Becton, Dickinson & Co.:
And Linda, on the Viper LT.
Linda Tharby - Becton, Dickinson & Co.:
Yeah, so on the Viper LT platform, of course, that's replacing our ProbeTec platform. We're seeing some gains in Western Europe, particularly with the ProbeTec CT Assay/ ProbeTec GC Assay that we talked about earlier on that platform, and we're beginning to see traction in the U.S. market on the platform.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay, thanks. Thanks, Linda. Thanks for the question. All five parts.
Operator:
Thank you. Your next question comes from Derik De Bruin of Bank of America Merrill Lynch.
Derik De Bruin - Bank of America Merrill Lynch:
Hi. Good morning. I only...
Vincent A. Forlenza - Becton, Dickinson & Co.:
Good morning.
Derik De Bruin - Bank of America Merrill Lynch:
HHave a two-part question. So just thinking about the CareFusion organic revenue growth rate of the business going forward, I mean you're talking about exiting in your Q4, their first quarter, in that 3% to 5% range. Is that a sort of a good basis just to think about the long-term organic revenue growth rate characteristics of that business? Assuming we're not talking about the synergies coming from international sales, your base assumption for the core.
Christopher R. Reidy - Becton, Dickinson & Co.:
Yeah, the way I would say that starts getting back into the range. We've been saying all along that we see it more as a kind of a 3.5% underlying organic. And I think that's about right. If you notice on my chart 15, we said for the pro forma fiscal year 2015, it was around 3%. But they had a particularly difficult compare in their fourth quarter, which we pointed to, of 5% to 7% down against a very significant quarter they had the prior year. So, if you normalize for that, it takes you up to that kind of 3.5%. So that's probably the way to be thinking about that going forward.
Derik De Bruin - Bank of America Merrill Lynch:
Thanks.
Operator:
Thank you. Our final question is coming from Mark Massaro of Canaccord Genuity.
Mark Massaro - Canaccord Genuity, Inc.:
Hey, guys. Thanks for taking the question. This will be a two-part question here. So, you guys called out good performance in Western Europe on BD MAX. Would be curious if you could describe the competitive environment in the U.S. and what you're seeing, and if that increased year-over-year in the United States. And then, secondly, on Veritor, could you update us maybe on your install base and thoughts on what the next gen Veritor will have that the existing platform does not have? Thanks.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Sure.
Linda Tharby - Becton, Dickinson & Co.:
Okay, so on the MAX platform specific to the U.S., what we're seeing there is we have got – now we're seeing increased placements but leveled off in terms of quarters. And we're really working on the efficiency of that platform and the reliability of that platform, as well as the expanded menu. So we're encouraged by what we see in Western Europe. It's just going to take us time to get those assays through the FDA. So look for more to come towards the back half of 2016 and 2017 on that platform. And then the second part of the question is on the Veritor. We continue to see expanded share placements on that platform. I don't have the total number of placements now in the U.S. market. But continue to see expanded placements, particularly in physician offices and in the retail setting. The second generation, we're really going to be working on, as Tom mentioned earlier. As we see care shifting to new environments, it's really important for us on the interconnectivity of IT on those platforms. So that's what the next generation of Veritor will bring in 16. So total placements now on Veritor, just over 15,000 placements globally.
Vincent A. Forlenza - Becton, Dickinson & Co.:
Okay, thank you for your questions. Any more questions? That's it. Okay. So thank you very much for being with us today. It was an exciting start to bring in these two companies together. As I mentioned in my remarks, we look forward to the future with a lot of confidence. We're excited about the solution that we have pulled together and look forward to talking to you about it as the year progresses. Thanks very much.
Christopher R. Reidy - Becton, Dickinson & Co.:
Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique Dolecki - Vice President of Investor Relations Vincent A. Forlenza - Chairman, Chief Executive Officer and President Christopher R. Reidy - Chief Financial Officer and Executive Vice President of Administration Bill Kozy - Executive Vice President and Chief Operating Officer Tom Polen - President Linda M. Tharby - Segment President of Life Sciences Alberto Mas - President of Diagnostic Systems
Analysts:
Kristen Stewart - Deutsche Bank Michael Weinstein - JPMorgan David Lewis - Morgan Stanley Frederick A. Wise - Stifel Derik De Bruin - Bank of America William R. Quirk - Piper Jaffray Vijay Kumar - Evercore ISI Douglas Schenkel - Cowen and Company Rich Newitter - Leerink Glenn Novarro - RBC Capital Larry Keusch - Raymond James Brian Weinstein - William Blair Mark Novarro - Canaccord Genuity
Operator:
Hello, and welcome to BD's First Fiscal Quarter 2015 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through February 12th, 2015, on the Investors page of the bd.com website or by phone at (800) 585-8367 for domestic calls and area code (404) 537-3406 for international calls, using confirmation number 64069271. I would like to inform all parties that your lines have been placed in a listen-only-mode until the question and answer segment. Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Christie. Good morning, everyone, and thank you for joining us to review our first fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our first fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules is posted on the bd.com website. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Segment President; Linda Tharby, Segment President; and Alberto Mas, President of Diagnostic Systems. This quarter we recorded pretax adjustments totaling $97 million or $0.34 per share. These adjustments consisted of acquisition related charges, legal charges and the amortization of acquisition related intangibles. Last quarter we noted that we would be moving to a cash EPS basis going forward. These adjustments were also made for the first quarter of fiscal year 2014 for comparison purposes and can be found in the appendix of the Investor Relations slides. I would also like to note, that the guidance provided today is on a BD standalone basis. If we close on the transaction before the end of the first calendar quarter, we plan to provide guidance for BD's together with CareFusion on our regularly scheduled second quarter earnings conference call. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we're off to a really good start this fiscal year. We're pleased with our first quarter results, with strength coming from both our Medical and Life Science segments. Our first quarter results were also aided by a stronger than expected flu season. Our core business remained strong, which is consistent with the results we've recorded for the past 10 consecutive quarters. We continue to have a robust pipeline, with recent product launches continuing to gain traction. Growth in the quarter was also driven by strong sales in emerging markets and safety engineered products. Our pending acquisition of CareFusion remains on track with an expected closing date before the end of the first calendar quarter. I will provide an update on our integration planning later in the call. Overall, things are progressing quite nicely. Our solid revenue growth in operating performance this quarter in combination with our performance in fiscal year 2014 gives us the confidence to raise our fiscal year 2015 currency-neutral revenue and earnings guidance. Moving on to slide 5, I will review our first quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Total company revenue growth was strong at 5.3%. Fully diluted EPS came in at a $1.20, which included a number of charges which Monique just mentioned. Adjusted EPS was $1.53, which represents growth of 15.4% over the prior year. Now I'd like to turn the call over to Chris, who will walk you through our first quarter financial performance, and updated guidance.
Christopher R. Reidy:
Thanks, Vince, and good morning, everyone. I'd like to begin on slide 7 by discussing the key highlights for the first quarter, which I'll speak to on a currency-neutral basis. As Vince just mentioned, we are pleased with our first quarter results, which were ahead of our expectations. Revenue growth of 5.3% was aided by stronger flu season in last year. This contributed about 80 basis points to grow. Our tax rate declined year-over-year representing the impact of the reinstated R&D tax credit as we had contemplated in our guidance. Adjusted earnings per share of $1.53 grew 15.4% in the first quarter when compared with the prior year. Earnings were ahead of our expectations, primarily due to stronger revenue growth, coupled with a lower tax rate. As Vince just mentioned, our strong performance in the first fiscal quarter gives us the confidence to raise currency-neutral revenue and EPS guidance for the year, which I will talk to in more detail in a few moments. On slide 8, I'll review our revenue growth by segment on a currency-neutral basis. As you know, we have recently moved to a two segments structure, for transparency and to align with how we provided guidance, we are providing additional summarized information for the Life Sciences segment. As I just mentioned, first quarter revenue growth was 5.3% for the total company. The impact of pricing pressure in the quarter was about 20 basis points as expected. BD Medical first quarter revenues increased 4.2%. Within the Medical segment, Medical Surgical growth was 6.8% this quarter, aided by strong international safety growth. Diabetes Care growth of 3.6%, reflects continued strength of pen needles, partially offset by order timing in the US and an unfavorable comparison for the prior year. Pharmaceutical Systems' decline of 1.9% was unfavorably impacted by ordering patterns, subsequent to strong fourth quarter revenue growth. This was inline with our expectations and consistent with our communications on our last earnings call. BD Life Science first quarter revenues increased 6.5%. The segment's growth was driven by strong sales across its three business units. Growth in Diagnostics was 6.5%. Preanalytical Systems' growth of 5.2% was driven by safety-engineered products and geographic expansion. Diagnostics Systems growth of 7.8% was driven by core microbiology growth which reflects a stronger flu season and strong blood culture performance. We continue to capture significant share with our Veritor platform. We now have over 15,000 instruments and used today at hospitals, clinics and doctor's offices. We also continue to see good traction with the BD MAX platform. Biosciences' revenue growth was 6.7% in the first quarter driven by strong instrument placements and international growth. Moving to slide 9, I'll walk you through our geographic revenues for the first quarter on a currency-neutral basis. BD's US revenues increased 3.7% versus the prior year, which benefited from some timing in the medical segment and flu sales in the Life Sciences segment. We view the hospital environment in the US as stable to improving slightly. Revenue in our US Medical segment increased by 3.6%. This was driven by pharmaceutical systems order timing, a favorable comparison to the prior year and solid growth in medical, surgical systems. The Diabetes Care unit was partly impacted by the aforementioned timing of orders. US Life Science segment grew 3.9%, strong diagnostic systems US growth was negatively impacted by continued declines in our women's health and cancer business, which have been – we have been discussing for some time now. Biosciences growth reflects strong research and clinical instruments placements. Moving on to international. We continue to see strong growth. Revenues grew 6.4%, driven by solid growth across both our Medical and life Sciences segments, which grew 4.6% and 8.5% respectively. Both segments continue to experience strong growth in emerging markets and international safety sales. Medical results were negatively impacted in part by the previously mentioned ordering patterns in pharmaceutical systems. On slide 10, emerging market revenues grew 12.4%, and accounted for 26.5% of total revenues. This strong performance was driven by growth across both segments. China revenues grew 23.1%, and safety sales in emerging markets grew 17.8%. Strategic investments in emerging markets continue to drive robust growth. Moving to global safety on slide 11. Currency-neutral sales increased 5.9% and grew to $573 million in the quarter. Revenues in the US declined 1.9%, which was impacted by an unfavorable comparison to the prior year. International safety sales grew 16.1%. Medical and Life Science safety growth was 6.6%, and 5.3% respectively. Both segments results were driven by strong international growth, particularly in emerging markets. Turning to slide 12. Foreign currency had an unfavorable impact of about 70 basis points on our gross profit margin in the quarter. On a performance basis, margin expansion was driven by positive contributions from continues improvements and favorable mix. These contributions were partially offset by the unfavorable impact of pricing and pension. We also incurred some one time cost related to the Kiestra platform, which included the integration into our business information systems. Raw materials were about flat in the quarter. For the full fiscal year, gross profit expectations remain inline with our previously communicated guidance. Slide 13 recaps the first quarter income statement and highlights our foreign currency-neutral results. Since we've already discussed revenue and gross profit, I'll move down the income statement to SSG&A. As a percentage of sales, SSG&A decreased in the quarter. This was driven in part by sustained cost containment. R&D was 6.3% of sales in the quarter, operating income grew 10.1% driven by solid revenue and gross profit growth, coupled with better leverage and SSG&A. Our tax rate improved 380 basis points over the prior year. The improvement was due to continued favorable geographic mix and the impact of the R&D tax credit reinstatement, which was contemplated in our full year guidance range. Adjusted EPS in the quarter was $1.53 or an increase of 15.4%. Turning to slide 14, I'd like to walk you through our expected revenue guidance for the full fiscal year 2015. In summary, we are increasing our guidance and now expect revenue growth of about 5% for BD in total. This increase reflects our improved performance in the first quarter, relative to our overall expectations. On a reported basis, revenue growth is expected about flat to a decline of 1%. This reflects a currency headwind of about 600 basis points and assumes the euro-to-dollar exchange rate of $1.14. At current spot rates, all major currencies relative to the US dollar are down about 15% to 20% versus last year. We continue to anticipate pricing pressure of 30 to 40 basis points for the year. We are increasing our adjusted earnings guidance to 9% to 10% growth currency-neutral. This is an increase from our previous guidance of 8% to 9% growth reflecting an improved revenue growth profile, along with lower oil prices. On a reported basis, earnings growth is expected to be about flat to 1% reflecting a currency headwind of about 900 basis points. All other full year guidance ranges provided on our November earnings call remain unchanged. Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio.
Vincent A. Forlenza:
Thank you, Chris. Moving on to slide 16 and product launch updates in the Medical segment. We recently announced the FDA approval of the BD Intelliport Medication Management System, intended for manual IV bolus injections. This product is the first and only solution providing real-time drug identification, dose measurements and allergy detection at the point of injection. Real-time wireless data collection is sent directly from the patient bed side into their electronic medical record. This product underscores our commitment to BD's medication management franchise, and is complementary to CareFusion's smart pump and informatics platform. This represents the next wave of patient safety related products. In Diabetes Care, we're looking forward to the FDA submission for our approval of our new BD infuse insulin, insulin infusion set this fiscal year. We expect a product launch in 2016. This product will improve the consistency of insulin delivery for insulin pump users. On slide 17, you can see the anticipated products in our Life Sciences segment. Within the Diagnostics business, our BD MAX molecular instrument continues to gain traction with customers and we remain focused on menu expansion on that platform. We anticipate launching a number of new enteric panel assays, including enteric parasite in fiscal year 2015, followed by enteric viral and extended bacteria, also in 2016, we expect to launch the Vaginitis and Vaginosis assays. As Chris mentioned earlier, we've seen a lot of success and we continue to gain notable share with our BD Veritor instrument. In 2016, we expect to launch the next generation of this instrument which will have smart device features. We continue to anticipate the full launch of BD's Totalys system in our Women's Health and Cancer area for cervical cancer screening automation. Within Bioscience's, we have launched another of our BD Horizon dyes, based on the Sirigen technology. As we have been sharing with you, these dyes are enabling significant gains in multi-parameter flow cytometry analysis. We continue to anticipate the launch of two additional instruments towards the end of this year, the BD X-15 high parameter, multi color research instrument and the BD FACSVia low cost clinical instrument. The FACSVia is primarily for emerging markets, with an initial focus on China. The diversity of these instruments, both in application and target demographic illustrates the wide customer base that we are enabling. In addition to these new product launches, we are also focused on successful, commercial launches of our many recently launched products. As you can see, we continue to have strong opportunities in our pipeline and we look forward to sharing our progress with you throughout the year. Moving on to the CareFusion acquisition timeline on slide 18, we continue to make progress in finalizing this acquisition. We successfully completed the Hart-Scott-Rodino review process in November, our financing was secured in December and most recently the CareFusion shareholders voted to approve the transaction on January 21st. Regarding Europe, we plan to file our final submission tomorrow. The EC has a 25 working day review period to decide whether to clear the transaction or enter into a second phase investigation. Assuming EC clearance at the end of the review period, we expect to close the transaction before the end of the first calendar quarter. Regarding integration planning and talent retention, things are on track and in terms of the value drivers we've outlined, we remain confident that we will deliver on these commitments. As a result of the financing structure we communicated in November, we expect the acquisition to be accretive to cash earnings on a high teen percentage basis for the total company in fiscal year 2016. We continue to expect to deliver $250 million of cost synergies, which will be fully realized in fiscal year 2018. As we focus on de-leveraging, we will consider appropriate timing to restart our share repurchase program, which we expect when we return to a leverage ratio of about 2.5 times gross leverage. We remain enthusiastic about the financial and strategic benefits of this acquisition for our shareholders and customers. On slide 19, before we open the call to questions, I'd like to reiterate the key messages from our presentation today. First, we are pleased with our strong start to fiscal year 2015. We are delivering on our commitment to top line growth, bottom line growth and underlying margin expansion. Second, our core business is strong, as evidenced by our consistent performance for the past 10 quarters. We continue to see good performance in both segments, coupled with strong growth in safety, and emerging markets. Our strategy continues to deliver results, as evidenced by our performance for this quarter. Third, we are on-track for anticipated CareFusion acquisition. Teams across both organizations are hard at work, planning for a successful integration. The powerful combination of the two companies will further enable us to deliver end-to-end solutions that increase efficiencies, reduce medication errors and improve patient safety in both hospitals and pharmacies. Finally, our strong financial performance in the first quarter enables us to raise currency-neutral revenue and earnings guidance for fiscal year 2015. We look forward to the future with confidence. Thank you. We will now open the call to questions.
Operator:
Thank you. The floor is now open for questions. [Operator Instructions] Thank you. Your firs question is coming from Kristen Stewart with Deutsche Bank.
Kristen Stewart:
Hey, good morning. Good results today. I was just wondering if you could walk through the guidance and just kind of the components that gives you confidence. How much I guess is flu, that's adding to the increased top line? And can you maybe just walk us through your commentary around lower oil costs and resin costs and how that could be contributing as well to the EPS line?
Vincent A. Forlenza:
Chris, can do that, but we had strong performance across all of our businesses, with flu on top of that. And flu was a combination of a stronger season and continued share gains in that business. So that’s kind of behind what we saw on the revenue side, plus we see good growth in emerging markets. We haven’t seen any turndown in any of our emerging markets. Though look at Brazil, and we are – we're careful about that and keeping an eye on it, because from an macroeconomic standpoint, you'd be concerned, but we saw good performance there this quarter. So, good emerging markets, good across the portfolio and good flu, that’s what got us to the top of the range. Chris, if you want to walk through the rest of it?
Christopher R. Reidy:
That sums it up in terms of the top of the range, flu certainly helps and we see that sticking. We don’t know what's going to happen in the next quarter regarding flu, but so far it’s been strong and again that’s been a combination of a strong flu season, as well as our taking share. So, that’s really what's driving the top line. The bottom line, is a number of things, certainly the contribution of the stronger revenue growth, including the lift from fluctuations, then as we look out at our cost structure, we do see the decline in oil prices. That’s going to have more effect in the back half of the year. It’s not directly related to the price of oil. The resin prices are going down about – at a one third rate of the oil price decline and some of that has to do with the dynamics of the market and others – in other industries still having a high demand. But we do see some impact to that. But you get about a half of year that because it runs through inventory. So, I think on the EPS, contribution from flu or contribution from oil prices, as well as the fact that we've got some upside on the tax side as well, coming a little bit to the low end of the range, primarily driven by the R&D tax credit that was re-enacted.
Operator:
Thank you. Our next question comes from Mike Weinstein with JPMorgan.
Michael Weinstein:
Hi, guys. Can you hear me okay?
Vincent A. Forlenza:
Yes. Good morning, Mike.
Christopher R. Reidy:
How are you?
Michael Weinstein:
Okay. Perfect. I just wanted to circle back on two things. So one, the CareFusion commentary, just with regards to the accretion. The high-teens accretion commentary, is that commentary first 12 months or is that FY 2016 commentary? And then, second, I was hoping you could spend a little more time on the China performance this quarter, which was north of 20% and I was hoping you could shed more light there. Thank you.
Vincent A. Forlenza:
Yes. Mike, on the first one, it is consistent with what we said in the past fiscal year 2016.
Christopher R. Reidy:
And then on China Mike, we continue to see strong performance pretty much across the board in China. And so the Medical segment continues to do very well. We're continuing to kind of expand our footprint there and as that’s happening we see the government continuing to spend on healthcare. We have not seen any slowdown. We track a number of measures. So, we haven’t really seen any significant issues in China. Tom, would you want to comment at all on the Medical side, Linda on the Diagnostics and Life Sciences.
Tom Polen:
I think you said we had a very strong north of 20% growth in the Medical segment in China this quarter, and we continue to see strong performance across all three businesses in the segment.
Linda M. Tharby:
On the Life Sciences segment, again, over 22% growth this quarter and we continue to see as expansion occurs in healthcare amongst different tiers, strong opportunity continuing for us in the China market.
Vincent A. Forlenza:
So pretty much across the board Mike. Thanks, for the question.
Operator:
Thank you. Your next question comes from David Lewis with Morgan Stanley.
David Lewis:
Good morning. Just one quick question, maybe for Tom or for Vince. I wonder if you could discuss the development of the pro forma growth story with CareFusion. Specifically what I wanted to center on was, how long is it going to take to really see benefits from CareFusion international product registration, and sort of what provides that confidence that the underlying CareFusion growth can sustain pro forma top line around 5% until that process sort of plays out and develops? So, confidence and timelines any development thoughts would be very helpful.
Vincent A. Forlenza:
Sure. We're doing a lot of work on that right now and Tom can comment and kind of bucket this thing for you in terms of near term opportunities where we don’t have registration issues, registration and then, longer term some of the kind of market development stuff. So Tom, why don’t you walk us through that?
Tom Polen:
Yes. Hi, David. Good morning. So, as we've shared in the past, we look at revenue opportunities really evolving more in the 17 plus timeline. And we see that in, in kind of three different buckets. The first is, there is a series of products in the CareFusion portfolio that do not require registration in emerging markets and ex-US and those would be primarily around the Roland Pyxis portfolio for pharmaceutical dispensing and automation. Then you've got – so that’s the near term horizon. And in the mid term horizon, then you've got products which do require registration, but fit into very strong existing BD channels. And so those were the portfolio components such as IV valves, sets, chloraprep can fit into that category where we got the existing infrastructure and it’s really sold as integrated solution with our current portfolio. And then I put the other third kind of horizon there as more complex capital that – such as pumps in certain markets where they are not already registered. And those require both registration, as well as building some basic infrastructure around service et cetera of that type of capital. And with that said, they do have of course, through the CMD [ph] equity stake that they took, position in a company that does have pumps registered in a series of emerging markets and we see that as a near term opportunity. But we're actively working with the CareFusion team on just further defining and putting timelines around each of those sub-components, and we'll be sharing certainly more of that after close.
Operator:
Thank you. Your next question comes from David Roman with Goldman Sachs.
Unidentified Analyst:
Good morning. This is actually Kyle calling on behalf of David Roman. Thanks for taking the question.
Vincent A. Forlenza:
Sure. Good morning, Kyle.
Unidentified Analyst:
Morning. I just wanted to talk a little bit about your woman's health segment and diagnostics. You called out kind of the extended interval screening for roughly a year now, it’s creating a headwind to growth in that segment. When can you see interval screening is kind of fully incorporated into, excuse me, as fully incorporated as behind you, and when do you see yourself as lapping that headwind going forward?
Vincent A. Forlenza:
Sure. Linda, will take that.
Linda M. Tharby:
Good morning, Kyle. So declines from our increased interval recommendations, we look at continuing for another 12 to 18 months as more physicians adhere the recommendation. So we estimate at this point about 70% are using the increased interval timelines. And I think of note this is obviously affecting us in the US and we continue to see very strong growth ex-US, on our share path platform.
Vincent A. Forlenza:
Thanks, Linda.
Operator:
Thank you. Your next question comes from Rick Wise with Stifel.
Frederick A. Wise:
Good morning, everybody. Couple questions. Maybe touch if you would on the current NIH budget proposal. I think it was a better proposal than we've seen, 3.3% I think in Obama's proposal. Is that good, bad neutral in your view? We feel more optimistic on the outlook as a result and maybe talk about US bioscience and was it helped by end of quarter budget releases?
Vincent A. Forlenza:
So, I think that it’s a good thing. I think that’s better than its been for quite sometime. We'll have to understand their priorities and how they spend that. Certainly, we're hearing about the whole program in next generation sequencing and the million people, individuals they are looking to do. But overall, I would say it’s a nice positive. So, things heading in the next direction. I think there is going to be continued debate in congress over this as well, with some, let say, thinking that supporting research is an important part of an innovation strategy for the country and that’s becoming more rationale debate. I think we're past the sequestration. But Linda do you have any other thoughts you might want to add?
Linda M. Tharby:
I think Vince summed it up very nicely, maybe the only the thing that I would add on the comment around priority of spending, obviously we're looking at how much goes into areas like core immunology versus translational research and of course with our acquisition of GenCell we're very excited about the news happening in the US on personalized medicine. Maybe the only thing we're watching on a global basis is the spending in Japan, where we're seeing some reductions overall and push-outs in spending in that environment.
Vincent A. Forlenza:
Yes. There was a little bit more than a 3% reduction Linda, if I remember correctly in Japan. And so we're watching that and we know that’s going to give us a little bit softness in the back half of year in biosciences, but overall, positive.
Operator:
Thank you. Your next question comes from Derik De Bruin with Bank of America.
Derik De Bruin:
Hi, good morning.
Vincent A. Forlenza:
Good morning, Derik.
Derik De Bruin:
In your microbiology segment, there is a number of new technologies that are emerging for both pathogen ID and in particular for antibiotics sensitivity testing. That potentially accelerate and automate the process in AST. Could you sort of talk about what you're doing in tech development in that area and how you see about protecting that franchise as some of these new technologies go out? This goes on to a question on, can you sort of like update us on Kiestra and where you're on that and how many systems have been installed? Thank you.
Vincent A. Forlenza:
So on Kiestra, we haven’t said how many systems have been installed, but we're continuing to make good progress. We've got a very nice pipeline on Kiestra and we're expecting very strong growth there, this year and continued demand. But Alberto, do you want to talk a little bit about rapid detection methodologies.
Alberto Mas:
So we are – good morning. We are definitely watching the space very actively and I would like to highlight as well the partnership that we have from a multi-talk perspective with Bruegger, we're partnering with them, not only on current technology, but potentially making an evolution next step, bringing our expertise in microbiology to their expertise from an instrumentation perspective and making an impact to the market that way.
Vincent A. Forlenza:
Okay. Thanks, for the question.
Operator:
Thank you. Your next question comes from Bill Quirk with Piper Jaffray.
William R. Quirk:
Great, thanks. So with the CareFusion acquisition closing next quarter, or it seems like it's going to close next quarter, when should we start to see some of the costs and revenue synergies leak through?
Vincent A. Forlenza:
So we said we're – our expectation is that by the end of the first calendar quarter it should close as long as we do not get a – I'll call it a second request from the EC just to make sure you understood what we said a few minutes ago. And so, with that, in terms of when do we expect to see the synergies, was that the second part of your question?
William R. Quirk:
Yes.
Christopher R. Reidy:
So let me jump in on that, at the next earnings call what we will do is tell you what the new color looks like on a combined basis for the remainder of 2015. So we'll address that then. We have obviously talked about the accretion in the high teens for fiscal year 2016, and again, a lot of that driven by cost synergies. I think Tom addressed it on an earlier question, the timing of revenue synergies which were not baked into that sort of more of a longer term synergy.
Vincent A. Forlenza:
Yes. First, revenues I think Tom said, starting about fiscal year, three years out basically, is what we said and that’s really driven by product registrations, as much as anything else.
Operator:
Thank you. And your next question comes from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Hey, guys. Thanks, for taking my question. Maybe a big picture question for you. Historically, you guys have been pretty conservative when it comes to cap deployment. You've been extremely focused on organic, the core if you will. And now that you've done the CareFusion deal, you've seen a lot of enthusiasm around the stock with investors cheering your strategy. As we look forward at this company, right, is this a new Becton, Dickinson, how is management thinking about cap deployment? Can you please just contrast sort of the old versus the new strategy if you will?
Vincent A. Forlenza:
Well, I would say that we move from a phase of being primarily tuck-in acquisition, building our acquisition capabilities, but at the same time being strategy driven and when that strategy calls for a larger acquisition that made sense both strategically and financially we did it. And that is still the way we think about things. It has to have attractive returns and it has to have a clear and compelling strategy, that hasn’t changed it all. And so, as we do this, we'll continue to build our capabilities. We have gone through a large integration process. We'll step – we always – we'll continue to step back and look at the corporate strategy and look at what is the next logical move. And that could be a series of tuck-in, so something, somewhat larger. But right now, we are focused on CareFusion getting that integrated and getting both the cost and the revenue synergies as we look forward.
Operator:
Thank you. Your next question comes from Doug Schenkel with Cowen and Company.
Douglas Schenkel:
Hey, good morning, guys. So I want to go back to I think what was really the very first question in the Q&A session. FX and revenue growth was much better than consensus in the first quarter, and it was strong across all businesses, not just diagnostics and flu. It was broader than that. And yet it looks like your revenue guidance for medical and biosciences was unchanged, really all it looks like you did was bump up diagnostics. And this seems pretty conservative relative to your tone and certainly the balance Q1 beat. Keeping in mind, running off a few things off the top of my head, I mean, women's health should presumably return to growth over the course of the year as you annualize the account loss. It seems like China momentum, if anything's building in really all segments, based on your prepared remarks there was some timing dynamics that actually seemed to push some revenue out of Q1 into the balance of the year, and you clearly have a good pipeline of products. So I'm just wondering, what's behind this? Should we view this as a continuation of your practice of being conservative with guidance increases earlier in the year, along the lines of what we've seen the last couple years? Is it about an uncertain macro environment? Just trying to dig in here. And then, I guess, related to that, the stronger than expected performance we've seen in the last couple quarters, has that allowed you to accelerate some of the investment that you need to make as you head into the CareFusion deal? Thank you.
Vincent A. Forlenza:
So, starting with your last part of your question, I think our investments are really on track with what we expected for CareFusion and other things that we're pursuing within the company, whether it’s GenCell, on the Life Science side, or in Intelliport or whatever. And so that really remains on track. Now, in terms of the – absolutely, we feel good about the first quarter and how it went. We didn’t change the bioscience guidance, because of the issue that Linda was putting on the table, which was what's happening in Japan with research spending being, I think it was 3.5%, somewhere around there approximately. And so we're going to have a tough compare in the back half of the year in biosciences. Good performance, improving performance, but from a market standpoint internationally that’s going to impact us. So that’s why we didn’t change it there. Diagnostics we did and I would say on medical and Tom can comment this, we are pretty much where we expected to be. It was strong and there was some puts and takes within that. And so we are encouraged about the remainder of the year, but we though 5 was about right, do you have any comments you'd want to make on medical.
Tom Polen:
Hi, Doug. This is Tom. I think obviously in the quarter we were at 4.2% growth versus our guidance for the full year of 4.5 to 5. So, obviously weren’t looking to raise from there. But we are confident that we were expecting a slightly lighter first quarter, its well within our expectations. We knew after a very strong performance in Q4 in pharma systems we are expecting some lighter ordering patterns in Q1 and a big higher year comparison in diabetes care. And so, our Q1 performance is right in line with our expectation and it does reinforce our confidence and our full year guidance so for the medical segment.
Operator:
Thank you. Your next question comes…
Vincent A. Forlenza:
Do you have anything else you'd like to add?
Linda M. Tharby:
Maybe just one other comment Doug, on the Life Sciences side, for Biosciences in particular, which is our competitor in Western Europe and particular we had a pretty strong first quarter, sorry light first quarter last year. So we're working off a weak competitor ourselves.
Vincent A. Forlenza:
So one last I like to, we saw a good performance across all of emerging markets. We're watching what happens in Brazil and whether that situation changes. And the reason I put it on the table is because we've seen good performance, but we're reading about some of our peer companies which are not doing as well. So we're watching it, and I think we've got a good organization. We're on top of it, but that was another part of our thinking.
Operator:
Thank you. Your next comes from Rich Newitter with Leerink.
Rich Newitter:
Hi, thanks for taking the questions. Just going back to cervical path testing, it sounds like your comments relative to a competitor, a little bit more conservative about the market outlook. They seemed reluctant to call it bottom, but things have improved, the declines have gotten less bad. And they also called out market share gains. So I'm wondering if you can maybe help parse that out a bit. Do you think the market may be – the margin is getting close to a bottom, anything on market share?
Vincent A. Forlenza:
Sure. Linda will take that.
Linda M. Tharby:
So, thanks, Rich. So as we commented earlier, we see about 70% of the market now having transition to interval testing. So continued impact of that and we also are seeing specific to the US market, some competitive loss occurring on that side and again, ex-US very strong performance on the platform.
Vincent A. Forlenza:
So with 70% it’s difficult to say does that finish off at 85% to where that goes. There probably would be some people who never make the change. So we're thinking it’s at least another year before we see the market flatten out.
Operator:
Thank you. Your next question comes from Glenn Novarro with RBC Capital.
Glenn Novarro:
Hi, good morning, guys. On safety, two questions here. In the US, I think you called out a tough comp. So maybe talk about how you see safety playing out for the rest of the year? And then outside the US you called out very strong emerging markets in the quarter. Can you talk about how Europe performed in the quarter and your outlook for Europe for the rest of the year? Thank you.
Vincent A. Forlenza:
Sure. So, US safety and I think that’s what you are referring to was down a little bit, but there was a product line that it was SSI, it was an acquisition, it was all reported in the US last year, and now we're reporting it in each of the regions where it sold. So that was the impact year-on-year. Otherwise you're really seeing no change in US safety sales. And Tom, maybe you want to comment on safety sales outside the US and what you're seeing?
Tom Polen:
Sure. So we were basically flat in the US when you take that reclassification and Glenn, you'll see that continue to annualize that effect in the US for the next couple of quarters. It will be – that re-class will be out like Q4, but you will see that have a slight drag on the US safety reported numbers for the next two quarters as well. Internationally, we were really pleased with 16.1% international safety growth, really driven by very strong performance in emerging markets. We continue to grow into the double-digits, really led by Asia and Latin America. And we're seeing good progress and continued interest in partnering in the number of emerging countries who continue to improve the safety of their healthcare worker. So, continued strong trajectory in emerging market performance there.
Vincent A. Forlenza:
So in Europe, it was 0.9% growth, but it was all driven by unfavorable timing in the pharma systems business. The usual lumpiness we see within that business, anything else you want to comment on…
Tom Polen:
Life Science strong and med surg, but really what we saw in pharma systems which we expected was this ordering pattern and that really hit you in Western Europe.
Vincent A. Forlenza:
So underlying we're releasing no change.
Tom Polen:
And as expected.
Operator:
Thank you. Your next question comes from Larry Keusch with Raymond James.
Larry Keusch:
Just a couple quick ones for you. Could you just, I'll rattle them off. How much was the R&D tax credit worth within the tax rate? And then, secondly can you remind us of resins, how much of that was in cost of goods, just trying to get a sense of magnitude of your resin spend.
Vincent A. Forlenza:
On the last one in terms of resins, about $260 million and so again, as you think about that oil prices declined about 40%. We see resin prices about a third of that rate and only about a half of it gets impacted because of the capital rolling [ph] inventory. The first part of the question was…
Larry Keusch:
The tax credit, the R&D tax credit?
Vincent A. Forlenza:
On tax credit. So, as we had said on the last call, that if the R&D tax credit was enacted we would be at the low end of our guidance range for the year, which is the way to think about that, towards the low end. Because if you really look at what they did, they didn’t do it the way they had done in the past, and extended out for this full year. We only re-enacted it through offers fiscal quarter, December 31st of last year, so you got to catch up, but you didn’t get the benefit of the next three quarters. But even with that it had a good impact in bringing us towards the low end of our tax rate range, which to remind you was 21.5 and 22.5. So things towards the low end of that tax rate, primarily driven by the R&D tax credit enactment.
Operator:
Thank you. Your next question comes from Brian Weinstein with William Blair.
Brian Weinstein:
Hi, good morning. Thanks for sneaking me in here. With respect to your Veritor product, you've called it out a couple of times on these calls as being particularly strong on placements. Obviously has an approval on the molecular side for a CLIA waiver. Can you talk about the potential impact from that product launch and your general thoughts about the need for a molecular product in the point of care, or CLIA waived chatting?
Vincent A. Forlenza:
Sure. Alberto, will take that.
Alberto Mas:
Yes. We are seeing the new product potentially over time impacted more on the hospital segment than in the point-of-care and retail segments where we are particularly strong in. So that will be a little bit of a transition over time in certain segments of the market.
Vincent A. Forlenza:
Okay. How we're doing. Any more questions?
Operator:
Your next question comes from Mark Novarro with Canaccord Genuity.
Mark Novarro:
Hey, guys. Thanks, for taking the question. Maybe just to follow up on that flu question. Obviously flu prevalence was significant in the quarter and continues to trend above last year's levels. What was your flu revenue in the quarter and can you comment on what you're seeing presently in the competitive environment? And finally, to what extent do you think your investment in smart device features can potentially accelerate your run rate somewhere above 1000 per quarter?
Vincent A. Forlenza:
So, Alberto, why don’t you comment on what you're seeing competitively, how you see importance of the smart features, the connectivity and what not and then I think we'll take a look at what the flu sales were.
Alberto Mas:
Yes. In terms of the competitive environment, about a third of our growth versus prior year is driven by share gains, and most it’s the [indiscernible] that we're seeing the gains. In terms of our next generation Veritor system, it will have connectivity associated with it, which will be a very positive obviously from a physician emphasis, but also integrated delivering networks, so they can actually get a better sense of the quality and the compliance of the flu. In addition to that, we'll have other features like bar coding and other capabilities, so we can develop future assays on the platform.
Vincent A. Forlenza:
The flu contributed about 80 basis points to our growth if I remember right Chris.
Christopher R. Reidy:
So if you translate that to the year, its worth about 20 basis points or so based on where we are today.
Operator:
Thank you. Our final question is coming from Kristen Stewart with Deutsche Bank.
Kristen Stewart:
Hey, thanks for the follow up. I just wanted to go back to the CareFusion deal and I wanted to get your thoughts on what you consider to be the underlying sustainable growth rate of that business. How you're looking at that and integrating. I think one of the other questions had mentioned about a 5% top line growth. And I'm just wondering if that's what you are expecting from that franchise and how to think about that. Thanks.
Vincent A. Forlenza:
So, when we value the deal, we did not value it at a 5% growth rate, we are looking more at it underlying growth rate, that was about 3.5%. and what we said is the challenge over the long-term based on the work that Tom was describing was that BD is about a 5% grower as we're seeing on the call today, and the work would be try to accelerate their growth rate up to forward into the 5%. But we didn’t start out with saying it’s a 5% grower, that is the work that we're doing and that would be a goal that we would have and we're working to try to put those plans in place, we'll be dependent on the three buckets that Tom talked about over time the geographic expansion and we're very also excited about long run how we leverage smart works and what other applications could be put on that.
Christopher R. Reidy:
Tom, do you have anything else, you want to add to that?
Tom Polen:
Maybe the only thing to add is, as Vince mentioned I think we see them in at 3, 3.5% underlying growth rate. We certainly recognize that’s primarily based on being a US company, which is very comparable or even slightly better than our US base growth rate. That’s of course we're 60% international, they will be less than 25%, we're 25% emerging market, they are less than 10% emerging market. And so, right that, that 3.5% underlying primarily US business we see an opportunity to really accelerate that based on international growth opportunities and continue to expand that as a percentage of the total sales.
Operator:
Thank you. I would now like to turn the call back over to Vince Forlenza for any additional or closing remark.
Vincent A. Forlenza:
Well, thank you very much for your participation today. We look forward to updating you as we move closer to the CareFusion acquisition. We are very excited about the start of the year and the strong start in core business and thank you very much for joining us.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time. And have a wonderful day.
Executives:
Monique Dolecki - Vincent A. Forlenza - Chairman, Chief Executive Officer and President Christopher R. Reidy - Chief Financial Officer and Executive Vice President of Administration Tom Polen - President Linda M. Tharby - Segment President of Life Sciences Alberto Mas -
Analysts:
Michael N. Weinstein - JP Morgan Chase & Co, Research Division David H. Roman - Goldman Sachs Group Inc., Research Division Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division Scott Alan Lange Kristen M. Stewart - Deutsche Bank AG, Research Division William R. Quirk - Piper Jaffray Companies, Research Division Douglas Schenkel - Cowen and Company, LLC, Research Division S. Brandon Couillard - Jefferies LLC, Research Division Brian Weinstein - William Blair & Company L.L.C., Research Division Vijay Kumar - ISI Group Inc., Research Division Glenn J. Novarro - RBC Capital Markets, LLC, Research Division Ravi Misra - Leerink Swann LLC, Research Division Derik De Bruin - BofA Merrill Lynch, Research Division Mark Massaro - Canaccord Genuity, Research Division
Operator:
Hello, and welcome to BD's Fourth Fiscal Quarter and Full Fiscal Year 2014 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through November 11, 2014, on the Investors page of the bd.com website or by phone at (800) 585-8367 for domestic calls and (404) 537-3406 for international calls, using confirmation number 14009656. [Operator Instructions] Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Christie. Good morning, everyone, and thank you for joining us to review our fourth fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our fourth fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Segment President; Linda Tharby, Segment President; and Alberto Mas, President of Diagnostic Systems. At this time, we would like to announce some leadership changes, which took place on October 1. Beginning in fiscal year 2015, we will organize BD into a 2-segment structure, which consists of a Medical and Life Sciences segment. Tom Polen has been promoted to the role of Segment President for BD Medical. This segment is comprised of the Medical Surgical Systems, Pharmaceutical Systems and Diabetes Care business units. Linda Tharby has been promoted to the role of Segment President for our Life Sciences segment. This segment is comprised of the Preanalytical Systems, Diagnostic Systems and Biosciences business units. In their new roles, Linda and Tom will continue to report to Bill Kozy, Executive Vice President and Chief Operating Officer. For the purposes of today's call, Tom will answer any questions related to Medical, and Linda will answer any questions related to Life Sciences. As we stated in our press release, earnings per share were impacted by some onetime charges this quarter. Further information about these charges and other adjustments in the current and prior year can be found in the additional reconciliation of non-GAAP financial measures. For the purposes of our conference call today, we will refer to adjusted diluted earnings per share excluding these charges. The medical device tax in the first quarter of this fiscal year 2014 was $14 million or $0.05 per share. In certain circumstances, we will also exclude the medical device tax from our results. Please note that all fiscal year 2015 guidance provided is on a BD standalone basis. As we move closer to our anticipated closing of the CareFusion acquisition, we will provide more explicit guidance on the pro forma financials for the combined company. We would also like to remind everyone that going forward, adjusted EPS will also exclude the amortization of acquisition-related intangibles. When we refer to EPS in our remarks, unless otherwise noted, we are referring to adjusted cash EPS. Also, guidance will be provided for Diagnostics and Biosciences for fiscal year 2015. However, beyond 2015, our guidance will reflect our new structure. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza:
Thank you, Monique, and good morning, everyone. Before we discuss the company's performance, I would like to comment briefly on the organizational changes Monique just walked you through. Last November, we had announced the promotions of Linda and Tom to Group President, as well as several other leadership changes. Over the past year, we have continued to bolster our leadership structure to help ensure our future success and continued development of our senior leaders. This new structure is more reflective of the company's strategy and increased focus on growth as we develop more impactful solutions for our customers. The change to a 2-segment structure will also enable us to seek strategic synergies across our portfolio, with the CareFusion business being reported within our Medical segment once the transaction is completed. We are extremely pleased to have Tom and Linda in their new roles as they help lead the company through our next phase of growth. Turning to Slide 4, I would like to highlight some key achievements in fiscal year 2014. First, our strategy of investing and innovating for growth continues to deliver results as evidenced by our strong finish to the year. Revenue growth was a -- was robust at 5.2%, which includes 20 basis points of growth from acquisitions. Our core remains strong, and our product pipeline continues to drive growth across the portfolio with new products as a percentage of revenue going from 13% to about 15% over the past year. Second, we have continued to strategically invest in higher-growth emerging markets. We made an incremental investment of $40 million in fiscal year 2014. Emerging markets grew over 12% and continued to be a key driver of growth for the company. We have one of the highest percentages of sales in emerging markets in our peer group at about 25% of total revenue. And third, we have continued to refine our operating effectiveness and efficiency initiatives, which continue to drive underlying margin expansion. Our ReLoCo program has benefited us incrementally by more than $30 million this year. We remain focused on these programs and also on efficient utilization of our global shared service centers and end-to-end process improvement opportunities. Fourth, we completed our 42nd consecutive year of dividend increases and also repurchased $400 million in shares through our share repurchase program, which highlights our effective deployment of capital. Finally, we have built a strong foundation for continued growth. We continue to proactively adapt to today's dynamic health care environment by transitioning from a product-focused company to a customer-focused provider of health care solutions. Our announced acquisition of CareFusion helps us significantly accelerate that strategy. The powerful combination of the 2 companies will further enable us to deliver end-to-end solutions that increase efficiencies, reduce medication errors and improve patient safety in both hospitals and pharmacies. Moving to Slide 5, you will see the guidance for fiscal year 2015 on a currency-neutral basis. For fiscal year 2015, we expect currency-neutral revenue growth of 4.5% to 5% based on our current view of the environment. Of course, we have contemplated a number of factors that could bring us above or below that range including pricing, a stronger or weaker flu season than expected, product launches, emerging market growth, macroeconomic conditions and the impact of the Affordable Care Act. On the bottom line, we will continue to drive high-quality earnings growth. For fiscal year 2015, we expect adjusted EPS growth to be between 8% and 9%. When excluding the unfavorable impact of the suspension of our share repurchase program, EPS growth would be between 9% and 10%. Now I'd like to turn the call over to Chris, who will walk you through our financial performance in the fourth quarter, along with additional details about our fiscal year 2015 guidance.
Christopher R. Reidy:
Thanks, Vince, and good morning, everyone. I'd like to begin on Slide 7 by discussing the key highlights for the fourth quarter, which I'll speak to on a currency-neutral basis. We are pleased with our fourth quarter results. Solid revenue growth of 4.6% was driven by our Medical and Diagnostics segment. As we anticipated and communicated on our last call, pricing declined about 50 basis points in the quarter, bringing the total year pricing impact to about flat. Biosciences growth was impacted by an unfavorable comparison to the prior year, as we expected. We continue to see strong growth in emerging markets and international safety sales. We also experienced a tax rate benefit in the quarter, which was offset by unfavorable currency. This quarter, we recorded EPS pretax charges totaling $46 million or $0.15 per share, which primarily consisted of a workforce reduction charge as a result of operational restructuring activities. Adjusted EPS growth in the quarter was strong at 13%. On Slide 8, I'll review our revenue growth by segment on a currency-neutral basis. Fourth quarter revenue growth was 4.6% for the total company. BD Medical fourth quarter revenues increased 6.1%. Growth in this segment was driven by good performance in all 3 business units. Medical Surgical Systems' growth was 4.7%, with continued strength in emerging markets and international safety sales. Growth in Diabetes Care was 8.1%. This reflects the continued strength of pen needle sales and a favorable comparison to the prior year. Pharmaceutical Systems' growth of 7% was favorably impacted by ordering patterns. For the total year, the Medical segment grew 6.3%, which was aided by a nonannualized acquisition. This contributed about 30 basis points, bringing organic growth to 6.0%. BD Diagnostics' fourth quarter revenues increased 4.2%. The segment's growth was driven by solid sales of Preanalytical Systems' safety-engineered products and solid growth in Diagnostic Systems. Diagnostic Systems benefited from strong sales in microbiology and continued progress with our KIESTRA rollout. For the total year, the Diagnostics segment grew 3.3%. BD Biosciences' revenue growth was about flat in the quarter, which was impacted by an unfavorable comparison to the prior year. You may recall last year, we had a particularly strong fourth quarter related to timing in Western Europe and Japan's stimulus revenues. For the total year, the Biosciences segment grew 5.5%. Moving to Slide 9, I'll walk you through our geographic revenues for the fourth quarter on a currency-neutral basis. BD's reported U.S. revenues increased 2.3% versus the prior year. We continue to view the hospital environment in the U.S. as stable. Revenue in our U.S. Medical segment increased by 3.4%. Strong growth in Diabetes Care was driven by pen needle revenues, which include our BD Nano and BD AutoShield Duo product. Growth was also aided, in part, by a favorable prior year comparison, as previously mentioned. U.S. Diagnostics' results were flat for the quarter. This reflects solid growth in Preanalytical Systems and strong growth in microbiology. This was offset by continued softness in Women's Health and Cancer due to extended cervical cancer screening intervals. We also continued to experience U.S. share losses in our ProbeTec business, which is consistent with what we've communicated the past 2 quarters. U.S. Biosciences' revenues grew 4.4%, driven by solid reagent and instrument growth. Moving on to international. We continue to see strong growth. Revenues grew 6.2%, driven by solid growth in Medical and Diagnostics, both of which grew 7.8%. Both segments experienced strong growth in emerging markets and international safety sales. Biosciences declined 1.8%. This was due to the aforementioned prior year comparison, primarily due to timing in Western Europe. For the total year, U.S. revenues grew 1.9%, and international revenues grew 7.6%. On Slide 10, emerging market revenues grew 13.2%, currency-neutral, and accounted for over 26% of our total revenues. This strong performance was driven by growth in Medical and Diagnostics. China revenues grew by 21.4%, and safety sales in emerging markets grew by 18.6%. We saw a double-digit growth across all emerging markets in the fourth quarter and for the total year. As we continue to build our infrastructure and focus on localized R&D, it is evident that our investments in emerging markets continue to drive robust growth for the company. Moving to global safety on Slide 11. Currency-neutral sales increased 5.5% and grew to $566 million in the quarter. Revenues in the U.S. declined about 0.8%, which was impacted by an unfavorable comparison to the prior year. International safety sales grew 13.7%. Medical safety sales grew 6.4%, while Diagnostics grew 4.6%, driven by a range of safety-engineered products. For the total year, safety revenue grew 6.6%, currency-neutral, driven by strong international growth of 12.3%. Turning to Slide 12. Foreign currency had an unfavorable impact of about 80 basis points on our gross profit margin in the quarter, which was higher than our expectations. On a performance basis, margin expansion was driven by positive contributions from ReLoCo, continuous improvement and pension. These contributions were more than offset by the unfavorable impact of mix, pricing, start-up-related costs and raw materials. Slide 13 recaps the fourth quarter income statement and highlights our foreign currency-neutral results. Since we've already discussed revenue and gross profit, I'll move down the income statement to SSG&A. As a percentage of sales, SSG&A decreased in the quarter. This was driven by sustained cost containment, a favorable comparison to the prior period's legal expenses and favorable pension benefit. R&D was 6.0% of sales in the quarter, which was in line with our expectations as we continue to invest in new products and platforms. Operating income grew 10.1%, driven by solid revenue and gross profit growth, coupled with better leverage in SSG&A. Our tax rate improved 280 basis points over the prior year, which was largely contemplated in our guidance. The improvement was due to favorable geographic mix. Adjusted EPS in the quarter was $1.68 or an increase of 13%. Turning to Slide 14, I'd like to walk you through our expected revenue guidance for the full fiscal year 2015. In summary, we expect revenue growth of 4.5% to 5% on a currency-neutral basis. From a timing perspective, we expect currency-neutral revenue growth in the first quarter to be below the low end of this range due to an unfavorable comparison to the prior year period. On a reported basis, revenue growth is expected to be between 2% and 2.5%, reflecting an FX headwind of 200 to 250 basis points. This assumes a euro-to-dollar exchange ratio of $1.27. At current spot rates, all major currencies relative to the U.S. dollar are down about 8% versus the first quarter of 2014. We expect this unfavorable impact to be most acute in the first quarter with a headwind greater than 250 basis points. We expect the currency impact to moderate through the rest of the year. Moving on to the segments. We expect BD Medical to grow between 4.5% to 5%. This is a slightly lower growth profile than we experienced in fiscal year 2014 due to share gains and a benefit from the SSI acquisition. We expect our Life Sciences segment to grow about 4.5%. And within Life Sciences, we expect Diagnostics to grow between 4% to 4.5% and Biosciences to grow about 4.5% to 5%. Our acquisitions have annualized and will be included in our base going forward. This excludes our 2 most recently closed acquisitions, which are not expected to contribute materially to revenue in fiscal year 2015. We expect revenue growth to continue to be driven by new product launches in all 3 of our segments, continued growth of safety-engineered devices and emerging markets. We anticipate emerging market growth in fiscal year 2015 to be broadly in line with 2014 growth. The growth drivers I just mentioned will be partially offset by the expected unfavorable impact of pricing pressure. Based on our current view of the environment, we expect pricing to normalize at about 30 to 40 basis points of pressure for the year. Now moving on to Slide 15. There are a number of moving parts that impact earnings per share in fiscal year 2015. For modeling purposes and to ensure consistency, I'd like to provide more color on EPS guidance. When we announced the CareFusion acquisition, we informed you that we would be moving to an adjusted cash EPS basis to increase transparency into our underlying business performance. Going forward, that means that we will add back the amortization of acquisition-related intangibles to adjusted earnings per share. For fiscal year 2014, this changed our adjusted EPS from $6.25 to $6.50, which is ratable across all 4 quarters. For fiscal year 2015, we expect to grow earnings by about 9% to 10% on an underlying basis. This is very consistent with the earnings growth profile we have communicated for some time. The unfavorable impact of the suspension of our share repurchase program is worth about 100 basis points, bringing earnings growth to 8% to 9%. Assuming current spot rates, the unfavorable impact of foreign currency is about 400 basis points, bringing adjusted earnings growth to 4% to 5%. From a timing perspective, the impact of unfavorable currency will be most acute in the first quarter, similar to revenue. In the first quarter, we expect EPS to be about flat when compared with the first quarter of fiscal year 2014. For the first half of the year, we expect currency-neutral earnings growth to track slightly below our guided range of 8% to 9%. Turning to Slide 16. I'd like to walk through our additional elements of our guidance for the full fiscal year 2015. As a reminder, all fiscal year 2015 guidance will exclude the amortization of acquisition-related intangibles. We expect gross profit margin to be approximately 52%. Performance improvements are largely offset by negative currency translation, pricing pressure and pension. Our ReLoCo cost savings program is expected to deliver savings broadly in line with benefits experienced in fiscal year 2014. SSG&A as a percentage of sales is expected to be about 25%. Our guidance also reflects continued investments in emerging markets, as well as costs related to new product launches. We expect our R&D investment to be in line with fiscal year 2014 at about 6% of revenues. We continue to invest in new products and platforms, including incremental R&D investments in emerging markets. As a result of the items I just detailed, operating margin is expected to be between 20.5% and 21% of revenues. Excluding the unfavorable impact of foreign currency, we expect our underlying operating margin to improve by about 40 to 50 basis points. This also excludes pension headwinds, which equal approximately half of the margin expansion. We expect our tax rate to be between 21.5% and 22.5% as we continue to see improvement from geographic mix. For fiscal year 2015, we anticipate our average fully diluted share count to be broadly in line with fiscal year 2014. Cash flow is expected to remain strong with operating cash flow of about $1.85 billion in fiscal year 2015. Capital expenditures are expected to be about $625 million. Our guidance also contemplates the GenCell acquisition, which does not materially impact earnings. With respect to our anticipated CareFusion acquisition, things are progressing according to plan, and we do not have any updates to the financial parameters we've described when we announced the deal last month. Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio.
Vincent A. Forlenza:
Thank you, Chris. Thank you, Chris. Before I review our pipeline, I would like to take a moment to provide a quick integration update on the CareFusion acquisition and make a few remarks about our recent acquisition of GenCell. While we announced the -- we just announced the CareFusion acquisition 1 month ago, our planning efforts are in line with where we expected to be and are off to a great start. I've had the opportunity to visit CareFusion's headquarters and have met with a number of the CareFusion associates. As we spend more time together, I feel even more confident that the complementary nature of our 2 companies will make for a successful integration. As we shared with you on our investor conference call on October 6, Bill Kozy is leading this integration effort. Our integration team is in place, which includes key members from BD and CareFusion. There has been a great deal of planning, hard work and activity in a short period of time. In a sizable acquisition like this, the success of the integration is of critical importance, and we will continue to keep you updated as we move forward. We are also underway with the integration activities of our latest acquisition in the Life Science area with our acquisition of GenCell. GenCell is a small biotech company that has developed proprietary technology to address key biological analysis protocols for library preparation for Next Generation Sequencing and genotyping applications. These technologies automate library preparation workflow, making it more efficient, reliable and less costly to perform. Next Generation Sequencing is a fast-growing space that represents a great opportunity for BD. As the NGS market moves to the clinic, BD is well positioned with relevant experience in bringing products from research to clinical markets, preanalytical sample collection and sample preparation in Diagnostic Systems. BD will combine this experience with GenCell's proprietary technology to meet unmet needs with upfront NGS workflow. Moving on to Slide 18. We have been discussing our robust pipeline for some time now. And in fiscal year 2014, there were a number of product launches. I will not review them in detail, but they are highlighted on Slides 18 and 19. We are committed to the successful ramp-up of these products, while we also look to the future and continue to expand our portfolio. Moving on to Slide 20. We have some new product launches that we would like to share with you. We are very excited about a new product in the insulin infusion set category, which we -- which you have heard us talk about for some time now. This new product introduction is the result of the work we have been doing together with the Juveniles -- Juvenile Diabetes Research Foundation. The BD infusion set is aimed at improving the consistency of insulin delivery for the users of durable infusion pumps, which aligns with the clinical goal of tight glycemic control and avoiding hyperglycemic episodes. We expect FDA clearance for this product in the second half of fiscal year 2015. We will update you on the product launch timing as we continue to make progress. For BD Simplist, we recently received FDA approval of midazolam. As we shared with you recently, BD Simplist requires a change in clinical processes, and uptake has been slower than expected. Those who have converted are pleased with the product. We have taken actions to reprioritize our portfolio to focus on drugs where a ready-to-use prefilled syringe is most valued by our customers, specifically those with the highest risk of medication errors or those used in the urgent care setting. The next 2 drugs meeting those criteria are hydromorphone and heparin, both expected to launch in 2016. We will continue to keep you updated as our launches progress. In Biosciences, we recently launched in Europe the first component of our BD OneFlow Solution for clinical reagents. This reagent and standardized instrument solution provides powerful analysis capabilities to improve efficiency, accuracy and objectivity in leukemia and lymphoma diagnosis. We also recently launched 3 new BD Horizon dyes and will be anticipating launching several more dyes in 2015. Our novel BD Horizon dyes, based on Sirigen technology, are used by external researchers to perform complex multi-color analysis and have increased the number of parameters or colors by which single cells can be analyzed using flow cytometry. In fiscal year 2015, we expect to launch the X-14 research instrument to deliver high-performance multi-color analysis with a compact footprint and a unique optical configurations to enable use of traditional or the novel BD Horizon Brilliant reagent portfolio for a wide variety of research applications. We are also looking forward to the launch of our BD FACSVia instrument. The FACSVia is based on the Accuri platform and is a low-cost, easy-to-use instrument for clinical applications. We're targeting this launch primarily for emerging markets, with an initial focus on China. On Slide 21, you can see the anticipated products in our Diagnostics business. On the BD MAX, we will be building upon the solid base of our novel assay launches in 2014, such as MRSA XT and our Enteric Panels. Our enteric strategy for 2015 includes assays for parasites as well as extended bacterial and viral testing. The availability of rapid molecular tests in these areas represents a significant improvement to the current testing methods available today, and we are confident that this will bring meaningful benefits to our customers. Our GC/CT assay is expected to launch in Europe in the third quarter of this year. This is a test that we currently have on our BD Viper instrument, which will now be available for our BD MAX customers as well. We are expecting the full launch of the BD Totalys system in our Women's Health and Cancer area. This front-end automation system for screening cervical cancer has already been well received in Europe this year, and we look forward to its launch in the U.S. As you can see, we continue to have strong opportunities in our pipeline, and we look forward to sharing our progress with you as we make progress throughout the year. Before I summarize the presentation and open up this call for questions, I'd like to take a moment to address the Ebola epidemic. We have been working with a number of foundations to provide essential medical supplies and support and have donated about $850,000 to date in cash and products. We have provided Safety Syringes, Vacutainer tubes, E-Z Care and Scrub products and the BD Insyte Autoguard with blood control to train -- and also to train and equip health care workers. With the recent launch of the Total Nucleic Acid kits on the BD MAX, the Diagnostics team has been working closely with multiple organizations to develop fully automated diagnostic tests for Ebola detection. Our molecular scientists and global partners are actively pursuing a fast, accurate and fully automated molecular detection solution that would fit in with the needs of the developing world, which is most impacted by the disease. We will continue to use our clinical knowledge and expertise to assist in this outbreak and fulfill our mission and purpose of helping all people live healthy lives. On Slide 22, before we open the call to questions, I'd like to reiterate the key messages from our presentation today. First, we are pleased with our strong fiscal year 2014 results. We have exceeded our financial and operating goals for this year, which delivered strong financial results and continued operating efficiencies. Second, our core remains strong. Our investments drove robust revenue growth of 5.2%, and we continue to deliver high-quality double-digit earnings growth of 11.4% this fiscal year. We expect to deliver a similar growth profile in fiscal year 2015 with top line growth of 4.5% to 5% and earnings growth of 8% to 9%. We're pleased with the financial performance we continue to deliver and believe we have built a strong foundation for future growth. Third, we continue to evolve and remain dedicated to becoming a customer-focused provider of health care solutions. We are excited about the acquisition of CareFusion and look forward to updating you as we continue to make progress. The powerful combination of these 2 companies will significantly accelerate our strategy. Finally, we continue to deliver superior health care products to our customers and value to our shareholders. We look forward to 2015 with enthusiasm and confidence. Thank you. We will now open the call to questions.
Operator:
[Operator Instructions] Our first question is coming from Mike Weinstein of JPMorgan.
Michael N. Weinstein - JP Morgan Chase & Co, Research Division:
So I want to start with the guidance. It looks like the -- if I look at your FY '15 guidance versus consensus, the underlying picture's the same, but the principal difference is the impact from FX looks like it's a little bit more than The Street was modeling. And obviously, The Street was still assuming a share count. So when we think about the base off of which we add in CareFusion, any additional comments you want to make? I mean, you said at the time of the CareFusion acquisition, double-digit EPS accretion in year 1. Anything else we should be thinking about just to get our models more in line with your comments today?
Vincent A. Forlenza:
So Mike, it's Vince. It was really difficult to understand what you were saying. What I picked up was that the guidance for 2015 was broadly in line on an FX-neutral basis. And so underlying, it was pretty much, I think, what you would have expected, most people would have expected, but also some people did not have the share -- cessation of the share repurchase in their estimates. So that was the first point. The second point was you were asking us, was there any update to the acquisition guidance that we're giving at all? There really isn't, but I'll ask Chris if there's anything else he'd like to say on that.
Christopher R. Reidy:
I'd like to say a couple of things, Mike. You're absolutely right that there was a mixed bag out there, a lot of moving parts, apples and oranges in terms of looking forward on '15, not the least of which is moving to a cash EPS. So I think this chart that we -- we've put up, Slide 15, was an attempt to kind of walk through that so we're all on the same page. So we got you the cash EPS. What we wanted to show is the underlying performance is very strong and consistent with what we've done over the last few years, and what we have as a goal is the 9% to 10%. We do get an impact of the fact that we're suspending the share buybacks in anticipation of the CareFusion deal of about 1%, and then the other is the headwinds from foreign currency. And we went into some detail to kind of give you not only the sense for the year, but how much of that impact is in the first quarter. So hopefully, that gets everybody on the same page. In terms of going forward on CareFusion, we'll provide much more clarity on that as we approach the deal and the deal close. And really nothing to update from what we talked about upon the announcement of the deal of the significant low-teens kind of accretion and the performance from an ROIC standpoint, et cetera. So really just a reiteration of that. Nothing new to report. We'll certainly keep everyone up-to-date as the deal progresses.
Michael N. Weinstein - JP Morgan Chase & Co, Research Division:
Okay. If I can follow up with one other question. And hopefully, the connection's fine here. We've had companies report different data points on the emerging markets this quarter. Your performance was strong, but we've had companies talk about Brazil not really growing this quarter. And that's as much outside of health care as in. And then there's been a number of reports about China slowing outside of health care. Are you seeing either of those end markets slow in your business? Any reason for concern that you're seeing?
Vincent A. Forlenza:
So Mike, this is Vince. No, we haven't seen emerging markets slowing down, and that's across-the-board in our product categories. So it appears to us that even though there's some macroeconomic factors out there in those marketplaces, for our categories and kind of fundamentals, the governments are still investing in health care, and we saw a strong performance across-the-board, not just in China, but in all geographies. But thanks for those questions.
Operator:
Your next question comes from the line of David Roman of Goldman Sachs.
David H. Roman - Goldman Sachs Group Inc., Research Division:
I want to start with one question, Vince, to follow-up on your pipeline discussion at the end of the call, and most specifically on the BD Rx side of the business. I think you did give us a number of updates about key new products coming in the 2016 time frame. But maybe you can just sort of help give us a broader update on that franchise, how things are going with respect to gaining traction with group purchasing organizations and where you are sort of in developing an appropriate-sized product bag to make yourselves more competitive with the bigger players.
Vincent A. Forlenza:
Sure. So as I mentioned in my remarks, it has been going slower, number one, and we have started to get some traction in the last quarter. But it's really fundamental to us to reorient that product line towards products that are really -- it's where safety errors, drug errors are much more important from a safety aspect. And I mentioned that we'll have 2 drugs coming out in 2016, which have those characteristics. So we're on a ramp that is slower than we thought. So we don't believe we're going to hit those initial targets in the time frame that we were talking about a couple of years ago. But we remain committed to the business. Anything else you would want to say from a portfolio standpoint, Tom?
Tom Polen:
David, this is Tom. I think, Vince, the only thing I can add is that -- to your question, David, we actually have put BD Rx successfully to a number of the large GPO agreements, so we do have that in place. We have 4 drugs launched today. As you think about -- really one of those fits that high-risk, high-value molecule, that's morphine. And as Vince mentioned earlier, the next 2 that fit that high need in a prefilled format are launching in 2016. So we'll continue to keep you updated as those progress.
David H. Roman - Goldman Sachs Group Inc., Research Division:
Okay. Can I ask a financial follow-up question?
Vincent A. Forlenza:
Sure.
David H. Roman - Goldman Sachs Group Inc., Research Division:
Okay. So maybe just looking at the guidance just on cash flow for fiscal 2015, and maybe, Chris, you could sort of comment on what looked to be a very significant step-up in CapEx in the fourth quarter. It looks like almost it's a doubling of where the run rate has been on a quarterly basis. And then what sort of drives the -- what's driving the CapEx side and what's driving the $100 million increase in free cash flow guidance for fiscal '15?
Christopher R. Reidy:
Sure. So the CapEx situation, as we had talked about a few times last year, we're looking at spending more capital internationally, and some of that is going into our plants within China, for example. And so a lot of that hits -- it's a lumpy kind of thing, and we knew it would be and we kind of expected it to hit in the fourth quarter. So we weren't surprised by that. And so we came in about where we expected to for the year. We have ramped that up again next year and pretty much for the same reason, a little bit more in the way of international spending, which we think is prudent and certainly is resulting in good returns. In terms of operating cash flow, really it's the total income flowing down through the operating cash flow. Sometimes that gets a little lumpy, as you know, in terms of timing of payments, et cetera, and the working capital. But as we look out next year, we see most of that flowing through, and everything else kind of staying neutral. So you get the benefit of that going up in the total cash flow.
Operator:
Your next question comes from Rick Wise of Stifel.
Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division:
A couple of questions. First, U.S. Medical, can you give us a little more color? U.S. Medical seemed a bit soft. I mean, I guess that's U.S. Safety. Any more color on what's happening there? I mean, it sounds like you see the environment as stable. Just remind us again what's happening there -- happened there in the fourth quarter and what may or may not change in the year ahead.
Vincent A. Forlenza:
Sure. Tom Polen will do that for you, Rick.
Tom Polen:
Rick, this is Tom. So as you said, as we've mentioned before, the U.S. market we do view as mature from a Safety perspective, but we also view it as stable. One of the things to note is that, in addition, the U.S. Safety sales in the quarter did reflect a small regional reclassification of certain sales related to the Safety Syringe acquisition. And so with that reclass, actually growth was slightly positive for the quarter in the Medical segment. And due to this change, our U.S. Safety growth rate may be just a little bit lighter for the next couple of quarters, with a corresponding uptick in international as that reclassification annualizes.
Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division:
Got you. And Vince, some of your recent public comments on G&A, you basically said, I think publicly, that x the China investment and EVEREST, that G&A is coming down and you're starting to see it come down. You used language like that, if I'm quoting you accurately. Just remind us, where are you with those investments. And just specifically on China, do you have to keep spending the $40 million per year to drive the growth we're seeing? Does that come to an end at some point? Just any more color there would be helpful.
Vincent A. Forlenza:
Sure. So Rick, that's 2 pieces. One is overall G&A has been coming down as a percent of sales as we move processes into shared service centers around the globe, and we believe we have much more to do in that area, number one. Number two, as we look at synergies with CareFusion, we'll be taking an all-in company look at that from an end-to-end business process standpoint. So more work to be done there and more opportunity. Now in terms of investments in emerging markets, it's more the investment in the sales and marketing side. There is some investment in G&A, but less going into G&A, more going into coverage build as we build into Tier 2 in China, and we continue to expand coverage in other geographies. In this plan, Rick, for 2015, we continue to have a significant investment in emerging markets to drive top line growth. So it's not so much G&A as it is the sales and marketing side.
Operator:
Your next question is coming from David Lewis of Morgan Stanley.
Scott Alan Lange:
This is actually Scott Lange in for David Lewis. Just 2 quick ones for me. First, Vince or Bill, you've now had the chance to spend some more time with CareFusion management and delve a little deeper into the integration planning. Can you share your updated thoughts around the fit of Infection Prevention? And also the ventilation business and whether that's a priority, longer term, for the pro forma company?
Vincent A. Forlenza:
So I'll take that one. We're still very early on in terms of looking at the portfolio. What I've said is that we will go through the same kind of strategic review we go through all of our product lines, number one. Number two, we'd be looking to see if we can develop leading positions with those product lines. And then based on that, we'll decide exactly where we're going to invest our money. And that work will go on over the next few months and will crystallize where we're going to come out, but it would be premature to say anything past that. We have seen some very exciting opportunities in those businesses. So we'll get back to you later as we clarify both strategically and financially on the deal.
Scott Alan Lange:
Fair enough. Can you also comment a little bit on share dynamics within Diagnostics, in particular in the molecular space? And also, give us some color as to why restructure the operations now versus later on down the line?
Vincent A. Forlenza:
So I'll take the second half of the question, and then I'll ask Linda and Alberto to comment specifically about Diagnostics and Life Sciences. So the work that we started was about a year ago to look at more solutions for the customer, and we started around individual businesses. You saw that in microbiology with the acquisition of KIESTRA, and you've seen how successful we have been with that plug-in acquisition. Linda's role on the Life Science side started with 2 of the 3 businesses, and the idea was to begin the work on what strategies can we develop more broadly around solutions, leveraging across the segment. We have not restructured the segment nor restructured those businesses. But this is more of a strategic thrust, looking at how we work across businesses and strategies that cross -- that can cross those businesses. And Linda started that work a year ago, and we will accelerate that work. Some of that work resulted in the acquisition of GenCell. So that's that piece. If we come to what's happening in Molecular, Linda, I'll ask you to make a first comment, and maybe Alberto will fill in some details.
Linda M. Tharby:
Sure. So thanks, Linda here. So first on the Molecular side, just broadly. As we've reported, we continue to see some share loss relative to our ProbeTec business; and also in our Women's Health and Cancer, also affected by the interval testing. We also, though, on a share gain, are doing very well with our core micro business, with our flu business and also increased placements on our MAX systems. Alberto, I don't know if you want to add anything to that.
Alberto Mas:
No, I think that's where -- we're seeing most of the share loss in the ProbeTec business, as you mentioned. On some older platforms, we're seeing some much more modest share erosion in some of the MRSA. But with the new assay in MRSA XT, we think that we can actually regain the momentum backwards. And also with our enteric launches and -- we think that we can build that momentum. But we're growing the other categories in MAX. So we're actually very happy with the momentum that we're actually getting with the platform.
Vincent A. Forlenza:
Alberto, you might want to comment on where we stand with that one big account that we lost, which has been the majority of the share loss.
Alberto Mas:
That's on the CT/GC side, and it's -- we expect a little bit more of -- it's mostly behind us, is the good news.
Vincent A. Forlenza:
Yes.
Alberto Mas:
So that's going to be annualized into -- going into next year. There's still a little bit still left in the first quarter, but to a much lesser extent this year. And after that, we're basically done and annualized.
Vincent A. Forlenza:
So year-on-year, we're starting to see the growth rate in that business go up when you net all that together, right?
Alberto Mas:
Correct.
Operator:
Your next question is coming from Kristen Stewart of Deutsche Bank.
Kristen M. Stewart - Deutsche Bank AG, Research Division:
I just want to go back, Chris, on the comments you'd made on the operating margin side. Can you maybe just go back and parse out how much of the operating margin movement is related to FX and pension? And then, what the kind of core expansion is for '15 relative to what you saw in '14?
Christopher R. Reidy:
Sure. So let's start, Kristen, with '14. '14 was basically about 70 basis points of underlying margin expansion, which was in line with what our expectations were. But as we had said throughout last year, we actually had a pension tailwind last year based on where the interest rates were as of the beginning of last year. So that accounted for about half of that. And then on a -- on a kind of a reported basis, including FX, you had about 70 basis points of FX pressure. And then just to complete the dots there, you also had additional 20 of the medical device tax, which flowed into the first quarter. So essentially the way to think about that is 70 basis points underlying and offset essentially by FX, and then a little bit of pressure down of 20 basis points for Medical device. As we look at '15, we're looking at the underlying margin expansion being 40 to 50 basis points. But as you probably know, pension flips the other way and the interest rates go the other way. And about half of that 40 to 50 will be pension headwinds going forward. We get a little bit of pressure from FX and not quite as much on the margin basis, as you saw this year. So probably 20 basis points or thereabouts of pressure from FX in the operating margin going forward.
Kristen M. Stewart - Deutsche Bank AG, Research Division:
Okay. So the pension amount is not included within the 40 to 50. So it's 40 to 50 underlying.
Christopher R. Reidy:
That's right.
Kristen M. Stewart - Deutsche Bank AG, Research Division:
And then pension takes that down about half?
Christopher R. Reidy:
About half, exactly. So kind of a flip to the story in '14.
Kristen M. Stewart - Deutsche Bank AG, Research Division:
Okay. Perfect. And then just in terms of CareFusion, I know there's been a lot of discussion out there on their aspirations for operating margin improvement. So I think they've quantified about 100 basis points here. Can you maybe just help us understand what you've said related to the acquisition with the incremental cost synergies and some of the margin expansion that you may be looking towards that may perhaps double count if -- some people are looking at their targets?
Christopher R. Reidy:
Sure. Yes, thanks. So what we had said when we made the announcement is that there would be $250 million of synergies, as you know. Now when we were looking at the pricing and what we would be interested in paying for CareFusion, we did our own modeling. We actually did baseline that at around 70 basis points of margin improvement, which is, quite frankly, still pretty high-stepping to get to 70 basis points, and a lot has to happen. So that's the way we valued it, and the $250 million was incremental to that. If you were modeling 100 basis points a year for the next 3 years, you should think maybe $200 million on top of the 100 basis points. So there is about a $50 million overlap on some of the things that we think are more likely to be done as we -- through synergies than would have been able to be done on a standalone basis.
Operator:
Your next question comes from Bill Quirk of Piper Jaffray.
William R. Quirk - Piper Jaffray Companies, Research Division:
First question, just hoping some additional details on the Diabetes franchise. I'm just trying to get a little better handle on the background from the underlying growth, and just talk to us a little bit about the sustainability here.
Vincent A. Forlenza:
Sure. Tom Polen can take that. You saw it was another strong quarter for Diabetes Care. Tom?
Tom Polen:
Bill, this is Tom. As you mentioned, overall a strong year for diabetes, driven, as Vince mentioned before, by new product launches, specifically the Nano Pen Needle, which continues to have very strong adoption around the world. I think in regards to your question around underlying growth, obviously in Q4, we did have a very strong quarter at 8.1%. Q4 was favorably impacted by a prior year comparison, and we do believe that, that growth rate is a little bit above the underlying growth of the business. And so we think back in perspective of the Medical segment growth in '15 guidance being in that 4.5% to 5%, we certainly see Diabetes Care on the upper side of that as one of the higher-growth businesses within the segment. And we see that sustaining going forward, which is maybe not at that rate that you're seeing in Q4 due to some onetime activity there.
William R. Quirk - Piper Jaffray Companies, Research Division:
Okay. Got it. And then just thinking about the flu season. Obviously, the Southern Hemisphere has been going through or went through a pretty severe one. There's some expectations here that we're going to see that ramp up this year as well. Certainly, we've seen some companies suggest that we've seen a little bit of stocking of product ahead of kind of the traditional season. So I'd be just curious what you guys are thinking about the flu season here for this coming year or kind of what's dialed into guidance, et cetera.
Vincent A. Forlenza:
Alberto will take that one for you.
Alberto Mas:
So our assumption is based on a normal flu season, that's what's incorporated into our numbers. Having said that, we are seeing some early stocking. You're right. But right now, we're not taking -- we're not assuming the assumption that this will -- that this eventually will filter through the system. And we're still assuming that, overall, it's going to be a normal flu season. If it's above that, obviously we'll communicate that at that point.
Operator:
Your next question is coming from Doug Schenkel of Cowen and Company.
Douglas Schenkel - Cowen and Company, LLC, Research Division:
Your initial growth guidance range for the year is a little bit more narrow than we've seen from you guys. Last couple of years, you've guided to a broader range. This year, it's a little bit tighter. Just wondering if that is indicative of more confidence in the outlook, better visibility heading into fiscal '15 or something along those lines.
Vincent A. Forlenza:
So I would say probably better visibility, and we've had a couple of years of a more stable environment. So that kind of gave us the confidence to narrow the range, nothing more than that at this point in time.
Christopher R. Reidy:
We narrowed the range last year fairly quickly. I think right at the end of the first quarter, we narrowed it pretty closely. So not that different.
Douglas Schenkel - Cowen and Company, LLC, Research Division:
Okay. And years ago, when we saw big changes in oil prices, we used to talk about related fluctuations in resin prices and how that might impact your margin outlook. Over the years, you've clearly made pretty significant efforts to mitigate this impact. I just wanted to make sure that there isn't any potential for margin benefit associated with this dynamic heading into fiscal '15.
Vincent A. Forlenza:
So there's 2 different things going on. One is the price of oil is coming down, and of course, we would see that as a good thing. But there is not the capacity in the resin market to let all of that flow through. In fact, there was a problem at one of the plants. There was a fire at one of the suppliers. So capacity is tight. So we are not forecasting that flowing through for the time being. That could change over time. But right now, we don't have any visibility to that.
Christopher R. Reidy:
And you do get a little bit of a lift in terms of shipping prices, or whatever, from vendors as oil prices go down, and that's already baked in.
Operator:
Your next question comes from Brandon Couillard with Jefferies.
S. Brandon Couillard - Jefferies LLC, Research Division:
Vince or Chris, in terms of the debt related to the CareFusion deal, are you able to lock that in, those debt terms in earlier rather than later at all? And when would you expect to complete or start the financing or the funding for that?
Christopher R. Reidy:
Yes, the answer is you can. As you know, the interest rates ticked down a bit fortuitously, and so we were able to take the opportunity to lock in some of that appropriately. And so we did take the opportunity to do that. We're in the process of rolling that out right now in terms of when we would actually do the financing. As we get greater visibility to different things like HSR, that type of thing, we'll have more confidence. But clearly, you want to do that in advance of the closing as you're gaining confidence in terms of the -- when the timing, more than anything else, of the close from an HSR standpoint. So you would see us do that in advance, particularly to take advantage of the rate environment.
S. Brandon Couillard - Jefferies LLC, Research Division:
And secondly, in terms of the restructuring or workforce reduction, what should we anticipate for the payback for that action to be in '15?
Christopher R. Reidy:
It's in the guidance, and so some of that does flow through. Maybe a 1/4 of that amount would flow through because of the amount, the severance payment and the like.
Operator:
Your next question comes from Brian Weinstein of William Blair.
Brian Weinstein - William Blair & Company L.L.C., Research Division:
A question on the infusion set launch. It looks like it's a little bit ahead of where the guidance was for the launch. Can you talk about what changed there? And also can you comment a little bit on the market opportunity and how fast you expect to penetrate this?
Vincent A. Forlenza:
So it's very close to what we were thinking, Brian. So nothing significant changed. We're making good progress on getting the manufacturing equipment installed and whatnot, that's probably the biggest thing. But Tom, anything else that you would say on that?
Tom Polen:
No, I think we'll obviously continue to update, post approval, more information on our launch timing. We're certainly, Brian, we're very excited about the -- this is a logical adjacency to our core diabetes pen and syringe business and add another growth driver to that organization. And we do see the opportunity to take that product both direct and through partnerships, and I think that's all we'd comment on at this point in time.
Brian Weinstein - William Blair & Company L.L.C., Research Division:
Okay. And then, Chris, can you comment a little bit about FX exposure by currency and kind of update us on that? And then typically we had thought about 30% to 40% of your top line exposure kind of falling through to the bottom line, given the fact that you're not doing any hedging. Has that changed at all?
Christopher R. Reidy:
Sure. So the impact that you will see -- because clearly everyone knows that the euro is down comparatively with all of last year, all of '14 for the most part. In fact, we pegged this at $1.27, it's down even a tick from that. And -- but then you also see weakness in the Japanese yen year-over-year. The Brazilian real is weak. The Canadian dollar is weaker. So all of those things, as I said my prepared remarks, they were significantly down, particularly in the first quarter. And so that's why the impact in the first quarter is greater on the bottom line than the 400 basis points we said for the year. It's really impacting the first quarter. In terms of the other way to think about it, it's difficult to give any kind of direction on that because, as you know, we have the profit and inventory impact, and we've talked a lot about that. If you remember in the first quarter of last year, it was kind of hitting us. And so it's hard to give any particular guidance around how much drops to the bottom. It depends on an awful lot of different factors. So it's hard to model, is probably what I'm saying, because of the profit and the inventory piece.
Operator:
Your next question comes from Vijay Kumar of ISI Group.
Vijay Kumar - ISI Group Inc., Research Division:
I think most of my questions have been asked. I had a couple of follow-ups. One I guess, Chris, you were mentioning on the deal closure timing. So apart from HSR, is there -- are there any other regulatory approvals that we need to be aware of, which could cause some uncertainty around the closure timing?
Christopher R. Reidy:
Well, it is the HSR and Europe, the equivalent in Europe would be the other. So those would be the most variable. And then obviously, you have the SEC review. We'll be filing the S-4 shortly, very shortly, and then that kind of starts the clock on their review. And which the hope is that the 2 of them come together nicely, but it is very variable. So we'll update you more on that as things progress.
Vijay Kumar - ISI Group Inc., Research Division:
And then one follow-up on the guidance front. When you look at your Life Science segment, really I thought the growth assumptions out there were better than expectation. I mean, particularly on Bioscience. Is this all new product driven? Or can you talk about sort of what's really driving growth in the Biosciences?
Vincent A. Forlenza:
So in Biosciences, you saw some really nice bounce back last year in the high-end instrumentation and some good performance with the Sirigen dyes as well. So you have that as the fundamental. And I think, Linda, we're forecasting that to continue to improve, and you have some new products that you're launching.
Linda M. Tharby:
Yes. So thanks, Vince. So across the board in our Life Sciences business, first of all, you saw we see increased stability in both U.S. and Europe in terms of the funding environment, and then very strong performance in our emerging markets business. So as Vince commented on, our Life Science research reagents, very strong performance, upside in clinical or instrument base and also our AB business. So across the board, seeing some nice growth. We expect, again, 4.5% to 5% heading into next year, which is pretty much what we saw this year.
Operator:
Your next question comes from Glenn Novarro of RBC Capital.
Glenn J. Novarro - RBC Capital Markets, LLC, Research Division:
I had 2 questions on the gross margin. If you look at fiscal 4Q, it came in 70 basis points below our forecast. Now I'm just wondering, did the gross margin come in below your forecast as well? And I know pricing wasn't a big hit, and I was wondering if you can give us any put and takes and any additional color. And then as my follow-up, I think you may have -- hopefully, I wrote this down correctly, you're guiding to a 52% gross margin for fiscal '15, which is an improvement over fiscal -- just over fiscal 4Q. And if I wrote this down correctly, what are some of the improvements and drivers of the better gross margin for next year?
Christopher R. Reidy:
Okay. So let me take a shot at that. For the fourth quarter, it came in pretty much upon our expectations. So we had been talking about the drag from pricing in the fourth quarter all year long. So that hit about where we expected. The only thing that I would say, it was probably about a 10 basis points more FX drag than we had anticipated, so that was the biggest difference from what our expectations are. And then I'm trying to think of what your other question was. Oh, the -- in terms of going forward, margin guidance, take a look at the chart that we took you through on Chart 16, because we reset on an adjusted cash EPS basis. And so the full year gross profit margin for fiscal 2014 was 51.2%, but then adjusted on a cash EPS basis kind of new foundation, that's 52%, and our guidance was about 52% as well. Now we actually get a little bit of a lift from operational improvements, the traditional things, ReLoCo and continuous improvement. But we also said that we have some unfavorable pricing in '15 and some pension headwinds as well, and the combination of those things get you at about 52%. So hopefully that gets you there.
Operator:
Your next question comes from Richard Newitter with Leerink Partners.
Ravi Misra - Leerink Swann LLC, Research Division:
This is Ravi in for Rich. Just a question on the Ebola and potential government spending. Is there any of that built into the Biosciences guidance? Or are you considering any potential spending allocation increases there in that segment?
Vincent A. Forlenza:
No, we have not built that in -- we don't have any direct visibility to any program that we could put in at this point in time. As we said, we are doing some work with partners on some diagnostic test development, but we don't think it's a big opportunity at this point.
Ravi Misra - Leerink Swann LLC, Research Division:
Great. And then sort of maybe the last one is a little bit more on GenCell, trying to understand the company's longer-term aspirations in Next-Gen Sequencing.
Vincent A. Forlenza:
Sure. Linda can talk to that.
Linda M. Tharby:
So thanks. Very excited about the acquisition of GenCell. Really if you think about the company, GenCell and then the NGS space, we really see a big movement now occurring from the research to the clinical space. And as we looked at overall NGS and an upfront sample and library prep, the fact that this takes upwards of 2 days to occur today is just too long if we bring it to the clinic. So GenCell really provided us the opportunity to get into that library prep space and really consolidate the workflow, automation, scalable throughput. So a lot of advantages we see here. And then as you think longer term about BD's position in the space, thinking about the work we do today with QIAGEN on our sample collection side and being able to expand upon that right through to the work we do in Diagnostics. As this moves to infectious disease, we see a lot of opportunities to provide BD skills combined with the technology of GenCell over the long term.
Vincent A. Forlenza:
So this is a very targeted play that Linda was talking about. We're not talking about going into sequencing. This is really leveraging, as Linda was mentioning, capability we have that comes out in Molecular Diagnostics and sample processing, PAS, also in sample collection and sample processing that we have had a joint venture, that's what Linda was mentioning. For a number of years now, that has been growing quite nicely. So it's a sample processing, laboratory prep, automation, leveraging the skills we have down at DS. So it's all of that together, but in a very targeted way.
Operator:
Your next question comes from Derik De Bruin of Bank of America Merrill Lynch.
Derik De Bruin - BofA Merrill Lynch, Research Division:
A lot of my questions have been answered, but I just want to clarify something. On your guidance for '15, does this include anticipated financing for the CareFusion acquisition in your interest expense? I guess, can you give us some clarity on sort of like your net interest income or interest expense guide?
Christopher R. Reidy:
Sure. No, it doesn't anticipate any additional financing for CareFusion. We wouldn't know the timing, et cetera. So it's not in there.
Derik De Bruin - BofA Merrill Lynch, Research Division:
Okay. And the -- even on an adjusted fiscal '14 basis, your -- even in '15, your tax rate's down pretty significantly next year. How sustainable is that? And can you remind us on the combined tax rate that you're looking at for BD and CareFusion?
Christopher R. Reidy:
Sure. So as you've seen over the last 3 or 4 years, we've made very good progress on the effective tax rate, bringing it down from somewhere north of 28% to this current range. You saw a good performance. We've done a lot in terms of building out legal entities internationally and putting structures in place. So you continue to see the benefit of that flowing through the rate as well. And as we think about the combination with CareFusion, I think as I mentioned when we had that call, that we just took their tax rate and our rate combined. We didn't evaluate it or we didn't include any synergies. What we did include is the tax yields from the financing, the debt that we had. So that was in the neighborhood of 50 to 100 basis points. Hard to calculate because there's a lot of moving parts, so we gave you the number. But longer term, we do see an opportunity to get some synergies and to put some of their revenues into our structure. And as we drive their revenues internationally, you'll see some benefit of that as well. But that's more blocking and tackling that needs to occur over the first couple of years and will bear fruit going forward. So continued sustainability of the ability to get the rate down. I think I've talked about the fact that when we look at our peer group, they tend to be still better than where we are. We're getting closer, but that's stuff that is basic blocking and tackling that we've been putting in place for years, and we're now seeing the fruit of that each and every year. One thing that I would mention about next year is that we do have the potential for the R&D tax credit to be reenacted. And so the way to think about that is if it does happen, the low end of our range would be more likely. And if it doesn't, we'll be above that, but it does contemplate the potential for that to occur as well. I guess my answer was too long.
Operator:
Your next question comes from Mark Massaro of Canaccord Genuity.
Mark Massaro - Canaccord Genuity, Research Division:
Maybe a question for Alberto. Could you please update us on the installed base of the BD Veritor, maybe discuss the competitive environment dynamics? And are you guys planning any additional investments in the technology, I'm thinking maybe cloud-based solutions or the like?
Alberto Mas:
Yes. So our -- we estimate our installed base at the end of the quarter to be around 14,000 units. So that's where we are on that. And yes, we are working on our next-generation Veritor that will have connectivity associated with it. So yes, we are working on that, in addition to other assays as well.
Vincent A. Forlenza:
Yes. Okay. Thanks very much, Mark.
Mark Massaro - Canaccord Genuity, Research Division:
And maybe just a quick follow-up. What is the timing of CT/GC on BD MAX?
Alberto Mas:
So as mentioned the -- in Europe, we're -- it's filed, so we're waiting for the approval that we're estimating around Q3. That's when we estimate the approval in Europe.
Mark Massaro - Canaccord Genuity, Research Division:
Right. And then for the U.S.?
Alberto Mas:
For the U.S., we're working on a next-generation assay that will be more into '16, and we'll update when we have a little bit more visibility on the date.
Operator:
With that, I will turn the floor back over to Vince Forlenza for closing remarks.
Vincent A. Forlenza:
Okay. So thank you very much for your participation today. It was a pleasure to update you on a strong performance in 2014 and some strong guidance for 2015. We will be updating you on progress with the CareFusion acquisition as that gets closer, and we look forward to doing that and talking to you soon. Thank you very much.
Christopher R. Reidy:
Thanks, everyone.
Tom Polen:
Thank you.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique Dolecki - Vincent A. Forlenza - Chairman, Chief Executive Officer and President Christopher R. Reidy - Chief Financial Officer and Executive Vice President of Administration Alberto Mas - William A. Kozy - Chief Operating Officer and Executive Vice President Tom Polen - President Linda Tharby -
Analysts:
Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division David R. Lewis - Morgan Stanley, Research Division Kristen M. Stewart - Deutsche Bank AG, Research Division David H. Roman - Goldman Sachs Group Inc., Research Division Vijay Kumar - ISI Group Inc., Research Division Robert Justin Marcus - JP Morgan Chase & Co, Research Division Brian Weinstein - William Blair & Company L.L.C., Research Division Derik De Bruin - BofA Merrill Lynch, Research Division Jonathan P. Groberg - Macquarie Research William R. Quirk - Piper Jaffray Companies, Research Division Douglas Schenkel - Cowen and Company, LLC, Research Division Richard Newitter - Leerink Swann LLC, Research Division Glenn J. Novarro - RBC Capital Markets, LLC, Research Division Daniel Sollof - Barclays Capital, Research Division
Operator:
Hello, and welcome to BD's Third Fiscal Quarter 2014 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through August 7, 2014, on the Investors page of the bd.com website or by phone at (800) 585-8367 for domestic calls and area code (404) 537-3406 for international calls, using confirmation number 69111053. [Operator Instructions] Beginning today's call is Ms. Monique Dolecki, Vice President of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Christie. Good morning, everyone, and thank you for joining us to review our third fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our third fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules, is posted on the bd.com website. Current quarter results include a pretax charge within R&D of $9 million, or $0.03 diluted earnings per share from continuing operations, relating to program asset write-offs and obligations. For the purposes of our conference call today, we will refer to adjusted diluted earnings per share, excluding this charge, and other items detailed in the reconciliation of non-GAAP financial measures. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Group President; Linda Tharby, Group President; and Alberto Mas, Vice President of Diagnostic Systems. It is now my pleasure to turn the call over to Vince.
Vincent A. Forlenza:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we were pleased with our solid performance this quarter. As you already know, there have been a number of changes in the marketplace in which we compete, but we are operating in a very dynamic health care environment. Our consistent performance demonstrates that our strategy remains sound. Moving on to our quarterly results. We achieved record revenues this quarter, and EPS growth was solid, as we expected. We saw strong core product growth, coupled with our recent acquisitions, which are overall performing in line with our expectations. Revenue growth in the third quarter was once again driven by our Medical and Biosciences segments. Diagnostics international growth was partially offset by continued challenges in the U.S. We saw continued strong international Safety and emerging market sales, and they remain key growth drivers for the company. Based on our third quarter and year-to-date results, we feel confident in our previously communicated revenue and EPS guidance ranges. We will review our guidance for the full year in more detail shortly. On Slide 5, we've outlined our third quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Total company revenues were solid, increasing by 4.6%. Fully diluted adjusted EPS came in at $1.68, which grew 7.8% in the quarter. Now I'd like to turn things over to Chris for a more detailed discussion of our third quarter financial performance.
Christopher R. Reidy:
Thanks, Vince. Thanks, Vince, and good morning, everyone. I'd like to begin by discussing the key financial highlights for the third quarter. As Vince just mentioned, revenue growth was driven by both core products and acquisitions performing in line with our expectations, with all segments contributing to growth. The quarter was impacted by the reversal of some favorable timing matters from the first half of the year, as we anticipated and shared with you earlier in the year. Pricing was about flat for the quarter. We also completed an additional $187 million of our share repurchase plan, bringing our year-to-date total repurchases to $400 million. As we continue to focus on new products and innovation, we remain disciplined as we evaluate our portfolio. In our reported results this quarter, you will see a pretax charge of $9 million, or $0.03 diluted earnings per share, resulting from our decision to end the continuous glucose monitoring program, or CGM. We have reallocated those resources to other areas of our Diabetes Care portfolio, in addition to our broader R&D efforts. Overall, we are pleased with our results, and we are on track to deliver on our commitment of 4.5% to 5% revenue growth and 11% to an 11.5% EPS growth for the full fiscal year. On Slide 8, I'll review our revenue growth by segment on a currency-neutral basis. Third quarter revenue growth was 4.6% for the total company. BD Medical third quarter revenues increased 4.7%. Growth in this segment was primarily driven by strong sales in our Medical Surgical Systems unit, which grew 6%. We saw a continued strength in emerging markets and international Safety sales. Revenue growth in Diabetes Care was 3.6%. This reflects continued strength of pen needles, partially offset by an unfavorable comparison to the prior year period and the timing of the tender order. We expect growth in this unit to normalize in the fourth quarter. Pharmaceutical Systems growth was 3.4%, which reflects the reversal of a favorable timing of orders that occurred in the first half of the year. This is in line with our expectations and consistent with our communications on prior earnings calls. BD Diagnostics third quarter revenues increased 3.7%. The segment's growth was driven by strong sales in our Preanalytical Systems unit. Growth in Diagnostic Systems was impacted by continued softness in U.S. Women's Health and Cancer. BD Biosciences revenues increased 6.6%, driven by solid instrument placements, new platforms and continued stability in the research spending environment in the U.S. Growth was also aided by a favorable comparison to the prior year. Now moving on to Slide 9. I'll walk you through our geographic revenues for the third quarter. BD's reported U.S. revenues increased 2.8% versus the prior year. We view the environment in the U.S. as stable. Revenue on our U.S. Medical segment increased by 4.4%, driven by strong growth in Pharmaceutical Systems and solid growth in Medical Surgical Systems. The Diabetes Care unit was impacted by the previously aforementioned difficult comparisons with the prior year period. Revenues in U.S. Diagnostics declined by 0.2%. This reflects continued softness in Women's Health and Cancer due to extended cervical cancer screening intervals and U.S. share losses, partially offset by solid growth in Preanalytical Systems. U.S. Biosciences revenue increased 5.1% due to solid instrument placements, reagent growth and a favorable comparison to the prior year. Moving on to international revenues grew 6% currency neutral, driven by growth in all 3 segments. Medical segment grew 5% and Diagnostics grew 7.3%. Growth in both segments was driven by emerging markets and international Safety sales. The Biosciences segment grew 7.4%, reflecting strong growth in Western Europe and a favorable comparison to the prior year. On Slide 10, we continued to see strong growth in emerging markets, which accounts -- accounted for approximately 25% of our total revenue. Emerging market revenues grew 8.9% currency neutral over the prior year, bringing our year-to-date growth to 12%. Slightly slower emerging growth this quarter reflects an unfavorable comparison to the prior year in Latin America. Growth is expected to normalize in the fourth quarter. As expected and discussed on our last call, revenues in China have returned to a more normalized growth rate, coming in this quarter at 20.9%. Sales of safety-engineered products in emerging markets grew 18%. Moving to global Safety on Slide 11. Currency-neutral sales increased 6.1% and grew to $569 million in the quarter. Revenues in the U.S. grew 1.2%. International sales grew 12.4%, driven by good performance in Western Europe, Asia and Latin America. Medical Safety sales grew 6.6%, driven by a range of safety-engineered products. Diagnostics growth was 5.7% in the quarter. Both segments experienced strong international growth, particularly in emerging markets. Turning to Slide 12. Gross margin performance in the quarter reflects benefits from ReLoCo, continuous improvement and favorable pension expenses. These items were more than offset by a mix, raw material and start-up costs. Currency had a favorable impact on gross profit by about 10 basis points. For the total year, we are reducing our gross profit guidance to between 51.2% to 51.4%. This is largely due to the cost to remediate quality issues, including an incremental investment in our manufacturing processes within the Pharmaceutical Systems business that impacts the second half of the year. Additionally, we are seeing continued margin pressures associated with the challenges in our Diagnostic Systems business. Slide 13 recaps the third quarter income statement and highlights our foreign currency-neutral results. As we discussed, revenues were in line and gross profit came in slightly below our expectations. SSG&A increased 3.4%. R&D increased 5.4% as we continued to invest in new products. Operating income grew 4.7%, impacted by a lower gross profit in the quarter. Our tax rate declined by 50 basis points, reflecting the benefits of favorable geographic mix. In the quarter, adjusted earnings per share were $1.68, which represents a 7.8% increase over the prior year. All of these items were in line with our expectations. Slide 14 recaps the adjusted year-to-date income statement and highlights our foreign currency-neutral results. I'll not review this slide in detail, but I would like to note our year-to-date operating income growth of 7%. Excluding the incremental impact of the medical device tax in the first quarter, underlying operating income growth was 8.2%. Also, despite our lower gross profit expectations for the year, we are still on track to deliver about 70 to 80 basis points of underlying operating margin expansion for the year. As a reminder, about half of the margin expense is the result of favorable pension expenses. All other P&L guidance remains in line with our previously communicated ranges. Slide 15 illustrates our revenue guidance by segment. We expect revenue growth for the total company to be between 4.5% to 5%. For the BD Medical and BD Biosciences segments, we expect growth to be at the upper end and Diagnostics to be at the lower end of our previously communicated ranges. This assumes a euro-to-dollar exchange rate of about $1.37. Now I'd like to turn the call back over to Vince, who will provide you with an update on our product portfolio.
Vincent A. Forlenza:
Thank you, Chris. Moving on to Slide 17, I would like to review the program and product launches. As we remain focused on new products and innovation, we're very pleased with the progress we've made. This year, we expect new products to account for approximately 16% of total revenue. In the Medical segment, we are continuing to make progress on our BD Simplist line of prefilled generic injectables. We currently have 4 drugs approved by the FDA, and we have applied for 4 additional drug approvals. We are continuing to focus on the commercial launch of Morphine, which was approved a few months ago. As we have been sharing with you, we continue to expect that this new initiative will take time to gain traction in the marketplace. In our Bioscience segment, we continue the launch of our BD FACSPresto. FACSPresto is a portable instrument which is used to stage and monitor HIV/AIDS patients by analyzing their CD4 and hemoglobin levels. This innovative instrument was created with resource-limited settings in mind, and it can be easily transported to meet customer needs in rural areas. We are also excited about our Sirigen dye portfolio, which has been making news in the flow cytometry community for its capabilities. We have launched 3 dyes throughout this year, and we plan to launch 3 more before the end of the year. Turning to Slide 18, you will see the various product launches in Diagnostics. On the BD MAX, our worldwide Enteric Bacteria launch is now underway, with the U.S. launch this quarter. Our Enteric Parasite assay has also launched this quarter in Europe. These unique assays combined our core microbiology and molecular competencies for a novel and rapid approach to enteric testing. Finally, we are pleased with our new GC/CT test has been approved on the BD Viper LT platform, in both the USA and Europe. This assay and platform combination will provide midsized testing facilities with the ability to use this smaller, efficient instrument with improved assay functionality. This is the second test approved on the Viper LT, joining BD's CE marked Onclarity HPV Assay with genotyping capabilities. As always, we will continue to update you on the progress as we are -- that we're making with our various pipeline opportunities. On Slide 19, before we open the call to questions, I'd like to reiterate the key messages from our presentation today. First, we are pleased with our solid performance in the third quarter and year-to-date. Second, our consistent performance demonstrates that our strategy remains sound in this dynamic health care environment. Third, we're seeking the continued success with our key growth drivers of geographic expansion, new products and acquisitions, which are overall performing in line with our expectations. Finally, we are pleased to reaffirm our guidance for fiscal year 2014. We believe we are positioned to continue our track record of delivering value to our customers and shareholders. Thank you. We will now open the call to questions.
Operator:
[Operator Instructions] Our first question is coming from Rick Wise of Stifel.
Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division:
Let me start off with just a bigger-picture question. I hate to quibble about yet another excellent quarter. This was a slightly smaller beat in recent quarters. Chris highlighted a couple of the moving parts there. But just broadly, anything we should appreciate about the quarter and the environment in a bigger-picture sense? And Chris, given the healthy divisional performance with Medical, Diagnostic, Biosciences all at or above your fiscal '14 guidance year-to-date, why wouldn't they do better if they've outperformed 3 quarters in a row through the fiscal year?
Vincent A. Forlenza:
So Rick, I'll take the environmental piece then Chris will get into the guidance a little bit. But we had a long discussion here about do we see anything really changing significantly globally, and the answer to that is no. We see the environment primarily as stable and not a whole heck of a lot of change. We know other people have talked about maybe some increased volume coming from the ACA. We don't think we've seen that yet. So -- and the same is true in emerging markets. We see consistency in emerging markets. Obviously, there's always some moving pieces with some of these tenders, but nothing significant in the environment. Chris, you want to add...
Christopher R. Reidy:
Right. And Rick, yes, you're absolutely right, we are doing better in...
Vincent A. Forlenza:
[indiscernible] mic.
Christopher R. Reidy:
It is on.
Vincent A. Forlenza:
Well, okay, fine.
Christopher R. Reidy:
We are doing better in the Medical and Biosciences business. We're coming down slightly on Diagnostics. If you do the math, that kind of takes you to the high end of the 4.5% to 5% range, and we thought that the range was tight enough at this point in the year. But you're absolutely right. If you do the math, you're a little bit better on BDX in the midpoint of the range.
Frederick A. Wise - Stifel, Nicolaus & Company, Incorporated, Research Division:
Yes. And just a follow-up question. If the -- you talked about the "difficult U.S. diagnostic environment." Maybe a little more color on that. And does the expanding BD MAX and Viper menu help stem the difficult environment or ward off that you've been talking about? Or are these secular changes as opposed to company specific? Just help us understand that a little more.
Vincent A. Forlenza:
So to that point, first just one more comment on the guidance. Keep in mind, as we go into the fourth quarter, that we had that large performance with Biosciences, and that was really driven by Japan and the stimulus. So you have a very tough compare there. So that all also figures. In terms of Diagnostics, would you like to comment, Alberto, on what's happening in the U.S. marketplace.
Alberto Mas:
Yes, I think the launches that happened this quarter in Enteric, as Vince mentioned, in Bacterial and Parasite in Europe, will give us momentum to continue growth, as expected, in the MAX platform. So I think that would -- definitely will be -- but most of the -- again, the international growth is solid. Our core growth is very solid. And what we're seeing, as we've been saying for a while now, the headwinds are more in the U.S. in Women's Health in terms of the interval testing, some account losses because some of our overall platforms are aging. But fundamentally, we're not seeing any, as Vince reiterated, any huge changes. We just have to execute on our strategy.
Vincent A. Forlenza:
And we think we're up to about 70% conversion on the intervals now. But thanks for your questions, Rick.
Operator:
Your next question comes from David Lewis of Morgan Stanley.
David R. Lewis - Morgan Stanley, Research Division:
Vince, it's nice to have you back. It wasn't the same without you last quarter.
Vincent A. Forlenza:
Thank you for the [indiscernible].
David R. Lewis - Morgan Stanley, Research Division:
So 2 questions, one strategic and one very specific for Chris. So Vince, if we go back to last -- I think if we go back 10 years and think about your diabetes initiatives, specifically the ones to expand your diabetic reach, we talk about the strip and meter business with Nova Biomed and, obviously, the CG mass initiative you announced this morning. So you clearly want to get bigger in diabetes, but some of these partnership models, to be frank, haven't really worked well for the company. So do you think in light of some of these partnership models these last 5 to 10 years, your view on how to get bigger in diabetes changes at all? You've got a lot of reach but not enough products, and these partnerships aren't working. So a very directed question there, and I had one quick follow-up.
Vincent A. Forlenza:
Sure. So I don't think it's an issue of it being a partnership model. I think that specifically, right now, this was an issue of technology that we had brought into the company a long time ago. The fact that we partnered on the development of it was really not the issue. The issue was did the technology work or not. And when we got into some human testing, we saw some issues. And so there was a technological failure. It had nothing to do with the partnerships. But we think that the partnerships we've put in place with the JDRF are very important, and we've very enthused with the partnerships that we have on the infusion area. So I certainly wouldn't draw that conclusion. Where I would agree with you is that we're working hard to expand the product portfolio, and this gave us the opportunity to reinforce some of the other programs in Diabetes Care. So I think we're optimistic about the other programs, and we'll be moving ahead.
David R. Lewis - Morgan Stanley, Research Division:
Okay. You think you're any more likely, Vince, to pursue M&A in diabetes? Is this more likely externally? Or are you still comfortable internally you can grow the portfolio?
Vincent A. Forlenza:
Well, we're still comfortable internally we can grow the portfolio, and we're making good progress on our other programs. But like -- each one of our businesses are challenged with developing solutions for the customer, okay? Whether it's Diabetes Care or Diagnostics or MedSurg, yes, you've seen what we've done across the portfolio. Diabetes Care would also fall under that blueprint. Chris?
David R. Lewis - Morgan Stanley, Research Division:
Okay. Just last quick one for me. Chris, just the gross margin guidance change for the year, obviously not very dramatic. But the outset for that wasn't clear to me. Is it likely that you offset that pressure through SG&A or more through R&D?
Christopher R. Reidy:
It's actually a little bit of both. We're running -- if you look at where we are year-to-date and with the slight improvement on revenue that we were talking about, holding the SG&A line about where we expect it is giving us a little bit more leverage in the fourth quarter. R&D is a favorable compare in the fourth quarter. And I'll remind you that on SG&A, last year we had legal expenses related to RTI in the fourth quarter. So there's a little bit of an easy compare in the fourth quarter as well. The combination of all those factors gets you down to the 7% of operating margin improvement.
Vincent A. Forlenza:
Okay. Thanks, David.
Operator:
Your next question is coming from Kristen Stewart of Deutsche Bank.
Kristen M. Stewart - Deutsche Bank AG, Research Division:
Just a follow-up on the Diabetes business. Can you maybe just talk through, I guess, where exactly you are with some of these other opportunities? I know you talked about the Infusion. That's just -- what would be the expected timeline by which you may have some new announcements to make within Diabetes?
Vincent A. Forlenza:
So Bill Kozy will take that question. Bill?
William A. Kozy:
Yes, we're focused on the portfolio on Diabetes on 2 programs. First is the insulin infusion. And we're not ready yet to talk about the exact time, but it's certainly within the business planning window here over the next 24 to 36 months that we expect to make significant progress on insulin infusion. And then as we've mentioned before, we are looking at, right now organically, internally, at type 2 opportunities within the -- for insulin delivery. And it's really just too early for us to start talking about that, but those are -- in terms of portfolio management, those are the 2 priorities in that R&D development cycle with Diabetes Care.
Operator:
Your next question comes from David Roman of Goldman Sachs.
David H. Roman - Goldman Sachs Group Inc., Research Division:
I wanted just to come back to the pipeline a little bit. I know, Vince, in your prepared remarks you did you walk through some of the milestones with respect to product launches, both in the U.S. and elsewhere. But very specifically, as you look at maybe BD Diagnostic Systems and then also the BD Rx business, when do you think we can see some of the initiatives in each of those segment lines start to overwhelm some of the macro pressures that you're facing in each of those categories? And how long, really -- how long do you think it takes to build scale there?
Vincent A. Forlenza:
Well, let's start with Diagnostics. We expect that this interval issue is -- we're up to about 70% conversion. It's hard to say exactly how much more we have left in that, but we've been thinking it's more than a year before the rest gets converted. I don't know if it tops out at 80%, where we might fall. In terms of ramping up the growth rate, we expect as we move forward into next year and whatnot, it -- this business will be improving. We're excited about what we have going on with KIESTRA. And with these new launches that we talked about with the enteric assays, it's going to give us more traction. The last other key piece, of course, is going to be the BD Viper and getting traction outside the U.S., both on chlamydia and HPV. Alberto, do you want to add anything more to that?
Alberto Mas:
I think the only thing that I'll add is that the account loss that we've been talking in last quarters will be played out mostly this fiscal year, a little bit still in the future but mostly in this fiscal year. So that will make it easier from a growth perspective.
Vincent A. Forlenza:
Yes, and that's why I was thinking that when you look at those product launches and you think about annualizing that, you'll start improving forward in that. Now BD Rx. Tom?
Tom Polen:
Right. This Tom. I think, as Vince mentioned before, we have 4 drugs approved by the FDA and have applied for 4 additional drug approvals. Well, at this point, we're really focused on the commercial launch of the Morphine as that's our most important drug approval so far. So once we make some progress with the Morphine launch, we'll have more information to share with you on our outlook going forward. Again, as we've previously said on prior calls, this is still a relatively new initiative for us, and it's going to take some time for us to see traction on these products in the marketplace. It's not a fast version product, yes.
Vincent A. Forlenza:
It's going to take a few more months for us to understand where we're really at with Morphine. We see that as a [indiscernible].
Tom Polen:
And we'll circle back, yes.
Vincent A. Forlenza:
Okay?
Operator:
Your next question comes from Vijay Kumar of ISI Group.
Vijay Kumar - ISI Group Inc., Research Division:
So maybe one -- first, a big-picture question for you. And, I mean, Diagnostics, right, you can see the environment changing, a lot of consolidation going. And clearly, you guys have seen the effect, just given the compare of landscape. Do you feel like you guys are at scale within this unit? Or do you feel like you need to add particular platforms just given what some of your competitors like Roche, Danaher, some of the large guys, what they're planning, right? So I'm just trying to think in this changing health care landscape how do you feel about your Diagnostic positioning.
Vincent A. Forlenza:
So we actually feel pretty good about our Diagnostic positioning. We don't think there's a lot of crossover, for example, in terms of applying hematology, applying microbiology. We think it's a much more potent strategy to have a complete solution like we had put together in the infectious disease, microbiology area, where we now have total lab automation. What we think we have to do is execute on the programs that we have in place and continue to drive in those segments. We have a lot of pieces like the previous questioner asked. David asked about when is it going take you -- how long is it going to take to get to scale? We have to implement on the assays and the menus that we have talked about and get approval through the FDA. And we're working to get Totalys approved, for example, right now. So it's building out those complete solutions before even getting broader in Diagnostics. It's more the strategic priority.
Operator:
Your next question comes from Mike Weinstein of JPMorgan.
Robert Justin Marcus - JP Morgan Chase & Co, Research Division:
This is actually Robbie Marcus in for Mike. Maybe just ask the first question. You put up another good quarter in Safety products, really good outside the U.S., just 1% growth in the U.S. Can you talk about what kind of runway you see there, both in the U.S. and o U.S.? and how much longer can this good growth last for?
Vincent A. Forlenza:
Sure. Tom Polen will answer that question.
Tom Polen:
This is Tom. So Safety continues to really remain largely in line with what we've discussed in the past. We see the U.S., acute care market in particular, is -- it already is highly converted, and so we're not expecting any significant trajectory change there going forward and it is mature. The U.S. is -- or the EU is continuing to actively convert, and we see emerging markets at still quite an early stage. Just maybe a little bit more perspective on that. The EU is just under about 50% converted for catheters and about 15% converted for injection devices. And we continue to see really positive market response to the new legislation, with strong growth in both Safety catheters and injection across the majority of the Western European market. I guess it's still early, and we're seeing some really promising signs of broadening Safety implementation and potential in Southern Europe. And certainly, the rate of conversions varies by country there. Maybe just a comment on emerging markets, Safety there continues to go well, as you just mentioned, and we're growing double digits really led by Asia and Latin America in emerging markets. Again, it's still early. We're seeing good progress. We're seeing continued interest in partnering in a number of emerging countries who are really committed to the safety of their health care workers. So I think x U.S., we see a good runway ahead still.
Operator:
Your next question comes from Brian Weinstein of William Blair.
Brian Weinstein - William Blair & Company L.L.C., Research Division:
I just want to follow up on kind of a question that was just asked a little while ago. And that is, given the struggle that you've had in Diagnostics, it would seem to me that it would make sense to continue to invest heavily in some R&D there in specifically places where you have an advantage like in micro where there's new ID products coming out and direct-from-patient products that are beginning to emerge in micro. Can you comment specifically about that -- those types of projects within micro? And then are there areas within Diagnostics that you think might be interesting for additional investments?
Vincent A. Forlenza:
Yes, sure. Alberto Mas will talk to that. Alberto?
Alberto Mas:
So it's -- definitely, our core credibility market is in our microbiology franchise that we've built over many, many years. We're very credible there, and we base our strategies on that. And we are definitely watching the radar screen in terms of any technologies and capabilities that we need to add to that portfolio, including all the Directed detection that you mentioned is definitely on the radar screen, and we'll be monitoring that space in -- over time and within our -- on microbiology.
Vincent A. Forlenza:
This is Vince. We'll continue to invest in our molecular platforms as well as, obviously, as -- rapid detection methods. We have the partnership with Bruker [ph]. So we are really focused in this area. And as Alberto said, it will be a matter of internal and external kind of plug-in thing.
Operator:
Your next question comes from Derik De Bruin of Bank of America.
Derik De Bruin - BofA Merrill Lynch, Research Division:
So could you talk a little bit about the HPV program? I mean, that's another market where HPV pricing has obviously been coming under pressure. I guess -- and specifically, pressure driven by your major competitor in the CT and G market. Can you talk about how you're pricing that product and sort of your expectations for when that is approved in the U.S., where you'll price it? And I guess how do you see the HPV/AIDS business, the molecular business, synergizing with what you currently have with your opportunities for bundling and gaining some share back?
Vincent A. Forlenza:
So we wouldn't get into the specifics of how we price the product. We would certainly price it competitively. We think we have a good cost position on this product. So we will have flexibility, and we think we can be very competitive with the HPV product. And we don't think about so much as bundling as we do about complete solutions for the customer, total automation, a complete menu and providing more value for the customers.
Operator:
Your next question comes from Jon Groberg of Macquarie.
Jonathan P. Groberg - Macquarie Research:
So maybe just a couple of clarifications. First, on gross margin. Chris, would you mind -- I think pricing seemed like it's actually coming in better than you anticipated at the beginning of the year. So can you maybe just give me -- just help us understand exactly again why gross margin is going to be a little lighter than you expected? And then on the launch of the new CT/GC product, I'm just curious, you had that day. You mentioned, Alberto, the loss in the U.S. Is there any way for you with this new launch -- are you going to -- aggressively trying to gain back that market share? Or -- I'm just -- I'm trying to think how you're going to go about in the U.S. with the launch in CT/GC, if it's just about stabilizing your share or if you're able to think about more aggressively going after regaining markets that you've had in the past.
Christopher R. Reidy:
Sure. Let me start with the pricing and gross profit comment. As we've been saying all year on our pricing focus, the fourth quarter is where we expect to see some negative pressures. Having said that, Q3 was slightly favorable to our expectations, and year-to-date pricing is slightly favorable. So as we now look at, we would anticipate that we'll finish the year flat to slightly negative on pricing, which is a little bit of a lift. And to your point, that drives a little bit of a lift in gross profit. But going back to gross profit, the way to probably think about is for the full year, we're anticipating, consistent with our original guidance, that the drag from FX would be about 60 basis points. Now originally, we said that we thought we could offset that operationally with a positive 60 basis points, and that was driven by the ReLoCo effort, pensions and continuous improvement. Now we expect that to be flat to up 20 basis points operationally. And the impact was the continued pressure from Diagnostic Systems. We brought that revenue guidance down. And that certainly has a mix issue, so that's dragging us down a bit. And as we talked about in our remarks, the remediation of the quality issue on -- in Pharm Systems and the related spend on improving the manufacturing processes puts pressure on it. But the bottom line is we still expect on an operational basis to be flat or slightly up 20 basis points, and the margins are in that 51.2% to 51.4% kind of range. So still very solid margins with a potential for a little bit of lift year-over-year.
Operator:
Your next question comes from Bill Quirk of Piper Jaffray.
William R. Quirk - Piper Jaffray Companies, Research Division:
Yes. Two questions for me. First off, just on emerging markets, guys. It did slow down here in the quarter. I would love some additional color there, particularly considering that we are heading into what looks like probably the most difficult comp here in the fourth quarter.
Vincent A. Forlenza:
So in emerging markets, we had strong performance, but there was a timing issue in Latin America on a tender. And that was really the issue. Otherwise, as we mentioned in the prepared remarks, China bounced back to where we expected it to be. And overall, we were pleased with the performance with that.
Christopher R. Reidy:
Yes, the big thing was Latin America. The year-over-year compare in Latin America was difficult because last year's third quarter was up over 18% in Latin America, and that's the timing of tenders that hit last year that didn't repeat. So that was the big driver. And Vince said China's back up over 20%. We're seeing good, double-digit growth in EMEA. India is very solid. And we are seeing some other timing of tenders in other parts, but we expect that to bounce back to more normalized growth rates going forward.
Operator:
Your next question comes from Doug Schenkel of Cowen and Company.
Douglas Schenkel - Cowen and Company, LLC, Research Division:
I wanted to start with a question on Sirigen and then just as a quick one on Women's Health. So on Sirigen, you noted the launch of 3 new dyes, plans to launch 3 more by year end. I believe there's also a couple of new lasers available. In combination, this allows for flow cytometry customers to perform higher parameter analysis on existing traditional flow cytometers, which also, importantly, allows customers to subsequently store up the cells if they so choose. So it does seem like you're moving towards a completely competitively unique value proposition with the addition of these dyes and lasers. With all that in mind, how many more dyes are expected in 2015? And how would you describe the demand for higher parameter analysis given some of the bioinformatics hurdles that exist in flow cytometry? And then quickly on Women's Health, would you be willing to quantify the year-over-year impact of intervals versus the loss of the account? And you did indicate the vast majority of the burden associated with the account loss is expected to be incurred by the end of the fiscal year. When does that negative base effect get annualized? Is that really in the second half of next fiscal year where the account loss becomes less of a headwind?
Vincent A. Forlenza:
Sure. So I'm going to move you into the flow cytometry marketing group. You really stated the value proposition very well, but I'll turn that to Linda.
Linda Tharby:
Thanks so much for the question. So as you noted, doing multiparameter analysis in flow cytometry is becoming more and more important. So very excited about the opportunity to bring together, as you mentioned, both the improved colored parameter on our flow cytometers with the Sirigen platform. So we did discuss that we intend to repeat the performance that you saw in Q4 that we saw in terms of new launches of dyes that we saw in Q3, which is 3. I can't speak on a go-forward basis, but you would expect us to continue to roll out many new dyes and many new SKUs related to our Sirigen platform. It's really helping to power both the traditional immunology and also some expansion into single-cell parameter analysis in the broader area of genomics. So very excited about that.
Vincent A. Forlenza:
Alberto, are you going to pick up the other piece?
Alberto Mas:
Yes. In terms of the -- our SurePath business, we estimate that about 2/3 of the impact is driven by interval extension and 1/3, more or less, off from an account loss perspective. Just to put it into perspective as well, the performance of the quarter, if you normalize for the big account loss that we've been referencing, would have been 3.9%. So I want to put that into context as well. And this will normalize in the first half of next year.
Vincent A. Forlenza:
3.9% positive.
Alberto Mas:
3.9% positive, yes.
Operator:
Your next question comes from Richard Newitter of Leerink.
Richard Newitter - Leerink Swann LLC, Research Division:
Vincent, if I could just ask a quick big picture and then just a follow-on, if you have time. The sort of the bigger picture, just we're seeing more consolidation, particularly across the medical device landscape. But elsewhere in health care, scale is increasingly becoming a topic of focus. I'd love to just hear your thoughts on where within your businesses you think scale actually has a significant advantage, if at all. And if you can comment on your view just of the consolidating landscape that we're seeing and where Becton stands today.
Vincent A. Forlenza:
So we're not a believer in scale for scale's sake. Our strategy is really focused on creating complete solutions for the customer and driving value that way. We think that, that aligns much more with the basic customer needs and how buying processes are evolving. So we really think strategically around each one of these business units and how they can build out solutions. And if you look at how we might work across business units to create more complete solutions, it's a second element of our strategy that we are developing. All of that lines up with -- more with our plug-in M&A strategy. And so that's really the core of what we're trying to do. And certainly, there are people who are playing this out differently in terms of just more and more breadth, but that's not what we're attempting.
Operator:
Your next question comes from Glenn Novarro of RBC Capital.
Glenn J. Novarro - RBC Capital Markets, LLC, Research Division:
Two questions. First, just a follow-up on the gross margin. I understand the issue that you're facing here in the near term and the offset being lower SG&A. But as you look at the gross margin going forward, what specifically can you do to address some of the pressures that you're facing? For example, as you look at ReLoCo, is there a little bit more from ReLoCo that you can extract? And then second, on the ACA and volumes, Vince, I understand that you said you didn't see much of a benefit here in the quarter. But I would imagine hospital volumes and physicians are just going to pick up and momentum's going to grow from the ACA. So does this benefit your U.S. business over the next 6 to 12 months?
Christopher R. Reidy:
I'll start on the gross profit margins. I think if you look at the performance that we would have had excluding these 2 pressures, which are focused on in-year pressures, we would have had 60 basis points of improvement. ReLoCo has been very successful for us. It's -- we're still seeing benefits from that this year of around $30 million. And initially, it was a bit larger, but we're still seeing some benefits from that. So without giving guidance on gross profit margin for future years, which we will do on the next call, I don't think you should view this kind of pressure as having a significant impact on our ability to drive margin growth, either at the gross profit or at the operating margin going forward.
Operator:
Your next question comes from Matthew Taylor of Barclays.
Daniel Sollof - Barclays Capital, Research Division:
It's actually Dan in for Matt. I just had a follow-up on SG&A. It came in better than we're expecting it. It's actually lower than it's been for a while. So I just wanted to ask, is there -- was there anything like deferral of spend, at least on a percentage of sales basis that, like, helped this quarter? Is this like a base where we can kind of, like, further leverage off of? I'm just kind of curious for some more color there.
Vincent A. Forlenza:
Yes, the best way to look at SG&A, I think, is for the year-to-date, and I think that's a pretty good indicator of where we'll be going forward. You're right, we're seeing some positives. We'll actually see a little bit more of a positive in the fourth quarter, as I mentioned, with the easy compare. But we are seeing leverage in the SG&A line. So that's positive.
Operator:
Your next question comes from Kristen Stewart of Deutsche Bank.
Kristen M. Stewart - Deutsche Bank AG, Research Division:
Yes, on the operating margin outlook, I know that you had mentioned half of the expansion this year is coming from favorable pension. Just how should we think about -- that the opportunities for margin expansion? You commented on gross margins seemingly having a runway for expansion, but you did also mention quality spending. How long does that last? And are you still kind of more in the investment spend area for emerging markets as well?
Christopher R. Reidy:
Well, we are investing in emerging markets. We're continuing to do that, as we have said. So we have that investment. We are making the investment this year. And we're just in the middle of our budgeting process, so how much of that extends into future years is still a question. Right now, it's a focus in-year more than anything else, but we'll give more color on that going forward. And so overall, we are making the right investments. We're investing in R&D but at the same time being very focused on reducing SG&A and improving the gross profit line, as we said, through ReLoCo. So there's a lot of levers that we're pulling while still making sure we're making the right investment that makes sense to drive future revenue growth and drive both. And we think we have evidence that we've been able to do that consistently to drive additional margin growth. Last year, it was 25%. And this year, 70% to 80%, with about half coming from pension. But again, continuous improvement in driving additional margin. So we'll talk more about that as we give guidance for next year on that as well.
Operator:
Our last question is coming from Bill Quirk of Piper Jaffray.
William R. Quirk - Piper Jaffray Companies, Research Division:
A follow-up. I'm just thinking about microbiology, guys. You've been in a nice position here relative to your principal competitor having some manufacturing challenges over the better part of the last year. Supposedly, this is going to be rectified here roughly by the end of this year. So how are you thinking about that competitive dynamic and just the franchise in general?
Vincent A. Forlenza:
I think in terms of microbiology, we feel very good about the product line that we've put together. Alberto, would you like to comment further?
Alberto Mas:
Yes, we definitely have had a strong quarter, especially in our BACTEC blood culture business that also was -- began to pick up in the last quarter. But we're seeing very, very healthy growth rates in that part of the business for sure.
Vincent A. Forlenza:
All right. Well, thank you very much. Are there any more questions, operator?
Operator:
There are no further questions. I would like to turn the floor back over to Vince Forlenza for closing remarks.
Vincent A. Forlenza:
I want to thank all of you for joining us today. It was a pleasure updating you on the quarter. We look forward to getting back with you next quarter and providing you with our guidance going forward. But we're very pleased with the strong results, and thank you for your attention. Thank you very much.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Executives:
Monique Dolecki - VP of Investor Relations Chris Reidy - CFO Bill Kozy - COO Tom Polen - Group President Linda Tharby - Group President Alberto Mas - President of Diagnostic Systems
Analysts:
Brandon Couillard - Jefferies Kristen Stewart - Deutsche Bank David Lewis - Morgan Stanley Matt McDonough - Goldman Sachs Mike Weinstein - JP Morgan Richard Newitter - Leerink Doug Schenkel - Cowen Jeff Frelick - Canaccord Vijay Kumar - ISI Group Jon Groberg - Macquarie Brian Weinstein - William Blair Derik De Bruin - Bank of America Larry Keusch - Raymond James
Operator:
Hello, and welcome to BD's Second Fiscal Quarter 2014 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through May 8, 2014 on the Investors page of the bd.com Web site or by phone at (800) 585-8367 for domestic calls and area code (404) 537-3406 for international calls, using confirmation number 24652897. (Operator Instructions) Beginning today's call is Ms. Monique Dolecki, VP of Investor Relations. Ms. Dolecki, you may begin.
Monique Dolecki:
Thank you, Kristy. Good morning, everyone, and thank you for joining us to review our second fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our second fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in the slides. A copy of the release, including the financial schedules is posted on the bd.com website. Leading the call this morning is Bill Kozy, Executive Vice President and Chief Operating Officer; Vince is not able to join you today. He is recovering nicely from orthopedic procedure, and will be back to work next week. Also joining us today are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Tom Polen, Group President; Linda Tharby, Group President and Alberto Mas, President of Diagnostic Systems. It is now my pleasure to turn the call over to Bill.
Bill Kozy:
Thank you, Monique, and good morning, everyone. As we stated in our press release, we are pleased with our performance in the second quarter. Our results this quarter highlight our consistent performance and the benefit of our diverse geographic and product portfolio. We delivered solid revenue and EPS growth where were in line with our expectations. Revenue growth in the second quarter was driven by our Medical and Biosciences segments. Diagnostics' international growth was partially offset by continued challenges in the U.S., which we will provide some color on later in the call. We saw continued strong international safety and emerging market sales and they remain as the key growth drivers for the company. Based on our solid results for the second quarter and the first half of the year, we are reaffirming our previously communicated currency-neutral revenue guidance and we are raising our adjusted EPS guidance for the full fiscal year 2014. On Slide 5 we have outlined our second quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Total company revenues were solid, increasing by 5.1%. Fully diluted EPS came in at $1.45 growing at 10.1% over the prior year. On an adjusted basis EPS of $1.53 grew 15.8%. Now I would like to turn things over to Chris to give you more detailed discussion of our second quarter financial performance.
Chris Reidy:
Thank you, Bill, and good morning, everyone. I'd like to begin by discussing the key financial highlights for the second quarter. As Bill just mentioned, we delivered solid performance. Revenue growth in the second quarter was in line with our expectations. We experienced strong growth in our Medical and Biosciences segments which were aided in part by timing of orders. As Bill just mentioned, there were some challenges in the Diagnostic segment, particularly in the U.S. I'll speak to that in just a moment. In the second quarter, performance improvements in our gross profit margin were more than offset by the unfavorable impact of foreign currency. On a currency-neutral basis we improved gross profit by 60 basis points. Our tax rate improved substantially due to geographic mix and some discreet one-time items. This benefited earnings by about $0.03. Adjusted earnings per share were $1.53 and grew 15.8% in the second quarter. Also during the second quarter we completed an additional 24 million of our approximate $450 million share repurchase plan for 2014. This brings our total share repurchases year-to-date to 213 million. As Bill just mentioned we are reaffirming our currency-neutral revenue growth guidance and raising adjusted EPS guidance for the total year. On Slide 8, I will review our revenue growth by segment on a currency-neutral basis. Organic revenue growth was 5.1% for the total company. The impact of price erosion was about flat in the quarter. And as a remainder the SSI acquisition is now included in our base. BD Medical second quarter revenues increased 6.3%. Growth in this segment was driven by a range of new products, emerging market strength and some timing benefits. Growth in Diabetes Care was 10.4%. This reflects continued strong sales of pen needles, which includes our Nano and AutoShield Duo products. Medical Surgical Systems growth was 4.4% led by emerging markets and international safety sales. Pharmaceutical System growth was 6.6%. As we expected and as we typically see in this business, this reflects a favorable impact from a timing of orders. Timing of orders in the quarter positively impacted growth by about 350 basis points within the Pharmaceutical Systems unit. BD Diagnostic second quarter revenues increased 1%. Solid sales in the Preanalytical Systems unit and the BD MAX GeneOhm platform were partially offset by a decline in our Women's Health and Cancer business. This was due to extended cervical cancer screening intervals and U.S. share losses. BD Biosciences revenue growth was 10.2% versus the prior year period due to solid clinical and research instrument placements and reagents along with strong emerging market growth. Growth in this segment also benefited from the timing of a government order in Latin America, a large tender order in Africa and more normalized stimulus spending in Japan. These items benefited growth by about 350 basis points. Growth in the second half of this year will decelerate due to these timing items. Moving to Slide 9, I'll walk you through our geographic revenues for the second quarter. As we expected softer growth in the U.S. was supplemented by continued strong international growth. BD's reported U.S. revenues increased 0.2% versus the prior year. We view the environment in the U.S. as constrained, but stable. Revenue on our U.S. Medical segment increased by 5.2%, which was largely driven by timing of orders in our Pharmaceutical Systems business and strong growth in Diabetes Care. U.S. Growth and Diagnostic segment declined by 6.4%. This was due to the challenges I just mentioned a moment ago coupled with the mild flu season. Growth in the U.S. this quarter was largely impacted by challenges in this segment. We are seeing some stabilization in our U.S. Biosciences business which experienced growth of 1.4%. Moving on to international, we continue to see strong growth. Revenues grew 8.5% currency-neutral with growth coming from all three segments. Medical segment grew 7.0% and Diagnostics grew 8.1%. This reflects strong growth in emerging markets and international safety sales. Biosciences grew 14.3% and benefited from the timing items I just mentioned. Our Biosciences segment also experienced strong growth in emerging market. On Slide 10, we continue to see strong growth in emerging markets, which accounted for approximately 24.5% of our total revenues. Emerging market revenues grew 13.9% currency-neutral over the prior year. This was driven by strong performance across all segments in those geographic regions. Slightly slower growth in China of 17% reflects a tough comparison to the prior year period. We continue to expect low double-digit growth in emerging markets, and growth in China is expected to be in the 20% range for the balance of this fiscal year. Moving to global safety on Slide 11, currency-neutral sales increased 4.9% and grew to 531 million in the quarter. Safety revenues in the U.S. were about flat. Our international sales grew 11.2% currency-neutral with emerging markets growing about 20%. Medical Safety sales grew 4.4% driven by a range of safety engineered products. Diagnostic safety growth was 5.5% in the quarter. As I mentioned earlier, the benefits of our SSI acquisition have annualized and are now included in the base. This impacted our U.S. safety and medical safety growth rates in the quarter. Moving on to gross profit on Slide 12, positive performance in the quarter reflects benefits from ReLoCo and other continuous improvement initiatives and pension savings. These items will more than offset by an unfavorable currency and higher raw material and startup costs. Our gross profit guidance remains on track for the year. Slide 13 recaps the second quarter income statement and highlights our foreign currency-neutral results on an adjusted basis. As we discussed, revenue and gross profit were in line with our expectations. SSG&A increased about 1.4% which reflects the benefit of the one-time item in Europe. R&D increased 3.8%. This remains in line with our expectations at 6.1% of revenue as we continue to invest in new product development and innovation. Operating income grew 13.5% in the quarter reflecting our ongoing focus on earnings quality at the corporate and business unit level. Our tax rate declined by 170 basis points, which benefited from geographic mix and some discreet one-time items. In the quarter, adjusted earnings per share were $1.53 which is a 15.8% increase versus the prior year. On Slide 14, we will review our revised outlook for the total year. As we mentioned earlier, we are reaffirming guidance for currency-neutral revenue growth and raising guidance for adjusted earnings per share. On a reported basis, our guidance assumes a Euro exchange rate of $1.37. Reported revenue growth is being negatively impacted by other currencies. As such, we are lowering our reported revenue guidance by 50 basis points. In our Medical and Biosciences segments, we have increased our revenue growth expectations. Our revised guidance in Medical of 5.5% to 6% reflects solid core growth and a benefit from new product launches. The Biosciences segment is now expected to grow 4% to 5% reflecting continued international growth. We now expect the Diagnostic segment to grow about 3% to 3.5% due to some of the U.S. challenges we mentioned earlier in addition to a lighter flu season than anticipated. Adjusted earnings per share of $6.22 to $6.25 reflect the benefit of an improved tax rate for the total year, partially offset by unfavorable foreign currency. Our expected tax rate is 23% to 23.5% contemplates a more favorable geographic mix. Moving on to Slide 15, I'd like to review the revenue guidance in further detail, one with the facing for the second half of the year as it is compared with a particularly strong back half of 2013. I'll speak to this slide in a currency-neutral basis. As you can see we delivered strong growth in the first half of the year, where the total company revenues grew 5.9%. Strong growth in the Medical segment of 7.4% benefited from timing in our Medical Surgical Systems and Pharmaceutical Systems business, and the acquisition contribution from SSI. You will see that the growth rate is expected to return to about 4% to 4.5% in the back half of the year as to normalizing for those items. We are also contemplating less favorable pricing. For the total year, we expect the Medical segment to grow between 5.5% to 6%. Diagnostic growth in the first half of the year was 2.6%, a benefit from share gains and point of care flu sales were offset by the U.S. challenges we mentioned earlier in Women's Health and Cancer. In the second half of the year we expect revenue growth to rebound a bit. Our revised guidance of 3.5% to 4.5% for the second half contemplates strong KIESTRA placement. For the total year we expect the Diagnostic segment to grow 3% to 3.5%. Despite the challenges we are facing in the U.S. Diagnostic Systems business we are still seeing success in our international businesses and are making good progress with various new product launches. We are confident we can continue to deliver solid growth in this segment. Our Biosciences segment grew 8% in the first half of the year. The strong growth was driven by the timing of orders I mentioned earlier. We expect growth in this segment to be between flat to 2% in the back half. It will be weighted more heavily in the third quarter. As you may recall the fourth quarter of last year was particularly strong as a result of the stimulus spending in Japan, which presents a difficult comparison. For the total year we expect the Biosciences segment to grow about 4% to 5%. Now, I'd like to turn the call back over to Bill, who will provide a more detailed update on our progress around our key initiatives.
Bill Kozy:
Thank you, Chris. Moving on to slide 17, I'd like to review the program and product launches in our Medical and Biosciences segment. In the Medical segment we continued to rollout our new BD Simplist line of prefilled generic injectables. We currently have four drugs approved by the FDA, and have applied for four additional drug approvals. As expected, we recently launched the morphine product. As we have been sharing with you, this is still a very new initiative, and it will take some time for these products to gain their traction in the marketplace. In our Biosciences segment, we recently launched our BD FACSPresto, CD4 and Hemoglobin Analyzer. The BD FACSPresto expands the ability to stage and monitor HIV/AIDS patients close to their homes. It is an easy-to-use system that meets the need of resource limited setting. The FACSPresto can be easily transported and operates off a rechargeable battery enabling patients even in remote settings to receive critical CD4 testing. Early customer feedback has been very positive. Also this year we have launched three dyes and plan to add several additional dyes to the surgeon portfolio. Turning to Slide 18 you will see the various product launches and diagnostics. On our BD Veritor platform, we launched our Strep A Test in the U.S. this past quarter. We also received clear waivers on both our Strep A and RSV tests, making these tests more accessible to clinicians in the U.S. To-date we have made over 12,000 Veritor replacements. On our BD MAX molecular platform, we look forward to the U.S. launch of our Enteric Bacterial Panel and CE marking of our Enteric Parasite Panel later this year. These tests which traditionally take three to five days to achieve results, it can be completed in minutes, which also reduces the need for unnecessary antibiotics in the meantime. We are excited about the unique assays in our pipeline which combine our deep microbiology know-how with our molecular capabilities. Our BD Onclarity HPV Assay was launched recently in Europe. This assay runs our new Viper LT automated platform, which is capable of both SDA and real-time PCR molecular amplification formats. During the second quarter there were numerous installations across Europe and Asia. We will add our CT/GC assay for the Viper LT as soon as we receive CE marking which is expected in the next quarter. We are also expecting U.S. FDA 510(k) clearings of CT/GC on the Viper LT in the third quarter. Of course we will continue to update you as we do make progress on these pipeline initiatives. On Slide 19, before we open the call to questions, I would like to reiterate the key messages from the presentation today. First, we are pleased with our consistent solid performance in the second quarter and our results here today. Second, we continue to execute on our strategy and deliver top and bottom line growth and margin expansion. Third, we saw solid growth in our medical and biosciences segments and continue to be pleased with the progress we have made on the key growth drivers across our various businesses and regions. Despite challenges we are facing the U.S. diagnostics systems business, we are confident we can continue to deliver solid growth in the diagnostic segment. Finally, we are positive about our outlook for fiscal year '14. We are committed to delivering current neutral revenue growth of 4.5% to 5% and 11% to 11.5% adjusted EPS growth. Our diverse product and geographic portfolio and the operational effectiveness programs we have in place provide BD with a strong foundation. We believe we are well positioned for continued success in fiscal year '14 and beyond. Thank you. We will now open the call for questions.
Operator:
Thank you. The floor is now open for questions. (Operator Instructions) Our first question is coming from the line of Brandon Couillard of Jefferies.
Brandon Couillard – Jefferies:
Thanks. Good morning.
Chris Reidy:
Good morning.
Bill Kozy:
Good morning.
Brandon Couillard – Jefferies:
I didn't catch if Alberto is there or not, but if so, could you elaborate on the U.S. Diagnostic Systems business in the second quarter slowed materially even though Quest has already been in the run rate? And then the guidance implies an acceleration in the back half, could you quantify the effect of the KIESTRA placements in that acceleration?
Bill Kozy:
Sure. This is Bill. I'll take a first shot, and Alberto is here and I'll ask him to comment also. One thing I will do is let me just give you our view on Diagnostics, including the U.S. piece. Our international growth is up about 6% in the second quarter, and year-to-date it's at about 7%. We're continuing to see good solid growth in the core part of our microbiology business and particularly our BACTEC business and our IDAST business are solid at round 4% or 5%. Also in the second quarter we had a very strong degree of placements with the BACTEC FX. That's one of the best quarters we've had in quite some time. That's a big part of some of our second half projection here that we will talk about. Additionally, the emerging markets continue to be pretty strong, both China and Latin America growing at strong double-digits contributing to an overall emerging market growth rate around 10%. Now, the equation of KIESTRA, we do have very strong demand, and as Chris indicated in his comments, we've got expectations for a strong placements in the second half of the year. I'll give that part to Alberto here in a second. Additionally, our POC, our Point of Care category share gain, which was somewhat dampened by weak flu season still should promise, gives us some encouragement on the second half of the year as does the MAX GeneOhm growth that we experienced in the quarter. To get at the challenge part, its Women's Health and Cancer, and it's in the United States. You might recall last year we described to you a major account loss. That of course is still playing out in fiscal year '14. Chris already mentioned the interval testing and the impact on cervical cancer, which is ongoing, particularly on our SurePath reagent business. And we've had some sales erosion on our ProbeTec platform, again concentrated in the U.S. We're hoping that we get Viper LT launched in the third quarter with CT/GC, which I mentioned in my remarks. That's key to defending that business and slowing down some of that sales erosion. Let me just slip in. Alberto, any color you would like to add particularly around the KIESTRA placements in the second half?
Alberto Mas:
Yes. If I focus on why we think the second half is going to be stronger, it's some of the underlying positive trends that we are seeing in the business are highlighted in the second half. And again, the KIESTRA obviously are going to be beginning to be placed in the market more strongly in the second half and into next year. We actually feel very positive about the demand patterns that we are seeing going forward. One of the things that is driving that is our expected launch of ReadA Compact, which was one of the components of the Lab Automation KIESTRA that we will expect in the next month and a half. We have it in four sites right now and with very positive feedback. We are expecting a global launch of that platform in the next couple of months. So that should be certainly an accelerated growth for the second half and in the future. MAX, again we are expecting -- we had a good quarter. We expect even stronger quarters in quoting the next couple of quarters and going forward. So this is an accelerating product line for us. And we are pretty much where we expected to be in overall revenues. As Bill said, BACTEC placements should begin to generate reagent revenue in the second half and going forward. And again, lots of the Viper LT will enable us to begin to -- it's a good tool for us to begin to defend our CT/GC business going forward as well.
Operator:
Thank you. Your next question comes from Kristen Stewart of Deutsche Bank.
Kristen Stewart - Deutsche Bank:
Hi. Thanks for taking the question. I was just wondering if you could -- I know you mentioned a couple of times the different timing orders and the impact within the individual businesses. What's the impact in aggregate I guess for the quarter, the 5.1 currency-neutral, what would that have been in your estimate excluding some of these one-time factors or timing factors?
Chris Reidy:
Great. This is Chris. The way to think about that is really on a first half/second half, because there is some timing even between the first and the second quarter. So if you look at the first half that's 5.9% that we had year-to-date, about 40 basis points of that was the lift from the SSI acquisition. And then there was about 50 basis points of timing of orders, and so that's from systems the BDB orders that we talked about and some Med/Surg timing of orders. On top of that you have a little bit of favorable pricing in there, and you had the Japan stimulus which is accelerated this year year-over-year, as we said, it all came in the fourth quarter. So if you normalize all of that, we get in the 4.5% to 5% range for the first half of the year. Then if you look at the second half, the 3.5 to 4 that we showed, the timing of orders brings you back to 4 to 4.5. The Japan stimulus and the unfavorable pricing flip get you in that 4.5 to 5 range. So that's the way to think about first half/second half.
Operator:
Thank you. Your next question comes from David Lewis of Morgan Stanley.
David Lewis - Morgan Stanley:
Hi, good morning.
Chris Reidy:
Good morning.
David Lewis - Morgan Stanley:
Bill, just thinking about your commentary on China and specifically the Biosciences slowed down in the back half of the year; can you give us a sense of how you expect your accounting to trend in the back half of the year relative to Biosciences? Some of your peers have talked about delays at the Ministry of Health is specifically affecting capital. I am wondering what impact, if any, that could have on your flow business. Thank you.
Bill Kozy:
Hi, David. Linda is obviously here with us and she is closest to that. Let me just pass that question over to her and ask for her comments. You are specifically interested in China, David, in second half impact on government influence.
Linda Tharby:
Good morning, David. It's Linda here. So we continue to see in our Biosciences business very strong growth in China, and we are seeing that come not only from the clinical market and expansion in lab presence and flow cytometry there, but also really strong presence from Accuri, which is our personal flow. So we continue to see our growth in the very high double-digits in China in the back half. And at this point we are not projecting anything with respect to a slowdown in that market due to a good balanced portfolio between both our research and clinical settings.
Chris Reidy:
I would like to take the opportunity to just emphasize as I mentioned in prepared remarks the 17% that we had in this quarter was driven more by the -- they are difficult compared to the second quarter of last year. So we see the rest of this year being in the 20% plus range.
Operator:
Thank you. Your next question comes from David Roman of Goldman Sachs.
Matt McDonough - Goldman Sachs:
Good morning. This is actually Matt McDonough in for David. Continuing with emerging markets, I was hoping you could provide a little bit more detail just on some of the moving parts, the different dynamics; you're now talking extensively about the China slowdown being driven more by the comp than actual slowing, but could you perhaps talk about trends you are seeing in other markets?
Bill Kozy:
Sure, I can -- let me make a couple of comments here. First of all, as we look at the scale of our emerging markets, China and Latin America are very, very critical drivers both in terms of scale and growth. Chris has already commented that we really see sustainability in China around that 20% number for the remainder of that year. We are seeing similar types of numbers coming out of Latin America. It's across -- I hate to generalize to your question, but it's pretty much strength across all of our businesses, medical, diagnostics and biosciences all reflecting very, very strong double-digit growth in each of those markets. That's supplemented a little bit at a lesser scale by Middle East and Africa. But think about China and Latin America as real drivers of our emerging market growth particularly at this window and time in fiscal year '14.
Operator:
Thank you. Your next question comes from Mike Weinstein of JP Morgan.
Mike Weinstein - JP Morgan:
Thank you, good morning. So just a couple of questions, number one, just one income statement question, in the SG&A lines you called out some benefit from Europe. I hope you could just clarify what that was?
Bill Kozy:
I think we are not hearing you. Operator, can you help us repeat that question? We didn't catch it.
Mike Weinstein - JP Morgan:
Is it a bad connection?
Chris Reidy:
Yeah.
Bill Kozy:
No, I think we got a bad connection. I am sorry, we just can't hear you. I apologize. We can't catch it.
Mike Weinstein - JP Morgan:
No worries. I will try again.
Bill Kozy:
Thank you.
Operator:
Your next question comes from Richard Newitter ofLeerink.
Richard Newitter - Leerink:
Hi, thanks for taking my question. I notice that price -- I think you said it was flat this quarter, it was up about 40 bips last quarter, can you maybe just comment on what you are seeing there in the environment and expectations for the rest of the year?
Chris Reidy:
Yes. So, this is Chris. I'll take a shot at that. The second quarter pricing was just about where we expect it to be. It was flat to slightly down a couple of basis points, right where we expected as we said pricing in the first quarter was a little bit better than we expected. So we had adjusted the pricing guidance for the year to about 20 basis points down. As we have been saying it's all about the second half of the year and particularly the fourth quarter. So we are still looking at it being down about 20 basis points for the year based on fourth quarter tenders that we are looking at and the pressures we see there, really no change since last quarter on that, kind of in line with where we were.
Richard Newitter - Leerink:
Okay, thanks a lot.
Operator:
Thank you. Your next question comes from Douglas Schenkel of Cowen and Company.
Doug Schenkel - Cowen:
Hi, good morning. Thanks for taking my questions. My first question is it appears you terminated European diagnostic distribution agreement in the quarter. Was there any revenue impact in the quarter, and do you expect any hangover associated with that? And I guess the second question somewhat related is SG&A was quite a bit lower than we expected in the quarter and dropped quite a bit sequentially. It's unclear if your guidance implies that this going to continue. Could you just talk us through how we should think about SG&A over the balance of the year? Thank you.
Chris Reidy:
Sure. The SG&A was 1.4%. As we mentioned, there was a one-time item in Europe that benefited us. It was collection of receivables that had been written off that we collected. That does flow through to the year. We increased the earnings per share by $0.03, but offsetting that was the impact of foreign exchange. As you saw that we adjusted our reported revenue guidance for foreign exchange that actually flows down through the EPS as well. So that was a couple of cents. So that foreign exchange pressure offset the benefit of the one-time item and then the [3%] (ph) rise that we had in EPS was essentially attributable to tax rate declines. So SG&A for the rest of the year absent that one-item will be still in the range basically that we had guided to.
Bill Kozy:
This is Bill. We did discontinue a distribution arrangement in Spain related to a couple of our businesses primarily with a Preanalytical systems relationship that does not carry any revenue impact for us on a go-forward basis. It's just a realignment of how we are going to go to market in that particular country.
Operator:
Thank you. Your next question is from Mike Weinstein of JP Morgan.
Mike Weinstein - JP Morgan:
Hi. (Indiscernible). So just a follow-up on that, the SG&A, the receivable benefit this quarter was about $0.03, is that what you said?
Chris Reidy:
It was actually more like $0.02. It is just slightly more than $0.02 and it was exactly offset by the FX pressure which is slightly more than $0.02.
Mike Weinstein - JP Morgan:
Perfect. Okay. And then just want to focus on the Biosciences business. It's hard to separate out the one-time positives in the first half in terms of versus the second half. Can you just talk a little bit more about the underlying business and maybe try and give us a better picture to how that second half would look actually the orders that pull them to the first half?
Linda Tharby:
Hi, Mike.
Chris Reidy:
Let me start by just saying, the best way to think about that is for the guidance for the full year. So there is lots of puts and takes quarter-to-quarter and as you remember the big impact in the fourth quarter. At the end of the third quarter last year, I think our Biosciences growth rate was 0.9%. I don't think we are close to 12% in the fourth quarter. So, lots of puts and takes. But when you boil it down or running about what we are for the year with our guidances for the year in Biosciences. And that's probably the way to think about the underlying business.
Bill Kozy:
This is Bill. I think the big factor to remember in that fourth quarter was the movement in fiscal year '13 of the Japan stimulus spend into the fourth quarter of '13. So our fourth quarter of '14 is up against a very unusual comp, a very strong Japan stimulus driven comp from FY'13. That's really the single biggest factor on that second half Bioscience growth.
Mike Weinstein - JP Morgan:
Okay. And then just to comment about less favorable pricing in the second half, what does that tie to?
Bill Kozy:
I think I didn't catch that whole thing. I heard -- less favorable pricing in the second half of the year, Chris.
Chris Reidy:
That's consistent with what we have been saying. I mean as we looked at vendors particularly in Europe, they come primarily in the fourth quarter. So I don't think you are going to see any much in the third quarter evidence either. We will be sitting here next quarter still kind of guessing what it's going to be for the year. But our best guess is kind of be down 20 basis points at this point.
Mike Weinstein - JP Morgan:
Thank you.
Operator:
Thank you. Your next question comes from Jeff Frelick of Canaccord.
Jeff Frelick – Canaccord:
Hi, good morning, folks. I just wanted to follow up on the strong Veritor placements on where you are to-date. Can you share kind of the mix, U.S. versus OUS on the 12,000 placements? Thanks.
Bill Kozy:
Sure. Let me just get back. This is Bill. I am going to give it to Alberto. He is here. Would you comment please?
Alberto Mas:
The big majority is in the U.S. There is also a component in Japan and the rest is a lot less. So those are the biggest components driving it. In the U.S. the season was milder as you probably already know in Japan it was slightly stronger than usual, but it's mainly U.S-driven.
Operator:
Thank you. Your next question is from Matt Taylor of Barclays.
Unidentified Analyst:
Hi, guys, good morning. This is actually Elliot filling in for Matt. I just wanted to touch on diabetes for a second, another nice quarter there; can you touch on any of the underlying fundamentals in that market? And maybe any other areas within that segment that maybe of interest to you guys going forward, whether it would be sensors or pumps or any other sort of product lines within that segment? That's been growing nicely for you guys that maybe of interest?
Bill Kozy:
This is Bill. We did have a solid quarter in diabetes. Interestingly enough we had double-digit growth both U.S. and international, both at right around 10% give or take a few basis points. The U.S. favorability is a continuing story. It's really around pen needle growth, and it's particularly been driven by our ongoing penetration with the Nano product. We had growth in the quarter in the U.S. on Nano that was well north of 50%. So we are really driving our penetration rates with Nano. We are wide now. We are actually north of 25% on Nano penetration. So that continues to be very, very key to the Diabetes Care business. International was also strong, and you had -- emerging market growth is the driving contributor there. Think about that being right around 17%, 18% for the quarter, similar comments to what I made before about emerging market, Latin America and Greater China being the real critical drivers there. In terms of what's next for us in Diabetes, we have referenced the fact that we continue to do product development in the area of insulin infusion. And at this point in time that is the high priority kind of product development activity in the company in the Diabetes Care business.
Operator:
Our next question is from Vijay Kumar of ISI Group.
Vijay Kumar - ISI Group:
Hey, guys, thanks for taking my question. I have a couple of specific questions on the Diagnostic piece, and one was Women's Health. In the past given this market conversion on related to end forecasting. I think you said core to 60% number. Where do you think we are? And second on BD MAX, your comments were up pretty positive. How many systems did you place in the queue, and what kind of acceleration can we expect going forward? Thanks.
Bill Kozy:
Okay. This is bill. Your question, Vijay, really on the interval testing, we got it somewhere right now, somewhere -- we think that about 60% to 65% of the physicians have adapted. It's a hard number to grab on to, but the takeaway is that we still think there is some room to go before you can see that there has been a significant 90% or higher adoption of a new interval testing. On BD MAX in terms of our placements to-date, we are right around 340 placements worldwide at this point in time. Alberto, double-check my numbers, is that …
Alberto Mas:
That's correct. It's 340 is around that number, but we are seeing encouragingly a lot of reagent throughput that is coming to our machine. So from a reagent perspective we are very really encouraged by what we are seeing and hopefully with the new launches of Enterix and other assays, we should see that increasing a lot.
Operator:
Thank you. Your next question comes from Jon Groberg of Macquarie.
Jon Groberg - Macquarie:
Hi, good morning. Thanks for taking the question. And Vince if you're listening, I hope you feel better soon. So, Bill, you guys obviously had another very strong quarter, 5% growth which is great. So I think you guys deserve some congratulations. Obviously if you break it down to one blemish is diagnostics and if I look at your second half guidance for the year, that's the one that you expect to improve in the second half. So I know you've been answering some questions on it, but maybe I can just -- if I think about the U.S. specifically, I think Women's Health at this point on your Diagnostic Systems is only like 10% to 13%, somewhere in there in terms of the revenue. So it seem like it's fairly small. Can you maybe talk about all the different pieces of the business within the U.S., and then whether or not you expect the U.S. business specifically to improve in the second half to drive that increase to 3.5 to 4.5 for the second half of the year? Thanks.
Bill Kozy:
Sure. This is Bill. I'll take a shot here. There are four key factors on that second half guidance that we provided. 1) For sure, if we have got this KIESTRA demand and we are expecting positive impacts from placements of KIESTRA, and particularly in the fourth quarter, more in the fourth quarter than in the third. 2) I mentioned the ongoing revenue performance of international. We expect that to continue, and again sustainably in that 6% or 7% range. 3) We are counting on BD MAX; we just commented on placements. Alberto mentioned our reagent pull-through running a little bit ahead of our expectation. That's a factor. And then there is a minor one, it's less important, but we don't have any point of care drag in the second half, and we took a little bit of a parachute drag on point of care in the first half. That goes away in the second half. So I'd say those four things are our key factors in upscaling that second half guidance.
Operator:
Thank you. Your next question comes from Brian Weinstein of William Blair.
Brian Weinstein - William Blair:
Hi, thanks for taking the question. You guys have talked a lot about some of the discreet benefits in the first half of the year, but what about any discreet headwinds? Can you quantify anything on seasonality, the impacts from flu, maybe calendar impacts that your peers have been consistently highlighting as calendar first quarter headwinds that should abate in the remaining quarters of the year? Thanks.
Bill Kozy:
This is Bill. We steered down a couple of other -- the things that we are paying attention to. We have to say that we didn't quantify any headwinds related to weather. It was nominal if we had anything. We did not quantify any headwinds related to U.S. utilization. I think Chris commented it's constrained but stable. And so we couldn't quantify anything there. I mean our commentary around -- our challenges, if you would, was all in that Diagnostic Systems area, and it was all concentrated in the U.S. So we could not, if you would assign any of our shortfalls to any other external factors, and I think that our ongoing international presence in emerging growth is kind of a foundation which shields us a little bit. Some of my comments about the diversity of the regional and product portfolio; that really helps us to get through these sporadic regional or country-based activities that you can experience during the course of the year.
Chris Reidy:
The thing I'd add is we did talk a little bit about the flu season being less severe. The good news for us is we actually took share with the Veritor product, and that helped make it essentially flat year-over-year, so much less severe, but upside on the market share. But having said that flat year-over-year is not what we're shooting for, so it's a little bit of a drag. But that would be the only one that I would add.
Operator:
Thank you. Your next question comes from Derik De Bruin of Bank of America.
Derik De Bruin - Bank of America:
Hi, good morning.
Chris Reidy:
Good morning.
Derik De Bruin - Bank of America:
So a little bit on the Bioscience, on the flow cytometry market, particularly on the high-end, I know we are starting to see some interest from researchers using some technologies like Mass Cytometry, sort of like with the deal that Fluidigm did with the DVS business. I'm just wondering how do you see the high-end Mass -- the high-end flow cytometry market, can you quantify how much of your business is bad versus some of the more clinical aspects, just a little bit more color on your businesses there.
Bill Kozy:
This is Bill. I'm going to turn this over to Linda. I'm not sure she -- a few comments you have that kind of a detail here today or …
Linda Tharby:
Yeah. What I can comment on is we certainly see very nice growth in our high-end research market. We had several launches in that market in the last several years. And with respect to the Fluidigm acquisition of DVS, we feel very comfortable relative to our ability to compete in that area in terms of our ease-of-use that we have with our instrument versus CyTOF placements.
Operator:
Thank you. Your next question comes from Larry Keusch of Raymond James.
Larry Keusch - Raymond James:
Hi, good morning. Two questions; on Simplist and the morphine launch specifically, obviously I know that's an important one for you guys, and you'd made some brief comments, but I'm wondering if there is anything that you can sort of add to that just relative to how that seems to be playing out? And then secondly, just on the capital allocation side, you're targeting $450 million of share repurchase for the year, but again if you can remind us how you're thinking about deployment of cash and also how much of your cash currently is sitting overseas?
Bill Kozy:
This is Bill. I'm going to turn the Simplist question over to Tom, and then he'll pass it on to Chris for the second question, if that's okay, huh?
Tom Polen:
Hi, Larry, good morning. This is Tom. So, on Simplist, just as a remainder, as Bill mentioned we've got four drugs now launched in the Simplist format. Morphine is as we have always said is actually our most significant launch to-date. It is the first drug that's both in the prefilled device, but it's also a high risk drug, the strongest value proposition of all the products today, and we view as a lead within our portfolio. We are getting very positive customer response on that early on. And as we've said before, this is a very new initiative and we still do expect that it's going to take some time for us to start seeing that ramp come through in our numbers, but positive overall feedback on morphine.
Chris Reidy:
Good, and to part two, really no change from what we've said in terms of capital deployment. We are still on track to do the 450 million of share buybacks. As you see the dividend has grown over time. We kind of like where the payout ratio is right now, so really no change from that standpoint. And from the outside the U.S. cash, the way to think about that is as we look at it between the cash on hand, it's right now in the U.S. at the end of this quarter is probably about 400 million, out of the 2.6 global. So a lot of it is outside the U.S. But between the U.S. cash on hand, the cash flow and our legal entity and dividend structure we know issues over the planning horizon and having cash to support the dividend and the share repurchase.
Operator:
Thank you. Your next question comes from Kristen Stewart of Deutsche Bank.
Kristen Stewart - Deutsche Bank:
Hi. Thanks for taking my follow-up. I just wanted to get your thoughts on M&A, if we should expect any additional activity here in the coming quarters?
Chris Reidy:
Really no change from what we had said in the past. And we've done more M&A over the last three years. I guess we've done seven deals now in the last three years or so. We are always looking for tuck-in acquisition. As usual, M&A is lumpy. So you don't do it just to do it. You do it when you got the right prospect at the right price. So no real difference in our M&A strategy from where we've been over the last two years.
Operator:
Thank you. There are no further questions. I'll now turn the floor back over to Vince Forlenza for closing remarks.
Bill Kozy:
This is Bill sitting in for Vince. Thank you all for your attendance today and participation. We appreciate your engagement and questions. And we remain committed to finishing our fiscal year '14 for the discussion we had earlier. Thanks very much.
Chris Reidy:
Thanks, everyone.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time, and have a wonderful day.
Operator:
Hello and welcome to BD's First Fiscal Quarter 2014 Earnings Call. At the request of BD, today's call is being recorded. It will be available for replay through February 11, 2014, on the Investors page of the bd.com website or by phone at 800-585-8367 for domestic calls and area code 404-537-3406 for international calls, using confirmation number 31318159. (Operator Instructions) Beginning today's call is Ms. Barbara Infante. Ms. Infante, you may begin.
Barbara Infante:
Thank you, Jackie. Good morning, everyone, and thank you for joining us to review our first fiscal quarter results. As we referenced in our press release, we are presenting a set of slides to accompany our remarks on this call. The presentation is posted on the Investor Relations page of our website at bd.com. During today's call, we will make forward-looking statements, and it is possible that actual results could differ from our expectations. Factors that could cause such differences appear in our first fiscal quarter press release and in the MD&A sections of our recent SEC filings. We will also discuss some non-GAAP financial measures with respect to our performance. A reconciliation to GAAP measures can be found in our press release and its related financial schedules and in slides. A copy of the release, including the financial schedules, is posted on the bd.com website. Leading the call this morning is Vince Forlenza, Chairman, Chief Executive Officer and President. Also joining us are Chris Reidy, Chief Financial Officer and Executive Vice President of Administration; Bill Kozy, Executive Vice President and Chief Operating Officer; Tom Polen, Group President; and Linda Tharby, Group President. It is now my pleasure to turn the call over to Vince.
Vince Forlenza:
Thank you, Barbara, and good morning, everyone. Before we get started, I would like to extend congratulations on behalf of all of us here at BD to Monique Dolecki, our Vice President of Investor Relations, and her husband on the birth of their daughter. We understand that everyone is healthy and we wish them all the best. With that, let's get started on Slide 4. As we stated in our press release, we are pleased with our strong start to the year. We experienced growth across all three of our segments with particularly strong growth in Medical and continued improvement in Biosciences. Growth was also driven by continued emerging market expansion and sales of safety-engineered products. Our first quarter results were also aided by a number of timing factors, which Chris will speak to in more details shortly. We've been talking to you for a few years about our long-term strategy for investing and innovating for growth. Back in 2011 and 2012, we embarked on a strategy to reinvigorate our portfolio with new products and complete solutions to better meet our customers' needs. We've been working to enhance our core businesses across our portfolio and expanding the categories in which we compete by moving into near adjacencies. Last year was the inflection point where we started to see the benefits of that strategy in our financial results and new products. In fiscal year 2014, we expect to continue ramping up our many recent new products and delivering on our strategy. Additionally, we announced a small acquisition in our Diagnostics segment, Alverix. They have been a technology partner of ours since 2008 on the Veritor platform. Our strong revenue and earnings growth in the first quarter along with our revised full year outlook gives us the confidence to raise the bottom end of our previous revenue and earnings guidance ranges for the full fiscal year. Moving on to Slide 5, we've outlined our first quarter revenue and EPS results, which I will speak to on a currency-neutral basis. Total company revenues were strong at 6.7%. This includes about 80 basis points from acquisitions and about 120 basis point contribution of timing items including an early flu season. Fully diluted EPS grew 8.1% over the prior year to $1.37. Excluding the impact of the medical device excise tax, adjusted EPS was $1.42 or 11.9% growth. Now I'd like to turn the call over to Chris for a more detailed review of our first quarter financial performance and updated guidance.
Chris Reidy:
Thanks, Vince, and good morning, everyone. I'd like to begin by discussing the key financial highlights for the first quarter, which I will speak to on a currency-neutral basis. As Vince just stated, results were ahead of our expectations and we experienced growth across all three of our segments. Our strong growth of 6.7% includes about 200 basis points from acquisitions and timing. Acquisitions contributed 80 basis points of growth in the first quarter, as anticipated. This was driven primarily by our Safety Syringes acquisition, which continues to perform well. We also benefited by about 100 basis points from timing in our Medical segment in both our Pharmaceutical Systems and Medical Surgical units. Additionally, we received the benefit of 20 basis points from an early flu season coupled with competitive gains in the Point of Care category. Positive pricing in the quarter of about 40 basis points was slightly ahead of our expectations. This was partially due to continued effective price management. I would like to note that based on the number of tenders anticipated in the back half of the year, pricing remains on our radar for the full year. This quarter, we experienced negative gross margin impacts from currency, raw materials, and startup costs, as anticipated. EPS in the quarter of $1.37 reflects 8.1% growth versus the prior year or about 11.9% excluding the medical device tax. EPS was ahead of our expectations this quarter largely due to our increased revenues. We repurchased about $190 million of our anticipated $450 million full-year 2014 share repurchase program. Our first quarter results and revised full year outlook give us the confidence to raise the bottom end of our revenue and EPS guidance ranges. We now expect revenues between 4.5% and 5% with adjusted EPS now expected between 9.5% and 10% excluding the medical device tax. I'll talk more specifically about guidance in a moment. Now let's move on to Slide 8 where I'll review the revenue growth by segment on a currency-neutral basis. As I just mentioned, revenue growth was 6.7% for the total company. BD Medical first quarter revenues increased 8.6%. Our results in this segment were driven by strong double-digit international growth across all business units and continued growth of safety-engineered products. Within the Medical segment, Diabetes Care growth of 10.1% reflects continued strong sales of our Nano Pen Needle products. Medical Surgical's growth was 9.1% this quarter, aided in part by a timing of orders, as I previously mentioned. Pharmaceutical Systems' growth of 5.5% reflects the strong contribution from our Safety Syringes acquisition and a benefit from timing of orders. BD Diagnostics' first quarter revenues increased 4.2%. The segment's growth was primarily driven by continued international expansion in both the Preanalytical and Diagnostic Systems units. BD Biosciences' revenue growth was slightly ahead of expectations at 5.7%. This was due to double-digit emerging market growth and clinical reagent sales. We also saw solid instrument placements in both the US and Western Europe, aided by improved stability and research market funding. We continue to see signs of stabilization in the Biosciences market. Moving on to Slide 9, I'll walk you through our geographic revenues for the first quarter. Overall, we saw stability in the US markets and an improvement in European end-markets. Particularly strong growth in Western Europe was driven by safety sales, Bioscience growth, the benefit of timing in Pharmaceutical Systems, and a favorable comparison to the prior year. BD's reported US revenues increased 2.3% versus the prior year. US growth in our Medical segment was 3.8%. Strong growth in our US Diabetes Care unit of 8.4% continues to be driven by our BD Nano Pen Needle products. Medical Surgical growth partially benefited from some one-time items. Pharmaceutical Systems' growth benefited from the SSI acquisition, which was more than offset by an unfavorable comparison to the prior year and the variability in our customers' geographic ordering patterns. US Diagnostics segment growth was about flat in the quarter due to the impact of the lost customer contract that we discussed on our last earnings call. We also saw continued declines in Women's Health, as we have been communicating with you for some time. This was partially offset by steady sales in microbiology, which includes Kiestra and the Point of Care categories. US Biosciences growth was 3.3%, driven by strong instrument placements, clinical reagents, and continued stability in the marketplace. International revenues grew 10% with double-digit emerging market growth and strong performance across the segments, particularly our Medical and Diagnostics segments. On a currency-neutral basis, the Medical segment grew 12.2%, Diagnostics grew 8.1%, and Biosciences grew 6.8%. Medical growth was driven by strong Safety sales and the benefit of timing of orders in Pharmaceuticals Systems that I mentioned previously. Diagnostics growth was solid across both the Preanalytical and Diagnostic Systems units. BD Biosciences growth benefited from solid instrument placements in Western Europe. Moving on to Slide 10, we continue to see strong growth in emerging markets, which accounted for approximately 25% of our total revenues in the first quarter. Emerging markets revenues grew 13.4% currency-neutral over the prior year. We have been making strategic investments in emerging markets over the last few years, which has helped deliver robust emerging market growth. We saw a double-digit growth in a number of our key markets, with China growing over 25% currency-neutral. Emerging markets continue to deliver significant safety growth with an increase this quarter of about 15%. Moving on to Slide 11, we have outlined our global safety revenues for the quarter. Currency-neutral safety sales increased 9.8% and grew to $557 million in the quarter. Revenues in the US increased by 8.1% and include the contribution from our SSI acquisition. International sales grew 12% on a currency-neutral basis with Western Europe and emerging markets both growing double-digits. Medical safety sales grew 14% and Diagnostics growth was 5.7%, driven by a range of safety-engineered products. Medical safety benefited from our SSI acquisition and strong growth in our Medical Surgical unit international safety portfolio. At the conclusion of this first quarter, our SSI acquisition has annualized and would be included in our base. Moving to solid 12 on gross margin, as expected and outlined to you on our last call, we experienced negative currency translation driven by the timing of the inventory movements. On a foreign currency neutral basis, benefits from our (inaudible) programs, favorable pricing and pension were more than offset by increased costs associated with raw materials, sought up items and acquisitions. Our gross profit guidance remains on track for the full year. Slide 13 recaps the first quarter income statement and highlights our foreign currency neutral results. Since I just discussed revenue and gross profit, I'll move to SSG&A, which grew 7.9%. Excluding the medical device tax, SSG&A grew about 5%, reflecting continued investments in areas such as emerging markets and new products. R&D increased just over 6%, which is in line with our expectations. Our operating income increased 3.2%. But excluding the medical device tax, operating income growth of 6.9% was slightly higher than the rate of sales this quarter. Our tax rate improved 170 basis points over the prior year. As we noted in last year's first quarter results, our tax rate was higher at that time due to some one-time items. In addition, there was a delay in the enactment of the R&D tax credit in the first quarter of last year. Both of those items contributed to a favorable comparison this quarter over the prior year. These items resulted in earnings per share of $1.37, which is an 8.1% increase versus the prior year. Excluding the impact of the medical device tax, earnings per share of $1.42 represent an 11.9% growth rate. Now turning to Slide 14, I'd like to review our updated guidance in more detail, which I will speak to on a currency-neutral basis. Our first quarter results, along with our revised full year outlook, give us the confidence to raise the bottom end of our fiscal year 2015 revenue guidance 50 basis points to 4.5% to 5% growth. This assumes a stable macroeconomic environment. As we discussed last quarter, we had reserved the bottom-end of our revenue guidance range for possible weakening in global macroeconomic conditions, unfavorable pricing impacts and/or other deteriorating factors and we're not seeing that. We have seen continued signs of stabilization in both the US and Western Europe. We are estimating a full year euro exchange rate of $1.36. Our full year outlook on pricing has improved slightly. As we noted, pricing remains a concern for the back half of the year. Given the current pricing environment, we are updating our pricing outlook to about 20 basis points of pressure for the year from our previous range of 20 basis point to 40 basis point. Within the segments, we are increasing our guidance for the Medical and Bioscience segments. And I expect the Medical segment to grow 5% to 5.5% and the Bioscience segment to grow about 4% for the year. Diagnostics segment growth expectation remained between 3.5% and 4.5% for the year. We remain on track to meet our goal of about 70 basis points to 80 basis points of operating margin expansion for the full year excluding the impact of foreign currency and the medical device tax. About half of that benefit is expected from favorable pension assumptions along with 30 basis points to 40 basis points of underlying margin expansion. In addition to revenues, we are raising the bottom end of our full fiscal year adjusted EPS guidance range by 50 basis points to between 9% and 9.5%. Excluding the medical device tax, we expect EPS to grow 9.5% to 10%. As a reminder, with the conclusion of our first quarter, the medical device excise tax has annualized and will be included in our base. Reported fully diluted EPS for the full year is now expected between $6.19 and $6.22. All other guidance components remain unchanged from what we provided on our year-end call in November. The revenue and earnings profile that we outlined for you on our last call remain intact. Revenue growth is still expected to be stronger in the first half of the year, accentuated by our accelerated first quarter results. Earnings growth is still anticipated to be weighted in the back half of the year, although that effect is slightly muted by our first quarter timing benefit. Looking forward, a good way to think about the balance of the year is that a number of the timing benefits that we experienced this quarter, will reverse during the second and third quarters. I would like to turn the call back over to Vince who will provide you with an update on our product portfolio.
Vince Forlenza:
Thank you, Chris. Now moving on to Slide 16, we see the program and product launches in our Medical and Biosciences segments. In fiscal years 2012 and 2013, we launched about 30 new products. As we've been communicating with you, our percentage of revenue from new products is coming from about 8% of our overall revenues in 2011 to an expected 15% or 16% by the end of this fiscal year. This year, we will focus on the successful scale-up of our recent years' new products and solutions, while continuing to add products who complement these offerings. In the Medical segment, we continue to look forward to the continued rollout of our new BD Simplist line of prefilled generic injectables. We currently have four drugs approved by the FDA, including our recent morphine approval, which we expect to launch in the coming months. We have five or four additional drug approvals with the FDA and we will update you as they complete the approval process. As we've been sharing with you, this is still a very new initiative and it will take some time for these products to gain traction in the marketplace. Our Simplist initiative is a good example of our strategy of building on our expertise to move into adjacent spaces. In our Biosciences segment, we are looking forward to the launch of our BD FACSPresto CD4 analyzer in addition to additional product offerings in our Sirigen dye portfolio. On Slide 17, you will see the various product launches in Diagnostics. We recently received FDA approval on our Staph SR and MRSA XT Assays on our BD MAX platform. We continue to focus on menu expansion and expect another four assays to be approved this fiscal year, including our Enteric Bacteria assay. We placed over 40 instruments in the first quarter, bringing our total number of placements currently in excess of 300. We remain very pleased with our BD Veritor Point of Care device. We've placed over 10,000 units to date, driving competitive gains for us in this growing market. Our BD Totalys front-end automation launched in Europe recently and our early customer feedback has been very positive. We anticipate the US rollout of this instrument in 2015. Also, our new BD Viper LT platform and BD Onclarity HPV assay are now CE marked and launched in Europe. Viper LT will provide fully integrated automated molecular test capability running both PCR and STA amplification menu. These include CT/GC and high-risk HPV. Our BD Onclarity HPV assay is the first DNA-based HPV assay that reports broad genotyping results for each patient with no additional processes. These products support our women's health and cancer business and are fully compatible with our shortpass liquid based cytology cancer screening test. We are particularly excited about our ability to provide broader HPV genotyping results as we see more clinical evidence that specific genotypes indicate a higher risk of developing cervical disease. Of course, we will continue to update you as we make progress on our pipeline initiatives. On Slide 18, before we open the call to questions, I'd like to reiterate the key messages from our discussion today. First, we are pleased with our strong start to fiscal year 2014 with solid underlying growth. Growth across all of our segments contributed to this quarter's results with particular growth in Medical and continued improvement in Biosciences. Second, our long-term strategy of investing in innovating for growth continues to deliver positive results. Key revenue opportunities will be driven by new products, tuck-in acquisitions, continued geographic expansion and sales of safety-engineered products. We are continuing to build on our leading global position and enhance our already robust core across all six worldwide businesses. Third, we are focusing on developing complete solutions to meet our customers' needs and improve clinical outcomes. We expect to expand the categories in which we currently compete by continuing to move into near adjacencies. We are raising the bottom end of our previous guidance ranges for revenue and EPS and have continuing confidence that we have built a solid foundation for future growth. Finally, we remain committed to delivering continued value to our customer and shareholders. Thank you. We will now open the call to questions.
Operator:
(Operator Instructions) Our first question is coming from David Roman of Goldman Sachs.
David Roman:
I wanted to see if you could go into a little bit more detail just on emerging markets overall as well as some of the tenders that you referenced in your prepared remarks, and I guess more specifically on emerging markets and not to sort of be negative on a 13% growth rate, but China is growing 25%, maybe you could just give some perspective on what's happening elsewhere, and obviously recently there've been a number of concerns as it relates to the macro environment in EM and healthcare spending? And then, I guess, lastly if you could just touch on the tenders you referenced in a little more detail.
Vince Forlenza:
Yes, we did have strong growth in emerging markets. China was up 25%. The only place where we had actually some negative timing is just a matter of when tenders come in is the Middle East. So we did well in Latin America. We did well in Asia-Pacific, but it was really some softness in the timing of tenders in EMA for us, that was the difference.
Operator:
Our next question comes from the line of Kristen Stewart with Deutsche Bank.
Robyn Karnauskas:
It's Robyn for Kristen, so I just wanted to touch on price. You guys obviously had a pretty good quarter, up 40 bps, and now you have taken your expectations up a little bit for the year. Can you just touch on what you're seeing more broadly in terms of pricing developed in the emerging markets?
Bill Kozy:
We had good solid price contribution, particularly from our Medical segment in the quarter, and that driven in part by Diabetes Care price improvement, and favorable mix and price from the Pharm Systems side. And those two units were significant price contributors to the company's overall price impact.
Operator:
Our next question comes from the line of Mike Weinstein with JPMorgan.
Kimberly Gailun:
It's Kim in for Mike. Just a follow-up on the price question as it pertains to diabetes, so you saw some really nice strength in the US Diabetes business, it sounds like it is driven primarily by Nano. And just maybe talk about why we're seeing the pickup now, what kind of account conversion and partnership you're seeing on the Nano side? And maybe, if you can, tie it in a little bit of your longer-term strategy on the Diabetes side?
Vince Forlenza:
First question was around how is Nano doing and where are we in the conversion of this, and then does this set the stage for a broader play in Diabetes Care, and we're still early on in the conversion to Nano. Yes, we're doing well in the U.S., but we're also doing well in other geographies with Nano. We do price Nano at a price premium. And so, you are seeing that in both the Medical segment's results, and Bill was referring to that, and in the company's results. And as part of a broader strategy in Diabetes Care, we are continuing to refresh the core, but we're also working on some new product areas that we touched on before, and Bill maybe you want to comment on some of the adjacencies that we're looking at in terms of moving into it.
Bill Kozy:
We're looking to explore other insulin delivery opportunities that we have in particular. We have referenced before a project we have on insulin infusion, and we're also actively looking at a longer-term program related to patch-pen types of insulin delivery. Those would be at the top of our project list for adjacency moves over the next two to four years.
Vince Forlenza:
And of course, we have the CGM, which is still really in technology development. So a significantly broader play in the longer term in Diabetes Care.
Operator:
Our next question comes from the line of Brian Weinstein with William Blair.
Brian Weinstein:
Was the Quest impact fully reflected in the first quarter results or is there an incremental step-down coming? Can you also just comment broadly about some of the trends you're seeing in the US diagnostics markets as there continue just to be a little bit lower than, I guess, what we thought even in light of some of the secular stuff going on? Thanks.
Vince Forlenza:
So in terms of that account loss, it was in the first quarter. It's slightly weighted more towards the second half of the year, but it's not a major step change would be the way to think about it. It was significant in the first quarter for the Diagnostics business.
Operator:
Our next question comes from the line of Richard Newitter with Leerink Swann.
Richard Newitter:
Just a broader macro question. We’ve heard from some other players that there could be some pull-through in strength, and seasonality in the calendar year fourth quarter or year-end deductibles, etc.. Could you comment on anything that you may or may not be seeing on this front and any commentary there on what this might portend for the quarter ahead and maybe the rest of the year?
Vince Forlenza:
So, we did talk about 120 basis points of timing within the quarter, but that was not seasonal timing. I'm going to ask Tom Polen to just comment on some of the timing that occurred on the Medical segment or just a major piece of it for us.
Tom Polen:
As Vince said, there were two businesses that we saw timing impact us in the quarter and in the segment were in Med Surg, specifically around clearing a backorder in the US as well as in the Pharm Systems, which tends to have some lumpiness associated with large customer purchases. So if you exclude that, as commented earlier, underlying growth was lower than reported, and those we view as one-time activities that were just in the first quarter.
Operator:
Our next question comes from the line of Matthew Taylor with Barclays.
Dan Sollof:
It's actually Dan in for Matt. And I had a question on the visibility you have in Biosciences. We've seen improvements there and you guys picked up your expectation for the year. But just into account conditions and the pressures that you've talked about in the US restructuring market, just wondering if you can address picking your expectation, is that really a function of both the US and OUS or just OUS?
Linda Tharby:
As you know that we're continuing to see in the US market with the recently released NIH funding continued stability in that market. But ex-US, we also saw some turnaround in Western Europe, which was positive for us. And also, we continued to see strength in emerging markets. So US stabilization and growth in Western Europe would have been the biggest turnaround.
Operator:
Our next question comes from the line of Bill Quirk with Piper Jaffray.
Bill Quirk:
First off, obviously European safety has been a nice growth driver here following the adoption of the safety directive last spring. Are you still going to suggest that there's a pretty significant proportion of hospitals that are not yet compliant with the directive? And so, Vince, help us think a little bit about how you frame the ongoing opportunity and then just help us think about the duration of the tail-wind.
Vince Forlenza:
Yes, we did see an uptick in European safety this quarter. And what was significant was we saw some uptick in Southern Europe for the first time. And so some of the first significant orders to matched geography. So there is a lot of runway here. There's still runway in Northern Europe as well. So we think the story has a few years to go in terms of ramping up. We would continue to think that this is not a step change kind of gain, that it's more of a hospital-by-hospital convert as these countries come online. So not US step-change situation, but kind of a steady movement in terms of conversion. Tom, is there anything else you'd like to add to that?
Tom Polen:
The only other thing to mention is you know the US is quite mature in the 90s, just to put it in perspective. We see EU overall at about 60% converted for catheters, about 15% converted for injection systems and I think about 45% for blood collection systems. So I think that just reinforces, as Vince mentioned, there's still some room and several years of conversion to go there.
Operator:
Our next question comes from the line of Derik De Bruin with Bank of America.
Derik De Bruin:
Was there any change to tax rate guidance for 2014, just to remind us on that? And I guess do you expect any impact from the weather in the US in the second quarter?
Vince Forlenza:
The tax rate guidance stays the same, 23.5% to 23.7%. So there is no change in that. The tax rate in the first quarter was as anticipated. In terms of the weather, very difficult to say whether we'll see any impact from the weather or not. And I guess there's probably not, but who knows what's going to happen in February and the rest of the quarter. But no so far.
Operator:
Our next question comes from the line of Brandon Couillard with Jefferies.
Brandon Couillard:
Vince, with the Simplist morphine product shipping in the second or third quarter, could you quantify the addressable market size for that specific product? And do you think you have enough approvals under your belt at this point to broadly go to market and capture market share or do you feel like you still need a few more approvals to make a broader push there?
Vince Forlenza:
We haven't broken it drug-by-drug, but it is one of the bigger ones now. And so it's a step-up for us in terms of addressable market. We said the market is about $1.2 billion in the US and we're targeting about 60% of that, so over $700 million. But Tom can comment on the kind of the competitive dynamics and the menu in terms of where we are and how we seize that? Tom?
Tom Polen:
I think we think about it in two ways. One is just regarding morphine and its relevance, we have three drugs on the market today if you think about the value of a prefilled drug delivery system and its ability to help reduce errors in the delivery process. The drugs that we on the markets today, some of them are sizeable in terms of market size, but are not necessarily high on the ranking of drugs associated with medication. Morphine really represents the first drug which is in the top 10 list of drugs associated with serious medications. So we see that the value proposition for morphine is really a key catalyst for us in that category. Are we still looking to broaden out our menu within the prefilled space? Absolutely. And I think as was mentioned earlier from Chris, we do have four additional drug approvals pending with the FDA and under varying stages of review. And so overall, as we discussed previously, this is a very new initiative and it is going to take some time for these products to gain traction in the marketplace.
Operator:
Our next question comes from the line of Jeff Frelick with Canaccord.
Jeff Frelick:
Vince, could you share some ways for acquiring the Alverix business? I assume you want to do more of the product menu. And do you have plans for the mini product that Alverix has?
Vince Forlenza:
We bought Alverix. They were a supplier, I think, as most people know of the Veritor system. And we were going to be co-developing a next-generation system with them. It made sense from a financial standpoint to bring that in-house and get complete control of it. We are in the process of continuing to ramp up that menu. We're still waiting for RSE approval in terms of the CLIA waiver, but the product is now intended to have some placements. So it just made a lot of sense as we expand the menu and continue to move into the POC space that we brought that technology in-house.
Operator:
Our next question comes from the line of Vijay Kumar with ISI Group.
Vijay Kumar:
One, in China, the 25% was really strong. I think it came in well above what some of your peers are reporting. Can you tell us what's driving the strength and the sustainability of the strong double-digit? And the second one was in the MAX. Are you seeing any pickup in system placements or give any color on installed base?
Vince Forlenza:
China, we continue to do well across the board with our entire portfolio. So it's balanced with Medical seeing the biggest part of that business and a very strong performance in our infusion business. So strong across the board, Medical being the largest. And I think we're seeing the benefits of our ability now to move into tier-2 to expand the distribution in China. And all of that is going quite well. In terms of BD MAX, I think Bill Kozy will comment on that.
Bill Kozy:
We placed just north of 40 new MAXes particularly in the US and Europe and that would put our total placements to date just a little bit beyond 300. Of course, when we get the menu for the Enteric and some of the other menu that Vince mentioned, that will continue to help us. But we're comfortable with our placements for the quarter and our outlook for the year.
Operator:
Our next question comes from the line of Doug Schenkel with Cowen and Company.
Doug Schenkel:
Just like some of the competitors in the US microbiology market have been pretty well over the past few quarters, can you just provide an update on competitive dynamics, end-market trends and core, I would say, US microbiology market? And then in light of MALDI-TOF and Kiestra, have they increased the catheter equipment mix in microbiology, had any effect on your visibility there?
Vince Forlenza:
The fact that we're selling more catheter because of Kiestra and what not, we have a very good view on that pipeline and we're doing well in core microbiology in the US and globally. And, Bill, anything else you'd like to add to that?
Bill Kozy:
No, just to echo Vince's comment, we didn't have any Kiestra placements yet in the US. So all of our growth in the US on that side was driven by very, very solid BACTEC and PHOENIX activity, as well as the Point of Care reference. So that total grouping of products that we tend to call Infection Prevention and Management and you got microbiology in there and Point of Care and Kiestra, if you just looked at the US, we got nice mid-single-digit growth in the quarter, which we were pleased with.
Operator:
Our final question comes from the line of Jon Groberg with Macquarie.
Jon Groberg:
Vince, on the emerging markets, if you strip down, about half of your growth is still coming from emerging markets. And I guess as a manager, given all the noise that we hear about, what are you looking at, what are the data points you're looking at to kind of track or what you're focusing on to see whether or not some of the growth slows down from these very high rates? Obviously there's a long runway there. Just curious given some of the challenges, what you're looking for?
Vince Forlenza:
The teams in the emerging markets will tend to have scorecards and they're looking at what's happening with various GDP statistics, then they're looking at healthcare spending and how healthcare spending is moving year-on-year, whether it's catheter or whether it's starting to move from bricks and mortar supplying those hospitals. So there's a number of different measures that they're looking at. And then I don't think they're more tender-driven. They're looking at the follow-up tenders in terms of what's in the queue to be brought.
Bill Kozy:
Well, I think I'd say that there's government health needs and their priority. Our focus on collaborating around the significant governmental agenda for their health programs for the coming years and almost all governments around the world have got that is a key point of engagement. If you link that to all the factors that Vince mentioned, we kind of get a constant rolling view of what we want to be doing in that particular targeted market.
Vince Forlenza:
And then lastly, we'll be in contact with the NGOs in those regions in terms of what they're looking to do and the programs that they have, so that we can stay on top of those. So those are kind of broadly what we look at.
Operator:
That was our final question. I'd like to turn the floor back over to Vince Forlenza for any additional or closing remarks.
Vince Forlenza:
So thank you to all of you for participating in our call today. We said we were pleased with the strong start to the year. We're happy to take up the bottom end of our values and we look forward to moving ahead with a strategy as we have it and updating you on the next quarterly call. Thank you very much.
Operator:
Thank you. This does conclude today's teleconference. Please disconnect your lines at this time and have a wonderful day.