• Medical - Instruments & Supplies
  • Healthcare
Baxter International Inc. logo
Baxter International Inc.
BAX · US · NYSE
36.92
USD
+2.28
(6.18%)
Executives
Name Title Pay
Ms. Tobi Karchmer M.D., M.S. Senior Vice President and Chief Medical & Scientific Officer --
Mr. Charles Rusty Patel Senior Vice President & Chief Information Officer --
Mr. David S. Rosenbloom Executive Vice President & General Counsel 777K
Mr. Alok Sonig B.E., Mba Executive Vice President & Group President of Pharmaceuticals 1.56M
Ms. Stacey Eisen Senior Vice President, Chief Communications Officer & Corporate Marketing? --
Mr. Joel T. Grade Executive Vice President & Chief Financial Officer 830K
Ms. Heather Knight Executive Vice President & Group President of Medical Products and Therapies 1.63M
Ms. Clare Trachtman Vice President of Investor Relations --
Mr. Christopher A. Toth Executive Vice President & Group President of Kidney Care 5.26M
Mr. Jose E. Almeida Chairman of the Board, President & Chief Executive Officer 3.62M
Insider Transactions
Date Name Title Acquisition Or Disposition Stock / Options # of Shares Price
2024-06-03 Toth Christopher A. EVP,Group Pres, Kidney Care D - F-InKind Common Stock, $1 par value 15202 34.08
2024-06-03 Rosenbloom David S. EVP and General Counsel D - F-InKind Common Stock, $1 par value 784 34.08
2024-05-07 WILVER PETER M director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 Wilkes David S. director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 Wendell Amy McBride director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 Smith Cathy R director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 Shafer David Brent director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 SCHLICHTING NANCY M director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 RUSCKOWSKI STEPHEN H director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 Oesterle Stephen N. director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 MORRISON PATRICIA director A - A-Award Common Stock, $1 par value 5952 0
2024-05-07 Ampofo William A. II director A - A-Award Common Stock, $1 par value 5952 0
2024-03-06 Toth Christopher A. EVP,Group Pres, Kidney Care A - A-Award Common Stock, $1 par value 119076 0
2024-03-06 Stevens Brian SVP, CAO & Controller A - A-Award Common Stock, $1 par value 14289 0
2024-03-06 Sonig Alok EVP,Group President, Pharma A - A-Award Common Stock, $1 par value 83353 0
2024-03-06 Rosenbloom David S. EVP and General Counsel A - A-Award Common Stock, $1 par value 53584 0
2024-03-06 Rasul Reazur EVP,Group Pres, Healthcare A - A-Award Common Stock, $1 par value 83353 0
2024-03-06 Mason Jeanne K EVP, Chief HR Officer A - A-Award Common Stock, $1 par value 47630 0
2024-03-06 Borzi James W EVP,Chief Supply Chain Officer A - A-Award Common Stock, $1 par value 33341 0
2024-03-06 Knight Heather EVP,Group Pres,Med Products A - A-Award Common Stock, $1 par value 107168 0
2024-03-06 ALMEIDA JOSE E Chairman, CEO, President A - A-Award Common Stock, $1 par value 142891 0
2024-03-06 Grade Joel T. EVP and CFO A - A-Award Common Stock, $1 par value 42867 0
2024-03-04 Stevens Brian SVP, CAO & Controller D - F-InKind Common Stock, $1 par value 545 42.5
2024-03-04 Rasul Reazur EVP, Group Pres, Healthcare D - F-InKind Common Stock, $1 par value 522 42.5
2024-03-04 Knight Heather EVP,Group Pres, Med Products D - F-InKind Common Stock, $1 par value 1320 42.5
2024-03-04 Mason Jeanne K EVP, Chief HR Officer D - F-InKind Common Stock, $1 par value 475 42.5
2024-03-04 Borzi James W EVP,Chief Supply Chain Officer D - F-InKind Common Stock, $1 par value 420 42.5
2024-03-04 ALMEIDA JOSE E Chairman, CEO, President D - F-InKind Common Stock, $1 par value 4779 42.5
2024-03-01 Stevens Brian SVP, CAO & Controller D - F-InKind Common Stock, $1 par value 673 41.01
2024-03-01 Sonig Alok EVP, Group President, Pharma D - F-InKind Common Stock, $1 par value 1832 41.01
2024-03-01 Rosenbloom David S. EVP and General Counsel D - F-InKind Common Stock, $1 par value 1416 41.01
2024-03-01 Rasul Reazur EVP, Group Pres, Healthcare D - F-InKind Common Stock, $1 par value 1538 41.01
2024-03-01 Mason Jeanne K EVP, Chief HR Officer A - M-Exempt Common Stock, $1 par value 64488 37.17
2024-03-01 Mason Jeanne K EVP, Chief HR Officer D - S-Sale Common Stock, $1 par value 64488 40.61
2024-03-01 Mason Jeanne K EVP, Chief HR Officer D - F-InKind Common Stock, $1 par value 963 41.01
2024-03-01 Mason Jeanne K EVP, Chief HR Officer D - M-Exempt Stock Option (Right to Buy) 64488 37.17
2024-03-01 Knight Heather EVP, Group Pres, Med Products D - F-InKind Common Stock, $1 par value 2154 41.01
2024-03-01 Borzi James W EVP, Chief Supply Chain Offcr D - F-InKind Common Stock, $1 par value 852 41.01
2024-03-01 ALMEIDA JOSE E Chairman, CEO, President D - F-InKind Common Stock, $1 par value 9701 41.01
2024-02-12 Knight Heather EVP, Group Pres, Med Products A - A-Award Common Stock, $1 par value 1027 0
2024-02-12 Knight Heather EVP, Group Pres, Med Products D - F-InKind Common Stock, $1 par value 356 40.31
2023-03-01 Knight Heather EVP, Group Pres, Med Products D - Common Stock, $1 par value 0 0
2024-02-12 Rasul Reaz EVP, Group Pres, Healthcare A - A-Award Common Stock, $1 par value 716 0
2024-02-12 Rasul Reaz EVP, Group Pres, Healthcare D - F-InKind Common Stock, $1 par value 248 40.31
2024-02-12 Stevens Brian SVP, CAO & Controller A - A-Award Common Stock, $1 par value 821 0
2024-02-12 Stevens Brian SVP, CAO & Controller D - F-InKind Common Stock, $1 par value 284 40.31
2024-02-12 Mason Jeanne K EVP, Chief HR Officer A - A-Award Common Stock, $1 par value 4602 0
2024-02-12 Mason Jeanne K EVP, Chief HR Officer D - F-InKind Common Stock, $1 par value 1463 40.31
2024-02-12 Borzi James W EVP, Chief Supply Chain Office A - A-Award Common Stock, $1 par value 4184 0
2024-02-12 Borzi James W EVP, Chief Supply Chain Office D - F-InKind Common Stock, $1 par value 1311 40.31
2024-02-12 ALMEIDA JOSE E Chairman, CEO, President A - A-Award Common Stock, $1 par value 32884 0
2024-02-12 ALMEIDA JOSE E Chairman, CEO, President D - F-InKind Common Stock, $1 par value 10863 40.31
2023-12-01 Grade Joel T. EVP and CFO A - A-Award Stock Option (Right to Buy) 102273 36.55
2023-12-01 Grade Joel T. EVP and CFO A - A-Award Common Stock, $1 par value 25189 0
2023-12-01 Grade Joel T. EVP and CFO A - A-Award Common Stock, $1 par value 27988 0
2023-12-01 Stevens Brian SVP, CAO & Controller A - A-Award Common Stock, $1 par value 13994 0
2023-10-18 Grade Joel T. EVP, Chief Financial Officer D - Common Stock, $1 par value 0 0
2023-09-01 Sonig Alok EVP, Group President, Pharm D - F-InKind Common Stock, $1 par value 2059 40.6
2023-09-01 Borzi James W EVP, Chief Supply Chain Office A - A-Award Common Stock, $1 par value 12016 0
2023-08-21 RUSCKOWSKI STEPHEN H director A - A-Award Common Stock, $1 par value 3049 0
2023-08-21 RUSCKOWSKI STEPHEN H director D - Common Stock, $1 par value 0 0
2023-06-29 Ampofo William A. II director A - A-Award Common Stock, $ par value 3811 0
2023-06-29 Ampofo William A. II director D - Common Stock, $1 par value 0 0
2023-06-01 Stevens Brian SVP,Interim CFO,CAO&Cntrl A - A-Award Common Stock, $1 par value 5909 0
2023-06-01 Rosenbloom David S. SVP and General Counsel D - F-InKind Common Stock, $1 par value 762 41.23
2023-06-01 Toth Christopher A. EVP, Group Pres, Kidney Care A - A-Award Common Stock, $1 par value 106358 0
2023-06-01 Toth Christopher A. EVP, Group Pres, Kidney Care D - Common Stock, $1 par value 0 0
2023-05-02 WILVER PETER M director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 Wilkes David S. director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 Wendell Amy McBride director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 Smith Cathy R director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 Shafer David Brent director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 SCHLICHTING NANCY M director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 Oesterle Stephen N. director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 MORRISON PATRICIA director A - A-Award Common Stock, $1 par value 4573 0
2023-05-02 Mahoney Michael F director A - A-Award Common Stock, $1 par value 4573 0
2023-03-20 STROUCKEN ALBERT P L director A - M-Exempt Common Stock, $1 par value 3930 36.93
2023-03-20 STROUCKEN ALBERT P L director D - S-Sale Common Stock, $1 par value 3930 37.52
2023-03-20 STROUCKEN ALBERT P L director D - M-Exempt Stock Option (Right to Buy) 3930 36.93
2023-03-20 Stevens Brian SVP. CAO and Controller D - F-InKind Common Stock, $1 par value 161 38.19
2023-03-03 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 184 39.94
2023-03-03 Rasul Reaz EVP, Group Pres, Healthcare D - F-InKind Common Stock, $1 par value 148 39.94
2023-03-03 Knight Heather EVP, Group Pres, Medical D - F-InKind Common Stock, $1 par value 220 39.94
2023-03-02 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 418 39.62
2023-03-02 SACCARO JAMES EVP, Chief Financial Officer D - F-InKind Common Stock, $1 par value 1061 39.62
2023-03-02 Rasul Reaz EVP, Group Pres, Healthcare D - F-InKind Common Stock, $1 par value 416 39.62
2023-03-02 Mason Jeanne K SVP, Human Resources D - F-InKind Common Stock, $1 par value 460 39.62
2023-03-02 Kunzler Jacqueline SVP, Chief Quality Officer D - F-InKind Common Stock, $1 par value 271 39.62
2023-03-02 Knight Heather EVP, Group Pres, Medical D - F-InKind Common Stock, $1 par value 1067 39.62
2023-03-02 Franzi Cristiano SVP, President, EMEA D - F-InKind Common Stock, $1 par value 146 39.62
2023-03-02 Borzi James W SVP, Global Supply Chain D - F-InKind Common Stock, $1 par value 474 39.62
2023-03-02 ALMEIDA JOSE E Chairman, CEO and President D - F-InKind Common Stock, $1 par value 4642 39.62
2023-03-01 Sonig Alok EVP, Group President, Pharm A - A-Award Stock Option (Right to Buy) 63965 39.06
2023-03-01 Sonig Alok EVP, Group President, Pharm A - A-Award Common Stock, $1 par value 15428 0
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare A - A-Award Stock Option (Right to Buy) 63965 39.06
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare A - A-Award Common Stock, $1 par value 15428 0
2023-03-01 Knight Heather EVP, Group Pres, Medical A - A-Award Stock Option (Right to Buy) 89551 39.06
2023-03-01 Knight Heather EVP, Group Pres, Medical A - A-Award Common Stock, $1 par value 21600 0
2023-03-01 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 6788 0
2023-03-01 Stevens Brian SVP, CAO and Controller A - A-Award Stock Option (Right to Buy) 14072 39.06
2023-03-01 SACCARO JAMES EVP, Chief Financial Officer A - A-Award Common Stock, $1 par value 22217 0
2023-03-01 SACCARO JAMES EVP, Chief Financial Officer A - A-Award Stock Option (Right to Buy) 92109 39.06
2023-03-01 Rosenbloom David S. SVP and General Counsel A - A-Award Stock Option (Right to Buy) 57568 39.06
2023-03-01 Rosenbloom David S. SVP and General Counsel A - A-Award Common Stock, $1 par value 13885 0
2023-03-01 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 10491 0
2023-03-01 Mason Jeanne K SVP, Human Resources A - A-Award Stock Option (Right to Buy) 43496 39.06
2023-03-01 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Stock Option (Right to Buy) 25586 39.06
2023-03-01 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 6171 0
2023-03-01 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 24685 0
2023-03-01 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 15428 0
2023-03-01 Franzi Cristiano SVP, President, EMEA A - A-Award Stock Option (Right to Buy) 63965 39.06
2023-03-01 Flynn Steven SVP, President, APAC A - A-Award Common Stock, $1 par value 12343 0
2023-03-01 Flynn Steven SVP, President, APAC A - A-Award Stock Option (Right to Buy) 25586 39.06
2023-03-01 Flynn Steven SVP, President, APAC A - A-Award Common Stock, $1 par value 6171 0
2023-03-01 Borzi James W SVP, Global Supply Chain A - A-Award Stock Option (Right to Buy) 35820 39.06
2023-03-01 Borzi James W SVP, Global Supply Chain A - A-Award Common Stock, $1 par value 8640 0
2023-03-01 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 67884 0
2023-03-01 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Stock Option (Right to Buy) 281445 39.06
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Common Stock, $1 par value 0 0
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Stock Option (Right to Buy) 6417 50.77
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Stock Option (Right to Buy) 8334 51.21
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Stock Option (Right to Buy) 15684 66.31
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Stock Option (Right to Buy) 17147 74.73
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Stock Option (Right to Buy) 14940 75.75
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Stock Option (Right to Buy) 15207 77.15
2023-03-01 Rasul Reaz EVP, Group Pres, Healthcare D - Stock Option (Right to Buy) 8269 85.23
2023-03-01 Sonig Alok EVP, Group President, Pharm D - Common Stock, $1 par value 0 0
2023-03-01 Sonig Alok EVP, Group President, Pharm D - Stock Option (Right to Buy) 25604 56.76
2023-03-01 Knight Heather EVP, Group Pres, Medical D - Common Stock, $1 par value 0 0
2023-03-01 Knight Heather EVP, Group Pres, Medical D - Stock Option (Right to Buy) 18861 74.73
2023-03-01 Knight Heather EVP, Group Pres, Medical D - Stock Option (Right to Buy) 20000 75.84
2023-03-01 Knight Heather EVP, Group Pres, Medical D - Stock Option (Right to Buy) 20979 75.75
2023-03-01 Knight Heather EVP, Group Pres, Medical D - Stock Option (Right to Buy) 21780 77.15
2023-03-01 Knight Heather EVP, Group Pres, Medical D - Stock Option (Right to Buy) 24807 85.23
2023-02-21 Kunzler Jacqueline SVP, Chief Quality Officer A - M-Exempt Common Stock, $1 par value 4163 37.82
2023-02-21 Kunzler Jacqueline SVP, Chief Quality Officer D - S-Sale Common Stock, $1 par value 3813 40.5
2023-02-21 Kunzler Jacqueline SVP, Chief Quality Officer D - M-Exempt Stock Option (Right to Buy) 4163 37.82
2023-02-13 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 646 0
2023-02-13 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 224 40.5
2023-02-13 SACCARO JAMES EVP, Chief Financial Officer A - A-Award Common Stock, $1 par value 3362 0
2023-02-13 SACCARO JAMES EVP, Chief Financial Officer D - F-InKind Common Stock, $1 par value 1059 40.5
2023-02-13 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 3621 0
2023-02-13 Mason Jeanne K SVP, Human Resources D - F-InKind Common Stock, $1 par value 1061 40.5
2023-02-13 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 2068 0
2023-02-13 Kunzler Jacqueline SVP, Chief Quality Officer D - F-InKind Common Stock, $1 par value 715 40.5
2023-02-13 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 5174 0
2023-02-13 Franzi Cristiano SVP, President, EMEA D - F-InKind Common Stock, $1 par value 275 40.5
2023-02-13 Flynn Steven SVP, President, APAC A - A-Award Common Stock, $1 par value 516 0
2023-02-13 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 31044 0
2023-02-13 ALMEIDA JOSE E Chairman, CEO and President D - F-InKind Common Stock, $1 par value 10053 40.5
2023-01-17 Mason Jeanne K SVP, Human Resources A - M-Exempt Common Stock, $1 par value 59477 37.82
2023-01-17 Mason Jeanne K SVP, Human Resources D - S-Sale Common Stock, $1 par value 59477 44.7
2023-01-17 Mason Jeanne K SVP, Human Resources D - M-Exempt Stock Option (Right to Buy) 19825 0
2023-01-17 Mason Jeanne K SVP, Human Resources D - M-Exempt Stock Option (Right to Buy) 19826 0
2023-01-17 Mason Jeanne K SVP, Human Resources D - M-Exempt Stock Option (Right to Buy) 19826 0
2022-09-01 Borzi James W SVP, Global Supply Chain D - F-InKind Common Stock, $1 par value 4649 56.76
2022-07-12 Flynn Steven SVP, President, APAC D - Common Stock, $1 par value 0 0
2022-07-12 Flynn Steven SVP, President, APAC D - Stock Option (Right to Buy) 4887 37.38
2022-07-12 Flynn Steven SVP, President, APAC D - Stock Option (Right to Buy) 11230 50.77
2022-07-12 Flynn Steven SVP, President, APAC D - Stock Option (Right to Buy) 8402 66.31
2022-07-12 Flynn Steven SVP, President, APAC D - Stock Option (Right to Buy) 10288 74.73
2022-07-12 Flynn Steven SVP, President, APAC D - Stock Option (Right to Buy) 12715 75.75
2022-07-12 Flynn Steven SVP, President, APAC D - Stock Option (Right to Buy) 15207 77.15
2022-07-12 Flynn Steven SVP, President, APAC D - Stock Option (Right to Buy) 6064 85.23
2022-06-01 Rosenbloom David S. SVP and General Counsel A - A-Award Stock Option (Right to Buy) 33442 0
2022-05-10 WILVER PETER M A - A-Award Common Stock, $1 par value 2481 0
2022-05-10 WILVER PETER M director D - Common Stock, $1 par value 0 0
2022-05-10 Shafer David Brent A - A-Award Common Stock, $1 par value 2481 0
2022-05-10 Shafer David Brent director D - Common Stock, $1 par value 0 0
2022-05-03 Wilkes David S. A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 Wendell Amy McBride A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 STROUCKEN ALBERT P L A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 Smith Cathy R A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 SCHLICHTING NANCY M A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 Oesterle Stephen N. A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 MORRISON PATRICIA A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 Mahoney Michael F A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 HELLMAN PETER S A - A-Award Common Stock, $1 par value 2706 0
2022-05-03 Chen Thomas F A - A-Award Common Stock, $1 par value 2706 0
2022-04-18 Rosenbloom David S. SVP and General Counsel D - Common Stock, $1 par value 0 0
2022-04-05 STROUCKEN ALBERT P L director A - M-Exempt Common Stock, $1 par value 4020 29.52
2022-04-05 STROUCKEN ALBERT P L director D - S-Sale Common Stock, $1 par value 2805 75.76
2022-04-05 STROUCKEN ALBERT P L D - S-Sale Common Stock, $1 par value 1215 76.63
2022-04-05 STROUCKEN ALBERT P L D - M-Exempt Stock Option (Right to Buy) 4020 0
2022-04-05 STROUCKEN ALBERT P L director D - M-Exempt Stock Option (Right to Buy) 4020 29.52
2022-04-05 HELLMAN PETER S A - M-Exempt Common Stock, $1 par value 4020 29.52
2022-04-05 HELLMAN PETER S D - S-Sale Common Stock, $1 par value 2827 75.76
2022-04-05 HELLMAN PETER S director D - S-Sale Common Stock, $1 par value 1193 76.63
2022-04-05 HELLMAN PETER S director D - M-Exempt Stock Option (Right to Buy) 4020 29.52
2022-04-01 FORSYTH JOHN D D - S-Sale Common Stock, $1 par value 1005 77.68
2022-04-01 FORSYTH JOHN D D - M-Exempt Stock Option (Right to Buy) 1005 0
2022-03-21 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 157 79.05
2022-03-02 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 8918 0
2022-03-03 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 172 85.19
2022-03-02 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 3567 0
2022-02-28 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 172 84.97
2022-03-02 Stevens Brian SVP, CAO and Controller A - A-Award Stock Option (Right to Buy) 8269 85.23
2022-03-02 SACCARO JAMES EVP, Chief Financial Officer A - A-Award Stock Option (Right to Buy) 49613 0
2022-03-02 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 5054 0
2022-03-02 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 6688 0
2022-03-02 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Stock Option (Right to Buy) 13781 0
2022-03-02 Frye Andrew SVP, President, APAC A - A-Award Stock Option (Right to Buy) 34454 0
2022-03-02 Frye Andrew SVP, President, APAC A - A-Award Stock Option (Right to Buy) 34454 85.23
2022-03-02 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 7432 0
2022-03-02 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 8175 0
2022-03-02 Franzi Cristiano SVP, President, EMEA A - A-Award Stock Option (Right to Buy) 37899 85.23
2022-03-02 Franzi Cristiano SVP, President, EMEA A - A-Award Stock Option (Right to Buy) 37899 0
2022-03-02 Borzi James W SVP, Global Supply Chain A - A-Award Stock Option (Right to Buy) 19294 85.23
2022-03-02 Borzi James W SVP, Global Supply Chain A - A-Award Stock Option (Right to Buy) 19294 0
2022-03-02 Borzi James W SVP, Global Supply Chain A - A-Award Common Stock, $1 par value 4162 0
2022-03-02 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 32699 0
2022-03-02 Accogli Giuseppe EVP, Chief Operating Officer A - A-Award Common Stock, $1 par value 11891 0
2022-03-02 Accogli Giuseppe EVP, Chief Operating Officer A - A-Award Stock Option (Right to Buy) 55126 85.23
2022-03-01 FORSYTH JOHN D director A - M-Exempt Common Stock, $1 par value 1005 29.52
2022-03-01 FORSYTH JOHN D director D - S-Sale Common Stock, $1 par value 1005 84.82
2022-03-01 FORSYTH JOHN D director D - M-Exempt Stock Option (Right to Buy) 1005 29.52
2022-02-28 Stevens Brian SVP, CAO and Controller D - S-Sale Common Stock, $1 par value 2325 85.46
2022-02-28 Stevens Brian SVP, CAO and Controller D - S-Sale Common Stock, $1 par value 175 86.07
2022-02-14 Mason Jeanne K SVP, Human Resources A - M-Exempt Common Stock, $1 par value 54143 30.95
2022-02-14 Mason Jeanne K SVP, Human Resources D - S-Sale Common Stock, $1 par value 35841 84.75
2022-02-14 Mason Jeanne K SVP, Human Resources D - S-Sale Common Stock, $1 par value 18302 85.54
2022-02-14 Mason Jeanne K SVP, Human Resources D - M-Exempt Stock Option (Right to Buy) 18047 30.95
2022-02-14 Mason Jeanne K SVP, Human Resources D - M-Exempt Stock Option (Right to Buy) 18048 30.95
2022-02-14 Mason Jeanne K SVP, Human Resources D - M-Exempt Stock Option (Right to Buy) 18048 30.95
2022-02-10 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 724 0
2022-02-10 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 468 87.75
2022-02-10 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 249 0
2022-02-10 SACCARO JAMES EVP, Chief Financial Officer A - A-Award Common Stock, $1 par value 7534 0
2022-02-10 SACCARO JAMES EVP, Chief Financial Officer D - F-InKind Common Stock, $1 par value 4807 87.75
2022-02-10 SACCARO JAMES EVP, Chief Financial Officer A - A-Award Common Stock, $1 par value 2607 0
2022-02-10 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 3853 0
2022-02-10 Mason Jeanne K SVP, Human Resources D - F-InKind Common Stock, $1 par value 2233 87.75
2022-02-10 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 1334 0
2022-02-10 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 1738 0
2022-02-10 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 2979 0
2022-02-10 Kunzler Jacqueline SVP, Chief Quality Officer D - F-InKind Common Stock, $1 par value 989 87.75
2022-02-10 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 599 0
2022-02-10 Kunzler Jacqueline SVP, Chief Quality Officer D - F-InKind Common Stock, $1 par value 1696 87.75
2022-02-10 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 1030 0
2022-02-10 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 4636 0
2022-02-10 Martin Sean SVP and General Counsel D - F-InKind Common Stock, $1 par value 2675 87.75
2022-02-10 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 1604 0
2022-02-10 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 4056 0
2022-02-10 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 1404 0
2022-02-10 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 4636 0
2022-02-10 Franzi Cristiano SVP, President, EMEA D - F-InKind Common Stock, $1 par value 523 87.75
2022-02-10 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 1604 0
2022-02-10 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 28978 0
2022-02-10 ALMEIDA JOSE E Chairman, CEO and President D - F-InKind Common Stock, $1 par value 23230 87.75
2022-02-10 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 10032 0
2022-02-10 Accogli Giuseppe EVP, Chief Operating Officer A - A-Award Common Stock, $1 par value 6374 0
2022-02-10 Accogli Giuseppe EVP, Chief Operating Officer D - F-InKind Common Stock, $1 par value 3800 87.75
2022-02-10 Accogli Giuseppe EVP, Chief Operating Officer A - A-Award Common Stock, $1 par value 2206 0
2022-02-02 Chen Thomas F director A - M-Exempt Common Stock, $1 par value 1680 35.03
2022-02-02 Chen Thomas F director D - S-Sale Common Stock, $1 par value 1680 84.53
2022-02-02 Chen Thomas F director D - M-Exempt Stock Option (Right to Buy) 1680 35.03
2022-02-01 FORSYTH JOHN D director A - M-Exempt Common Stock, $1 par value 1005 29.52
2022-02-01 FORSYTH JOHN D director D - S-Sale Common Stock, $1 par value 1005 85.59
2022-02-01 FORSYTH JOHN D director D - M-Exempt Stock Option (Right to Buy) 1005 29.52
2022-01-07 Kunzler Jacqueline SVP, Chief Quality Officer A - M-Exempt Common Stock, $1 par value 2215 30.95
2022-01-07 Kunzler Jacqueline SVP, Chief Quality Officer D - M-Exempt Stock Option (Right to Buy) 738 30.95
2022-01-07 Kunzler Jacqueline SVP, Chief Quality Officer D - M-Exempt Stock Option (Right to Buy) 738 30.95
2022-01-07 Kunzler Jacqueline SVP, Chief Quality Officer D - M-Exempt Stock Option (Right to Buy) 739 30.95
2021-12-13 SCHLICHTING NANCY M director A - A-Award Common Stock, $1 par value 743 0
2021-12-13 SCHLICHTING NANCY M director D - Common Stock, $1 par value 0 0
2021-12-03 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 3050 78.05
2021-11-01 Martin Sean SVP and General Counsel A - M-Exempt Common Stock, $1 par value 21450 50.77
2021-11-01 Martin Sean SVP and General Counsel D - M-Exempt Stock Option (Right to Buy) 21450 50.77
2021-11-01 Martin Sean SVP and General Counsel D - S-Sale Common Stock, $1 par value 19876 79.53
2021-11-01 Martin Sean SVP and General Counsel D - S-Sale Common Stock, $1 par value 1574 80.03
2021-09-01 SACCARO JAMES Executive VP and CFO D - F-InKind Common Stock, $1 par value 34678 77.6
2021-09-01 Accogli Giuseppe SVP, Pres, Amer, Global Bus D - F-InKind Common Stock, $1 par value 11559 77.6
2021-08-02 Martin Sean SVP and General Counsel D - M-Exempt Stock Option (Right to Buy) 19800 50.77
2021-08-02 Martin Sean SVP and General Counsel A - M-Exempt Common Stock, $1 par value 19800 50.77
2021-08-02 Martin Sean SVP and General Counsel D - S-Sale Common Stock, $1 par value 19800 77.26
2021-05-04 FORSYTH JOHN D director A - A-Award Common Stock, $1 par value 1116 0
2021-05-05 FORSYTH JOHN D director D - G-Gift Common Stock, $1 par value 8560 0
2021-05-04 FORSYTH JOHN D director A - A-Award Stock Option (Right to Buy) 5685 87.44
2021-05-04 Wilkes David S. director A - A-Award Common Stock, $1 par value 2230 0
2021-05-04 Wendell Amy McBride director A - A-Award Common Stock, $1 par value 1116 0
2021-05-04 Wendell Amy McBride director A - A-Award Stock Option (Right to Buy) 5685 87.44
2021-05-04 STROUCKEN ALBERT P L director A - A-Award Common Stock, $1 par value 2230 0
2021-05-04 STALLKAMP THOMAS T director A - A-Award Common Stock, $1 par value 2230 0
2021-05-04 Smith Cathy R director A - A-Award Common Stock, $1 par value 2230 0
2021-05-04 Oesterle Stephen N. director A - A-Award Common Stock, $1 par value 2230 0
2021-05-04 MORRISON PATRICIA director A - A-Award Common Stock, $1 par value 2230 0
2021-05-04 Mahoney Michael F director A - A-Award Stock Option (Right to Buy) 5685 87.44
2021-05-04 Mahoney Michael F director A - A-Award Common Stock, $1 par value 1116 0
2021-05-04 HELLMAN PETER S director A - A-Award Common Stock, $1 par value 2230 0
2021-05-04 Chen Thomas F director A - A-Award Common Stock, $1 par value 2230 0
2021-04-12 Frye Andrew SVP, President, APAC D - S-Sale Common Stock, $1 par value 10999 84.79
2021-04-05 STROUCKEN ALBERT P L director A - M-Exempt Common Stock, $1 par value 4990 31.26
2021-04-05 STROUCKEN ALBERT P L director D - S-Sale Common Stock, $1 par value 4990 84.56
2021-04-05 STROUCKEN ALBERT P L director D - M-Exempt Stock Option (Right to Buy) 4990 31.26
2021-04-05 HELLMAN PETER S director A - M-Exempt Common Stock, $1 par value 4990 31.26
2021-04-05 HELLMAN PETER S director D - S-Sale Common Stock, $1 par value 4990 84.56
2021-01-06 HELLMAN PETER S director A - G-Gift Stock Option (Right to Buy) 6437 69.45
2021-01-06 HELLMAN PETER S director A - G-Gift Stock Option (Right to Buy) 6138 76.69
2021-01-06 HELLMAN PETER S director A - G-Gift Stock Option (Right to Buy) 5293 88.74
2021-04-05 HELLMAN PETER S director D - M-Exempt Stock Option (Right to Buy) 4990 31.26
2021-01-06 HELLMAN PETER S director D - G-Gift Stock Option (Right to Buy) 6437 69.45
2021-01-06 HELLMAN PETER S director D - G-Gift Stock Option (Right to Buy) 6138 76.69
2021-01-06 HELLMAN PETER S director D - G-Gift Stock Option (Right to Buy) 5293 88.74
2021-03-22 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 155 81.24
2021-03-03 Accogli Giuseppe SVP, Pres, Amer, Global Bus A - A-Award Stock Option (Right to Buy) 121969 77.15
2021-03-03 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 1750 0
2021-03-03 Stevens Brian SVP, CAO and Controller A - A-Award Stock Option (Right to Buy) 17424 77.15
2021-03-03 SACCARO JAMES Executive VP and CFO A - A-Award Stock Option (Right to Buy) 82369 77.15
2021-03-03 Mason Jeanne K SVP, Human Resources A - A-Award Stock Option (Right to Buy) 48788 77.15
2021-03-03 Martin Sean SVP and General Counsel A - A-Award Stock Option (Right to Buy) 63360 77.15
2021-03-03 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Stock Option (Right to Buy) 31680 77.15
2021-03-03 Frye Andrew SVP, President, APAC A - A-Award Stock Option (Right to Buy) 79201 77.15
2021-03-03 Franzi Cristiano SVP, President, EMEA A - A-Award Stock Option (Right to Buy) 79201 77.15
2021-03-03 Borzi James W SVP, Global Supply Chain A - A-Award Stock Option (Right to Buy) 44352 77.15
2021-03-03 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Stock Option (Right to Buy) 348483 77.15
2021-03-01 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 201 77.94
2021-02-16 Accogli Giuseppe SVP, Pres, Amer and Glbl Bus A - A-Award Common Stock, $1 par value 4032 0
2021-02-16 Accogli Giuseppe SVP, Pres, Amer and Glbl Bus A - A-Award Common Stock, $1 par value 998 0
2021-02-16 Accogli Giuseppe SVP, Pres, Amer and Glbl Bus D - F-InKind Common Stock, $1 par value 3173 77.8
2021-02-16 Accogli Giuseppe SVP, Pres, Amer and Glbl Bus A - A-Award Common Stock, $1 par value 1101 0
2021-02-16 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 114 0
2021-02-16 SACCARO JAMES Executive VP and CFO A - A-Award Common Stock, $1 par value 5241 0
2021-02-16 SACCARO JAMES Executive VP and CFO A - A-Award Common Stock, $1 par value 1179 0
2021-02-16 SACCARO JAMES Executive VP and CFO D - F-InKind Common Stock, $1 par value 4308 77.8
2021-02-16 SACCARO JAMES Executive VP and CFO A - A-Award Common Stock, $1 par value 1432 0
2021-02-16 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 2519 0
2021-02-16 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 603 0
2021-02-16 Mason Jeanne K SVP, Human Resources D - F-InKind Common Stock, $1 par value 2004 77.8
2021-02-16 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 688 0
2021-02-16 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 3225 0
2021-02-16 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 726 0
2021-02-16 Martin Sean SVP and General Counsel D - F-InKind Common Stock, $1 par value 2552 77.8
2021-02-16 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 881 0
2021-02-16 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 1310 0
2021-02-16 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 272 0
2021-02-16 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 466 0
2021-02-16 Kunzler Jacqueline SVP, Chief Quality Officer D - F-InKind Common Stock, $1 par value 1064 77.8
2021-02-16 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 366 0
2021-02-16 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 635 0
2021-02-16 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 2419 0
2021-02-16 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 659 0
2021-02-16 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 726 0
2021-02-16 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 2822 0
2021-02-16 Franzi Cristiano SVP, President, EMEA D - F-InKind Common Stock, $1 par value 439 77.8
2021-02-16 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 770 0
2021-02-16 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 20160 0
2021-02-16 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 4535 0
2021-02-16 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 5510 0
2021-02-16 ALMEIDA JOSE E Chairman, CEO and President D - F-InKind Common Stock, $1 par value 22003 77.8
2021-02-16 Wilkes David S. director A - A-Award Common Stock, $1 par value 366 0
2021-02-15 Wilkes David S. director D - Common Stock, $1 par value 0 0
2020-12-31 Chen Thomas F - 0 0
2020-09-03 Kunzler Jacqueline SVP, Chief Quality Officer D - M-Exempt Stock Option (Right to Buy) 1861 28.97
2020-12-03 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 749 76.32
2020-11-02 Martin Sean SVP and General Counsel D - M-Exempt Stock Option (Right to Buy) 47001 50.77
2020-11-02 Martin Sean SVP and General Counsel A - M-Exempt Common Stock, $1 par value 47001 50.77
2020-11-02 Martin Sean SVP and General Counsel D - S-Sale Common Stock, $1 par value 36608 78.52
2020-11-02 Martin Sean SVP and General Counsel D - S-Sale Common Stock, $1 par value 10393 79.22
2020-10-01 Kunzler Jacqueline SVP, Chief Quality Officer D - J-Other Deferred Comp Plan Baxter Common Stock Fund 2449 0
2020-09-11 GAVIN JAMES R III director D - J-Other Deferred Comp Plan Baxter Common Stock Fund 11894 0
2020-09-14 FORSYTH JOHN D director A - M-Exempt Common Stock, $1 par value 310 31.26
2020-09-14 FORSYTH JOHN D director D - S-Sale Common Stock, $1 par value 310 83.59
2020-09-14 FORSYTH JOHN D director D - M-Exempt Stock Option (Right to Buy) 310 31.26
2020-09-01 Franzi Cristiano SVP, President, EMEA D - F-InKind Common Stock, $1 par value 1132 85.55
2020-09-01 Borzi James W SVP, Global Supply Chain A - A-Award Stock Option (Right to Buy) 60000 85.55
2020-09-01 Borzi James W SVP, Global Supply Chain A - A-Award Common Stock, $1 par value 12000 0
2020-08-24 Borzi James W SVP, Global Supply Chain D - Common Stock, $1 par value 0 0
2020-08-20 HELLMAN PETER S director D - J-Other Deferred Comp Plan Baxter Common Stock Fund 1660 0
2020-08-20 Chen Thomas F director D - J-Other Deferred Comp Plan Baxter Common Stock Fund 3386 0
2020-08-03 GAVIN JAMES R III director A - M-Exempt Common Stock, $1 par value 10789 37.5
2020-08-03 GAVIN JAMES R III director A - M-Exempt Common Stock, $1 par value 4110 39.83
2020-08-03 GAVIN JAMES R III director D - S-Sale Common Stock, $1 par value 11548 86.26
2020-08-03 GAVIN JAMES R III director D - S-Sale Common Stock, $1 par value 3351 86.91
2020-08-03 GAVIN JAMES R III director D - M-Exempt Stock Option (Right to Buy) 4110 39.83
2020-08-03 GAVIN JAMES R III director D - M-Exempt Stock Option (Right to Buy) 10789 37.5
2020-06-19 Accogli Giuseppe SVP, President, Americas A - M-Exempt Common Stock, $1 par value 62388 50.77
2020-06-19 Accogli Giuseppe SVP, President, Americas A - M-Exempt Common Stock, $1 par value 8334 46.18
2020-06-19 Accogli Giuseppe SVP, President, Americas D - S-Sale Common Stock, $1 par value 72341 85
2020-06-19 Accogli Giuseppe SVP, President, Americas D - M-Exempt Stock Option [Right to Buy) 62388 50.77
2020-06-19 Accogli Giuseppe SVP, President, Americas D - M-Exempt Stock Option (Right to Buy) 8334 46.18
2020-06-15 FORSYTH JOHN D director A - M-Exempt Common Stock, $1 par value 1500 31.26
2020-06-15 FORSYTH JOHN D director D - S-Sale Common Stock, $1 par value 1500 82.95
2020-06-15 FORSYTH JOHN D director D - M-Exempt Stock Option (Right to Buy) 1500 31.26
2020-06-08 Franzi Cristiano SVP, President, EMEA A - M-Exempt Common Stock, $1 par value 46600 62.23
2020-06-08 Franzi Cristiano SVP, President, EMEA D - S-Sale Common Stock, $1 par value 23900 87.33
2020-06-08 Franzi Cristiano SVP, President, EMEA D - S-Sale Common Stock, $1 par value 22700 87.96
2020-06-08 Franzi Cristiano SVP, President, EMEA D - M-Exempt Stock Option (Right to Buy) 46600 62.23
2020-06-03 Frye Andrew SVP, President, APAC D - S-Sale Common Stock, $1 par value 3742 91
2020-05-05 Wendell Amy McBride director A - A-Award Common Stock, $1 par value 1099 0
2020-05-05 Wendell Amy McBride director A - A-Award Stock Option (Right to Buy) 5293 88.74
2020-05-05 STROUCKEN ALBERT P L director A - A-Award Common Stock, $1 par value 2197 0
2020-05-05 STALLKAMP THOMAS T director A - A-Award Common Stock, $1 par value 2197 0
2020-05-05 Smith Cathy R director A - A-Award Common Stock, $1 par value 1099 0
2020-05-05 Smith Cathy R director A - A-Award Stock Option (Right to Buy) 5293 88.74
2020-05-05 Oesterle Stephen N. director A - A-Award Common Stock, $1 par value 2197 0
2020-05-05 MORRISON PATRICIA director A - A-Award Common Stock, $1 par value 2197 0
2020-05-05 Mahoney Michael F director A - A-Award Stock Option (Right to Buy) 5293 88.74
2020-05-05 Mahoney Michael F director A - A-Award Common Stock, $1 par value 1099 0
2020-05-05 HELLMAN PETER S director A - A-Award Common Stock, $1 par value 1099 0
2020-05-05 HELLMAN PETER S director A - A-Award Stock Option (Right to Buy) 5293 88.74
2020-05-05 GAVIN JAMES R III director A - A-Award Common Stock, $1 par value 2197 0
2020-05-05 FORSYTH JOHN D director A - A-Award Common Stock, $1 par value 2197 0
2020-05-05 Chen Thomas F director A - A-Award Common Stock, $1 par value 2197 0
2020-04-27 Mason Jeanne K SVP, Human Resources A - M-Exempt Common Stock, $1 par value 47146 28.97
2020-04-27 Mason Jeanne K SVP, Human Resources D - S-Sale Common Stock, $1 par value 38477 92.99
2020-04-27 Mason Jeanne K SVP, Human Resources D - S-Sale Common Stock, $1 par value 8669 93.74
2020-04-27 Mason Jeanne K SVP, Human Resources D - M-Exempt Stock Option (Right to Buy) 47176 28.97
2020-03-20 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Stock Option (Right to Buy) 381437 75.75
2020-04-01 STROUCKEN ALBERT P L director A - M-Exempt Common Stock, $1 par value 4320 24.27
2020-04-01 STROUCKEN ALBERT P L director D - S-Sale Common Stock, $1 par value 1300 78.79
2020-04-01 STROUCKEN ALBERT P L director D - S-Sale Common Stock, $1 par value 3020 80
2020-04-01 STROUCKEN ALBERT P L director D - M-Exempt Stock Option (Right to Buy) 4320 24.27
2020-04-01 HELLMAN PETER S director A - M-Exempt Common Stock, $1 par value 4320 24.27
2020-04-01 HELLMAN PETER S director D - S-Sale Common Stock, $1 par value 1800 79.05
2020-04-01 HELLMAN PETER S director D - S-Sale Common Stock, $1 par value 2520 80.1
2020-04-01 HELLMAN PETER S director D - M-Exempt Common Stock, $1 par value 4320 24.27
2020-03-30 Martin Sean SVP and General Counsel A - P-Purchase Common Stock, $1 par value 9780 82.19
2020-03-23 Blanco Alex N SVP, Chief Supply Chain Offcr D - Common Stock, $1 par value 0 0
2020-03-20 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 1579 0
2020-03-20 Stevens Brian SVP, CAO and Controller A - A-Award Stock Option (Right to Buy) 15893 75.75
2020-03-19 SACCARO JAMES Executive VP and CFO A - A-Award Common Stock, $1 par value 12774 0
2020-03-19 SACCARO JAMES Executive VP and CFO D - F-InKind Common Stock, $1 par value 10131 84.59
2020-03-19 SACCARO JAMES Executive VP and CFO A - A-Award Common Stock, $1 par value 4377 0
2020-03-20 SACCARO JAMES Executive VP and CFO A - A-Award Stock Option (Right to Buy) 41322 75.75
2020-03-19 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 8128 0
2020-03-19 Mason Jeanne K SVP, Human Resources D - F-InKind Common Stock, $1 par value 6665 84.59
2020-03-19 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 2786 0
2020-03-20 Mason Jeanne K SVP, Human Resources A - A-Award Stock Option (Right to Buy) 44501 75.75
2020-03-20 Martin Sean SVP and General Counsel A - A-Award Stock Option (Right to Buy) 50858 75.75
2020-03-19 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 9290 0
2020-03-19 Martin Sean SVP and General Counsel D - F-InKind Common Stock, $1 par value 8661 84.59
2020-03-19 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 3184 0
2020-03-20 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Stock Option (Right to Buy) 25429 75.75
2020-03-19 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 2903 0
2020-03-19 Kunzler Jacqueline SVP, Chief Quality Officer D - F-InKind Common Stock, $1 par value 1789 84.59
2020-03-19 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 1025 0
2020-03-20 Frye Andrew SVP, President, APAC A - A-Award Stock Option (Right to Buy) 57216 75.75
2020-03-20 Franzi Cristiano SVP, President, EMEA A - A-Award Stock Option (Right to Buy) 63573 75.75
2020-03-20 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Stock Option (Right to Buy) 349650 75.75
2020-03-19 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 58065 0
2020-03-19 ALMEIDA JOSE E Chairman, CEO and President D - F-InKind Common Stock, $1 par value 53573 84.59
2020-03-19 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 19898 0
2020-03-20 Accogli Giuseppe SVP, President, Americas A - A-Award Stock Option (Right to Buy) 95359 75.75
2020-03-19 Accogli Giuseppe SVP, President, Americas A - A-Award Common Stock, $1 par value 10161 0
2020-03-19 Accogli Giuseppe SVP, President, Americas D - F-InKind Common Stock, $1 par value 8620 84.59
2020-03-19 Accogli Giuseppe SVP, President, Americas A - A-Award Common Stock, $1 par value 3483 0
2020-03-17 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 12759 0
2020-03-17 ALMEIDA JOSE E Chairman, CEO and President A - A-Award Common Stock, $1 par value 14182 0
2020-03-19 Wendell Amy McBride director A - A-Award Common Stock, $1 par value 1500 79.94
2020-03-18 FORSYTH JOHN D director A - M-Exempt Common Stock, $1 par value 1500 31.26
2020-03-18 FORSYTH JOHN D director D - S-Sale Common Stock, $1 par value 1500 76.7
2020-03-18 FORSYTH JOHN D director D - M-Exempt Stock Option (Right to Buy) 1500 31.26
2020-03-17 Stevens Brian SVP, CAO and Controller A - A-Award Common Stock, $1 par value 318 0
2020-03-18 Stevens Brian SVP, CAO and Controller D - F-InKind Common Stock, $1 par value 169 80.51
2020-03-17 SACCARO JAMES Executive VP and CFO A - A-Award Common Stock, $1 par value 3317 0
2020-03-17 SACCARO JAMES Executive VP and CFO A - A-Award Common Stock, $1 par value 3687 0
2020-03-17 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 1697 0
2020-03-17 Mason Jeanne K SVP, Human Resources A - A-Award Common Stock, $1 par value 1773 0
2020-03-17 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 2041 0
2020-03-17 Martin Sean SVP and General Counsel A - A-Award Common Stock, $1 par value 2270 0
2020-03-18 Martin Sean SVP and General Counsel D - F-InKind Common Stock, $1 par value 8360 80.51
2020-03-17 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 766 0
2020-03-17 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 1311 0
2020-03-17 Kunzler Jacqueline SVP, Chief Quality Officer A - A-Award Common Stock, $1 par value 922 0
2020-03-17 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 1786 0
2020-03-17 Frye Andrew SVP, President, APAC A - A-Award Common Stock, $1 par value 1702 0
2020-03-17 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 2041 0
2020-03-17 Franzi Cristiano SVP, President, EMEA A - A-Award Common Stock, $1 par value 1985 0
2020-03-17 Accogli Giuseppe SVP, President, Americas A - A-Award Common Stock, $1 par value 2806 0
2020-03-17 Accogli Giuseppe SVP, President, Americas A - A-Award Common Stock, $1 par value 2836 0
2019-12-13 FORSYTH JOHN D director D - S-Sale Common Stock, $1 par value 1500 83.64
2019-12-13 FORSYTH JOHN D director A - M-Exempt Common Stock, $1 par value 1500 31.26
2019-12-13 FORSYTH JOHN D director D - M-Exempt Stock Option (Right to Buy) 1500 31.26
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Transcripts
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Second Quarter 2024 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Senior Vice President, Chief Investor Relations Officer at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning, and welcome to our second quarter 2024 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Joel Grade, Baxter's Executive Vice President and Chief Financial Officer. On the call this morning, we will be discussing Baxter's second quarter 2024 results, along with our financial outlook for the third quarter and full year 2024. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the third quarter and full year 2024, the status and anticipated timing of our ongoing strategic actions, including the proposed Kidney Care separation and the potential impact of our recent pricing actions, regulatory matters and the macroeconomic environment on our results of operations contain forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in the accompanying investor presentation and also available in our earnings release issued this morning, which are both available on our website. Now, I'd like to turn the call over to Joe. Joe?
Joe Almeida:
Thank you, Clare, and good morning, everyone. Thank you for joining us. Our second quarter 2024 results reflect the continued progress and momentum of our ongoing strategic transformation. Our performance in the quarter was strong, reinforcing the benefits of our redesigned operating model fueled by the commitment and hard work of our outstanding Baxter team. I will start the call today with some brief commentary on our strong second quarter performance before turning the call over to Joel to provide more detail on our results as well as our outlook for the rest of the year. Then, as always, we open up to your questions. As you saw in this morning's earnings release, Baxter's second quarter results exceeded our previously issued guidance on both the top- and bottom-line. This performance further enhances our confidence in our ability to continue executing against our strategic priorities and build upon this underlying momentum. As such, we have increased our full year sales outlook and adjusted EPS guidance accordingly. Our second quarter performance provides further evidence that the steps we have taken to-date to centralize and streamline our operating model are yielding results. These actions allow for improved visibility both externally and internally to our markets as well as increased accountability for our segment leaders. These benefits, coupled with enhanced operational rigor, have enabled our teams to better identify opportunities to accelerate innovation to drive growth and expand margins. Turning to some of the highlights from the quarter. Second quarter sales from continuing operations grew 3% on a reported basis and 4% at a constant currency rates. As a reminder, continuing operations exclude the impact of our BioPharma Solutions business, BPS, which we divested at the close of the third quarter of 2023, in line with our strategic transformation roadmap. Sales growth was broad-based with all four Baxter segments delivering growth above our expectations, reflecting positive demand and improved pricing for products across much of the portfolio. On the bottom-line, adjusted earnings per share from continuing operations were $0.68. These results were driven by our top-line performance combined with our continued emphasis on operational efficiency across the company with ongoing contributions from our integrated supply chain network. Our strong operational performance more than offset a negative impact from foreign exchange and a higher-than-expected tax rate in the quarter. Now, looking at performance by segment. Medical Products and Therapies, or MPT, delivered second quarter sales growth of 4% at reported rates and 5% at constant currency rates. Growth was fueled by demand across the segment and results included first US sales of our leading-edge Novum IQ large volume pump with Dose IQ Safety Software. Customer interest is high for the Novum platform, including both large volume and syringe pumps with their ability to advance connectivity and intelligent infusion therapy. These pumps are already live and in use at multiple sites, making a difference for caregivers and the patients they serve. We have a healthy funnel of opportunities and anticipate continued strong steady uptick from Novum across the balance of 2024 and beyond through the upgrades of existing customers and conversions of new customers. Our Pharmaceuticals segment grew 9% at reported rates and 11% at constant currency rates. Performance was driven by double-digit growth in our specialty injectables portfolio, reflecting the recent launches of a range of new differentiated injectables as well as significant growth in our Drug Compounding business. Growth in this segment was partially offset by lower sales of inhaled anesthetics. Healthcare Systems and Technologies, or HST, performance advanced to 1% at both reported and constant rates. Our Care and Connectivity Solutions division delivered mid-single-digit growth, reflecting positive market demand and strong [US-capped] (ph) orders, which increased meaningfully both sequentially and year-over-year. Growth in the quarter was partially offset by an expected decline in the Front Line Care division, primarily due to a difficult comparison to the prior-year period and continued softness in the US primary care market. Overall, HST results in the quarter benefited from the operational improvements that we are in process of implementing to enhance ongoing performance. As we discussed last quarter, we expect to see these efforts continue to yield positive results as 2024 continues and going forward. Finally, Kidney Care was flat year-over-year at reported rates and grew 3% at constant currency rates. Performance continues to be fueled by demand for our acute therapies portfolio plus a strong growth for peritoneal dialysis products due to positive volume and pricing globally. Growth was partially offset by an expected decline in sales of in-center hemodialysis products due to select product and market exits. Looking ahead, we remain confident and excited about the future of our company and our potential to continue to accelerate sales growth, expand our margins, and drive innovation that we'll deliver benefits to our customers, shareholders and many other stakeholder communities. As you all know, we launched our strategic transformation in January of 2023 to recast Baxter as a more simplified, more agile and more focused company, passionate in its commitment to operational excellence and better-positioned to accelerate growth through customer-inspired innovation. Among the elements central to our plan was the separation of the Kidney Care business from Baxter in order to provide both companies with improved strategic clarity and greater flexibility to pursue their unique investment priorities. We are continuing to make steady progress toward the separation, and while the ultimate pathway has not yet been determined, we currently expect the separation will occur in late 2024 or early 2025. With the separation of Kidney Care, we have a unique opportunity to redefine ourselves while also remaining firmly grounded in what has powered our success for nearly a century
Joel Grade:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we are pleased with our second quarter results, which came in ahead of our expectations and further reinforce our goal of consistently meeting and exceeding our financial objectives. Second quarter 2024 global sales of $3.8 billion increased 3% on a reported basis and 4% on a constant currency basis, and as mentioned, compared favorably to our previously issued guidance. Outperformance in the quarter benefited from better-than-expected sales in many product categories and particularly in patient support systems, infusion therapies, peritoneal dialysis and drug compounding. As compared to the prior-year period, sales, excluding Kidney Care, increased approximately 5% on a constant currency basis. On the bottom-line, adjusted earnings from continuing operations totaled $0.68 per share, increasing 24% versus the prior-year period and ahead of our prior guidance of $0.65 to $0.67 per share. Results in the quarter were driven by strong operational performance with continued momentum commercially, partially offset by a negative impact from non-operational items totaling $0.05 per share due to foreign exchange and a higher-than-anticipated tax rate. Now, I'll walk through our results by reportable segments. Commentary regarding sales growth will reflect growth at constant currency rates. Sales in our Medical Products and Therapies, or MPT, segment were $1.3 billion, increasing 5%. Within MPT, second quarter sales from our Infusion Therapies and Technologies division totaled $1 billion and increased 5%. Sales in the quarter benefited from strong growth internationally across the division, particularly for our IV solutions and infusion systems products, which benefited from both volume and pricing gains. Solid demand for nutrition globally also contributed to growth in the quarter. Sales from Advanced Surgery totaled $277 million and grew 4%, reflecting solid growth internationally. For our Healthcare Systems and Technologies, or HST, segment, sales in the quarter were $748 million and increased 1%, coming in ahead of our expectations. Within the HST segment, sales in our Care and Connectivity Solutions, or CCS, division were $452 million, growing 4%. Performance rebounded in the quarter, driven by significant growth in orders, both sequentially and year-over-year for our CCS products. As Joe mentioned, the actions we are taking to enhance our operational rigor and improve execution are yielding results. These factors contributed to orders growth across our CCS division of more than 40% compared to the prior year and over 60% sequentially. Results in the quarter included upgrades to both existing customers and competitive gains within our patient support systems business. We are very encouraged by the growth of orders in the US this quarter, which will be phased in over the course of the second half of this year and into 2025. Overall, we believe the initiatives we are implementing to improve commercial execution will continue to lead to improved performance, both in the second half of this year and beyond. Front Line Care sales in the quarter were $296 million, declining 4%, in line with our expectations and represented a double-digit improvement sequentially. Growth in the quarter continued to be impacted by a difficult comparison to the prior year as backlog reductions positively contributed to growth in the prior-year period. Performance in the quarter was also impacted by ongoing softness in the primary care market, which negatively impacted growth in both our connected monitoring and intelligence diagnostics product portfolios. The timing and release of government orders in the US also impacted growth in the quarter. We expect this division to return to growth in the second half of the year as growth for products in other settings such as cardiology and acute is anticipated to more than offset the continued softness in primary care and lower government orders. The anniversary of the prior-year impact from the backlog reduction will also benefit performance in the second half of the year. Moving on to Pharmaceuticals. Sales in this segment were $602 million, increasing 11%. Performance in the quarter reflect double-digit growth in our US injectables portfolio, driven by new product launches as well as strong demand for services from our Drug Compounding portfolio internationally, which has benefited from supply constraints for certain customers that are expected to ease in the second half of the year. Performance in the quarter was partially offset by lower sales in inhaled anesthetics globally. Sales in the quarter for our Kidney Care segment totaled $1.1 billion, increasing 3%. Within Kidney Care, global sales for Chronic Therapies were $917 million, increasing 1%. Strong PD growth in the quarter was partially offset by the expected negative impact from certain product and market exits in our in-center HD business as well as lower sales in China due to government procurement initiatives. We estimate that these items negatively impacted sales by just over $50 million in the quarter. Sales in our Acute Therapies business were $201 million, representing growth of 9%, driven by strong demand and competitive conversions in the United States. Other sales, which represent sales not allocated to a segment and primarily includes sales of products and services provided directly to certain of our manufacturing facilities, were $22 million and declined 5% during the quarter. Now, moving on to the rest of the P&L. Our adjusted gross margin totaled 41.2% and represented an increase of 80 basis points over the prior year. The year-over-year improvement in gross margin primarily reflects the strong operational efficiencies we are realizing within our integrated supply chain network, resulting from execution of the margin improvement programs we were implementing and the anniversary of the negative margin impacts from inflationary pressures that drove higher cost of goods sold in the prior-year period. Pricing initiatives in select markets also positively contributed to margin improvement in the quarter. Product mix and foreign exchange partially offset margin expansion in the quarter. Adjusted SG&A totaled $873 million, or $22.9 million as a percentage of sales, an increase of 10 basis points from the prior-year period as we are making select investments to support our growth objectives and new product launches. SG&A leverage is expected to continue to improve as sales ramp over the course of the year. Adjusted R&D spend in the quarter totaled $175 million and represented 4.6% as a percentage of sales, an increase of 10 basis points compared to the prior-year period and reflects our continued investments in advancing new products across the portfolio and bringing innovation to patients across our segments. These factors resulted in an adjusted operating margin of 13.7%, an increase of 50 basis points versus prior year, driven by the factors above, which more than offset a negative impact on operating margins of approximately 70 basis points due to foreign exchange. Net interest expense totaled $85 million in the quarter, a decrease of $39 million versus the prior-year period, driven by debt repayments in the fourth quarter of 2023 associated with the proceeds of our BPS divestiture. We plan to continue to repay debt in 2024, consistent with our stated capital allocation priorities. During July, Baxter finalized a bank finance bridge loan in the form of a delayed draw term loan, or DTTL, in lieu of a public bond financing with a total size of $2.05 billion. The DTTL provides certainty of ability to fund debt maturities coming due in the fourth quarter in the event we haven't completed the Kidney Care separation by that time. We expect to utilize proceeds from the separation to repay the loan if outstanding. We felt this was a better option as compared to bond financing given the more temporary nature of the cash need and the high cost of issuing new term debt in current markets. Adjusted other non-operating income totaled $20 million in the quarter compared to an expense of $22 million in the prior-year period, which included losses on both foreign exchange and marketable securities. The adjusted tax rate for the quarter of 23.9% came in higher than expectations and increased as compared to the prior-year tax rate of 17.8%. The year-over-year increase is primarily driven by the geographic mix of earnings, decreased utilization of foreign tax credits in the current year period and a non-recurring foreign tax incentive in the prior-year period. And as previously mentioned, adjusted earnings from continuing operations totaled $0.68 per share and increased 24% versus the prior year, primarily driven by improved commercial performance and a reduction in interest expense, offset by the impact of foreign exchange and a higher tax rate. Let me conclude my remarks by discussing our outlook for the third quarter and full year 2024, including some key assumptions underpinning the guidance. For full year 2024, Baxter now expects total sales growth of approximately 3% on both reported and constant currency basis, which is an increase from prior guidance of 2% to 3% on a constant currency basis. This increase reflects the outperformance we realized in the second quarter and continued momentum for our businesses. Constant-currency sales guidance for the full year by reportable segment is as follows
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Robbie Marcus of JPMorgan. Your question, please?
Robbie Marcus:
Great. Thanks for taking the questions, and congrats on a nice quarter. Two from me. Wanted to start with the revised guidance. And it looks like it's pretty much going higher from the second quarter beat and then third quarter upside versus the Street. So, you gave a lot of detail, but I was hoping you could just walk us through the underlying drivers and did I get the raise and impact correct? Thanks.
Joel Grade:
Hi, good morning, Robbie. It's Joel. Thank you for the questions. Yes, I think certainly, the new guidance is actually starts with the performance we had in Q2. We had a strong operational quarter and obviously, that's part of what's carried through to the rest of the year. What I would just say in general, though, is that our businesses continue to have strong momentum in them. And so, I think when you think about this from a sales perspective, it's the recovery -- continued recovery over the course of the year sequentially in HST. Again, we've raised the guidance for MPT as well from a sales perspective as well as Pharma. And so, I think the -- and all those businesses are going to continue to improve from a sales perspective. So, on the top-line, that's part of the really key driver. From a margin perspective, we continue to expect a positive progress from a pricing standpoint from an ISC standpoint. I think our margin improvement programs and the continued work there are also a part of obviously what's driving ultimately the bottom-line beat as well. The offset of some of that from an operating margin perspective, we do make -- we're making continued investments in our business from a sales and marketing standpoint, from an R&D perspective, from new product launch perspective. And so, those things continue to impact the opposite direction. As well as we've got an MSA in Pharma that I think you're aware of was related to BPS sales. So that's an offset. And then finally, on the bottom-line from a -- we do have a headwind from an FX and a tax rate perspective. But again, punchline here, continued sales momentum, margin expansion with a couple of the offsets I talked about.
Robbie Marcus:
Thanks. And maybe just a quick follow-up here. The HST had a tough first quarter. It looks like it improved sequentially in second quarter. Front Line Care still negative year-over-year. Maybe just speak to the underlying trends you're seeing in the two businesses there and your confidence in a reacceleration and return to a positive growth in the second half of the year? Thanks.
Joe Almeida:
Hi, Robbie, good morning. We feel that a great deal of the operational issues are being addressed and behind us. We still are addressing them and will be throughout the 2024 calendar year. Primarily the one involved in one of our plant transfers is being addressed and is in really, really good shape at the moment. I want to make sure that we also have -- our sales force is doing a fantastic job. We did a significant amount of revamping there. So, we see that going well. We also see a very positive trend in capital and the positive trend in capital allows us to have very strong, one of the strongest quarters we ever had in orders, it was the second quarter. So, we see that going extremely well. This is in the CCS business, which is our beds and nurse call systems. FLC, completely different dynamic that has to do with the primary care market that has significant shift during 2024 with big players coming in and out. We believe our market share is still growing in that slightly, but it's very high, and we feel that business is going to come back into normality towards the end of the year, as well as in government orders, which has been very, very low. And the most important factor was the comp versus last year. All in all, I think HST has turned the corner. We see some very interesting dynamics on the market with our product offering gaining ground and stable market share and possibly growing into Q3 and Q4.
Robbie Marcus:
Great. Thanks a lot.
Operator:
Travis Steed of Bank of America Securities is on the line with a question. Please state your question.
Travis Steed:
Hey, thanks for taking the question. I wanted to ask about the KidneyCo separation. I think that was new that you added early 2025, so I wanted to ask about that. And does your thinking change at all on spend versus sell? And also noticed an impairment charge on that business. So, wasn't sure if there's anything to kind of read into that impairment charge this quarter.
Joel Grade:
So, a couple of things on this. First of all, thanks for the question, Travis. From a timing perspective, again, look, we're continuing to make progress and continue to move forward on a dual path to ensure that we're ready for both of -- from a sale and spin process. And so, we're obviously doing that in a way that's going to maximize our shareholder value for all of our stakeholders. And so, we continue to make solid progress, what I would say. I think the timing difference, again, I just look at it as we've continued to evolve the process and move it forward, again, we're in -- I think we're in a good place from the perspective of both, but the timing has shifted a little bit as we continue to move through the year. And so, our plan is to still continue to get it done by the end of 2024, but it could move into the early part of 2025, which is why we put the guidance out that it did. From a goodwill perspective, the way I would take that is we've had a -- now a process where we actually had bidders put a value into what the goodwill is. And so, as we assess that relative to the obviously the value of the books, there is a negative impact there from a goodwill perspective. I would say this, in the event that there was a sale moving forward, we would be recognizing a gain on that sale. So, there's a little bit of a timing issue from that perspective. But it's just part of a normal process to reassess our goodwill. And now that again, we have an actual kind of what I call market value for that, so to speak, and that's where that came from.
Travis Steed:
Great. Thanks a lot. I wanted to ask a follow-up on the margins. So, first of all, the second half total company, you got a couple of hundred basis points second half margin ramp. So, I wanted to ask about the confidence and kind of what's driving that. But also if you think about the segment margins, in the first half of the year, all the margin expansion for the total company was more on the renal side and the core of Baxter business down year-over-year. I wanted to kind of think about how we get confidence that ex the RenalCo longer-term, like the RemainCo Baxter business is going to be expanding margins kind of the 50 basis points or so a year that you've kind of set out in the past?
Joel Grade:
Sure. Let me start by taking what I call some of the drivers of our margin perspective and then I'll get to the second part of your question. Our margin drivers continue to be from a couple of different things. One is, again, our top-line -- obviously, our top-line growth and some of the new product launches that are coming into play, that's both a short-term and something over the longer term, that's going to be a driver from a margin perspective. Pricing, we continue to see upside opportunities from a pricing perspective. In the current year, it's been primarily outside the US. We looked for some of that inside, in the US next year as again some of the GPO contracts take hold, et cetera, et cetera, but -- and we continue to take pricing. ISC continues to be a area where we expand our margins. Again, both the margin improvement programs and just the efficiencies we continue to gain from some of our investments in automation, et cetera, et cetera. And so that's where the kind of the really key drivers and why we feel continued confidence in our ability to actually drive our margins going forward. I think the -- from an ex-Kidney perspective, there's a couple of things that I would just say. Number one, as we move to a vertical structure in this company, we've continued to refine the process of allocations. So, some of this from an ex-Kidney perspective is an impact. Again, as we continue to refine our allocation methodology and you see some of that again impacting where the [indiscernible] Kidney and some of them margins ex-Kidney. The other part to it from -- just as I mentioned in some of my comments in the earlier question, we are continuing to invest in R&D. We are continuing to invest in new product launches and things that ultimately are going to again drive growth that are impacting operating margins in general. So that's the -- did that answer your question?
Travis Steed:
Yeah, thanks a lot. I appreciate that.
Operator:
David Roman of Goldman Sachs is on the line with a question. Please state your question.
David Roman:
Thank you, and good morning, everybody. I wanted just to start on the revenue outlook for the balance of the year, and recognizing the comment on exiting the year at the higher end of the 4% to 5% on the core Baxter business. But as you look at the sort of guidance that you've provided for Q3 and the balance of the year, I think that implies revenue growth in Q4 below 1%. Can you maybe just help us understand the drivers of the phasing of revenue for the balance of the year? And then, I have one follow-up on the strategic capital allocation side.
Joel Grade:
Sure. Thanks for the question. Yeah, the primary driver of some of the movement there in terms of, I'll call, the squeeze math in the fourth quarter is really product mix impacted. It starts with compounding in Pharma. We've had some -- again, that's been a significant driver of some of the upside. In addition, obviously, other parts of the business and that actually starts to slow down in the second half of the year, but in particular in the fourth quarter. And so, I would say that's really one of the key drivers of some of the little bit of the phasing from what you'd call third quarter perspective and again the squeeze math on the fourth quarter.
David Roman:
Got it. And then maybe just a follow-up, if you look at kind of the increases in discretionary spending on the SG&A and R&D side, could you maybe go into a little bit more detail about the internal capital allocation priorities? Where those incremental dollars in SG&A and R&D are being deployed? And maybe any early look you can give us into some of the either product launches or geographic expansion initiatives that may come out the other side of these investments?
Joe Almeida:
Good morning, David. How are you?
David Roman:
Hello, Joe. Thank you. Nice to talk to you.
Joe Almeida:
Likewise, listen, just adding a bit to Joel's previous answer is compounding, we had a customer in Australia, which had maintenance planned into their hospitals, and we took a great deal of that volume. So, you see their volume dwindling down in the third and fourth quarter, which we knew about it. So, when you do this squeeze method in the fourth quarter, you get what you -- or you get, but primarily driven by that part of the business having a specific event in the first and second quarter. Moving to the capital allocation, our capital allocation, now putting Kidney Care on the side, is driven by innovation. So, what is the highest innovation drivers for the company is going to be in infusion technology. So, we have more investment to do into new categories of pump, more software. We have intelligence software coming out in 2025 with artificial intelligence that attaches to the pump. We also have five new product launches that we're planning the next 12 months for HST, significant ones, really good ones. We need to put the money behind to close the gap in the research and development regulatory affairs as well as the commercial launch. So, that is where we allocate the money, and we have some molecules in Pharmaceuticals. So, you're talking about infusion systems, specifics into PSS and care communications and what we call the injectable specialty drugs, primarily [indiscernible] that we have coming out of one of our facilities. So, all the capital allocation is going into products that have higher margin and higher contribution to the company plus associated to that is the spending that goes along. So, it's a good spending put for good use. We did a lot of work internally to understand the major drivers of shareholder value to be able to achieve that.
David Roman:
Very helpful. Thank you for taking the questions.
Operator:
Larry Biegelsen of Wells Fargo is on the line with a question. Please state your question.
Larry Biegelsen:
Good morning. Thanks for taking the question, and congrats on the nice quarter here. Joel, I was hoping you could just give us a refresher on the key assumptions for Kidney Care sale or spin. The tax basis, how might it look different from the BPS sale? Just the margins for KidneyCo, first half was 10.9%, which is much higher than in prior year. So, when we're trying to estimate the dilution, what should we think about for margins and the stranded cost assumptions and use of proceeds would be helpful. Any color on that? Thanks for taking the question.
Joel Grade:
Sure. Thanks for the question. Let me just start with the -- again, a little bit from a margin perspective. Again, our first quarter with Kidney, you'll recall, was -- had some substantial one-time impact that drove that margin that, what I'll call it, disproportionately high level. So, I think as we've talked about Kidney in general, think about that, I think as a high single-digit sort of low double-digit margin profile at this point. And again, that was somewhat inflated though particularly in Q1 will be the way I would answer that question. From a stranded cost perspective, look, this is an area we haven't specifically given that type of guidance yet on it. What I will tell you is that that's one of the key initiatives that I'm driving personally in terms of our ability to again to reduce the dilutive impact on that. And so, I think that's something we're going to -- you'll hear more about as we go forward. But that's really, again, we haven't come out yet and given that type of information. And we have plans really underway and again, we're starting execution of that to get way ahead of it. Certainly, from a sales versus spin perspective, obviously, the overarching goal is to maximize shareholder value. And so, we're going to do what is best in order to accomplish that. And if I weigh the puts and takes on some of that kind of stuff, obviously, all else evaluations being equal, so to speak, there are certain advantages of the sale from the perspective of more cash earlier, from the perspective of valuation, certainly, et cetera, but obviously, there's lots of parts to play in that. And then, from a tax perspective, I guess, to answer your final question, I think I look at that as a part of the overall economics of what we're going to do. I think there's been a lot of questions on tax leakage, et cetera, et cetera, et cetera. But in the end, it really is about economics in terms of what we end up with from a net tax proceeds and again what maximize the shareholder value.
Larry Biegelsen:
All right. I'll leave it at that. Thanks for taking the question, guys.
Joel Grade:
Thank you.
Operator:
Vijay Kumar of Evercore ISI is on the line with the question. Please state your question.
Vijay Kumar:
Hey, guys, thanks for taking my question. Joel, I just want to go back on the fourth quarter, you implied sort of 1% organic. And if I heard you correctly, is the only thing that's changing is Drug Compounding. So, should the exit rates for MPT, HST, KidneyCo they should all be in that sort of annual range rate in the low- to mid-singles for MPT, HST, KidneyCo in the 1% to 2%, and only thing that changes for Q4 is Drug Compounding, is that correct?
Joel Grade:
It's primarily that and some Kidney, but I think the Drug Compounding is the main part of it. We haven't talked about the fact that our ex-Kidney exit rate for the year will be in the 4% to 5% range. So I think the -- but yeah, it's primarily compounding and then some slowdown in Kidney.
Joe Almeida:
So Vijay, the Kidney part is primarily driven by value-based procurement in that specific business. So, as we await the inclusion or not, we look at our forecast and we look -- that is the biggest impact that we're going to have in Kidney is VBP. And of course, that associated with Drug Compounding have muted the good growth and results of the rest of the businesses of Baxter.
Vijay Kumar:
Understood, Joe. And maybe, Joe, a bigger-picture question for you. If I just go back last 18 months, there's been a lot of moving parts, challenges, a lot of questions raised on, is Baxter losing share. When I look at your order commentary within HS&T in some of the performance in core business, it looks like we're back to 4%-plus. When we look at the sort of the forward trajectory here, right, the implied exit rate, is that 4%-plus organic sustainable? Any one-offs we should be aware of? I know this year we had China VBP and some product exits. Any other noise factors that we need to be aware of as you look at the outlook and your comments on share losses?
Joe Almeida:
Let me start from the beginning -- from the end of your question. On VBP, VBP is a factor in Kidney Care. It is a very muted factor in the rest of Baxter, because our presence in China is quite different. Our Kidney holds the vast majority of profitability in China for Baxter in the product offering as well. So, put that aside now. So, VBP Baxter ex-Kidney is a non-event at the moment. Moving to share. We had a tough first quarter for HST. And that greatly was self-inflicted. We had execution issues, which are behind us, as you could see. We had really good performance in PSS. Our orders are significantly up and we're back on the saddle on that without any hesitation. I see us moving forward into Q3 and Q4 with possibility of share gains in that space due to our offering and our ability to bring Baxter together, okay? We have a great offering that actually underscore our mission to save and sustain lives and that is becoming more clear to hospital customers and IDNs when we present, then we've seen a movement towards Baxter, what called the Baxter accounts. The other portion of the market share, which has been spoken as of lately in some of the other calls is on the pump. Baxter will continue to gain 1% plus, the Novum can get up to 2% of market share points on a yearly basis and hopefully more as we continue to see great opportunities. Baxter has converted some really large and important accounts from the competition with our Novum pump. So, I want to make sure that we are a really strong company competing in the marketplace and we're having some successes, as you can see by our guidance going into Q3 and Q4. And the Q4, just to close the loop on that, is depressed primarily by Kidney Care going into negative growth territory for sales and the reduction into compounded sales.
Vijay Kumar:
Fantastic. Thanks guys, and congrats on the execution.
Joe Almeida:
Thank you.
Operator:
Danielle Antalffy of UBS is on the line with a question. Please state your question.
Danielle Antalffy:
Hey, good morning, everyone. Thank you so much for taking the question. Congrats on a good quarter here. Joe and Joel, I wanted to ask a high-level question, and that was really you've been undertaking a sort of a restructuring over the last few quarters here. I'm just curious about, Joe, where you think you guys are? Have you completely turned the corner? This is obviously quite a good quarter, relatively speaking and even not relatively -- on an absolute basis. So, how do you guys turned the corner? Where -- are there still more areas for improving execution that you see going forward, or are we on the path to more consistent improvement from here? And I'll leave it at that. Thanks so much.
Joe Almeida:
Thank you, Danielle. Listen, one of the things I want to underscore has been Baxter's capability bringing together a life-saving portfolio of products. And we have made significant progress in the last two years in our enterprise accounts and how Baxter-connected products now are starting to show to our customers and how interested they are. So, I feel that commercial execution not by segment or division only, but as a company has been very successful as of late, and we're starting to see that coming around. Second thing is now moving down from the sales into the ISC, we have turned the corner. Our colleagues in supply chain and our presidents of the segments have worked very, very closely and have devised and are implementing and executing really good plans in terms of cost optimization. And we can see that in our margins, start to turn the corner and we have made great changes to accomplish that. Going down one level, SG&A is all about what Joel spoke about, is our stranded cost associated with other efficiencies, primarily in G&A. This is where the recipe is for the next 12 to 24 months is to optimize the Baxter shared services organization even further and there's great opportunity there as well as contain and offset the stranded costs, so we can show progressively in the next year, two, three, consistent improvements in operating income margins.
Danielle Antalffy:
Thanks.
Operator:
Matt Miksic of Barclays is on the line with a question. Please state your question.
Matt Miksic:
Hey, thanks so much, and congrats on a really strong quarter here. I wanted to just touch on a couple of things that I don't know where [indiscernible] framed out yet in the call. One was just, where you are in terms of the pricing resets that you've talked about a fair amount? And then, also just any sense that you can get from the patient support side of the business or call it the capital equipment side of the business that maybe speaks to overall demand in the market that you're seeing around investment in infrastructure and capacity as that's come up a few times this earnings cycle? And again, congrats, and thanks so much for taking the questions.
Joe Almeida:
Thank you. As we had previously disclosed, we have negotiated two very large GPO agreements and conversations now have moved to the IDN level. As expected, customers are being thoughtful and thorough about evaluation -- evaluating their options. We believe now with the Novum launch and our ability to provide product, our supply chain resilience, by the way, is second to none. We have proven that over the years and that resonates with our customers tremendously. The association of that and the ability to have a large-volume parenteral pump as well as a syringe pump on a novel platform on the market makes a huge difference. So, I feel optimistic that we're going to close those negotiations in the next four months and be able to move on into 2025 with these things behind us. And by the way, pricing has been a contributor to Baxter, in Q2 2024, was about 100 basis points and expect to be roughly 100 basis points for the full year.
Joel Grade:
Yeah. And then I'll just take that from a capital perspective, you'd asked about investments in capacity and other types of things. I mean, I think the way I would think about this obviously is as we contemplate our world post-separation, this certainly is an opportunity from -- to really evaluate the -- I guess I'll call it our overall network. There's a lot of things that are intertwined while Kidney is part of our company and the ability to actually really reevaluate that once again that separation does happen is really going to be a key driver of how we think about our network, how we think about our manufacturing, how we think about our distribution network, et cetera. So again, as we think about our capital spend moving forward, and again, with now the ability to allocate capital, if you will, in a way that's really focused on both -- it allows both companies to where both companies can really focus their capital on their highest priorities. Again, that's really how we're going to think about the way we evaluate our capital investments and our infrastructure moving forward.
Operator:
Rick Wise of Stifel is on the line with a question. Please state your question.
Rick Wise:
Hi, good morning to you both. Joe, I was just hoping you would expand on your Novum comments. Where are we in the rollout? Is this -- you talked about the positives about high customer interest and the healthy backlog or funnel of orders. Does adoption -- does growth accelerate in the second half and into '25? Is that the right way to think about it? And are you seeing more orders than you were expecting last quarter or sort of in line?
Joe Almeida:
Rick, good morning. We found, as a matter of fact, we have sales of Novum in the second quarter, which we did not expect to have, but we're a little faster in having the product ready for the market. What we've seen is great interest. It plays well for our ability to compete. As you know, Spectrum is a great product, but it does not have a syringe pump. And having a syringe pump makes a huge difference. So, we're very happy with the momentum that we're getting in Novum. We'll been showing that to very large hospital systems and small as well. Our team is very hard at work and we feel confident in the technology. So, we have the ability to take market share. I think that is an important thing. This is about providing our patients and our customers with the best technology on the market, not a re-engineered technology from many, many years ago.
Rick Wise:
Got you. And Joel, maybe just one for you. You obviously -- you and Joe highlighted multiple times in multiple ways Front Line Care and your optimism that things improve from here. And I was hoping you'd just dig in a little deeper on the turnaround. So, will patient care and government, is that potentially going to get better? And maybe talk about that transition to cardiology and acute, I think those are two areas you mentioned. What do you need to do to get there and how soon can it have a positive impact? Thank you both.
Joe Almeida:
You're welcome. So, Rick, let me break up a little bit, break down FLC for -- or Front Line Care to all listening to the call. Primary care is one segment, one division of that business. We have other divisions such as cardiology and monitoring. Those are going very well. We have no issues in the acute care space. So, let's focus on a specific, the patient, the primary care physician office. We believe this market has two dimensions. One is the amount of backlog we had in 2023 that we're able to catch up and ship and sell and fulfill orders that were outstanding. The second one is the slowdown in churn that we've seen due to several of these large primary care outfits exiting the market and moving. The demand is still there. Primary care demand is still there. We're number one shareholder, gaining a slight share with 80%-plus of market share already. So, we see that coming back because the demand is not going anywhere. The demand is high. So, the churn due to the changes on the market as well as what we saw last year, we're catching up with the backlog. Government orders is a completely different thing altogether. So eventually the government will need to buy the products that are needed for the government. And when that happens, we'll see the orders come in. We are a very large supplier of the government and I feel comfortable that those problems that we've seen in '24 with the decline in primary care, this year will turn the corner in 2025. The business has solid footing, good technology. On the other side of Front Line Care, we have technology that will be launched in early -- in mid-2025 to compete into monitoring and we are very happy with new launches that will happen in the MedSurg monitoring products that we have coming out in mid-2025. So, technology launches will fuel FLC in 2025 as well as the comp between '24 and '25, a re-emerging of the primary care and probably resuming orders with the government.
Rick Wise:
That's a great overview. Thanks, Joe.
Joel Grade:
You're welcome.
Operator:
Pito Chickering of Deutsche Bank is on the line with our final question. Please state your question.
Pito Chickering:
Hey, good morning, guys. Nice quarter and thanks for fitting in here. Looking at the infusion pumps, what do you think the market is growing sort of in 2024? And are you guys picking up or losing share this year? And with all the RFPs out for '25 and beyond, do you guys see yourselves as market share gainers or market share maintainers? And then, on the strong pricing gains for infusion that you talked about, as we think about pricing in 2025, should we see an acceleration of this pricing for next year?
Joe Almeida:
Pito, can you repeat the last part of your question on the pricing, please?
Pito Chickering:
Yeah. So, you talked about the 100 basis points of pricing sort of this quarter and that continued in the back half of the year. Should that be accelerating in 2025 as you think about the GPO contracts?
Joel Grade:
Yeah. So, this is Joel. Let me take that. I think the way I would think about that is we talked about some pricing of maybe 100 basis points this year as part of the gain that was again mostly outside the US across our portfolio. We think about that -- it's about that same pricing bump from next year as we think about -- as we move into the GPO contracts that come through and that's primarily US pricing. So, I think that's the way I would interpret that. I don't know I'd call it accelerating necessarily, but I would call it consistent with what our expectations were for this year, heading into next year.
Joe Almeida:
And Pito, answering the question on the infusion pump, first of all, we are market share gainers and have been for a long time, just about 100 basis points a year. This will accelerate and is accelerating with Novum we're going to see Q3, Q4 into 2025. So, we find that we have great interest in our pump. I think there is a churn -- a natural churn of the market in terms of number of pumps that need to be replaced and our objective is to be -- in every competitive account with our new technology.
Pito Chickering:
And then, a quick follow-up to David's question, not asking for 2025 [indiscernible] the year with revenues growing under sort of 1% with compounding slowing due to competitors' issues lapping. I guess, how should we model revenue growth compounding in the fourth quarter and then what are the headwinds and tailwinds that we should be thinking about for 2025 revenues?
Joel Grade:
Can you just repeat that? So, your phone was going in and out during that question. I apologize. Do you mind repeating that one more time, please?
Pito Chickering:
Oh, yes, -- so apologies. So, a follow-up to David's question just about the fourth quarter revenues. We're exiting the year growing less than 1% with compounding becoming a headwind in the fourth quarter. So, I guess the question number one is, how should we model compounding growth in the fourth quarter? And number two, with the compounding slowing, how should we think about headwinds and tailwinds for 2025 revenue growth?
Joel Grade:
Yeah. I mean, look, I think the main thing here is really we're going to continue to see, again, improvements in HST. So that's where I'm going to start with. In other words, we've seen that over the course of this year as that HST business has continued to accelerate, again, we think there'll be a strong exit rate for that business and that will continue to accelerate into 2025. I think as we talked about from a Pharma perspective, again, compounding is going to be a portion of that, that's going to drag. I don't know that we've specifically guided the actual compounding business, but that is something that is again going to be a continued -- it's slowing, as Joe talked about, for various customer reasons that that's happened. From MPT perspective, again, we continue to believe we've got some really solid momentum going into 2025, certainly coming out of 2024. And then, obviously -- so just to kind of summarize all that, I think the -- while there is a bit of a squeeze math from the -- we talked about the Kidney and the compounding, the reality of it is that we have a 4% to 5% growth of ex-Kidney that we're heading into -- exiting the year with and heading into next year. So that momentum is really strong, again ex-Kidney, and that's the part that we feel really excited about as we head into 2025.
Joe Almeida:
Pito, just reinforcing and underscoring, our exit rate is 4% to 5%. We feel comfortable with that. That's what Baxter is taking into 2025 and we tend to think that our business and innovation can drive even further going into '26 and '27.
Pito Chickering:
Great. Thanks so much.
Joe Almeida:
Thank you.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's First Quarter 2024 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time.
I would now like to turn the call over to Ms. Clare Trachtman, Senior Vice President, Chief Investor Relations Officer at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning, and welcome to our first quarter 2024 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Joel Grade, Baxter's Executive Vice President and Chief Financial Officer.
On the call this morning, we will be discussing Baxter's first quarter 2024 results along with our financial outlook for the second quarter and full year 2024. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the second quarter and full year 2024; new product development, including the potential impact of recent regulatory clearances with status and potential impact of our ongoing strategic and recent pricing actions, business development, regulatory matters and the macroeconomic environment, including commentary on improving supply chain conditions and evolving customer capital spending trends; contain forward-looking statements that involve risks and uncertainties and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in the accompanying investor presentation and also available in our earnings release issued this morning, which are both available on our website. Now I'd like to turn the call over to Joe. Joe?
José Almeida:
Thank you, Clare, and good morning, everyone. We appreciate you taking the time to join us today. I will begin with an overview of our first quarter results and then provide some updates regarding our ongoing strategic transformation. Joel Grade will follow with a closer look at our financials as well as our outlook for the second quarter and the remainder of the year. Then, as always, we'll open it up to your questions.
Baxter started the year on a positive note, delivering solid results, which exceeded previously issued guidance on both the top line and bottom line first quarter sales from continuing operations with 2% on a reported basis and 3% at constant currency rates. This compares to our original outlook of approximately 1% reported and 1% to 2% constant currency. Overall revenue growth was driven by positive demand and pricing for a broad range of Baxter products. On the bottom line, adjusted earnings per share for continuing operations of $0.65 came in above our prior guidance range of $0.59 to $0.62 per share. This performance was fueled by top line results, combined with our intense focus on driving improved supply chain execution across our manufacturing network. Overall, performance is clearly benefiting from the streamlining and strategic clarity afforded by our newly implemented operating model, as we leverage the advantages of improved visibility globally, increased accountability and function of verticalization. Crisp execution of our margin improvement initiatives, along with a more stable macroeconomic backdrop, is driving enhanced performance across our integrated supply chain operations. And as always, Baxter benefits from its emphasis on essential health care needs in combination with the diversity and durability of our portfolio. This is clearly affecting our overall performance this quarter as the strength of our results across Medical Products and Therapies, Pharmaceuticals and Kidney Care helped offset underperformance in our Healthcare Systems & Technology segment. Taking a closer look at our performance by segment. Medical Products and Therapies, or MPT, delivered first quarter growth of 6% above reported and constant currency rates. Growth was fueled by both pricing and volume gains amid stable market conditions globally. We believe we're well positioned to build on our momentum in MPT with the recent U.S. FDA clearance of our leading-edge Novum IQ large volume infusion pump and Dose IQ Safety Software. This integrated platform, which also includes our previously cleared syringe pump, comprises a single connected intelligent system offering a broad range of benefits for nurses, physicians and other clinicians as well as the patients who depend on them. Our Novum IQ technology is now available to order in the U.S. as part of our expanding portfolio of connected care solutions. Customers are excited about the Novum platform's ability to advance connectivity and intelligent infusion therapy. And the team is already engaged with many customers interested in this new technology. In fact, the large existing Novum syringes Spectrum customer will begin implementing the full Novum platform in the next few months. In just last week, we secured a 100% competitive account conversion to Baxter pumps with a top-tier multistate health system. As you may remember, Novum LVP clearance was not factored in our original FY 2024 outlook. Given the time of the approval, we expect the contribution from Novum launch to be more notable in the second half of the year, even as it displaces, to some degree, sales of our Spectrum IQ pump and the outlook we are sharing today reflects this expected benefit along with the outperformance in the first quarter. Also in late-breaking MPT news last week, we received FDA approval of an expanded indication for Clinolipid, our mixed oil lipid emulsion that provides a source of calories and essential omega fatty acids for parenteral nutrition patients. Clinolipid is now indicated for use in pediatric patients, including preterm and term neonates. This is an example of our continued commitment to meeting the nutritional needs of patients of all ages and is expected to be a positive addition to our nutrition portfolio. Our Pharmaceutical segment achieved a growth of 11% in the first quarter at both reported and constant currency rates. Results for the quarter reflect a benefit from our recent new product launches in the U.S., including 5 new injectables in key therapeutic areas, including anti-infective and antihypertensive medications. Together, these new product introductions demonstrate our continued focus on innovation and delivering differentiated products that address areas of need with proprietary ready-to-use presentations, they can simplify the preparation process and support patient safety. Our performance in this segment was also strengthened by heightened demand outside the U.S. for our drug compounding services. This overall momentum more than offset declines from inhaled anesthesia products. Our Kidney Care segment delivered 3% growth at reported rates and 4% at constant currency. Growth was driven by pricing benefits as well as a strong demand for our Acute Therapies portfolio and steady gains of peritoneal patients in nearly all markets. Growth in this business was tempered by the impact from select product and market exits and reduced volumes in China due to government-based procurement initiatives and a lower patient census. As noted, positive results across these 3 segments helped offset disappointing performance in Healthcare Systems & Technologies, or HST, which declined 9% at both reported and constant currency rates. This decline was driven to some extent by order timing as well as operational factors. Our new operating model has been vital in helping us isolate underlying challenges affecting this segment. The size of steps are already underway to address and enhance performance in this business and help realize our full opportunity in this space. These include forging a deeper partnership between the commercial and enterprise account teams focused on the value and quality of the broader portfolio. Implementing new tools and processes focused on increasing visibility to historical purchases, creating greater differentiation in customer engagement practices and related measures. We expect these steps collectively to improve operational performance for HST, particularly in the second half of the year. I remain excited about HST and the positive contribution it is expected to deliver to the overall Baxter portfolio. The team is working incredibly hard to address this challenge and turnaround performance in this business and I'm grateful for their dedication and efforts. Before I pass it to Joel, I will share an update on our proposed Kidney Care separation as we announced in the March 4th 8-K filing, we are now pursuing dual pathways in the proposed separation of this business, including potentially selling the business to a private equity investor. The ultimate path forward will be determined consistent with our objective to accelerate performance for both entities and maximize shareholder value. We currently expect the separation to take place in the second half of 2024. Looking ahead, I want to express my excitement about Baxter overall trajectory. Our life sustaining mission is as always our North Star and our colleagues around the world making it come alive tenacious focus on execution and operational excellence. Our progress against our strategic transformation initiative showcases our ability to deliver on what we set out to accomplish. The benefits are clear in our overall outperformance for the quarter. Our building momentum, our recent innovation milestones and the progress of our proposed Kidney Care separation journey. We will continue to maintain the pace and intensity of our transformation and take the necessary steps so that all of our segments are well positioned to power our performance going forward. I will now pass it to Joel to provide more detail on our performance and outlook.
Joel Grade:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we are pleased with our first quarter results, which came in ahead of our expectations. First quarter 2024 global sales of $3.6 billion increased 2% on a reported basis and 3% on a constant currency basis, and as mentioned, compared favorably to our previously issued guidance.
Performance in the quarter benefited from better-than-expected sales across all our product divisions, with the exception of those within our Healthcare Systems & Technologies segment. On the bottom line, adjusted earnings from continuing operations totaled $0.65 per share, increasing 33% versus the prior year period and ahead of our prior guidance of $0.59 to $0.62 per share. These results reflect the meaningful operational improvements we are recognizing both commercially as well as within our integrated supply chain network, and these factors drove our outperformance in the quarter. Now I'll walk through our results by reportable segments. Commentary regarding sales growth will reflect growth at constant currency rates. Sales in our Medical Products & Therapies, or MPT segment, were $1.2 billion, increasing 6%. Within MPT, first quarter sales from our Infusion Therapies & Technologies division totaled $966 million and increased 6%. Sales in the quarter benefited from strong growth internationally across the division, including in our IV solutions, nutrition and infusion systems portfolios. Solid demand in the U.S. for IV solutions also contributed to growth in the quarter. Sales in Advanced Surgery totaled $263 million and grew 8%, coming in ahead of expectations, and reflecting strong growth internationally. For our Healthcare Systems & Technologies, or HST segment, sales in the quarter were $667 million and declined 9%. Within the HST segment, sales in our Care and Connectivity Solutions, or CCS division were $402 million, declining 7%. Performance in the quarter was impacted by several factors, including the phasing of product installations, particularly for care communications, which is expected to accelerate later in the year by the timing of capital orders, which increased mid-single digits in the quarter,, but are expected to ramp more meaningfully over the course of the year. By lower rental revenues, which negatively impacted sales by approximately $5 million. And finally, by certain operational challenges, for which the team is in the process of implementing clear plans to improve performance and enhance commercial rigor. Given all these factors, we expect to see significant improvements for CCS in both orders and revenue in the second half of the year, which is similar to the [Audio Gap] we experienced last year in this division. Front Line Care sales in the quarter were $265 million, declining 12%. Growth in the quarter was impacted by a difficult comparison in the prior year as backlog reductions positively contributed to growth in the prior year period. Performance in the quarter was also affected by softness in the primary care market which negatively impacted sales in both our connected monitoring and intelligent diagnostics product portfolios. Similar to CCS, we expect performance to meaningfully improve in the second half of the year as market conditions for primary care are anticipated to ease, the pace of customer orders are expected to increase, and we anniversary the prior year impact from the backlog reduction. Sales in our Pharmaceuticals segment were $578 million, increasing 11%. Performance in the quarter reflected double-digit growth in both our U.S. and international injectables portfolio, driven by new product launches as well as continued strong demand for services within our drug compounding portfolio internationally. Moving on to Kidney Care. Sales in the quarter were $1.1 billion, increasing 4%. Within Kidney Care, global sales for chronic therapies were $888 million, increasing 2%. Solid PD growth in the quarter was partially offset by the negative impact from certain products and market exits in our in-center HD business as well as reduced sales in China due to government procurement initiatives and lower patient census volumes following the pandemic. We estimate that these items negatively impacted sales by approximately $50 million in the quarter. Sales in our Acute Therapies business were $214 million, representing growth of 15%, driven by strong demand and competitive wins in the U.S. and solid performance internationally. Other sales, which represent sales not allocated to a segment and primarily includes sales of products and services provided directly through certain of our manufacturing facilities, were $16 million and declined 47% during the quarter, in line with our expectations and reflecting reduced demand for certain contract manufacturing volumes. Now moving on to the rest of the P&L. Our adjusted gross margin totaled 42.5% and represented an increase of 170 basis points over the prior year and was favorable to our expectations. The year-over-year improvement in gross margin primarily reflects the strong operational efficiencies we are realizing within our integrated supply chain network, resulting from execution of the margin improvement programs we're implementing and the anniversary of the negative margin impacts from inflationary pressures that drove higher cost of goods sold in the prior year period. Pricing initiatives in select markets also positively contributed to margin improvement in the quarter. First quarter margins also reflected a benefit from the closure of our dialyzer facility as production in the facility was increased in advance of the closure, resulting in better absorption and lower costs for these dialyzers. This benefit is expected to be isolated to the first quarter. Overall product mix in the quarter did partially offset margin expansion in the quarter. Adjusted SG&A totaled $856 million or 23.8% as a percentage of sales consistent with the prior year period as ongoing transformation initiatives to enhance operational efficiencies were offset by higher spend in select investments in sales and marketing initiatives. SG&A leverage is expected to improve as sales ramp over the course of the year. Adjusted R&D spending in the quarter totaled $160 million and represented 4.5 as a percentage of sales, similar to the prior year period and reflects our continued investments in advancing new products across the portfolio and bringing innovation to patients across [Audio Gap]. These factors resulted in an adjusted operating margin of 14.3%, an increase of 180 basis points versus the prior year. Net interest expense totaled $78 million in the quarter, a decrease of $39 million versus the prior year period, driven by debt repayments in the fourth quarter of 2023 with proceeds from our BPS divestiture. We plan to continue to repay debt in 2024, consistent with our stated capital allocation priorities. Adjusted other nonoperating income totaled $7 million in the quarter, compared to income of $2 million in the prior year period. The adjusted tax rate in the quarter was 25.0% compared to 23.1% in the prior year period. The year-over-year increase is primarily driven by a valuation allowance recognized in the quarter. And as previously mentioned, adjusted earnings from continuing operations totaled $0.65 per share and increased 33% versus the prior year, primarily driven by commercial performance and operational efficiencies within our integrated supply chain. Let me conclude my remarks by discussing our outlook for the second quarter and full year 2024, including some key assumptions underpinning the guidance. For full year 2024, Baxter now expects total sales growth of approximately 2% on a reported basis and 2% to 3% on a constant currency basis, which is an increase from prior guidance of approximately 2% on a constant currency basis.
Constant currency sales guidance for the full year by reportable segments is as follows:
For MPT, we expect sales growth of 4% to 5%. This is an increase from the prior guidance of 3% to 4% and reflects the first quarter outperformance and the inclusion of Novum, which is currently expected to contribute an incremental $25 million to infusion pump sales and reflects some cannibalization of prior planned sales of Spectrum.
Sales in our Healthcare Systems & Technologies segment are expected to be flat to the prior year as compared to previous guidance of approximately 3%. As mentioned earlier, we expect performance to meaningfully improve in the second half of the year, driven by the factors discussed, including timing of installations, order phasing and improved operational execution. We expect pharmaceutical sales growth of 6% to 7%, which compares favorably to prior guidance of 4% to 5% and reflects the strong start to the year and continued momentum for our new product launches. Collectively, sales for these Baxter businesses are expected to increase 3% to 4% in 2024. For Kidney Care, we expect sales growth of flat to 1% as compared to 2023. This also compares favorably to prior guidance and reflects the underlying momentum of this business. Now turning to our outlook for other P&L line items. We continue to expect adjusted operating margin to increase by at least 50 basis points in 2024. We expect our nonoperating expenses, which include net interest expense and other income and expense, to total approximately $350 million in aggregate during 2024. We continue to anticipate a full year adjusted tax rate between 22.0% and 22.5%. We expect our diluted share count to increase slightly and average 511 million shares for the year. Based on all these factors, we now anticipate full year adjusted earnings, excluding special items, of $2.88 to $2.98 per diluted share, which also compares favorably to prior guidance of $2.85 to $2.95 per diluted share and reflects the outperformance we realized in the first quarter. Specific to the second quarter of 2024, we expect global sales growth of approximately 1% on a reported basis and 2% to 3% on a constant currency basis. And we expect adjusted earnings, excluding special items, of $0.65 to $0.67 per diluted share. With that, we can now open up the call for Q&A.
Operator:
[Operator Instructions] I would like to remind participants that this call is being recorded, and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com.
Our first question comes from Vijay Kumar of Evercore ISI.
Vijay Kumar:
I guess, my first one is on top line here. When I look at the business here, the Hillrom portion health care tech part of the business underperformed, all other segments came in about right. And Joe, when you think about this exiting fiscal '24, can Baxter get back to like 4% top line, like when does Hillrom normalized? And perhaps talk about what gives you confidence that this business is actually growing? Is there any reason to fear share loss within that part of the business?
José Almeida:
Vijay, we are committing to a 4% -- around 4% exit rate for the year. We see what happened in HST in the first quarter as a postponement of orders and some operational issues that we have, that we're addressing very diligently. We're starting to see good results coming out of it.
What gives me confidence in the second half of the year for HST is that the orders that we have, have improved in the exit of Q1 into Q2 with a healthy funnel of opportunities over the rest of 2024. We have commercial and operational challenges that we identified and we have very specific action plans in place. We also are executing on the existing backlog and we also saw some typical seasonality. The first quarter is always the weakest quarter for HST, and the fourth quarter is the highest quarter for HST. Vis-a-vis 2023, we exit Q4 with 7% growth. So what I want to make sure to our investors that we are -- we will exit Baxter around 4% this year -- 4% to 5%, actually -- 4% to 5%, and we will have a recovery of HST based on their operational results and the good funnel that we have established and we're starting to see. This is ex Kidney. I want to make sure that you know. When I talk about Baxter exit 4% to 5% is ex Kidney. So to your question, there's good confidence in exiting the business 4 to 5, good plans in place and starting to see the recovery in HST. This is the headline.
Vijay Kumar:
That's helpful comments, Joe. One on maybe margins here. Q1, both gross margins and operating margins came in above. What drove that gross margins? Are we seeing benefits of cost actions or is this any timing element? Are we seeing pricing contribution? Because when I look at the second quarter EPS, it's below 3. So was there any timing element here on that margins?
Joel Grade:
Yes. This is Joel. And so a couple of things on the Q1 margins, I would call out. Number one, the ISC drove a substantial portion of that. We had strong operational efficiencies. We had positive manufacturing variances that flowed through. And so I think just in general, our ISC performance was a strong contributor there.
Our pricing also had, I'd say, a modest, but partial part of that is well in terms of enhancing our margins. There's a little bit of a mix impact that was offsetting some of that, but I think that's really -- those are some of the really primary drivers in the first quarter. I think from a second quarter standpoint, there's a couple of things I'd just call out there. Number 1 is there was some favorability in the first quarter that was related to the closing of our dialyzer facility. And we had production that was increased. So we had better absorption there. And so from a timing standpoint, those -- that benefited the Q1 margins to some extent that you won't see as much in Q2. And I think the other thing I would call out in Q2, while we certainly continue to have positive contribution from the IHC, positive contribution from pricing, and in particular, some OUS markets, but we also did have a pharma MSA that was part of our BPS divestiture that has -- is impacting the pharma margins in the second quarter as well. So those are a few of the puts and takes from the Q1, Q2 margins.
Operator:
Pito Chickering of Deutsche Bank is on the line with a question.
Pito Chickering:
Going back to the softness in Healthcare Systems & Technology, can you give a little more detail on what exactly were the operational factors that impacted the first quarter? And why it should ramp sort of in the back half of the year? And also on the capital orders, I guess, why did those not flow through in the quarter as you guys were expecting?
And then finally, kind of why you saw lower rental revenues you're expecting? I guess I'm just trying to understand that the delta and the guidance you're seeing sort of today is down 300 bps for the year versus 3 months ago. And what changed so dramatically?
José Almeida:
I will take the first part of your question and Joel will take the second part of your question. We saw the operational issues were more related to how we were integrating our enterprise accounts and our folks who are every day in the field. We had made significant changes halfway through the quarter but did not catch up fast enough.
We've been seeing a great deal of larger orders being signed today. As a matter of fact, a couple of them are full conversion -- competitive conversions. We have a very effective and large enterprise account that now is fully integrated with HST. And those were the things that we saw and didn't start in the first quarter, we should have been integrated and done a better job in -- probably in August, September last year. We did catch up to that, and we see that better. We also have integrated some of the sales systems with more rigor than we had before, and we are making some changes at the mid-level management in that operation so we can get more rigor in how we sell product. But I have to tell you that we're already seeing the momentum that Baxter brings to HST, the part of the 2 companies and how the connectivity of our, for instance, a new Novum pump and how that works with the beds and the monitors how that makes a difference. So that is one part. There were operational issues in frontline care completely different than our CCS business. Front Line Care were related to government orders is slowed down by the government, also primary care issues with the payment system that was got hacked in the first quarter that was a division of United Healthcare that affect the primary care physicians offices, therefore, affect how they're ordering the products and getting paid. So that affects us as well. And there is a temporary contraction in the primary care physicians market, which we have very high market share. As a matter of fact, we probably gained share in that business. Instead of losing, we actually have proof that we gained share. So we see that as a temporary blips in the Front Line Care. In the CCS business were pure operational issues, a lack of better integration in our key account management or enterprise accounts. So the headline of the answer is, we are executing much better right now. We're starting to see the effect in the CCS. We have converted couple of very large accounts from the competition and our offering of launches from last year, Progressa+ and Centrella CLR with a continuous lateral rotation have done very, very well. As a matter of fact, that was the reason why a Midwest system converted from the competition to us. In terms of Front Line Care, we're starting to see the rebound. I think we hit the bottom in the primary care office. And what we saw there in terms of all the things coming together, the payment system and the slowdown of the market and we're starting to see that is starting to pick up. So I feel cautiously optimistic that our actions are starting to provide results and Baxter, in general, has a pretty strong portfolio that bringing together, as you could see by the results of the quarter. Now passing on to Joel on the second part of the question on the revenue.
Joel Grade:
Yes. I would say your question around the second half of year, why are we not recovering fully all the way to the 3%? I mean, I guess what I would say, the first quarter was a fairly sharp decline relative to expectations. And I think more than anything, it's simply that we're not fully anticipating making that up throughout the rest of the course of the year. Having said that, to Joe's point, we certainly do remain optimistic about the growth prospects in this business.
We have a number of new product launches that are coming in, they are going to continue to enhance our growth. As Joe pointed out, the improvement in Front Line Care, we had a lot of issues. We had gone through a lot of backlog last year and so there was actually a lot of difficult comparisons in the first half of the year that we're going to be lapping in the second half of the year. We certainly expect our orders from CCS to continue to meaningfully accelerate. And as Joe said, we've taken specific actions to ensure that commercially and operationally, we're executing better as we head into the back half of the year. So I guess, again, in summary, I don't know we're planning that -- we're not going to be able to make up the entire impact that we had in the first quarter of the year, but we're still confident in how we're moving forward. And I would say this, we started to see some modest improvements even starting in Q2 in that business as well.
Pito Chickering:
Okay. And then a follow-up question on the gross margin. Is it just such a key part of the Baxter story here. Can you quantify the impact of the closing of the dialyzer facility in the quarter?
Looking at the rest of the gross margin improvement year-over-year, what's the split between the inflationary pressures easing versus increased pricing versus just simple operational efficiencies? And should inventories rolling through the balance sheet on the P&L be a tailwind to margins this year? And any seasonality around that occurring?
Clare Trachtman:
So Pito, I'll take that. There are a lot of questions in there. What I would say is that the key is within our integrated supply chain, a lot of this comes down to the execution on our margin improvement initiatives. They've always been designed to offset inflation.
So even this year, we do have normal inflationary pressures within our organization, but the MIPs that the team is executing against are more than offsetting that and driving the savings both on a year-over-year basis and relative to our expectations. Now in the first quarter, we did benefit from some of the positive and favorable manufacturing variances that Joel was referencing. So within the fourth quarter, we did have better volumes than we had anticipated that did -- so those favorable manufacturing variations rolled off in the first quarter giving us a benefit inclusive of what Joel referenced on Opelika where we were preparing for the closure of that dialyzer facility down in Opelika, Alabama. So that's really what I would say. Pricing is a benefit. It's a benefit on a year-over-year basis and it's a benefit relative to our expectations. And this is pricing again across the organization on a net basis. And what we're doing is really outside the U.S., we're looking at those businesses and driving a lot of targeted actions within those markets outside the U.S. So I think this is collective. This is in line with what we said earlier that a lot of our margin improvement this year would be coming from gross margin.
Operator:
Larry Biegelsen of Wells Fargo is on the line with a question.
Larry Biegelsen:
Joe, there was a lot of strength in Q1 outside of HST, but the guidance implies growth slows in all segments. Why would growth slow so much relative to Q1 in Q2 through Q4 in those other segments? And I had one follow-up.
Clare Trachtman:
So Larry, maybe I'll start with that and let folks. I would say most of it -- we did see some strength within our Kidney Care that came in favorable to our expectations. So I think that we are still anticipating that to slow in the second half of the year as we get the impact from some of the government-based pricing initiatives in China. Also just the impact of some of the market exits that we will be incurring for the rest of the year.
So that's probably one of the biggest differences if I think about kind of the rest of the year. In addition, within our Pharmaceuticals business, we had really strong performance from our hospital pharmacy compounding business outside the U.S. We are continuing -- we have strong demand for that business. But we are also really focused on improving the profitability of that business. So as we look at it going forward, being very disciplined about some of the business and demand that we're taking on for that. So I'd say that's probably the other impact. Besides that, I think most of the other businesses really kind of continue to perform in line. But those are the 2 big drivers of what changes between the first half and the second half.
José Almeida:
And you'll see a tremendous acceleration for HST, Larry, that is reflective of the pace of the business but also acceleration of some of our actions that we took mid-Q1, that is starting to get effect in Q2. We have accelerated our pump sales.
We also see tremendous demand for our IV solutions and our nutrition -- IV nutrition doing pretty well. And our Pharmaceutical is doing extremely well with the 5 launches. We put those gains into the forecast, into the guidance going forward. However, we see this -- us seeking profitability ahead of sales growth. So we will make some of the decisions to be markets where we can actually improve the bottom line. So it's a combination. You saw what happens. We beat the top. We beat the bottom and we continue to seek for opportunities to hopefully overperform.
Joel Grade:
And if I could just add one thing on the kidney piece for a little bit just 1 order of magnitude. That business that we talked about going from flat to 1% from a guidance perspective would be closer to mid-single digits without some of the market exits. So to Clare's point, that is a fairly sizable impact as we head into the remaining part of the year as well on a holdco basis.
Larry Biegelsen:
That's helpful. Just one quick follow-up. Joe, on the plan for Kidney Co. spin versus sale, when do you expect to make a decision? And how do you guys think about the pros and cons of the spin versus a sale?
José Almeida:
Larry, we will be separating the business in the second half of 2024. And I don't want to comment at the moment and which option is a better option than the other. We're contemplating both options, and we have said that before that we will maximize shareholder return for the option. So whatever option we choose is going to be one of 2. We will separate first of all. Second, when we separate, we will separate with maximization of shareholder return in mind.
Operator:
Robbie Marcus of JPMorgan is on the line with a question.
Robert Marcus:
Maybe one on R&D. This is one of the first years in a while that R&D is growing slower than sales. How do you think about your R&D investment and where it's going? And are we just seeing some of the benefits of the Hillrom integration here?
José Almeida:
I want to start by saying that we actually increased R&D in HST, the former Hillrom business, we call HST in Baxter now. We increased R&D there. We are very, very judicious about capital allocation within the business and what put money in R&D. We also have plans in '24, but also in '25 to continue to increase the dollar's value, not as a percentage of sales, the dollar's value that we put there.
So we have not reduced the dollar value of R&D for '24, we actually increased that. As a percentage, that number may show a slowdown, but it has dollar-wise improved. There's no -- there are no savings that we are requiring from research and development. As a matter of fact, we continue to hire folks. We are right now exploring alternate sites for more R&D centers in one in Ireland and another one in the East Coast of the United States, we are actually increasing that. So our objective is to drive our goal to 4% to 5% top line growth with innovation, and that's going to be fueled by R&D. You're going to see the Novum, we just had Clinolipid approved in the U.S. for neonate and term babies utilization. We also had -- we have significant pipeline coming in from HST. We have wireless communication device. We have new monitors, new thermometers. We have a significant amount of new technology. So there's no slowing down in R&D. It's the other way around.
Robert Marcus:
Great. And maybe one, it doesn't get a lot of attention, but I feel like almost every quarter for the past few years, it keeps driving upside and now it's broken out as drug compounding. Nice high-teens growth here. Kind of same question, following up on Larry, but more specific to the drug compounding.
How do we think about the trajectory of this business? It's one that keeps growing double digits year in and year out and the expectations it always will slow, but it hasn't yet. So what are your views here on how to think about this for the rest of the year?
José Almeida:
Robbie, we at pharmaceutical relied outside the U.S. in very key markets, the combination of drug compounding and premix and vial pharmaceuticals as well as IV solutions as Baxter provides a full solution to the customers.
Drug compounding is not an area -- a strategic area for Baxter, but it's strategic in specific markets that we do business. I would look at the performance of injectable pharmaceuticals, which has been -- was 8% this first quarter, we're starting to see the new products really taking shape and helping offset the price erosion headwinds as well as the gross margin that got eroded during the pandemic. So I would say to you that I'm always optimistic on the second half of the compounding business volume. It is an opportunity that we have to continue to grow. But it's more important to us to grow the new products that we're launching because for every dollar that we sell of a new molecule or a new launched premix, the gross margin is one of the highest in the company, and it goes between 70% and 85%. So that's the focus. Compounding is a good all-around business in Australia, New Zealand, U.K., Canada, Ireland to bring the IV solution volumes and some of the pharmaceuticals, but it's not the driver of the business in pharmaceutical. The new product launches and the volume is.
Operator:
Danielle Antalffy of UBS is on the line with a question.
Danielle Antalffy:
Congrats on a good start to the year here. I just wanted to ask about Novum. Obviously, that's probably the biggest event that has happened now since we were all asked on the phone together. So just curious what you're seeing. I know it's early days, but with Novum, how much of that is factored into the Q1 outperformance or maybe drove some of the Q1 outperformance and into the higher guide? And just sort of what you're seeing from a competitive dynamic now that you do have Novum out there?
José Almeida:
Thank you for the compliment. Opening the question, it was very nice of you to recognize that, we agree with you. Novum has had no impact in the first quarter. As a matter of fact, that performance is driven by strong volumes all around the MPT portfolio, but Novum.
So Novum is going to be -- will have an impact on the company in the second half of the year when we start shipping. As we noted in the prepared remarks, we have 2 large accounts that just order the product. One is a full conversion from our competitor, our largest competitor, and we're going to continue to see that as our technology is modern, is new. The equipment was designed with a significant amount of productivity built in. It comes with the best drug library on the market. And we're going to continue to have a combination of good alternatives to our customers between SIGMA SPECTRUM and Novum. So we -- as we transition between one technology and the other, we will have customers who will continue to use SIGMA SPECTRUM with our award-winning version 9 of the pump and the ones who will have the need for Novum to go there. But our objective right now is competitive conversions. And I think we can make a significant impact there, some in 2024 and more so in 2025.
Joel Grade:
Yes. And if I could just add a couple of things to that. Number one, keep in mind, as Joe talked about, we continue to see really strong performance in our Spectrum pump. And so throughout the course of the year, we've anticipated still strong double-digit growth in Spectrum.
As we head into the second half of the year, again, we will start rolling out Novum. We talked about them from the prepared remarks, we've anticipated some cannibalization of Spectrum with the Novum rollout, but we've included certainly $25 million in the fourth quarter of the year as an anticipation of incremental impact from the Novum rollup -- rollout and as Joe said, much more heading into 2025.
Operator:
Patrick Wood of Morgan Stanley is on the line with a question.
Patrick Wood:
Amazing. I'll keep it to one given the amount going on this morning. So thank you for taking it. Pharmaceuticals, obviously, again, very strong growth. I'm just trying to think bigger picture. The drug shortage list is still very high. You've got some onshoring certainly of the syringe side of things. And I think the Civica experiment didn't really work and some of the Indian manufacturers have been having a difficult time.
I guess what do you see as a long-term opportunity there within that business to keep pushing out ANDAs and potentially either benefit from onshoring or pulling back some capacity and better pricings of the drug shortages? Just curious for the outlook there.
José Almeida:
Patrick, we are in an injectable space that is -- it's called a specialty generic. We take ANDAs, and we create premixes. They're very safe, they have good shelf life and they can be deployed to hospitals very quickly. So as we think about drug shortages, we continue to explore drugs that can be put into that format.
But we have also a different -- we have 2 technologies, one we call Calix, but we have another 1 that we call Viaflo. And the Viaflo technology also allows for premix even better without having to refrigerate for the most part. So our portfolio and Alok Sonig who runs that business has brought in a significant amount of opportunities for us to look at more drugs, more molecules. We revamped our portfolio of new molecules that is going into premix and put more relevant ones. So they see the 5 we just launched. We have a really good effect in '24 and '25 for Baxter. That business is launching probably 3 to 4, 5 relevant molecules a year. And between expansion of markets outside the U.S. and the U.S., we will have more than 25 different launches in 2025. So we continue to accelerate the innovation, but it's the quality of the innovation. In terms of making the product available, we will continue to invest in the technology. As you know, all GALAXY technology is U.S., base is made here in Illinois, and we have some of our products made in Puerto Rico as well as Ireland, but most onshore. So there should be of a good value proposition for our customers who look for security of supply.
Operator:
Travis Steed of Bank of America Securities is on line with a question.
Travis Steed:
I wanted to ask some of the segment margins, like Renal margins were really strong this quarter, HST margins were lower. I assume that's the revenue stuff, but I just wanted to make sure any other color you can provide on kind of those segment margins this quarter just given they were kind of way off trend?
Joel Grade:
Yes. Thanks for the question. Yes, you're correct in your assumption on that. And then on the Kidney side in particular, there is a lot of impact on that, and something I referred to you earlier in terms of closing our Opelika plant. So again, in that -- in the first quarter, there was -- I call there's a lot of increased production that drove a fairly significant amount of margin in our Kidney business in Q1 in particular. So I think that's really the main driver of that business that you saw that looked like a bit of an outsized margin. We're certainly not anticipating that to continue in Q2.
Travis Steed:
Okay. And then just kind of bigger picture, when you think about the core Baxter business kind of excluding the Renal business, just the opportunity for continued margin expansion. You're getting good margin expansion this year. But just in general, like what are the line of sight that you have? Is it cost rolling off? Is it based on revenue growth acceleration, cost opportunity that you can take out of this business just to kind of keep this margin trajectory and expansion kind of going longer term?
Joel Grade:
Yes. I think it's really a combination of things. First of all, it's the volume, as you said, it is continued opportunities from pricing. As you know, we've had some pricing impact this year. And we've renegotiated some of our contracts with our GPOs as we head into next year. We're anticipating continued favorability from a pricing standpoint.
We also continue to -- the IFC continues to be an area of strength for us that is going to be positively impacting our margins. I think the continued operations for execution, the operational efficiencies, some of the automation opportunities we've had, we continue to do work from a procurement standpoint and some of the buying opportunities we have both to leverage our scale as well as for risk mitigation, we -- I see continued opportunities in the IFC space. And I think the other thing I would say is I've said this before, I'll say it again, we're not going to SG&A are way to prosperity. However, there are areas of opportunity there. For example, we'll be hiring, even starting next week, a person that's going to be leading our global business services. That is an opportunity for us to continue to think about how we -- what our operating model is, as opposed to verticalization and how we can leverage some of the -- those opportunities across our organization. So I think, again, I see a variety of ways really up and down our P&L in terms of those type of opportunities to continue to expand our margins.
Operator:
Josh Jennings of TD Cowen is on the line with the question.
Joshua Jennings:
I was hoping to ask Joe and team just about the geographic expansion initiative for the Hillrom or HST portfolio. Has it taken a little bit longer than Baxter initially thought? Or are there challenges to bring Hillrom technologies into international geographies where Baxter are present and Hillrom didn't? It sounds like some of the international softness was based on government order timing in Q1, but just wanted to get an update there as it was part of the strategic rationale for the Hillrom acquisition.
José Almeida:
Yes. We have good performance in Western Europe, we see that, and we see good performance in Latin America as well. So we see that Baxter combination with Hillrom has expanded Hillrom opportunity in those markets. We are making changes in our Asia Pacific organization to bring more focus on capital sales to supplement what Baxter is strong, which is general acute market sales.
So we're increasing talent in Asia Pacific with some changes we just recently made. And Western Europe continues to be a strong market for us, and we continue to strengthen the group there, Latin America as well. So it has been a positive take on Baxter and Hillrom combined for outside the U.S. One market where things are not as strong is China, but China because specifically Made in China restrictions in VBP is known in the market, but our sales ambitions there were not very great as opposed to the fact that in Latin America, Europe, Middle East and Africa and the rest of Asia Pac, they become very strong, including Australia. We're very successful in Australia, just closed some really good deals there. So Baxter brought a lot of talent into that equation, and we continue to strengthen the team with new hires that we're bringing on board.
Joshua Jennings:
Understood. And just one follow-up. Wanted to just ask about the Connectivity Solutions technology. It sounds like Novum IQ, the smart beds, they're adding to that connectivity solutions portfolio. But maybe if you could just share with us any pipeline initiatives and how you think they can roll in and then start delivering bigger sales impacts as we move into '25 and 2026?
José Almeida:
We, with Novum IQ, syringe and LVP, large volume parenteral, now we have a suite that connects with Baxter, gateway, overall gateway called Connex. And the Connex brings all these devices to talk to each other. So right now, if you went to our center, our customer experience center in Batesville or in any other place that we have, you would see the pump communicating to devices like Volt, the bed communicating to Volt.
You see the connectivity. And as it becomes more important to our customers, Baxter has the right solutions for the hospitals. Interestingly speaking that it has to bring productivity improvement to the hospital. The ability to connect by just connecting is table stakes. But what Baxter is seeking is continue to innovate to bring specific solutions to improve productivity in the hospital setting. So we -- when we do our -- later this year, we do our Investor Day, we'll be able to bring a demo where you're going to be able to see how these devices will be connecting to each other. But they are very important. And with Novum now, the last piece of this puzzle is complete.
Operator:
We have time for one final question. Matt Miksic of Barclays is on the line with our final question.
Matthew Miksic:
So I'd love to understand one of the things that a question I get often on Baxter is sort of where is the sort of tall pole in the tent? Where is the sort of significant single growth driver, if there is one? And looking into the end of back half of this year and '25, maybe, Joe or if you could highlight which of the product lines or business lines do you think are going to emerge as something that we're all going to look to, to sort of see lift in growth or lifting leverage into '25?
José Almeida:
Matt, one of the advantages of Baxter, it's diverse portfolio that brings things to a point where acute -- the acute market, we provide significant amount of infrastructure products for those markets, IV solutions, pharmaceuticals, pumps.
We also have the capital market with beds, monitors. And so when we think about Baxter in general, our -- we have several of -- several drivers of growth. You could see this quarter was a significant amount of growth and it was more than enough to offset some headwinds that we had in HST and HST is going to continue to -- I'm cautiously optimistic about the business. And I think we have -- we're back into our cadence of growth for that business. We have innovation of every single part of Baxter. We have significant drivers coming out of pharmaceutical, our injectable pharmaceutical portfolio. Our pump conversion rates will be what's going to make that business grow is going to be competitive conversions to our biggest competitor because we have a product that is new and it fulfills significant market needs. We also have, in our HST portfolio, more than 7 significant launches in 2025. So innovation in Baxter is not dependent on 1 or 2 products, it's a wide range of products that derisk the company and put the company in a good solid footing to achieve ex Kidney 4% to 5% growth.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Executives:
Clare Trachtman - VP, IR Jose Almeida - Chairman, President and CEO Joel Grade - EVP and CFO
Analysts:
Travis Steed - Bank of America Securities Matt Miksic - Barclays Vijay Kumar - Evercore ISI Pito Chickering - Deutsche Bank Securities Matt Taylor - Jefferies Danielle Antalffy - UBS
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International’s Fourth Quarter 2023 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today’s call. [Operator Instructions]. As a reminder, this call will be recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter’s permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Senior Vice President, Chief Investor Relations Officer at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning, and welcome to our fourth quarter 2023 earnings conference call. Joining me today are Joe Almeida, Baxter’s Chairman and Chief Executive Officer; and Joel Grade, Baxter’s Executive Vice President and Chief Financial Officer. On the call this morning, we will be discussing Baxter’s fourth quarter and full year 2023 financial results along with our financial outlook for 2024. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the first quarter and full year 2024, new product development including the impact and status of pending regulatory approvals, the status and potential impact of our ongoing strategic and recent pricing actions, business development, regulatory matters, and the macroeconomic environment, including commentary on improving supply chain conditions and evolving customer capital spending trends contain forward-looking statements that involve risks and uncertainties. And of course, our actual results could differ materially from our current expectations. Please refer to today’s press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today’s call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in the accompanying investor presentation, along with our earnings release issued this morning, which are both available on our website. Now I’d like to turn the call over to Joe. Joe?
Jose Almeida:
Thank you, Clare, and good morning, everyone. We appreciate you taking the time to join us. I will begin with a brief overview of Baxter’s performance for the quarter and the year. After this, I will review our progress against the transformational actions we laid out for you just over a year ago, including the planned separation of our Kidney Care business. I will then turn it over to Joel Grade, who will walk through our results and outlook in more detail. Finally, we will open it up for your questions. As you saw this morning, Baxter reported strong performance for the fourth quarter of 2023 with top line sales exceeding our projections and bottom line results coming in at the high end of our guidance range. As a reminder, continuing operations exclude the impact of our biopharma solutions business, which we divested at the close of the third quarter. Sales from continuing operations rose 4% on a reported basis ahead of our outlook of 1% to 2% growth. On a constant currency basis, sales increased 3%, also ahead of our guidance, which projected growth of approximately 1%. Strength in the quarter was broad-based with year-over-year growth in the Healthcare Systems and Technologies, Medical Products and Therapies and Pharmaceuticals, which was slightly offset by an expected decline in Kidney Care. Relative to expectations, both of our chronic therapies and drug compounding divisions reported better-than-expected sales. On the bottom line, adjusted earnings per share from continuing operations came in at $0.88 at the top end of our prior guidance range of $0.85 to $0.88. Our fourth quarter results further reinforce our building momentum. In 2023, we focused on consistently meeting and/or exceeding our financial outlook, particularly in light of the significant supply chain and macro environmental challenges we encountered during 2022. As a testament to this focus, over the course of 2023, we were able to deliver sequential improvement every quarter, and we believe this performance provides us with a solid foundation to build off in 2024. Turning to the full year sales from continuing operations of $14.8 billion advanced 2% on a reported basis and 3% on a constant currency basis, driven by sales growth for all of our segments at constant currency rates. First, looking at the constant currency sales growth in the segment set to comprise our future Baxter portfolio following the planned Kidney Care separation. Sales in Healthcare Systems & Technologies were up 7% in the fourth quarter and 3% for the year. Medical Products and Therapies sales rose 4% in both the quarter and for the year, and sales in Pharmaceuticals were up 7% for both the quarter and the year. Performance in these segments was filled by strong execution across our commercial and manufacturing teams. New product launches increased the availability of electromechanical component and a more stable supply chain and macroeconomic environment relative to the significant volatility experienced last year. With respect to hospital capital spending, while we still believe there may be pockets of softer spending, we are encouraged by the sequential improvement we experienced every quarter in 2023 within our Care and Connectivity Solutions division. Our Kidney Care segment, which will be called Vantive post separation, declined 1% in the quarter and grew 1% for the year at constant rates. Strong growth in acute therapies was offset by flat growth in chronic therapies, reflecting a difficult year-over-year comparison due to certain discrete items that benefited sales in the prior year as well as lower sales in China due to the impact of government-based procurement initiatives and the lower patient census due to the pandemic. The underlying state of the Kidney Care business continues to improve and the momentum we are building is evident. Among key indicators, we are seeing renewed growth in the peritoneal dialysis patient population following the earlier impact of pandemic-driven mortality issues. Our strategic rationale and hypothesis for an independent Kidney Care business remains as strong as ever. Our team is executing and gearing up for a successful separation this year. Given overall business performance and environmental dynamics, I’m optimistic as we look ahead to the prospects for both Baxter and Vantive as separate entities. Our solid financial performance was achieved in parallel with meaningful progress against the strategic priorities we announced to open 2023. We kicked off the year with an urgency to rethink both the scope and velocity of our transformation. Since then, our team delivered executing on a range of goals to position a separated Baxter and Vantive for a new era of enhanced patient and shareholder impact, enabled by heightened strategic clarity, operational efficiency and innovation. We realigned our businesses into newly streamlined simplified operating model based on globally integrated business segments. Each segment is led by a seasoned and knowledgeable executive who has profit and loss accountability, inclusive of dedicated commercial research and development, manufacturing, supply chain and functional teams. We are already seeing the benefits of improved line of sight to our customers and greater agility to recognize and capture growth opportunities. We completed the divestiture of our biopharma solutions business at the close of Q3, which further allowed us to streamline our strategic focus on our core businesses. We are in the process of utilizing the after-tax proceeds of approximately $3.7 billion to pay down debt in line with our stated capital allocation priorities, including $2.8 billion of repayments in the fourth quarter. Finally, we continue to make progress towards separating Vantive out of Baxter. As we have consistently stated, we believe this separation will ultimately empower both companies to pursue their own unique strategic and investment priorities. Many of you had the opportunity to meet the designated Vantive CEO, Chris Toth at the JPMorgan conference last month. Chris has been hard at work building out his organization, meeting customers and setting near-term and long-term strategies. Among recent developments, Chris has onboarded Matt Harbaugh as designated Vantive CFO. Many of you may know Matt from his days as CFO at NuVasive. Meanwhile, we continue to hit key separation milestones across operational, legal, regulatory, supply chain IT domains. In summary, 2023 was a year of rebuilding and renewing our momentum. We made significant progress on an ambitious slate of strategic initiatives coupled with solid financial performance, while never losing focus on our foundational commitments to our customers and patients. Additionally, we have created a new potential to embrace more exciting opportunities to come. I do not take the accomplishments of this past year for granted, I want to thank and recognize all of the employees who hard work and commitment helped us to achieve our objectives. I have never been more impressed by what a team could achieve in a single year and that is why I’m so energized by our potential to seize on opportunities we have created together. Now we turn it over to Joel for a closer look at our fourth quarter and full year 2023 performance as well as our 2024 outlook.
Joel Grade:
Thanks, Joe and good morning, everyone. I’m happy to be joining the call this morning to provide some additional details on Baxter’s fourth quarter and full year 2023 financial performance as well as commentary on our financial outlook for 2024. As Joe mentioned, we are pleased with our fourth quarter results, which represented another step forward in our on-going business transformation. Fourth quarter 2023 global sales of $3.9 billion increased 4% on a reported basis and 3% on a constant currency basis and compared favorably to our previously issued guidance of 1% to 2% reported and approximately 1% constant currency. Outperformance in the quarter benefited from better than expected sales in many product categories and particularly in chronic therapies and drug compounding. As compared to the prior year period, we reported solid quarterly growth in health care systems and technologies, pharmaceuticals and medical products and therapies. And collectively, sales for these three businesses, which will comprise Baxter post the separation, increased approximately 5%. As expected, Kidney Care sales declined slightly in the quarter due to the factors Joe mentioned earlier. On the bottom line, adjusted earnings totalled $0.88 per share, increasing 13% versus the prior year period. These results reflect the ongoing operational improvements we are recognizing both commercially, as well as within our supply chain network as that team successfully executes on its margin improvement programs. Lower interest expense and a benefit from foreign exchange also contributed favorably to the quarter, partially offset by the impact of a higher tax rate compared to the prior year. Adjusted earnings per share for the quarter came in at the high end of our expected range of $0.85 to $0.88 per share, primarily driven by better sales and operational performance. Now I’ll walk through performance by our reportable segments. Commentary regarding sales growth will reflect growth at constant currency rates. Sales in our Medical Products and Therapies segments were $1.3 billion, increasing 4%. Full year 2023 sales totalled $5 billion also advancing 4%. Within Medical products and therapies, fourth quarter sales from our Infusion Therapies and Technologies division totalled $1 billion and increased 4%. Sales in the quarter benefited from strength in our IV Solutions portfolio, particularly outside the United States, as well as solid performance in our infusion system portfolio. Sales from Advanced Surgery totalled $278 million and grew 6%, coming in ahead of expectations and reflecting strong growth internationally. For our Healthcare Systems & Technologies or HST segment, sales in the quarter were $795 million and increased 7%. Full year 2023 sales totalled $3 billion, advancing 3%, within the HST segment, sales in our Care & Connectivity Solutions, or CCS division or $492 million, increasing 11%. Performance in the quarter benefited from double-digit growth in all key product categories within the division, including our care communications, surgical solutions and Patient Support Systems product offerings. Growth in the quarter was partially offset by lower contribution from rental revenues. Fourth quarter United States orders within CCS continued to improve sequentially, but notably also grew on a year-over-year basis for the first time in 2023. While we are encouraged by the improvement in capital spending we’ve seen from our U.S. hospital customers, we continue to believe there may still be select pockets of cautiousness in the marketplace. Front Line Care sales in the quarter were $303 million, increasing 2%, given the improvements in electromechanical component availability over the course of 2023, we’re able to successfully address our elevated backlog and exited the year at more normalized levels. Sales in our Pharmaceuticals segment were $596 million, increasing 7%. For the full year, sales were $2.2 billion, also advancing 7%. Performance in the quarter reflected double-digit growth in our U.S. injectables portfolio driven by new product launches, as well as continued strong demand for our services within our drug compounding portfolio internationally. Other sales, which represent sales not allocated to a segment and primarily include sales of products and services provided directly through certain of our manufacturing facilities were $18 million and declined 58% during the quarter in line with our expectations. This lower level of sales reflects reduced demand for certain contract manufacturing volumes and the termination of a royalty arrangement. Moving on to Kidney Care, sales in the quarter were $1.2 billion and declined 1%. Full year 2023 sales totalled $4.5 billion and increased 1%. Within Kidney Care, global sales for chronic therapies were $950 million, declining 3%, though as mentioned earlier, came in better than expected. Sales growth in the quarter was impacted by a difficult comparison to the prior year period, which included certain discrete items in the U.S. that totalled approximately $25 million. Finally, performance in chronic therapies continues to be impacted by lower sales in China due to certain government-based procurement initiatives and a lower patient census due to the pandemic. We estimate that collectively, these country-specific factors negatively impacted sales by approximately $35 million in the quarter. Sales in our Acute Therapies business were $206 million, representing growth of 6% with strength across most regions, including double-digit growth in the United States, where we’ve now rebased this business following the pandemic-related benefits we previously experienced. Now moving through the rest of the P&L. Our adjusted gross margin totalled 42% and represented an increase of 80 basis points over the prior year. The year-over-year improvement in gross margin primarily reflects the stabilization of macroeconomic factors and inflationary pressures that previously contributed to higher cost for raw materials, overhead and labor that impacted our margins earlier in the year. Margin improvement in the quarter also benefited from pricing initiatives in select markets and on-going margin improvement programs in our integrated supply chain network. Performance for the quarter was inline with our expectations as topline outperformance in the quarter was driven by lower-margin divisions, which drove a slightly negative gross profit mix in the quarter. Adjusted SG&A totalled $829 million or 21.3% as a percentage of sales, an increase of 20 basis points versus the prior year period. Performance in the quarter benefited from our on-going transformation initiatives to enhance operational efficiencies, offset by higher bonus accruals under our annual employee incentive compensation plans compared to the prior year and select investments in sales and marketing initiatives. Adjusted Research & Development spending in the quarter totalled $172 million and represented 4.4% as a percentage of sales, increasing 20 basis points versus the prior year. We have ramped up our R&D efforts, particularly increasing our investments in advancing new products across the portfolio and like SG&A, R&D expenses include the impact of higher employee incentive accruals as compared to the prior year period. These factors resulted in an adjusted operating margin of 16.2% and an increase of 30 basis points. Overall, we are very pleased with the second half margin expansion we’re able to realize with operating margins improving approximately 300 basis points in the second half of the year as compared to the first half of 2023. Net interest expense totalled $73 million in the quarter, a decrease of $44 million versus the prior year and down $55 million sequentially, driven by debt repayment of approximately $2.8 billion associated with the utilization of the proceeds from our BPS divestiture. We plan to continue to repay debt in 2024, consistent with our stated capital allocation priorities. Adjusted other non-operating income, totalled $11 million in the quarter compared to an expense of $11 million in the prior year period. Year-over-year improvement was largely due to lower foreign exchange losses incurred as compared with the prior year period. The adjusted tax rate in the quarter was 21.0% compared to 14.6% in the prior year period. The year-over-year increase is primarily driven by statute expirations on certain tax positions benefiting the prior year period. The tax rate in the quarter came in higher than expected, primarily driven by changes in geographic earnings mix. And as previously mentioned, adjusted earnings totalled $0.88 and increased 13% versus the prior year, primarily driven by better-than-expected sales and operational efficiencies, as well as lower interest expense, partially offset by the tax rate in the quarter. For the full year, Baxter’s adjusted earnings from continuing operations decreased 14% to $2.60 per diluted share, reflecting the impact of higher cost of goods sold, driven primarily by the macro environmental factors we previously discussed, greater annual employee bonus accruals, as well as increased non-operating expenses. These factors were partially offset by our operational and supply chain savings initiatives. With respect to cash flow, we generated free cash flow for the year of over $1 billion from continuing operations compared to $411 million in the prior year period. Going forward, cash flow generation and in particular, improving our working capital metrics is a key priority both for me and the Baxter team. To close on our full year results, we are pleased with our operating performance through 2023, which reflected both consistent progress and building momentum. And it is important to note that our teams were able to achieve this performance, while also making meaningful progress against our strategic initiatives designed to enhance our future performance and drive incremental value for all stakeholders. We look forward to building on that positive momentum as we enter 2024. Let me conclude my remarks by discussing our outlook for the first quarter and full year 2024, including some key assumptions underpinning the guidance. For full year 2024, Baxter expects total sales growth of 2% on both a reported and constant currency basis, as the impact from foreign exchange is currently expected to be minimal on a full year basis. Constant currency sales guidance for the full year by reportable segments is as follows; for Medical Products and Therapies, we expect sales growth of 3% to 4%; sales in our Healthcare Systems and Technology segments are expected to increase approximately 3%; we expect Pharmaceuticals sales growth of 4% to 5%. Collectively, sales for these remaining Baxter businesses are expected to increase 3% to 4% in 2024; for Kidney Care, we expect sales growth to decline 1% to 2% as compared to 2023. Factors impacting year-over-year growth are primarily driven by select market and product exits in connection with our margin expansion initiatives for this segment which we estimate will negatively impact sales by approximately $150 million. Additionally, the incremental impact from the ongoing government procurement initiatives in China is expected to total approximately $70 million in 2024. Now turning to our outlook for other P&L line items. We expect adjusted operating margin to increase by at least 50 basis points in 2024. We expect our non-operating expenses, which include net interest expense and other income and expense to total approximately $350 million in aggregate during 2024. We anticipate a full year adjusted tax rate between 22.0% and 22.5%, which reflects an approximate 100 basis point impact to the 2024 tax rate from the implementation of Pillar 2 [ph]. We expect our diluted share count to increase slightly and average 510 million shares for the year. Based on all these factors, we anticipate full year adjusted earnings, excluding special items, of $2.85 to $2.95 per diluted share. Specific to the first quarter of 2024, we expect global sales growth of approximately 1% on a reported basis and 1% to 2% on a constant currency basis. And we expect adjusted earnings, excluding special items, of $0.59 to $0.62 per diluted share. With that, we can now open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions]. I would like to remind participants that this call is being recorded, and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. Our first question is from Travis Steed of Bank of America Securities. Your question, please.
Travis Steed:
Hi. Good morning, everybody, and thanks for taking the question. I’ll go ahead and ask both of mine upfront. One, on the revenue side, talked about sequential improvement every quarter and when you look at the 2024 revenue guidance to 2%, maybe think through like some of the areas that could improve over the course of the year, where there could be some conservatism built then to the ‘24 and how to think about the cadence of the year? And the second question really is on margins. If you think about the 50 basis point margin guidance. Curious what some of the underlying assumptions are on FX and inflationary pressures and stuff like that? Thanks a lot.
Joel Grade:
Hi, Travis. It’s Joel. Thanks for the call. So I guess I’d say a couple of things. First of all, we feel very good about the momentum in our business. I think we had a – we saw a solid fourth quarter. We are pleased with some of the results that we have heading into this year. And I think the revenue guidance that you see, if you think about overall, the business outside of Kidney is growing 3% to 4% that we have, as we’ve talked about our forecast. With Kidney itself, if you think about that, we actually have about – there’s about $150 million of purposeful business that we’re actually exiting products. We’re exiting markets. And so if you actually factor that into that equation, again, we’re up over that 3% number for the year, which I think is great. If you think about the full year guidance itself, a couple some of that strong sales performance with the fact that we’re actually expanding our margins by over 50 basis points – and we’re actually leading to double-digit EPS growth. I said we feel really good about that. Now on the margin side, what you asked the question you asked, I think the main puts and takes of that – the main part is the operational cost improvements in that. There’s a big piece of that from also pricing, from volume. And again, so I think some of the things that you have in there are some of the key assumptions on the margins. I think in all those areas, we feel good about the opportunities again to build on momentum we’ve had. If you remember in the last quarter, our HST business, we’re very pleased with the momentum we had from a sales perspective in Q4, and we do anticipate that heading into the year as well. So again, lots of good stuff there, but I’ll pause there for any other.
Clare Trachtman:
Yes, in that, I’ll just – I’ll add in a little – or sorry, Travis. I’ll add in a little bit here. That was my fault. So in terms of the cadence, I would say if we think about just the shape of the P&L, I think sales will be relatively – you’ll see some slight acceleration in the second half of the year. But in terms of margin expansion, you are going to see first half margin expansion more outsized than you will see in the second half, obviously, just given the comp and similarly, you’ll see that on earnings growth. So earnings growth in the first half of the year will be very strong. Your question on FX, Travis was FX is negative on margins for the year, about 40 basis points of an impact on our operating margins on a year-over-year basis.
Travis Steed:
Great. Thanks a lot, Clare, and everybody.
Clare Trachtman:
Great. Thank you.
Operator:
Robbie Marcus of JPMorgan has a question. Please state your question.
Unidentified Analyst:
Thanks. This is Allen on for Robbie. I had a question on some of the strength that we saw in the fourth quarter and a little bit of the softer first quarter guide. Was there any pull forward of sales into this quarter? You talked about how you recovered some of the backlogs. I expect some of that drove the outsized strength. But also just looking at first quarter, given what we view as an easy comp, why aren’t you able to put up a better growth number at the start of the year? How much of that is conservatism versus realism?
Clare Trachtman:
Yes. So what I would say is probably one of the biggest drivers in terms of the quarterly cadence is within our HST business, where sales do ramp over the course of the year. So very similar to what we saw in 2023. You will see our HST business have growth – accelerated growth in the second half of the year as compared to the first half of the year. So I think that’s probably one of the bigger drivers in terms of the first quarter guidance.
Jose Almeida:
And also, we are continuing to see momentum from 2023 into 2024. So I feel cautiously optimistic about the momentum that we got in Q4 going into Q1. Of course, we look at many different factors when we are guiding. But I can tell you that based on the market growth, some of the demand that we’re seeing, we feel very comfortable with Q1. And also, we have always a crescendo throughout the year, whereas we have product launches. We have 10 molecules launching in pharmaceutical. They’re starting this quarter that we see ramping throughout Q2, Q3 and Q4. And also, there are some very important accounts that we – is still closing on for the rest of the year that we will also boost our ability to do well in 2024.
Unidentified Analyst:
Got it. And then if I could slip in a quick one. You talked about the capital equipment environment continuing to improve some pockets of weakness. What are you assuming for 2024 in the guidance? Are you expecting continued – a little bit of pockets of weakness? Or are you having that basically normalized over the course of the year? Thank you.
Jose Almeida:
Most of our assumptions are large system – medium to large systems continue to improve. We can see that, and we’re going to see that slightly in Q1, but going into Q2, Q3 and Q4. There are pockets of softness in capital like always are primarily smaller systems. Remember, interest rates are still very high and those affect the smaller systems. But for the majority of our customers, we’re starting to see a recovery in capital when we feel really comfortable in 2024 that is recovering completely from what we saw in the beginning of – end of ‘22 into ‘23.
Clare Trachtman:
Yes. And Allen, just to add on to that. Similarly, I think we will see sequential improvement for capital orders within our CCS business every quarter this year, leading to orders being up on a year-over-year basis. And as mentioned in our prepared remarks, we saw a very similar trend kind of in 2023 as well. And then in the fourth quarter, we did see our orders up on a year-over-year basis. So we’ve been seeing this steady sequential improvement. And so we’re going to build on that momentum as we go into 2024.
Operator:
Matt Miksic of Barclays is on the line with a question. Please state your question.
Matt Miksic:
Hi. Thanks so much for taking the question. Can you hear me okay?
Jose Almeida:
Yes, we can.
Matt Miksic:
Great. Thanks. So I had – congrats on the solid results here and the pickup in the Hill Rock business. So I just have a question on the seasonality of that business. And also if you could maybe just the – to the extent of recurring revenues in that business. And I think we’re used to a history there being capital driven, Q4 driven. But with some of the increase in sort of contracting around connected care and systems that – I’m wondering, is that a mix of recurring revenue that we should see over time? Or you’re starting to see a mix change in that business? Any color on that front would be super helpful. Thanks.
Jose Almeida:
So we always have the seasonality. We see hospitals a little bit more cautious in the first quarter. And then as they get through the first quarter, they start spending the money that they have for the year and it culminates usually with a strong Q4 in terms of growth because a lot of spending gets done there. We try to, as much as possible, create more – a less seasonal less seasonality, but those things happen. And our focus are the – I think one important program we have in Baxter, as you noticed, strengthen our beds in the fourth quarter. We continue to go for some large accounts and conversions and we’re starting to get some success there. When we bring Baxter together, what Baxter can do as one company is incredible for hospitals. So we feel that, that momentum is starting to kick in with accounts that are partially penetrated, going full blow into a Baxter account. We saw that with the conversion that we get this kind of launch in early 2025 in Northern Cal that we have large accounts and other things that we can see. So this is a really good momentum for Baxter. We can see that going. But the first quarter is always a much lighter quarter than the rest of the year. The revenue in terms of Front Line Care is a business that has less seasonality than the CCS business under HST. The reason is that it’s more consistent with procurement in doctors’ offices and monitors into hospital med search floors. So that brings less seasonality. A business that is very predictable is our MPT business, which has been successfully growing, as you can see in 2023. 150 basis points above its market growth rate, driven tremendously by infusion systems as well as solutions, IV solutions. So that brings that business to a quite less seasonable, more repeatable. I hope I was able to answer your question.
Joel Grade:
Yes. Thank you. If I could just add one thing to that. I mean I think the way to think about that HSD business over the course of the year just a bit on what Joe said is that we’re going to see, I’d say, sequential ramp up over the course of the year in that business. So I think the – again, as Clare talked a little bit earlier. I mean there’s going to be somewhat of a ramp up in sales that you’re going to see, and that’s particularly going to be applicable to that segment. The other thing I would just say, you recall last year, Front Line Care had a fairly sizable amount of growth in 2023 as they work through some of the backlog. There’s a bit of an early headwind on that business during the first part of the year as well. So again, sequential ramp-up in that business is just one add I would make to that. So, thanks.
Unidentified Analyst:Great. Thank you.:
Operator:
Vijay Kumar of Evercore ISI is on the line with a question. Please state your question.
Vijay Kumar:
Hey, guys. Thanks for taking my question. Joe, maybe my first one for you. High level when I just look at the business ex Kidney Care. 3% to 4%, that’s a reasonable number, but it’s still below MedTech, right? When I look at the utilization environment, what some of your peers are talking about? Like why is Baxter 3% to 4%? Are there any one-offs in that 3% to 4% ex-Kidney Care? When I look at the legacy Hillrom business, Q4 was really strong. Why should that business slowdown of capital order book is turning around in fiscal ‘24?
Jose Almeida:
Vijay, let me give you a perspective on 3% to 4% for this business. It’s still growing above its market growth rate because we expect to be on the high end of that guidance. What breaks that business go 100 basis points above that? We have, first of all, this business has pharmaceutical in it. We still have price erosion there, but pharmaceutical is going to be punching 4% to 5%. Our NPT is going to be between 3% and 4% and probably with the opportunity to go above that. Now becomes HST. What is happening in HST? We have significant amount of launches going in, the end of ‘24 and ‘25. We have new monitors. We have new cardiology device and we continue to be successful on Progressa+. So a lot of that has to do with our – to get to the 4% to 5%, it has to be new product launches in 2025. Not for pharmaceutical because then you can see already is making a difference to their growth rate – is now for MPT, which is – continues to do extremely well in infusion systems. We’re going to have more than 40% growth between ‘24 and ‘23 in our infusion pumps. It’s going to be new products in HST primarily in Front Line Care and CCS with care communications, new versions of Voalte. There is the two new – three new versions will be launched this year as well as our new wireless communication device that we plan to launch in 2025. So monitors, wireless communication and cardiology, that is what’s going to drive that business to go above 4%. And if we execute well, you will do it.
Joel Grade:
I would also say too, if you think about the as we separate the Kidney business and we talk about later on in this year, having an Investor event. What you’re going to hear us talk about is how we think about capital allocation. How we think about the opportunity for, again, the portfolio ultimately to – because think about – we have a lot of products with very high market share businesses. And so the opportunity to accelerate that growth is something we’re going to talk about later on. But again, that’s part of the benefit of the kidney. Separation is the ability to actually really focus our capital allocation on accelerating the growth to the levels you’re thinking about there.
Vijay Kumar:
Understood. And then maybe one on the guidance question. What is – is inflation still a headwind to margins? What is price versus inflation and interest expense Q4? You didn’t note the sequential step down in debt payments. Is that a sustainable number? Thank you.
Clare Trachtman:
So you want me to –, I’ll start with interest. What I would say, Vijay, on interest is that in the first half of the year, it’s probably, I’d say, first quarter, probably similar. It steps up likely a little bit in the second quarter, and then we’ll step up in the second half of the year. We are planning to pay down some low coupon debt in the second quarter. And so right now, we’re earning some cash – or earning interest income on the cash that we have. And so that will go away in the second half of the year. So that’s why you’ll see a bit of a higher interest expense in the second half of the year as compared to the first half.
Joel Grade:
Yes. And on the debt paydown, I mean, again, we – of the $3.7 billion of proceeds after tax we got from the sale of EPS, we actually used $2.8 million of that to pay down debt in the fourth quarter. Again, we have some debt coming due that’s maturing in 2024 that will use some of the rest of that for, particularly the Euro bond as Clare talked about. And then obviously, we have some debt during later in the year that we’ll actually address at that point in time.
Clare Trachtman:
And then to your other question, kind of just on overall the inflationary environment and pricing. What I would say, and we referenced this earlier, is that our integrated supply chain team is executing on their margin improvement program. And so those programs and the savings we will generate this year will positively contribute to our margin expansion. So they will more than offset any sort of normalized inflation that we have. In addition, we are getting pricing will be a benefit this year as well. So we are getting pricing, particularly in markets outside the US as well, so we are going after all of those all of those – our businesses are targeting price in all of those markets as well. Still pricing will be positive for the year as well. In terms of kind of all of those pieces, what I would say on the non-op side is that you have a positive on interest, but you will see that our tax rate is increasing. We did comment on that because of the implementation of Pillar Two. FX – so we have some FX. I talked about it being kind of negative on the operating margin. So all in, our non-op is probably a couple of cents negative impact for us on the year.
Vijay Kumar:Thank you, guys.:
Operator:
Pito Chickering of Deutsche Bank Securities is on the line with a question. Please state your question.
Pito Chickering:
Hey good morning guys. Joel, like you’ve been in that seat for very long, but I just think a fresh set of eyes on the operations of Baxter. Can you walk us where you think the most margin upside is over the next several years? And what you need to do to take those cost reductions in the areas that you want to hit like procurement or any other sort of low hanging fruit?
Joel Grade:
Sure. Absolutely. Thanks for asking the question. Yes, I think one of the biggest opportunities we have from a margin perspective is to continue the work that we’re doing in our independent supply chain group. I think the team has got a lot of really good margin improvement programs going that are designed specifically around things like automation. They’re designed around things like how do we enhance our procurement abilities. They’re around – continuing around things about how do we optimize our network and some of the logistics opportunities. I think some of the areas that are the most impactful over time sit in that space, again, and that’s – as the team has gotten off to, again, a really good start on that. You’ve heard Clare talk about the fact that as we continue to see some inflationary pressures coming out, I think the work that they’ve done has gotten us to a place where we have the ability to offset that. But to continue the expansion of the margins, to your point, fall into some of those categories that I just referred to. I think the other piece of some of you heard me say this already. We’re not going to SG&A ourselves to prosperity. But nonetheless, there are still opportunities in that space as well around things like again, how do we think about a shared services environment that actually allows for consistent execution of operations across the business. And I know this is not a margin question, but the other part of what we’re going to focus on heavily is our – is cash that we will continue to – how do we drive an improved use of working capital. How do we improve our cash conversion ratio again? I know that’s not specifically what you asked. But again, that’s going to be a – some in area I see the opportunity. And what that all leads to is then the opportunity for us to continue to reinvest some of that back into our business around innovation, around new product development. And back to the question that was asked earlier, how do we continue to accelerate growth. That’s what I call a flywheel that allows us to continue to grow, continue to invest and continue to grow, etcetera, etcetera, which is where we want to get to the company.
Pito Chickering:
Great. And then for a follow-up, you opened Pandora’s box, a little bit here by providing segment level margins for 4Q in 2023. Now we’re going to be looking possibly to rebuild their models. Can you break out sort of the margins in each division for what you’re seeing for 2024? And then a quick pump question here, how is market share for pumps and 4Q as you compete against next-gen pumps and any update on Novum?
Jose Almeida:
Let me start with the pumps and then Clare is going to answer the first part of your question. Yesterday, we just got awarded best-in-class KLA for our Sigma Spectrum pump, which is a great honour. That pump continues to do a great job nonetheless, we’re looking forward to get Novum approved. But in terms of market share, we continue to advance our market share. This year, we have 40%-plus growth in our pumps versus last year. That’s our forecast. So we continue to do well, and we look forward to continue to gain market share and now with a nice award to our pump is the seventh award that, that pump received since it was launched. So, back to Clare now to answer the first part of your question.
Clare Trachtman:
Yes. Pito, in terms of the 2024 operating margin guidance, we aren’t going to give that by segment. But obviously, all of our actions are aligned to improve both the segment and total Baxter margins. The one caveat I would point out is that within our Pharmaceuticals business. As you’re aware, we did divest our BioPharma Solutions business last year. And so as a result, we entered into some MSAs, which will have a negative impact on the pharmaceutical margins and obviously on total Baxter margins for the year as we’ve now entered into the MSA. So you will see that impact in the pharmaceuticals margins.
Pito Chickering:
Great. Thanks so much.
Operator:
Lei of Wells Fargo is on the line with a question. Please state your question.
Unidentified Analyst:
Hi. It’s Lei calling in for Larry. Thanks for taking my question. I just want to make sure I didn’t miss it. Did you comment on the status of Novum IQ, the resubmission, and your thoughts on potential approval in ‘24? And I have a follow-up.
Jose Almeida:
I didn’t comment on the details, and we usually don’t comment on anything that is with the FDA on behalf of the FDA. We can tell you that we answer all their questions. There’s no other questions to be answered. All the documentation was submitted. So as always, is at their side now to make a final decision on this. But as I said before and I said this about a month or so ago. I feel cautiously optimistic because there is nothing else for us to do. We answer all the questions. So there will be – if that happened in ‘24 will be a great thing. Nevertheless, we continue to gain market share for Sigma Spectrum. As I said before, we just got an award a best-in-class for that pump, and we’re very happy, and we continue to be very busy quoting new accounts and competitive accounts, which we are actually winning with that pump.
Unidentified Analyst:
Got it. And my follow-up is just on your – what you said about expectations for the 2 segments in ‘24. So Baxter Ex-Reno, you expect 3% to 4% growth. Is that the right way to look at – is that the right way to look at it longer term? And similarly, in the renal business itself, you’re expecting 1% to 2% decline this year. But once you adjust for the exits in China VVP, does renal normalized to kind of low single-digit growth longer term? Thanks again for the question.
Clare Trachtman:
Yes. So Lei, I’m going to go back to something that Joel mentioned earlier. We plan to have a Capital Markets Day later this year, where we will discuss our long-term expectations for the business. And – but I think that both Joe and Joel have said that, while we’re growing 3% to 4% through the introduction of new products, continued market expansion, our goal is to grow ahead of our weighted average market growth rate. So we do want to grow in advance of that. And so we’ll be unveiling kind of those longer term. But no, I would say our goal is to accelerate growth off of that. With respect to Kidney Care, again, yes, we made $150 million of exits to that business, all aligned with our goal of enhancing profitability for that business post separation. So I think that what we want to ensure is that we’re setting this business up for success as a stand-alone entity. We also have the value-based procurement. There might be some follow-on to that in 2025. But I think the key is that the fundamentals for this business are improving. We’re seeing solid patient growth. We’re seeing a rebound in our Acute Therapies business. So I believe this business can accelerate off the levels – that will grow at the levels that we’re seeing once we make these adjustments.
Joel Grade:
Yes. And I would just – the question you asked, the – we did again make purposeful decisions around exiting markets, exiting products. And so if you actually add that back from that $150 million we referred to earlier, I think, yes, you could find yourself in a place where there’s a – the growth is actually in the low single digits.
Operator:
Matt Taylor of Jefferies is on the line with a question. Please state your question.
Matt Taylor:
Hi, thanks for the question. I know you noticed noted some progress on pricing. I was wondering if you could comment on that in your expectations for pricing in ‘24. And any updates on some of those bigger contracts that you’ve talked about in the past and your opportunities to reprice solutions, dialysis, nutrition, et cetera.
Joel Grade:
Yes. Sure. So we did make progress in pricing in 2023. And some of that was – were temporary in nature in the sense that we had some adds to pricing that will again fall off at the end of the year here. But we do have part of our growth and our margin expansion in 2024, that is continued progress in the areas of pricing. And I think one of the things that we’ve talked about is – just as a reminder, some of the contracts with the GPOs that we’ve signed, we’ve made continued progress on them. That actually doesn’t kick in until 2025. So just to remind you of that, that’s not part of what we’re talking about in terms of progress. But again, the team has made solid progress in terms of continuing to take pricing in 2024. And the other thing I would say that we’ve done a good job of – are going to continue to do an even better job of is to give ourselves the opportunities to actually have indexes within our pricing that allow us more flexibility to pass along cost that are coming into our world that we have historically struggled to pass along to our customers. Again, we’re making progress in that area as well. So generally speaking, as Clare talked about, our expansion margins really is focused on some of the operational work that we’re doing, but also, again, our pricing progress continues in 2024, and we look to accelerate that further in 2025 and beyond.
Matt Taylor:
So I just ask a follow-up. I mean when can we hear more about the bigger contracts? Are you going to talk about that throughout the year? And can you comment at all on the kind of opportunities you have with some of those contracts, what’s the order of magnitude of pricing you could get?
Jose Almeida:
We are making great progress. We’re in the middle of doing it. Once these contracts are signed, the next steps for us to secure the IDNs underneath them. And back to do well on that. We are well poised to take that action. We are feeling quite comfortable where we are today in terms of signing these agreements. We’re not going to tell exactly the status of – where we are signing them for competitive reasons, neither the volume of dollars. So you need to think about this as value. Value is dropping profit to the bottom line is value. That will be achieved with pricing and volume. Volume is important to us, the size of our plants. So we’re getting a combination of both is the important thing for us. So our focus price is always important because the amount of headwind that we had in 2022, of course. So we are considering that, but also expansion of market share is important to us as well because we have capacity. We’ve been serving the market very well. So think about our objective in 2024 into 2025 is to continue to add value and significant accretion potentially to the bottom line by getting those contracts signed, but we are in good position.
Joel Grade:
And we’re not going to give specific details on the pricing or volume, as Joe referenced. So just think about that as guidance that we ultimately give on margins and volume growth will be inclusive of the progress we’ll make with those contracts.
Matt Taylor:Thanks, Joe. Thanks, Joel.:Joel Grade:Thank you:
Operator:
Danielle Antalffy of UBS is on the line with a question. Please state your question.
Danielle Antalffy:
Thanks, everyone. Good morning. And just a quick question on sort of what the longer-term focus is post Kidney Care? I assume we’ll get some more color here once we have the pre-spin Analyst Day. But just at a high level, Joe and Joel, curious about where you see the most opportunities to improve whether organically or inorganically from an R&D perspective? And just longer term, i.e. over the next few years, where you think Baxter will be most focused and investing behind? Thanks so much.
Jose Almeida:
So Danielle, we’re thinking about the strategy and the overarching imperative of this strategy is to advance and significantly improve the intrinsic value of the company. And we’re going to do that organically and eventually inorganically as well with some tuck-ins and strategic acquisitions that will supplement some of our business. But – so in the organic side to drive that, that intrinsic value multiplier is innovation, acceleration of innovation, expansion of our commercial footprint in areas that we currently don’t participate well, as well as doubling down in operations excellence in all of our – in all aspects of Baxter from the plants all the way to our back office. So creating value in all parts of the company. So we can take some of that money, reinvest modestly in research and development and continue to accelerate the innovation. And the innovation, all of this is going to be done with a significant amount of importance to capital allocation, meaning where money goes inside of the company, how much is share buyback. So this is a post spin when we are looking at a different debt structure and a different company as that. So think about our strategy to accelerate innovation, accelerate penetration in commercial areas. We’re not like alternate sites of care, ASCs. Those are the drivers of our organic growth, and that should drive a request for a multiplier on our intrinsic value as a company.
Clare Trachtman:
And Danielle, just to follow on and specific to kind of Kidney Care. What I would say is within Kidney Care, and obviously, Chris Toth will elaborate more on this. But they’re going to focus on continuing to increase PD penetration globally. Really focusing on how do they enhance this digitally as well and what digital capabilities are out there to really help both clinicians and patients advance that therapy. In addition, within the acute therapies business, I think they’ll continue to build upon the continued renal replacement therapy and broaden into more multi-organ support therapies as well. So I think that they have a strategy there that they’ll continue to build upon and execute as a stand-alone entity.
Joel Grade:
Yes. And I just think what Joe said and what Clare has talked about is just reinforcement of the strategic rationale for the separation that then allows us and Kidney, frankly, to both focus their capital allocation on those areas that really accelerate their growth. And as Joe said, I see that one start debt is at a level that we’ve targeted to actually reinforce this idea that we’re going to have both organic and inorganic growth opportunities ahead of us.
Danielle Antalffy:
Thank you so much.
Operator:
Ladies and gentlemen, this concludes today’s conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Third Quarter 2023 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today’s call. [Operator Instructions]. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Senior Vice President, Chief Investor Relations Officer at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning, and welcome to our third quarter 2020 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Joel Grade, Baxter newly appointed Executive Vice President and Chief Financial Officer; and Brian Stevens, Baxter’s Senior Vice President, Chief Accounting Officer, Controller and former Interim CFO. On the call this morning, we will be discussing Baxter's third quarter 2023 financial results, along with our financial outlook for the fourth quarter and full year 2023. Please note, that we close the sale of our BioPharma Solutions or BPS business at the end of the third quarter, and results in the current and prior periods have been adjusted to reflect BPS as discontinued operations. Restated schedules reflecting that discontinued operations presentation are included in the appendix to our earnings presentation, and available in the IR section of our website. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the fourth quarter and full year 2023, new product developments, including the impact and status of pending regulatory approvals, the status and potential impact of our ongoing strategic and recent pricing actions, business development, regulatory matters, and the macroeconomic environment, including commentary on continuing supply chain challenges and evolving customer capital spending trends, contain forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in the accompanying investor presentation and in our earnings release issued this morning, which are both available on our website. Now, I'd like to turn the call over to Joe. Joe?
Joe Almeida :
Thank you, Claire, and good morning everyone. We appreciate you taking the time to join us today. I am pleased to be joined this morning by Chief Accounting Officer and Controller Brian Stevens, and to welcome our new Chief Financial Officer Joel Grade to the call. I will begin the call today with an overview of our third quarter performance and the continuing momentum of our ongoing transformational initiatives. I will also share perspective on the progress and potential of our proposed Kidney Care spinoff, including some context around recent developments in that therapeutic area. Brian will provide a more detailed account of Baxter's third quarter and financial outlook, and as always, we will close with your questions. To get started, Baxter reported solid third quarter results that came in ahead of our projections, both on the top and bottom line. Sales from continuing operations rose 3% on a reported basis and 2% on a constant currency basis. As Claire noted earlier, sales from continuing operations exclude Baxter's BioPharma Solutions or BPS business, which Baxter divested at the close of the quarter. Sales in the aggregate, including discontinued operations, also increased 3% on a reported basis and 2% on a constant currency basis. Our better than expected top line performance was driven by positive demand for many of Baxter's products, combined with continued abatement of supply chain challenges. On the bottom line, third quarter aggregate adjusted earnings per share totaled $0.82, comprising EPS of $0.68 for continuing operations and $0.14 for discontinued operations. Adjusted EPS from continuing operations exceeded the top end of our outlook range of $0.65 to $0.67, driven by end market stabilization and good sequential margin improvement across our business, which reflects strong execution against our strategic priorities. Overall, and especially when compared to what we've seen in recent quarters, we view the current market environment as relatively stable, though we continue to monitor hospital capital spending, particularly in light of an elevated interest rate environment. While we have seen sequential improvement in orders within our Care & Connectivity Solutions Division, we continue to expect hospitals to exercise some degree of caution with their capital budgets. The momentum we are building in financial performance is also reflected in the progress we're experiencing across the strategic priorities we laid out for you earlier this year. These initiatives, in combination, are focused on enhancing strategic clarity, increasing operational efficiency, and accelerating innovation to deliver greater value for all of our stakeholders. During the third quarter, we achieved some pivotal milestones towards driving this improved performance. First, we've been hard at work realigning the businesses to simplify and streamline our operating model. These efforts are resulting in a more agile company with better visibility to our global markets and customers. In line with this realignment, today is the first time we formally report our results under the new operating model as four global vertically integrated business segments, Medical Products & Therapies, Healthcare Systems & Technologies, Pharmaceuticals & Kidney Care. Each segment now has global profit and loss accountability, dedicated commercial operations, and fully aligned research and development, manufacturing, supply chain and functional support teams. This reorganization is already creating meaningful advantages in helping us set priorities, build alignment and operationalize our strategy. Advantages they have already and are expected to continue to pay dividends going forward. Our new segments are also a reminder of our highly diversified portfolio with strong brands, a global presence, and high trust among clinicians and patients. The diversity and durability of our portfolio focused on essential healthcare needs helps fuel sustained demand on multiple fronts, allowing us to better weather challenges that can emerge while continuing to deliver on our mission of saving and sustaining lives. As discussed, this quarter we also completed the divestiture of our BioPharma Solutions business, further streamlining our focus on our core businesses. We are deploying substantially all of our estimated net after-tax cash proceeds of approximately $3.7 billion to pay down debt in accordance with our restated capital allocation priorities. The third transformational action we laid out at the start of the year was the planned separation of what is now our Kidney Care Segment. We are making significant progress and currently expect to launch Kidney Care as an independent, publicly traded company by July 2024. I continue to be impressed with the leadership of Chris Toth, who joined us in June as President of our Kidney Care Segment and designated CEO of Vantive. In just five months, he has already proven himself as an astute, decisive, engaging leader. He has already surrounded himself with an outstanding team of experienced direct reports drawn from across Baxter and externally, and we expect to finalize the organizational structure for the new company by the end of the year. Meanwhile, the hard work of separating Kidney Care from Baxter is ongoing across commercial, legal, regulatory, supply chain, and numerous other key operational channels. Just like Baxter post-separation, Kidney Care will be positioned to benefit from heightened focus and the ability to pursue its unique investment priorities to serve patients and clinicians, drive growth and innovation, and create added value for shareholders. With this as context, I wanted to briefly share some perspective on recent headlines regarding GLP-1, including Novo Nordisk October announcement about its flow study and broader speculation about the future of dialysis therapy. We, like the rest of the dialysis community, continue to follow developments closely, and we are eager to see the full study results, which are expected to be published in the first half of 2024. Given Baxter's life-sustaining mission, we welcome any new therapeutic approaches that have the potential to improve the lives of patients, particularly those with chronic conditions. We also believe that it is premature to assume that these drugs, particularly given the full trial results have yet to be published, will bring about any material shift in the need for dialysis services from a global market perspective. We believe that dialysis therapy will remain in demand and a critical element of patient care for the foreseeable future. Let me highlight a couple of data points that we believe are relevant. The existing data on demographics and disease patterns continue to consistently suggest that the global incidence of end-stage kidney disease or ESKD will continue to rise over the next 15 to 20 years. To provide a bit more context, current data suggests that the global ESKD incidence overall will continue to grow, driven by a greater than 35% expected increase in the prevalence of diabetes by 2040. At the same time, global demographic data show that the number of people over 65 years old should be increasing by approximately 75% globally between now and 2040, which is also expected to increase the number of potential patients at risk of developing ESKD. Collectively, these macro changes suggest the global incidence of ESKD is expected to continue to rise over the next 15 to 20 years, even with important innovations in CKD Therapeutics. We also believe these new drugs are doing important work in raising the awareness and prevalence of primary care discussions about CKD diagnosis and management. We welcome this focus, because better informed and empowered patients drive better preparation for dialysis. And studies have shown that the more informed the patient is about their treatment options, the more likely they are to choose home dialysis over other forms of dialysis when given the option. To that end, we're looking forward to seeing the new study data and understanding how it may provide additional options and benefits for patients with CKD. My excitement for the trajectory of Kidney Care remains high. Our thesis and sense of opportunity for an independent, stand-alone Kidney Care business remain unchanged from the day we first announced this spin. This has been a year of investment, of transformation, of important and sometimes difficult steps taken to strengthen our present and redefine our future. We knew when we first laid out this transformation in January that we had to get it right, and less than a year later, our progress is evident and our path forward is clear. We have delivered on our BPS divestiture. We have implemented our verticalized segment structure, and we are well on our way toward achieving the planned Kidney Care separation. Our continued progress on this transformational journey is a credit to the exceptional hard work and commitment of our Baxter colleagues worldwide, who as always have my profound thanks. I'm confident these actions are strongly positioning Baxter and in turn, Kidney Care to unlock meaningful long-term value for all stakeholders. Now before we take a closer look at our third quarter financials and outlook for the remainder of the year, I want to recognize Brian Stevens for serving so well as Interim CFO for over the past five months. We are also pleased to welcome incoming CFO, Joel Grade, whose wide-ranging experience and track record make him an outstanding fit at this time of transformation. I will first hand the call over to Joel for a few introductory comments before Brian then provide a more detailed overview of our results for the quarter.
Joel Grade :
Thanks, Joe. Let me start by saying how excited I am to join all of you today for my first earnings call as Baxter's new CFO, and more importantly, how motivated I am to be joining Baxter during such an important point in its transformational journey. For many years, I've admired Baxter as an iconic company with an incredible mission to save and sustain lives. When the opportunity arose to join the team, I recognize that this is the right next step in my career. The position presented me with the ability to utilize my broad experiences in finance, operations, strategy and transformation, to help the company deliver on its strategic actions that Joe outlined earlier. While early, I've been extremely impressed with the talented and dedicated employees at Baxter and their unwavering passion for and commitment to our mission. In addition, I'm very optimistic about the numerous opportunities that exist for the company to increase long-term value for our stakeholders. Finally, I look forward to both speaking with and meeting many of you over the next coming months. Your perspective on our business and the surrounding market landscape will be incredibly valuable as we move forward in our transformation journey. With that, I'll turn it over to Brian to take us through the Q3 results. Brian, over to you.
Brian Stevens :
Thanks, Joel, and good morning everyone. I'm happy to be joining the call this morning to provide some additional details on Baxter's third quarter financial performance, as well as commentary on our updated financial outlook. As Joel mentioned, we are pleased with our third quarter results which came in ahead of our expectations. Third quarter 2023 global sales included $3.71 billion from continuing operations and $191 million from discontinued operations. Sales in the quarter increased 3% on a reported basis and 2% on a constant currency basis and compared favorably to our guidance. Sales performance in the quarter benefited from better than expected sales in medical products and therapies, particularly our infusion systems and IV solutions products, as well as continued strength in our pharmaceuticals business, driven by injectables and drug compounding. On the bottom line, adjusted earnings from continuing operations totaled $0.68 a share, decreasing 4% versus the prior year period and reflecting the ongoing operational improvements, primarily offset by the impact of increased interest expense. Adjusted EPS from continuing operations for the quarter came in ahead of our expectations of $0.65 to $0.67 per share, primarily driven by sales and operational performance, and partially offset by higher than expected tax rates. In the aggregate, inclusive of both continuing and discontinued operations, adjusted EPS was flat year-over-year and totaled $0.82 per share. Now, I’ll walk through the performance by our new reportable segments. Sales in our medical products and therapies segment were $1.26 billion, increasing 4% on a constant currency basis. Within medical products and therapies, sales from our infusion therapies and technologies division, which includes our former medication delivery and nutrition businesses, totaled $1 billion and increased 4% on a constant currency basis. Sales in the quarter benefited from strong growth in our infusion systems portfolio, driven by continued demand for our infusion pump hardware, including the Spectrum LVP. Sales from advanced surgery totaled $255 million and grew 3% on a constant currency basis, in line with expectations and surgical procedure growth. Moving on to Kidney Care, sales in the quarter were $1.1 billion and were flat year-over-year on a constant currency basis. Within Kidney Care, global sales for chronic therapies were $921 million, declining 3% on a constant currency basis. Sales performance in the quarter was impacted by a difficult comparison to the prior year period, which benefited from certain discrete items that totaled approximately $20 million. In addition, and consistent with our plans to enhance performance in our HD business, sales in the quarter reflect the exit of a distribution agreement in the U.S. earlier this year. Finally, performance in chronic therapies continues to be impacted by government-based procurement initiatives in China, and a lower patient census in the region due to the pandemic. We estimate that, collectively, these region-specific factors negatively impacted sales by more than $40 million dollars in the quarter. Sales in our Acute Therapies business were $188 million, representing growth of 12% on a constant currency basis, with double-digit growth across all regions and reflecting a more stabilized environment for this business, following significant heightened demand during the pandemic. For our Healthcare Systems & Technology segment, sales in the quarter were $744 million and were flat to the prior year on a constant currency basis. Within the segment, sales in our Care & Connectivity solutions division, which includes our former Patient Support Systems and Surgical Solutions businesses, were $443 million, decreasing 4% on a constant currency basis, primarily driven by a lower contribution from rental revenues and lower hospital capital spending as compared to the prior year period. Orders within our Care & Connectivity Solutions division continued to improve sequentially, increasing more than 10% as compared to the second quarter. Frontline Care sales in the quarter were $301 million, increasing 8% on a constant currency basis and reflecting the continued benefit of easing supply constraints. During the quarter, the business was able to continue to reduce its backlog and we expect to exit the year with a more normalized backlog level. Sales in our pharmaceutical segment were $580 million, increasing 9% on a constant currency basis. Performance in the quarter reflected continued strength in our U.S. injectables portfolio, driven by new product launches, as well as continued strong demand for our services within our hospital compounding portfolio internationally. Other sales, which represent sales not allocated to a segment and primarily include sales of products and services provided directly through certain of our manufacturing facilities, declined more than 50% during the quarter. This lower level of sales reflects reduced demand in 2023 for certain contract manufacturing volumes and the termination of the royalty arrangement following our acquisition of the rights to the underlying products. BPS third quarter sales reported as discontinued operations were $191 million, increasing 11% on a constant currency basis. Now, moving through the rest of the P&L. Our adjusted gross margin from continuing operations totaled 41.7% and represented a decline of 70 basis points over the prior year, but improved 130 basis points sequentially. The year-over-year decline in gross margin reflects the impact of higher costs for raw materials, overhead and labor, driven by the elevated inflationary impacts we've absorbed over the last couple of years. We were able to partially offset these cost increases through pricing and ongoing margin improvement programs and our integrated supply chain network. Adjusted SG&A totaled $820 million or 22.1% of sales, a decrease of 50 basis points versus the prior year period. Performance in the quarter benefited from our ongoing transformation initiatives to enhance operational efficiencies, partially offset by higher bonus accruals under our annual employee incentive compensation plans compared to the prior year. Adjusted R&D spending in the quarter totaled $161 million and represented 4.3% of sales, an increase of 20 basis points versus the prior year. We have ramped up our R&D efforts, particularly increasing our investments in advancing our Connected Care Technologies and like SG&A, R&D expenses include the impact of higher employee incentive accruals as compared to the prior period. These factors resulted in an adjusted operating margin of 15.2%, a decrease of 50 basis points versus the prior year, but a sequential improvement of 200 basis points in operating margin as compared to the second quarter. Operating margin came in ahead of our expectations, primarily driven by top line performance and enhanced execution on our initiatives focused on driving improved operational efficiency. Net interest expense totaled $128 million in the quarter, an increase of $24 million versus the prior year, driven by the impact of higher interest rates on our variable rate debt. Adjusted other non-operating income totaled $7 million in the quarter compared to $4 million in the prior year period. Results were unfavorable to expectations, driven mostly by losses in foreign exchange. The adjusted tax rate in the quarter was 21.8% compared to 22% in the prior year period. The year-over-year decrease, as well as the unfavorability versus expectations was primarily driven by changes in geographic earnings mix. And as previously mentioned, adjusted earnings from continuing operations totaled $0.68 and declined 4% versus the prior year, primarily reflecting the increase in cost of goods sold due to inflation, as well as higher interest expense and foreign exchange headwinds. With respect to our prior guidance, earnings favorability was driven by better than expected sales and operational efficiencies, partially offset by negative impacts from FX and a higher than expected tax rate in the quarter. Total company adjusted earnings of $0.82 per diluted share, which includes discontinued operations, was flat versus the prior year period. With respect to cash flow, in the first nine months of 2023, we generated free cash flow of $666 million, including discontinued operations, compared to $293 million in the prior year period. And we remain on track to more than double our free cash flow in 2023 from prior year levels. Now, let me conclude my remarks by discussing our outlook for the fourth quarter and full year 2023, including some key assumptions underpinning that guidance. For full year 2023, Baxter expects total sales growth from continuing operations of 1% to 2% on a reported basis, and approximately 2% on a constant currency basis. Foreign exchange is expected to be an approximate 50 basis point headwind to reported results on a full year basis. On a Continuing Operations basis, we expect full year adjusted operating margin of 14.3% to 14.5%. With the closing of the BPS transaction and related debt pay down, we expect a reduction of net interest expense of approximately $45 million in the fourth quarter. For the full year, we expect net interest expense to be approximately $450 million. We anticipate a full year adjusted tax rate of 20.5% to 21%. And lastly, we expect a diluted average share count of 508 million shares. We now expect full year adjusted earnings from continuing operations of $2.57 to $2.60 per share. Specific to the fourth quarter of 2023, we expect global sales growth of approximately 1% to 2% on a reported basis and approximately 1% on a constant currency basis. And we expect adjusted earnings, excluding special items of $0.85 to $0.88 per diluted share. With that, we can now open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions] I would like to remind participants that this call is being recorded and a digital replay will be available on Baxter International's website for 60 days at www.baxter.com. Your first question comes from a line of Matt Miksic from Barclays. Your line is open.
Matt Miksic :
Thanks so much for taking the questions and congrats on a really strong quarter here. I appreciate all the color around dialysis and your position on all these concerns around GLP-1. That's super helpful. I'm wondering if you could talk a little bit about the loops and hurdles such that they are in front of you, still to complete this spin of Kidney Co. And if you could maybe just comment on where you're at, what the next steps are. And I have one follow-up if I could.
A - Joe Almeida:
Thank you, Matt. Good morning. Matt, our preparations for the proposed spin-off of the Kidney Care segment into its own company, Vantive, continues to progress well. We've made significant progress in the – in Vantives operating model. We are designing the organization finished actually and we are allocating personnel to the company in all operational levels, and so it continues to progress well. But consistent with Board's exercise of its fiduciary duties, we'll continue to pressure test the related financials, including as a result of the evolving market conditions to ensure we proceed in the interest of maximizing shareholder value.
Matt Miksic :
Of course. And the – any timeline for that sort of approval and presentation? Does that happen in the first half of next year at the round side of the board meeting? What should we expect?
Joe Almeida:
Matt, July 2024 is – the end of July 2024 is where we stand today as the date. As far as we know today, the plan is July 2024.
Matt Miksic :
Fair enough. And then maybe just if I could ask a business line question. The Hill-Rom businesses has been kind of under some pressure last year. Obviously everyone's aware of that for a variety of reasons. Just wondering if you could speak a little bit about how the back half is shaping up relative to your expectations and if we should expect things to continue to improve into your end and if you can give us some idea of a cadence into the fourth quarter year or any sort of puts and takes or updates as to how the sort of bounce back in that company, in that part of the business has progressed. Thanks.
A - Joe Almeida:
Matt, we've made a lot of progress. We redesigned the organizations. We put some really good people. We had to replace key positions as we thought that we needed higher caliber in some areas of the business and we have those folks in place. We put Reaz Rasul as the segment President. We had Julie Brewer who came in and brought a new team in place. So we feel that we've seen steady momentum in our front-line care business as well. The front-line care managed by Jim O'Connell is doing well with the improved supply chain availability for electro-mechanic components is up 8% in the quarter and 7% year-to-date and is doing well. CCS, which is, we have the PSS and GSS and the Care Communications, the former group that we used to call is called CCS today as you see in your financials, has been impacted by lower rental revenues and a bit of softness in the capital expanding. We're seeing improved in order sequentially and expect that to continue in the fourth quarter into 2024. We have increased our investments in HST. As you notice, our research and development has increased and we're going to continue to increase to get more innovation out. But I have to say that the whole overall business of HST is going to have a very large fourth quarter in terms of growth compared to the rest of the year, and bring them more in line with our expectations, including its profitability, which will increase in the fourth quarter as the rest of the company.
Matt Miksic :
Great, thanks for the color. A lot to cover, but I'll leave it there with you and thanks again for taking the questions.
Clare Trachtman:
Thanks, Matt.
A - Joe Almeida:
Thank you.
Operator:
Your next question comes from the line out of Vijay Kumar, Evercore ISI. Your line is open.
Vijay Kumar:
Hi, Joe. Good morning and thanks for taking my question. I had one on a financial question and one on fiscal ‘24. On the updated guidance here, what is fourth quarter assuming for interest expense? Is that stepping down? I'm getting implied operating margins close to 18%. That's a pretty big sequential step up. Does that math make sense to you?
Clare Trachtman :
Yes. Vijay, I'll just quickly. Obviously, interest expense would be kind of a below the line item, so would not be part of our operating margin. But we are expecting – I'll let Brian get into the details in terms of what we're expecting. But as we said in the prepared remarks, we expect interest to be down about $45 million, net interest expense about $45 million in the fourth quarter.
Brian Stevens :
Yeah, and speaking to operating margin, you're correct. Our full year operating margin guidance that we gave of 14.3% to 14.5% implies a fourth quarter adjusted operating margin that exceeds 16% versus the 15.2% adjusted operating margin we landed at in the third quarter. Really, the primary driver of that increase is the sequential improvement in our sales, which is typical seasonally. That provides us a lot better operating leverage against our cost base, and we're really encouraged to see the progress we've made in significantly expanding our margins in the second half of the year compared to the first half. As we discussed on our last two earnings calls, that expansion is driven not just by the higher sales, but also by cost favorability in our supply chain network, as we sold through a lot of our higher cost inventory during the first half of the year. And we're starting to see these savings from our margin improvement initiatives, we think is going to begin to slightly outpace inflation starting in the fourth quarter. And then finally, driven by cost savings from the operational efficiency initiatives we've been undertaking in recent periods.
Vijay Kumar :
Understood. And maybe just off of that question, Joe, for you on fiscal ’24. Can you talk about the big variables? What gets better? What gets worse in ‘24? When can Baxter get back to that mid-single LRP thesis? I think the street's modeling 100 basis points of margin expansion based on some of Joel's comments here. Does it seem reasonable for you for the street to be modeling 100 basis points margin expansion?
Joe Almeida:
So Vijay, let's start with the top line. We see stability in the market, in admissions, market growth rates. You saw some of the published numbers from other companies, their hospitals. We see that as well, and we continue to have a pretty stable top line growth, and consistently into 2024. So I'm confident about that. We have ex, our Kidney Care, the other three businesses of Baxter have steady growth into next year. They will probably be higher than in 2023. Talking about the bottom line, if you see the sequential improvement in our bottom line, that will continue into 2024. We continue to have cost reductions in our manufacturing facilities. We also get more stable volume and growth in volume, absorption of overhead, and some pricing opportunities in a couple of our businesses. I just highlight, for instance, the turnaround that we're seeing in our pharmaceutical business that will continue with new product launches from ‘23 into ‘24, and also the good demand for a SIGMA Spectrum pump from ‘23 into ’24 just to mention a couple of things. And also a stabilization of our HST business that we see in terms of our anniversary, some of the differences in end of fiscal years between Hill-Rom and Baxter. We start seeing the stabilization and the successful launch of our Progressive Plus. Just to give you a couple of things that give us more confidence in 2024 in terms of top and bottom line.
Vijay Kumar :
Thanks, guys.
Operator:
Your next question comes from the line of Rick Wise from Stifel. Your line is open.
Rick Wise:
Good morning, everybody. Good morning, Joe. It's a funny place to start maybe, and I know that Joel is fairly new to the job, but it's hard to resist asking, both from your perspective Joel, what did you charge Joel? What are you tasking him? Maybe talk about your requests of him as he steps into the role. And Joel, I'd be curious to hear what kind of special sauce you're going to bring to the job, and where your priorities lie and just your initial thoughts there.
Joe Almeida:
Rick, good morning. Good to hear your voice. Listen, we're in the process of selecting the CFO for the company. We're looking for the ability for the person to get operationally into the details and continue to help the transformation of the finance organization. And if you look back at the finance organization in BAS [ph], we had a lot of things that we changed. We have initiated and have done successfully shared service organizations across the board. Also, the development of new talent, the culture, and the people are very important to Baxter. So Joel coming to the company, need to understand that we are a complex operating company. We have a lot of manufacturing sites. We have a significant amount of R&D sites across the globe. It is a company that spans over 100 different countries in terms of sales, and more than 25 to 30 countries in terms of manufacture and distribution alone. So somebody who had the intellect to combine that ability to understand complexity and get through it and get operational efficiencies out of it, but continues to transform the finance organization and bring the talent and the culture to the point that we need the agility and the ability to cope with different inputs. Also, experience in the M&A space that we continue to rotate the portfolio of Baxter, look at opportunities to transform Baxter's WAMGR into a higher WAMGR to better value for our shareholders. But I pass on to Joel to answer the other side of your question.
Joel Grade :
Thank you. Great to be with all of you this morning. And I really look forward to meeting all of you in person, hopefully in the near future. So look, I'm first of all really excited to be here. I think all the things that I thought about when I was going through the process with Joe and with the team have only been reiterated to me as I've gotten here and realized the wonderful opportunities that we have here at Baxter. Yeah, I'd say early impressions, certainly as I said, lots ahead of us, there's lots to do, but we have great people here and incredibly passionate people as it relates to the mission of this company. And again, really a lot of talent as well is my early review. Yeah, I'd say my early focus, first of all, is going to be about learning the business. As you know I'm newer to the industry, but certainly I'm going to be focused heavily on making sure I understand and learn this complex, interesting business, so I can really make the best decisions to support the team. And from there, we're going to focus a lot on how do we continue to accelerate growth, how do we accelerate consistent execution of things, and how do we think about where those mechanisms are to ultimately fund growth and value creation. I’ll certainly be spending time understanding our talents and really just to focus the organization. As Joe said, the background I've gotten is both been rounded in finance, ops strategy, M&A, and transformation. And so bringing all those things to the table here for all the opportunities we have at Baxter, just really thrilled to be here, and those are some of the areas I'm going to be spending time focusing on going forward.
Rick Wise:
That's great. And one quick follow-up if I could, sort of picking up on Vijay’s question earlier on ’24. Just from one angle, when we think about current consensus ex-Kidney Co, how do we think about the impact of the spin relative to dis-synergy? Does consensus adequately reflect numbers inclusive of the dis-synergy costs for, when you think about the separation of the two companies and standalone standup costs, said differently, will numbers need to come down? That's what I think people are, that's what I'm concerned about, and I think that's what folks are concerned about. Thanks, Joe. I appreciate it.
Brian Stevens:
Rick, maybe a few comments on that. As Joe mentioned earlier, the process of the spin is going between now and we're planning to wrap up in July of 2024. All the models are still in progress and we are refining our dis-synergy and standalone cost estimates. We do plan to be providing additional information on this in connection with our 2024 guidance that we provide at year end, as well as in connection with an Investor Day that we intend to have in advance of that spin taking place. So no specific guidance on the particular quantification of the synergies at this time.
Joe Almeida:
And I want to underscore the fact that we're going to continue to see progress on Baxter's top line and bottom line ex those synergies, because we continue to accumulate the cost improvements that we put in place. Also, margin improvement programs, new product launches, the turnaround of pharmaceuticals, and the great demand that we're having for our SIGMA Spectrum pump. So there are some really good catalyzers I would say, in place that will make ‘24 a better year than ‘23. But I want to make sure that you understand that we will have the dis-synergies. We're in process of putting them in place.
Rick Wise:
Thank you, Joe.
Operator:
Thank you. Our next question comes from the line of Pito Chickering from Deutsche Bank. Your line is open.
Pito Chickering:
Hey. Good morning, guys, and thanks for taking my questions. On the Novum IQ pump, you now have two competitors with the next-gen pumps in the market right now. Yet your pump sales remain pretty robust in the quarter. At what point do you worry about losing market share to the other pumps? And then on your pump approval, any updates there? Is it worth pulling the 510-K and refilling helps you with the process or any updates there?
Joe Almeida:
On the current fusion market, we have really good demand, really, really good demand. We haven't lost 1% of market share at all. As a matter of fact, we gained market share. Our growth, our infusion hardware growth has increased in the mid-teens. And for next year, the demand is pretty solid for our product. Remember, our product has – SIGMA Spectrum has the right precision, the pump has the right precision, and it has what – it’s very well-liked in the marketplace. So we continue to get significant income interest from competitive accounts to our pump, okay. On the specifically Novum, I want to make sure that we continue to work with the FDA. We have given them all the information required. We submitted with a package. We also give them all the incremental changes that we've made to the product, and we are in continual and regular conversations with them during their review period. This is where we are with Novum. But I just want to let you know, we really want to get this pump approved. We're doing everything we can. But in the meantime, we have a very capable and really good pump out there. That continues to gain market share and has very good demand as you'll see this year, and you're going to see next year as well. So it's altogether a good situation for Baxter. Of course, we are working very hard to have the other pump approved. We want to have that approved.
Pito Chickering:
Okay. And then, next question. Oil and diesel have been very volatile over the last few months and why aren't giving 2024 guidance? If oil and diesel stay in this range, can you help us quantify the headwind for 2024 as the costs roll through the balance sheet and on the P&L, and in any ways of how you can offset those costs? Thank you.
Joe Almeida:
Yeah. We have put a significant amount of operational efficiencies in place, primarily in our logistics and transportation and supply group. We see the headwinds in parts of the business about the cost of energy, primarily fuel, but that has been more than offset by the programs that we put in place. So our initiatives are expected to, as I said, more than offset any increment impact from rising of oil and diesel and diesel prices.
Pito Chickering:
Thank you.
Joe Almeida:
Thank you.
Operator:
Your next question comes from a line of Robbie Marcus from J.P. Morgan. Your line is open.
Robert Marcus:
Great. Thanks for taking the questions and congrats on a nice quarter. Maybe to start, I know there's been a couple of questions on ‘24 that have been centered around margins, but I wanted to ask on the top line. At the Analyst Day, your long range plan was for 4% to 5% organic top line growth. The street's modeling 4% next year, coming off a year of around 2%. What's your confidence level in being able to reach your long range plan targets? Don't focus on that.
Joe Almeida:
Robby, good morning. We expect, as I say, ex our kidney business, that our margin will be in line with the expectations, okay. Of the short term, and our objective for mid to long term for the company is 4% to 5% as we improve the WAMGR as well. But we have plans ex, to get back at a growth close to what it is today expected. So it is a good story there, as we have momentum in several different areas of the company with some product launches. As I said, one of the biggest headwinds that we had experienced in the past few years had been our pharmaceutical business that we were able to turn around with great launches. So not giving guidance in 2024, but our expectations is to be around the expectations of the market in terms of growth, and our mid to long term expectations is to be 4% to 5%.
Robert Marcus:
Great, I appreciate that. And, I want to say it's really helpful to get the segment margins, thank you for that. But I want to ask on sort of the trends here. We got year-to-date, and third quarter, and as well as ‘22. How should we think about maybe some of the past few years and your expectations for margins in the segments here? And now with four segments and more ownership on the leadership within each, what are some of the examples of things they could do that weren't able to be done before to help improve margins on a segment basis? Thanks a lot.
Joe Almeida:
Robby, we have a significant amount of programs in our manufacturing team, logistics team, also pricing initiatives, as well as new product launches. So it's a mixed volume and cost reduction story. We will be improving sequentially our margins. As you've seen, as we said, remember we're executing on everything that we said we're going to do. We are improving our margins. You're going to see that in the fourth quarter as we have guided, as well as you're going to see that in 2024. So our confidence in continuing to improve our margins. And once we have the business spun off, the remaining Baxter we'll have even further ability to continue to grow its margins, okay. So because it's all about mix and new products and also pricing. So our story is about the same, is the aspiration to 45% on the top and the bottom – top line I’m sorry. And the bottom line continued to improve sequentially and continue to find a ways of getting productivity improvement through volume, mix and pricing.
Brian Stevens :
Yeah, and Robby, our plan right now, this third quarter, completing our verticalization and reporting out segment profitability was a big milestone for us, and we're extremely excited to be able to share that with you. And I think our long-term plan is when we get to year end and we're putting out information, we do plan to go back and provide supplemental information on history, to provide some better comparability as we've done in other situations in the past. But I think, the way to generally think about it, as you're looking at the overall directionality of where Baxter margins have trended from the first half of the year, as we're selling through some of our higher cost inventory to the second half of the year, pretty much across all of our segments, you're going to see sequential margin increases in the back half, contributing not just to the items I've pointed out before, but also to additional operating leverage just from higher sales in the back half of the year. So stay tuned and we will be providing you more of that information.
Robert Marcus:
Very helpful. Thanks a lot.
Operator:
Your next question comes from a line of Travis Steed from Bank of America Securities. Your line is open.
Travis Steed :
Hey Joe, thanks for taking the questions. I just wanted to follow up on something you said earlier in the call about on the renal spend pressure testing and evolving market conditions to maximize shareholder value. I assume, current market conditions, you're still okay with the Renal thing going forward given you're still talking about it, but maybe just talk about what's left of analysis, the pressure tests, the Renal spend and kind of what you meant by that comment.
Joe Almeida:
Well, as I mentioned before, it's the same answer. We are very much into the preparations. We have the team in place. We have put all the things in place. The company is working very hard. It is a complex separation, primarily not from the point of view of sales and marketing and the company itself, but it's all the manufacturing and distribution of it. So we're working on that. We have put people in place. We always, always have the fiduciary responsibility and duty, as our Board has it as well, to continue to pressure test the related financials and including as a result of evolving market conditions in the interest of maximizing shareholder value to ensure that we proceed with that in mind. That is our number one responsibility when we do anything in Baxter. So yes, we're moving forward, but we are always making sure that every step is taken and being analyzed and checked.
Joel Grade :
And Travis, one thing I would just say, it's Joel. This is also an opportunity to get me up to speed on all this. Again, I think there's going to be very sound strategic rationale on this bid, and obviously the team is taking me through a lot of the financials and a lot of those things. So part of this is also helping me, bring me up to speed in terms of sort of all the financial implications that are involved, so just to add that to this. Thanks.
Travis Steed :
Helpful. Thanks for that clarification. And then on 2024, I guess it sounds like you're confident in accelerating growth kind of above this 1% to 2% that you're doing now, but not quite back to 4% to 5%. So is there any examples you can give on reasons we should believe in kind of a little bit better growth in 2024? I guess Novum would be one of those. Anything else that could really kind of point out that? Can you give us some confidence that ‘24 revenue growth can be above this kind of 1% to 2% that you're seeing right now?
Joe Almeida:
Well, we're going to anniversary some headwinds that we had in HST, primarily in the CCS business is one of them. Then we have some good launches in our pharmaceutical business, and we have continued demand increase for our SIGMA Spectrum pump, not even taking into consideration Novum on this, okay. Just by what we currently have today, give us confidence in our growth next year; ex-Renal to be higher than what we have today across all the three segments; MBT, HST, and Pharma.
Clare Trachtman :
You know what Travis, why don't I just add a little context here? Because the 1% to 2% you're pointing out, remember, does have some of the Kidney Care impacts in it this year from some of those one-time payments we received last year. So that is kind of putting some pressure if you think about just how much Kidney Care represents of Baxter are contributing to that 1% to 2%. In addition, within our other segment, you'll see that down pretty significantly. So I think for the base Baxter business, this is what Joe was alluding to, you are seeing nice progression this year. Within the HST business, I think you're seeing some momentum within the frontline care. I think as we get to next year, within the CCS business, we'll see some of that momentum going into 2024. Now, with respect to Kidney Care in 2024, that's one of the businesses. We will anniversary some of those one-time payments, but we will have to continue to look at some of the other factors that impacted growth this year, including just sales within our China region that have been impacted by the government procurement initiatives, as well as just the rebasing following the pandemic last year.
Joe Almeida:
Just underscoring that the growth is in the remain part of Baxter ex-Renal is steadily improving and our MPT business has been growing above market every quarter and continues to do well. So I want to make sure that you appreciate the momentum that we are embarking and we have shown with the third quarter results what we meant by that.
Travis Steed :
Great. Thanks a lot for that.
Joe Almeida:
Thank you.
Operator:
Your next question comes from the line of Joanne Wuensch from Citi. Your line is open.
Joanne Wuensch:
Thank you so much and good morning and thank you for taking the questions. I have two. The first one is, when I take a look at medical products and therapies year-over-year, the margin was down about 190 basis points. And I think someone was heading towards this question earlier. I'm trying to figure out the trend in that and if we should look at that continuing to be pressured as we look into next year. And then my second question has to do with some of your GPO contracts and pricing and how we should think about restructuring or renegotiating those and the potential for taking higher price. Thank you.
Clare Trachtman :
So Joanne, I'll first take the MPT question. I would say, within this quarter, there was a little bit of mix coupled with some increased investments within MPT, but we should see sequential improvement within that business as well as we go into the fourth quarter, similar to what we will see with most of the businesses as well, so kind of following the general trend of Baxter. But this quarter on a year-over-year basis, if you look at it, just face differences within mix and some increased investments.
Brian Stevens :
And I think adding to that, as Joe mentioned, we have a strong pump on the market right now and we're seeing mid-teens growth in some of the equipment sales that are coming through that business. So I think that is something that has helped us that we'll be continuing to focus on next year. Regarding the second question on pricing, there's some puts and takes here. We do have some of our GPO contracts coming up for renewal and we are committed to negotiating pricing that reflects current costs that have increased in recent years and is fair to both parties. We did get some temporary price increasing during the – in recent periods that's going to be rolling off, but shortly after that we'll be entering it into the negotiation stage. So stay tuned on that, but we are committed to focusing on pricing as one of our levers in the future.
Joe Almeida:
Just closing on the GPO contract, we're very engaged, the two out of three being negotiated at the moment. They are for 2025. And as Brian said, we are looking at all the opportunities to compensate the company for the significant cost increase that we had experienced in 2022.
Joanne Wuensch:
Thank you.
Operator:
And your final question comes from the line of Danielle Antalffy from UBS. Your line is open.
Danielle Antalffy:
Hey. Good morning, everyone. Thanks so much for taking the question. Joel, excited to meet you. You have a great team over there with Clare and Company, so very excited to work together. My question is around the new operating model and how to think about from a tangible perspective, how this changes the way Baxter invests in R&D. Should we be thinking about the real benefit of the operating model, more on the accountability and cost side or on the R&D side and elevating the TAM and WAMGR of the company over the next few years? I guess I'm trying to get an understanding of where the real benefit comes from this new operating model, and that's it for me. Thanks so much.
Joe Almeida:
Thank you. It comes first from the accountability of each one of the segment Presidents, who are fully accountable for the profit and losses of their business, including all the allocations that got put on. As you saw, is a fully allocated P&L. So they make all the decisions on portfolio management within their spectrum of business. Also, all the decisions in investment research and development. So you look at HST. This year we've been investing with higher intensity in the HST to get products out faster. There is no two different parties to talk to. It all sits within the business. Also a great advantage is to have the manufacturing supply chain reporting into this business. Despite the fact we still have a coordination overall for the company, we do have this business, the plants and the heads of those plants in the business, and they are on the same page. And that drives quite a bit of the cost reductions, the optimization of product design, because it's all within the same group. Some are fungible. Some are not fungible. Some are qualitative improvements that we see by communication. The other is really communication when you have set growth targets for CAGR for the business, it's easier that way. There's no two different parties. We don't have a region of the world that will decide on growth versus a business line that goes across the globe, which is trying to negotiate those numbers. So it's a very simple conversation. It's very easy to do it, and we're starting to see the effect in the creation of our annual operating plan at the moment, is an easier and better process.
Danielle Antalffy:
Thank you.
Clare Trachtman :
Thanks, everyone. Rob, this can conclude our call.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Second Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms.Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trackman, you may begin.
Clare Trachtman:
Good morning, and welcome to our second quarter 2020 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Brian Stevens, Baxter Interim Chief Financial Officer and Chief Accounting Officer. On the call this morning, we will be discussing Baxter's second quarter 2023 financial results along with our financial outlook for the third quarter and full year 2023. Please note, results in the current period and prior periods have been adjusted to reflect the pending sale of our biopharma solutions or BPS business. While the closing of this transaction is subject to the satisfaction of customary closing conditions. That business is now reported as a discontinued operation. We have posted restated schedules reflecting that presentation for prior periods to our IR website. In addition, we will be providing a walk to reconcile our prior guidance for full year 2023 for updated financial outlook for continuing operations and in the aggregate. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the third quarter and full year 2023, new product development including the impact of pending regulatory approvals; the potential impact of our in-flight strategic and pricing actions, business development, regulatory matters, in the macroeconomic environment, including commentary on continuing supply game challenges and evolving customer capital spending contain forward-looking statements that involve risks and uncertainties. And of course, our actual results could differ materially from current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Sector's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in the accompanying investor presentation and in our earnings release issued this morning, which are both available on our website. Now, I'd like to turn the call over to Joe. Joe?
Jose Almeida:
Thank you, Clare. And good morning, everyone. We appreciate you joining today's call. I will begin with an overview of Baxter's second quarter 2023 performance followed by a look at the progress we're making across the strategic actions we announced earlier this year. I will then turn it over to our interim Chief Financial Officer and Chief Accounting Officer, Brian Stevens, who will walk you through our quarterly performance and outlook in more detail. Finally, as always, we will welcome your questions. Second quarter sales rose 3% on a reported basis and 4% on a constant currency basis both measures exceeding our prior guidance of 1% to 2% and 2% to 3%, respectively. As a reminder, and as Clare noted, we are reporting results of our biopharma solutions or BPS contract manufacturing business as discontinued operations in light of its pending sale which I will touch on shortly. I would note there was no impact in the quarter on top line growth rates from discontinued operations on either a reported or constant currency basis. Our top line outperformance was driven by solid demand across the portfolio. On the bottom line, second quarter adjusted earnings per share from continuing operations totaled $0.55 a and discontinued operations totaled $0.11. In the aggregate, adjusted earnings per share totaled $0.66 and exceeded our outlook range of $0.59 to $0.61 and driven by a combination of top line performance and operational efficiencies. Several factors combined to help bolster both top line and bottom line results. First and foremost, I want to highlight positive demand and greater stability across most corners of the health care marketplace. Following the erratic impact of the pandemic and its recurrent surges over the past few years. Overall, we are continuing to see sustained recovery in hospital admissions and procedural volumes as well as in alternate sites of care, which are contributing to solid performance across the portfolio. The more stable inflationary environment is also contributing to an improved macroeconomic backdrop, further helping to steady our operational performance. while positive signs are emerging, we remain cognizant of the potential for inflationary disruptions consistent with our approach this year. And in general, we have tried to capture these potential risks in our updated financial outlook. Similar with last quarter, we are also seeing continued improvements in availability of key electromechanical components. This reflects a combination of overall environmental impacts and steps we have taken to shore up supply within our own integrated supply chain operations while there is still work to do with these factors and actions are contributing to enhanced cost management and greater predictability on the supply chain front. As we have previously commented, we continue to see a degree of cost in hospital capital spending, which has impacted our patient support systems or PSS performance, Encouragingly, we saw a significant sequential improvement in the second quarter for orders and are building momentum with the recent launches of our Progressa plus ICU bed and enhanced features to our segment-leading Centrella band. [Indiscernible] is the latest version of our unique ICU focused bed which now offers a range of additional features developed to help health care professionals address the complex critical needs of ICU patients. Our current expectation is for hospital capital spending to improve in the second half of the year as compared to the first half of the year as hospitals reevaluate their budgets and reprioritize areas of spend. We are building momentum and making significant progress across the transformative strategic actions we announced to kick off 2023. The proposed spin-off of our renal care and acute therapies businesses into an independent publicly traded company, the pending sale of our BPS business and the implements for the remainder progress [ph], these efforts are already enhancing strategic clarity across the company, increasing account [Technical Difficulty].
Brian Stevens:
Joe mentioned, we are pleased with our second quarter results, which came in ahead of our expectations. Second quarter 2023 global sales included $3.71 million from continuing operations and $142 million from discontinued operations. Sales in the quarter increased 3% on a reported basis and 4% on a constant currency basis and compared favorably to our guidance. Sales performance in the quarter benefited from better-than-expected sales across nearly every business line with particular outperformance realized in Medication Delivery, Pharmaceuticals and patient support systems. On a year-over-year basis, we recognized solid growth across much of the portfolio, which was partially offset by a 1% decline in Patient Support Systems, primarily reflecting lower rental revenues and reduced hospital capital spending as compared to prior periods. We also generated lower sales in BPS, which is now reported in discontinued operations due to a reduction in revenues from COVID vaccine manufacturing. On the bottom line, adjusted earnings in the aggregate, inclusive of both continuing and discontinued operations, decreased 24% to $0.66 and reflecting the impact on our results of the increased cost of materials, labor and freight we've absorbed due to the significant inflationary environment experienced over the past few years. Adjusted EPS for the quarter came in ahead of expectations of $0.59 to $0.61 per share, primarily driven by sales and operational performance. A lower-than-expected tax rate offset the negative impacts from foreign exchange and losses on equity investments. Now I'll walk through performance by our regional segments and key product categories, starting with sales by operating segment. Sales in the Americas grew 5% compared to the prior year on a constant currency basis. Sales in Europe, the Middle East and Africa grew 3% on a constant currency basis, and sales in our APAC region increased 4% constant currency. As we look to the second half of the year, we expect performance in APAC to be negatively impacted by a decline in China sales resulting from the effect of excess mortality on ESRD patient volumes due to the pandemic as well as the impact from the ongoing implementation of value-based procurement initiatives. Moving on to performance by key product category. Global sales for Renal Care were $936 million increasing 2% on a constant currency basis. Performance in the quarter was driven by mid-single-digit growth in our U.S. PD business, partially offset by lower U.S. in-center HD sales following the exit of a distribution agreement at the end of last year consistent with our optimization plans for this business. Globally, both PD and in-center HD sales advanced low single digits. Results in the quarter were partially offset by lower sales in China due to the factors just mentioned, including government-based procurement initiatives and the lower patient census in the region due to the pandemic. Sales in Medication Delivery of $761 million grew 7% year-over-year at constant currency rates, driven by strength globally for both infusion systems and IV solutions products. We continue to experience healthy demand in the U.S. for our Spectrum LVP pump. As we continue to work to improve the availability of components for spectrum, we expect sales to ramp in the second half of the year, and we also continue to focus on growing our Novan syringe base. Pharmaceutical sales of $550 million increased 6% on a constant currency basis. Performance in the quarter reflected strength in our U.S. injectables portfolio driven by new product launches, including Zosen, [indiscernible] room temperature and bendamustine as well as increased sales internationally for our hospital compounding portfolio. Total sales for Clinical Nutrition were $243 million, increasing 7% on a constant currency basis. Performance in the quarter was driven by a strong performance internationally, partially offset by declines in the U.S., reflecting a difficult comparison against the prior year period. Sales in Advanced Surgery were $272 million, advancing 4% on a constant currency basis. Growth in the quarter reflects an improvement of surgical procedures globally with particular strength internationally partially offset by the impact from exiting a distribution agreement in the U.S. as well as select supply constraints that hampered performance in the quarter. Sales in our Acute Therapies business were $180 million, representing growth of 6% on a constant currency basis and represented a return to growth in the U.S. and strength in our APAC region. Sales in our Patient Support Systems business were $359 million, decreasing 1% on a constant currency basis primarily driven by lower contribution from rental revenues and lower hospital capital spending as compared to the prior year period. In the quarter, we realized better-than-expected sales for ICU beds in the U.S., driven by the launch of Progressive Plus. We have experienced positive demand for that new entrant to our smart bed portfolio since its debut. As Joe mentioned, we saw a significant sequential improvement in orders, increasing approximately 30% and driven by demand for our segment-leading hospital beds and care communications products. We currently expect this momentum to continue with orders increasing in the second half of the year as compared to the first half. Front Line Care sales in the quarter were $307 million, increasing 9% on a constant currency basis. This growth reflects demand for our intelligent diagnostics, respiratory health and connected monitoring portfolios. We saw continued improvement in supply availability of electromechanical components during the quarter, which enabled us to address a portion of the backlog associated with the Front Line Care business. While we are pleased to see improvements in our supply constraints, the business continues to have an elevated backlog level, which we will continue to work down over the course of the year as anticipated demand remains strong for this portfolio of products. Global Surgical Solutions sales in the quarter were $77 million, increasing 9% on a constant currency basis. Performance in the quarter was driven by continued geographic expansion and increased hospital access. BPS second quarter sales, which are now reported as discontinued operations, were $142 million, decreasing 7% on a constant currency basis. This decline was in line with expectations due to lower COVID vaccine-related revenues of approximately $27 million compared to the prior year period. Underlying business momentum continues to build with strong growth, excluding the vaccine impact realized in the quarter. Moving to the rest of the P&L. Our adjusted gross margin from continuing operations totaled 40.4% in line with our expectations and represented a decline of 160 basis points over the prior year. The year-over-year decrease reflects increased cost of goods sold, primarily driven by material and labor inflation, freight and supply constraints partially offset by favorable pricing in select areas of the portfolio. The impact of discontinued operations reduced Q2 2023 adjusted gross margins by 40 basis points and Q2 2022 adjusted gross margins by 50 basis points. Adjusted SG&A totaled $844 million or 22.8% as a percentage of sales, a decrease of 40 basis points versus the prior year period. Performance in the quarter benefited from our ongoing transformation initiatives to enhance operational efficiencies, partially offset by higher bonus accruals under our annual employee incentive compensation plans versus the prior year. On an aggregate basis, inclusive of discontinued operations, adjusted SG&A was 22.1% as a percentage of sales in Q2 '23 and 22.4% as a percentage of sales in Q2 '22. Adjusted R&D spending in the quarter totaled $165 million and represented 4.5% as a percentage of sales, an increase of 40 basis points versus the prior year. We have ramped up our R&D efforts, particularly increasing our investments in advancing our connected care technologies on an aggregate basis, inclusive of discontinued operations, adjusted R&D was 4.3% as a percentage of sales in Q2 '23 and 4.0% as a percentage of sales in Q2 of '22. These factors resulted in an adjusted operating margin of 13.2% and a decrease of 150 basis points versus the prior year. On an aggregate basis, inclusive of discontinued operations adjusted operating margin was 14.4% as a percentage of sales in Q2 of '23 and 16.2% as a percentage of sales in Q2 of '22. Operating margin came in ahead of our expectations primarily driven by top line performance and enhanced execution on our transformational initiatives driving improved operational efficiency. Net interest expense totaled $124 million in the quarter, an increase of $35 million versus the prior year, driven by the impact of increased interest rates on our variable rate debt. Adjusted other nonoperating expense totaled $22 million in the quarter compared to $33 million of income in the prior year period. Results were unfavorable to expectations and driven by losses in both foreign exchange and marketable securities compared to gains in the prior year. The adjusted tax rate in the quarter was 17.8% compared to 20.5% in the prior year period. The year-over-year decrease was primarily driven by changes in geographic earnings mix. With respect to cash flow, in the first half of 2023, we generated free cash flow of $485 million, including discontinued operations compared to $171 million in the prior year period. we expect to remain on track to more than double our free cash flow year-over-year in 2023. And as previously mentioned, adjusted earnings from continuing operations totaled $0.55 and declined 25% versus the prior year. Adjusted earnings, including discontinued operations of $0.66 per diluted share declined 24% versus the prior year period, reflecting the increased cost of raw materials freight and labor as well as the impact of higher interest rates on variable rate debt, foreign exchange headwinds and higher bonus accruals. With respect to our original guidance, earnings favorability was driven by better-than-expected sales and SG&A savings as the benefit from the lower tax rate offset the negative impacts from FX and losses on marketable securities. Let me conclude my comments by discussing our outlook for the third quarter and full year 2023, including some key assumptions underpinning the guidance. As mentioned, we are pleased with the operational performance to date and positive momentum we have seen through the first half of the year. While we continue to work to mitigate the macroeconomic challenges that have impacted our results to date, the latest signs are reassuring. Our business fundamentals remain solid and demand for the portfolio is broad-based. Taking into account our positive second quarter results, I'll now walk through our updated guidance. Our current expectation is that the pending sale of VPS is likely to close towards the end of the third quarter. However, as the ultimate timing of completion is uncertain, we are providing adjusted operating margin and EPS guidance for full year 2023 that contemplates 2 scenarios, 1 where the deal does not close in 2023 and another that assumes it closes at the end of the third quarter. For full year 2023, Baxter now expects total sales growth from continuing operations of 1% to 2% on a reported basis and approximately 2% on a constant currency basis. We now expect foreign exchange to be a 50 basis point headwind to reported results on a full year basis. Assuming that BPS were to remain a part of Baxter through year-end 2023, our outlook for sales growth in the aggregate, including discontinued operations, would be the same as continuing operations growth on both a reported and constant currency basis. If BPS were to remain a part of Baxter through year-end, we will continue to expect full year adjusted operating margin in the aggregate, including discontinued operations, of 15.5% to 16%. On a continuing operations basis, we expect full year adjusted operating margin of 14.1% to 14.6% and which would not be significantly impacted by the timing of the pending BPS closure. If the pending BPS transaction does not close by year-end, we would expect to incur interest expense of approximately $500 million for fiscal 2023. However, if the BPS transaction closes by the end of September as currently anticipated, we would expect a reduction of interest expense of approximately $40 million, which would result in a benefit to continuing operations in the fourth quarter. We now anticipate a full year adjusted tax rate of 20.5% to 21% on both an aggregate and continuing operations basis. Given current foreign exchange rates, we expect to absorb a negative earnings impact of $0.05 to $0.07 per share in the second half of the year relative to prior expectations. Lastly, we expect a diluted average share count of 508 million shares. Under this scenario, where BPS remains a part of Baxter through year-end 2023, we now expect 2023 adjusted earnings on an aggregate basis, including discontinued operations to total $2.92 to $3 per diluted share, which includes adjusted earnings from continuing operations of $2.49 to $2.57 and adjusted earnings from discontinued operations of $0.43. If the pending BPS sale were to close at the end of the third quarter as currently anticipated, we would expect full year adjusted earnings in the aggregate, including discontinued operations of $2.87 to $2.95 per diluted share, adjusted earnings from continuing operations of $2.54 to $2.62 and adjusted earnings from discontinued operations of $0.33. This outlook excludes estimated fourth quarter adjusted earnings attributed to BPS consistent with the assumed September 30 closing date and includes a benefit of approximately $0.05, primarily due to reduced interest expense after giving effect to the anticipated debt repayment plan associated with closing of the pending BPS sale. Specific to the third quarter of 2023, we expect global sales growth from continuing operations of approximately 2% on a reported basis and 1% on a constant currency basis and we expect adjusted earnings from continuing operations, excluding special items, of $0.65 to $0.67 per diluted share. We expect adjusted earnings of $0.13 per diluted share from discontinued operations. Taking this into account, we would expect adjusted earnings in aggregate of $0.78 to $0.80 per diluted share. With that, we can now open up the call for Q&A.
Operator:
We will now begin the question-and-answer session. [Operator Instructions] I would like to remind participants that this call is being recorded, and a digital replay will be available on the Baxter International website 60 days at www.baxter.com. And your first question comes from the line of Robbie Marcus from JPMorgan.
Robert Marcus:
Congrats on a good quarter. Joe, maybe to start, it looks like the recovery is progressing nicely beat and raised but it's a bit complicated with discontinued and continuing operations. So would love to get a sense of -- how did the pro forma, the combined company do in the quarter on margins? And so we can compare it apples-to-apples. What's the expectation for the back half of the year and your confidence in regaining the margins?
Jose Almeida:
Thank you, Robbie. Good morning. I ask Brian Stevens to ask. We will make sure that everything you guys need to know is clarified as we had a very solid quarter, and I want to make sure that the information is clearly understood and then we can talk about the other things that drove our success this quarter.
Brian Stevens:
Thanks very much, Robbie, for the question. And as you mentioned, due to the signing of our agreement to sell BPS, which right now we expect is going to close likely in about 2 months at the end of September, although that's subject to customer closing conditions, as you can imagine. This has triggered discontinued operations reporting. One thing I did want to highlight is that at the end of our investor presentation, we have gone back and casted, recasted recent quarters to show our adjusted results on a discontinued operations basis to provide some visibility apples-to-apples going forward. One thing to point out though that what that does is while it takes out the contribution from BPS in the comparable periods, that recasting does not reflect the benefits that we expect to get going forward from interest expense savings. So I think if you're looking at EPS for the full year, while we expect about a $0.43 impact from discontinued operations after you net in the interest savings and things like that, we really think the headwind on an annual run rate basis is probably closer in the range of $0.15 to $0.18. So specific to your question, as far as where our operating margins landed, we reported on a discontinued operation basis, adjusted operating -- or adjusted operating margins of -- in the ballpark of about 13.2%, including the full company, we came in for the quarter at 14.4%, which was a little bit above where we were expected to land. On a full year basis for the entire company as if we own BPS for the full year, we would expect our operating margin -- our adjusted operating margin to come in at 15.5% to 16% and which is consistent with the prior guide that we gave last quarter. Now you'll note that this guide implies a 300 basis point margin expansion in the second half of the year. There's really 3 main drivers of that. The first driver is sales growth. As you know, our sales tend to be very back-end loaded in the second half of the year, which gives us greater absorption against our fixed cost base. And that is what the largest driver of the sequential operating margin improvement that we see and that we continue to be on track for the second component really relates to integrated supply chain. As you recall, we had adverse manufacturing variances coming into the year that rolled out during the first part of the year as the related inventory was sold. Additionally, a lot of the margin improvement initiatives that our integrated supply chain and manufacturing teams have been working on have been overshadowed by the high levels of inflation. As we've seen inflation start to stabilize in recent periods, we're now expecting in the back half of the year, the benefits from the savings from those initiatives is now we're starting to lap the inflation we're seeing such that we're expecting that's going to drop to the bottom line with expanded margins. And then finally, we're seeing benefits from cost savings. As you'll recall, we had some significant cost savings initiatives earlier this year in connection with our reorganization to a new operating model. And those cost savings already benefited and contributed to our beat this quarter, which, as you saw, we came in $0.05 above the top end of our guidance range for EPS on overall company and then even more of those cost savings initiatives are going to flow through in the second half. So really good traction we're seeing, and we're confident about where we're landing on the operating margin side.
Robert Marcus:
Great. That's really helpful. And maybe as a follow-up, your competitor recently got approval for their infusion pump platform in the U.S. I know you've resubmitted [indiscernible] large volume pump in early June. I was just wondering if there's any update there or any comments you could provide?
Jose Almeida:
We believe we have successfully resolved the open issue that was primarily subject of the FDA's last additional information that they requested. Additionally, we have proactively implemented software changes that we had planned in consultation with the FDA. We have regular communications with the FDA during the review. We are committed to resolving any questions or issues that come up during the process and through learnings in connection with the recent launch of Novo LVP in Canada and related regulatory issues. So we are working on software upgrades to our current version of the Canadian pump. As we work through this in the next few months, we work alongside the FDA to tell them what's going on. And we are cautiously optimistic [indiscernible] updates to the product are implemented before in Canada and so we can communicate with the FDA properly. We are in constant communications with them. I just also want to add that our SIGMA Spectrum pump is doing extremely well. We are augmenting the supply chain of that pump to make sure that pump continues to be available. We need that pump to be available. We have hundreds of thousands of these pumps on the market, and by doing that, we're able actually to give continuity to hospitals, which own that today. It's a matter of fact that growth has been great. This year, we upped our forecast twice since the beginning of the year as the supply chain became better, and we are making sure that in the next 12 months, that pump will be backward integrated into the new gateway system that Novum uses in hospitals. So we have really alternatives for everything. I'd tell you, we've been getting market share steadily year-over-year. and we'll continue to do that. Of course, we're looking forward to have normal LVP in the U.S. market in just a little for our syringe pump, which has done extremely well, and we are actually exceeding by far our expectations for this year.
Operator:
And your next question comes from the line of Larry Biegelsen from Wells Fargo.
Larry Biegelsen:
Congrats on a nice quarter here. Joe or -- sorry, or Brian, yes, I wanted to ask about the guidance. You put up a nice 4% growth number in the second quarter, but I believe the third quarter you're guiding to about 1%. And Joe, you talked about improving trends so maybe talk about what you're assuming in the second half and why growth might be lower in the second half than what we've seen here in the second quarter? And I had 1 follow-up.
Brian Stevens:
Sure. I'll skip the started and then Joe can add anything. Thanks very much for the question. as you saw in the current quarter, we're really excited about our growth. We came in at 4% on a constant currency basis, which reflected really strong contributions and performance from our MPT business, which came in around 7%; our pharma business, which was at around 6%, reflecting some of the recent launches we've had in the U.S., including Zosia [ph] room temperature [indiscernible] our Frontline Care business came in around 9% as it worked down some of the backlog, and we saw strong demand for intelligent diagnostics and respiratory health and then finally, we started to see some traction in PSS in recent periods, which as we talked about before, we have seen some softness in capital orders that appears to be stabilizing, and we're seeing good traction going into the second half of the year as our order volume has picked up, although that business is still facing some headwinds from lower rental revenues following COVID where demand for rental beds was high. So really, the story for the sequential deceleration in our growth going into the third quarter where we're expecting it to slow down a bit to around 1% and is really driven most significantly by the headwinds facing our PD business in China. As we mentioned, within that business, we have excess mortality that has reduced our patient census counts following some of the impact of the pandemic that they've had over there. And then also in the second half of the year is where we're starting to see a little bit more of the impact of volume-based procurement in China. So I think net-net for that Kidney Care business, which includes renal as well as acute, we're seeing about a 250 basis points impact from some of those headwinds. Additionally, there are some discrete items that happened in the prior year period that we've highlighted currently or previously that we're going to be lapping, which is driving down our sequential growth a little bit. But I think overall, we've still been able to offset those headwinds with strong performance across the rest of our portfolio.
Jose Almeida:
Augment the part on the concerns in the beginning of the year that we had with capital. We've seen that alleviating -- and I have to say that the launch of Progressive Plus has been a tremendous success. We've seen good momentum, a very update in quotations and also conversion from quotations to PO into delivery. That, as a matter of fact, we're starting to see competitive conversions, which is we're taking market share for competitors -- from competitors. So this has been a good track record for the company when they launch new products. And now with a very good team in place, we are able to actually execute on the plan above and beyond the great performance from Linecare and our medication delivery business as well in the U.S. So just a little bit of more color to Brian's comments on our excitement around the business.
Larry Biegelsen:
Just one quick follow-up for me. Obviously, the Pfizer injectable plant, the damage definitely got a lot of media coverage the last couple of weeks. It seems like it was more just a warehouse that was negatively impacted. Do you see any potential benefit from that? Or is it your understanding it was more the warehouse, not the manufacturing that was impacted.
Jose Almeida:
Larry, I'm not going to comment on Pfizer's status. They have to answer their own questions. I can tell you that from the portfolio that they sell, we have a little bit of competitive products that we can ramp up in the second half of the year. Will depend a lot about how much inventory is in the chain. But I'd say probably a little bit north of $10 million. is one opportunity that we have, maybe a little bit more than that, a little bit less. It depends what's in the chain. It depends how this is going to be there. One important thing is Baxter will be there for the patients when they need it. And if the customer needs will be there to serve them with the products that we have.
Clare Trachtman:
Larry, just to clarify that we have not included any upside in the guidance that we provided. Obviously, we're continuing to evaluate the situation. As Joe mentioned, we do believe there is some overlap. And so the team is working and how we can address and fill those gaps in the marketplace to ensure the customers get those products.
Operator:
Your next question comes from the line of Danielle Antalffy from UBS.
Danielle Antalffy:
And not to be too greedy here. I know we just have updated 2023 guidance and tough to talk about 2024 at this point given all the moving parts here. But I would love to get some thoughts maybe at a qualitative or high level. As we look ahead to 2024, in the RemainCo piece of the business, ex renal, what the key growth drivers will be? Obviously, hopefully, Novo IQ [ph] is one of them. But beyond that, Joe or Brian or Claire, if you can talk about sort of over the next 12 months, what you see as the key growth drivers beyond [indiscernible] that we should be focused on here for the business?
Jose Almeida:
I want to highlight what we call HST, which is our former call the Huron business, HST I think there is a great opportunity still in the frontline care. Front Line Care is really driving high single-digit growth. I think that will continue. And I think the recovery and the potential gain of market share in beds is a good possibility for us looking at the performance of our new bed launch today. I think another one is advanced surgery. We have per cloud coming in, the demand is high. The product is superior in side-by-side testing that we've seen to competitors. I'm not claiming anything on the label. I'm just saying that when we do, it looks like the product has a performance that pleases the customer by the speed and completeness of the hemostasis products. This is the first product that is Baxter's are passive hemostat. We don't have a test hemostat. And we're now constrained just by the capacity of the company to make the products, but we are working the supply chain to get a second supplier and which is going to come in line hopefully in 2024, but the demand is really good, and that's a good driver for it. And we have in the pharmaceutical business, we have new launches. Our new management in pharmaceuticals has really improved our ability to launch products and get the time to pick sales. So we have some really good stuff happening. And clearly, we would like to count on Nova. We're going to do everything we can to get that on the market. But as a backup to tell, we have a very solid platform with spectrum are still taking market share. And the syringe pump really makes it easier for us to penetrate hospitals that otherwise were never available to us before. So I think Baxter all in all, as we execute all those changes, the sale of BPS then spin off Renal is to create a company that is smaller, driven by innovation and the ability to actually impact lives of our patients is what we're targeting for 2024.
Brian Stevens:
And maybe if I could add to that a little bit, Joe. Another item that we're really excited about is the recent launch of our Progressive Plus ICU bed. We're seeing really good demand from that even though it's in the early stages. And we're also excited about some of the new features that we just came out with for our Centrella bed platform as well. The other item I'd like to highlight that's a big internal focus for us in terms of driving growth going forward is really the impact of the new operating model that we're transitioning to. As we've talked about previously, earlier this year, we started the process of shifting from a regional and focused organization is really a vertical-focused organization where we have leaders of our new segments that are really like many CEOs that own the entire business from top to bottom, including the supply chain aspect of that. And I think as we mentioned before, we're planning to transition to our new segment reporting in the second half of the year. Right now, we're actually expecting that that's going to be coming off this coming quarter. So we're really excited to be able to share some of the financial performance at that cut with all of you at that time. But as part of this transition, our new segment leaders are very much focused on developing portfolios of initiatives that we're looking to really grow the business going forward.
Operator:
And your next question comes from the line of Patrick Wood from Morgan Stanley.
Patrick Wood:
Amazing. I'm just curious in renal, if we make the adjustment, obviously, in HD for that distribution agreement, how you're seeing the relative performance of PD versus HD, if you're seeing any kind of a shift there? Or if you're seeing comparatively similar trends in patient flow across those 2 sort of verticals, very curious there.
Jose Almeida:
Our PD business, with exception of China, which I think we -- in the prepared remarks, we spoke about the 2 things affecting the being the VBP and also the mortality due to COVID. If you isolate that, the rest of the business is starting to recover from the COVID. We're starting to see patient growth, some geographies with mid-single-digit growth. Some others with low single digits, but coming up from negative growth last year. So we're starting to see that going well. We also took other initiatives to augment that business. We see HD as a portfolio rotation for us. We're looking at where to be, how to make that business accretive to Baxter, and we are in full-fledged optimization process. So we have -- we're looking at our dialyzer business. We're looking our HD monitors. And making sure that we are in the right place at the right time, competing in the right way. We want to make sure that, that is a supplemental business to Baxter that is profitable and is growing. But we're starting to see with optimism with the exception of China growth and recapture of the PD market. Remember, this is a business that we post COVID project long term to be a mid-single-digit growth business in terms of patient so we want to make sure that as the situation stabilized in China, we are prepared 100% to continue to grow in that market.
Operator:
Your next question comes from the line of Travis Steed from Bank of America Securities.
Travis Steed:
I did want to follow up, Joe, on Nova. It sounds like you have to upgrade the Canada pump first and that takes for a few months. And then after that's finished, then you can move it and work with the FDA. I just want to make sure understand the nuances there from your earlier response
Jose Almeida:
Yes. Travis, the pump in Canada is on market. The U.S. doesn't have Nova is not approved. So to your point is we had some software updates. We're making -- we have some available to go through working with Health Canada to make sure they are okay with us moving forward. We also have other changes that we're going to be making in the next couple of months. to make sure that that bump is all the potential upgrades and improvements are in place and then as we work with the FDA. Our application has those changes factored in, but we want to make sure that we want to -- we execute them in Canada, and we work with the FDA. We want to make sure that but I want to tell you that we don't speak on behalf of the FDA, neither Health Canada. We work with both of them trying to -- and we will address all those problems as we confident that our technology and our platform is solid. We continue to upgrade like we would have done to any other products to address any concerns on the market.
Travis Steed:
Perfect. And then the other question I had was on the CFO update, ability to announce that by year-end. Any color on the type of person you're looking for or progress you're making with that search?
Jose Almeida:
Well, first of all, we have Brian doing a great job here sitting in for CFO. And as always, a great contributor to Baxter. And then during this quarter, a tremendous amount of work our teams were able to do to be able to provide you guys with discontinued operations or the reconciliation. We are in process, continue to interview internal and external candidates, and we will be hopefully in a position in the next 30 to 45, 60 days to make a final call.
Clare Trachtman:
Travis, the one thing I would just want to augment to Joe's comments on [indiscernible] is to remind everyone that NOVUM is a brand-new innovative platform. that has some of the most advanced safety features out there. So again, to Joe's point, we're going to look at that and obviously work with FDA. We can't speak on behalf of FDA. But this is a brand-new innovative platform. And we mentioned the NOVUM syringe is doing really well in the market already. So we're going to look at -- obviously, address the situation with Health Canada and some of the issues as you find when you launch a brand-new platform, those issues can come up. So we're going to address those and obviously work with both agencies to get this pump on the market.
Jose Almeida:
This is not a legacy pump, which is decades old in the market. They had issues to be remediated -- this is a brand-new pump like Claire said. It is a complex technology, and we have the competency in Baxter to address those issues. And as I said, I'm very confident in the technology, and we are cautiously optimistic about how we get this approved.
Operator:
Your next question comes from the line of Vijay Kumar from Evercore ISI.
Vijay Kumar:
Congrats. Good print here. Maybe my first question on the product side, Joe, I think you mentioned 30% orders growth. How does it translate to revenue growth for your PSS segment, U.S. pharma up double digits. Are we seeing pricing being stable in the U.S. at this point in time?
Jose Almeida:
Vijay, we'll take one thing at a time. We are seeing the order between Q1 and Q2 growth for PSS, and that has encouraged us. We are we're going to cross the threshold on growth. Remember, this growth now was slightly negative. This quarter was ahead of our expectations. And we were looking at sequential growth in this product line.
Clare Trachtman:
Yes. So here's what I would -- let me augment that a little bit. So to Joe's point, we did see around 30% sequential improvement across all of PSS, which is obviously is both our furniture plus our care communications products. Just to be -- in the third quarter, Hill-Rom did have their year-end in the third quarter. We do face -- obviously, as we continue to kind of anniversary that, we do face a little bit more of a challenging comp from just an overall sales dollar in the third quarter. But the order rates are improving. And as we go to the second half, we expect the second half orders to be ahead of what the first half is. So we're kind of seeing that continued momentum second half versus the first half of the year. But I think the key is that both on the Progressive Plus and the Central CLR, we're seeing a lot of positive momentum there, and we're going to continue to augment that with a lot of the features that we have within the Connected Care for the HST business.
Jose Almeida:
And in terms of pricing, I think you referred to pricing in general, are you talking about pricing of PSS.
Vijay Kumar:
Sorry, for U.S. pharma pricing?
Jose Almeida:
For U.S. pharma. We see continued pressure what Baxter is doing is by launching new products that we call the specialty generics, which are our premixes like we did with Norepinephrine and [indiscernible]. It has been a phenomenal execution of launches. And those products carry significant gross margin. So as we continue to face price pressure on more generic molecules, we're able to offset that, as you can see by the growth of this business in the second quarter and how we're going to go forward with this business we are making huge progress against price erosion. And that can only be done, can only be done with launches of new products, and we've been executing extremely well in all of them.
Clare Trachtman:
Yes. What I would say to that, Vijay, within our U.S. injectables business, I mean, this business is really growing double digits, low -- kind of low double digits really driven on the success of these launches. So we have been able to now fully offset that price erosion. That will go on, but we will be offsetting it with our new product launches.
Vijay Kumar:
That's helpful. Then maybe one on margins, your back half, 200 basis point step up. How much of that is related to the volume leverage on higher revenues versus your supply chain and cost actions. And those supply chain cost actions, should we assume those are structural and should flow through for next year?
Jose Almeida:
So if we're looking at our overall operating margin improvement, I think just sales growth alone is contributing close to 200 bps of the moment I think on the supply chain side with some of the stabilization of inflation and the continued savings initiatives, I think we're seeing roughly about 70 basis points of improvement and then on the cost savings initiatives that we've been undertaking, the impact for the back half of the year, we're expecting is going to drive around 80 basis points and those 3 items are actually offset by the impact of FX versus where we're at when we gave our prior guidance, which is coming back about 50 basis points.
Clare Trachtman:
We have time for one more question.
Operator:
Our final question comes from the line of Matt Miksic from Barclays.
Matt Miksic:
So I guess, I'd love to ask just a couple of broad questions, if I could. And the first, I think the perception may be that one of your comp competitors got out of approved. You have not yet got your new pump approved, the perception is that this is viewing the sort of the competitive landscape in a way that may be disadvantageous to Baxter in the near term. And I know you've just stepped through a little bit of this, but I'd love to get your sense of having statement of spectrum on the market, and this being your next-gen pump, if you could talk a little bit about what the current competitive dynamics look like on the pump front? And what you expect them to look like from now until when you're able to introduce your sort of next-gen platform? And then I have one follow-up, if I could.
Clare Trachtman:
Yes. So I'll let Joe weigh in on this map. But as I just reiterated, again NOVUM is a brand-new innovative platform. But we also do have spectrum, Sigma Spectrum or version 9, and we have been Spectrum IQ that has been -- we've been successfully selling that. We are ramping up production of that. And to Joe's point, we are going to make it backward compatible with our gateway so that it will have all the features and be able to integrate within the hospital EMR similar to what NOMVUM was going to do.
Jose Almeida:
I think we said this more times, Matt, it is we have an on-market pump and we've been converting market share. As a matter of fact, we just converted accounts from a competitor for the reasons of the merits of spectrum by itself. So we do have that opportunity. Do we have greater opportunity with NOVUM? Of course, we do because it's a platform that has some safety features and integration that is a great opportunity for customers to have other software that we have come into play. So we're looking forward to that approval. But until then, we continue to do well with the current platform, and it's going to make that even more friendly by backward integrated into our new gateway, which is also develop by Baxter for our new platform that makes it easier to integrate between the syringe and the SIGMA spectrum.
Matt Miksic:
That's super helpful. And then just on growth. I think we understand the sale of biopharma and a deleveraging opportunity that, that's provided and change positive change year-to-year capital structure. In terms of the Hill-Rom business and the growth trends, I think -- we get the question often like what can that business grow? I mean it looks like it's already kind of accelerated from maybe down 1% in the first quarter on a combined basis, still like up 4% or something like that here in the [indiscernible] if I'm looking at the numbers right, are we on our way to -- is that current growth rate representative growth rate based on what you would say, what you know about the business now? Do you think there's more room to lift that business into the back half and into 2024? Any color there? And I know -- sorry, you touched on these topics also during the call. I just want to be clear about the growth potential as you look at it right now?
Clare Trachtman:
Yes, Matt, I'll just give some of the facts. You're exactly right. In the first half of the year, the Hill-Rom or did call it the AST business was up low single digits. We expect that to accelerate to mid-single digits in the back half of the year, consistent with our expectations. Really driven by all the factors that we've talked about, improvement in Front Line Care, both and then within the PSS business, the new product launches. So that -- we believe that, that is that mid-single digit that underlying run rate is what we will continue to see going forward. But I'll let Joe.
Jose Almeida:
Yes. I think not only the product launches in PSS, but also some of the success that we have in cardiology, which is smaller still in our Frontline Care as well as some other new products that we have in store for 2024. I believe this business is their growth is above the Baxter weighted average growth rate. So that is augmented is an augmented growth for us. I'm excited about that. That's the reason why we acquired Heron was to create that differentiation in growth rates to be able to get to mid-single digits for our businesses. And with the portfolio moves we are making, we're going to get there and has been a really -- last year was all about supply chain and with a real difficult period for both businesses as we see us making significant progress in creating resiliency to the business, I see that PSS with great opportunity and don't discount our surgical business, our GSS business, which also is a great potential source of growth in the future. So we are excited about that business, and we have the potential to transform even further Baxter with even more growth in adjacencies through that business.
Matt Miksic:
Congrats on the quarter.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's First Quarter 2023 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today’s call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning, and welcome to our first quarter 2023 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's first quarter 2023 financial results, along with our financial outlook for the second quarter and full year 2023. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the second quarter and full year 2023, new product development, the potential impact of our in-flight proposed strategic and pricing action, business development, regulatory matters and the macroeconomic environment including commentary on anticipated customer capital spending contains forward-looking statements, that involve risks and uncertainties and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I'd like to turn the call over to Joe. Joe?
Jose Almeida:
Thank you, Clare, and good morning, everyone. We appreciate you taking the time to join today's call. I will begin with an overview of our first quarter performance and trajectory. Jay will follow with a closer look at our financials as well as our outlook for Q2 and the remainder of 2023. After that, we will open up the lines for Q&A. First quarter sales declined 2% year-over-year on a reported basis and rose 2% at a constant currency, exceeding our original outlook, driven primarily by better-than-expected sales in Renal Care, Pharmaceuticals and Front Line Care. On the bottom line, first quarter adjusted earnings per share of $0.59 also came in above our guidance range of $0.46 to $0.50 per share, again, driven primarily by operational performance in the quarter. Results in the quarter were impacted by the expected declines in two of our legacy Baxter businesses. Biopharma Solutions and Acute Therapies, reflecting the tough comparisons to the prior year period due to COVID. Looking at our legacy Hillrom businesses, a strength in Front Line Care and Global Surgical Solutions was offset by decline in Patient Support Systems or PSS performance. This reflects what we believe to be softness in certain hospital capital spending patterns in the current economic environment. Following what I will candidly describe as a difficult 2022, we begin 2023 with a solid quarter and on a strong footing for future momentum. From a macroeconomic perspective, while the high rates of inflation we absorbed last year continued to impact our performance, most notably in the first half of the year, we are beginning to see more stability in the overall market. We are also starting to see an improvement on the supply chain front, which includes the increased availability of electromechanical components, creating more predictability in our operations in a reduced need for premium cost spot purchasing. Specifically, in terms of the health care marketplace, admissions and procedural volumes continue to recover from pandemic lows, contributing to positive demand. We also continue to see steady improvement in PD patient growth in many markets following several quarters of this lower demand linked to pandemic-related mortality issues. In another crucial signal, health care staffing levels have stabilized or are rising hospitals and other facilities following some concerning laws. With that said, we believe, based on conversations with our U.S. customers, the hospital capital spending has been deprioritized for certain product areas, which has impacted near-term performance of our PSS business. Our current expectation is that the situation starts to improve over the course of the year. We're nearing the launch of our next version of our market-leading ICU beds, Progressa Plus. Progressa Plus is the only through ICU bed with new features to help clinically staff address complications and provide the best care possible for patients. We are already seeing strong customer interest in the new solution and look forward to the anticipated launch this quarter. Lastly, regarding this topic, I will highlight that we are not currently seeing the softness in capital spending extend to our other businesses, such as Infusion Systems or Front Line Care, where demand remains strong for the products. Alongside these trends, we are, of course, moving full speed ahead on the critical strategic initiatives I announced at the outset of the year, focused on enhancing our impact and long-term shareholder value. Our plan to spin off our Renal Care and Acute Therapies business into a stand-alone kidney care companies well underway. The stand-alone company will emerge as a leader in a growing market segment with 2022 sales of approximately $4.5 billion and more than 1 million patients across more than 70 countries. You will hold leading positions across its portfolio and a well-established presence in homes, hospitals and clinics worldwide. Perhaps most importantly, as a stand-alone entity, it will benefit from increased management focus and the pursuit of its unique investment priorities, better positioned to accelerate growth and innovation, emphasizing its distinct market drivers. We are finalizing our search process to identify the future CEO of our spinoff company and hope to share more information on this front shortly. We currently expect the spin-off Kidney Care to occur by July 2024 or earlier, and we'll continue to keep you informed of our progress. Last week marked the initial launch phase of the new operating model we previewed for you last quarter, realigning our current portfolio of 10 businesses into four vertically integrated global business segments. Each segment is being led by an experienced, passionate senior executive with a proven track record of success and compelling vision for the future. Medical Products and Therapies, led by Group President, Heather Knight comprises our current Medication Delivery, Advanced Surgery and Clinical Nutrition portfolios. Healthcare Systems and Technologies led by Group President, Reaz Rasul includes our legacy Hillrom businesses, including Patient Support Systems, Global Surgical Solutions and Front Line Care. Pharmaceuticals, led by Group President, Alok Sonig, includes our current Pharma portfolio as well as our BioPharma Solutions business. And finally, Kidney Care comprises our Renal Care and Acute Therapies businesses. Each of these segments has global profit and loss accountability, dedicated commercial operations and fully aligned research and development, manufacturing, supply chain and functional support teams. Note that our global manufacturing sites are being aligned to each business to help fuel greater transparency, foresight and resilience across the supply chain. While we are in the early stage of this implementation, our teams are moving fast, eager to capitalize on the tighter alignment that can help fuel enhanced strategic clarity, agility and innovation. Even as we advance organizational and efficiency efforts, we also know that high impact innovation is a critical factor to delivering accelerated growth among recent innovation milestones. We're very pleased to share that we have resubmitted our leading edge Novum IQ large-volume pump for FDA 510(k) clearance. The Novum IQ syringe pump is now in use in the United States. As a reminder, we have not included any U.S. sales for the Novum IQ LVP in our guidance. I'm also pleased to report that our newly launched Zosyn premix is experiencing solid uptake in the U.S. hospital pharma marketplace. Other recent launches include Baxter’s new patient warming system, which minimizes risks associated with forced air warming, reduces noise and waste in the operating room and lessens the burden on clinician workflows. Floseal + Recothrom, the first and only active flowable hemostat with a recombinant thrombin, resulting in 1.5 times faster preparation ReadyConnect System for Baxter’s Centrella Smart+ Bed, which delivers reliable, cable-free connectivity between the hospital bed and most nurse call systems on the market. And finally, ExactaMix Pro, the next-generation automated nutrition compounder designed to enhance security and improve customer experience and offer stronger data reporting capabilities. Looking ahead, while macroenvironmental factors show signs of improvement, we remain cautious and balanced above the pace of recovery. This is why our current transformational initiatives are so vital. Our goal is to redefine our operations for sustained success in a rapidly evolving environment, while always remaining true to our life sustaining mission and focus on medically essential health care. Our momentum today and tomorrow is fueled entirely by our employees. I thank them for their dedication and resilience, which are vital to the transformation journey we are taking together. Now I will pass it on to Jay for a closer look at our performance and outlook.
James Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our first quarter results, which came in ahead of our previous guidance range. First quarter 2023 global sales of $3.6 billion declined 2% on a reported basis and increased 2% on a constant currency basis. This compared favorably to our guidance, which called for constant currency sales to decline approximately 1%. As mentioned earlier, sales performance in the quarter benefited from better than expected sales in Renal Care and Pharmaceuticals as well as Front Line Care, which have reflected improvement in availability of electromechanical components. On the bottom line, adjusted earnings decreased 37% to $0.59 per share, reflecting the increased cost we've recognized due to the significant inflationary impacts on materials, labor and freight, along with certain supply chain constraints. Adjusted EPS for the quarter also came in ahead of our expectations of $0.46 to $0.50 per share, driven by improved operational performance and a benefit from lower than expected interest expense. Now I'll walk through performance by our regional segments and key product categories. Starting with sales by operating segment. Sales in the Americas declined 1% compared to the prior year on a constant currency basis. Sales in Europe, Middle East and Africa grew 9% on a constant currency basis, reflecting broad based recovery in hospital admissions and surgical procedures across the region, and sales in our APAC region increased 3% constant currency. APAC sales reflected strength across the region, offset by a decline in China due to the impact from various government based procurement initiatives being implemented in that market. Moving on to performance by key product category. Global sales for Renal Care were $892 million, increasing 4% on a constant currency basis. Performance in the quarter was driven by mid-single digit growth globally in our PD business, partially offset by lower U.S. in-center HD sales following the exit of a distribution agreement at the end of last year. Results in the quarter also reflected the negative impact from ongoing government based procurement initiatives in China. Sales in Medication Delivery of $687 million were flat year-over-year at constant currency rates. Strong international growth in solutions was offset by lower infusion system sales. As mentioned, we've resubmitted our Novum IQ large-volume pump for FDA 510(k) clearance. In the meantime, we continue to promote our spectrum IQ LVP which has been impacted by supply constraints for electromechanical components. Our teams have been and will continue to work diligently to secure additional parts to meet customer demand for the spectrum IQ large-volume pump. Pharmaceutical sales of $523 million increased 5% on a constant currency basis. Performance in the quarter reflected increased demand for our drug compounding portfolio internationally as well as double-digit growth in our U.S. injectables portfolio. This help to offset lower sales internationally for injectables. Moving to Clinical Nutrition. Total sales were $224 million, increasing 3% on a constant currency basis. Performance in the quarter was driven by demand for our nutrition compounding services. Sales in Advanced Surgery were $246 million, advancing a 11% on a constant currency basis. Growth in the quarter reflects an improvement of elective procedures globally. Surgical volume recovery was strong across all regions. Sales in our Acute Therapies business were $180 million, declining 1% on a constant currency basis and reflecting a difficult comparison to the prior year, where we had experienced elevated demand for CRRT given the rise in COVID cases. BioPharma Solutions in the quarter were $139 million, decreasing 9% on a constant currency basis. This decline was in line with expectations due to lower COVID vaccine-related revenues of approximately $35 million compared to the prior year period last year. Sales in our Patient Support Systems business were $348 million, decreasing 8% on a constant currency basis. As Joe mentioned earlier, we believe performance in this business has been impacted by a slowdown in capital spending with respect to certain product categories. In addition, this business is experiencing lower rental revenues as compared to the prior year period. For the year, we expect growth will continue to be dampened by these factors, but we expect our order rate to improve over the course of the year. In addition, our backlog remains elevated and to date, we have not had any material cancellations. We're excited to launch Progressa Plus this quarter and expect it to positively contribute to future performance. Front Line Care sales in the quarter were $302 million, increasing 4% on a constant currency basis. This reflects demand for our intelligent diagnostics portfolio. We saw a slight improvement in supply availability of electromechanical components during the quarter, which enabled us to address a portion of the backlog associated with the Front Line Care business. While we're pleased to see improvement in our supply constraints, the business continues to have an elevated backlog level, which we hope to continue to work down over the course of the year as anticipated demand remains strong for this business. Global Surgical Solutions sales in the quarter were $81 million, increasing 8% on a constant currency basis. Performance in the quarter was driven by increased international placements in the quarter. Moving through the rest of the P&L. Our adjusted gross margin of 41.2% decreased 380 basis points over the prior year, reflecting cost of goods sold, primarily driven by the factors we've discussed around material and labor inflation, freight and supply chain constraints. Adjusted SG&A of $845 million represent 23.2 percentage sales, an increase of 10 basis points versus the prior year period, reflecting higher annual employee-based compensation accruals. Adjusted R&D spending in the quarter of $157 million represented $4.3 million as a percent of sales, an increase of 30 basis points versus prior year, as we increased our investments in innovation, particularly around advancing our connected care technologies. These factors resulted in an adjusted operating margin in the quarter of 13.8%, a decrease of 420 basis points versus the prior year. Net interest expense totaled $117 million in the quarter, an increase of $32 million versus the prior year, driven by the impact of increased interest rates on variable rate debt. Other non-operating income totaled $1 million in the quarter compared to $16 million of income in the prior year period. Results in the quarter reflect a benefit from the amortization of pension benefits as well as an equity gain, which we were offset by foreign exchange losses. The adjusted tax rate in the quarter was 23% compared to 20.8% in the prior year period. This increase was driven primarily by a change in stock-based compensation impacts. And as previously mentioned, adjusted earnings of $0.59 per share declined 37% versus the prior year period. Earnings in the quarter reflected the increased cost of raw materials, freight and labor as well as the impact of higher interest rates on variable rate debt and foreign exchange headwinds. Let me conclude my comments by discussing our outlook for the second quarter and full year 2023, including some key assumptions underpinning the guidance. As mentioned, we're pleased with the solid start to the year. After the challenging macroeconomic environment we experienced in '22, the challenges of which we continue to address. Our business fundamentals are solid and we're seeing positive trends externally. We're cautiously optimistic and continue to work to position ourselves to see improved performance in the years ahead and we remain steadfastly focused on execution. Taking into account first quarter results, I'll now walk through our guidance and expectations. For full year 2023, we expect global sales growth of 1% to 2% on a reported basis and approximately 1% growth on a constant currency basis. We now expect full year adjusted operating margin to be between 15.5% and 16%. Interest expense is now expected to total approximately $500 million. We continue to anticipate an adjusted tax rate of approximately 22% and a diluted average share count of 508 million shares. Based on these dynamics, we expect 2023 adjusted earnings, excluding special items of $2.85 to $3 per diluted share. Specific to the second quarter of 2023, we expect global sales growth of approximately 1% to 2% on a reported basis, 2% to 3% on a constant currency basis. And we expect adjusted earnings, excluding special items of $0.59 to $0.61 per diluted share. With that, we can now open the call up to Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions] We would like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. Your first question comes from the line of Vijay Kumar with Evercore ISI. Please go ahead.
Vijay Kumar:
Hey, guys. Congratulations on a good start here. Maybe my first question here, Joe and Jay. You mentioned utilization trends move in the right direction, supply chain constraints easing. So when I looked at your Q1 performance and your Q2 guidance, the annual guide implies back half of 0% constant currency growth. So maybe just walk us through on -- is this conservatism? Were there any timing elements or what's being assumed for the back half?
James Saccaro:
Yeah, Vijay. Thanks for the question and the comments. So far so good in terms of sales performance in the first quarter of the year. And to your point, I think importantly, we've seen a fairly cooperative environment both on the top line and also very importantly, from a general macro context. Those were some really important underpinnings of the guidance that we originally shared. We needed to see that and we did. So really, really good start to the year. As it relates to sales cadence first half versus second half, really there are a couple of specific drivers that lead to a slightly slower growth in the second half. And it's really not unplanned or it's consistent with our expectations. Essentially, our renal business has nearly $100 million of one-time headwinds, i.e., through specific payments that occurred exiting of distribution agreement last year or exiting lower margin arrangements. And so all of those things take renal from positive growth in the first half to negative growth in the second half. So very discrete item there. We expect that to sort of normalize and see growth more consistent with patients going into the future. And then, as we look at our Pharmaceuticals business, we really had outstanding performance in the first quarter. We'll expect to see some continued growth there, but we do see a little bit of a deceleration, most notably compounding in the second half of the year. So that has an impact on the overall sales cadence. I think the most important thing from my perspective was the steady macroenvironment and utilization and patient trends. So we saw that in the first quarter. We're happy to carry that forward.
Vijay Kumar:
That's helpful [indiscernible]. And perhaps one follow-up on Hillrom. I think the prior guidance was 4% constant currency. Did that change at all? And perhaps Joe, if you can comment on, Hillrom was 2% decline, mostly driven by PSS. I think most of your peers, they're talking about easing supply chains, electronic components, backlog getting converted. Like, why is Baxter confident that this is not share loss? I think you made some comments on backlog and orders. So maybe if you could size it for us.
Jose Almeida:
Vijay, good morning. Just to preface on Hillrom, we're very happy with the performance of most of the businesses under Hillrom and how we've been integrating the business into Baxter. We had a very strong FLC quarter. Front Line Care has done a great job and this has improved because supply of product. So we see low to single -- mid-single -- low to single mid-single digits, 3% versus 4%. Suppliers are really -- supply is really getting better. And this is affecting FLC. Not only the performance of FLC is doing better, but also our backlog is increasing further than we thought was going to increase. So it's a really good momentum. We see PSS with a reduction in sales in the first quarter. I want to remind you that we had a reduction of 20% in rentals. This is from the peak of COVID and a lot of rentals going on in '21 and early '22. We saw a significant reduction, also some postponement of capital spending. But we're very excited about the launch of Progressa Plus, an improvement our Centrella Bed. So those are coming in this quarter and will be great launches for us. We haven't launched a new platform like Progressa Plus in almost 10 years. So this is a really good thing. We are number one in the ICU and we'll be able actually to continue to capitalize not on the Baxter accounts, but hopefully, into new accounts, competitive accounts. I would say that it is important to note that capital postponement has specifically been focused in this category of spending. We have not seen that at all in the other Baxter categories. As I just mentioned, FLC has shown very strong growth. Our infusion therapies business, our pumps business now has shown very strong growth and strong forecast growth for the rest of the year. So this is a phenomenon specifically for beds. But as I said, with the launch of new products, we're really excited to come in and have this -- the situation reversed as we plan to have it reversed and ameliorates in the second half of 2023.
Vijay Kumar:
Fantastic. Thanks, guys.
Jose Almeida:
Thank you.
Clare Trachtman:
Thanks, Vijay.
Operator:
Your next question comes from the line of Pito Chickering with Deutsche Bank. Please go ahead.
Pito Chickering:
Hey. Good morning. Thanks for taking my questions. The first one is similar sort of Vijay's question. But relative to your guidance that you've updated today, sort of what has (ph) been the biggest source of upside and downside in the first quarter as it relates to both revenues and inflationary pressures?
James Saccaro:
Sure. I think there were a few areas where we saw solid performance in the first quarter. Our Pharma business, we added a new leader to this area last year. That team is really doing an excellent job with respect to new products and accelerating commercialization of some of these products. So we saw we had a really nice performance in the first quarter. Now some of that did benefit from a buoyant procedure and admissions backdrop. But overall, really happy on the pharma side. From a renal standpoint, I think this is an important one. Renal benefited from solid pricing and mix, along with outside of certain markets in Asia, we saw some decent patient growth. So I think the Renal story, notwithstanding my comments earlier around second half comparable issues. The renal story has started strong this year and we expect that to continue. And then finally, our Advanced Surgery, another area. We've got a great leader in this business and that team as well, benefiting from procedures clearly, but at the same time, solid execution across the board leads to some favorability there. So those were some of the bright spots that we saw. As it relates to challenges, I think Joe explained clearly, we were a little bit soft in PSS, but we remained very optimistic. I spent some time looking at our Progressa Plus, our new product there. It's really an exciting new development. So we'll see how that goes. That launch is happening, and it's something that I think the market will welcome. So those are a few comments on favorability and unfavorability for Q1. And then Pito, your question about supply chain and what I would say there. Obviously, after the challenges that we experienced from a general macro backdrop last year, I was really happy to see, generally speaking, cooperative environment. And when I say generally speaking, on the one hand, commodities are going in the right direction. We're seeing indices support the forecast that we put forth. Some of our suppliers are still looking to sort of increase prices to Baxter. And we constantly work through those situations very carefully. But I would say, generally speaking, we have a fairly stable backdrop from a supply chain standpoint.
Pito Chickering:
Okay. And then specifically, can you refresh us on what assumptions you made in your updated guidance around transportation costs for 2023? What percent of those costs are over the ground? And what do you assume in diesel costs for the rest of the year? Just [indiscernible] diesel serve in the low 4s at the pumps now. How should we think about the tailwinds from lower diesel costs rolling through the P&L?
James Saccaro:
So listen, I don't want to do a detailed operational review here. So -- and we don't really share mix by ground versus air on freight costs and things of that nature. What I will tell you is, we try to reflect -- in terms of the forecast that we put together, we try to reflect the most current indices that we have, along with expectations from a number of reputable sources in terms of where those areas are going when we put the forecast together. And when we do this not only for diesel, freight, logistics costs, but also for resins, packaging, corrugate, et cetera. I think we have definitely significantly improved how we forecast this area as a necessity coming out of last year. Our supply chain finance team working with the team there has done a lot of work to enhance this. But generally speaking, we look at current index levels. We look at the most reliable forecast going forward and our performance is directly tied out to that. Part of the reason why we do see a step-up in margin in the second half of this year relates to some of the costs that we're experiencing at this point in time, not only from our freight and logistics, but also in some of those other categories.
Pito Chickering:
Great. Thanks so much.
James Saccaro:
Thank you, Pito.
Operator:
Your next question is from the line of Travis Steed with Bank of America Securities. Please go ahead.
Travis Steed:
Hey. Thanks, everybody. Jay, I'd love to dig a little bit deeper in that second half margin ramp that you just mentioned. I know you had the $300 million in cost savings, the macro cost. Can you help just give some confidence in the back half margin ramp?
James Saccaro:
Yeah. I think it's interesting. The first quarter performance really was a nice element for the performance sake in the first quarter. But importantly, I think some of the assumptions that we had were confirmed and that really gives us some solid confidence as we move to the second half of the year. But admittedly, there's a big step up first half to second half. And I would say that there are really three drivers of the operating margin improvement that we expect to see. The first relates to -- generally, in the second half of the year, we have more sales than the first half of the year. So in the second half of this year, we expect north of $400 million, approaching $500 million in more sales in the second half versus the first half. That's not a dynamic that is unique to this year. If you look at any of the last couple of years, you would see that normal sales step up first half to second half. And that has margin benefit, that also has a significant EPS benefit. So you'll see about $0.30 plus of EPS from those incremental sales dropping through. The second thing is, integrated supply chain. We -- the costs that we're experiencing today are costs that we realized or experienced in Q3, Q4 of last year when there were very elevated prices. As those indices have eased in the last few months, we have line of sight to improvements in supply chain that yield roughly $0.15 approximately of improvement first half to second half. Now I should say it's not just indices that are cooperating, it is also the hard work that goes into what we call value improvement programs, which are essentially efficiency initiatives in plants, but that's $0.15 of improvement. That's a very real impact from our supply chain team. And then the final thing is, listen, we've talked previously about some of the cost efforts that we're undertaking. And those benefit more in the second half than the first half. And we've largely concluded those programs. They're in place. And so -- but because a lot of those activities occurred in the first and second quarters, the benefit only is realized in the third and fourth quarters, and that's roughly $0.15. So if I were to say why are we going to go from point A to point B with a very substantial improvement in margin, it really comes down to those three specific factors.
Travis Steed:
That's super helpful. Thank you, Jay. And a follow-up question on Novum IQ. Just assume when it gets approved, is that -- should we think about that as like $100 million in full year revenue, $200 million margins? Are those above, below corporate average? And when you think about the potential for share gains, I wonder you think you'll be on the market before your other competitor. But how do you think about the opportunity for share gains there?
Jose Almeida:
We were not going to comment on the approval of the pump because it's not dependent upon us, it's with the FDA at the moment. We are optimistic about the performance of the pump when it gets approved. But we're not commenting in anything that the FDA is doing. I would say to you that there's an opportunity. There's a significant amount of pumps on recall at the moment, including brand new pumps, which just launched, I recall, Class 1 the other day. So we are currently capitalizing on that with our Sigma spectrum. We upward forecast significantly on Sigma Spectrum. We are now more optimistic about the components. We are also doing some redesign of components to make sure there's more durability. And when Novum gets to the market, it's going to be for us to make the decision, how to phase that in. Customer comes to me want to stay with the current model of Sigma Spectrum because they have a fleet of it and we have significant opportunities to gain market share once Novum is approved. So we're very excited about the platform that we have in front of us, and we're going to be putting more money in research and development assets to develop other categories of pumps within Baxter. So I will tell you that we're not giving you what's the forecast for Novum once approved. As soon as we get news about Novum from the FDA, we'll let you know what that means in terms of numbers. But at the moment, I tell you the demand for pumps is high, primarily because Sigma Spectrum is a good pump that is performing extremely well and facing competitors who have consent decree and recalls in many different categories.
Travis Steed:
Great. Thanks, Joe and congrats on a good quarter.
James Saccaro:
Thanks.
Jose Almeida:
Thank you.
Operator:
Robbie Marcus with JPMorgan is on the line. Please go ahead with your question.
Robert Marcus:
Great. Thanks for taking the questions. Maybe to start, I would love to get your thoughts on pricing. What it was in the quarter and your ability to take price going forward, we see peers taking it in the capital components. And we hear some of your peers talk about it in some of the hospital supply areas. Would love to get your thoughts on the potential for Baxter moving forward?
James Saccaro:
Sure. I'm not going to get into specific amounts in the first quarter, but pricing was a contributor and an important one. And I think for us, what -- as we went through last year, we had significant incremental costs across the portfolio and basically every single product line that we sell. And at the end of the day, sometimes you don't have the ability to address price in the short term, in a given quarter or a given year. And in some instances, you actually have to wait a couple of years before you actually address price because of long-term agreements that you have in place. What's really important for our team is that we capture our fair share of the economic value that we provide to our customers. And so this year, we're working very carefully. There was positive pricing in renal. There will be positive pricing from a hospital capital standpoint. In all of the areas that we operate, we are expecting to see decent price. The one exception, of course, is Pharma, where that's been more stable, particularly in the first quarter, but that's still an area of more price competition. But I think, Robbie, from our standpoint, this is going to be an important driver for us, not only this year, but I think in future years as well.
Robert Marcus:
Great. Thanks. Maybe one more, we saw some news reports on a potential sale of the bioprocessing unit. Just the latest update on your thoughts on that business and how it will proceed. And if a sale does go through, is that repayment the primary use of cash? Thanks.
Jose Almeida:
Robbie, good morning. We have experienced significant interest in this business. We still are exploring strategic alternatives and we'll let you folks know as soon as we make the decision. If there is a sale, the proceeds will be exclusively and mostly directed to debt repayment. So it opens the opportunity for Baxter for future reinvestment and even stock share buybacks and other opportunities. But the first thing for that amount of cash, if that is the alternative we decide to go forward with, will be to repay debt.
Robert Marcus:
Thanks for taking the questions.
James Saccaro:
Thank you.
Operator:
Your next question is from the line of Rick Wise with Stifel. Please go ahead.
Rick Wise:
Good morning, Joe. Hi, Jay. A couple of questions. Joe, maybe talk us through where you see -- I mean you've addressed them several times. Where you feel like you are with the Hillrom integration? Is it fully integrated, so to speak into Baxter now? You've got the people and everything is functioning and we're just waiting for supply chain to sort of cooperate sort of -- and maybe just help us think about how you're thinking about the time line that it's going to take for Hillrom to get back to a more typical mid-single digit kind of growth rate, if you would? Thanks, Joe.
Jose Almeida:
Good morning, Rick. We have been very successful with the integration. So the first part of your question is the integration of Hillrom. We have retained some key talent, but also we put a lot of Baxter talent in Hillrom. Right now, we have Reaz Rasul running Hillrom with the three divisions of Hillrom, with a mix of Baxter and former Hillrom employees in charge of the divisions under Reaz. In terms of the synergies, we -- as I mentioned before, we -- in the first year, came to realized twice as much as we had planned. And we continue on track to deliver what we promised at the onset of the acquisition. Other than the supply chain issues that we had last year, we start to see the power of frontline care and the power of the portfolio right now delivering good growth for us in the U.S. and OUS. Chips are made more available. And as I said before, our backlog in Front Line Care is actually growing with growth in sales and growth in backlog. So we're very excited about that business. Our PSS business in the U.S., like I said, has a setback in this first quarter. As I said, 20% reduction in the rentals due to COVID partially last year and the year before. But we see the launch of Progressa Plus and enhancements to Centrella, a great catalyst for us in the second quarter that we believe with alleviation of specific postponement of capital buying, that is going to accelerate in the second quarter and we are confident to reestablish that business in a more normal run rate, hopefully, towards 2023, ex in '23 and 2024. We continue to look at opportunities to enhance leadership in all parts of that business by the way. So PSS outside the U.S. is doing well. In the GSS business, albeit smaller is doing well both in the U.S. and outside the U.S. So all-in-all, we're excited about Hillrom. We think it brings new avenues for growth for Baxter and also product launches. I'm looking at our pipeline of new launches and a great deal of them are coming from pumps. So there's a lot to come from there. We're going to navigate the short-term constraint in the U.S. for [indiscernible] beds. But as I said, launching these new products represent a great catalyst for the future.
Rick Wise:
Great. Thanks for that. And a follow-up, maybe Jay or Joe. It's sort of a simple moderate way to ask this question, but clearly, electromechanical components are critical to this ongoing turnaround process. I mean -- and you can reframe the way I'm asking it, but are you 50% of the way back in terms of having what you need, 10%? 90%? Are you optimistic that you largely have what you need as you exit the second half? Can you just Help me think through that a little bit? Thank you so much.
Jose Almeida:
Rick, the worst thing we can do is to feel good about something that just start turning around. So we're very excited about having availability, as I said before, the demand for our Sigma Spectrum infusion pump is very high. And we're very happy actually to have significant amount of components that will allow us to increase the sales of that product and satisfy the backlog that we have. If we had more, we could sell more. We see alleviation of backlog of products that need to be shipped on Front Line Care already coming out. Our back order has reduced in half what we had about nine months ago, and a lot of that is related to semiconductors. With that said, we're not letting this go away. We got an opportunity to improve. So we have significant amount of initiatives within the company for redesign of components to go on boards. Some are very critical. Some are less critical. We have a transfer office established within Baxter, not only for microprocessors, but also for other components. Things are not 100% normal right now. We still have a great deal of suppliers trying to get pricing out of Baxter. We're offsetting those. We're absolutely not accepting, but also offsetting with significant amount of cost reductions. So as we navigate through 2023, it will be very important that the company does not lose its focus in finishing what we started in the semiconductor transformation in the supplier chain resilience. But we feel cautiously optimistic that we have turned the corner when it comes to supply of components into our business.
Rick Wise:
Appreciate the perspective, Joe. Thanks.
Jose Almeida:
You’re welcome.
Operator:
Matt Miksic with Barclays is online. Please go ahead with your question.
Matthew Miksic:
Hi. Great. Thanks so much for taking the questions. So Joe or Jay, some of the themes that have obviously come in here for Q1 so far this earnings cycle, health care and med tech. And I guess providers as well as improving utilization volumes, strong emissions is going to hear from my neighbor that covers services and improving staffing and easing of those constraints. You talked about some of these things in the -- in your prepared remarks. But could you maybe just give us a sense of what strong uptick in these sort of elements mean to you -- meant to you in the quarter? And then what do they mean in terms of pull through increased assumption of some of the products that you sell as well as the availability of staff to get some of the implementations of these systems done like in connected care or the rollout of the beds? Maybe just some additional color on that. And then I have one follow-up.
Jose Almeida:
Larry, what we see is -- Matt, I'm sorry. Matt, what we see is an alleviation of the pressure of the hospitals were having last year with more availability of nursing. We -- just as a point of reference, we had some one-timers in our medication delivery business as we reported as we're continuing to report. Medication delivery, if you exclude the one-time between gains and losses between '22 and '23 first quarter, our growth is around 6.2%. This is exactly what we see in terms of growth coming out of hospitals, which are publicly traded companies and are reporting right now. So we see that is for a business like medication delivery, which are sets and infusion of solutions and vitamins. And that is a pretty good pickup on a business. They usually have a growth of low-single digits. So that is twice as much. So there is a rebound and back to normality that we see. So hence our comments on our prepared remarks. When you think about the relentless look for optimization of workflow in hospitals, that's when we start seeing some of our products coming to fruition. We just integrated our Sigma Spectrum the other day on a two way communication for hospitals. There's no more hospitals that will come in and ask just for a pump or a monitor. Everything needs to be integrated. The workflow needs to be improved. And that's where Baxter is focusing on a significant amount of extra money we gave to research and development of Front Line Care, for instance, to increase their ability to launch products faster, to integrate to create solutions to help hospitals. So we are cautiously optimistic that we've seen an uptick in procedures. We see higher admissions in ER, higher admissions in operating room. You can see the growth of our Advanced Surgery business. It was very, very robust -- very robust, close to 10%. And that shows that in the U.S., you have a good flow of procedures. So all-in-all, indicates that that's a good track for 2023.
Matthew Miksic:
That's terrific. And then just if I could, a follow-up on a question that we get occasionally here on the spin. I know it's still early, and you're working through many of the details as you lead up to that event. But around the dividends, Jay, if you could talk a little bit about how you're thinking about managing that and what at this stage is your expectation or aspiration to sort of, to continue to pay the Baxter dividend for the entire entity as you kind of get through the spin transaction next year?
James Saccaro:
Yeah. It's -- listen, in terms of capital structure for the two companies and dividend policies and approaches and all of that, it is very early days. We understand the importance of the dividend. We, at Baxter take the dividend very seriously. So we understand that's a great tool to return capital to shareholders. And it's been a very effective one for us over the years. So we take the dividend very seriously. But at this point, it's too early to comment on capital structure and all of those things. We'll unveil all of this as we go -- as we get much closer to the spin. And I think we'll talk about things like what is the dividend policy for Renal Co if they have one. All of these things will come to bear, but I think it's a little premature to do and as we're still in the early stages of preparing for the spinoff.
Matthew Miksic:
Got it. Congrats on the quarter and thanks for the color.
James Saccaro:
Thank you.
Operator:
Joanne Wuensch from Citi is online with a question. Please go ahead.
Joanne Wuensch:
Good morning, and thank you, nice quarter. Two questions. One big picture, one specific big picture. You talked about transformational initiatives. And I'm curious how you start to measure those and over what time frame you see the goals? Is this a 2023 thing? Is this role over the next five years called DLRP? And then my more specific question is, Progressa Plus Bed, how do new beds get taken up? Is it -- you have a backlog of people saying, now that you've launched it, I want or just walk us through how we think about that new tail end. Thank you.
Jose Almeida:
Hi, Joanne. Good morning. The transformation has three specific objectives. The one is, of course, bring a more effective way of managing Baxter business instead of regionally managing the business between three large regions in the world, give P&L responsibility to business leaders who are mini CEOs who control 100% of that business, including supply chain and all aspects of that business. So that transformation is in process and we're starting to see the difference in how the ownership of this business have transitioned and how effective this new model is. The second is, through a new model, you're doing it not only because you need more effectiveness in our organization, but also we need to reduce cost of operating. So Baxter is a company that has one of the lowest SG&As amongst peers. We are at 21%, 22%. We want to be sub-20. And to do that, we need to do it two different ways. One is more effectiveness -- effective use of personnel. The second is, use of systems such as fish intelligence (ph) in different locations in the world for us to provide our service. We are on that path. For instance, Jay’s (ph) organization finance has done a significant amount of work with moving back-office to different parts of the world. And this specific change we just made in organization is going to give Baxter significant amount of dollars that we're going to realize in ‘23, but also full [indiscernible] ‘24, very large cost savings that we did through the reorganization that show our reduction in force. So reduction force in come first, the organization design came first, reduction in force was a consequence of better use of our resources. And lastly, and also probably the most important is the ability to accelerate innovation and move some of the money that we are saving back in research and development. We just did that. We just gave the HST or the new Hillrom business under Reaz Rasul. More money for research and development. And we're going to actually also improve and increase the amount of dollars going into our pump platforms because we want to accelerate some of the R&D development in that area. So this transformation is very profound for Baxter. It's part of transforming the company that I started back in 2016, and this is the third leg and is still the third phase of this transformation.
James Saccaro:
Joanne, I think, we lost you. Perhaps, we move to the last and final question.
Operator:
Yeah. We'll move to the final question now, and it comes from the line of Matt Taylor with Jefferies. Please go ahead.
Matthew Taylor:
Hi. Thanks for taking the question. Jay, if I wanted to ask you kind of a big picture question. And I was just thinking about the 2022 Analyst Day, you talked about $1 billion in gross savings through 2025 and now you've got this $300 million restructuring. And I know some things have changed. But I guess I was just hoping you could give us some perspective on how those things are related, if at all? And then, you gave a gross savings number. Could you talk about what are kind of the net savings we could see from some of these programs?
James Saccaro:
Well, what I would say is, as a company, we are very much committed to enhancing operating margin over time. And there are a lot of different levers to get after that. New products, sales growth, pricing and then things like operational efficiency. And so we outlined a series of activities in 2022 at our Analyst Day. And I would say that, in the short term, they were overshadowed meaningfully by inflationary impacts. What I'm really excited about is our ability to put those on full display in the backdrop against the backdrop of a calmer inflationary environment. Because what you'll see is you'll see some of the savings initiatives that Joe discussed, but you'll also see some of the great progress that we're making from -- hey, Matt, maybe could you go on mute?
Matthew Taylor:
Sorry.
James Saccaro:
Yeah. No problem. You'll also see the tremendous work that we're doing in the integrated supply chain area. We recently approved a very large automation program that will allow us to simplify how a number of our plants operating and that's going to have a great impact for years to come. So what I would say is, we feel very good about the activities that we outlined in 2022 at the Analyst Day. And then now we've supplemented that with a reorganization that Joe described. All of this is intended to accelerate margin improvement and so we're excited to see the impact of that over time.
Matthew Taylor:
Thank you for that.
James Saccaro:
All right.
Clare Trachtman:
Great.
James Saccaro:
Thanks, everybody, for joining us today.
Clare Trachtman:
This concludes the call.
Operator:
Thank you all for joining today's meeting. We appreciate your participation. You may now disconnect.
Operator:
Good morning ladies and gentlemen and welcome to Baxter International's Fourth Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning. and welcome to our fourth quarter 2022 earnings conference call. Joining me today are Joe Almedia, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's fourth quarter and full year 2022 financial results, along with our financial outlook for 2023. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the first quarter and full year 2023, new product development, the potential impact of recently announced strategic actions, proposed pricing actions, business development and regulatory matters contain forward-looking statements that involve risks and uncertainties. And of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. On the call this morning, we will be discussing operational sales growth which for the fourth quarter and full year 2022, adjust for the impact of foreign exchange and the acquisition of Hillrom. Now, I'd like to turn the call over to Joe. Joe?
José Almeida:
Thank you, Clare and good morning, everyone. We appreciate you taking the time to join us. I will begin with a brief overview of Baxter's performance for the quarter and year and then provide some additional information on the strategic road map we announced on January 6. These actions, further outlined in this morning's press release, will help Baxter to emerge as a more agile, innovative market responsive enterprise with expanded opportunities to create long-term shareholder value. Jay will follow with a deeper dive on our 2022 results and outlook for 2023 and we will close with Q&A. Starting with our financial results. Sales for the fourth quarter 2022 were $3.9 billion, growing 11% on a reported basis, 17% at constant currency and 2% on an operational basis. Fourth quarter adjusted earnings per share were $0.88 came in below our expectations, primarily driven by foreign exchange losses and product mix in the quarter. For the full year sales of $15.1 billion advanced 18% on a reported basis, 23% at constant currency and 2% on an operational basis. Adjusted earnings per share for the year were $3.50. Jay will provide more granularity on the numbers but some themes are clear. Demand across our portfolio remains solid and sales rose across the majority of our legacy Baxter and Hillrom businesses, offsetting modest or expected declines in others, driven by factors such as generic competition or challenging year-over-year comparisons. As we've discussed previously, this top line growth was offset by weighing of macroeconomic and supply chain factors that has continued to put pressure on the cost of doing business. And as I have stressed many times, we will never pursue reduced costs in ways that could compromise our fundamental mission to save and sustain lives. But even factoring in these headwinds, we did not perform at the level we expected and demand of ourselves. And our ability to advance our mission is grounded, first and foremost, in our capacity to deliver steady, solid performance as a sustainable corporate enterprise. This is precisely why, earlier this year, we announced plans to accelerate our transformation journey, the actions we announced on January 6 and are expanding on today are as necessary as they are timely. As I shared in January, we spent the latter part of 2022 undertaking a comprehensive review of our operations focused keenly on opportunities to improve our commercial responsiveness, reinvigorate our innovation engine and streamline our operations. This work led to last month's announcement of our intention to spin off a new kidney care company, explore options for our BioPharma Solutions contract manufacturing business and implement a new operating model for our remaining Baxter businesses. These are 3 distinct initiatives with a single agenda, increase stakeholder impact with improved long-term shareholder value. Cutting across these actions are common goals, enhancing refining strategic clarity, increased accountability and line of sight, enhance agility and bring our global businesses even closer to the patients, clinicians and customers they serve. Today, I will share the next level of detail on the Baxter business model, we expect to begin implementing next quarter. This work entails a fundamental reconfiguration of how we operate and deliver products to the customers and markets we serve. This new operating model is focused on 4 vertically integrated global business units, or GBUs, grouped along general therapeutic areas encompassing multiple sites of care. These GBUs which will become Baxter's core operating and reporting segments when implemented, include medical products and therapies, comprising our current Medication Delivery, Advanced Surgery and Clinical Nutrition portfolios. Healthcare Systems and Technologies comprising our legacy. Hillrom businesses, including Patient Support Systems, Global Surgical Solutions and Front Line Care, pharmaceuticals which will include our current pharma portfolio as well as our BioPharma Solutions business until its potential separation. And finally, Kidney Care comprising our current Renal Care and Acute Therapies businesses to reiterate our intention subject to satisfaction of customary conditions used to spin Kidney Care into an independent publicly traded company in the next 12 to 18 months. Until then, this GBU will benefit from the strategic work we are doing right now helping to hone a well-focused and streamlined entity in preparation for its anticipated launch as a stand-alone company. In this way, we can think of Baxter as having 4 GBU structure, or perhaps a 3 plus 1 GBU structure once the model is in place later this year. Each new GBU will have its own President, reporting directly to me. Each will have full global P&L accountability. We will begin to realign our current 3 region global commercial structures. So the global commercial teams will report directly into each GBU. The dedicated R&D manufacturing and supply chain and functional support teams will also be embedded by GBU to optimize visibility and oversight. This restructure is designed to generate more direct, clear accountability across each business and promote more agile decision-making across sales, marketing, manufacturing, distribution and innovation. So what you see upon completion of this process is that each of the GBUs will have more autonomy and agility than the current businesses do today. GBUs will be able to respond to market dynamics faster, more effectively, accelerate commercial investments, design and produce products and prioritize R&D spending, all to help meet critical market needs and accelerate business performance. From a manufacturing perspective, Baxter will become more nimble with manufacturing sites mapped directly to each GBU leading to an optimized manufacturing footprint in a more resilient supply chain. Preparation for the new operating model is already surfacing opportunities for streamlining and efficiency that are intended to further bolster bottom line performance. The redesign being contemplated, coupled with additional actions the company has undertaken to enhance performance, are expect to deliver more than $300 million in total savings during 2023 and a workforce reduction of less than 5%. We plan to begin implementing our new operating model early in the second quarter. Looking ahead to 2023. More broadly, we expect to continue navigating a challenging operational environment, hand-in-hand with our transformation effort. We have been taking a hard look at our forecasting models and processes as we reflect on our performance last year and the lessons learned in an era of unprecedented macroeconomic challenges. We have taken the stance of incorporating more financial downside risks into our financial outlook for 2023. Jay will provide additional details on our outlook and various assumptions included. Before I pass it out to Jay, I want to close by reinforcing my confidence and optimism for the future in our commitment to continue to maintain the important work we do every day. Baxter holds a fundamental place in global health care, with a durable portfolio of essential products, market-leading position and passionate employees who bring our mission to life. We're setting out on a well-considered plan to redefine our operations and potential in pursuit of incremental long-term value for the stakeholders and shareholders that rely on us. 2023 now becomes a pivotal year. We are on our way to creating -- to leading health care companies with robust portfolios and strong market momentum. We look forward to sharing our progress and performance in the quarters to come. With that, I'll pass it over to Jay.
James Saccaro:
Thanks, Joe and good morning, everyone. Despite in line sales results, our fourth quarter earnings performance came in below our expectations. This variance was primarily driven by foreign exchange losses and product mix in the quarter. As Joe mentioned, we're not satisfied with our results and as such, we're taking a number of actions to improve our performance. Some of these initiatives are already underway and will be further enhanced with the cost reduction program that we are in the process of finalizing, in parallel with our operating model redesign. These actions are necessary and are expected to accelerate future performance. Collectively, these actions are expected to deliver more than $300 million in savings in 2023. Turning to our financial performance. Fourth quarter 2022 global sales of $3.9 billion, advanced 11% on a reported basis, 17% on a constant currency basis and 2% operationally. Sales performance in the quarter continues to underscore the strength of our broad portfolio of core therapy and connected care offerings across the care continuum. As we've discussed previously, supply for select products remains constrained and we estimate that these constraints impacted our revenues by approximately $50 million in the quarter or approximately 140 basis points. These supply constraints are a mixture of electromechanical components and shortages from other third-party suppliers. On the bottom line, adjusted earnings decreased 15% to $0.88 per share outside our guidance range of $0.92 to $0.99 per share. As mentioned earlier, this was due to unfavorable product mix and an approximate $0.04 headwind from foreign exchange losses on balance sheet positions, primarily due to the devaluation of the Russian ruble during the quarter. Now, I'll walk through performance by our regional segments and key product categories. Note that constant currency growth is equal to operational sales growth for all global businesses, in Baxter's 3 legacy geographic regions. Starting with sales by operating segment. Sales in the Americas were flat to the prior year on a constant currency basis. Sales in Europe, Middle East and Africa grew 5% on a constant currency basis and sales in our APAC region increased 2% constant currency. Quarterly sales in the region reflected strength in geographic segment sales offset by relatively flat growth in China due to the impact from various government-based procurement initiatives being implemented in that market. Moving on to performance by key product category. Global sales for Renal were $981 million, increasing 3% on a constant currency basis. Performance in the quarter was driven by solid growth in our PD business, where we observed an increase in PD patients globally, particularly in the U.S. which saw a sequential improvement in growth of 100 basis points and ended the year with patient growth of approximately 4%. Mid-single-digit PD growth in the quarter benefited from incremental revenues of nearly $20 million, resulting from a customer that was looking to build out a new business and did not meet its contractual minimum purchase requirements. This arrangement has been terminated and the related revenues will not recur in future periods. Performance in the quarter was partially offset by lower in-center HD sales due to HD monitor and associated consumable component supply challenges. Sales in Medication Delivery of $745 million declined 2% on a constant currency basis. Performance in the quarter was affected by a difficult comparison to the prior year which benefited from higher levels of infusion pump placements. Demand remains strong for Baxter's smart infusion pumps and as we have discussed, is currently outpacing our ability to supply, given continued challenges sourcing components. Our IV therapy portfolio grew low single digits globally, driven by strong demand internationally. During the quarter, we did not see pronounced impact from flu-related cases which, although reported case numbers were high, did not translate into increased hospital admissions. Pharmaceutical sales of $552 million declined 1% on a constant currency basis. Performance in the quarter reflects the continued impact of generic competition in the U.S. which was partially offset by increased demand for our drug compounding portfolio internationally. Moving to Clinical Nutrition. Total sales were $243 million, increasing 6% on a constant currency basis. Performance in the quarter was driven by demand for our broad multi-chamber bags and vitamins product portfolio. Sales in Advanced Surgery were $260 million, advancing 8% on a constant currency basis. Growth in the quarter reflects an improvement of electric procedures globally. Surgical volume recovery was strong across all regions. Sales in our Acute Therapies business were $182 million, declining 3% on a constant currency basis and reflecting a tough comparison to the prior year, where we had experienced elevated demand for CRRT given the rise in COVID cases. BioPharma Solutions sales in the quarter were $153 million, increasing 12% on a constant currency basis. Demand for non-COVID services more than offset the decline in COVID vaccine-related revenue compared to the same period last year. COVID vaccine sales for the quarter totaled $22 million. Legacy Hillrom contributed $734 million in sales in the quarter compared to $212 million in the prior year period after the acquisition closed on December 13, 2021. Hillrom sales included $360 million of sales in Patient Support Systems, $293 million of sales in Front Line Care and $81 million of sales in Global Surgical Solutions. Legacy Hillrom sales grew mid-single digits on a pro forma and FX-neutral basis as compared to Q4 2021. This growth reflects demand for the physical assessment and cardiology portfolios within the Front Line Care business. Within the quarter, we were able to secure some additional electromechanical components on the spot market which enabled us to address a portion of the backlog associated with the Front Line Care business. Sales in Patient Support Systems declined low single digits in the quarter, primarily driven by lower rental revenues in the quarter as the prior year period benefited from more than $10 million in sales due to COVID-related rentals. Moving through the rest of the P&L. Adjusted gross margin of 41.6% decreased 270 basis points versus the prior year, reflecting increased cost of goods sold, primarily driven by the factors we've discussed around inflation, freight and supply chain constraints. Adjusted SG&A of $797 million represented 20.5 as a percentage of sales, an increase of 30 basis points versus the prior year, driven by the addition of Hillrom as well as higher freight expenses. Adjusted R&D spending in the quarter of $157 million represented 4% of sales, an increase of 10 basis points versus prior year. Both SG&A and adjusted R&D reflected a benefit from lower bonus accruals under our annual employee incentive compensation plans which are directly tied to Baxter's performance. These factors resulted in an adjusted operating margin in the quarter of 17.1%, a decrease of 310 basis points versus the prior year. Adjusted net interest expense totaled $117 million in the quarter, an increase of $73 million versus the prior year, driven by higher outstanding debt balances related to the acquisition of Hillrom and the impact of interest rates on the variable rate debt. Adjusted other nonoperating expense totaled $12 million in the quarter, a decrease of $9 million versus the prior year, driven primarily by amortization of pension benefits. As I mentioned earlier, nonoperating expenses were unfavorable to our expectations primarily due to foreign exchange losses. The adjusted tax rate in the quarter was 16.1% compared to 18.6% in the prior year period. The year-over-year decrease was primarily driven by statute expirations on certain tax positions, partially offset by an increase due to a change in geographic earnings mix following the Hillrom acquisition. And as previously mentioned, adjusted earnings of $0.88 per share declined 15% versus the prior year period. Earnings in the quarter reflected the increase of cost of raw materials, freight and labor as well as the impact of rising interest rates and foreign exchange headwinds. Turning to full year 2022. Sales of $15.1 billion increased by 18% on a reported basis, 23% on a constant currency basis and 2% operationally. Legacy Hillrom's Front Line Care, Patient Support Systems and Global Surgical Solutions businesses contributed $2.9 billion to full year sales on a reported basis. On a pro forma basis and after adjusting for foreign exchange, full year legacy Hillrom sales were flat as compared to the prior year period, primarily reflecting the impact of supply constraints for electromechanical components. On the bottom line, Baxter's adjusted earnings decreased 3% to $3.50 per diluted share, reflecting the impacts we just highlighted. On a full year basis, we generated operating cash flow from continuing operations of $1.2 billion and free cash flow of $532 million. Throughout 2022, we remain focused on debt repayment following our Hillrom acquisition with 900 million paid boards deleveraging. We also returned approximately $600 million to shareholders through dividends and share repurchases. As we execute on our strategic actions outlined in the beginning of 2023, we are first and foremost committed to meaningfully improving our cash flow generation. Our priorities for cash deployment are focused on accelerating debt repayment, maintaining our dividend and resuming share repurchases over time. We are also actively pursuing strategic alternatives for our BioPharma Solutions business, while continuing to assess additional inorganic growth factors for products, therapies and connected care platforms for our new streamlined operations. As we progress towards the proposed spin-off of Kidney Care company, we'll look to utilize proceeds from these actions to accelerate Baxter's debt repayment schedule. We remain committed to an investment-grade credit rating profile, including taking actions towards achieving our previously stated commitment to achieve 2.75x net leverage. Although current business conditions might challenge our ability to satisfy that commitment, by the end of 2024, we do expect to make significant progress towards achieving the target during 2023 and 2024. Additionally, given the proposed spin-off and potential sale of BPS, we expect to provide additional information regarding our forward-looking outlook for both Baxter RemainCo and KidneyCo at a Capital Markets Day prior to completion of the proposed spin-off. Let me conclude my comments by discussing our outlook for the first quarter and full year 2023, including some key assumptions underpinning our guidance. On the top line, 2023 is expected to benefit from underlying volume growth, the pricing actions taken last year as well as new product launches across our GBUs. Some of these new planned product introductions include more than 5 injectable drug launches, a next-gen ICU bed, ExactaMix Pro, Nutrition Compounder, continued rollout of our Novum IQ LVP and syringe pump in Canada and launch of the Novum IQ syringe pump in the U.S. At this time, our 2023 guidance does not contemplate any U.S. revenues for the Novum IQ large-volume infusion pump. We anticipate submission of our final responses to FDA within the quarter. We continue to be very excited about the prospect of this launch and the benefits it offers our customers. Our objective remains to launch this pump in 2023. Throughout 2022, demand for our products and therapies remained solid but supply chain challenges impacted our ability to fully supply this demand. We experienced record levels of backorders and backlog, particularly for the legacy Hillrom business. And while we observed positive development and supply availability in the fourth quarter of 2022, we currently anticipate component availability will remain challenging and will continue to hamper top line sales in 2023. We are working relentlessly to secure components and address order backlog and our expectation is that supply for electromechanical components will improve in the second half of the year. As Joe outlined, we're implementing a series of changes across our organization that are designed to meaningfully simplify the operating model and manufacturing footprint drive strategic clarity, improve operational efficiencies and accelerate future growth. In addition to consolidating our operations into 4 vertically integrated global business units, we're also evaluating additional strategic actions, including potential product line and country exits to better position the company for more profitable growth over the mid to long term These exits are expected to reduce sales by more than $100 million as compared to full year '22. Lastly, as it relates to the top line 2022 results, included approximately $140 million of sales that are not expected to repeat in 2023 as well as the benefit of approximately $50 million due to lower customer rebate costs, this includes lower COVID vaccine revenue of approximately $100 million and 2 contractual payments which benefited Renal Care sales by approximately $40 million in the second half of 2022. Moving on to dynamics impacting the rest of the P&L. First, I want to point out a couple of factors that are impacting our 2023 performance as compared to 2022, such as higher annual incentive compensation payments for employees, increased interest expense and a higher tax rate assumption. In addition, while we see some improvement in the external macro environment, with select indices coming down from the peaks seen last year, our cost base is still elevated relative to historic norms. As such, cost of goods sold is expected to be a headwind compared to 2022. This is due to the rollout in the first half of 2023 of manufacturing-related costs capitalized into inventory in the second half of 2022 as well as a challenging comparison to the first half of 2022 prior to the start of significant increases in inflation. We expect the impact from these inflationary pressures to begin to ease in the second half of the year. Also, as mentioned earlier, in response to the significant macro challenges the company has experienced over the last 2 years, we will be implementing a cost reduction program in parallel with our operating model redesign that is expected to be finalized later this quarter. This initiative and additional actions the company has undertaken to enhance performance are expected to deliver more than $300 million in total savings during 2023. These savings are expected to increase over the course of the year, with the majority of the savings being realized in the second half of the year. The lower cost of goods, coupled with the increased savings, are expected to drive meaningful margin expansion and earnings growth in the second half of the year as compared to the first half. We also expect the impact from foreign exchange to lessen in the second half of the year. Finally, as Joe mentioned, with respect to our outlook for 2023, we biased our guidance towards capturing additional potential downside risks. We recognize that our performance last year disappointed investors and us alike. While we are confident the actions we are undertaking will set us on force for improved performance longer term, we have recognized that 2023 will be a transition year on our path to achieving this objective. Incorporating all of these factors, I'll now walk through our guidance and expectations. For full year 2023, we expect global sales growth of 1% to 2% on a reported basis and flat to 1% growth on a constant currency basis. We expect full year adjusted operating margin to be between 15% and 16%. Interest expense is expected to total approximately $540 million which reflects pass and potential future rate increases and adjusted tax rate of approximately 22% and a diluted average share count of 508 million shares. Based on these dynamics, we expect 2023 adjusted earnings, excluding special items, of $2.75 to $2.95 per diluted share. Specific to the first quarter of 2023, we expect global sales to decline by approximately 3% on a reported basis and approximately 1% on a constant currency basis. And we expect adjusted earnings, excluding special items, of $0.46 to $0.50 per diluted share. With that, we can now open the call up for Q&A.
Operator:
[Operator Instructions] And we'll go to our first question from Pito Chickering at Deutsche Bank.
Pito Chickering:
So I guess the first one is going to be on the operating margin expression. I guess, details on what the split is between SG&A, cost of sales and R&D. And can you point to the biggest pressure points in the gross margins? Is it diesel, resin, microchips, labor? I think investors understand the macro pressures for facing you guys, it's been challenging to understand how these macro pressures flow through the P&L? Any color there would be great.
James Saccaro:
Sure, Pito. And -- is your question in reference to '23 or Q4 '22 -- or what is -- what period are you referring to?
Pito Chickering:
Apologies; this is all for 2023. A 15% to 16% operating margin that you guys referenced.
James Saccaro:
Sure. Sure. So overall, we are seeing increased pressure on operating margin in the first quarter and throughout in 2023. And a lot of that relates to supply chain costs that we've incurred in the second half of the year that start to roll out into 2023. And as we think about the timing of those pressures, really is most prominent in the first quarter of the year. So we'll have a trough margin in the first quarter of the year and then it starts to accelerate from there moving forward. As we think about where the impacts are, it is, as I say, largely related to gross margin. Although because of freight costs, we do see some incremental SG&A costs that show up throughout the year. And like I say, it starts to much more normalize by the fourth quarter of next year.
Pito Chickering:
Okay. And then would you have your talks to your customers about increased pricing? I guess, any color on how those are going? And what is your overall pricing view in 2023 versus 2022? And then if you break out gross margins from pharma specifically, do they have any outsized movement in your surprising for '23.
José Almeida:
Peter, I'll take the price question overall and Jay can give a little bit more detail. We are able to put price through where we can and we see price being neutral to slight positive in 2023 and for the company. Obviously, we have long-term contracts. As these contracts become available for negotiation will have a different viewpoint in how we're going to put in escalation for inflationary pressures the way we just saw them in '21 and '22. So in terms of the -- how that more specific about your question, Jay can comment.
James Saccaro:
Sure. Overall, pricing is a net positive as we look at the year. So there is some benefit that we've reflected based on all the work that we've conducted over the last year, along with some existing contractual arrangements. There is some negative pricing pressure in pharma that offsets a higher number, excluding the impact of the pharma business.
Operator:
We'll take our next question from Robbie Marcus at JPMorgan.
Robbie Marcus:
Great. Jay, maybe to start, I think it'd be helpful for everyone to try and get a sense of what's conservatism in the guide with some the new philosophy you talked about. What's -- and what's actually being contemplated? There's $300 million in cost savings but margin is down as you just talked about. So really just help us understand what are some of the negative assumptions in there that you're putting in to help add more cushion on the bottom after the 2022 cadence?
James Saccaro:
Sure. Listen, as I mentioned in my prepared remarks, Robbie, we were disappointed with performance in 2022, clearly. And frankly, as we reflect back, it was a highly volatile and dramatic environment that we were faced with and that we were operating through over the course of the year. As we put together guidance for this year, I would say a couple of things. We've taken levels in terms of indices as they currently sit today. We've reflected continued supply constraints in things like electromechanical components. And then in addition to that, we've added margin of safety in terms of contingency to offset which is why you see a much wider range than we've had previously. I would add to that, we've also done things like taking out the LVP pump. We're really optimistic about the large volume pump getting approved this year. We're working very closely with FDA towards achieving that goal. But from a guidance standpoint, we've removed $100 million related to sales for that product. And so, I'm hopeful that these assumptions prove conservative. And that by the end of the year, we're looking at a very different world in terms of indices, electromechanical component availability and it really sets the stage up for a nice second half and a nice 2024 but we'll continue to watch these very carefully. Part of the issue, as we look at the 2022 to 2023, is the rollout of the very significant manufacturing costs that we've incurred this year. And so we have a big headwind that we're faced there. Offsetting that is $300 million worth of savings. Now that's not all incremental based on the new model. What I would tell you is approximately $200 million of that or so relates to previously discussed or identified initiatives, including the Hillrom synergies. There's roughly $100 million related to the new program that we put in place that will be reflected in our numbers. So really, that's the overall story. We've tried to take all of the learnings as we look at volatility and those items and reflected as we put it together.
Robbie Marcus:
Great. And Jay, how should we think about cash flow going through the year here? And how it will play out in '23 relative to '22? Will these cost savings actually cost money in '23 to achieve? Or do you think you could see cash flow improve despite the lower margins?
James Saccaro:
Sure. Robbie, we have an intense focus on cash flow. And I will tell you that the financial performance in 2022 was challenging. And certainly, the free cash flow performance reflected those challenges. As we move to next year, my expectation is that free cash flow will more than double relative to the 2022 level. And a lot of that has to do with improvements in working capital balances. If you look at the working capital balances, as I currently sit, the days inventory on hand has expanded over the course of the year, in large part due to missing components and having our plans run sub-optimally, longer lead times for products leading to disruptions of our supply chain, longer shipping lanes. All of those things have led to a higher days inventory on hand. Additionally, from a receivable standpoint, because of the cadence of sales, we actually had very strong sales in December, leading to a higher receivables balance than we would normally have relative to prior years. And finally, due to timing of some vendor payments, our payables balance came in low. So our clear expectation is each of these categories will improve. And by -- and along with careful CapEx management, our expectation is more than doubling free cash flow because, like I said, at the end of the day, that's an important valuation metric for us. In addition to that, it's an important incentive compensation metric for us.
Operator:
We'll go next to Vijay Kumar at Evercore ISI.
Vijay Kumar:
My first one, Joe and Jay, for you guys on revenues. If I go back to the third quarter commentary of that 4% [ph] organic growth assumptions for fiscal '23. The updated guidance here is reflecting a 350 basis point change. And I understand product exits in pumps or incremental rate, that's maybe 100, 150 basis points impact. Can you help us bridge what changed from that 4 to the 50 basis points? Because I feel like vaccine headwinds, these were known as of the third quarter call last year. Are you contemplating some incremental supply chain headwind here on revenues? Or what changed from the 4%?
James Saccaro:
Sure. Vijay, let me walk through that specifically. To your point, we have a reduction from 4% which we talked about on the earnings call to flat to 1%. And there's really a few primary drivers of that. And interestingly, a lot of those impacts will be confined to 2023 which I think is really good news as we look at setting the stage for 2024. It begins with the large volume pump. And this -- in my view, this is really about conservatism on the sales guide. We've taken out $100 million relative to our prior expectations, roughly 70 basis points of growth relative to that 4%. The second item relates to the weighted average market growth. If you reflect back on our January 6 call, we talked about a slight lowering of the WAMGR of our markets on a compounded basis. But interestingly, a lot of that impact is most prominent and in fact, in some cases, confined to 2023. What I mean by that is the renal mortality issue that we face with -- that we've been faced with really collide into 2023. In addition to that, the acute growth challenge really is a 2023 impact. And then some of the capital assumptions that we've made which, again, is another area we hope to prove conservative, is really focused on 2023. And so as we approach year-end and refreshed our view of patient census of expectations into 2023, we did lower the WAMGR for 2023 by approximately 100 basis points which is included in the commentary that we made on January 6. In addition to that, we're looking very carefully at profitability by product line. At the end of the day, we're ensuring that every dollar in every market is a profitable one and a cash flowing one for Baxter. And so we have to made the decision to exit approximately $100 million or 70 basis points worth of sales. And then we did have roughly $50 million shift from 2023 to 2022 and I did make some commentary on this in the call. And so listen, we obviously don't like to lower expectations on the sales line. But what I take part in is the fact that many of these impacts are not sustainable impacts but are rather discrete to 2023. And then we'll expect to see acceleration from there. In the case of the pumps, let's watch carefully how that evolves over the course of the year.
Vijay Kumar:
Understood. That's helpful, Jay. And then one on margins here. I think your prior commentary was 75 basis points on margin expansion and the current guidance is a decline of 150 basis points at the midpoint. So that's a 225 basis points change. Maybe can you bridge us to what's changed versus your prior expectations? Where the impact is coming from? Is this current guidance including any dis-synergies from spin? Or is that an incremental headwind as they think throughout fiscal '24?
James Saccaro:
Sure. So overall, with respect to operating margins, we do now anticipate a reduction, as you pointed out. And I would say that there are a few drivers of that. First, the lower sales outlook. When you think about things like absorption, some of the higher-margin areas, the lower sales outlook does have an impact of $0.40 to $0.50 in earnings with an attending operating margin impact. Secondly, I'd point to supply chain headwinds that impact the first half of the year, most prominently. And these are incremental to what we previously said. As we went through the fourth quarter, we were still purchasing electronic components at much higher levels than we anticipated. The spot market was very challenging. So things like that led to incremental costs that roll out into the first half of the year. And then, we do have some benefits related to the incremental savings program and FX is a modest headwind overall. As we look at operating margin, it's basically flat, maybe a little bit of a -- maybe -- it's basically flat as we look at the bottom line. And so, those are the factors that impact the operating margin. But Vijay, I do want to make a really important point. As we think about the cadence of the story that occurs over the course of the year, first half of the year will be a challenging operating margin story, as I've discussed. But as we start to benefit from indices that currently sit at today's levels in the product that we sell in the second half of the year, as we start to benefit from more electronic component availability and only reflected modest, very cautious improvements in this area in the second half and as we add incremental sales to the second half as we always do, the second half margin starts to look a lot nicer and a lot more consistent with the trajectory that we expect to see. As far as the synergies and incremental costs and so on, from a cash flow standpoint, we've included roughly $100 million in our cash flow statement. There is maybe $0.03 or so of non-adjusted impact in the P&L for things that are suboptimized as it relates to the spin. So a modest impact in that regard. We've reflected that. It's a bigger impact from a free cash flow standpoint. I've discussed this with a number of you already. So I think we've got that correctly modeled. And like I said, I think the operating margin story really does start to look a lot better as we approach Q3.
Operator:
We'll go next to Mike -- I apologize. Matthew Mishan with KeyBanc.
Matthew Mishan:
How are you guys looking at R&D into 2023? Do you have the flexibility to kind of speed up some projects, especially in the transition like this that sets you up for better growth in 2024 and 2025?
James Saccaro:
We have earmarked some R&D dollars, in particular, for some of the Hillrom portfolio and some of the connected areas there in Front Line Care, in particular. I will say that as we look at the opportunities presented by the Hillrom acquisition, it's a really tremendous one long term. And we're talking -- once we've resolved the supply constraints, last year growth was essentially flat. We're seeing -- we're expecting mid-single growth -- mid-single-digit growth in the Hillrom portfolio this year in the face of continued supply constraints. And part of that comes from new products. We'll launch a new ICU bed, as I referenced in my prepared remarks. But to your point, Matt, there are some really interesting opportunities that will protect investment for as we go forward. And I think that should start to accrue to the benefit of frankly, both companies in 2024 and beyond.
José Almeida:
Yes. I just want to complement that we're planning for double-digit R&D increase in 2023 versus 2022. And we're going to do -- no, probably this cadence year-over-year. We found some debt in the Hillrom portfolio, primarily parts in Connected Care will receive a significant portion of our increase in research and development. This is one of the things that we discussed in the thesis of the separation but KidneyCo was the ability to allocate capital to the right places. So if you look forward to Baxter will be significant investment in connected devices as well as smart devices. So, you look at continuation once we get through the large volume rental pump approval is the next generation of integration of the pump and safety software. And you'll see us in Q3 launching the progressive FLOSEAL, really making solid our position in terms of market leader in beds. So there's quite a bit of change in how we've seen R&D. We think innovations a path forward to Baxter. And the way to do it is actually to do what we're doing in '23 and allocating dollars on a double-digit growth to that line.
Matthew Mishan:
Okay. And then if I heard you right, I think you said a 22% tax rate for 2023. What's changing there? And then is that the go-forward tax rate for the core Baxter moving forward?
James Saccaro:
Sure. We did have some onetime and planning benefits accrued to 2022. And then as we look at 2023, we included things like sort of modified assumptions related to FAS 123R benefits, among other things. And so it's hard to say what to go-forward is beyond 2023. I think we've got it correctly pegged. We'll -- the tax team is hard at work and I know many of them, coming to this call, looking at planning ideas for 2022. But as we look beyond that, so much of this will depend on the setup of the 2 new companies that it's very challenging for me to comment specifically in this forum around the tax rates for the 2 companies but 22% is a good number for this year.
Operator:
We'll take our next question from Matt Miksic at Barclays.
Matt Miksic:
I wanted to just follow up on where things stand with the integration and sort of synergies for Hillrom. Maybe Jay, if you could talk a little bit about how some of the inflationary pressures, energy costs, et cetera, have weighed on that business? And whether this sort of change in componentry and supply chain is something that you expect to kind of be able to sustain here in the first half? Or is that still sort of choppy? And then I have one follow-up.
James Saccaro:
Sure. So from an integration standpoint, I would say, overall, the integration is going very well. We had a disruption last year and that disruption has continued all the way through today. In terms of electromechanic component availability, the ability to procure at reasonable prices, all of those things has been very disruptive to the initial stages of the Hillrom acquisition. But having said that, we're very pleased with where we currently sit and the path forward. I commented moments ago, flat growth last year, largely driven by supply constraints. Ex-supply constraints, we would have seen nice mid-single-digit growth. We start to see some of that normalize but we do see residual impacts from supply chain into 2023. But despite that, we're talking about mid-single-digit growth this year. From a cost synergy standpoint, we're ahead of our expectations. And in the numbers that we've reported, there's a clear benefit included for Hillrom integration. And then as we look forward, I think we have a lot of optimism about the portfolio, the interaction with Baxter products and where we can take this going forward. And maybe, I'll turn it over to Joe to talk a little bit about some of the things that we've seen there.
José Almeida:
Yes. We have a pretty rich pipeline of products, starting with progressive FLOSEAL. As I said, it's going to really put Baxter -- continued probation of a very solid leadership position in the PET market. our Centrella bed has done a great job and is a product that continues to sell well. When we look at our Front Line Care, that business could have grown double digits easily in 2022 as well as in 2023. We're planning for Hillrom as a whole to grow around 4%. It could be north of that if few components become more available. We're starting to see that showing up the market, primarily from like [indiscernible] to see more components coming. We just look at them in the month of January. We're able to see some of that coming through. And also the innovation pipeline coming out of those 2 businesses look really good. And the Connected Devices, what we call care communications. We see good backlog coming into Nurse Call System as well as installation of Voalte. We see in the first half of the year a little bit depression in that as the nursing shortages continue to apply pressure the hospitals and also the macroeconomic indexes make hospitals be more cautious but we see that improving in the second half. So, you look at the market for capital, improving the second half. We look at the product launches that we have coming up. And the pipeline of innovation coming out of Hillrom is very exciting. Further to that, we're putting more money into research and development in 2023 disproportionately into Hillrom to accelerate the growth of that business.
Matt Miksic:
That's super helpful. And if I could, just maybe at a high level, Joe, you touched on some of the things just now but I think most folks are looking at the guide and more conservative than folks were expecting. And I think you get that and I think we'll be able to sketch out the script for today. They might have recommended something like that, given the struggles that the company and the sector really has had in energy and technology, everything last year. So, maybe -- with that in mind, if this is kind of sort of rebasing and taking all these things into account, what are some of the things that you think could kind of potentially present some bright spots and upside as we kind of get into -- from the year, getting to kind of a turning point in the business, turning point in some of the inflationary pressures that you're seeing? What are some of the things that you say could possibly go well or better this year?
José Almeida:
Listen, when I look at 2023, coming from 2022, we saw an incredible pressure in our manufacturing base. If you think about us, we're disproportionately affected by the significant increase in energy cost, transportation. Remember, Baxter's transportation as a percentage of sales is the high single digits. And go into some of our markets, it's even higher than that for some of the renal products. So what I think is remarkable is how we're able to get very quickly. Once we start seeing those things coming up so fast, we went on the other hand, we have created significant programs to offset -- the offset is not what transformed, what transforms Baxter is the amount of automation that we are putting into our manufacturing operations. The amount of plants we're going to be able to consolidate because of that. And this is all will take place in 12 to 24 months. We also looking at disproportional allocation of capital into businesses that are connected and have the possibility for growth. The market is very anxiously waiting for our pump. We feel optimistic where we are with the pump today. We don't speak on behalf of the FDA. Neither we're making a prediction about that but we're saying that we're enthusiastic because we know the products are doing very well in Canada. We just closed another -- a few thousand pumps deal in one of the provinces. So we are excited about the portfolio. So, when I look -- all in all, '23 is the year that has 2 different stories. The first half, the story of paying for some of the incremental cost and significant cost that we had in '22 coming through the inventory selling of the inventory that was produced with that incremental cost. I see the second half of the year becoming more focus on what Baxter used to be which is time to see leverage of the bottom line in bringing back the things that used to be part of Baxter. But this crisis brought to surface a lot of weaknesses in some of our supply chain operations. And while we took the opportunity was to regroup and understand how to modify this permanently and take away some of this variability from our future. I'm going to get out of being in the resin-based business, no. But we're going to make sure that our plants are in the right place. Our plants are automated and we have the ability to get really efficiency out of our system. So the cost reduction that we're putting, for instance, into 2023 are over $300 million. So that efficiency will pan out in '24 with another $300 million in '24 coming to our supply chain. So, all those things that we're doing is a transition year for Baxter. One that we reset, we regroup, look at our portfolio, restructure our capital structure with the selling of PPS, getting that to help us take the debt down but also feel future inorganic tuck-in opportunities. So this is the year that Baxter will execute in its final stage of the transition that we started 7 years ago.
Operator:
We'll take our final question from Lawrence Biegelsen at Wells Fargo.
Lawrence Biegelsen:
Jay, maybe it would be helpful to give us an update on the standup cost and the stranded cost. Is the right assumption about 1% of the respective company sales and the onetime disentanglement cost of 3% to 4% of total company sales? What's the timing on that? And will some of that impact non-GAAP earnings? And any -- Jay, I mean you know it's early but people are looking at '24 for valuation. Any framework on -- could margins get back to 2022 levels?
James Saccaro:
Sure. No commentary yet on 2024. We are incredibly focused on delivering 2023, period. And we do believe that there are some discrete headwinds that we're facing in 2023 that abate in 2024 or go completely away. So as Joe commented just moments ago, we're really excited about where this thing goes into the future as evidenced by what happens in the second half of the year as we look at the operating margin of the company. So we're very optimistic. But at this point, I have to stand down in terms of giving multiyear guidance. As it relates to standup costs and dis-synergy or onetime costs, stand-up costs for NewCo, we've said around 1% to 2%. No real adjustment at this point. From a onetime cost, we've commented previously on the higher end of the 3% to 4% precedence that we've seen. But you're seeing some of that in the numbers that we shared today. Specifically, we have roughly $100 million in cash-related costs that impact cash flow but much of that is either CapEx or non-GAAP, so to speak. And so in our non-GAAP results, we have roughly $0.03 of impact costs related to this program in the numbers that we shared today. So that's really how we're looking at it in 2023. And the cash is a very real cost. And to my comments earlier, in relation to Robbie Marcus question, for us, cash flow is a crucial and important area of focus for us in 2023. So those are very real costs. But as it relates to what's impacting the P&L, it's a couple $0.02, $0.03.
Lawrence Biegelsen:
Jay, that's helpful. Just let me ask one quick one here. The backlog and backorders, can you quantify those? And do you expect to get those back over time? We have seen some companies report Q4 results where we've seen some benefit from those coming through.
James Saccaro:
Sure. I won't get into too much specifics on this. We do have some benefit from improvement in backlog, where we have clear line of sight. And so we have reflected a little bit of that in our numbers. But what I will tell you is in the plan that we've reflected here today, there continues to be supply constraints on what we could otherwise sell. And so once we have line of sight to freeing up of electronic components among other key inputs, we'll hopefully modify that assumption to the better. But at this point in time, there is still some backlog that exists over the course of the year and we did comment in the prepared remarks on continued impacts in the fourth quarter.
José Almeida:
Yes, just I would add that the backlog. We're starting to see some movement -- positive movement in semiconductors, primarily Front Line Care. We're starting to see that and that is very encouraging to us. But I think it is early to take a victory lap here. I think our supply chain folks have done a lot of work. However, we're starting to see this progress coming through, hopefully continues on and we can actually, in the next quarter, speak more about the positive tailwind that, that can plus. Thank you.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Third Quarter 2022 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions]. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning, and welcome to our third quarter 2022 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's third quarter 2022 financial results and full year financial outlook for 2022. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the fourth quarter and full year 2022, our 2022 to 2025 long range plans, the acquisition of Hillrom, new product development, the potential impact of proposed pricing actions, business development, portfolio optimization and regulatory matters contains forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our Web site. On the call this morning, we will be discussing operational sales growth, which adjusts for the impact of foreign exchange and the acquisition of Hillrom. Now, I'd like to turn the call over to Joe. Joe?
José Almeida:
Thank you, Clare, and good morning, everyone. We appreciate your joining today's call. I will start with a look at our third quarter performance, including some perspective on the macro environmental factors impacting our near-term trajectory. Jay will provide a deeper dive on our financials and outlook, after which we will open up the lines for your questions. Q3 2022 represents the third full quarter since the close of our Hillrom acquisition. Total company sales of $3.8 billion grew 17% on a reported basis and 23% at a constant currency rates. Legacy Hillrom contributed $735 million to sales in the third quarter. Excluding the impact of Hillrom and foreign exchange, third quarter sales rose slightly on an operational basis. On the bottom line, third quarter adjusted earnings per share of $0.82 were the higher end of the guidance range we had provided previously. Both top line and bottom line performance in the quarter reflect the continued impact of macroeconomic headwinds, including significant inflationary pressures, as well as ongoing global supply chain constraints consistent with what many others are encountering globally. With further regard to the macroeconomic environment, I want to note the impairment charge in our third quarter financials related to the Hillrom acquisition. Jay will provide additional details. But in short, this charge relates to many of the shifting market dynamics, including rising interest rates and lower valuation multiples, that there have reduced equity values broadly along with the increased supply chain related costs that we've previously discussed. With that said, and with 10 months of progress and perspective, I want to underline our continuing confidence in the potential of the Hillrom acquisition. This is already playing out as an opportunity to expand the reach of both legacy portfolios geographically and across the continuum of care. It is also accelerating our connected care journey, expanding our digital footprint and helping to unlock the next wave of innovation across our R&D pipeline. Integration of our legacy organization is advancing swiftly. And as previously shared, we are achieving even greater value capture through cost synergies than initially anticipated. Additionally, overall demand across the Baxter and legacy Hillrom portfolios remains solid, but we continue to experience meaningful backorders and backlogs due to reduced access to a variety of raw materials in electromechanical components. As I have shared previously, this has resulted not only in higher cost, spot purchases, but also expedited freight costs as we work steadfastly to get our lives to steady products to the patients and clinicians who depend on us. While we see signals that some of these macro factors may begin to ease next year, our current expectation is that select supply constraints will persist into 2023, particularly as it relates to semiconductors where we continue to see high levels of volatility in supply. During the quarter we experienced several decommits from various suppliers, meaningfully impacting our overall demand planning process. We have also seen supply constraints from other raw materials, which has further impacted performance. In total, we estimate that the semiconductor and raw material constraints we've experienced negatively impacted Baxter top line performance in the quarter by more than $100 million, or approximately 400 basis points. And on a year-to-date basis, we estimate this figure to be approaching $300 million. We continue to take the size of action to help mitigate these constraints and position the company for improved future performance. Some of the actions we have already undertaken include extending the horizon of our demand forecasts out to 24 months for supply constrained categories to allow our suppliers to allocate capacity and inventory to Baxter over long horizon, validating alternate supply options to provide flexibility in sourcing, establishing direct buying relationships with critical secondary component suppliers, enhancing our manufacturing processes to further optimize mature usage and reduce waste and meeting with management teams of our key suppliers and select government officials to reinforce the criticality of Baxter’s products. We are confident that these actions will further enhance our ability to help mitigate supply chain impacts on Baxter’s near and mid-term performance. At the same time, we remain focused on improving the operational efficiency across the organization with already implemented several initiatives that I expect to drive improved future performance, including ensuring that we have the optimal organizational structure and business processes in place. In addition, we are pursuing some near-term actions to help offset the increased expenses we're experiencing. These actions, including recent restructuring initiatives, broad hiring freeze, reduced discretionary spending, and accelerating our Hillrom integration efforts. Additionally, we do expect to realize savings this year through lower annual employee incentive bonuses, which are directly tied to business performance. Also, as mentioned last quarter, we have already passed on a portion of the incremental costs we've absorbed through our customers and are collaborating with them to finalize agreements which include revised pricing terms to address continued cost pressures. We deeply value these relationships and appreciate the challenges our customers themselves are facing. Upon successful execution and implementation of these agreements, we anticipate the related revenues will be reflected in our results this year. We believe these actions will help underscore our unwavering commitment to our patients and customers. Collectively, these initiatives are fueled by the sustained emphasis on operational efficiency and cost-based optimization that has powered our transformation to date. And, as I will continue to stress, we will never pursue any action that compromise our fundamental mission to save and sustain lives. We are also actively advancing our strategic review of the portfolio to ensure the optimal structure to execute on our vision of transforming healthcare to improve patient outcomes, enhance workflow efficiency and enable cost effective care. We anticipate that we will be in a position to provide more details on these ongoing activities early next year. I want to reiterate that our strategic core and prospects remains firm as is our commitment to driving long-term value for our shareholders and the many other stakeholders we serve. Baxter’s strength is founded on our diverse durable portfolio of essential healthcare products which will continue to be enhanced by our focus on driving innovation in connected care and core therapies. Baxter’s industry leadership and increased scale, combined with our rapidly advancing digital capabilities, create a spectrum of prospects to help advance our impact in line with our lifesaving mission, and in turn to share our success with our shareholders and other stakeholder communities. Finally, I want to recognize and thank our employees for their remarkable effort always, and especially as we navigate the current macro environment. Our global team consistently embraces our life saving mission above all, rising to meet each new challenge with dedication, passion, and a keen focus on serving the many stakeholders who depend on us. Now, Jay will provide more details on our third quarter performance and outlook for the remainder of the year.
James Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, our results for the quarter came in largely as expected, with some impact to sales due to select supply chain-related constraints. As discussed earlier, our teams have been and continue to identify opportunities to help mitigate the unprecedented macroeconomic headwinds we continue to face and we remain committed to delivering on our long-term objectives. Turning to our financial performance, third quarter 2022 global sales of 3.8 billion advanced 17% on a reported basis, 23% on a constant currency basis and rose slightly on an operational basis. On the bottom line, adjusted earnings decreased 20% to $0.82 per share, falling within our guidance range of $0.79 to $0.83 per share. Earnings in the quarter reflect the increased costs of raw materials, freight and labor, as well as the impact of rising interest rates, foreign exchange headwinds, and the higher tax rate. Before I review our financial performance for the quarter, I wanted to spend a moment discussing the non-cash impairment charge that we recorded related to the Hillrom acquisition. When we purchased Hillrom, we valued the business based on anticipated cash flows, Baxter’s prevailing cost of capital and market EBITDA multiples at the time of the transaction. As Joe mentioned, the primary reason for the write down was due to changes in external factors that have occurred since the acquisition date, specifically the significant increase in interest rates we have seen and the reduction in market-based EBITDA multiples. As we evaluated these environmental factors and coupled them with the supply chain impacts we've incurred, which we carry forward in our projections, we deemed it appropriate to reduce the carrying value of goodwill and certain other intangible assets associated with Hillrom. I want to reinforce Joe's earlier comment that we continue to see tremendous potential for our combined portfolios. We have accelerated our cost synergy targets, which continue to track ahead of our expectations, and our commercial leaders are driving actions to unlock the growth of the combined company. Now, I’ll walk through performance by our regional segments and key product categories. Note that constant currency growth is equal to operational sales growth for all global businesses and Baxter’s three legacy geographic regions. Starting with sales by operating segment, sales in the Americas were flat to the prior year on a constant currency basis. Sales in Europe, Middle East and Africa grew 3% on a constant currency basis, and sales in our APAC region decreased 2% on a constant currency basis. Quarterly sales in that region reflected a slowdown in growth in China, due to the country's zero COVID policy, which we estimate impacted sales by approximately 10 million in the quarter, as well as the anticipated impact from various value-based procurement initiatives being implemented in the region. Moving on to performance by key product category, global sales for renal care were $942 million increasing 4% on a constant currency basis. Performance in the quarter was driven by solid growth in our PD business, where we observed an increase in PD patients globally. PD growth was augmented by two discrete items totaling approximately $20 million. Performance in the quarter was partially offset by lower in-center HD sales partially due to HD monitor supply challenges due to component availability. Sales in medication delivery of 725 million were a similar level to prior year sales on a constant currency basis. Within the quarter we observed strong demand for products in our IV therapy portfolio. This growth was more than offset by lower infusion system sales, as component availability remain challenged, coupled with the large hospital system order in Q3 in 2021, which created this difficult comparator to the prior year. Pharmaceutical sales of $525 million declined 3% on a constant currency basis. Performance in the quarter reflects declines in our global generic injectables portfolio due to continued increased competitive activity, which were partially offset by increased sales of inhaled anesthesia globally. Moving to clinical nutrition, total sales were $231 million increasing 4% on a constant currency basis. Performance in the quarter was driven by demand for our broad multi-chamber product offering, partially offset by supply-related challenges for our vitamins. Sales in advanced surgery were $247 million advancing 6% on a constant currency basis. Growth in the quarter reflects recovery of elective procedures relative to pre-COVID levels. Surgical volume recovery was strong in Europe, while procedures in the U.S. and APAC region came in slightly below our expectations. Within the U.S. we observed a slow start to July, with an uptick in August and September. Sales in our acute therapies business were $158 million declining 9% on a constant currency basis and reflecting a tough comparison to the prior year where we had experienced elevated demand for CRRT given the rise in COVID cases. BioPharma Solutions sales in the quarter were $172 million declining 10% on a constant currency basis, and reflecting a step down in sales of COVID vaccines compared to the same period last year. COVID vaccine sales for the quarter totaled approximately $30 million. Hillrom contributed 735 million in sales to the quarter, which included 380 million in sales and patient support systems, 279 million of sales in front line care and 76 million of sales in global surgical solutions. Hillrom declined mid-single digits on a constant currency basis as compared to Q3 2021 when the company was a standalone entity. Performance in the quarter reflects a difficult comparison to the prior year period, as well as the impact of the semiconductor supply constraints we've discussed. We continue to experience record levels of backlog for the legacy Hillrom business. Our order book remains strong and to date, we have not seen any significant cancellations from customers. As mentioned last quarter, we remain somewhat cautious on capital spending, as hospitals continue to assess their budgets in light of the current market environment. Moving through the rest of the P&L, our adjusted gross margin of 42.9% decreased by 110 basis points over the prior year, reflecting increased cost of goods sold primarily driven by the factors we've discussed around inflation, freight and supply constraints. Adjusted SG&A of 821 million represented 21.8 as a percentage of sales, an increase of 200 basis points versus prior year, driven by the addition of Hillrom as well as higher freight expenses. As mentioned earlier, we continue to tightly manage our G&A base. Adjusted R&D spend in the order of $148 million represented 3.9 as a percentage of sales, a decrease of 10 basis points versus prior year. Both adjusted SG&A and adjusted R&D reflect a benefit from lower bonus accruals under our annual employee incentive compensation plans which is directly tied to Baxter's performance. These factors resulted in an adjusted operating margin in the quarter of 17.2%, a decrease of 300 basis points versus the prior year. Adjusted net interest expense totaled 104 million in the quarter, an increase of 72 million versus the prior year driven by higher outstanding debt balances related to the acquisition of Hillrom. Adjusted other non-operating income totaled 2 million in the quarter compared to a 12 million loss in the prior year period, driven primarily by amortization of pension benefits. The adjusted tax rate in the quarter was 23.8% as compared to 14.8% in the prior year period. The year-over-year increase was primarily due to the mix of earnings in the quarter, which has changed following the Hillrom acquisition. In addition, during the third quarter of 2021, the company recognized the benefit in its effective tax rate from a discrete item due to a reserve release resulting from a favorable tax ruling. And as previously mentioned, adjusted earnings of $0.82 per diluted share declined 20% versus the prior period. Let me conclude my comments by discussing our outlook for the fourth quarter and full year 2022, including some key assumptions underpinning our updated guidance. We have adjusted our full year earnings per share outlook primarily to account for a strengthening U.S. dollar and the resulting foreign exchange headwind, increased interest expense assumptions given rise in interest rates, and a higher expected full year tax rate due to earnings mix. As discussed, we anticipate electromechanical component availability will remain challenged in the fourth quarter and into 2023, which will continue to hamper sales growth for select businesses, including medication delivery, front line care and patient support systems. For the fourth quarter of 2022, we expect global sales growth of mid-to-high single digits on a reported basis, mid-teens on a constant currency basis and approximately flat on an operational basis. And we expect adjusted earnings, excluding special items, of $0.92 to $0.99 per diluted share. For full year 2022, we now expect global sales growth of 17% to 18% on a reported basis, approximately 23% on a constant currency basis, and low single digits operationally. Moving down the P&L, we expect full year adjusted operating margin to be between 17% and 17.5%, reflecting the impact of all of the various dynamics we've discussed today. For the year, we now expect interest expense to total approximately $400 million, given rate increases and adjusted tax rate of approximately 20% and a diluted share count of 508 million shares. Based on these factors, we now expect 2022 adjusted earnings, excluding special items, of $3.53 to $3.60 per diluted share. With that, we can now open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions]. I would like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. Our first question comes from the line of Travis Steed of Bank of America Securities. Your question, please.
Travis Steed:
Hi. Good morning, everybody. Thanks for taking the question. I guess, Jay, just to start out, bridging the gap on the changes of the 2022 guidance would be helpful, but more importantly we'd love to see if you would provide some initial thoughts on 2023 if you'd commit to some level of earnings growth off the 3.60 for next year and still at 75 basis points of margin expansion as before?
James Saccaro:
Sure. Travis, I missed the first part of the question.
Clare Trachtman:
So the 2022 bridge for the EPS guidance.
James Saccaro:
Okay, great. So yes, let's walk through the different pieces. I think all of these are starting to set up well for 2023. But it starts with the third quarter. Overall, Q3 came in largely in line with our expectations. We were pleased to put $0.82 in the books. And really the commercial operations were off a couple of cents, in large part related to shortfalls in sales driven by supply constraints in certain areas. The tax rate and FX came in a little bit worse than our expectations. But offsetting this, and I think this is important to know, was better than anticipated performance in our supply chain. As you know, this has been an area of extreme volatility for us as we've navigated the complicated macro environment. So it was really nice to see our supply chain team deliver in the quarter and set the stage for the fourth quarter and beyond. Now, as we go to Q4, with respect to EPS, we now expect roughly a $0.05 headwind from foreign exchange, tax and interest relative to our previously issued guidance. On a year-over-year basis, these items impact us roughly $0.15. And so we expect a continued supply constrained environment on the sales line. This is an area that we're navigating very carefully. But overall, the real driver in the fourth quarter relates to this headwind from these non-operational items. So now as we transition to next year, what I previously shared with you all is a template which says 4% to 5% compounded sales growth, minimum 75 basis points of operating margin expansion in a given year. As we thought about 2023, the sales growth will come in on the lower end of the range closer to 4%, in large part because of lower levels of COVID vaccines emanating from our BPS business. But as it relates to margin, through continued focus on costs, through execution of our Hillrom synergies, along with a real and significant impact of value improvement programs in our plans, we can confirm at this point the 75 basis points of margin expansion. Now, of course, we're going through our plan as we speak. And I will tell you that the world has been extremely volatile. But it's very nice to be able to share that with you at this point in time. And a lot of this comes down to stability coming out of our supply chain organization. Now the one thing I will say is part of the reason we're not seeing accelerated sales growth is as we look at 2023, there are continued headwinds from a supply constraint standpoint. So we're going to expect to see component challenges through parts of 2023 and other areas. And so from a supply and semiconductors will continue to be challenging as we move through next year. So that's going to be something that we have to live with for a while. We're hoping that rehabilitates over the course of next year and certainly provides a tailwind as we move to 2024. Now, moving to some other items, as we look at foreign exchange, that's going to be fairly neutral to operating margin, but it will be roughly $0.15 headwind year-over-year, and a lot of that will be concentrated in the first half of the year. Because we've seen rates really deteriorate in Q3 and Q4. And then from an interest expense standpoint, we're looking at approximately a $0.15 headwind. So this is a – before that - and the interest rate will start to become a tailwind later on in this long range plan. And so I think for us as we sit here today, we feel really good about the prospects going into 2023. And so we've been dealing with a lot of volatility, and I think really putting controls in place to navigate some of that. And I think our ability to confirm that 2023 is an important step as we move forward. Joe, I don’t know if you'd want to add anything to that.
José Almeida:
No, you have covered it all.
James Saccaro:
Thanks, Travis.
Travis Steed:
Thanks. A quick follow up just to make sure, I think putting that all together, it still sounds like earnings can be up next year versus 2022. And on the 75 basis points, what’s assumed on the $1 billion inflation, assume that’s stable and does it assume Novum IQ?
James Saccaro:
So as it relates to EPS, I think there's a little bit of EPS growth as we look at it based on some of the non-operational items impacting us, but we do expect some level as we look at it. And then I'm sorry, I missed the second part of your question. I couldn't quite hear that.
Travis Steed:
So the 75 basis points, what’s assumed on inflation in Novum IQ.
James Saccaro:
Okay. So from an inflationary standpoint, I think we're looking at kind of consistent levels today. So we're not anticipating significant price up in any commodities. We're anticipating some slight improvement in certain areas, but also some negatives related to utilities, for example, in Europe. Joe, you want to address the Novum question.
José Almeida:
I will. So we always preface any conversation on products which are not approved that we do not, I speak on behalf of the FDA. We believe that we have successfully resolved the issue that was the primary subject of the FDA’s last additional information request. We referenced this on the Q2 call. We will submit data and we believe demonstrates successful resolution of the interest as part of our response. Since that time, we have identified additional software changes we're planning to implement proactively in consultation with the FDA. We're in process of updating our response. And because of that, we're doing everything we can to submit our response as quickly as possible. While we hope that to be in a position to submit those responses by late Q4, it may spill over into a couple of weeks of January, maybe half January. So we're doing the best we can to pull this together. We are very comprehensive in how we answer the FDA. We work very collaboratively with them. And we want to make sure that the product has all the information before we send to them. So there's no further request for information. That's our objective.
Travis Steed:
Really helpful color. Thanks a lot for taking the questions.
José Almeida:
Thank you.
Operator:
Robbie Marcus of JPMorgan is on the line with a question. Please state your question.
Robbie Marcus:
Great, thanks. Maybe I could start off on capital allocation, how you're thinking about the business mix. We saw some reports in the news about potential sales or divestitures of some of the assets within renal that were low to no growth and low to negative margin. Maybe just give us a sense of how you're thinking about your portfolio here in the environment to get deals done, whether it's additive or subtraction?
José Almeida:
Robbie, good morning. We are actively looking -- first of all, I'm not going to comment on the rumors from the market. But I'm going to tell you what we are doing. We are actively looking at portfolio by the company. We will be ready to speak about that by early January, not at the moment. But I can tell you some bits of information what is going on. We are looking at every opportunity at the company to focus on the vision that we had set forth during our Investor Day back in May, which is connected care, the areas that will drive higher gross margin, areas of higher top line growth, software and the ability to be ahead of connecting the dots for clinicians and institutions. So when we look at that, we're looking at our portfolio. Some products will make sense for us to retain, some products will not. So we are looking to optimize our portfolio. We are in about three quarters of the way there in terms of understanding and we will make a decision with our Board of Directors and then come forward with what we think is going to be the new portfolio of Baxter going forward, as I said early January. So I want to just also underscore that any portfolio movement which implies sale of assets or any kind of transaction always takes into account number one, creation of shareholder value. It is never secondary. It is always primary and that is creation of improved return on invested capital with accretion of value through discount cash flows. So we're going through this process. It is being very, very intense. And we hope to have the new set of the businesses going forward and what we're going to deal with, and how we're going to suffice our mission and vision by as I said early January.
Robbie Marcus:
Great. Maybe just as a follow up, Jay, you talked about something like $100 million, and I guess theoretical lost sales in the quarter from supply chain issues, but also about how the supply chain was a positive in the quarter and helped the margins. How should we think about those two reconciling next year? And in that 4% growth and 75 bips of margin, how should we think about what's being resolved in the backlog and how much improvement we'll be seeing in the supply chain? Thanks a lot.
José Almeida:
Robbie, I'll let Jay really comment on the numbers. I'll tell you about a couple of aspects. While we are seeing supply chain is performing well against the very difficult sets of circumstances, as we said, labor inflation and material inflation has been significant to Baxter, and they're doing a great job navigating through that. Our procurement group is doing a great job getting the products to us. What is happening is there is a significant amount of backlog and backorder for the company on products depending on semiconductors. And it's not one company or two. It is several. It's a plethora of companies that produce products for us, and we source semiconductors from them. A couple of things that we are doing that I feel are more confident that throughout 2023, the situation will be to keep more will be better is that we are developing long-term relationships directly with the manufacturers of the chips instead of going to distributors or going directly to board assemblers. The second thing is, the amount of decommit that companies are coming forward during the quarter makes sometimes very difficult for us to predict what we can assemble and ship at the end of the quarter is getting better into 2023, as our supply chain now has a full view of commitments into 2023 of what we need to make our growth. Business has been very effective by the use of front line care, which is our business under our acquisition Hillrom, our PSS, patient support systems, the ability to make more funds, we have very good demand for our current pump, our SIGMA Spectrum pump, we can’t make more because we’re missing two or three key components that are in shortage in the marketplace due to high demand from other sources, in the automotives and other areas. So what I can tell you is we are doing everything we can and the supply constraint is really what has impacted Baxter’s performance in the top line. Now VIPs, our value improvement programs, have been a significant driver of cost reduction for us in our operations group. I’ll pass on to Jay to give you more clarity on numbers that you asked.
James Saccaro:
Sure. Robbie, as we move to next year, we continue to assume a constrained top line due to semiconductors and availability of other components. So that does not fully resolve next year. We do expect to see some improvement and no deterioration relative to today's level. But we will live with this throughout most of next year. As we think about the margin improvement, really that's emanating from a significant improvement in value improvement programs, things like automation initiatives that we have going on in the plan. And that really helps support the 75 basis points improvement that we've discussed. We'll see lower than expected freight. And we are only targeting roughly 75 basis points or in excess of 75 basis points, because we don't have a big commodity easing assumption in the numbers that we're sharing. To the extent that materializes, certainly that could be an upside, but we're not banking on that at this point. We're banking on living in a challenging commodity world for 2023 for the most part, along with a supply constrained world. Those two items are very big uncertainties. I'm hopeful that we take a conservative decision and those break our way over the course of the year. But we'll have to watch that very carefully.
Robbie Marcus:
Great. Thanks a lot.
James Saccaro:
Thank you.
Operator:
Rick Wise of Stifel is on the line with a question. Please state your question.
Rick Wise:
Good morning, Joe. Hi, Jay. I thought I'd focus on Hillrom which you described as down mid single digits. First, I wanted to understand is the decline -- if I think of Hillrom maybe as a mid single digit-ish kind of grower, it was a decline -- to what degree was it integration bumps with Baxter, to what extent was it components? Was it all supplying components? I’d just like to frame that. And Joe, when do you think -- based on what you know today, Hillrom could return to being Hillrom for you? Is it going to take into '24? Do you think it's second half of next year? And then I have a follow-up question also related to Hillrom.
José Almeida:
Rick, I'm going to have Jay answer that. And I'll close answering the question, but Jay should start.
James Saccaro:
Yes, sure. Overall, Rick, Hillrom did decline in the quarter, roughly 5% and was down roughly 1% year-to-date. And what's interesting is that the demand for Hillrom products remains incredibly strong. We've seen historic levels of backlog in our front line care business. We've seen backlog in our PSS business as well. So as we look at the portfolio of products, the innovation, the complementarity with the Baxter portfolio, we're incredibly excited. And the environment for their orders has been fairly strong throughout the year, it's been fairly consistent. But we've had severe supply constraints. And so without supply constraints, Hillrom would have been probably flat in the third quarter, and on a year-to-date basis would be growing close to mid single digits, which I would characterize as kind of where we would have hoped it would have been. But with these supply constraints that have been extremely challenging, in particular, in the case of front line care, it's been hard to get to the sales level that we hoped for. So Joe, maybe you want to add to that.
José Almeida:
Yes. Rick, we have done as a company a very thorough integration job here. Our synergies are coming higher, much higher than we had estimated in the first year of the integration. Our supply chain people had to come into Hillrom and do a lot of work to reestablish lines of supply into the business. When the semiconductor prices hit, Baxter was better prepared to handle the Hillrom loss. And what we did is we put our best to handle issues, primary front line care. The supply chain really came through for us and today is doing a much better job as a matter of fact. We had better performance that we planned in front line care in the third quarter, because we're able to get the products out of the door. We also have extremely competent management in both businesses. We have Reaz Rasul, the Head of Front Line Care. We have Andy Frye, the Head of GSS and PSS. So we are very confident in the business we purchased. The business has the ability to perform. We will fix the supply chain issues as we're currently doing. And we'll be able to get back the Hillrom that we made assumptions to buy. As you heard from Jay, our growth would have been ex supply chain what we had expected to be. So I think Baxter brought to Hillrom a combination of great portfolio. Hillrom brings with great management and discipline than Baxter has to replace the team that was there and was able probably to do in the long term a better job of this combination.
Rick Wise:
Got you. Maybe I'll change the topic, but for my follow up you talked about passing on the cost pressures and you're in the process or you're well along signing new price agreements. Can you help us think through -- is this 100% of your business? How do we think about the impact and just even touchy feely, Jay, how do we sort of factor that into our thinking as we look ahead to '23 that you could have another 50 basis points of price on half the portfolio? Any extra depth or color perspective would be great. Thank you so much.
José Almeida:
Rick, they are great questions. So we're going to split Jay and me here. But let me start by saying that we do not comment in pricing on general course of business. But as Baxter has taken so much into input costs that went up significantly in the last two years, we are very focused in recouping a portion of that, if all possible. So we already had, as I mentioned, price actions throughout the year. But I would say that beyond what I have said, I'm not going to comment on any specifics about pricing discussions or agreements with our customers. But I can say to you, in my opening remarks, as I said, we strongly prefer to build on our long-term relationships with our customers to reach agreements on how best to share an increased cost of delivering products to them, which causes a significant amount of more money, because the cost of oil, the cost of logistics, cost of raw materials, cost of labor and everything that goes in. We have made significant process -- I’m sorry, I’d rather say we have made significant progress towards that end. But to the extent that we do not reach agreement with any customer, we will, of course, continue to evaluate the options in front of us to recover the increased costs of our delivering and on our mission to serve patients. That's very important to us, because Baxter -- if you ask any of our 65,000 employees, it’s all about the mission of the company. It is an incredible company. I came here seven years ago almost to the date and I’m continuing to be impressed by the dedication of our employees. But we took a significant amount of cost increase in the last two years in our input costs and supply chain has done a great job trying to defray that and offset, but as you can see by our margins, it’s not possible. We would like there to be a partnership with our suppliers that continue to understand that for us to deliver what we're delivering to them and the innovation in the products, we need that partnership to continue on. So I'll end there and pass on to Jay.
James Saccaro:
Sure. Rick, I don't want to get into too much detail on specifics around price and what pieces of the portfolio and so on. But it's safe to say we expect price will be a positive contributor to our numbers next year in 2023. The other thing I would say is it is something that we look at in every single market, in every product line. Why? Because in every one of our areas, we have been challenged with very high levels of inflation, very high levels of incremental costs. So from our perspective, we really have to challenge every sale to make sure that we're garnering enough profit from it and offsetting some of the significant costs that we've had.
Rick Wise:
Thank you very much.
James Saccaro:
Thanks.
Operator:
Pito Chickering of Deutsche Bank is on the line with a question. Please state your question.
Pito Chickering:
Good morning, guys. Thanks for taking my questions. You mentioned that you haven't seen any cancellations due to hospital CapEx pressures and that the backlog remains full here. How do you look at new orders on that backlog versus supply issues sort of keeping that backlog high? And are you seeing any impact to new sales versus stroke levels as hospitals struggle with lower margins and lower cash flows?
José Almeida:
We have seen sporadic cancellations of orders in institutions that are small and have labor issues in implementing CapEx projects that sometimes are large. But for the most part, we haven't seen that wave of retraction of capital programs. As a matter of fact, if we could make 3x, 4x more infusion pumps, we would have sold I believe those pumps. If we had made twice as many of our monitors, we would have sold the monitors. So it becomes a little different when it comes to beds. Beds are a larger implementation. And software, software like nurse call buttons, software like phones becomes more elaborate. Those are the ones that sometimes we see postponement. Not because the price for more, because of the labor, not because of the cost, I should say, but more because of the labor. So at the moment in time, I don't believe we're seeing a retraction in the capital market. We're seeing a high cost of labor for hospitals and a shortage of labor that makes difficult for them to undertake large programs sometimes.
Pito Chickering:
Okay, fair enough. And then a follow up on the supply chain, can you breakout the $100 million of impact to revenues in 3Q on semiconductors versus the other raw materials, out of curiosity, what are the other raw material shortages? And then on the semiconductor side, the macro data shows that the pressure peaked sort of into 2Q, has been improving sort of during 3Q. So curious if you see any semiconductor shortage improvement from July versus October?
James Saccaro:
Sure. So a couple of things I would say related to this question. First, the vast majority of the sales impact relates to semiconductors. I would say that over 90% of the challenges that we've faced relate to semiconductors. There are other select areas where we have seen meaningful impact. For example, in our nutrition business, there are certain ingredients and vitamins that we're unable to secure due to supplier challenges. And that's had an impact as well, but the majority relates to semiconductors. Now, as it relates to your semiconductor question, the type of semiconductor used in medical devices is a little bit different than standard semiconductors that are used in the highest tech products available today. And so while there has certainly been a curtailment of demand for some of these consumer products, the size of the semiconductor that we use does not benefit from this curtailment of demand and normalization of supply. And I would even say, for some semiconductor manufacturers, they are seeing inventory levels build of the super thin semiconductor. And so we just have not yet seen this normalize in our case where we are all hands on deck working to secure the components that we need. And we'll continue to do that. But this is something that, as I've said, we don't have a pathway for this getting resolved in the immediate term. Joe, I don't know if you'd like anything to that.
José Almeida:
More so what we're doing is because we're seeing this issue with the semiconductor manufacturers, not all chips are created the same. So you hear Intel sales are down quite a bit in PCs. This is good news for our chips, it's not. We don't use the same chips at all. We actually use very little, very few chips from Intel, for instance. Our chips are IoT, Internet of Things. They are much thicker and they are chips that are using better software. So that demand -- by the way, some of these chips are about 12% of the semiconductor industry output. So because of that, we work very close now directly with companies. We're being very successful with few companies who are working very well with us. But what we also do is start a redesign program for our boards. We have identified critical components and we have started a process in our Reno business to redesign 30 of our boards with one of our suppliers and we have front line care programs started by now to replace six key semiconductors that may be constrained in the next 18 months with a redesign of boards. So redesign of boards is not as simple as everybody think. It is not a plug and play, because the form and fit and function of the semiconductors change. We have to redesign the board. We have sometimes to revalidate and clinically revalidate the board. So saying just that we're redesigning boards [indiscernible] is not. It is all hands on deck is finding new ways to deal with our current suppliers, it is buying directly from them, buying through brokers throughout the world, inventory there is available as well as redesigning the boards so we can have alternates that can be put in, in the future. So we became a much more sharp company when it comes to semiconductors and boards and this process in fact is very painful. We had to acquire significant expertise in this area. It’s going to pay dividends in the future.
Pito Chickering:
Okay, great. And Joe, just to sort of follow up on the first question just to make sure I have this right. You're saying that new orders for capital equipment in the last 90 days in 2022 is in line or better than it was at this time in 2021 for new orders? Thanks so much.
José Almeida:
No, I'm saying that in 2021, this time of the year and last year in 2021, we were not -- we did not own Hillrom, but their orders were extremely high. Primarily, the rentals were extremely high because of COVID, okay. What I'm saying to you is we have not seen our book of business be affected by capital constraint. Now and going forward, what we see is delays in some accounts due to labor shortages in primary large installations. But we have continued dialogue with everyone about our orders. As a matter of fact, I'm planning to see in the first quarter next year a large installation that we're going to probably be doing in hospitals in the U.S. So I don't see -- we don't see today a significant change in the order pattern in capital. That's what I meant. I'm not comparing to 2021, which has significant high rental revenue into Hillrom, because the COVID effect primarily as you know coming out of the summer is going to Omicron in October and November of last year.
Pito Chickering:
Great. Thanks so much, guys.
José Almeida:
Thank you.
Operator:
Joanne Wuensch of Citi is on the line with a question. Please state your question.
Joanne Wuensch:
Thank you for taking my question. Briefly, it sounds like you have significant back orders and backlogs. What is happening to those orders? Are they being fulfilled by somebody else? Are they just piling up so that at some stage in the future, they get met? And I'll toss my second question at the same time? It sounds like you're also working to get better expense synergies out of Hillrom. Is there a way to quantify what you think those may be now versus what you thought they would be before? Thank you.
James Saccaro:
Sure. So from a backlog standpoint, overall, we are seeing those orders for the most part stay in place. We're not seeing others take share as a result of these constrained supply environment that we have in place. Frankly, a number of manufacturers have similar challenges. Now, the question is how long will those orders remain? In some cases, if they're short-term needs, then those are things that perhaps might be impacted. But as we think about longer term for the most part, I think that these sales will represent some level of opportunity in the future. As it relates to Hillrom, we feel very good about where things are trending with the exception of the constraints that we have in place. And so we highlighted increased incremental cost capture at the May Investor Day and we're still trending along those lines, very much in line with that with increasing confidence. I think it's important because we have some big step ups as we move to 2023 and 2024 in terms of incremental cost synergies. What's great at this point is, as we sit here today, we feel we have clear line of sight and continue to make progress towards those numbers. So I think, as far as that goes, it's a very good story.
Joanne Wuensch:
Thanks.
James Saccaro:
Thank you, Joanne.
Clare Trachtman:
We have time for one more question.
Operator:
We have Joshua Jennings of Cowen on the line with a question. Please state your question.
Joshua Jennings:
Good morning. Thanks a lot. Joe, I wanted to ask just about connected care initiatives and just how -- anything you can share just on progress post the Hillrom acquisition on developing these connected care technologies or programs? And how should we be thinking about updates and tracking the progress? And then maybe just a second question for Jay, just thinking about the target of getting down to 2.75x net leverage in 2020. Just help us think through some of the puts in takes and your confidence level in terms that you are on pace to hit that target? Thanks for taking the questions.
José Almeida:
Josh, good morning. So we are seeing several programs where we are working across divisions in the connected care. We established a new group that is actually under Andy Frye, one of our executives who is also the Head of GSS and PSS, patient support systems. And we are seeing several programs from basic creating unified portals to access EMR systems in hospitals, to features that can be enabled by commonality and connecting the devices. So there's a lot going on. I think we should give an update to investors probably in the first quarter of 2023 about where we are with this connected care programs. So we have a brand new group that is now across Baxter that is looking at this and creating opportunities. So we're making good progress in this area. I’ll pass on for Jay for answering the other question.
James Saccaro:
Sure. As you know, we're really focused on maintaining solid investment grade credit ratings. We define that as BBB. So the rating that we currently have is one that we're maintaining. And in order to do that, we want to make very good progress towards the 2.75 net debt to EBITDA which is our objective. I would say that from a cash flow standpoint, this year has fallen short of our expectations. And I would say that, of course, we've had some challenges on the income statement. But as we look at inventory, we've had a fairly substantial inventory build over the course of the year, which is interesting, because of what's happening is you have a pump, which is lacking one critical component. And so you're unable to sell that pump until you get that critical component. For example, we also saw extended shipping lane times over the course of the year and increases in the cost of our inventory due to our suppliers. And so for all those reasons, we've had a very challenging year from an inventory standpoint. I would note that in the third quarter, we did see a decline in inventory. And we are expecting a fairly substantial improvement in free cash flow in the fourth quarter, as is typically the case. But here's the interesting thing. While net income growth next year is low, free cash flow growth we expect to be substantial. And so we're still finalizing our plans. But you're going to start to see a very significant acceleration of free cash flow growth as the inventory situation normalizes over the next one to two years. And that will really support some of the work that we're doing to get to 2.75x net debt to EBITDA which again is a clear focus for our entire management team.
Joshua Jennings:
Thanks a lot.
Clare Trachtman:
Thank you very much.
Operator:
Ladies and gentlemen, that is all the time we have today for questions. This concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Second Quarter 2022 Earnings Conference Call. Your line will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin your conference.
Clare Trachtman:
Good morning, and welcome to our second quarter 2022 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer, and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's second quarter 2022 financial results and our full-year financial outlook for 2022. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the third quarter and full-year 2022 and our 2022 to 2025 long range plans, the recent acquisition of Hillrom, new product development, the potential impact of proposed pricing actions, business development and regulatory matters contains forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. On the call this morning, we will be discussing operational sales growth, which adjusts for the impact of foreign exchange and the acquisition of Hillrom. Now, I'd like to turn the call over to Joe. Joe?
José Almeida:
Thank you, Clare. And good morning, everyone. We appreciate your joining today's call. I will begin with an overview of the macroeconomic factors that have and will continue to impact our performance in 2022. I will then provide some commentary on the second quarter. Jay will take a closer look at our financials and outlook, after which we will open up the lines for your questions. I want to start by thanking many of you for joining us at our 2022 investor conference, whether in person or virtually. Our goal was to share our strategies that drive leading edge healthcare innovation, create compelling value for patients, clinicians, employees and investors. It was also a great opportunity to showcase how the acquisition of Hillrom is helping power the next phase of our transformation journey by fueling connected care innovation, expanding the global reach of our combined portfolio and growing our presence across the continuum of care. And our innovation hall offered a firsthand look at how this momentum is already coming to life in tangible ways in hospitals, homes, and physician's offices worldwide. With respect to our current environment, overall demand remains strong across our combined portfolio. At the same time, we experienced significant back orders and backlogs for certain products due to ongoing supply chain challenges, like those impacting industries globally. This is affecting access to a variety of raw materials and components, including electromechanical components using many of our products. Securing these necessary components has resulted in incremental spot purchases with costs that are meaningfully above and beyond what we had anticipated earlier this year. In addition, the delays in receiving many of these materials and/or components have forced unplanned temporary shutdowns in our manufacturing facilities, which negatively impact our absorption rates. Taken together, the negative impact of these increased spot purchases and temporary shutdowns will primarily be realized in Baxter's results during the second half of the year. In addition, ongoing inflationary pressures coupled with increased freight expenses, primarily driven by the rapid rise in diesel and jet fuel prices has created incremental pressures on the cost of doing business for the company. As the quarter progressed, we saw both diesel and jet fuel prices diverging from crude oil, increasing at a much faster pace. Historically, changes to both diesel and jet fuel prices have trended in line with the degree of change seen in crude oil prices. And with our mission to save and sustain lives, we will never compromise on doing what is right to address the urgent needs of the patients and clinicians that depend on us. This means utilizing more expedited shipping channels than anticipated as we work relentlessly to ensure products get to where they are most needed. It also means carrying higher levels of inventory than normal as many of our raw materials and finished goods are held up in transit, given ongoing global supply chain challenges. At our investor conference, you will have heard some of the significant actions we have been implementing in response to unprecedented challenges. Our actions reflect the unrelenting commitment to operational excellence that has been a signature of our multi-year transformation. This tenacity is helping us navigate and mitigate near-term pressures to the degree possible as we stay focused on driving long-term value and growth for our shareholders and other key stakeholders. As always, we remain committed to ensuring we have the optimal cost structure. And to that end, we are actively identifying opportunities to further optimize our expense base to enhance performance, including pulling forward certain Hillrom cost synergies. Given the significant increase in costs that we have absorbed and continue to incur in the production and delivery of our portfolio of life saving products, we are preparing to pass through a portion of this incremental cost to our customers in the second half of 2022 and beyond. Shifting now to our second quarter financial performance, which is the second full quarter since the close of our Hillrom acquisition. Sales for the quarter grew 21% on a reported basis and 26% at constant currency rates. Legacy Hillrom sales contributed $750 million to our total $3.7 billion in sales for the second quarter. Excluding the impact of Hillrom and foreign exchange, second quarter sales increased 3% on an operational basis. On the bottom line, adjusted earnings per share of $0.87 were up 9% year-over-year. Growth on both the top and bottom line continues to be constrained by the macroeconomic factors shared previously. That said, performance across our businesses in the second quarter reflects our overall positive trajectory amid the broader state of the market demand. This includes solid growth at constant currency rates in renal care, medication delivery, pharmaceuticals, clinical nutrition, and advanced surgery. With the specific regard to pharmaceuticals, I want to flag that we are continuing to experience price erosion in the US due to generic competition, as well as some pressure from supply constraints and a shift in demand for inhaled anesthesia. As we noted at our investor conference, we are continuing to emphasize differentiated generic formulations and packaging, as well as international opportunities to drive growth for this business moving forward. I'm also pleased to share that Alok Sonig joined us a few weeks ago as our new president of pharmaceuticals. Alok brings to Baxter more than 25 years of experience in the life sciences industry, most recently serving as the US CEO and Global Head of Research and Development in Biosimilars at Lupin. We are excited to welcome Alok to the team and look forward to realizing the benefits of the experience he brings to this business. Both Acute Therapies and BioPharma Solutions declined mid-single digits year-over-year at constant currency rates, reflecting a challenging comparison to last year due to pandemic-related sales for both of these products categories. As compared to Q2 2021 when our newly acquired Hillrom business was a standalone company, its sales rose low-single digits at constant currency rates. This demand reflects mid-single digit growth in frontline care, offset by softness in patient support systems and global surgical solutions. Sales in all three of the legacy Hillrom businesses have been impacted by significantly higher-than-normal backlogs reflecting challenges in accessing components as well as delays in certain product installs because of hospital staffing concerns and challenges. On a positive note, our integration process continues to proceed rapidly with key milestones on track or ahead of expectations. And as you saw at our investor conference, we are moving swiftly on our opportunities to expand access across our combined portfolio and embrace heightened potential in connected care. Now looking ahead, given the factors I outlined earlier in my remarks, external conditions, expectations and the market's ability to project trends continue to evolve rapidly, both upstream and downstream, even in the months between our investor conference and today, and this is impacting our business. As such, we're adjusting our guidance for the balance of 2022 as indicated in our press release. Jay will share additional commentary in his remarks. At the same time, we continue to foresee long-term stabilization of conditions. Given this anticipated stabilization and our updated 2022 guidance, I want to reiterate my confidence in our long-term outlook and prospects as provided in May. Baxter has proven its resilience time and again over the course of its 90 plus years. Our durable portfolio focused on essential care and vast global footprint remain the strategic core of our underlying strength and stability. The acquisition of Hillrom has expanded the scope of our essential portfolio and has also created additional opportunities in connected care that are vital to accelerating our future impact as a healthcare leader and innovator. Finally, I hope that you have had a chance to review Baxter's annual corporate responsibility report issued in June. It highlights our progress toward our 2030 corporate responsibility goals, which reflect our commitment to empower patients, protect our planet, and champion our people and communities. If you have not yet had the opportunity, you can find the report posted on our website, baxter.com. Now I'll pass it to Jay to share more on our performance and outlook.
James Saccaro :
Thanks, Joe. And good morning, everyone. As Joe mentioned, we're continuing to navigate a dynamic and ever-changing macro environment. This near-term volatility has created certain challenges for our business, and led us to lowering our full-year outlook. But we're committed to working through these headwinds and delivering on our long-term commitments off this new base. Most importantly, demand for our Baxter products remain strong and our integrated supply chain and commercial teams are working tirelessly to get products in the hands of our customers and patients to fulfill our mission. Turning to our financial performance. Second quarter 2022 global sales of $3.7 billion advanced 21% on a reported basis, 26% constant currency, and 3% operationally. As the US dollar strengthened over the quarter, foreign exchange negatively impacted reported sales by approximately 500 basis points. And as Joe mentioned, sales within the quarter were constrained due to lack of both raw materials and component availability, particularly as it relates to electromechanical components. Second quarter sales were also impacted by a lack of hospital access, which is needed to install select products, particularly in our patient support systems product category. We estimate these constraints negatively impacted sales by over 300 basis points in the quarter. Compared to the prior-year period, operational sales grew 3%, reflecting a gradual recovery in hospital admission rates and elective surgeries, strength in our medication delivery and nutrition businesses and solid growth in PD. On the bottom line, adjusted earnings increased 9% to $0.87 per share, falling within our guidance range of $0.86 to $0.89 cents per share. Now I'll walk through performance by our regional segments and key product categories. Note that constant currency growth is equal to operational sales growth for all global businesses and Baxter's three legacy geographic regions. Starting with sales by operational segment, sales in the Americas increased 2% on a constant currency basis. Sales in Europe, Middle East and Africa grew 6% on a constant currency basis, and sales in our APAC region increased 1% on a constant currency basis. Sales in our APAC region were negatively impacted in the quarter by the resurgence of COVID cases in the region, particularly in China, which we estimate was an impact of approximately $15 million. Moving on to performance by key product category, global sales for renal care were $931 million, increasing 2% on a constant currency basis. Performance in the quarter was driven by solid growth in our PD business where we observe both a sequential and year-over-year improvement in global patient volumes. This growth was partially offset by lower in-center HD sales, partially due to HD monitor supply challenges due to component availability. Sales and medication delivery of $710 million increased 4% on a constant currency basis. Growth in this business reflects strong global demand for our products and our IV therapy portfolio. This was partially offset by lower sales in APAC, driven by COVID-related lockdowns in China and the resulting impact on utilization. This product category was also impacted by lower sales of large volume pumps in the quarter due to constrained demand from the lack of component availability. Pharmaceutical sales of $528 million grew 3% on a constant currency basis. Performance in the quarter was driven by increased sales internationally for inhaled anesthetics, offsetting increased competition within our US generic injectables portfolio, as well as supply constraints for select molecules. Moving to clinical nutrition. Total sales were $230 million, increasing 4% on a constant currency basis. Performance in the quarter was driven by demand for our broad multi-chamber product offering, vitamins and automated compounding. Sales in advanced surgery were $263 million, advancing 8% on a constant currency basis. Growth in the quarter reflects continued gradual recovery of elective procedures in the US and Europe, as well as strong demand for RECOTHROM given competitive constraints. Recovery in our APAC region remains subdued, with several countries experiencing somewhat depressed levels of surgical volumes. Sales in our acute therapies business were $173 million, declining 4% on a constant currency basis, reflecting the difficult comparison to the prior-year period where we experienced elevated demand for CRRT, given the rising COVID cases. Biopharma solutions in the quarter were $163 million, declining 5% on a constant currency basis and reflecting an expected step down in sales of COVID vaccines compared to the same period last year. COVID vaccine sales for the quarter totaled approximately $35 million. Hillrom contributed $715 million in sales in the quarter, which included $364 million of sales in patient support systems, $282 million of sales in frontline care and $69 million of sales in global surgical solutions. Hillrom grew 2% on a constant currency basis as compared to Q2 2021 when the company was a standalone entity. Despite solid growth in the quarter, sales came in below our expectations largely due to the supply constraints for electromechanical parts, primarily implant packing frontline care, as well as select delays in product installations and patient support systems in global surgical solutions due to lack of hospital access. As a result, we're experiencing unprecedented levels of product backlog throughout these businesses. Demand remains strong, though, and we'll continue to monitor the situation and work this backlog as rapidly as possible. And while to date, we haven't yet seen an impact on the flow of capital orders, we are taking a more conservative approach for the second half given delays related to hospital staffing challenges, as well as more cautious commentary from customers regarding hospital CapEx. Moving through the rest of the P&L. Our adjusted gross margin of 42.5% decreased by 10 basis points over the prior year, reflecting the impact of increased expenses, primarily driven by inflation and freight. Adjusted SG&A of $839 million represented 22.4% as a percent of sales, an increase of 150 basis points versus prior year, driven by the addition of Hillrom, as well as higher freight expenses, partially offset by lower bonus accruals under our annual employee incentive compensation plans. Adjusted R&D spending in the quarter of $148 million represents 4% as a percent of sales, a decrease of 50 basis points versus prior year. Adjusted operating margin in the quarter was 16.2%, a decrease of 100 basis points versus the prior year, primarily driven by incremental freight expenses in the quarter, resulting from higher fuel prices and inflation, partly offset by actions we are taking to improve productivity and reduce spend. Adjusted net interest expense totaled $89 million in the quarter, an increase of $55 million versus the prior year, driven by higher outstanding debt balances related to the acquisition of Hillrom. Given the current interest rate environment, we now expect net interest expense to be slightly higher than we had previously forecasted. Adjusted other non-operating income totaled $33 million in the quarter, an increase of $31 million compared to the prior-year period, driven by foreign exchange and equity investment gains, as well as amortization of pension benefits. The adjusted tax rate in the quarter was 18.8% as compared to 17.8% in the prior period. The year-over-year increase was driven by the addition of Hillrom as well as lower stock-based compensation award deductions as compared to the prior-year period. And as previously mentioned, adjusted earnings of $0.87 per diluted share advanced 9% versus the prior-year period. Let me conclude my comments by discussing our outlook for the third quarter and full-year 2022, including some key assumptions underpinning our revised guidance. As discussed, throughout the second quarter, Baxter experienced increased inflationary pressure related to fuel commodity and labor prices. Our prior outlook did not assume the divergence we're experiencing between diesel and crude oil, but did assume an easing commodity pricing, in line with external indices forecasts. Our current outlook now assumes pricing for these key raw materials remains at current levels for the remainder of the year. We anticipate component availability remains challenging through the second half of 2022, which will continue to impact our overall production volumes and absorption rates. We anticipate our order backlog will stay at elevated levels, resulting in a phasing impact of top line sales, primarily for infusion pumps in the frontline care business. Our teams are working tirelessly to secure key electronic components to lower our backlog to more normalized levels. In addition, we project a potential slowdown in hospital capital spending in the second half of the year, which will impact our PSS and GSS businesses. For the third quarter of 2022, we expect global sales growth of high teens on a reported basis, mid-20s on a constant currency basis and low-single digits operationally, and we expect adjusted earnings excluding special items of $0.79 to $0.83 per diluted share. For full-year 2022, we now expect global sales growth of high teens on a reported basis, mid-20s constant currency, and 2% to 3% operationally. As mentioned earlier, operational growth for Baxter excludes the impact of foreign exchange and Hillrom. The reduction in our sales guidance reflects increased foreign exchange headwinds, a lower sales outlook for our pharmaceuticals business and the legacy Hillrom business. Moving down the P&L, we expect full-year adjusted operating margin to be between 17% to 17.5%, reflecting the impact of all the various macroeconomic dynamics discussed today. For the year, we now expect interest expense to total approximately $400 million, given rate increases and adjusted tax rate of approximately 19%, and a diluted average share count of approximately 510 million shares. In addition, we expect the incremental FX top line headwinds will negatively impact earnings per share by approximately $0.05 in the second half of the year. Based on these factors, we now expect 2022 adjusted earnings excluding special items of $3.60 to $3.70 per diluted share. With that, we can now open the call up to Q&A.
Operator:
[Operator Instructions]. Our first question comes from Robbie Marcus.
Robbie Marcus:
Jay and Joe, there's a lot of moving pieces. And we just had the Analyst Day in May. So I was hoping maybe you can bucket for us the biggest changes from when you first gave guidance in January, EPS is now about a 15% lower. How should we think about the biggest impacts? How many are transitory? And how much of that is, would you say, more semi-permanent or permanent?
James Saccaro:
I'll start by answering this question in relation to the guidance that we shared in April. And then I'll add some additional commentary as it relates to what changed since May. Because I think that's perhaps the easiest way to do it. Q2 from an earnings standpoint largely came in line with our expectations. And the complexion of that was a bit different. But, really, the big driver of this relates to the second half of the year, where we're reducing the outlook by over $0.45. And I think there are a few different component pieces to this. First of all, from a commercial sales standpoint, we have had serious constraints related to electromechanical components, along with other raw materials. The result of that is our Hillrom business is off over $100 million in sales, in large part because of these constraints. We're also seeing some pharma pricing that's been challenging on the Baxter side. So, in combination, the commercial sales has impacted us roughly $0.15, maybe a little bit more than that, with the lion's share of that impact related to product shortage and component shortages. Now, on the offset side to that, we are offsetting that with lower spending, lower bonus accruals, and so the work that we're doing in terms of P&L preservation is offsetting that miss and it's also offsetting a $0.05 FX headwind in the second half of the year. The major impact comes down to headwinds that we're experiencing in our integrated supply chain. We have a roughly $0.45 impact in the second half of the year, and it's across a number of factors. Higher fuel rates and freight, roughly $0.15 of impact. Some of this has to do with the decoupling that was described between diesel prices and the price of oil that we started to see and that has continued through the second quarter. Some of it has to do with the fact that, because our supply chain is so strained, we are forced to expedite freight and we were experiencing significantly higher outbound freight and inbound freight than we normally would experience. From an inflation standpoint, on materials, it's roughly $0.05, and other inflation related to labor, utilities, and overhead is $0.04. We had been hoping for some improvement in these categories. But, frankly, we've seen elevated levels in Q2 remain elevated. And so, as a result, we see a roughly $0.09 impact in these inflationary categories. And then, the final piece, and it's substantial, relates to the productivity of our facilities. We're off roughly $0.20 of impact. And what this comes down to is, our supply chain relies on critical components from our suppliers in order for us to produce the products that we produce. There have been many instances where we are not able to secure electromechanical components, other components necessary to our manufacturing products, or critical raw materials. And so, the result of that is, this is the first time in my career I've seen numerous unplanned stoppages in our facilities as a result, and it's having a dramatic impact on a couple of things. First, on absorption levels in those facilities. That's obvious. But in addition to that, in terms of our ability to pursue planned VIPs, it's seriously hampered and impacted by our ability to continually run those facilities. And just to share a couple of examples. We have a manufacturing facility in Hechingen in Germany. And that's a manufacturing facility that produces dialyzers on a continuous basis. It's a continuous flow plant. So, disrupting that is a real serious deal, as you think about the operational efficiency of that. We've been forced to shut that plan for three days as a result of lack of power coming from the company that we deal with in Germany. Our North Cove manufacturing facility, our flagship facility, recently had to close a first shift, as a result of lack of critical components. Our facility Skaneateles has been running suboptimally. We had anticipated that that would improve. It has not. Our facility that manufactures pump Sigma Spectrum, we've been running at very low levels, if at all, because of lack of electromechanical devices. So, Robbie, it's an interesting and very challenging confluence of events. And it's an incredibly volatile dynamic that we're experiencing as we look at our supplier base. But in combination, these headwinds have impacted us $0.45. Now, the good news is, operationally, we see a path forward, I commented that from a long range plan standpoint, assuming things stay at these levels, we have a pathway to the improvement that we outlined. I am certainly hopeful that we see easing of electromechanical components, along with some of the prices that I discussed, along with the normalization of freight lanes and freight times and the impact. So, I'm optimistic that all of those things will occur. But in the short term, we're not anticipating that. And we've made necessary adjustments to our cost structure to offset as much as possible. So really, that's the story now. As we think about what's changed since May, in May, every one of these categories on the supply chain that I've described, and most prominently, some of these disruptions that we're seeing, those are the things that have changed the most since May. And so, it's been widespread and a very difficult environment. I think we have put forth the best forecasts available, the most conservatively realistic forecasts available, reflecting what current prices are, what our current understanding of plant shutdowns will be, but it's been a very dynamic environment that's led us to this place.
Robbie Marcus:
And maybe just as a follow up, Jay, at the Analyst Day that you talked about in the new LRP that you think – floor of 75 basis points and margin expansion, I guess would be the floor over the LRP. Do you think that still holds, given the new environment? Or there may be some changes to that comment?
James Saccaro:
We do. Robbie, we went through an analytic exercise based on the evolution of the environment over the last four to six weeks. We went through an analytic exercise and we looked at, first of all, the overall quantum of improvement over the LRP, that 350 to 400, the expected sales compounded growth rate of 4% to 5%, along with the free cash flow conversion. We looked at all of that. In addition, we looked at 2023 and the statements that we made. We validated all of those statements, that those are intact, relative to where things currently sit. So, based on the challenging environment that we've experienced, I was pleased that we're able to confirm that at this point. Listen, if European gas gets shut off in the winter, if that situation exacerbates and takes a further toll, a further step down on the supply chain, who knows what will happen? But as we sit here today, based on what we know and the current rates and the current expectations around chips and so on, we feel good about the long range plan commitment, albeit starting off the lower base.
Operator:
Vijay Kumar of Evercore is on the line with a question.
Vijay Kumar:
Jay, just off of those last comments you just made on affirmation of LRP plan, I think the LRP had 350 to 400 basis points of margin expansion. I guess my question is expansion over what baseline? Are we looking at 2022 as the baseline? I think the updated guide implies 17.5% op margins. If you could just clarify that thing, that'll be helpful.
James Saccaro:
The updated LRP is off the lower base. So, it was a relative improvement from 2022. Vijay, the factors that I listed, the $0.45, I suspect that a number of them will be transitory, okay? But as we've thought about the modeling, we really don't have enormous easing of some of these constraints that we've seen. So, let's see how that evolves over time. But for now, what we're able to do is confirm the growth against this lower level.
Vijay Kumar:
One for Joe. Joe, these electronic components shortages, et cetera, some of your peers are seeing some alleviation. And I guess, from a Street perspective, the fear is, is this what we're seeing in Hillrom? Is this a CapEx slowdown, right? Based on your comments, it feels like this is not a demand issue and there is a potential for a catch up based on your comments on backlog and order book. Maybe talk about why this is not a demand issue, why you're confident about the outlook for Hillrom and the business?
José Almeida:
Vijay, when we look at Baxter, let me take this in two portions. We have experienced significant shortages of semiconductors. And the semiconductors – and sometimes, we all read in the news, the semiconductor business may alleviate as consumer goods will decline due to recession, potential recession, inflation and so forth. We as a company and many, many people in the medical devices use chips that are not the same chips used in consumer goods, and that varies by nanometers. You probably know this as well. We use thicker chips, chips that have embedded software. Our suppliers – we have a half a dozen suppliers. And one of these suppliers has been a real problem. And coincidentally, this supplier is one that supplies most of our frontline care products. This is not an issue in our [indiscernible] but more so into our frontline care. And also affects our ability to make Sigma Spectrum pump, as Jay mentioned. So, we need to separate that. So when it comes to capital, we have not seen a widespread change in demand. What we saw in the second quarter are fewer accounts that moved the implementation and the justification was more on staff shortages and the ability to really deploy them to get the products installed, which requires manpower and they were short in that area. We look conservatively at this. We look at our business in many dimensions. We have a very healthy backlog at the moment. Very, very healthy. I can sit here today and say that, if I had enough chips, we could produce a significant amount of revenue due to pumps, monitors and other devices that we have. One of the things that bite us twice in this conversation is not having the chips is the ability to program and plan your factories accordingly because it becomes a real ramp at the end of the quarter when the supplier sends us a bunch of chips, and then we assemble them and we get them out of the door as soon as possible. So, it has been a real tricky situation. It seems to – that we see the light at the end of the tunnel as we start to make progress with some of our suppliers. But we're sitting here today, I would say the demand is strong. This is the headline. Second is the chip – the semiconductor situation is very fluent. Third is that we have the capability to put those products on the market and have the demand for them as soon as we've got the product, the components shipped to us. So, I want to make sure that those two things are separate. Capital has slowed down. We haven't seen that. Our backlog, as I said, has been all-time high in both business. However, we had people postpone installations in the second quarter due to staff shortage, as we were told.
Operator:
Pito Chickering of Deutsche Bank is on the line with a question.
Pito Chickering:
The first one is on the CapEx side. You talked about seeing some delays from customers who are pushing out orders on CapEx spending. Is this a [indiscernible] Hillrom, I guess any color you can give us on what parts of your book business you're seeing those delays of CapEx.
James Saccaro:
A lot of this comes down to staffing availability. I think that's been the primary driver that we've seen in terms of – we've seen a bit of an expansion in terms of installations on our care solution. So hospital beds, care communication, some of those items, it's taking longer – the installation process has been taken longer as a result of some of the staffing shortages that we've outlined in the prepared remarks. And then, Joe, again – we don't see at this stage a substantive change to the appetite for capital at hospitals. But we're watching this very carefully. And we're watching to ensure that the delays that we're seeing are related to staffing versus budget constraints or something like that. We've tried to take a cautious forecast through the balance of the year, which protects us in the event that there's some further shortage impacts. But that's what we said. Now as far as pumps, we're not selling an enormous number of pumps, in large part because of the constraints on electromechanical components. So, that's a huge challenge that we're faced with until we resolve that at some point here in the future.
José Almeida:
As a matter of fact, we have significant demand for pumps. We just cannot take the orders and we cannot make the products because we don't have the semiconductors going in. But I want to also to underscore what Jay said. When it comes to capital, capital is not the same for every hospital system. The hospital systems, they are large, they have the capacity to move forward. So we are observing very rapidly what is happening. So, is this postponement of capital issue or supply or staffing issues. Right now, the information that we have is a staffing issue, and those are the smaller accounts that we saw in the second quarter. We have large installations coming in third and fourth quarter, will be a telling point how those go through in the third and fourth quarter.
Pito Chickering:
My second question is on the margins. Looking at the implied margin growth from 3Q to 4Q, can you walk us through how you get that margin improvement sequentially? Is this from getting the chips back online and getting leverage from that? Or is it from [indiscernible] margins 3Q from diesel fuel costs. Any color there would be great.
James Saccaro:
Looking at that, I think there's a few things in play. First of all, the fourth quarter of the year is typically our highest margin quarter as a result of incremental sales. And so, if we look at the cadence between the third and fourth quarter of the year, we add well over $100 million in sales. And given that, there is a fairly substantial fixed cost base at a company like ours. Those sales tend to flow through at a much higher margin than the corporate average. So, if you look at the last few years, the fourth quarter is normally higher. Now, that's not always the case. But generally speaking, it's normally higher than the third quarter as a result of these incremental sales. The second thing is, listen, we take the preservation of the P&L very seriously. And so, while we weren't able to offset the extreme challenges that we've seen, we have offset a portion of those through some cost actions that we're taking. And many of those cost actions, the benefit of those accrues more to the fourth quarter than the third quarter. So, I think, perhaps, those are the two primary drivers that lead to the fourth quarter accelerated versus the third. And then, the final thing I would say is, we are ramping on the Hillrom synergy side throughout the year. That's been an area that's been going quite well. But each quarter that rolls on, we're adding synergies. So, that's another factor that comes to bear on the fourth quarter in excess of the third on our way to achieving the long term goal that we outlined at the Investor Day.
Operator:
Travis Steed of BofA Securities is on the line with a question.
Travis Steed:
Jay, obviously, a lot of macro pressures right now, but maybe talk a little bit about some of the offsets, things that are in your control. You mentioned pricing a little more visibly, as other companies have as well, just maybe talk a little bit about how much of this inflationary pressures can you actually offset with price? And how long does it take to roll through the P&L, given contracts?
José Almeida:
Historically, we have realized price increases in the US as part of our standard contracting process. This is normal practice increases. We have taken pricing actions to date, and they are reflected in our 2022. They can offset 100% of our incremental cost. So, therefore, we additionally, right now, are preparing the implementation of a second wave of actions in response to the significant price increases that we have received from our suppliers and our cost increase, Jay outlined in the beginning of the call, in terms of the labor cost and other internal costs, fuel costs, and energy costs and everything. So, we're putting an additional cost increase. At the moment, we're planning to start rolling out the second wave to customers on a global basis, by the way, not only US, in most of our businesses in the coming weeks. The actions that we're intending right now are to help offset a portion of the significant cost increase that we have, a portion, and doesn't cover everything. But we are determined to go through a second wave of price increases, price actions, I would say – better defined as price actions – throughout the company because of the incremental unprecedented cost increase that we are receiving right now.
Travis Steed:
Jay, in an earlier question, I think to Robbie, you're still committed to the 75 basis point floor per year. Just curious, when you think about on earnings, does that still translate into low-double digits or is 2023 probably more likely to be more of a transition year with less than double-digit earnings growth for that one year? Any comments on there? And also, where divestitures might fit in the LRP? If you've got to wait on somebody as more macro pressures ease before you'd move into divestitures or you could do that more near term?
James Saccaro:
As it relates to the cadence of earnings, we're committed to the floor of 75 basis points of margin improvement in any given year. And also, as you point out, we're looking at double-digit earnings growth compounded over the period of the plan. 2023, there's two factors in play. Right now, the operating margin expansion, barring meaningful improvements in some of these exogenous factors, will be towards the lower end versus the average rate that we expect to see over the term of the plan, but above the 75 basis points. The second thing that impacts 2023 in the short term is, given some of the rate hikes that we're seeing from the Fed, you do have that interest expense impacting the 2023 numbers, as we rapidly look to deleverage over the next few years. So that's another factor that comes to bear. So I would say that the 2023 earnings will be a bit below the compounded growth for the overall plan period.
Travis Steed:
And then divestitures?
José Almeida:
Listen, when we think about our portfolio management, it's something very actively in our minds. Some are easily executed than others. We have a couple of areas we're working very diligently. One of them is a much faster process, the other one is a little longer. And we're looking at feasibility of the second one, which is a little longer at the moment. It's all about making sure that Baxter is set up for the future. This portfolio actions that we're going to take and are currently examining are long-lasting initiatives to make sure that Baxter is aligned in allocating capital to the businesses that will be connected to our strategy and our vision in terms of the digital work that we're doing in healthcare, with our ability to deploy our technology across the globe. And right now, Baxter has some businesses that fall – not fall outside our main area of vision. So we're looking at those. I don't have any news about the nature of these businesses. We're probably going to have one action later this year. The second one, we're still analyzing, because of the complexity.
Operator:
Joanne Wuensch of Citi is on the line with a question.
Joanne Wuensch:
Two parts. One, can you quantify the backlog that you're building associated with all these factors? And then second piece of it is, headwinds that are going to roll into 2023 on the revenue side. And thank you for color on the EPS and operating margin side of it.
José Almeida:
Let me talk about the backlog and Jay will supplement my answer and go to the second part of the question, Joanne. Our backlog has been growing primarily in frontline care. So let me define what we think – how we define backlog because we have two things going on. One is backlog and one is back order. Our back border is all time high. And what is back order? It is when we take an order and we cannot fulfill 100% of that order. The order is still pending in the system. As soon as we get inventory in the warehouse, it gets shipped to that customer. So, that is all time high at the moment at most probably sevenfold what normally we would see. Backlog is something new actually because if we don't have to assemble pumps, those pumps don't get into a backlog system. Baxter never used that system, but backlog comes with Hillrom and it's very appropriate for them to look at their business such as this, which is future orders put in the system for delivery in the future. We've been accumulating significant backlog in our frontline care. Right now, we have significant demand, primarily now with the graduation of med school students and students going back. It's one point that we do with that part of the business, [indiscernible] business. There are other parts of our business, monitors as well, that we feel if we had those chips would have significant revenue increase in the future. So, we're planning, as we receive those chips, the situation eventually normalizes, the backlog will come back to normal levels. I would say that our backlog today are multiple times what was used to be called normal for Hillrom. And we have also a healthy backlog in our bed system, the traditional Hillrom. So I want to make sure that you all know that backlog is something new for us. We're going to be talking every call about that and we're telling you right now that backlog is multiple times what is considered normal for Hillrom and Baxter.
James Saccaro:
Looking to 2023, as we think about 2023 sales, there's a couple of factors, headwinds and tailwinds, that are in play here. One headwind for next year is COVID vaccines. We expect that to be a reduction to next year. So that's one factor, and that really hasn't changed since our Investor Day. In addition to that, we don't expect that the chip shortage will be fully alleviated. So we think that will continue to depress the demand to some extent, as we move through next year. Now, I'm hopeful that this will provide an upside for us. But at this point, I don't necessarily see that alleviating. And then finally, we do hope to have a large volume pump available for the marketplace in 2023. We're extremely excited about all of the work that's going into that, and what that means for the future of our company. So we're hopeful that we will have that to bring to bear in 2023, which would be an upside. As it relates to margin going into 2023, I guess the big thing I would say is, we are assuming many of the factors that we're experiencing today remain at essentially current levels. And so, we are not anticipating a major alleviation in these product categories. So, that's going to be a continued factor. I'm hopeful that this resolves over time as well, but we've trying to be very, not pessimistic per se, but ultra-realistic as we're looking at the situation. And then, in addition to that, we'll have the continued benefit of Hillrom synergies rolling through to next year's results as a tailwind. So, that's a little bit of color as we're seeing things shakeout to 2023, but we continue to watch this very carefully.
José Almeida:
I would just add that we're also excited about the syringe pump that may come faster in terms of approval. They are the large volume parenteral pump, which is the LVP. So, the update is that we are under active review with the FDA on Novum IQ syringe infusion pump. And the large volume infusion pump, it is pending, our response to the FDA additional information request, which we are expecting to respond within this calendar year. And hopefully, both pumps will satisfy the FDA's questions, and hopefully, we can get them approved. But we're excited about the launch of both.
Clare Trachtman:
And one comment I would add is that we don't anticipate having the same chip issue with Novum that we are currently experiencing with Spectrum. So we do have some Novum pumps in inventory.
José Almeida:
Yeah, we have about probably close to 20,000 Novum pumps, large volume pumps in inventory. Yet more will be made preparing for the hopeful launch this year and full next year sales. So, we're working very close to our suppliers, but this is very different. This is a next generation chip, a new generation chip versus what is in Sigma Spectrum.
Operator:
Larry Biegelsen of Wells Fargo is on the line with a question.
Larry Biegelsen:
Jay, two to free you. First, simple, on interest expense, based on the $400 million this year, this run rate right now about $440 million, is that how we should think about it for 2023. Or maybe just some color on what you're assuming for rate increases and debt paydown. And then I just have one follow up.
Clare Trachtman:
I'll take that one. We do expect interest rates to come down a little bit next year because as we continue to pay off some of our debt balances. So interest rate will come down. It'll be elevated next year, but it won't be at the same level in 2023 as it was this year, given some of our debt paydowns.
Larry Biegelsen:
So, the math I did there, Clare, is probably not the right way to think about it?
Clare Trachtman:
You should not take into account any of the term loans that we will pay down.
James Saccaro:
There should be some paid down. Larry, wildcard, what does the Fed do with rate increases, but as we currently see it.
Larry Biegelsen:
Jay, everyone's asked on this call about the macro headwinds. What happens if diesel prices come down? What happens if some of these headwinds ease? Do we get some of this back? What's the right way to think about it, if, actually, some of these prices come down.
James Saccaro:
Larry, the answer is yes. We get benefits. So, we have been severely impacted by a lot of factors. So, the worldwide stress on the supply chain, the inability of our suppliers to supply and that shows up all over the operations of our company. If we do get alleviation of diesel rates, if we get alleviation of the global supply chain crunch, which would allow us to use less expedited freight, if we're able to see some improvement in material inflation, and finally, and perhaps most importantly, if we can run our plants consistently with the products and the inputs that they need, then, yes, the situation will be significantly better than it is today. Now, the way we've modelled this, as we look to the second half of the year, we are assuming some level of shutdown. We're assuming elevated rates, continued use of expedited freight. So we've got all that embedded. And that's embedded in much of our thinking for 2023. We should get this back at some point. And so, I'm optimistic that this will turn. I just don't know when, and we're not prepared to call that at this stage.
José Almeida:
I'd just underscore the fact that we will have benefits. So, if diesel cuts – goes down 20%, 25%, this directly impacts our ability to ship products, so ship for less money, affects our renal business profitability, as well as surcharges that we're currently getting from our suppliers on every invoice that we pay for shipment of products. So, that is a potential tailwind if the situation turns. We're watching that very closely. But Jay said, we want to make sure that you have a picture of the future as we see today, as we also understand the trends on the market.
James Saccaro:
And to add to that, Larry, if we have normalized back order/backlog levels, that's another tailwind. And we're not there yet. We're not anticipating that we get there in the near term. But to the extent that we secure the critical components that we have, then we'll be able to see some sales uplift as well.
Operator:
Joshua Jennings of Cowen is on the line with a question.
Joshua Jennings:
Just wanted to ask, it's only been a couple of months since the Investor Day, but just on the Hillrom sales synergy side of the forecast in the LRP, I know there's a lot of muddling with the supply constraints and then the current environment, but just any data points you can share just in the 2Q in terms of how your outlook of Hillrom synergies are advancing or is evolving? And then second, Jay, and I think you called here the guidance updates conservatively realistic. And that makes sense. Assuming that the environment stays consistent, have you baked into the guidance update? Where do you see areas of conservatism in this update? I think investors probably concerned about the potential for another revision. Clearly, if the environment gets worse, it will impact the entire group of large cap medtech players. But it seems like the capital spending slowdown that you're assuming by hospitals in the back half, particularly on the PSS and GSS businesses, there's some conservatism there. But are there any other areas of conservatism you've called out in this guidance revision?
James Saccaro:
I think, by the way, we will conclude with this question. So, appreciate everybody joining us today. Here's the interesting thing. While the short term has been extremely volatile, as we look at the acquisition of Hillrom, we are very excited about the long-term prospects. So much of the issue that we're seeing relates to shortfalls and components at this point. But as we laid out the strategy for this business over the long term, from a revenue standpoint, from an integration standpoint, all of those elements are in place and continue to excel. Our synergies are doing better than expected. We reflected that in the financials that we've shared with you for this year. Longer term, tremendous opportunity in terms of product combinations. We are really excited about the innovation potential. So, what I would say is a lot has changed since May. And nobody appreciates that more than me. But what has not changed is our real excitement about the acquisition and where we can take it over the long term. So, we didn't really have revenue synergies meaningfully in the second quarter, but didn't expect that. But as we move forward, the plan in terms of the revenue synergies that we outlined is very much intact. Now, as we think about conservatism and things of that nature, I guess what I would say is we've taken a perspective on the worldwide situation that we're currently facing, and reflected that in the forecast that we share. And so, where I think there might be some opportunity is, to Larry's question, if diesel improves, if all of the work that we're doing to secure electronic components is successful, those kinds of things are the things that would drive us above this forecast. I think it's an accurate portrayal of kind of where we sit. I'm just hopeful that this situation that we're in, well, I know that, over time, it will resolve. I just can't answer at this point how quickly that will occur.
James Saccaro:
So with that, I think we appreciate everybody joining us today and we will conclude the call and are obviously available as always for follow-ups. Thank you all very much for joining.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's First Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's pression. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning, and welcome to our first quarter 2022 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; Jay Saccaro, Baxter's Chief Financial Officer; Giuseppe Accogli, Baxter's Chief Operating Officer; and Jim Borzi, Baxter's Chief Supply Chain Officer. On the call this morning, we will be discussing Baxter's first quarter 2022 financial results and full year financial outlook for 2022. On the call this morning, we will be discussing Baxter's first quarter 2022 financial results and full year financial outlook for 2022. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the second quarter and full year 2022, the recent acquisition of Hillrom, new product development, business development and regulatory matters including ones related to the 510(k) review of the NOVUM IQ infusion platform contains forward-looking statements that involve risks and uncertainties. And of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. On the call this morning, we will be discussing operational sales growth, which adjusts for the impact of foreign exchange and the acquisition of Hillrom. Before I turn the call over to Joe, I wanted to let everyone know that the registration link for our 2022 Investor Conference, which is being held on Wednesday, May 25 in Glenview, Illinois is now available on our website. Please visit the Investor Relations section of Baxter's website to register for the event. With that, I'll now turn the call over to Joe. Joe?
Joe Almeida:
Thank you, Clare. Good morning, everyone, and thank you for joining today's call. I will get started with an overview of our first quarter performance, trajectory and a quick preview of what you can expect our upcoming investor conference in May. Jay will take a closer look at our financials as well as our outlook for the current quarter and balance of the year. Then we will close with your questions. As you know, first quarter 2022 represents our first full quarter since the close of Hillrom acquisition. I'm pleased to report solid results for the combined company on both the top and bond line, reflecting the ongoing momentum of legacy Baxter businesses as well as the early promise and potential of our Hero integration. First quarter sales grew 26% on a reported basis and 29% at constant currency. With legacy Hillrom sales contributing $755 million to our total $3.7 billion in reported sales for the quarter. Excluding the impact of Hillrom and foreign exchange, first quarter sales rose 3% on an operational basis. On the bottom line, adjusted earnings per share of $0.93 increased 22%, exceeding our guidance of $0.79 to $0.82. Performance in the quarter reflects the contribution from Hillrom. First quarter performance continued to reflect the ongoing erratic impact of the COVID-19 pandemic, which fueled demand in some of our businesses, while dragging on performance in others. As ever, the diversity and durability of our portfolio in combination with our global footprint, add as buffers that help us weather the extremes in these factors are only bolstered with at its scope and opportunity created through the addition of Hillrom. We continue to see solid demand across both legacy Baxter and Hillrom businesses. We are still experiencing pockets of back orders and backlogs due to the significant supply chain challenges that have made it increasingly difficult at times to access a range of raw materials and components, particularly electromechanical components. Similarly, we continue to experience increased inflationary pressures and rising freight costs, which have only intensified in the wake of the war between Ukraine and Russia. Our focus on efficiency and disciplined expense management has gone a long way to partially offset these challenges. And I'm proud of our integrated supply chain team for its strategic moves in procurement and logistics that are helping us meet the needs of patients and clinicians while helping to support sustained value and growth of our shareholders. Taking a deeper dive by business, performance was led by biopharma solutions, which advanced 21% at constant rates. This was driven by a favorable year-over-year comparison related to revenues from the manufacture of multiple COVID-19 vaccines. Our Medication Delivery business increased 10% at constant rates, driven by growth in IV therapies. As you saw in this morning's release, we shared a status update on our NOVUM IQ large-volume infusion pump with those IT safety software, which has been under review by FDA. We received the letter from the agency last Friday with a request for additional information. As a result of the 510(k) review window has been placed on hold so that our team can address accordingly. The team currently plans to respond to FDA within the calendar year. We remain on track to submit responses on the NOVUM IQ syringe pump filing to FDA in the second quarter of 2022. I want to emphasize why we can speak for FDA or the eventual outcome of their review process. We are confident our leading-edge NOVUM IQ technology. We are committed to responding to FDA's request and to bringing the benefits of NOVUM IQ patients and clinicians in the U.S. and beyond. Advanced Surgery performance was up 8% at constant rates, driven by year-over-year improvement in the rate of surgical procedures following depressed rates due to the pandemic. Renal Care rose 1% at constant currency rates, with a mid-single-digit growth in the U.S., partially offset by a low single-digit decline internationally. Growth in the quarter was driven by global demand for our home peritoneal dialysis products, partially offset by lower sales of dialyzers internationally. As we have discussed previously, PD patient demand has been constrained due to the pandemic driven factors, including higher mortality rates for kidney disease patients and the lower rate of new patients diagnosis. We remain confident of renewed uptake in PD therapy over the upcoming years as well as in the health and lifestyle factors that make home-based therapy, a compelling choice for patients and clinicians. Clinical Nutrition also grew 1% at constant currency, reflecting improving demand for selected parenteral nutrition products, growth in the quarter was dampened by ongoing supply constraints for vitamins globally. Pharmaceuticals declined 2% at constant currency, reflecting continued increased competitive activity for certain U.S. generics as well as the impact of supply constraints that impacted production volumes during the quarter. We continue to focus on launching new molecules in complex formulations as well as embracing our international growth opportunities to help accelerate performance in the business moving forward. Finally, among our legacy business, acute therapies declined 7% at constant currency, reflecting a challenging year-over-year comparison due to the last year's surge in demand for continuous renal replacement therapy or CRRT products amid the pandemic. Underlying performance in this product category continues to build momentum with the pandemic only further highlighting the vital role of CRRT products in the ICU. As I stated earlier, our newly acquired Hillrom businesses contributed $755 million to sales in the quarter our global integration is proceeding on course, and we are starting to seize our key opportunities to expand global access to our growing portfolio as well as uniting our capabilities to expand our presence in connected care. Looking ahead, I want to note that our regional outlook for 2022 did not anticipate the tragic outbreak of a war in Ukraine. The conflict is partially disrupting our ability to serve patients locally, although we are working hard to serve Ukrainian patients and refugees directly and through our humanitarian aid partners. We are also, like many other companies, assessing our profile in Russia, although as a health care company, there are certain life-sustaining products that we are continuing to make available to patients in line with current sanctions. The conflict has also caused a ripple effect across the supply chain network globally resulting in rising oil prices, which we expect to negatively impact freight material and utility costs this year. In addition, given the current time line anticipated for NOVUM IQ, we have made the decision to remove any related sales contribution in 2022. These factors, coupled with ongoing increased inflationary pressures have resulted in adjustments to our guidance for the balance of the year As Jay will review in a moment. Our teams are working diligently to find potential offsets to these increased expenses. And as we mentioned last quarter, we have identified opportunities where it may be possible to pass through some of these costs in select geographies. While the global macroeconomic landscape continues to present unique challenges, we are nonetheless excited about our overall prospects, momentum and capacity to make a difference for our many stakeholders. We look forward to giving your deeper insights on our trajectory next month at our 2022 investor conference. We will share a broader look at our growth strategy, fueled by advances in connected care as well as our commitment to ongoing therapeutic innovation. We will also provide more detail on how expanded global access and uncompromising portfolio management should contribute to profitable growth. In addition, we will highlight the rapid evolution of our integrated supply chain function as we work to address today's operational challenges head on and continue to evolve for the future. You'll see Baxter's health care innovations first-hand at our interactive innovation hall. -- and as always, we'll be including plenty of time for your questions and informal networking with our senior leadership team. I look forward to seeing many of you in person in the event will also be webcast for online viewing. Now I will pass it to Jay who will take a closer look at our first quarter results and '22 outlook.
Jay Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our first quarter performance especially in light of the geopolitical unrest and macroeconomic headwinds causing incremental supply chain challenges, inflationary pressures and elevated freight costs. We're working through these headwinds with consistent focus on operational efficiency and disciplined expense management. Turning to our financial performance. First quarter 2022 global sales of $3.7 billion advanced 26% on a reported basis, 29% on a constant currency basis and 3% on an operational basis. Sales came in at the high end of our guidance range this quarter, with growth reflecting recovery in hospital admission rates and elective surgeries, the benefit from revenues associated with the manufacturing of COVID vaccines and strength in our medication delivery business, which benefited from growth of IV therapies as well as lower customer rebate costs during the quarter. On the bottom line, adjusted earnings increased 22% to $0.93 per share. This compared favorably to our guidance of $0.79 to $0.82 per share, driven by better-than-expected gross margins, which was driven by product mix as well as disciplined execution on cost synergies associated with the acquisition. Now I'll walk through performance by our regional segments in key product categories. Note that constant currency growth is equal to operational sales growth for all global businesses and Baxter's 3 legacy geographic regions. Starting with sales by operating segment. Sales in the Americas increased 5% on a constant currency basis. Sales in Europe, Middle East and Africa grew 2% on a constant currency basis and sales in our APAC region were flat on a constant currency basis. Sales in our APAC region were negatively impacted in the quarter by the resurgence of COVID cases in the region particularly in China, we are continuing to monitor the situation in China and the potential impact on our operations from further lockdowns. Moving on to performance by key product category. Global sales for Renal Care were $894 million, increasing 1% on a constant currency basis. Performance in the quarter was driven by growth in our PD business as global patient volumes increased on a year-over-year basis despite persistent pressures from increased mortality rates in ESRD patients delays in new patient diagnoses and market-wide staffing shortages. This growth was offset by lower dialyzer sales in our international in-center HD business. Sales in Medication Delivery of $706 million increased 10% on a constant currency basis. Strong U.S. growth in this business reflects continued recovery in the pace of hospital admissions compared to pre-COVID levels as well as increased demand for IV administration sets and solutions. Sales also benefited from lower customer rebates in the quarter. For the quarter, we estimate that U.S. hospital admissions were down low single digits compared to pre-COVID levels. Pharmaceutical sales of $521 million declined 2% on a constant currency basis. Performance in the quarter was negatively impacted by increased competition for select molecules in our U.S. generic injectables portfolio lower sales of inhaled anesthetic and pandemic-related supply constraints driven in part by labor shortages at certain of our manufacturing facilities. Moving to Clinical Nutrition. Total sales were $227 million, increasing 1% on a constant currency basis. Performance in the quarter was driven by the benefit of new product launches within our broad multi-chamber product offering. Sales in Advanced Surgery were $228 million, advancing 8% on a constant currency basis. Growth in the quarter reflected elective procedure recovery in the U.S. and Europe. We've seen recovery stall in our Asia Pacific region with Australia, Korea, Japan and Taiwan experiencing somewhat depressed levels of surgical volumes. In the U.S., we saw surgical procedures come under pressure in January as a result of the Omicron variant, but the impact on volumes was short-lived with procedural volumes improving into February and March. Our current assumption is for U.S. surgical procedures in the U.S. to remain above pre-COVID levels for the remainder of the year. Sales in our Acute Therapies business were $188 million, declining 7% on a constant currency basis and reflecting a difficult comparison to the first quarter of 2021 when we experienced heightened demand for CRRT given the rise in COVID cases. BioPharma Solutions sales in the quarter were $156 million, representing growth of 21% on a constant currency basis, reflecting incremental sales related to the manufacturing of COVID vaccines, which totaled approximately $45 million in the quarter. For the remainder of the year, vaccine sales are forecasted to be approximately $60 million lower than prior year sales. Hillrom contributed $755 million in sales for the quarter, which included $383 million of sales and patient support services $294 million of sales in Frontline Care and $78 million of sales in Global Surgical Solutions. On a constant currency basis as compared to Q1 2021, when Hillrom was a stand-alone company, its sales were flat year-over-year, reflecting a challenging comparison as sales in the first quarter of 2021 benefited from COVID-related sales of approximately $40 million. Moving through the rest of the P&L. Our adjusted gross margin of 45% increased by 300 basis points over the prior year, reflecting the contribution of Hillrom within the quarter and lower rebate costs. Adjusted SG&A of $855 million, representing $23.1 million as a percentage of sales, an increase of 240 basis points versus prior year, driven by the addition of Hillrom as well as higher freight expenses. Adjusted R&D spending in the quarter of $149 million represented 4% as a percentage of sales, a decrease of 30 basis points versus prior year. Increased levels of SG&A and R&D spend reflect the contribution from Hillrom. We're on track with our cost synergies target for the year, and we're able to pull forward certain initiatives resulting in a benefit to operating expenses in the first quarter. Adjusted operating margin in the first quarter was 18%, an increase of 100 basis points versus the prior year, reflecting the various factors I just discussed. Adjusted net interest expense totaled $85 million in the quarter, an increase of $51 million versus the prior year, driven by higher outstanding debt balances related to the acquisition of Hillrom. Given the current interest rate environment, we now expect net interest expense to be higher than we had previously forecasted. Other nonoperating income totaled $16 million in the quarter, an increase of $21 million compared to the prior year period, driven by foreign exchange gains and amortization of pension benefits. The adjusted tax rate in the quarter was 20.8% as compared to 16% in the prior period. The year-over-year increase was driven by the addition of Hillrom as well as the prior year tax rate reflected a discrete benefit. The tax rate in the quarter was unfavorable to our expectations due to the mix of earnings within the quarter. And as previously mentioned, adjusted earnings of $0.93 per diluted share advanced 22% versus the prior year period. Let me conclude my comments by discussing our outlook for the second quarter and full year 2022, including certain key assumptions around phasing for the year. As Joe mentioned earlier, we have made the decision to remove any NOVUM IQ Infusion System sales in 2022, which is reflected in our updated sales outlook. At this time, we are not able to offset the expected NOVUM sales with Spectrum as we are supply constrained on certain electromechanical parts for the spectrum pump. In addition, the global macro disruptions emerging from new COVID outbreaks in China, the war between Russia and Ukraine and continued supply chain constraints across our network have created challenges to our ongoing operations. While we continue to evaluate opportunities to drive better efficiency in our integrated supply chain as well as pass through some of these costs to our customers. These factors have resulted in increased expenses, which are expected to negatively impact our results throughout the remainder of the year. These incremental expenses, which are primarily related to higher oil prices and increased inflationary pressures are reflected in our updated financial outlook. For the second quarter of 2022, we expect global sales growth of approximately 26% on a reported basis, 29% to 30% on a constant currency basis and approximately 4% operationally. And we expect adjusted earnings, excluding special items, of $0.86 to $0.89 per diluted share. For full year 2022, we now expect global sales growth of 23% to 24% on a reported basis, 25% to 26% on a constant currency basis and approximately 3% on an operational basis. As mentioned earlier, operational growth for Baxter excludes the impact of foreign exchange and Hillrom. Moving down the P&L. We expect full year adjusted operating margin to be similar to the prior year period. For the full year, we now expect interest expense to total approximately $375 million and adjusted tax rate of 19% to 19.5% and a diluted average share count of 508 million to 510 million shares. Based on these factors, we now expect 2022 adjusted earnings, excluding special items, of $4.12 to $4.20 per diluted share. With that, we can now open the call up to Q&A.
Operator:
[Operator Instructions] Our first question comes from Travis Steed at Bank of America Securities.
Travis Steed:
Jay, I'd love just to get a bit more of a bridge on the guidance changes here for the full year, both on the top line and the bottom line. It looks like a 1 point reduction in the revenue guidance. I'm just curious how much that's NOVUM IQ, how much of it's supply shortages and the same thing on the bottom line as well. It looks like $0.25 difference if you account for the Q1 beat?
Jay Saccaro:
Sure. If -- from a revenue standpoint, really the entirety of the reduction relates to NOVUM we've taken out roughly $100 million in sales. Previous guidance was roughly 4% operational. Now we're approximately 3%. of course, there's always puts and takes as we put together our forecast but we thought it was prudent under the circumstances to remove NOVUM from the guidance, and so you see that reduction. As far as the forecast period goes, we did make some more significant adjustments to the bottom line in light of the circumstances we are currently faced with. Oil is 1 primary driver. That's roughly an $0.11 impact. We have freight headwinds, excluding the impact of oil of roughly $0.11. And what this really comes down to is it's an incredibly tumultuous supply chain environment today. And as the company looks to fulfill our mission to save and sustain lives, moving product around the world is increasingly complicated at the moment. And so the result of that is roughly $0.11 of incremental headwind from Q2 to Q4 outside of the oil impact that I just described. And then finally, securing parts and securing raw materials is also very, very challenging. And roughly, we're experiencing roughly $0.08 of material inflation. You add to that the NOVUM impact, and you offset that by certain pricing actions we're taking along with manufacturing optimization and improvements. And that really is what describes the change in guidance to the back portion of the year.
Travis Steed:
That's great. I'd love to hear a little bit more color on some of the pricing actions that you're taking that you just mentioned and kind of where in the portfolio you're doing that and more shipping and freight cost that you're charging customers or actual price increases?
Joe Almeida:
We have taken pricing actions to customers in different geographies where we can. And -- but we don't go into specifics where we did, how much and our customer, but we have taken pricing actions.
Operator:
We'll move next to Robbie Marcus at JP Morgan.
Robbie Marcus:
Maybe to start, Jay, to follow up on that, I think, and Joe, for you as well. A lot of investors are trying to sift through the moving parts. There's a lot going on, both on the top line and the bottom line. At the same time, there's a big integration going on. So maybe you could just step back and walk us through, how you feel about, let's call it, the underlying end market fundamentals versus transitory headwinds and all while doing the integration, how do you feel basically about the health of the markets and how Baxter is performing relative to them?
Jay Saccaro:
So Robbie, thanks for the question. Overall, we feel very good about the durability of the business, the long-term potential to outgrow our markets. If you think about the first quarter performance, that really is a classic illustration of how we perform, right? We delivered solid sales growth 3%. We were able to deliver ahead of our expectations on the bottom line, which was great. All the while, continue to pursue the integration, which as Joe described, and we -- I'm sure we'll get into later, is going quite well. Very happy with the acquisition of Hillrom, very happy with the opportunities that it opens up to us in terms of synergies and some of the end markets that it exposes us to. So all of that is really a nice story. We are faced with 1 of the most complicated supply chain environments, I have personally seen the war in Ukraine, coupled with an already fraught supply chain creates very significant short-term factors impacting our performance. Do I think we'll be talking about supply chain in 2 years? I certainly hope not, nor do I expect that, that will be the case. But at least for the next 9 months as we see it, there will be continued pressure on the supply chain. And if you think about our mission, that's our primary focus, but it's more costly to do that in the short term. I think over time, we'll see oil prices eased. I think over time, the complexity of moving product around the world will decrease. And all of those things will accrue to the benefit of the long-term story for Baxter. Right now, it's some choppy waters that we're navigating. And I think all of the teams, including in particular, our supply chain team are doing a tremendous job working through all of that. Joe, I don't know if you want to add anything to that.
Joe Almeida:
Would add that we see our demand, our top line back order, our backlog, very healthy, backlog, very healthy. Our back order is all-time high, meaning that we have strong demand, we are sometimes struggling to fulfill all the demand because the shortage of chips and microprocessors and Northern Electronics. As a matter of fact, that has consume our top executives, a great deal of their time either by speaking to company CEOs in this area or trying to get product shipped more often to our factories. So this is not a unique problem to Baxter, but it shows that the top line, when I see that level of demand, you see that our business has a resilience that Jay just outlined. So I don't see a problem with the market dynamics. I see underlying issues that Jay outlined. They are somehow not short-term temporary will be with us throughout this year. And I said that in the previous call that this will take quarters to be fixed, and we think towards the end of the year, we may see some progress in that area. We also are redesigning some of our boards. We're trying -- we're getting secondary raw material suppliers in place. So there's a significant amount of work to shore up the company not only for the short term, but also for the long term and create a resilience that will be with us for a long time.
Robbie Marcus:
Great. And maybe 1 more to follow up on pricing. This is -- your business has a lot of different products that go through a lot of different channels and contracts. Some are capital items, some are drugs. Some are more supplies historically, this has been a very difficult market to take pricing in. But given the inflation, the shipping, et cetera. What's the ability by each of the different businesses you participate into put through pricing? And is there any -- do you foresee any change in the go-forward pricing environment due to this?
Joe Almeida:
Clearly, the inflationary pressures on Baxter, a very clear display here, and we have taken pricing actions in selected markets. Why do I say selective markets because some markets, we have contracts that are long term, that to take price actions? Sometimes you have to break the contracts. And we evaluate case-by-case -- this is not a blanket. We're not a consumer company, neither we are selling staple products out in known-to-direct-to consumer. So we can't just blanket raise prices everywhere. What we do is we raise prices where we think is just and fair. And we try to do it in a way that is that is also considered to the customer and legally possible. So there's all those considerations that we put in place. It is a tough market at the moment. and it's a tough market for everyone. So we do what we can, and we're taking pricing where it's possible.
Operator:
Larry Biegelsen with Wells Fargo has our next question.
Larry Biegelsen:
Just 1 on the margins this year and 1 on kind of the upcoming analyst meeting. Jay, on the margins, it's still -- it looks like the guidance implies second quarter margins down sequentially. And then to get to the full year guidance, it implies kind of a ramp in the second half. So what drives that ramp? And are we thinking about the cadence correctly? And I have 1 follow-up.
Jay Saccaro:
Larry, you are thinking about the cadence of margins correctly. And if you think about Baxter overall, historically, we see first half margins lower than second half margins looking at 2021, the margin went from 17% first half to 20% second half, despite some significant issues with respect to inflation that impacted the second half of last year. And a lot of that comes down to significant incremental revenue that we see in the second half of the year. So as we fast forward to 2022, you're right, we'll see a several hundred basis point step-up from first half to second half. And there's really a few contributing factors. One, the revenue step-up that we anticipate seeing in the second half. Second, incremental synergy capture that accrues to the benefit of the second half and then finally, our manufacturing team is hard at work, accelerating the pace of what we call VIP programs. But what are really about is increasing the efficiency of our manufacturing facilities. And really, we'll see some of those benefit more in the second half than the first half. So you add those 3 factors together, and the cadence of margin as you correctly point out, will be similar to what it's been in past years.
Larry Biegelsen:
That's helpful. And then on the upcoming analyst meeting. My question is, one, it's a volatile environment. So how are you going to factor that in and what -- when you did the Hillrom deal, you guided to Baxter stand-alone sales CAGR of 4% to 5%, a 300 basis point margin expansion. And obviously, we know that Hillrom synergies you've assumed my question is kind of what has changed, Jay or Joe, that you can share with us today to just help us calibrate going into that meeting? And how are you going to approach kind of the long-term outlook given the volatile environment that we're in.
Joe Almeida:
Sure. I can start, Jay, and you can please come in. We have a long-range plan in the company that is drawn and takes into account several different factors, including the short-term disruptions that affect in 2022 in terms of supply chain. We have a forecast that we're going to tell you what our assumptions are going into the meeting. We're going to tell -- this is what we're assuming things are happening. So what we present, you have all the all the numbers, we have a footing on what are the assumptions that we are making in this world today in terms of supply demand pricing and other things, including commodities and other things. So we will be prepared to disclose that at the time of the meeting, game.
Jay Saccaro:
No, that's exactly right, Joe. And I think we're going to try to put forth conservative assumptions, but what we see today is an incredibly volatile world. And to that effect, we'll want to share some details around what are we assuming around the price of oil over the years, and we're going to try to have the best intelligence around that assumption as possible. As far as what's changed, really, the integrity of the businesses that we have and acquired that's fully intact, and we feel very good about the long-term potential of both platforms, and I should say, the combined platform. We look to feature that, and we're very excited to share our perspective on that when we sit down. In the short term, we've seen massive supply chain disruption. That really is the most significant factor that is different from September to today. Things like oil price, things like freight and logistics challenges, the global supply chain really, those are the issues that we're contending with at this point, and we'll try to have a point of view on that as well. So really, that's the approach that we're going to take, Larry, and we look forward to seeing you in Chicago in a month.
Operator:
We'll come next to Pito Chickering with Deutsche Bank.
Pito Chickering:
Just sort of going back to the question on the impact from oil, you quantify lens of oil lenses of freight material pressures. Just can you sort of give us some more color on sort of the cadence of the timing throughout the year? And do you some updated guidance and your relief sort of in the back half of the year versus the prices we're seeing today?
Jay Saccaro:
We really have not forecasted relief this year. We've taken roughly $100 barrel of oil and are looking at that through the rest of the year, and we're also anticipating some level of complexity with respect to the supply chain, along with challenges procuring components and raw materials for the balance of the year. The way we see it, there could be some easing of oil prices over time, but we think probably that benefits more 2023 than 2022. The other fact that you have to keep in mind is there is a lag between alleviation of oil price and when we see that in the P&L. Said another way, our Q1 -- our Q1 was not that negatively impacted by the movement in oil price that occurred during Q1, that really impacts the period from Q2 to Q4. So I think the way we see it, Pito, we're going to assume challenging levels for the balance of the year. And then we're optimistic that this sorts itself out towards the end of '22 and into '23, but we're cautious about that.
Pito Chickering:
Okay. And then for a follow-up, like you talked about backlogs for sourcing Microchips and other products. Can you sort of size up the size of the backlog? Has it gotten bigger in April? What do you assume in guidance in terms of working down that backlog? And then any color that you can give us on China on both revenues and manufacturing in China with all the COVID lockdowns occurring there?
Jay Saccaro:
Sure. We don't really get into backlog by specific product area. What I can tell you, and nor we get into product line availability and components impacting specific product lines. What I will tell you is we're very tight in terms of spectrum parts, as I commented in my prepared remarks. And as a result of that, we're not able to see some of the offsets that perhaps we've seen in the past with respect to NOVUM delay. So that's 1 factor. In the first quarter, we did have some backlog with respect to the Hillrom products. We expect those things to sort out over the course of the coming months. But again, with availability of product, we're always careful and cautious about watching this closely. As it relates to China, the big -- the lockdowns that we've seen there, we expect roughly a $15 million to $20 million impact to sales. Obviously, our hearts go out to all of our employees in China who are really doing yeoman's work trying to ensure that we get product out of the manufacturing facilities, and we have folks that are staying in plans overnight so that they can secure product and get product out but from a demand standpoint and a supply impact, we're seeing roughly $15 million, perhaps $20 million in impact as it relates to those measures. We expect those -- some of that occurred in Q1. We expect some more of that to impact Q2 and then we are expecting that to alleviate later in the year that's really the story on China.
Operator:
We'll move next to Danielle Antalffy at SVB Leerink.
Danielle Antalffy:
Hey, good morning, everyone. Just 1 question on the NOVUM platform. I'm just curious, Joe, if you -- this delay here, if that changes your view of the potential longer term or even in the midterm, once the platform does launch in the market share gains that Baxter should be able to get? And then I have 1 follow-up.
Joe Almeida:
Danielle, we have received the latter. We understand what needs to be addressed, and we plan to address towards the end of the year, like we just said in our prepared remarks. Addressing the request does not change the faith I have in the product line. We have this product currently working in Canada and is, from my perspective, a great product. We have tremendous respect for what the agency sells and I don't speak on behalf of the FDA. So we're working very closely to make sure that we can address the outstanding main issue as soon as we can in the stores at the end of the year. I have faith in the platform. We designed them from scratch. It was the first product electromechanical product designed by Baxter from scratch. We put the resources in place and we're still very optimistic about what we can do in the marketplace. So it's a great technology and -- but this is my opinion, and I hope that we can get this clear towards the end of the year.
Danielle Antalffy:
Okay. Got it. That's good to hear. And then just on Hillrom, I was wondering if you could touch a little bit more. I know it's early days still, but how it's been from a sales synergy side or maybe how you guys are seeing any changes in the sales process with Hillrom as part of the product portfolio today, just broadly speaking?
Jay Saccaro:
Great. Danielle, thanks for the question. We're really pleased with how things are going with respect to Hillrom. I think what we're finding is a company whose culture aligns very well with Baxter. As we explore the products more, we're increasingly excited about the product line and portfolio that they have, some of the innovation that they're undertaking. As we think about our ability to commercialize their products and drive things like synergies. We're also really excited about those kinds of opportunities. And then finally, from a cost synergy standpoint, things are going as well or better than we originally anticipated. So from our standpoint, all signs are up with respect to Hillrom, and we feel very excited about the deal that we put in place. As far as revenue synergies go, I think we'll outline when we see you in May, a few categories that we're increasingly excited about. Things like geographic expansion, things like product synergies some of the promotional opportunities that we see, some of the new products that we can develop. There's a number of categories that we'll outline for all of you at our Investor Day but it's safe to say that there's real opportunity. And I just recently spent some time with some of our international teams talking about the distribution opportunities that exist. And the reality is they're there. We have a global footprint. We sell products around the world in over 100 countries with direct presence in most of those countries. Hillrom doesn't have that level of footprint in place, and there are select products that can really benefit from that kind of promotional effort. So we're excited about it. I hope to see you in in May, again. We'll talk about all of these categories in more detail, but I think it's a really nice long-term story that we're putting together here.
Operator:
Joanne Wuensch, Citi has our next question.
Joanne Wuensch:
I actually have 2. I'm curious about your thoughts on the pathway for the renal recovery. It sounds like you do expect it to come, but over time, and I'd love to know how you plan to get there?
Joe Almeida:
Daniel -- Joanne, how are you?
Joanne Wuensch:
I'm well.
Joe Almeida:
We are experiencing a moment of reduction in the patients in renal due to the 2 years of COVID that affected the number of patients who died, who are at risk and for ESRD patients or potential patients. So we started to see the pickup of the patients in PD at the moment. We see that continue on primarily in the U.S. and Americas. We still need to see that coming in through Europe. The HD patients, we see that more as a more lingering effect of the pandemic. So PD separate PD from HD or peritoneal dialysis from hemodialysis we see PD recovering throughout this year and picking up for momentum probably in 2023.
Joanne Wuensch:
And as a follow-up, I'm curious what you're thinking about hospital volumes for the remainder of the year?
Joe Almeida:
We see the recovery coming in and it's going to be a rebound. So we project to see a rebound in surgical volumes and hospital volumes in most places that we do business today ex-Asia. I think in China, we need to watch what's happening in terms of their lockdown and how we're able to react to that as well as in Japan. But ex those 2 large markets, we see other markets picking up momentum and the demand that was suppressed coming back up in -- with volumes above last year and probably at or above pre-COVID times.
Operator:
We'll move next to Drew Ranieri at Morgan Stanley.
Drew Ranieri:
Just to go back on Hillrom for a second. If you adjust out for the COVID benefit, it's growth. And even in the Patient Support Systems business, it looks like it was closer to 7% growth. So kind of better than expected. But within PSS, can you maybe go into some detail about what you're seeing from the hospital bed component and the connected care component as well, just kind of given the light that some hospitals might be pulling back on capital expenditures. Just kind of curious what you're seeing in this quarter and kind of what you're expecting for the remainder of the year in those franchises?
Joe Almeida:
Yes. We're going to ask Giuseppe to answer that.
Giuseppe Accogli:
Yes. So I think when it comes to BSS, what we see is continuous and strong amount on the care communications side. Care communication is a very strong platform with unique unique features that come from the nurse coal system to the bold system. So over there, we see a strong demand. This demand is difficult to implement being difficult to implement due to the COVID impact. So our access to the hospital has impacted that code -- but what we see is a very healthy backlog when it comes to care communication and to the overall PSS business.
Operator:
We'll move next to Matt Miksic at Credit Suisse.
Matt Miksic:
Just a couple of follow-ups, if I could, Jay or Joe, on how you're thinking about some of these factors in your guidance. One is China, you talked about it a couple of times. So if maybe you could give us a sense of how your -- what assumptions you're baking into the sort of easing and lockdowns there? Does it happen in the second quarter? Or is that sort of happened in the back half by your estimation and guidance. And then the other is FX. We've seen significant moves in FX, expected some folks in our universe more than others and just would love to get a sense you have some other major moving parts that you described, Jay, that make up the guide change, but maybe talk a little bit about how you're managing through or what the impact of changing FX has been?
Jay Saccaro:
Sure. As it relates to China, our expectation is that the situation improves not in the second quarter, but into the third and fourth quarters. Obviously, it's a complicated situation that they're dealing with, and we do expect some improvement occurring later in the year, just for your benefit, on the impact of the lockdown in Q2, we expect roughly around $10 million and similar impact level in Q1. So we don't have any improvement baked in until later in the year. As it relates to foreign exchange, we are expecting -- relative to prior year, we're talking about roughly $0.05, $0.06 of impact, maybe a little bit more than that. And relative to our previous expectations, which we shared with you in February, we're off several cents from that. Now this is a very highly volatile situation. And even as of yesterday, we were seeing substantial movements in the euro we'll watch this very closely. But right at this point, we have several cents of impact relative to the prior forecast. We'll continue to monitor this.
Operator:
And we'll take our final question from Vijay Kumar with Evercore ISI.
Vijay Kumar:
Thanks for squeezing me in here. Jay, I had a 2 part. Maybe I'll ask both of them -- when I look at the guidance here, first half is 3.5 operational, the annual implies 2.5 in the back half. given that utilization is improving in the back half, why is 2.5 the right number? And I understand none was pulled out. If we didn't have no IQ in first half, so maybe talk to at first half versus second half cadence? And then on the supply chain cost. Is there a simplistic part of thinking about when I look at all the cumulative cost that Baxter has incurred over the course of the pandemic -- is there a way to quantify the cost versus pre-pandemic levels? And what are the different buckets that they went into raw materials versus any manufacturing investments versus transportation?
Jay Saccaro:
Great. Thanks for the question, Vijay. The -- as it relates to the second half versus first half sales guidance, what I will tell you is that the primary drivers are a reduction in vaccine sales as anticipated, along with the removal of NOVUM with no offset because if you think about last year, we have very strong spectrum sales in Q3 and Q4 of last year. And we don't have that available that lever available to us as we look at the second half of this year, which is why Joe's comments around our intense focus to get NOVUM approved, that's really a core focus of our organization and our R&D team. So those are really the drivers as far as changing of cadence. Most other factors I would say, are kind of moving along similarly, although we did see some heightened level of medication delivery sales in the first quarter of this year. That was a bit anomalous and we do expect that to lower as we approach the back portion of the year. So really, that's the story on the sales line. As it relates to supply chain costs that we're experiencing inflationary pressures that we're experiencing over the last several years from 2019 or '20 through to today. We're talking about $0.5 billion of incremental costs that we're experiencing. And really, it's things like increased labor costs, increased material costs and freight costs that is driving this substantial uptick. What's interesting is, despite that very significant number, we've been able to offset an enormous amount of that through manufacturing VIPs, as I described earlier through operational performance, some of the pricing mechanisms that Joe described earlier. So this is -- Vijay, this is a really significant number that we're faced with and frankly, what I am somewhat optimistic and even excited about is as those pressures alleviate, you'll get to see the momentum with respect to all of the operational efficiencies and enhancements that we're undertaking without that offset. So that's what we're working towards. As Joe and I mentioned, I don't think -- I think we're going to contend with some of these pressures for the rest of the year, but I am hopeful that we start to see some benefit as we move to next year. So thank you very much for the question.
Operator:
There are no further questions at this time. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Fourth Quarter 2021 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Good morning and welcome to our fourth quarter 2021 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; Jay Saccaro, Baxter's Chief Financial Officer; and Giuseppe Accogli, Baxter's Chief Operating Officer. On the call this morning, we will be discussing Baxter's fourth quarter and full year 2021 financial results along with our financial outlook for 2022. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for the first quarter and full year 2022, including the anticipated impact of COVID and inflationary pressures on this outlook, the recent acquisition of Hillrom, including anticipated cost synergies from future net leverage targets, new product developments or launches, business development and regulatory matters, contain forward-looking statements that involve risks and uncertainties. And of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. As mentioned in our press release this morning, following Baxter's acquisition of Hillrom on December 13, 2021, Baxter's fourth quarter and full year 2021 financial results include Hillrom financial results for the last 19 days of the quarter ended December 31, 2021. Hillrom financial results for these periods are reported as the new operating segment in addition to Baxter's existing three geographic segments. On the call this morning, we will be discussing operational sales growth, which for the fourth quarter and full year 2021 adjusts for the impact of foreign exchange, the December 2021 acquisition of Hillrom and the February 2021 acquisition of the rights to Caelyx and Doxil for specified territories outside of the U.S. Later in the call, Jay will discuss our guidance for the first quarter and full year 2022. Operational sales growth for 2022 will exclude the impact of foreign exchange and the acquisition of Hillrom. Historical 2021 quarterly sales for Hillrom have been posted to the Investors section of our website. Now I'd like to turn the call over to Joe.
Joe Almeida:
Thank you, Clare. Good morning, everyone, and thank you for joining today's call. As always, I hope that you and your loved ones are healthy and safe. We start this morning with some perspective on our performance last year and future trajectory. Jay will take a closer look at the financials and share our outlook for the first quarter and full year 2022 then we'll take your questions. As you all know, this is our first earnings call since acquiring Hillrom, the next inflection point in Baxter's multiyear transformation. The combination further extends our already diverse med tech portfolio and provides opportunities to broaden our reach, both geographically and across the care continuum. Importantly, it also unlocks exciting new possibilities for connected care innovation across our product lines with the potential to spark clinical insights, enhance patient outcomes and increase workflow efficiencies. In short, it holds the promise of greater value for all of our stakeholders from patients and clinicians to our employees and investors. The deal closed on December 13. So our Q4 and full year 2021 financials reflect 19 days of contribution from Hillrom. Looking at company-wide performance, Baxter delivered fourth quarter 2021 sales growth of 10% on a reported basis, 12% at constant currency and 4% at operational rates. Fourth quarter adjusted earnings per share were $1.04, up 30% year-over-year. Hillrom contributed $212 million in sales and $0.08 of adjusted earnings per share in the quarter. For full year 2021, sales growth was 10% on a reported basis, 7% on a constant currency basis and 5% on an operational basis. On the bottom line, adjusted earnings per share of $3.61 increased 17% year-over-year, which also reflects the contribution of Hillrom. Growth for both the quarter and year reflect the ongoing somewhat erratic impact of COVID-19, which negatively affected top line sales for certain businesses while fueling demand for others, particularly later in the fourth quarter as the Omicron variant surged. Our top line performance for the year continues to demonstrate the diversity and durability of our portfolio, which allowed us to deliver operational sales growth of 5% for the year. Demand across both our legacy Baxter and legacy Hillrom businesses is strong. During the fourth quarter and continuing through the start of this year, we have been experiencing a higher than normal rate of back orders due to certain supply chain limitations and staffing-related challenges in our plants resulting from high rates of absenteeism amid the rising cases of COVID. We are working expeditiously to address the situation and anticipate continued improvement in the coming weeks. As we have discussed throughout the year, our cost structure has been negatively impacted by rising rates of inflation as well as an increasingly challenging supply chain network, which has at times resulted in expedited shipments and extraordinary steps to procure necessary components. While our teams have worked diligently to offset many of these pressures, our fourth quarter results reflect higher than expected freight costs given the critical and essential nature of our products. We made decisions to expedite product to our customers to ensure we stay true to our mission, which means prioritizing the needs of patients and clinicians who depend on steady access to our life-saving products. We will never compromise on this commitment. We are realistic about the supply chain challenges that continue to test the global industry as a whole and we are laser-focused on addressing them successfully now and going forward. We are in the process of implementing new measures in procurement and logistics, including evaluating opportunities to pass through certain costs in selected geographies that will enhance performance and deliver value to our stakeholders, both in the near term and long run. We're focused on making sound choices to promote our long-term success as a viable growing enterprise. We're building off our solid foundation and remain focused on executing against our multiyear transformation. This transformation has bolstered our operational efficiency and giving us the tools to navigate through these challenging times where the resilience and tenacity this team has demonstrated over the course of the last two years. Beyond this, the acquisition of Hillrom introduced crucial growth drivers across multiple fronts. The integration process is moving forward productively. We are already identifying opportunities for geographic expansion as well as synergies to drive meaningful cost reduction and margin expansion. And we are advancing connected care across our newly expanded capabilities. As always, we continue to evaluate our portfolio to ensure the businesses we operate are aligned with our long-term strategic objective to accelerate top-line growth and expand margins. This commitment was clearly demonstrated with the Hillrom acquisition, which augmented and strengthened our underlying portfolio. As part of this ongoing process, to the extent we identify areas that do not align with our long-term objectives, we will look to exit or divest these businesses while also continuing to identify new opportunities to enhance future performance. We recognize that innovation is at the core of any successful enterprise, and we are focused on introducing new products to address the evolving needs of our customers and patients. Some of these include the anticipated U.S. launch of our NOVUM IQ smart pump this year as well as our TrueVue connected digital solutions for our PrisMax 2 continuous renal replacement therapy technology, which is in early stage launch right now in the U.S. and Europe, Middle East and Africa. Obviously, we assess our performance across multiple dimensions just as we must continually strengthen our performance as a thriving and resilient enterprise. Our mission also demands our continued leadership as a corporate citizen. 2021 marked the launch of our 2030 corporate responsibility commitment, comprising 10 key goals for the next decade and beyond, focused on three key action areas
Jay Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our fourth quarter results, particularly in light of ongoing pandemic and global supply chain disruptions that we experienced during the quarter. Fourth quarter 2021 global sales of $3.5 billion advanced 10% on a reported basis, 12% on a constant currency basis and 4% operationally. Sales came in at the high end of our guidance range, which is in line with the commentary we shared in early January and underscores the essential nature and durability of our portfolio. Sales growth this quarter reflects the benefits of revenues associated with the manufacturing of COVID vaccines, strength in Medication Delivery, Renal Care, OUS sales of Caelyx, Doxil, which totaled approximately $35 million in the quarter, and a contribution of $212 million from Hillrom. On the bottom line, adjusted earnings increased 30% to $1.04 per share. Results in the quarter reflected a contribution of $0.08 per share from Hillrom, inclusive of incremental interest expenses related to the transaction as well as unplanned foreign exchange losses totaling $0.04 and higher than expected freight costs of $0.05. As Joe mentioned, we incurred significant expedited freight costs late in the quarter as cases of COVID-19 surged. Now I'll walk through performance by our regional segments in key product categories. Starting with sales by operating segment. Sales in the Americas increased 5% on both the constant currency and operational basis. Sales in Europe, Middle East and Africa grew 5% on a constant currency basis and 1% operationally and sales in our APAC region advanced 6% on a constant currency basis and 5% on an operational basis. As Clare mentioned, Hillrom's financial results are reported as a new operating segment in addition to Baxter's existing three geographic segments. Moving on to performance by key product category. Note that for this quarter, constant currency growth is equal to operational sales growth for all global businesses, except for our Pharmaceuticals business, for which we will provide both constant currency and operational growth adjusting for the acquisition of rights in select territories outside the U.S. for Caelyx, Doxil. Global sales for Renal Care were $1 billion, increasing 4% on a constant currency basis. Performance in the quarter was driven by global growth in both our HD and PD businesses. PD benefited from year-over-year improvement in global patient volumes despite persistent pressures from increased mortality rates in ESRD patients, delays in new patient diagnoses and market-wide staffing shortages. Patient growth improved sequentially throughout the year, with Q4 representing the highest patient growth in 2021. Renal Care sales in the quarter also benefited from mid-single-digit growth in our HD business primarily driven by increased international sales of dialyzers. We expect that higher mortality rates and delays in new patient diagnoses resulting from the pandemic will continue to somewhat dampen the rate of new patient growth in 2022, although we do anticipate these rates to improve from 2021 levels. Sales in Medication Delivery of $784 million increased 6% on a constant currency basis. Strong global growth in this business reflects continued recovery in the pace of hospital admissions compared to pre-COVID levels as well as increased demand for large volume infusion pumps and small volume parenterals. For the year, we estimate that U.S. hospital admissions were down mid-single digits compared to pre-COVID levels. Pharmaceutical sales of $604 million advanced 8% on a constant currency basis and 2% operationally. Performance in the quarter was driven by demand for our international pharmacy compounding business, growth in anesthesia as our international markets continue to recover from COVID-19 and the contribution from OUS sales of Caelyx, Doxil. This growth was partially offset by declines in our U.S. generic injectables portfolio business related to lower surgical procedures and increased competitive activity for certain molecules. Moving to Clinical Nutrition, total sales were $249 million, increasing 4% on a constant currency basis. Performance in the quarter was driven by the benefit of new product launches within our broad multi-chamber product offering. Sales in Advanced Surgery were $255 million or flat on a constant currency basis. Within the quarter, we saw a strong growth in some of our international businesses, but this was offset by performance in the U.S. as surgical procedures, particularly in the second half of December, came in below our expectations due to the impact from pandemic along with staffing shortages. Sales in our Acute Therapies business were $202 million, declining 7% on a constant currency basis, reflecting a challenging year-over-year comparison. Despite this, performance in the quarter did exceed our expectations as we continue to see elevated demand for CRRT given the rise in COVID cases associated with new variants. BioPharma Solutions sales in the quarter were $145 million, representing growth of 31% on a constant currency basis, reflecting incremental sales related to the manufacturing of COVID vaccines, which totaled approximately $50 million in the quarter. While our results only include Hillrom's financial results for the final 19 days of the quarter, for transparency and completeness we're providing some sales commentary for Hillrom's full quarter ended December 31, which would have represented their first quarter of fiscal year 2022. Unaudited Hillrom sales for the full quarter were $724 million. Sales in the quarter reflect a difficult comparison from prior year period following the exit of the international surgical OEM business as well as significant supply constraints, which impacted Hillrom's ability to ship products within the quarter. Moving to the rest of the P&L. Our adjusted gross margin of 44.3% increased by 290 basis points over the prior year, reflecting the favorable product mix, operational improvements in manufacturing and the contribution from Hillrom to our financial results. Adjusted SG&A of $710 million increased 14% as compared to the prior year and represented 20.2 as a percentage of sales. Adjusted R&D spending in the quarter of $133 million increased 1% versus the prior year and represented 3.8 as a percent of sales. Adjusted SG&A and R&D spend both include the incremental contribution from Hillrom. In addition, adjusted SG&A expense in the quarter reflects the higher freight expenses we absorbed in the quarter as well as higher bonus accruals compared to the prior year under our annual employee incentive compensation plan. Adjusted operating margin in the quarter was 20.3%, an increase of 260 basis points versus the prior year, reflecting the factors I just mentioned. Adjusted net interest expense totaled $44 million in the quarter, an increase of $6 million versus prior year, driven by higher outstanding debt balances related to the financing of the Hillrom acquisition. Other non-operating expense totaled $21 million in the quarter compared to $5 million in the prior year period. Fourth quarter 2021 reflects [indiscernible] expenses related to foreign exchange losses from our subsidiary in Turkey as a result of the devaluation of the Turkish lira as well as an unrealized loss on an equity investment. The adjusted tax rate in the quarter was 18.5%, above our expectations driven primarily by the mix of earnings in the quarter. The tax rate in the quarter also reflects the inclusion of Hillrom's income, which carries a higher tax rate than legacy Baxter. And as previously mentioned, adjusted earnings of $1.04 per share advanced 30% versus the prior year period. Turning to full year 2021. Sales of $12.8 billion increased by 10% on a reported basis, 7% on a constant currency basis and 5% operationally. On the bottom line, adjusted earnings increased 17% to $3.61 per diluted share. On a full year basis, we generated operating cash flow from continuing operations of $2.2 billion and free cash flow of approximately $1.5 billion. Throughout 2021, we remain focused on strategically redeploying capital to advance our performance and position Baxter for future success. We returned approximately $1.1 billion to shareholders through dividends and share repurchases and deployed over $12 billion to inorganic investments to fuel growth, including our acquisition of Hillrom. With the acquisition now closed, our capital allocation priority will be to aggressively delever through the next two years to reach our net leverage target of 2.75 times by year two post close. Let me conclude my comments by discussing our outlook for the first quarter and full year 2022, including some key assumptions around phasing for the year. We currently anticipate that many of the factors that impacted our fourth quarter results, including increased inflationary fractures, supply chain disruptions, staffing challenges across our manufacturing network and ongoing impact of the pandemic, will continue to weigh on performance with the anticipated impact expected to be most pronounced in the first quarter. We're working expeditiously to address order backlog and anticipate a strong ramp in sales into the second quarter and the remainder of 2022 driven by new product launches and easing of COVID-19 dynamics globally. In addition, we're continuing to implement actions to increase operational effectiveness within our integrated supply chain network as well as evaluating opportunities to pass through certain costs in select geographies. We anticipate these actions, coupled with the improving sales performance, will result in meaningful margin expansion and earnings growth for the company, particularly in the second half of the year as compared to the first half of 2022. Given these dynamics for the first quarter of 2022, we expect global sales growth of 24% to 25% on a reported basis, 27% to 28% on a constant currency basis and low single-digit revenue growth on an operational basis. And we expect adjusted earnings, excluding special items, of $0.79 to $0.82 per diluted share. For full year 2022, we expect global sales growth of 24% to 25% on a reported basis, 26% to 27% on a constant currency basis and approximately 4% on an operational basis. Moving down the P&L, we expect adjusted operating margin for the year of approximately 19% with first half margins below this estimate and second half margins above as we expect performance to significantly improve throughout the year. For the year, we expect an adjusted tax rate of approximately 19% and expect diluted average share count to stay consistent with 508 million shares exiting 2021. Based on these factors, we expect 2022 adjusted earnings, excluding special items, of $4.25 to $4.35 per diluted share. With that, we can now open the call up to Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Robbie Marcus of JPMorgan, your question please.
Robbie Marcus:
Hello. Good morning, everyone.
Joe Almeida:
Good morning, Robbie.
Jay Saccaro:
Good morning.
Robbie Marcus:
Maybe to start, if I use the low teens accretion you've talked about for Hillrom, it gets me to somewhere around 7% EPS growth for base Baxter, which is below the LRP. So maybe first start off with what's driving it? You touched on supply chain issues and inflation, but I think it'd be important to put a finer point on it. And then I'll just ask the second question upfront as well. The first quarter is coming in a good clip below where the sell side is sitting coming into today. What gives you the confidence that supply chain issues will resolve in the second quarter, and you could see that acceleration and the drivers for the big discrepancy? Thanks.
Jay Saccaro:
Sure. Robbie, there are a few impacts that we're seeing in 2022 relative to previous LRP expectations. The good news from my perspective is a lot of these issues are short term in nature, many of them related to the Omicron variant and some of the challenges that's created in our manufacturing facilities and supply chain. So, if you think about it, over the last six weeks, we've seen increases in our expectations around expedited freight. We've seen some increases in expectations related to supply chain labor costs, in part related to absenteeism in the plants. We've also seen a bit more inflation. And then finally, we've had a back-order situation that really is some of the highest levels of back orders, both on the Baxter side and the Hillrom side that we've ever seen. And so, from my standpoint, we have weathered a very challenging short-term environment, some of that featured in our Q4 results. But it clearly impacts our Q1 and as a result, the full expectations for 2022. And so, what's interesting is we are seeing improvements in absentee levels at our plants. We are also seeing supply chain situation improve as we speak. So, all of these things, we believe, are short term in nature, but they definitely impact the first quarter and then also the second quarter from a margin standpoint before we get back to a trajectory which is much more normal and much more in line with our expectations in the third and fourth quarter. I think as we take a step back, look, we acknowledge there is some disruption in the short term, but really, really like the durability of the business along with the pathway we have going forward over the course of this year and then the future years. So really that – and then as it relates to Q1, the issues are most pronounced and really centered on Q1. We won't resolve the back-order issues until at some point in Q2. Furthermore, we won't get out of an expedited freight situation for a few more months here. So that's really why Q1 is where it is, and then we start to see improvements as we move forward.
Robbie Marcus:
Great, thanks a lot.
Joe Almeida:
Thank you.
Clare Trachtman:
We can take our next question.
Operator:
Vijay Kumar of Evercore ISI is on the line with a question. Please state your question.
Vijay Kumar:
Good morning, Joe and Jay. Thanks for taking my question. Maybe one on the revenue guidance here. Perhaps we're up, Jay, I'm not sure if I'm doing the math right. The implied Hillrom revenues, it seems to be perhaps down year-on-year because if I look at your operational growth for stand-alone Baxter and then look at the implied Hillrom, are there any – can you just one, remind us, has any assumptions change on these two businesses where Hillrom was five plus, Baxter, clearly, you guided to four plus. Are there any COVID headwinds, tailwinds we need to be aware of when I'm doing this year-on-year math?
Jay Saccaro:
Sure. Good question, Vijay. The Hillrom business, our expectation is mid-single digit constant currency growth. As I said earlier in my prepared remarks, Baxter is approximately 4% operational growth with the real [indiscernible] it's not a demand-related item, it really is related to back orders in the first and second quarter. And as I said, we hope to resolve those throughout the year. So, the Baxter side, we're talking about approximately four. Hillrom is mid-single-digit constant currency. And then the reported growth, I think, that there's some rounding going on, on both the Baxter side and the overall reported revenue growth side that leads you to the numbers that you're looking at. But as we look at it, we see Hillrom in the mid-single digits.
Vijay Kumar:
And then my follow-up, yes, sorry. Are there any COVID headwinds? And I think one of your – when the deal was announced, a lot of questions around the strategic rationale. And now one of your peers just did a connected care or communications deal. So maybe elaborate, perhaps for Joe, on this strategic rationale, connected care. How big of a deal is this, Joe, as you look at the next three to five years?
Joe Almeida:
Vijay good morning. We are working on those opportunities, and we'll have more on that when we speak to the – to our investors at our Investor Day. But let me give you three different examples. The first one is a short-term opportunity that we have is our home peritoneal dialysis and [indiscernible] remote monitoring. Bringing them together is a very short-term opportunity that we have, will give us insight into fluid overload and also the workflow of current PD patients and allows us to do Bluetooth-enabled vitals and analytics integrated with a share source, reducing then the potential burden for patients and more proactive and accurate management of patients. This is a very short term. The [indiscernible] alarm systems, midterm one to two years, bringing together delivery of digitalization of alarms from the Baxter infusion pumps, CRT devices. Starling is our monitoring platform to both. Bringing that together improves the workflow in med search, for instance, ICU, pharmacy and other parts of the hospital. Just some benefits would be fatigue reduction transition from reaction to proactive. So, you can see things ahead of time, creates a much better environment for the nursing staff who will be focused on what actually matters versus alarm overload. So, we think that is a good opportunity to bring to get both the platforms and both these are very important part of the platform that Hillrom has. And then on a long term, we're going to closed-loop fluid management system, which is how do you actually monitor from a series of inputs, including hourly urine output, to the infusion pumps output, and alarms and types of drugs, bringing our monitoring together and all the information that comes out of the smart beds. How do we create an environment that reduces significant load to the clinician and alarms to the clinician when problems are really arising and preventing, eventually preventing some of the bad outcomes to happen? Those are just three examples of things that we are working on, and there is much more that we had a significant amount of workshops that one is specific with a significant amount of ideas. So, I'm very excited about that.
Giuseppe Accogli:
And maybe – hi Vijay, this is Giuseppe. Maybe I would add a couple of other or probably another angle to that, that is the site of care. There is a lot that we can do having two million connected devices or connectable devices in the field of the two companies together. So, there is a lot that we can do in the acute environment, but there is a lot that we can do in the home care environment. Joe touched based on the Voalte and Care Communication, think about the PD patients now at home with hypertension. We can monitor them in a better way and we can communicate to them, we can add more critical vital signs collection together with the cycle. And we can involve with both families, we can involve the family in the treatment of the patient, which is very important.
Vijay Kumar:
That's helpful.
Jay Saccaro:
Vijay, just to close out on your question, we have roughly year-over-year $50 million worth of headwind in our DPS business related to vaccines. And then as we look at admissions and procedures, we expect those to normalize throughout the year. But in the first quarter, they are down a bit low, perhaps low, mid-single-digit impacts in the first quarter of the year. So down approximately 4% as we see it today. Now from a COVID impact standpoint, I'm not speaking to the back-order situation and the situation that we've seen in the plant. I'm viewing that separately. It's more of a supply chain-related issue. But from a demand standpoint, those are the key items impacting sales in 2022.
Vijay Kumar:
Thanks guys.
Jay Saccaro:
Thank you.
Operator:
Pito Chickering of Deutsche Bank is on line with a question. Please ask your question.
Pito Chickering:
Hey good morning guys. Thanks for taking my questions. The first one is actually a bridge. Can you help us sort of bridge the midpoint of the 1Q guidance of $0.81 versus last year's $0.76? What's the contribution from Hillrom within the first quarter guidance? I was trying to understand the cost and backlog pressures on sort of core Baxter. And can you quantify the backlog you're assuming in the first quarter and 3Q?
Jay Saccaro:
Sure. From an EPS standpoint, there is definitely a good contribution from Hillrom as we look at it year-over-year. And if you think about 2021 Q1 actual $0.76. But really between some price impact, some inflationary impacts and freight, we're talking about roughly $0.15 of negative impact. And what we would normally expect to see on the Baxter side is really substantial organic volume growth to offset that. We see some of that, but it's not sufficient enough to really carry the day in terms of driving the normalized levels of earnings growth and power that we expect from the business. So, we're not seeing that organic volume pick up in part because of the supply chain situation, which, as I said, should normalize throughout the year. And then Hillrom is north of $0.10 in terms of contribution in the quarter, which is something that is – it's a great add. The business is impacted is well thought by some of these supply chain issues. And so Hillrom's growth accelerate throughout the year as well.
Pito Chickering:
Great. And then a follow-up question. You talked about passing on some of the inflationary costs to customers in some geographies. Can you expand on which product lines and geographies you can pass through those costs? And as I think about sort of global revenues, any ballpark or sort of what percentage of those can be passed through and sort of what pricing you can get on that?
Joe Almeida:
Pito, this is something that we comment very little. Our pricing is a strategy that the company has. We have pricing built into our contracts. What we're looking at here is an exceptional amount of extra cost the company has to carry on the expedited freight, the ability to get components in the door, inflation and labor as well as the components that are coming in. So we will selectively decide where we're putting those costs – those price increases. They will come in different forms, but we're not going to specifically speak about geography. We know that we have put them in our plan, and we'll be executing on to them.
Pito Chickering:
Great. Thanks so much.
Operator:
Larry Biegelsen of Wells Fargo is on the line with a question. Please state your question.
Larry Biegelsen:
Good morning. Thanks for taking the question guys. Just first on NOVUM IQ, Joe, I heard your comments upfront about expecting approval this year in the U.S., I believe. I think at J.P. Morgan earlier this year you talked about some cybersecurity issues that you were, I think, re-filing on or submitting additional information on. Could you please update us on the timing, a little bit more detail on the timing there on NOVUM IQ and your confidence in approval this year, and I had one follow-up?
Joe Almeida:
Larry, good morning. We want to file this last set of documentations, which the FDA will have 31 days to provide a response to us, okay? So this is not the beginning of the application. This is the end. So to that end, we want to make sure we have some new set of eyes. We looked at the whole application, it looks really good. But there were areas that we think we could do better. Cybersecurity is one of them that we want to be always top decile when it comes to that. So we went back and made some adjustments and improvements, and that took time. So we will be filing with the FDA hopefully soon. And we're expecting that to be 31 days after that, we'll have the answer on our large volume parenteral LVP pump. And they are following that, we're going to apply the same 31 days at the end of it for the syringe pump and related software that will be our enterprise software as well as software controls, the pumps, the way they work with the networks. So that's pretty straightforward. We are doing the best we can to get the best chance to get this product. I don't speak on behalf of the FDA, I never do. I don't have any control on the internal process. One thing that we can control is the quality of the application that we have. And to that end, we want to make sure that we increase our probability to be high as possible before it goes in for those 31 days.
Larry Biegelsen:
Thanks for that, Joe. And one other thing you talked about in your prepared remarks was about evaluating the portfolio and potentially exiting or divesting, I think, non-core businesses. How long will that process take? And when do you think we'll hear more about it? Thanks for taking the questions.
Joe Almeida:
Larry, we – when we started transformation on Baxter, we had three very specific areas of improvement. I would say four, not three, four. First is to bring the company into profitability state, put us with – close to our peers and transform the company's ability to generate free cash flow. The second was most importantly, the culture of the company bringing the right talent to get the culture going. The third was innovation, and we just spoke about it getting a bump with the FDA that was unthinkable when I first got here because we did not have any internal programs or any devices within the company other than few that we acquired through Gambro. And the fourth piece was the one that we haven't touched much. We did some tuck-in acquisitions. And then we thought about how do we transform the portfolio, the company changed the CAGR, the direction, the innovation, go where the puck is going. That was the acquisition of Hillrom brings that part into Baxter. Conversely, we do have a couple of areas that we don't believe are the right businesses for Baxter to own. And to that end, we are in the middle of analysis and we should have more in that area either by May or a little later than that in how we're going to adjust our portfolio. What we want to do is always look at the portfolio in a way that can increase the CAGR of the markets we serve, increase the profitability of the company and remove businesses that have been sometimes legacy businesses. They are sitting here with probably not a right capital allocation and bring that to people who can bring that capital allocation to them, freeing up the cash flow for Baxter to invest in what really we want to invest, which is in our connected care, digital health and then to double down on parts of Hillrom, they're doing so well.
Larry Biegelsen:
Thank you.
Operator:
Joshua Jennings of Cowen is on the line with a question. Please state your question.
Joshua Jennings:
Hi. Good morning, thanks for taking the questions. I wanted to just ask, it sounds like from your commentary, Joe, Jay cleared that there are potential revenue synergies with this combination. I was wondering if there are any sales synergies baked into 2022 guidance and then just [Technical Difficulty] communicate fully the level of sales revenue synergies. And then the follow-up is just any change to the outlook in terms of the potential for the combined business to accelerate organic revenue growth as we move through 2022 and some of the challenges that are present throughout the med-device industry and into 2023 and beyond? Thanks for taking the questions.
Jay Saccaro:
Sure. As far as revenue synergies go, we have included none in our numbers for 2022. So there's no revenue synergies. Now having said that, we're incredibly excited, and Joe highlighted some of the work, and I'll let Giuseppe talk in a second about some of the progress that we're making because we're really excited about the opportunity for revenue synergies long-term. And I think as we learn more about the Hillrom business, and then we also see how the Baxter business has weathered a very volatile environment, I think we're very confident about our long-term ability to drive growth across this combined platform. So Giuseppe, why don't you talk about some of the revenue synergy ideas and some of the excitement we're generating there?
Giuseppe Accogli:
Sure, Jay. So the teams both the regional teams and the GBU teams work diligently on understanding which are the themes and the drivers of sales synergies, and we see a few of them very clearly. The first one, geo expansion and channel optimization, it is clear that Baxter presence outside of the U.S. is much stronger than legacy Europe presence, and that will end up to good sales synergies there. But there are also synergies in connected care, analytics and services. There are synergies in strengthening our position in alternate care and synergies in strengthening our position at home as well. Don't forget that before the Hillrom acquisition, home for Baxter was mainly [indiscernible]. Now we have new therapies like respiratory, like monitoring, cardiology monitoring, which [indiscernible] of course. That are very, very interesting to us. So we have a more comprehensive offer as well at all. So just to recap, geographic expansion, connected care, alternate care and home are the main drivers of synergies.
Jay Saccaro:
We will have the opportunity to share more about this at the upcoming Investor Day, including some quantification of revenue potential and some refreshment of the financial long-term outlook for the combined company.
Joshua Jennings:
Great. Thank you.
Operator:
Matt Miksic of Credit Suisse is on the line with the question. Please state your question.
Matt Miksic:
Hi. Thanks so much for taking the question. I just have one follow-up on this – the topic of synergies if I could and then on supply chain and staffing. So appreciate the color on the revenue synergies you were just describing. Can you maybe talk a little bit about what you've seen so far in terms of the cost side, logistics and operations, integration that have begun? And both on the positive side and any risks you're building into your outlook in terms of dissynergies as you bring these organizations together here in the near term?
Jay Saccaro:
So on the cost side, we previously shared $250 million in expectations by year three as part of really focusing on certain G&A areas and procurement opportunities and so on. And what I will tell you is we are very comfortable with that number and as we learn more, we're getting increasingly comfortable. So there have been no negative surprises as we think about the cost synergy opportunity. So this one has been very much according to plan. I think we've been really pleased with the talent that we've seen at Hillrom, the processes. So there's a lot of great opportunity there and thoughts that we can leverage. But as far as the cost synergy goes, its right in line with where we hoped it would be, if not trending even more positive.
Matt Miksic:
That's great. And then on supply chain, I know there's been a couple of questions, but you made a comment and I think some other companies presenting Q4 earnings and talking about outlook that made similar comments about this idea of improvements in the back half. And we've been talking about supply chain and input costs for over a year now, I think. And I guess the visibility of just putting a stake in the ground and saying, we do expect these things to improve, both in terms of staffing and inflationary cost and backlog and things like that. Can you maybe just give some sense as to your confidence in that visibility? It would be appreciated.
Joe Almeida:
Matt, I will start. I want Jay to actually also supplement my answer. I see this in two different buckets. I see the short-term or the COVID impact, and then what is the long-lasting effect of having those inflationary costs. So the first is labor availability created by Omicron was significant, didn't take much, you could read the news and how it affects the country and the curve and acceleration of that infection, took a lot of people from our plants. They were either infected or had contact with people infected very much in number one priority of the company's patient safety and quality as well as employee safety. So we did not allow people to come to work, and we follow the guidelines with [indiscernible]. To that end, we end up with significant disruptions that caused all this air freight that we have to actually incur, which came actually towards the end of the fourth quarter as we will never let patients other products. As soon as we found that we start flying products despite, in fact, some of the products in value of ships that were going in because the rate and escalation of that. That problem of the labor availability and absenteeism is starting to subside; we have significant efforts in place and we start to see our plants filling up with people, and the situation will be resolved. Also, part and parcel to that was the fact that you have to attract employees to your plant. And there is an inflationary cost to the labor cost of the company and that is the one that we also are upping our salaries and making sure that we retain people. Those cost of inflation will go on for a long time. You don't reverse salary increases. What you do actually is create more cost reductions and automation to offset that. And our supply chain has a pretty healthy cost reduction program in 2022 and beyond to offset this inflationary cost. The component availability is nothing new. We've been signaling that for a long time. We're working very hard to get to our components, buy in advance, buy large loss and things like we're managing that, and that is in Baxter being managed. And we just acquired Hillrom, they had similar issues. We are resolving those along the way, and we believe the alleviation of our back quarter and backlog will happen throughout 2022. One last point I want to add is that the demand is very strong for our products from two different things. One is the Omicron variant itself, but also a lot of consumption of product that happened, and shelves are empty. So you're probably going to have replenishment of those products going out throughout the year. So we don't see demand at this moment, from our vantage point, abating. So we have some short-term capacity issues that we're taking care by adding shifts and other things that will alleviate that. So we're doing everything we can always with the first thing in mind to serve the patient. Secondly, to do it in a cost-effective manner. So I think we have managed this to the best of our ability and done pretty well based on our footprint and the size of our company. Going into 2022, we will alleviate these pressures throughout the year, and it's not an immediate solve in the component issue. It's going to go through our second quarter and continues to improve throughout Q3 and Q4. And we want to make sure – we want to make sure that our cost reduction and we just verified that is very healthy. As a matter of fact, I would say our cost reduction program for 2022 is the largest the company ever had in terms of integrated supply chain.
Matt Miksic:
Very helpful. Thanks.
Joe Almeida:
You are welcome.
Operator:
Joanne Wuensch of Citi is on the line with the question. Please state your question.
Joanne Wuensch:
Good morning and thank you for taking the question. In your 2022 guidance, could you share with us what your COVID vaccine revenue is?
Clare Trachtman:
Sure. Joanne, it's about $100 million, a little north of $100 million is what COVID revenues this year.
Joanne Wuensch:
Okay. And then also historically you've given us your thoughts on hospital census and returns to sort of – I'm not sure what we're calling normal anymore. But could you sort of give us a backdrop of how you thought about that and putting together the guidance?
Jay Saccaro:
Sure. We have – we're down roughly 4% on surgical procedures and admissions. And then we have that improving throughout the year to be perhaps slightly below towards the end of the year and on a full year basis relative to 2019 normalized levels. We're not banking on a significant new variants. So that's an important assumption that underlies our guidance. And we're not banking on that both from a revenue side and also from a supply chain disruption side. We don't have any line of sight that, that's going to be a phenomenon that we have to deal with. And we certainly hope we won't have to deal with that through the remainder of 2022. So really, the story is down 4%, a lot of that relates to Omicron and then it improves throughout the balance of the year.
Clare Trachtman:
Yes. And that's specific to surgical procedures, Joanne. So again, down kind of that mid-single digit, low- to mid-single digits in the first quarter and improving throughout the rest of the year. With respect to admission, we kind of have a plan versus kind of those pre-COVID levels down kind of in that low-single digits really throughout the course of this year.
Joanne Wuensch:
Terrific. Thank you so much.
Clare Trachtman:
We will take one more question.
Operator:
Matt Taylor of UBS is on the line with a question. Please state your question.
Matt Taylor:
Hi. Thank you for taking the question. I just wanted to clarify on the NOVUM pump. It doesn't sound like you're baking any revenue for that in the guidance, just wanted to clarify that. And then previously, when you gave guidance in Q4 of 2020, I think, it was about a 1% contribution. Is that how you're still thinking about it once it gets launched? Or any other thoughts you could provide there?
Jay Saccaro:
So we've included guidance – we've included in our guidance revenues for NOVUM and really prominently in the second half of the year that reflects the successful launch of the product. As always, if that changes we're happy to adjust that moving forward. As far as specific volumes, I don't know that I would get into too much detail on specific amounts. But to the extent that the pump is deferred, we've been able to offset that either with sales of spectrum or other product sales. So it's definitely underlying in our guidance.
Matt Taylor:
Thank you, Jay.
Jay Saccaro:
Thanks Matt.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning and welcome to Hill-Rom’s Fiscal Third Quarter 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Hill-Rom and is copyrighted material. It cannot be recorded, rebroadcast or transmitted without Hill-Rom’s written consent. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Senior Vice President, Corporate Development, Strategy and Investor Relations. Ms. Ladone, you may begin.
Mary Kay Ladone:
Good morning and thanks for joining us for our fiscal third quarter 2021 earnings conference call. Joining me today are John Groetelaars, President and Chief Executive Officer of Hill-Rom and Barbara Bodem, Chief Financial Officer. Before we get started, let me begin by reminding you that this presentation includes forward-looking statements that are subject to risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from those described, including any impact related to the COVID-19 pandemic. Please refer to today’s press release and our SEC filings for more information concerning risk factors that could cause actual results to differ materially. In addition, on today’s call, non-GAAP financial measures will be used. Reconciliations between GAAP and non-GAAP financial measures are included in our earnings release issued this morning. Finally, I would also like to mention that in addition to the press release, we have posted a supplemental presentation which highlights Hill-Rom’s performance and our 2021 financial guidance. These materials can be accessed on the Investor Relations page of our website. So with that introduction, let me now turn the call over to John.
John Groetelaars:
Thanks, Mary Kay and good morning, everybody. Let me begin with a review of our fiscal Q3 financial results, which reflect another strong quarter of execution by our Hill-Rom team. We continue to see building momentum and recovery in the underlying business. This resulted in third quarter financial performance that exceeded expectations. This clearly illustrates the benefit of Hill-Rom’s transformation, the resiliency of our portfolio, and our ongoing commitment to advancing connected care. As previously highlighted, last year in Q3, we benefited from one-time COVID-related demand, generating approximately $130 million in revenue and adjusted earnings of $0.60 per share. With this challenging comparison, Q3 revenue declined 6% on a reported basis. Excluding the COVID headwind, revenue advanced 10% on a constant currency basis, fueled by stronger than expected performance across the vast majority of the portfolio. Adjusted earnings of $1.38 exceeded our guidance range of $1.32 to $1.36 per diluted share. Given our strong performance over the course of this year and positive recovery dynamics, we are pleased to be raising our financial guidance across all metrics for fiscal 2021. Even with the unprecedented impacts from the global pandemic, Hill-Rom has successfully navigated a challenging environment and will have delivered double-digit EPS growth over the last 2 years, something we are very proud of. Looking forward, we remain very committed to our category leadership strategy with new product momentum, international expansion, emerging market growth and creating value through portfolio transformation and business development, all of which further strengthened our durable growth profile. Let me take a few moments to share a few highlights. First, we are making excellent progress with our strategic focus on connected care. One measure of success is the growth we are achieving from our connected care solutions. We define this measure as devices and software that can collect, analyze or communicate information back to caregivers. Examples span across all three businesses and include our care communications platforms, connected monitoring devices, intelligent diagnostics and connected devices and software for the operating room. We are pleased to report today nearly one-third of Hill-Rom’s revenue is connected versus less than 20% of revenue just a few years ago. For fiscal 2021, we are on track to realize growth of more than 20% from across this connected care portfolio. We look forward to updating you on this important metric going forward as it reflects the evolution and advancement of Hill-Rom’s compelling transformation. It’s also worth noting that we do not include our connected smart beds in this measure, which as you know, represent another 20% of Hill-Rom’s annual revenue. Turning to new products, we remain on track to exceed our objective of $620 million in new product revenue for 2021. Year-to-date, we have achieved new product revenue of more than $480 million, an increase of 11% and we have launched 10 new products over the course of the year. Our new product pipeline is robust and remains weighted towards our connected care growth platforms, which is intended to boost our overall weighted average market growth rate towards mid single-digits in the years to come. On the international front, given tough year-over-year comparisons due to COVID, revenues were down, but the underlying business grew in low single-digits. Our top performing region was Asia-Pacific, with 10% growth in the quarter. We continue to see strong China performance as revenues more than doubled in Q3 off of an easy prior year comparison related to the pandemic. In terms of M&A, we continue to transform our portfolio with a growth-oriented strategy. We remain focused on deploying capital with a disciplined approach adhering to our rigorous strategic and financial criteria to drive attractive returns and shareholder value. Over the last 2 years, we have deployed capital of approximately $350 million across 6 transactions. In fiscal ‘21, these acquisitions are expected to contribute approximately $80 million in annual revenue and collectively generate organic growth of more than 30%. M&A has been and continues to be an important part of our overall growth strategy. With improved balance sheet flexibility, we are in a strong position to enhance our category leadership and further our growth objectives. We remain active in evaluating additional tuck-in opportunities that are aligned with our connected care vision, enhance our business and improve outcomes for patients and their caregivers. Now, let me briefly review performance by business at constant currency rates. First, as you may recall, our Patient Support Systems business generated record last revenue year of 21% growth. The business benefited from the global surge in demand for ICU and med surg bed systems as hospitals around the world expanded capacity in the early phase of the COVID outbreak. This translated into the PSS headwind of more than $105 million, resulting in the expected Q3 revenue decline of 18% when compared to the prior year. However, excluding last year’s one-time COVID benefit, PSS revenue growth was 9%, reflecting sequential improvement and underlying growth of our bed systems and rentals as well as strong demand for our care communications platforms. In care communications, revenue increased more than 35% in Q3, setting the stage for sustained acceleration. This business remains an important platform within our connected care ecosystem in the acute care setting and is on its way to comprising nearly 10% of Hill-Rom’s total annual revenue. In frontline care, third quarter revenue increased 3%. However, excluding last year’s one-time impact from the ventilator stockpile orders of approximately $25 million, growth was 14%, representing the highest quarterly growth rate since the Welch Allyn acquisition in 2016. Solid performance was driven by accelerated recovery as physician office visits returned to pre-COVID levels as well as the continued contribution from new products, including the RetinaVue Imager for screening of diabetic retinopathy. Lastly, Surgical Solutions revenue increased 8%, reflecting strong growth in operating room tables, including record placements of Integrated Table Motion as well as patient positioning products as surgical procedures rebound. This more than offset the difficult comparison from the completed exit of the international surgical OEM business. Excluding the surgical OEM revenue in Q3 last year of approximately $13 million, surgical revenue growth exceeded 30%. Overall, we are very encouraged by the positive momentum and growth in our surgical order book and backlog, a strong indication that hospital constraints are easing and providing enhanced visibility into growth acceleration for fiscal 2022. Before turning the call over to Barb, I’d like to update you on the Bardy Diagnostics transaction. Following the Delaware Court of Chancery’s ruling 2 weeks ago, we thoroughly explored and assessed a variety of strategic options. We have now concluded that the best path forward for our company and for our shareholders is to complete the transaction under the previously announced terms. Even with recent reimbursement decisions, we have renewed confidence in the underlying strength of the Bardy business, the value Bardy solutions provide to caregivers and patients and the opportunities that lie ahead for the Bardy portfolio as part of Hill-Rom. Although this didn’t turnout as originally contemplated, we believe there is a compelling strategic rationale for the acquisition. Bardy’s differentiated diagnostic cardiology platform is complementary and further strengthens Hill-Rom’s existing cardiology portfolio and our connected care vision. We expect to be able to leverage our brand and presence in the acute and primary care settings and capabilities around market access, payer contracting, data security and EMR integration to accelerate the adoption of Bardy’s CAM patch, among other solutions. Additionally, the Bardy technology and innovation capabilities will enable us to advance the roadmap of our digital transformation. As for the reimbursement landscape, once we closed the transaction, we will be in a better position to work directly with reimbursement decisions with CMS and Medicare administrative contractors, including Novitas, to ensure that patients have access to critical life-saving monitoring solutions at appropriate and accessible prices. We look forward to closing the acquisition in the next week or so and welcoming the Bardy team to Hill-Rom. With that, let me now turn the call over to Barb.
Barbara Bodem:
Thanks, John and good morning everyone. I will briefly walk through our financial results before turning to our updated guidance. As mentioned, worldwide revenue in Q3 of $718 million declined by 6% on a reported basis compared to $768 million in revenue last year. Revenue declined 9% on a constant currency basis. Excluding last year’s one-time COVID benefit of approximately $130 million, revenue growth was 10%. Adjusted gross margin was 52.2%, which exceeded our expectations. This is 160 basis points below last year’s record gross margin of 53.8%, which included a benefit of 230 basis points from one-time COVID-related purchases. Excluding the COVID impact, our gross margin expanded 70 basis points due to continued favorable product mix and operational improvements. R&D spending of $36 million or 5% of total revenue was in line with expectations and nearly $2 million higher than last year. Adjusted SG&A of $202 million increased 3% as we continue to invest in our strategic growth platforms, while also realizing benefits from our business optimization program implemented last year. As a result, the adjusted operating margin was 18.9%. Interest and other non-operating expenses totaled $19 million and the adjusted tax rate was 21%. Overall, this translates into an adjusted earnings for the fiscal third quarter of $1.38 per diluted share, a decline from the record set last year of $1.95 per diluted share. Now, turning to cash flow. Cash flow from operations for the first 9 months of 2021 was $410 million, a 30% increase compared to prior year, primarily driven by higher net income and favorable change in working capital. Capital expenditures on a year-to-date basis totaled $69 million, $3 million lower than the prior year, which includes the investment we are making in our global information technology transformation. As a result, year-to-date, free cash flow was $341 million, an increase of 41%. Our balance sheet and financial position remains very strong. To-date, we returned $186 million to shareholders through dividends and share repurchases and we raised our dividend for the 11th consecutive year. We ended the quarter with $272 million in cash and our debt to EBITDA ratio at the end of June was 2.6x or 2.2x on a net basis. Now, let me conclude my remarks with our updated fiscal 2021 guidance. As John shared earlier, we now plan to close the Bardy Diagnostics acquisition in the coming weeks. Therefore, our fourth quarter and full year guidance now includes Bardy. Despite modest solution related to the Bardy transaction, we are pleased to be raising our revenue, adjusted earnings and operational cash flow guidance for fiscal 2021. So, for the full year, we now expect revenue to increase 3% to 4% on a reported basis, which includes the benefit from foreign currency of at least 150 basis points. Excluding the COVID impact in both the current and the prior year, our underlying revenue growth is expected to be 5% to 6%. By business segment at constant currency rates, we now expect Patient Support Systems revenue to decline between 1% and 2%; Front Line Care revenue to grow between 5% and 6%, which includes Bardy; and finally, we continue to expect Surgical Solutions revenue of 3% to 5%. From a profitability perspective, we continue to expect adjusted gross margins of approximately 52% and an operating margin of approximately 19%. We continue to expect R&D to approach 5% of sales and SG&A to represent approximately 28% of revenue. We continue to expect other expense which includes interest of approximately $60 million reflecting estimated savings related to bond redemption and our tax rate of approximately 20%. This translates into adjusted earnings of $6.08 to $6.12 per diluted share for the year, which reflects double-digit adjusted earnings per share growth. Excluding the COVID impact from both the current and the prior years, our updated guidance contemplates earnings per share growth of nearly 20%. From a cash flow perspective, we are now expecting operating cash flow of approximately $480 million an increase of $30 million at the midpoint compared to our prior guidance of $440 million to $460 million. We continue to expect capital expenditures of approximately $100 million, resulting in free cash flow of approximately $380 million. For the fiscal fourth quarter 2021, we expect revenue growth of 6% to 7% on a reported basis and expect adjusted earnings, excluding special items, of $1.44 to $1.48 per diluted share. As a reminder, last year in the fourth quarter, one-time COVID-related purchases contributed revenue of $35 million and estimated earnings per diluted share of approximately $0.10. Excluding the COVID impact, we expect Q4 revenue growth of 10% to 13% and adjusted earnings per share growth of 35% to 38%. I would highlight that our fourth quarter outlook continues to reflect recovery momentum in the underlying business as we exit this fiscal year and does not include any COVID-related purchases. The ongoing scope and evolution of the pandemic remains uncertain and could present pandemic-related risks or opportunities that may require updates to the fiscal 2021 guidance ranges provided today. And now I will turn the call back over to John.
John Groetelaars:
Thanks, Barb. In summary, we reported solid results for Q3 and raised our guidance for the third consecutive quarter. We are on track to deliver another year of strong financial performance with underlying mid-single digit revenue and double-digit bottom line growth, showcasing the benefits of our diversified portfolio and optionality it creates as we successfully navigate challenging events like the global pandemic. Importantly, we continue to generate this high level of performance, while investing in our business to drive accelerated and sustainable growth in the future. We appreciate that many of you are evaluating Hill-Rom’s growth prospects and opportunities beyond the current fiscal year. And while it’s too early to provide detailed 2022 guidance, we want to reiterate our conviction and commitment towards our previously disclosed long-term growth profile. This includes mid-single digit revenue growth and double-digit EPS growth for the future years. Specifically for fiscal 2022, we expect the floor of our guidance range to reflect this profile after adjusting for the one-time COVID-related benefit in the first half of fiscal ‘21. This benefit includes approximately $80 million in revenue and adjusted earnings of $0.40 per share. Obviously, there continues to be uncertainty regarding the pandemic, the effectiveness of vaccination efforts and resurgence of new variants. These factors as well as the underlying strength of the portfolio, the impact of the Bardy transaction and mitigations around a rising cost environment are all contemplated in this outlook. Let me close by once again thanking the Hill-Rom team around the world for their resilience, unwavering commitment, passion for meeting the evolving needs of our customers and their winning spirit. Our vision of advancing connected care is more vital than ever. By successfully executing on our strategy, we look forward to unlocking significant value for patients, caregivers and shareholders as we deliver on our mission. That concludes our prepared remarks. And now I would like to open it up for Q&A.
Operator:
[Operator Instructions] Our first question comes from Rick Wise of Stifel. Your question please.
Rick Wise:
Another excellent quarter and the beaten rates. I am going to start off, hope not in an uncomfortable place, there has been a few rumors and speculation in the market as you know. I am sure you don’t want to address them specifically. But I thought that maybe a way to ask you about it would be to ask the following question. John, where do you see yourself – where does the Hill-Rom team see themselves and what I know is a multiyear positive transformation, acceleration in growth, margin expansion? And is there anything as we contemplate the future that you might be as a team better able to achieve inside maybe a larger portfolio or access to greater capital or something that you could do better to reach those goals as opposed to independently pursuing a clearly positive plan that’s underway?
John Groetelaars:
Yes. Thanks, Rick. As you can appreciate, we can’t comment on rumor or speculation. What I can say is that we are laser-focused on driving our strategy of connected care and category leadership, and we are very pleased with the progress we are making. To your question, where are we in the journey, my point is a statistic that we shared on the call today that 30% of our revenue today is connected care devices, and it’s growing at 20%. So as a proxy, we think that’s a very important metric that we will continue to update investors on. So, you might say that we are one-third of the way there. And we have two-thirds of our portfolio to go to turn it into a complete connected care portfolio growing at those kind of market growth rates. And as you may have seen in our slide, Slide #8, you will see that those growth categories of care communications and connected monitoring, that – those are the highest growth categories that we are in, double-digit growth categories. If we can move our entire portfolio into double-digit growth markets, I would say we have achieved our objective.
Rick Wise:
Got it. That’s great. And just as a second question, a follow-up on the guide. Totally understand the fourth quarter guide. And I appreciate the comments and sort of early setup and look at ‘22. But just – sorry to use your words against you here, John, but I mean, my goodness, a third of the portfolio growing more rapidly in the rest, ten new products still launching, markets recovering, the acceleration in investments, continuing M&A, the great balance sheet, why should we believe you? And I say that with a smile. When you talk about mid-single digit fiscal ‘22, as a way to start, why wouldn’t it be given all these things that are happening and recovery and portfolio mix, why wouldn’t we be sort of thinking that instead of your 5% plus language that you used in the past, why are we thinking 6% plus as we contemplate the year ahead? I know you are conservative, but anyway, thank you for the question.
John Groetelaars:
Yes. Thanks, Rick. I appreciate that. And you take it with a smile. I can see in your face. We are very pleased with the progress, right. If I just start with the stripping out all these COVID factors for this year, we would be first half of the year flat growth on the top line. We just reported 10% in Q3. And our guide in Q4 is 12% plus. So, we like the momentum we see in the underlying business and are very pleased with the progress that we are making with all of the various investments you outlined through M&A, through new products, through connected care, through emerging markets. So, those are all clicking. It’s a little bit early for us to provide guidance for 2022. And we like having a stellar record of meeting or beating guidance that we put out there. I think we have done that now 16 quarters in a row. We will be measured and will be balanced in our outlook. And as we get closer to each of the quarters, we will update you. But there is reason for optimism. We are comfortable with where consensus currently sits. And we will, in the next couple of months, close out our year and talk about ‘22.
Rick Wise:
Thanks John.
Operator:
Bob Hopkins of Bank of America is on the line with a question. Please state your question.
Bob Hopkins:
Great. Thank you and good morning. So, just a follow-up there on the ‘22, I guess, John, I heard you like – when you contemplate all the things that you mentioned there, that now the party is happening and all the things you see and kind of dealing with the comparisons on COVID that you are – where it stands today, you are roughly comfortable with how consensus modeling for next year at this point. Is that the message on next year?
John Groetelaars:
Yes.
Bob Hopkins:
Okay. Great. And then couple of other really quick things on Bardy, can you just give us a sense for what that is growing today, how things are progressing with that business? And I just want to make sure that previously, you had said kind of whatever happens with Bardy, you won’t let it disrupt the double-digit EPS growth outlook. Just want to confirm now that that’s officially part of the portfolio or going to be that, that remains the same. So, how is Bardy doing now and still have that same 10% commitment even with this deal now going to close?
John Groetelaars:
Yes, sure. Great question, Bob. When we – obviously, we were in litigation for several months with Bardy. We didn’t have visibility to their performance during that period. But a few weeks ago, we got visibility to it. And we were extremely impressed with the execution of the team has continued to work against. To answer your question about growth, it’s well over 50% growth in revenue on a year-over-year basis. It’s going to contribute even just in two months of our fourth quarter. There will be 100 basis points of inorganic growth. And we expect there will be a minimum of 100 basis points of inorganic growth next year as well at gross margins better than the company average. From a dilution point of view, obviously, a cut in reimbursement for roughly 30% of the business does have a bottom line impact. It’s about $0.04 to $0.05 this quarter. And as the business scales into next year, that kind of quarterly dilution rate will subside. And we have a lot of levers inside the company. We are a big diverse company. We have a lot of levers we can pull to offset dilution. So yes, there is some dilution in ‘22, but nothing we feel we can’t handle and incorporate as we manage this business going forward. What we – but we still love the Bardy team, the Bardy technology, it is growing at 2x to 3x market growth rates. It’s highly differentiated. It is exceptionally good at diagnosing cardiac arrhythmias. And we bring a tremendous amount of capability with EMR integration and market access and payer relations, not to mention the important, really important work of Medicare and MAC pricing decisions that will be forthcoming in the near future. So, we intend to lean in on all those items and really help the business accelerate under our ownership.
Bob Hopkins:
Great. Thanks very much. I will get back in the queue. Thank you.
John Groetelaars:
Thank you, Bob.
Operator:
Mr. Michael Polark of Baird is on the line with the question. Please state your question.
Michael Polark:
Hi, good morning. I will double-click on the Bardy thread there on reimbursement, John. I would just love to get your latest thoughts there. I mean I think the current posted Novitas rate in Houston, $115, what do you think is a realistic outcome here and over what time horizon? Whether that would be through the contractors or with Medicare, would love to get your update there now that you are moving forward with the transaction?
John Groetelaars:
Sure. Thanks Mike. Another really important part of our diligence or evaluation of strategic options in the last few weeks and we are really pleased with the progress Bardy was making as well as the work that they were doing with other industry players. And without getting into specifics, we feel confident that positive changes can be made with either CMS or the MAC or Novitas in the coming months that we can make some progress to advance those discussions. And we are hopeful that a more positive reimbursement rate will follow for calendar year ‘22. No promises yet. We haven’t factored in that kind of upside into our outlook. But there is reason to have hope that, that could be in the cards for the next calendar year.
Michael Polark:
Appreciate that. And I know you don’t know, the old rate round numbers, $300 range, $115, do we – what are you seeing something with a higher 1, with a 2 on it, back to the 3 order of magnitude? What are we talking about here?
John Groetelaars:
Yes. I think, Mike, you or maybe another sell-side analyst observing that the proposed higher rate of mid-400s was probably viewed as too high. And then the current, certainly, the $55 initially, now the $110 Novitas rate was viewed as too low. So, I think someone was framing it that way. And that seems like a reasonable way to frame it. I am not going to put a number out there. But at its current level, it’s not sustainable for appropriate access for Medicare patients. That, we all agree on. And that’s the case that we need to present data to the MAX and Novitas and CMS that that’s not a reimbursement rate that is viable and does not provide appropriate access for these patients. So we will see where those discussions end up. But we – I think we all in the industry side and those who have accessed this information and see what the true cost of delivering service and the devices is all can agree that the current reimbursement rate is too low.
Michael Polark:
If I can sneak one last one in on Teracom, shifting gears, heard about a good revenue growth rate in that business in the quarter. I would be curious what the forward-looking indicators look like, new bookings in the period, backlog development? Your close peer in that space out with another positive set of numbers last night, so I would love your comments, John.
John Groetelaars:
Yes. I mean in our prepared remarks, we commented it grew 35% in the quarter, which was an acceleration from Q2 at 15%. We’re really pleased with our broad portfolio of offerings there. We generally don’t comment on the details of our backlog. But I will tell you that, that large deal that we discussed several quarters now is underway. Orders are being received and being shipped. We will expect to see some revenue recognition in our current fourth quarter. And with that in our pipeline and into next year, we continue to expect double-digit growth in that overall category.
Michael Polark:
Thank you so much.
John Groetelaars:
Thank you.
Operator:
Drew Ranieri of Morgan Stanley is on the line with a question. Please state your question.
Drew Ranieri:
Hi, everyone. Thanks for taking my question. John, just to touch on the Breathe acquisition that you made some time ago, just like to get – you made some time ago, just like to get it there, now that we’re kind of getting back to normal in the environment, kind of what’s your vision for the product in the home setting and maybe what investments are you going to be putting behind the product to kind of really see that vision playing out?
John Groetelaars:
Yes. Thanks for the question. We’re – the COVID period of time was very challenging for that component of our respiratory health business, because respiratory therapists were so busy with COVID patients. Now returning to normalcy of workflow and patient therapies that respirologists and respiratory therapists are dealing with, we’re seeing really nice traction resuming in the last couple of quarters with our at-home ventilator product, which is the Life2000 device. And we’re kind of back on track with the trajectory that we had shortly after the acquisition. As you’ll remember, last year, we had a very large stockpile order for that ventilator product. And now that we’re passing in Q4, we will pass the comp of that, which we passed part of it in this last quarter, but it’s a significant, I think, $25 million comp in Q4. And once we cycle past that, we will start to see more transparently the performance of that business. But we’re really pleased with the rate of prescription growth and the rate of placements in the home for that therapy.
Barbara Bodem:
Drew, just to clarify, the $25 million year-over-year comp was in Q3, and it’s about a $10 million headwind in Q4 on Breathe. And excluding the COVID impact, this business continues to generate double-digit growth.
Drew Ranieri:
Okay. Great, thank you. And just shifting gears to the Surgical Solutions business. John, you talked about constraints being lifted in the hospital environment. But just maybe talk about the remaining opportunity that you see for Integrated Table Motion. I know you said record placements in the quarter. And then just help us frame the order book backlog, anything that you can give to just show us the health of the business would be appreciated. Thank you.
John Groetelaars:
Yes. Obviously, now that things are normalizing and access has largely normalized, we’ve been building a backlog and an order book during the last six quarters, and now that’s starting to get deployed. So we’re really pleased with the performance there. As we talked about in our prepared comments, GSS grew at 80%, excluding COVID. But if you take out the OEM exit, it’s actually 30%. And then if you look into Q4, we expect that growth rate at that high, high double-digit growth to continue. And we’re really excited about the new Helion launch, which is our, really, our first truly connected OR integration product. It is such a cool product for you to see. If I can definitely demonstrate it one day for you, but without the surgeon touching anything, they are able to control all the video elements that are going on in the OR, all the video, the imaging elements, other data that they need to use to navigate during the procedure and have access to timely information. This is really truly next-generation integration in the OR. And we’re very excited about the opportunities for that platform to serve as our OR connectivity hub as we build out additional digital solutions in the operating room. So we’re excited about that business. We’re really excited about the new launch for Helion. On Integrated Table Motion now that, again, robotic placements start picking up, our attachment rate to that robotic system is extremely high. So we’re pleased with that performance, too.
Drew Ranieri:
Thanks, John. And just one last one on the China performance in the quarter, you called out double-digit growth but on an easy comp, would just like to hear maybe an update on that segment of the business where you’re seeing the most growth? And just remind us kind of where your emerging market penetration is today and what the growth options are going forward? Thank you.
John Groetelaars:
Yes. Just to clarify, Asia Pacific was up 10%, but the China business last quarter doubled, wasn’t double digit. We have had double-digit growth in China for eight of the last nine quarters. There was one quarter during the pandemic where it went backwards. But otherwise, we’re very pleased with the traction we’re seeing there and continue to believe we have significant untapped potential in our China market for our portfolio.
Drew Ranieri:
Thanks for taking the questions.
John Groetelaars:
Thank you.
Operator:
Matt Taylor of UBS is on the line with a question. Please state you question.
Matt Taylor:
Hi, thanks. Can you hear me, okay?
John Groetelaars:
Yes.
Matt Taylor:
Great. So the first question I wanted to ask you is now that you just reported a quarter for the first time in a while that hasn’t had this COVID impact, could you talk about your ability to grow in fiscal ‘22 over what you still have tough COVID comp in the first half? Or should we continue to see any COVID benefit going forward? Or is that all done?
John Groetelaars:
Yes. We’re not calling out any expected COVID benefit in the future. We didn’t see anything in Q3, don’t expect any in Q4. So with the exception of the $80 million of benefit that we saw in the first two quarters this year, $40 million each quarter on top line, that’s the comp or the headwind that will overcome as we enter ‘22.
Matt Taylor:
Okay. And could you make any comments on your ability to grow over that comp based on the interest in the underlying business?
John Groetelaars:
Look, I think the underlying business, I will repeat those metrics. I think the progression we’re seeing on the acceleration of our performance this year. If you do apples-to-apples, excluding COVID, Q1 and Q2 were flat. Excluding COVID, we had a COVID benefit in Q1 and Q2 that drove the growth. If you strip that out as flat, Q3 was 10% growth and we expect Q4 to be 12%. So, that’s pretty good progression. We are very pleased with that progression. We will obviously have some headwind comps to overcome in Q1 and Q2. And once we finalize guidance for ‘22, we will be here in 3 months talking about it.
Matt Taylor:
Okay, okay. And then this may be an unanswerable question, but I have to ask because there is been speculation about turning down $144 offer. Could you just offer some thoughts on what you think the business is worth? And I guess if there was an approach from someone, notwithstanding the rumors how would you think about addressing that kind of an approach?
John Groetelaars:
Yes, I can’t comment on those kind of rumors, Matt.
Matt Taylor:
Okay, alright. Thanks, John.
John Groetelaars:
Thank you.
Operator:
Matthew Mishan of KeyBanc is on the line with a question. Please state your question.
Matthew Mishan:
Hey, good morning. Just first, can you guys give us a sense of the earlier actions in the docs, on the digitalization of the physical assessment tools?
John Groetelaars:
Yes, great question. This is our enhanced physical assessment tools. It adds a smartphone technology to otoscopes and ophthalmoscopes. And the initial response has been very strong. We’re seeing a lot of great use cases that we expected. The ability to capture images, store them, see disease progression, share them with other caregivers or share with family members are all the things we expected would delight those customers. There hasn’t been that kind of innovation in this space for a long, long time. So we’re super excited about the feedback we’re getting. And we think it’s going to bring growth to a large category that is largely been flat year-over-year for many years.
Matthew Mishan:
And then a follow-up on Breathe, have you seen any opportunity from a competitor ventilator recall?
John Groetelaars:
I’d say nothing material to date. We’re looking closely at ways we can help meet patient needs and demand. But we haven’t directly seen any benefit there.
Matthew Mishan:
And then the last one as a follow-up on Bardy, I just want to make sure I understand. I think when you announced it, you said it would be $0.10 dilutive, but it would be captured within the range. It wasn’t part of guidance before it now is part of guidance. And it’s $0.04 to $0.05 dilutive to the fourth quarter, which you could have – if it wasn’t part of it, your EPS would have been a little bit higher. Is that correct?
John Groetelaars:
That’s exactly right, Matt.
Matthew Mishan:
Okay, alright. Thank you very much.
Barbara Bodem:
Brancy, it’s time for one more question.
Operator:
Thank you. Mr. Mike Matson of Needham & Company is on the line with a question. Please state your question.
Mike Matson:
I wanted to ask about Slide 9, where you show the change in a portion of your business that’s coming from connected care. I mean I don’t know if you can answer this, but how much of that 15% to 30% increase driven by M&A versus internal product involvement or just growth of the products that you have already?
John Groetelaars:
Sure. Well, of the six acquisitions we’ve done, five of them would be in the connected care category. In total, as we said in our prepared comments, all those acquisitions were $80 million. So of the five that are connected care, the one that’s not is the ventilator, right, the Breathe acquisition. So of that $80 million, I think it’s around $50 million of it would be connected care. So it’s not a material portion of that growth. It’s really just part of it, but it’s not a meaningful material needle-mover.
Barbara Bodem:
Mike, one other point is that about 40% of the connected care revenue is also in the new product bucket that we talk about.
Mike Matson:
Okay. Just in terms of an upper limit. I mean I think you mentioned earlier, John, and you think you get us to 100% of the business. I mean that’s essentially taking things that products that you’re selling and just adding in some sort of connectivity to them essentially or...
John Groetelaars:
Yes. That’s probably more of a hypothetical. Let me clarify that comment. I mean we are at 30% today. Of course, there is no reason to have certain parts of our portfolio connected. So, maybe the upper limit of the practical – we are not going to say anything just for the sake of connecting them. It’s got to add value to the customer. So maybe it’s more like that the upper threshold is probably more like 80% of the portfolio would be benefited by a connected solution. And that’s – it’s also incorporating the mix right, of new products becoming a larger portion of the mix, the acquisitions becoming a larger portion of the mix. And that also helps our gross margin by the way, because these are accretive gross margin products. So, that’s another benefit to these connected care product. As that mix shifts over time and it’s moved quite a bit in the last couple of years as you have seen from that slide on Slide 9 that becomes the growth driver in the company and gives us that gross margin and not margin leverage we are looking for.
Mike Matson:
Okay, got it. Thank you.
John Groetelaars:
Thank you. I think that wraps it up, operator. Thank you for everyone joining the call today.
Operator:
Ladies and gentlemen, this concludes today’s conference call with Hill-Rom Holdings Incorporated. Thank you for joining.
Operator:
Good morning and welcome to Hill-Rom’s Fiscal Second Quarter 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Hill-Rom and is copyrighted material. It cannot be recorded, rebroadcast or transmitted without Hill-Rom’s written consent. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Senior Vice President, Corporate Development, Strategy and Investor Relations. Ms. Ladone, you may begin.
Mary Kay Ladone:
Good morning and thanks for joining us for our fiscal second quarter 2021 earnings conference call. Joining me today are John Groetelaars, President and Chief Executive Officer of Hill-Rom and Barbara Bodem, Chief Financial Officer. Before we get started, let me begin by reminding you that this presentation includes forward-looking statements that are subject to risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from those described, including any impact related to the COVID-19 pandemic. Please refer to today’s press release and our SEC filings for more information concerning risk factors that could cause actual results to differ materially. In addition, on today’s call, non-GAAP financial measures will be used. Reconciliations between GAAP and non-GAAP financial measures are included in our earnings release issued this morning. Finally, I would also like to mention that in addition to the press release, we have posted a supplemental presentation which highlights Hill-Rom’s performance and our updated 2021 financial guidance. These materials can be accessed on the Investor Relations page of our website. So with that introduction, let me now turn the call over to John.
John Groetelaars:
Thanks, Mary Kay, good morning, everybody. We are pleased to present our Q2 financial results, which reflected another strong quarter of execution. As a result, we are raising both our revenue and earnings guidance for the full year. We continue to see momentum building with continued recovery across our portfolio and geographic regions. Hill-Rom’s performance highlights the resilience of our diverse portfolio and our on-going transformation. This strengthens our ability to unlock significant value for patients, caregivers and shareholders as we deliver on our mission. I remain extremely impressed by the passion of our team around the world who are executing against our four strategic priorities while managing a more challenging environment and delivering financial results that exceeded our guidance. Q2 revenue advanced 5% was stronger than expected performance across the vast majority of the portfolio. Operating margin expanded by 280 basis points while we continue to invest in our strategic growth platforms, and benefited from our accelerated business optimization program. Finally, adjusted earnings of $1.73 per diluted share increased 35% versus the prior year. Barb will walk through the updated guidance, which now includes reported revenue growth of 1% to 3% and adjusted earnings of $6 to $6.10 per diluted share. This reflects solid mid-single digit top line growth and high teens EPS growth after excluding the COVID impacts in both the current and prior year. Importantly, we are continuing to deliver this high level of performance while investing in our business to drive accelerated and sustainable future growth. We continue to make excellent progress in advancing our category leadership strategy with new product momentum, international and emerging market growth and creating value through portfolio transformation and business development, all of which further strengthens our durable growth profile. Let me take a moment to share a few highlights. First, new product revenue again grew 20% in Q2 exceeding $160 million. We have now launched seven new products, several of which were highlighted in today's press release that advanced our vision of connected care. We remain on track to achieve our goal of at least 10 new product launches in 2021. And despite a tougher comparison in our third quarter we are on track to exceed our objective of 620 million in new product revenue for the fiscal year. On the international front, revenue increased 6% on a constant currency basis, with double-digit growth across Europe and emerging markets. In Europe, we continue to see healthy growth across the entire portfolio with particular strength coming from a favorable environment where Hill-Rom products have received greater priority. Across other regions, there has been more variability driven by elevated COVID dynamics. In emerging markets, growth was led by China, where our strategic investments continue to pay dividends, resulting in double-digit growth for seven of the last eight quarters. With a targeted go-to-market commercial strategy, on-going recovery and new opportunities, we expect China to continue to deliver strong performance in the coming years. We continue to transform our portfolio with a growth oriented strategy. As you know, we've divested approximately $300 million of low growth, non-strategic revenue over the last several years. And this quarter, we finalized the exit of our international surgical OEM business. At the same time, we've deployed capital towards six acquisitions while adhering to a disciplined approach with rigorous strategic and financial criteria. The organic growth of these completed acquisitions is expected to exceed 30% for the year. We remain focused on driving attractive returns and enhancing shareholder value with our M&A initiatives. Now, let me provide some additional perspectives on our quarterly financial results. For Q2, revenue growth of 5% reflects stronger than expected performance as recovery progressed faster than expected and as we continue on this path towards normalization. Relative to our guidance, one time COVID purchases accounted for about half of the upside, with revenue of approximately $40 million and adjusted earnings at $0.20 per diluted share. This was the result of a steep rise in COVID hospitalizations in January and February. In March, the volume of cases began to decline. And as a result, we are not anticipating any material one time COVID purchases in the second half of our fiscal year. Now let me briefly review the performance by business at constant currency rates. First, patient support systems revenue increased 2%, which includes the one-time COVID benefits mentioned earlier. PSS performance reflects strong international growth of 12% driven by continued market expansion of med-surg and ICU bed systems across Europe and other markets. This performance is the basis of our optimism on a long term potential to expand international ICU market. In the U.S., bed purchases showed sequential improvement over the last two quarters, but were down versus the prior year. Similar to Q1, bed system rentals were very strong given the rising COVID cases, resulting in growth of more than 20% and care communications rebounded with growth of 15% setting the stage for sustained acceleration. We continue to be very well positioned with our superior value proposition of smart beds, smartphones and connected care solutions. This includes our early sense, contact for a continuous monitoring technology, integrated with our centralized smart bed that helps identify clinical deterioration that can lead to improve survival, decreased costs and decreased need for ICU admissions. We have now activated early sense in over 150 hospitals, and initial feedback has been very positive. One major customer recently noted that they have experienced zero code blues or cardiac arrest since turning on this capability. This further validates the clinical and economic value of our offering that sets us apart from others in the industry. We continue to build on our legacy of leadership and care communications with several new product launches that will allow us to sustain above market growth and double digits as the recovery progresses. This includes the modernization of a traditional nurse called system and new digital patient and visa application on an iPad called Voalte Experience and the Voalte alert and alarm management solution aimed at reducing alarm fatigue, and providing real time streaming of waveforms on a physician’s mobile device to aid in clinical decision making. By expanding these capabilities within the Hill-Rom Connected Care ecosystem, we are delivering significant differentiation and addressing key customer challenges. In Front Line Care, second quarter revenue increased 8%, driven by strong demand for patient monitoring equipment, and accelerated recovery across key products as physician office visits return to pre-COVID levels. Physician based products consist of physical assessment tools, diagnostic cardiology monitors, and vision care products, including retina view for screening of diabetic retinopathy. Year-to-date, Front Line Care has led company performance with revenue growth of 7% new products have contributed over half of this growth. Adding new innovations like the recent global launch of our digital physical assessment tools is a game changer. We aim to improve patient outcomes with earlier and more accurate diagnosis of ear and eye conditions. These new devices are digital image ready and allow for the capture, secure tracking, trending and transfer of images for easy and efficient consultation with specialists. Lastly, surgical solutions revenue declined 9% reflecting strong growth in our tables, including Integrated Table Motion, this was more than offset by the impact of the now completed exit of the International Surgical OEM business and a more gradual recovery in infrastructure projects due to the pandemic. Excluding the surgical OEM business revenue growth was flat to the prior year. Despite first half dynamics in surgical, we remain encouraged by the positive momentum and growth in our order book and building backlog. As surgical procedures bounce back and hospital access constraints moderate, we expect improved performance in this business for the rest of the year. In closing, I want to reiterate how proud I am of our year-to-date, performance and the conference we have in the bright future for Hill-Rom as we continue to drive meaningful value to all stakeholders. This year has demonstrated more clearly than ever, the importance of our vision of advancing connected care. Our strong and diverse portfolio sets a solid foundation for durable growth and other exciting catalysts like new product momentum, emerging market penetration and contributions from completed M&A transactions. We expect Hill-Rom to uniquely benefit from the accelerated transformation of the global healthcare environment. Now let me turn the call over to Barb.
Barbara Bodem:
Thanks, John. And good morning, everyone. I will briefly walk through our financial results before turning to our updated guidance. As mentioned, worldwide revenue in Q2 of $762 million grew 5%, compared to $723 million in revenue last year. Revenue growth on a constant currency basis of 3% was balanced, reflecting the continued recovery of the underlying businesses, and one time COVID benefits of approximately $40 million. Adjusted gross margin was 53.7% and expanded by 250 basis points versus the prior year. This was the result of favorable product mix and operational improvements. The one time COVID purchases accounted for approximately 100 basis points of this expansion. R&D spending of $35 million was comparable to the prior year. Adjusted SG&A of $214 million increased 5% as we continue to invest in our strategic growth platforms, while also realizing benefits of 150 basis points from our business optimization program implemented last year. As a result, adjusted operating margin improved 280 basis points to 21.1%. Interest and other non-operating expenses for the quarter totaled $16 million, and the adjusted tax rate was 20.1%. Overall, this translates into adjusted earnings for the fiscal second quarter of $1.73 per diluted share, which is an increase of 35% from $1.28 per diluted share in the prior year. Now turning to cash flow. Cash flow from operations for the first six months of 2021 was $279 million, a 78% increase compared to the prior year, primarily driven by higher net income and changing working capital. Capital expenditures on a year-to-date basis totaled $53 million, $7 million higher than the prior year, which includes the investment we are making in our global Information Technology transformation. As a result, year-to-date, free cash flow of $226 million has more than doubled versus the prior year. Our balance sheet and financial position also remains very strong. Today, we've returned $86 million to shareholders through dividends and share repurchases. And we have raised our dividend for the 11th consecutive year. We ended the quarter with $270 million in cash. And our debt-to-EBITDA ratio at the end of March was 2.4 times or 2.1 on a net basis. Now, let me conclude my remarks with our updated fiscal 2021 guidance. Similar to last quarter, we have not included the impact of the Bardy diagnostics acquisition in our revised revenue guidance. However, the new earnings guidance range does contemplate sufficient flexibility to absorb deal related dilution in fiscal 2021 under various scenarios. So with that said, for the full year, we now expect revenue to increase 1% to 3% on a reported basis, which includes a benefit from foreign currency of approximately 100 basis points. This compares to our prior guidance of revenue growth in the 0% to 2% range. As John mentioned, we are not contemplating in a one-time COVID purchases and our current fiscal 2021 second half outlook. By business segment, at constant currency rates, we now expect patient support systems revenue to decline between 1% and 3%. Front Line care revenue to grow between 3% and 5%. And finally, we continue to expect surgical solutions revenue growth of 3% to 5%. From a profitability perspective, we now expect adjusted gross margin of approximately 52% and an operating margin of approximately 19%. We continue to expect R&D to approach 5% of sales, and SG&A to represent approximately 28% of revenue. We now expect other expense, which includes interest of approximately $16 million reflected the estimated savings related to our upcoming bond redemption and we now expect a tax rate of approximately 20%. This translates into adjusted earnings of $6 to $6.10 per diluted share for the year, which reflects earnings per share growth of 8% to 10%. Excluding the COVID impacts on both the current and the prior year period, our new guidance contemplates earnings per share growth of 17% to 19%. From a cash flow perspective, we are now expecting operating cash flow of $440 million to $460 million, an increase of $35 million at the midpoint compared to our prior guidance of $400 million to $430 million. We continue to expect capital expenditures of approximately $100 million, resulting in free cash flow of $340 million to $360 million. For the fiscal third quarter 2021, we are facing some challenging comparisons to the prior year. As a reminder last year, one time COVID related revenue contributed revenue of approximately $130 million, an estimated earnings per diluted share of $0.60. As a result, we expect revenue to decline 7% to 9% on a reported basis, and expect adjusted earnings excluding special items of $1.32 to $1.36 per diluted share. I'd also like to highlight that our second half outlook remains unchanged from last quarter, and reflects recovery momentum and the underlying business as we exit this fiscal year. The on-going scope and evolution of the pandemic remains uncertain and could present pandemic related risks or opportunities that may require updates to the fiscal 2021 guidance ranges provided today. And now I'll turn the call back over to John.
John Groetelaars:
Thanks, Barb. We are very pleased with our strong execution in our ability to support our customers during the pandemic. Our first half financial performance has been better than expected reflecting our portfolios resilience and benefits from our company's compelling transformation. Our updated financial outlook remains balanced and achievable. We remain optimistic and the returns in normalization later this year, and the tremendous opportunities afforded to Hill-Rom to improve patient outcomes and the delivery of healthcare while unlocking significant value for shareholders. Before opening up the call for Q&A, I'd like to close by saying that the last year has created new challenges for many, both personally and professionally. As we all faced new realities posed by the pandemic. I'd like to take a moment to acknowledge Barb for her strength and resolve as she has been dealing with their own personal health issue over the last several months. I am pleased to share that she has now completed her treatment and is on the road to recovery. And we continue to wish her well and thank her for the resilience and commitment that she has demonstrated to our organization during this difficult period. So that concludes our prepared remarks. And now I'd like to open up the call for Q&A.
Operator:
Thank you. [Operator Instructions] Our first question comes from Rick Wise of Stifel. Your question please.
Rick Wise:
Good morning, John. Good morning, everybody. Wonderful to see another solid quarter and solid quarter of improvement. And that's sort of my first question. I feel like you were in a way seeing a stronger recovery than we've heard for from others. You know, particularly in Europe, I mean, do you think it's the unique nature of your business? Is it I'm sure it's a combination of your product offering, but maybe the new product offerings, just maybe help us better understand at a high level, what you're seeing, and how that impacts your confidence in your second half outlook?
John Groetelaars:
Yes, thanks, Rick. Appreciate the question. We’re very confident and have high conviction around the transformation steps we've made. And I think we're seeing that play out. We could think about the acquisitions that we made, all around supporting connected care and category leadership, the investments we've made in emerging markets, particularly in China, and then our new products, performance has continued to exceed expectations. So all three of those growth drivers really have laid the foundation for sustained and durable top line performance. As we entered the year, we had to anticipate what was the pandemic would give us in the winter quarter. And I think we've been impressed with our overall performance, both pandemic related, but the underlying organic growth exceeded our expectations with recovery across our Care Comms business, across our physician office, businesses, and really are pleased with the speed of recovery. But it does demonstrate that the parties, the portfolio that does have CapEx exposure is prioritized. And then our customers have prioritized elements of our portfolio that improve patient monitoring, patient workflow, and, and IT investments. And that's really where our, where our current portfolio is nicely positioned. So I hope that captures the elements you're asking about Rick?
Rick Wise:
Yes, thank you. And just, maybe as I speaking two for Barb if I could, maybe help us understand where you are Barb in the business optimization, process and how much more to go And the implications of this programs Barb. And maybe on the guidance front, you can help us just more clearly understand full year guidance implies second half gross margin stepped down a bit. I think if I'm understanding it from the 53.7% in the tech world are more like 52%, if I'm my rough math is right, is that the COVID benefit? Are there other reasons, just making sure I'm understanding the cadence of gross margins in the second half. And I'm thrilled you're feeling better and doing better.
Barbara Bodem:
Thanks Rick. That's very kind of you. With regards to the business optimization, last year, at the end of the year, we announced a $50 million business optimization program for 2021. And we executed that quickly. And that has been in place for the full year. So what you're seeing in the first half of the year is the first half of that 15. So we're well on track there. As to whether or not this is the end of business optimization, it's never the end of business optimization that this was a significant program that we put into place at the end of last year. And that piece is in place, we will always look for opportunities to continue to improve the performance of the business. With regards to gross margin and the guidance, you have it exactly right. But the step down is really related to a not anticipating any further expansion or benefit in gross margin, from our one time COVID sales. We don't expect that the sales are going to be significant in the second half of year, it's not going to be material, and therefore we're not going to see that continued gross margin benefit.
Rick Wise:
Got it? Thank you.
Barbara Bodem:
Thank you.
Operator:
Bob Hopkins of Bank of America is on the line with a question. Please state your question.
Bob Hopkins:
Oh, great. Thanks very much. Just a couple of things I'd love to get some comments on. First, maybe Barb with the guidance, can you just kind of walk through the difference between EPS this quarter versus the guidance for next quarter? I'm sure some of that's COVID versus non-COVID. But the just love to understand the kind of the breakdown of the decline from this quarter versus next?
Barbara Bodem:
So as we as we think about Q3, the key thing to keep in mind is we have a significant comp to overcome from last year. So in Q3 of 2020, we had approximately $130 million of onetime COVID revenue and a $0.60 benefit from that. As we think about our Q2 2021, if you talked about the results this year, at the 173, we're still getting about a $0.20 benefit as we as we look at that. So going into next quarter, and for the second half of the year, we're not expecting to see any continue to one time COVID benefit. We're going to see more of the underlying business and the recovered curves as we improve in the latter half. And that's really what is driving the comparison on EPS from quarter-to-quarter and year-over-year.
Bob Hopkins:
Okay. Great. I just wanted to ask also, John one other question. I guess two things. One, first, just give us any thoughts on Bardy and just kind of maybe some thoughts on next steps from here or catalysts for timelines that we should be aware of? And then secondly, also just want to ask kind of a longer term question, a year from now; hopefully, we'll have some cleaner year-over-year growth rates to look at. And, certainly not asking for guidance for next year. But when you think about the progress you're making with your new products and your growth businesses, by the time we get to the second half of next year, do you think directionally, you can be approaching more of that mid-single digit type growth rates that you aspire to, by that time given the progress you're making, making currently in the in the underlying business?
John Groetelaars:
Yes, sure Bob. Let me take that last question first. As it relates to guidance and looking around the corner into 22. Let me talk about the exit for this year first, and then come around to that. If you take the underlying revenue growth and exclude the COVID impact, our second half top line performance is actually double digits at 10% approximately constant currency growth rate compared to a first half of 2021 that was flat, if you exclude the COVID impact and looking at constant currency rates. So we see a really nice acceleration, first half to second half, removing all the noise of the COVID benefit from last year and this year. And then looking around the corner to 2022, although we're not giving guidance here, we do remain committed to what we've said many times that mid-single digit top line and a double digit EPS growth is something we remain committed to. And excluding the COVID benefit, we feel we can deliver that with confidence. So that's, that's the first question. As it relates to Bardy so obviously, as we're in the middle of litigation. So my, my comments need to be very limited. But I would say, first of all, we do believe and reaffirm our position that our company material adverse effect has occurred, or Mac, and therefore the polling conditions have not been satisfied. We've said this consistently. And although we're not going to speculate on the outcome, we have high conviction and confidence in our case. And that trial will begin next week, starting on May 5, and we would expect a ruling sometime in mid to late June. So I thought I could really save both Bardy this time as far as I’ve said in your prepared comments we looked at all the various scenarios for Bardy and incorporated any potential impact in our guidance with respect to EPS.
Bob Hopkins:
That's great, really helpful. Thanks very much.
John Groetelaars:
Thank you.
Operator:
Larry Kirsch of Raymond James is on the line with a question. Please state your question.
Larry Kirsch:
Great. Thanks. Good morning, everyone. I guess this may be partially for Barb, partially for John, the leverage Barbara; you've talked about now around 2.1 times. I would have to believe that's probably at the low end of your target zone. So, how should we be thinking about, M&A and maybe just a little bit of a refresh on the M&A strategy would be helpful?
John Groetelaars:
Yes, maybe I'll start out with the M&A strategy. We remain busy here, Larry, with a lot of activity going on as normal. And we're pleased with the progress of, of the opportunities in our pipeline will remain focused on shareholder value creation and our financial criteria, as well as strategic fit. But we like what we see there. And then hopefully, in the coming quarters that’s some worth talking about. I'll turn it over to Barb for the remainder of the question.
Barbara Bodem:
So Larry, we, we are really pleased with the cash generation that we've had and are happy that we've created as much room as we do have for additional M&A. Our capital allocation priority has remained the same. So we're going to continue to focus on M&A and where can we continue to grow the business to dividends remains the same. We announced a 9% increase in our dividend earlier in the year that marked the 11th consecutive year of increases so that that approach to dividends is going to be unchanged. We're going to continue to look at repurchases as an opportunity to offset dilution. And then, any excess cash was going to use it to pay down debt and create more capacity for more M&A when the right deals come along.
Larry Kirsch:
Yes, no, that's great. Thank you. And then I guess, second question here, just I guess it's kind of a two part. First, John how you thinking about, the OUS Patient Support business in the second half of the year, and sort of then longer term? And then the second part of the question is, I was really intrigued by early sense now, as you indicated in 150 hospitals, and it made me start to think about, how do you how do you monetize all of this connected care? Maybe you can just kind of refresh us on how you're actually getting paid for these various feature sets that you've got out there?
John Groetelaars:
Yes, sure. I figure to answer that question. So on the international front, first of all, our first half overall international performances now 12%, because of challenging comps in the second half and, and an anticipated slowing of some COVID related purchases around ICU expansion in our PSS, we do expect that to moderate in the second half, as the U.S. begins to pick up steam, and Asia-Pac begins to pick up steam, so all-in-all, that's kind of the way that we see things playing out. We do believe there's still an ICU expansion opportunity, internationally as we've mentioned before, I see capacity as severely limited in many countries across Europe and Canada. And we’ve seen in the last several quarters a spike in that demand and we don’t think it’s just a onetime thing, it’s going to be on-going acceleration of demand and we paid around $200 million in incremental opportunity over the years to come. I’m glad you asked the question on the connected care piece, Larry, because as we think about cancer care, and we've talked about it quite a bit, we've recently gone back and look at our portfolio. And so what part of our portfolio today is connected care? And how fast is it growing. And you might be surprised to learn that the over 20% of our current portfolio, and total revenue is connected care revenue. And it's growing at 20% plus. So we're very pleased with the underlying performance there. It's closely linked in overlaps with our new product launches, because many of our new product launches are aligned around connected care. However, you're really seeing that those investments that are taking place both organically and inorganically are really driving towards the strategy of advancing connected care having a meaningful and material impact to our top line.
Larry Kirsch:
Terrific. That, that's super helpful. Thank you very much.
John Groetelaars:
Thank you.
Operator:
Matt Taylor of UBS is online with a question. Please state your question.
Matt Taylor:
Hi, thank you for taking the question. And Barb, glad that you're doing well. That's good to hear. So I just wanted to ask Barb's question in a slightly different way. I guess if I strip out all the COVID benefits to EPS, if you look at the forecast for next quarter, in terms of the relationship to 2019 it’s growing about 9% I think versus last quarter if I strip that out it would be more like 30%, so can you just talk about the difference in the phasing there if there’s underlying doses between the quarters that are driving that for spending. Can you help us bridge that a little bit better?
Barbara Bodem:
Matt, it’s a great question. I’m glad you gave me an opportunity to come back to the question Bob asked earlier. I think the key difference that you want to think about in both year-over-year on Q3 is really around SG&A spend. So in Q3 of 2020 it would have been very much surprised because we are in the height of the pandemic and activities were all surfaced very much on delivering product to our customers. And so you probably would have seen the lowest point of our SG&A spend relative to where we are today and what we were anticipating for the remainder of the year. And that really is a reflection of two things; one is the normalization of some of the activity and getting back to normal and the fact that we’ve turned on significant investments as we’ve looked at our opportunities to continue to show [ph] top line growth going forward. So as we talked about Q2 performance, in our Q2 performance we showed both the contribution from our business optimization which was about 150 basis point, but that was more than offset by the investments that we are making and best thing and where we want to go going forward. Our commitment around delivering the double-digit earnings per share growth remained strong and we just are looking for those opportunities where our performance on the top line is allowing us to bring investment as they are in. So as you think about that sequential and you think about the year-over-year guidance that SG&A investment is – to the equation for you.
Matt Taylor:
Okay. Great. That makes sense. And then as we think about the second half outlook, you got another COVID benefit deal with purchasing of beds in this quarter, but you’re not forecasting much or any going forward. Are you finally seeing [Indiscernible] now kind of caught up to where they want to be in the short run around being able to manage COVID patients or is it possible that some orders come in this quarter that you are not anticipating in to get more upside I guess towards the end of the quarter when capital typically comes in.
Barbara Bodem:
Certainly in the U.S. John, if you’d like to go ahead.
John Groetelaars:
No, I think we’re there. I think we are seeing normalization. We don’t have any additional upside anticipated in our rental fleet or any surge demand from international that we did see in Q1 and Q2. Now that was anticipated nor put into our guidance for the rest of the year.
Matt Taylor:
Okay, great. Thanks a lot for the color.
John Groetelaars:
Thank you.
Operator:
Michael Polark of Baird is on the line with a question. Please state your question.
Michael Polark:
Good morning. Two from me please. Care communications appreciate the update there in the evolution of the portfolio highlighted some inhibitions as it relates to both. I heard a comment on revenue performance in the quarter, I didn’t hear a comment on bookings or pipeline how that is trending. I recall last quarter, you called out the largest win, in this platform history, curious for any press comments on how the March quarter was from a booking standpoint or how the pipeline looks, next couple of quarters for care communications.
John Groetelaars:
Yes. Hey, Mike, thanks for the question. Bookings are up and continue to look strong. We had a very large deal we talked about last quarter, that's just beginning to flow in terms of orders. And we expect that will continue to accelerate into the second half, with most of the revenue recognition actually happening next year, on that large deal. But we're seeing a very nice recovery. As we said, in our prepared comments, we saw about 15% growth. In the quarter, we expect that to accelerate as we get to the second half of the year, and are very pleased with our performance there in Care Comm. And, the whole portfolio, as you know, between our Nurse Call business, our mobile phone business, the enhancements we've made to a couple of acquisitions, with enhanced alert and alarm management, and now a real time waveforms really provide a such a comprehensive and integrated communication platform, that we're really pleased with how we're positioned in the marketplace.
Michael Polark:
Shifting gears. Do you see business in India, we see that headline, and they're heart-breaking. COVID really taking its toll. Do you have a business there? Number one? And if not, is there there an easy on ramp to do business there to, help that country deal with the stresses and strains that are quite severe at the moment?
John Groetelaars:
Yes, Mike, we do a small amount of business there. In fact, it's not been a strategic focus for us over the last couple of years, just our product mix and the market opportunity we did see a good alignment for the long term. So we have some presence, but it's very minimal at this point. So if we, if we're looking for places where we can help, and we're certainly looking for that opportunity, but as of now, we have not been called to duty, so to speak, to really help out in the crisis.
Michael Polark:
Okay, thank you very much.
John Groetelaars:
Thank you.
Operator:
[Indiscernible] of Morgan Stanley is on the line with a question. Please state your question.
Unidentified Analyst:
Hi, John. And I just wanted to kind of go back to CareCom for a second. So you were just mentioning the comprehensive portfolio, it's clear that it touches many aspects of the hospital. But can you maybe talk about the opportunity you have in front of you to add existing hospitals to upsell the entire portfolio versus just entering new accounts? Just kind of want to get the magnitude of the opportunity at existing accounts versus what you could even go with for new accounts coming up?
John Groetelaars:
Yes, true. Good question. I would say the majority of our revenue growth is coming from existing installed base. Slightly more than half of that growth would come from upselling and cross selling between the mobile platform, the alert, alarm management, and MDI opportunity, medical device integration, opportunity. And, and our installed base with Nurse Call and moving into the mobile space. So for us, it's been it's not always, it's not always taking out a competitor, it's really enhancing the systems that are in place, integrating them more efficiently, and more effectively to drive a better clinical workflow and better outcomes and really better productivity for the healthcare system, which, which is why it's so well positioned in the, in the current environment, especially on a kind of post event analysis, or post mortem analysis of COVID and the stresses and strains that put on the acute care systems. How can they do more with the same resources? And as hospital volumes ramp up in a post COVID environment? So we're like, I think Mary Kay might have a comment she wants to add to that, but I think that's, how I would answer it.
Mary Kay Ladone:
Yes, Drew, the total market as we look at it is about a $2 billion market from a mobile platform perspective, and that's less than 25% penetrated today. So as John mentioned, it's more about penetration and increasing penetration versus, competitive games.
John Groetelaars:
And one final comment Drew, you made that investors may not be aware of this, but it's mandatory that Nurse Call systems are installed in every hospital, right. So by virtue of that, we have a nice footprint already because we're a leader in the Nurse Call business. So we have a natural opportunity to upsell, both, our next generation Nurse Call system, which we just announced, as well as cross sell into mobile platforms.
Unidentified Analyst:
Got it? Thanks for thanks for the color there. And then just two last questions, just one on physician offices. John, can you just talk about the recovery trends you're seeing in physician offices? Are they 80% 90% back to normal? And how much pent up demand is there for evaluating new product launches? And then the second question is just touching on Breathe the acquisition made a couple of years ago, but besides you're looking to get past COVID, can you just talk about any investment and or development plan you have for Breathe to bring it to the home? Thank you.
John Groetelaars:
Yes, okay. So on frontline care, or specifically, in the physician offices, we're pretty close to pre-COVID levels right now. It’s probably 95% ish, in that range. And we would expect that it gets back to normalization in the second half of the year. So that's, that's very positive. And, the second half year of comps for our frontline care division has the Breathe or non-invasive ventilation comp in there, and that was $30 million last year. So from a full year growth perspective, we expect 3% to 5% growth. But if you exclude the stockpiling orders, we're the high single digit growth rate for the second half of the year, which is similar to the first half of the year. So, consistent performance out of our Front Line Care business, first half and second half as we look at the total portfolio. With respect to Breathe, the opportunity there was is primarily in the home and in a non-acute environment, and taking ventilation into the home, and, and allowing patients who have COPD or other chronic conditions, to avoid hospitalization, and to get their ventilation therapy has been home, and to be mobile and ambulatory, in the process. So we would like we continue to like that opportunity. We're seeing that underlying prescription volume grow for the Breathe device. And we would expect it to be a growth driver for many years to come as that market expansion continues to take shape.
Unidentified Analyst:
Thank you, John.
Mary Kay Ladone:
Casey, we have time for two more questions.
Operator:
Thank you, Matt Mishan of KeyBanc is on the line with a question. Please state your question.
Matt Mishan:
Thank you for taking the question. Hey, John can you give us an update on that you roll out where you are with a large retail pharmacy partner you talked about last quarter?
John Groetelaars:
Yes, we're excited about it. Matt it's really in the early phases of rollout. The equipment's being placed in various locations in a retail environment. Shipments began for that in Q2. And we would expect as those get connected and training occurs that the recurring revenue portion of that begins to occur late this year and into next year. So everything's on track, very pleased with the way it's rolling out, exceeding our expectations and exceeding, I think creating delight in the eyes of our retail partner there.
Matt Mishan:
Okay, can you can you name the retail partner yet?
John Groetelaars:
No, it's still waiting to do a bigger announcement later this year, but there'll be a similar name.
Matt Mishan:
And then, you mentioned digital capture images for the new physical assessment tools that get the center specialist. I mean, maybe speculate a little bit. Are you contemplating the strategy with those tools, your own network of specialists?
John Groetelaars:
That is one of the potential opportunities there. They're probably a little longer term, Matt in the near term. I mean, the ability to this is such an exciting product. I mean, we all know, we use physical assessment tools. We've had over scripts and family skills news on all of us in our kids, many, many times. But this is the first time we're able to first of all, get a better image, we've actually made improvements to the lighting and the image quality itself. But now we're going to actually capture it digitally. And by doing that, we can we can archive it, we can share it, we can get a referral. It's going to be recorded in the EMR. So you'll have a longitudinal history that's going to develop over time of these images to track the progress of ear and eye diseases. So we're excited about that and does it create an opportunity for a retina view type business. It could, it could and something will evaluate. I think importantly, also, it could help enable a further reach of telemedicine because now you can remotely capture images and share them. It doesn't need to be a synchronous telemedicine visit. But it could be an asynchronous visit where you have an image captured in a review that just like you would a lab result during a telehealth visit. So we're excited about it from many angles, first time in many, many years, if not decades, where innovations were brought to the physical assessment tool space. And as you know, we lead to a wealth challenge and are by far the market leader in that space.
Matt Mishan:
That's exciting. And there's going to be one more and I just want to make sure I'm clarifying it. As you think about FY 2022, you're going to have, you're going to have the $80 million to probably $100 million in both the COVID water hurdles, you're going to have to get through next year. But I think what I heard you say is in the first half of this year, you're also now back to pre-COVID levels and a lot of your businesses. And that may be necessarily, an offset to that. Has to be -- there has think about that?
Barbara Bodem:
Matt, this is Barb. Yes, I, I think that that is I think that is how you want to look at it. John talks about how excluding the COVID benefits for the first half of this year, we've been we've been roughly flat, and that is reflective of the fact that we're still in the recovery mode, in parts of our business. As we continue to see that improve, and we see that going into 22 that will be, that will help be an offset to the COVID benefits that we've received so far this year.
Matt Mishan:
Thank you.
Barbara Bodem:
As we think about, the future, continue to focus on that mid-single digit, and top line and double digit growth. And as we think about 2022 absolutely committed to delivering that excluding the COVID impacts that we we've seen in 2021.
Matt Mishan:
Thank you, Barb.
Operator:
Mike Matson of Needham and Co is on the line with a question. Please state your question.
Mike Matson:
Yes, thanks. Just in terms of M&A, in the Bardy deal, going to the trial and everything. I mean, is if anything contingent upon what happens with Bardy? In other words, if the deal doesn't end up happening, does that mean that you have something else kind of waiting in the wings? Or is that all completely independent of whatever happens with Bardy?
John Groetelaars:
Yes, good question. Like it's completely independent. What go around Bardy has no impact on our ability or bandwidth to execute additional M&A.
Mike Matson:
Okay, thanks. And then just, the integrated table motions done really well, with your partnership with Intuitive. And we've got a couple other surgical robots coming from Medtronic, and J&J. So, are there any opportunities there to offer something similar with those platforms?
John Groetelaars:
Our relationship with Intuitive has been a very positive one and one where, I think both parties have a high level of loyalty. So it's not something we would look to, proactively change. We do get, of course, integrated with not just robotics, but what is CT and MRI imaging systems and interoperative environment as well. So, when it comes to being a preferred partner, and having a technology and capability to integrate with various imaging or robotic modalities, we've been really well positioned with some of the top, companies you want to be aligned with. So we're pleased with that not looking for any changes. In terms of the essential products surgical, I did want to just reiterate that despite and we just exit noncore. If you look at the headwind provided, we have 100 basis point headwind, in this current year and current year guidance, we just finished the exit of our surgical OEM business, which was about $15 million in revenue this year, and $46 million last year, so it's about a 1% or 100 basis point headwind for the top line this year.
Mike Matson:
Okay, great. Thank you.
John Groetelaars:
Thank you. Well, I guess that concludes our call and I'd like to make a closing comment and embarrass one of my colleagues who was celebrating her 100th earnings call today. Miss Mary Kay Ladone 100th earnings calls. I don't know how many other people can have that that kind of bragging rights but she carries the banner and she carries it well. I want to congratulate here on completing her 100th earnings call today.
Mary Kay Ladone:
Thank you, John. Thanks everyone. Look forward to chatting with you later today.
Operator:
Thank you. Ladies and gentlemen, this concludes today’s conference call with Hill-Rom Holdings, Incorporated. Thank you for joining.
Operator:
Good morning and welcome to Hill-Rom’s Fiscal First Quarter 2021 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Hill-Rom and is copyrighted material. It cannot be recorded, rebroadcast or transmitted without Hill-Rom’s written consent. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Senior Vice President, Corporate Development, Strategy and Investor Relations. Ms. Ladone, you may begin.
Mary Kay Ladone:
Good morning and thanks for joining us for our fiscal first quarter 2021 earnings conference call. Joining me today are John Groetelaars, President and Chief Executive Officer of Hill-Rom and Barbara Bodem, Chief Financial Officer. Before we get started, let me begin by reminding you that this presentation includes forward-looking statements that are subject to risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from those described, including any impact related to the COVID-19 pandemic. Please refer to today’s press release and our SEC filings for more information concerning risk factors that could cause actual results to differ materially. In addition, on today’s call, non-GAAP financial measures will be used. Reconciliations between GAAP and non-GAAP financial measures are included in our earnings release issued this morning. Finally, I would also like to mention that in addition to the press release issued this morning, we have posted a supplemental presentation which highlights Hill-Rom’s performance and 2021 financial guidance. These materials can be accessed on the Investor Relations page of our website. So with that introduction, let me now turn the call over to John.
John Groetelaars:
Thanks, Mary Kay and good morning, everybody. Today, we are pleased to announce strong financial results for Q1. And as a result, we are raising both our revenue and earnings guidance for the full year. We started our fiscal year building momentum, accelerating recovery and expanding demand for many critical care products. This underscores our significant transformation, the diversity of our product portfolio and strong execution against our strategic priorities. Q1 revenue grew 8% and adjusted earnings of $1.53 per diluted share increased 35% versus the prior year. We exceeded guidance on both metrics. New product revenue exceeded $150 million, an increase of more than 20% and we achieved significant operating margin expansion of 260 basis points. We executed on our accelerated business optimization program and advanced our strategic growth platforms with both organic and inorganic investments. We listed several other accomplishments in the press release issued this morning, but none of these could be possible without the dedication and commitment of the entire Hill-Rom team around the world. I continue to be impressed and proud of how our team members are rising to the occasion to support our global customers and the broader healthcare community. Now, let me provide some perspective on our quarterly financial results before turning the call over to Barb for more detail. For Q1, revenue growth of 8% reflects better-than-expected performance across all three businesses, as the recovery progresses faster than anticipated, along with the benefit of select one-time COVID purchases. At this point, more than 80% of the Hill-Rom portfolio is showing stable or sequential improvement compared to the fourth quarter. Relative to our guidance, we estimate one-time COVID purchases accounted for about half of the upside or about $40 million and $0.20 per diluted share as COVID cases began peaking late in the quarter. We expect to see some ongoing benefit in the fiscal second quarter, although at a more measured pace, given the good news about the declining volume of COVID hospitalizations. The remainder of the Q1 upside can be attributed to recovery of the underlying business as we continue on the path toward normalization. Geographically, U.S. revenue exceeded our expectations and increased 1% as lower capital revenue like beds and surgical equipment was offset by higher demand for bed rentals and several Front Line Care products. International revenue increased 19% on a constant currency basis with double-digit growth across Europe, Asia-Pacific and Canada. We are encouraged by the strong execution in these markets as we strengthen our engagement and partnership with local governments and customers while supporting their needs during the pandemic. We are also pleased that our strategic investments in China are paying dividends, with a targeted go-to-market commercial strategy and ongoing recovery delivering double-digit growth for six of the last seven quarters. Now, let me turn briefly to review the performance by business at constant currency rates. First, Patient Support Systems revenue increased 8% in Q1, which includes the one-time COVID benefit mentioned earlier. PSS performance reflects the strong international growth of 33% driven by market expansion of med-surg and ICU bed systems across Europe and other markets. As expected, U.S. bed purchases and care communications revenues were down modestly compared to the prior year, but we continue to anticipate sequential recovery from here. We believe we are very well positioned with our strong value proposition and differentiated ecosystem of smart beds and connected care solutions as hospitals prioritize clinical workflow efficiencies. This continues to be validated by several recent competitive wins, including a 5-year standardization project for Hill-Rom with Nurse Call, Voalte mobile applications and medical device integration across one of the nation’s largest healthcare systems. In Front Line Care, first quarter revenue increased 5%. Performance continues to be driven by double-digit growth in patient monitoring, blood pressure and thermometry. Physician office-based products, including our vision care and physical assessment tools, also continue to rebound as U.S. physician office visits resume. In our Vision Care business, we successfully obtained CMS coverage for annual diabetic retinopathy exams in the primary care setting and secured an agreement with a national pharmacy chain to improve access to screenings. Lastly, Surgical Solutions revenue increased 4% in Q1, reflecting strong international growth with the completion of some large projects in EMEA and as expected, lower revenue for surgical equipment in the U.S. due to access limitations related to the pandemic. As I mentioned last quarter, this pandemic has demonstrated that the work we have done to build a strong portfolio will allow Hill-Rom to uniquely benefit from the accelerated transformation of the global healthcare environment. Hill-Rom is well positioned to drive meaningful value and deliver our long range of aspirations of mid single-digit top line and double-digit bottom line growth. We continue to execute on our strategic priorities, including new product momentum and emerging market expansion, while creating value with our business development activities. As you know, on Monday, we acquired the contact-free continuous monitoring technology from EarlySense. This digital sensing technology is currently integrated into our Centrella Smart+ bed to help identify clinical deterioration that can lead to improved survival, decreased costs and decreased need for ICU admissions. By expanding capabilities of the Hill-Rom’s connected care ecosystem, we continue to widen the differentiation gap by transforming the bed into a patient monitoring platform that acts as the hub for digital connectivity and communications. Earlier this month, we also announced our intent to acquire BardyDiagnostics. Bardy is an innovator in digital health and a leading provider of ambulatory cardiac monitoring technologies. The Carnation Ambulatory Monitor, or CAM patch, provides a differentiated, wearable bio-sensing technology that is designed to promote patient comfort and compliance, streamline clinical workflow and yield clinically actionable data that enables physicians to identify specific cardiac arrhythmias. There is a clear value proposition, vast body of clinical evidence, cost effectiveness data and physician support for this category of devices. That said, we are actively monitoring the situation related to the announced category 1 reimbursement rates by Novitas last week and we will provide an update when more definitive information is available. In summary, I am pleased with our strong start to the fiscal year and how our team is executing during these unprecedented times. Despite the challenges posed by the ongoing pandemic, our customers’ continued trust and support for the solutions we provide demonstrates our resiliency and why our vision of advancing connected care is more vital than ever. Now, let me turn the call over to Barb.
Barbara Bodem:
Thanks, John and good morning, everyone. I will briefly walk through our financial results before turning to our updated guidance. As mentioned, worldwide revenue in Q1 of $741 million grew 8% compared to $685 million in revenue last year. Revenue growth on a constant currency basis was 6.5%. All three businesses generated higher than expected growth driven by accelerated recovery trends and expanded demand for critical care products. Adjusted gross margin was 51.2% and expanded by 130 basis points versus the prior year. This was the result of favorable product mix and operational improvements. R&D spending increased 11% to $35 million, highlighting our commitment to drive innovation and advance our portfolio of connected care solutions. Adjusted SG&A of $205 million increased 3%. We continue to fund our strategic growth platforms and IT transformation, while managing discretionary spending and realizing planned savings from our business optimization program implemented last year. As a result, adjusted operating margin improved 260 basis points to 18.8%. Interest and other non-operating expenses for the quarter totaled $11 million. This is lower than the prior period due to the benefit of insurance recoveries totaling approximately $5 million or $0.06 per diluted share. The adjusted tax rate was 20.5%, slightly higher than our original expectation due to the geographic mix of our profits. Overall, this translates into adjusted earnings for the fiscal first quarter of $1.53 per diluted share, which is an increase of 35% from $1.13 per diluted share in the prior year. Now, turning to cash flow. Cash flow from operations for Q1 was $100 million, a 30% increase compared to the prior year, primarily driven by higher net income. Capital expenditures totaled $29 million, $5 million higher than the prior year, driven by the continued investment in our global IT transformation. Free cash flow advanced 35% to $71 million. Our balance sheet and financial position remains very strong. In Q1, we returned $70 million to shareholders through dividends and share repurchases. We ended the quarter with $295 million in cash and our debt-to-EBITDA ratio at the end of December was 2.7x or 2.3x on a net debt basis. Now, let me conclude my remarks with our updated guidance. Let me start by saying we have not included the impact of the BardyDiagnostics acquisition in our updated revenue guidance. However, the earnings per share guidance ranges provided today provides sufficient flexibility to absorb deal-related dilution in fiscal 2021 under various scenarios. So with that said, for the full year, we now expect revenue to increase 0% to 2% on a reported basis, which includes a benefit from foreign currency of approximately 100 basis points. This compares to our prior guidance of a revenue decline in the 3% to 5% range. By business segment, at constant currency rates, we expect Patient Support Systems revenue to decline between 2% and 4%, an improvement of more than 400 basis points from our previous guidance range. We now expect Front Line Care revenue to grow between 2% and 4% as recovery in the underlying businesses continues. And finally, we continue to expect Surgical Solutions revenue growth of 3% to 5%, with recovery towards pre-COVID level. From a profitability perspective, we now expect adjusted gross margin and operating margin to be approximately flat to the record levels set in fiscal 2020, with gross margin of approximately 51.5% and operating margin of approximately 18.8%. We expect R&D to approach 5% of sales and expect SG&A to represent approximately 28% of revenue. We now expect other expense, which includes interest, of $65 million to $70 million and a tax rate of 19% to 20%. This translates into adjusted earnings of $5.70 to $5.90 per diluted share for the year, roughly an increase of $0.45 per diluted share compared to our previous guidance range and reflecting mid-teens earnings per share growth after excluding the one-time COVID impacts from both the current and the prior year period. From a cash flow perspective, we are now expecting operating cash flow of $400 million to $430 million, an increase of $30 million compared to our prior guidance. We continue to expect capital expenditures of approximately $100 million, resulting in free cash flow of $300 million to $330 million. For our fiscal second quarter, we expect revenue to increase 0% to 2% on a reported basis and adjusted earnings, excluding special items of $1.40 to $1.45 per diluted share. And now, I will turn the call back over to John.
John Groetelaars:
Thanks, Barb. In closing, while we expect the pandemic to continue to impact the global healthcare landscape in the near-term, we remain optimistic about the year ahead and our continued execution on a path toward recovery and normalization. With the diversity of our portfolio, we are well positioned for growth as we navigate this transition throughout fiscal 2021. Over the long-term, we remain committed to driving sustainable and profitable growth, achieving our strategic objectives and unlocking significant value for patients, caregivers and shareholders as we deliver on our mission. So now I would like to open up the call for Q&A.
Operator:
Thank you. [Operator Instructions] First question comes from Rick Wise with Stifel. Please go ahead.
Rick Wise:
Good morning, John. Good morning, Barb. Let me start with, I think, focusing on two things, one, the better-than-expected beat business performance. And this is sort of a general question, but help us better understand the drivers of that beat business improvement? To what extent, is it just recovery environmentally in various geographies or execution? To what extent, is it new products? If you could give us a little more color there? And maybe just as part of that, John, you could talk about the pipeline you highlighted, you have emphasized in the past the 10 new products coming in the current fiscal year. How is that – how do we think about the impact there as well? Does that – how quickly does it help you drive accelerated growth? Is that all fully dialed into your guidance, just help us understand those two big picture things for starters? Thank you so much.
John Groetelaars:
Yes. Thanks, Rick and thanks for the question. Well, we are very pleased with the performance in Q1. It’s really split between accelerated recovery at a pace faster than we expected and that’s really good news. And it was broad-based across all businesses and across all geographies. So even feel better about that knowing how broad-based it was across our entire portfolio. So that was about half the driver of our beat versus consensus. The other half came from some COVID benefit. It’s important to say that it wasn’t a pull forward, but it was rather an expansion of demand that we have been talking about for the last couple of quarters. We have been anticipating and expecting international markets to expand their ICU capacity and that’s exactly what we are seeing out of Europe, particularly in France and Italy in the prior quarter. So hope that helps characterize the nature of the beat, broad-based more rapid acceleration of recovery and some COVID benefit, particularly out of Europe on the ICU expansion category. With respect to the growth driver of new products in the second part of your question, new products in the quarter grew over 20% and $150 million for the quarter. So, very pleased about the performance of that growth engine and its ability to deliver throughout this pandemic. We saw last year in fiscal ‘20 that we beat our expectations on new products. Our pipeline is chock full of new launches this year. We have 10 new launches expected. A great number of those happen in Q2. And if you will recall, Rick, by the time we reach peak revenue of our typical launches, it takes about 2 to 3 years. So what we are really building out is kind of springing the coil to leap us forward into the future because we have so many product launches planned this year. We had 6 last year. We had over 10 this year. And I think that positions the company very well for continued new product performance as we look into the out years.
Rick Wise:
That’s great. And just one quick housekeeping question, just because I think some – there might be some questions about it. I know you’ve retired your non-core revenue use of that term with the exit of the international surgical OEM business. But did this quarter complete that? Was there an impact in this quarter or is that all behind us now? Thanks so much.
John Groetelaars:
Yes. Thanks, Rick. We have retired the definition of core, non-core. However, in this quarter, we did have $11 million of what we would normally call non-core in the revenue number. And that was due to our partner on the surgical OEM side, who really requested an additional buy-in of inventory. So that was fulfilled in the first quarter.
Rick Wise:
Thank you very much.
Operator:
Next question comes from David Lewis with Morgan Stanley. Please state your question.
David Lewis:
Hi, good morning and thanks for taking the question. I guess a couple of things here for me. John, just thinking about sort of the enthusiasm for growth vectors, there is a lot of enthusiasm heading into 2020. I mean do you think it’s safe to say what we are seeing here is those investments with new product growth of 20% and EM traction, do you think you can be definitive those investments are now playing off and your confidence in that 5% plus growth is now elevated or do you think we are sort of putting the cart before the horse?
John Groetelaars:
Great question, David. I think if we break out the COVID impact last year and this year, what we are actually seeing is mid single-digit top line growth and 15% EPS growth. And even if we do the similar math and compare ‘19 to ‘21 in our new guide, similar mid-single-digit top line, higher than 15% EPS growth. So I think those underlying to your question, the underlying growth vectors of new products in emerging markets and growth-oriented acquisitions are all delivering throughout this period of time and feel very good about the outlook there. Of course, as you know, as all of our investors know, we had a really strong Q3 last year. So we’re going to have to cycle past that Q3 comp in a couple of quarters. And then I think the ongoing transparency on a constant currency and reported basis, we will demonstrate that strength in that top line performance.
David Lewis:
Okay. And just two more quick ones for me, I’ll ask them both together. Barb for you, I mean just given John referenced the strong third quarter there is some historical volatility in the business. Can you just give people a sense of what assumptions you made in this forward guidance this early in the year to give people confidence that this guide still remains risk-adjusted. And then John for you, just on Bardy, it sounds like you are confident in your EPS guidance regardless of the outcome with Bardy. What are the next steps from your perspective with Bardy? Thanks so much.
John Groetelaars:
Thanks, Dave. I will turn the first part of the call over to Barbara to answer and then I will come back.
Barbara Bodem:
Good morning, David. Thanks for the question. If I heard you correctly, what you’re looking for is how balanced and achievable is our guide for the remainder of the year. And as you think about the two – the top and the bottom line, as you think about the improvement on revenue guidance for the year, the majority of the roughly $140 million, $150 million worth of improvement that we’ve signaled with this guide is coming from our overall performance in Q1. And as John talked about, part of that is coming from onetime COVID, but more importantly, it’s coming from the underlying momentum of the business and the stronger-than-expected recovery. And we will see that momentum play into Q2, which also plays into the improvement as we think about the full year revenue improvement. The other thing I’d drive there is we have been more explicit about FX and the impact for the full year. And we anticipate that on the top line, we’ll have about 100 basis points of benefit from FX on revenue for the full year. So really what we’re reflecting is we’re reflecting the first half strength of the year, recognizing that we have very challenging comps in Q3 and we have three quarters ahead of us to go. From a bottom line perspective, we are looking at an improvement in our bottom line EPS trajectory of $0.45, and that really reflects the performance of Q1. What that does is that it reserves any further favorability that we would see in Q2 to offset any potential dilution from business development deals. And you should think about it as a floor. So as we have looked at this, we’ve looked at it very much as it is balanced and achievable, but it also takes into consideration that we’re early in the year and there is uncertainty regarding the pandemic and uncertainty related to the overall trajectory of where we’re going. But we believe that this is an achievable and balanced view.
John Groetelaars:
And then, David, to your question on Bardy, as we’ve said in our opening comments, our prepared comments, we’re continuing to monitor the reimbursement situation closely. And our guidance contemplates various scenarios that can absorb or cover the dilution that was expected from the Bardy deal. So as Barb just mentioned, you can think of this guidance as the floor in those various scenarios of a different party outcome. I am going to really limit any further comments on Bardy going into this call. It’s a really sensitive period of time in light of some pending discussions that will likely take place with [indiscernible] and other industry stakeholders. And for that reason, I don’t think it’s productive to have speculative comments and read into it too much. I would like to say that given the strength of our business and given the strength of our Q1 performance and our rate and our increase in guidance for the full year, we feel very good about the growth of our underlying business and our ability to meet this increased guidance.
David Lewis:
Great. Thank you so much.
Operator:
Michael Polark with Baird is on the line with a question. Please state your question.
Michael Polark:
Hey, good morning. I was curious about the 5-year standardization project you called out in Care Communications. Wondering if you could give us any more color there. Would you name a name, who is the customer? If not, frame size, number of facilities, total number of beds, perhaps contract value to you over the 5-year term. And then maybe just a little bit of color, as you put together that platform, right, Nurse Call plus Middleware and Voalte, maybe would be interested in hearing about the sales process there and why you won and what sort of things the customer seems most interested in?
John Groetelaars:
Yes, great question, Mike. Happy to answer that. Unfortunately, I can’t mention the name of the customer, but it was one of the largest – one of the top three largest hospital systems in the country. And the full end-to-end solution that Hill-Rom was able to bring and our enterprise ability to scale a solution like that is really what made us well positioned to win. So when I say end-to-end, I’m talking about Nurse Call, the middleware to do medical device integration, which came from our EXL acquisition and then the Voalte or mobile communications that also came to that acquisition of Voalte. So that combination of those full – that full communication suite of digital communications is really what made the difference. And having the comments and trust that Hill-Rom was an organization that could scale that type of deployment over a 5- year period, it would go up there. I haven’t – didn’t have a chance to go back and confirm, I believe this is our single largest deal that the company has ever done as part of one contract. So it was a big win. And we expect it to provide a nice backlog of orders and future revenue as we recognize revenue over the next 5 years.
Michael Polark:
Appreciate that. And Barb, I have to ask one. So, let’s assume you move forward with the transaction, I know that sounds like it’s very much TBD, but let’s assume you move forward, I understand there is an earn-out structure in the current arrangement. Sometimes when those frameworks are put in place, the acquirer isn’t plugging the product into its existing commercial infrastructure right away. Let the acquiree execute against the earn-out. What is the base case in terms of taking the Bardy product to your current Welch Allyn physician office sales force? Is it wait 1 year or 2 and let the earn-out unfold or is the expectation that if and when the deal closes, that your sales force would be able to sell that product on day 1?
John Groetelaars:
Yes. Our going-in proposition there, Mike, was to lead that sales organization to its own and to invest in it and then separately add the channels that we have in primary care and Welch Allyn to complement it. So that was our approach. Going in, that is our approach.
Michael Polark:
Thank you very much.
John Groetelaars:
But again, thanks for the question. I just want to reiterate that our focus is on long-term shareholder value. And in any scenario related to acquisitions or related to things that are going on in our core business, our overwhelming commitment is to drive double-digit EPS growth and mid-single-digit top line growth. And we’ll manage accordingly in various scenarios.
Operator:
And Matt Taylor with UBS is on the line with a question. Please state your question.
Matt Taylor:
Hi, good morning. Thanks for taking the question. I just wanted to ask one about the comments that you made on ongoing demand for ICU bed expansion. Going back to last year, there was – mid Q3 where you talked about a lot of that being more one-time and the ICU opportunities being longer term. But it sounds like its coming capacity even sooner than you expected. So I was hoping you could help kind of square those comments and discuss whether your order book looks good and you are continuing to see strong demand there and whether we should view this as more one-time or the start of a new stronger trend?
John Groetelaars:
Yes. Thanks, Matt, for the question. Yes, so what I tried to indicate in the past was that we would probably see that ICU expansion come in lumpy, right? It’s going to come in at times in a quarter, and it’s going to come in hot and heavy and feel kind of like a onetime. And then it might be off for a quarter and then might come back a quarter after that. So our current outlook and it’s incorporated into our guidance, so we do expect another strong performance out of Europe in the bed category. It’s – we see it in our backlog. We do expect another strong performance out of Europe in that category for ICU expansion requirements. So this will be a couple of quarters in a row now where we’re seeing it. And it’s a little bit hard to predict longer term, say, beyond a couple of quarters, because that visibility is not there when the timing is going to happen. However, from a broader aperture or broader time frame point of view, in over a multiyear period, that growth opportunity is definitely there, we believe. We have – we were hesitant to call it out back in the middle of last year. And then we saw enough data to give us the confidence that it was real. And now we are seeing it showing up in the results. So it will, at times, come in lumpy. We’ll try to give investors a great heads-up to when we’re seeing it coming and incorporate that into our guidance. But we see that – at this point, we see it obviously, in Q1. We see it again a little bit in Q2 attenuating from Q1. And then we just don’t have clear enough visibility to call it out yet in the back half of the year.
Matt Taylor:
Okay, okay. And just had a question on the Care Comms, I was hoping you can comment on that specifically in your installation-related businesses. It sounds like that have gone better than you expected in the period. Can you talk about the growth for that and the outlook for installation-based things given continued pandemic stress?
John Groetelaars:
Yes. So, we are very pleased about the deal that we just discussed and the orders that are coming in. However, from a recognized revenue point of view, Care Comm was relatively flat to last quarter. It’s gradually recovering. And as our access improves – but during the last quarter, access into hospitals and even in the current period is very limited. So our ability to complete installations and recognize revenue has been stalled. However, the pandemic continues to wane and hospitalization has continued to drop. We’re very optimistic about the back half of the year and seeing that business come back to pre-COVID levels.
Matt Taylor:
Okay, very good. I will leave it there. Thank you so much.
John Groetelaars:
Thanks, Matt.
Operator:
Matt Mishan with KeyBanc is on the line with question. Please state your question.
Matt Mishan:
Hey, thanks. Good morning, guys. Just first on RetinaVue, I think you mentioned that you signed a deal with a national pharmacy chain for increased screening, can you talk a little bit more about that channel versus the primary care physician and the strategy to growth that?
John Groetelaars:
Yes. Thanks for the question, Matt. The whole premise of the technology is to provide better access for patients. So you don’t need to see an ophthalmologist to have their annual retinal exam. And putting it in the hand of either a primary care physician’s office or, in this case, a retail pharmacy location helps us achieve both the promise of the technology married up with the improvement in the sales channel or the access channel. So this is an exciting opportunity for us. I’m unable to announce who the partner is, but it’s one of the largest chains in the country. And we are very pleased about that partnership. And we’re in the early phases of rolling that out and looking forward to a ramp of that activity in the second half of the year.
Matt Mishan:
Okay, excellent. And then I hate to go back to Barbie, and I realize it’s a sensitive period of time, but I’m just curious, the reimbursement decision from Novitas and you mentioned there is pending discussions there, is that a final decision or are there mechanisms in place to comment or appeal?
John Groetelaars:
Yes. I think this is a well-covered topic by a lot of the sell-side analysts. So I’m really, as mentioned, I am not going to actively – we are actively monitoring developments on reimbursement and we will provide an update when more definitive information becomes available.
Matt Mishan:
Okay. Thank you, John.
John Groetelaars:
Thank you, Matt.
Operator:
Mike Matson is on – with Needham is on the line with a question. Please state your question.
Unidentified Analyst:
Hi, guys. This is Joseph on for Mike. Just one today, I was curious on the cost savings in the quarter from the restructuring. You guys could maybe explain if there was any, how much and where did that come from? Thank you.
John Groetelaars:
Thanks, Joseph. I’ll turn it over to Barb.
Barbara Bodem:
Hi, Joseph. Thanks for the question. Hey, what we talked about at the end of last year is that we were triggering a $50 million sort of accelerated business optimization activity. Most of that, over two-thirds of that was going to be coming from sort of reductions in headcount. So, it’s going to come more from the [indiscernible] areas. The balance of it was coming from reprioritization of discretionary spend across the business. So we are on track to deliver that $50 million. It’s roughly equal as you think about it over the course of the year. We did realize significant savings in Q1, which we’ve been, as we talked about last fall as well, reinvested in the business. And we have been spending a lot of time making sure that as we identify opportunities to save or optimize the business that we are reinvesting it behind our growth drivers and in those levers that we think are going to support our mid single-digit top line growth and our acceleration out of the pandemic. So, we are realizing the savings. It’s pretty equal across the course of the year. And we have got mix now between what is coming from sort of [indiscernible] and then what’s coming from other levers.
Unidentified Analyst:
Awesome. Thank you very much.
Operator:
At this time, I will turn the call over to the presenters.
John Groetelaars:
Well, thank you all for your questions today and really was a great quarter and a great start to our year. Momentum is building. We feel very good about the growth drivers that we have been investing in over the last several years and it’s really leading to great margin expansion and sustainable durable growth. So we are confident moving forward and thank you all for joining our call.
Operator:
Ladies and gentlemen, this concludes today’s conference call with Hill-Rom Holdings, Inc. Thank you for joining.
Operator:
Good morning. And welcome to Hill-Rom’s Fiscal Fourth Quarter 2020 Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Hill-Rom and is copyrighted material. It cannot be recorded, rebroadcast or transmitted without Hill-Rom’s written consent. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Senior Vice President, Corporate Development, Strategy and Investor Relations. Ms. Ladone, you may begin.
Mary Kay Ladone:
Good morning. And thanks for joining us for our fiscal fourth quarter and full year 2020 earnings conference call. Joining me today are John Groetelaars, President and Chief Executive Officer of Hill-Rom; and Barbara Bodem, Chief Financial Officer. Before we get started, let me begin by reminding you that this presentation includes forward-looking statements that are subject to risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from those described, including any impact related to the COVID-19 pandemic. Please refer to today’s press release and our SEC filings for more information concerning risk factors that could cause actual results to differ materially. In addition, on today’s call, non-GAAP financial measures will be used. Reconciliations between GAAP and non-GAAP financial measures are included in our earnings release issued this morning. Finally, I would also like to mention that in addition to the press release issued this morning, we have posted a supplemental presentation, which highlights Hill-Rom’s performance and details regarding our 2021 financial guidance. These materials can be accessed on the Investor Relations page of our website. So with that introduction, let me now turn the call over to John.
John Groetelaars:
Thanks, Mary Kay. Good morning, everyone. Today, we are pleased to announce our fiscal 2020 financial results and provide guidance for 2021. It goes without saying that fiscal 2020 has been an extraordinary and historic year for Hill-Rom and the world at large. I’m impressed by the progress we have made toward our vision of advancing connected care. I’m inspired by the commitment and execution of our global team and energized by the steps we have taken to accelerate Hill-Rom’s business transformation. Despite challenging circumstances posed by the pandemic, Hill-Rom’s overall financial performance has been strong relative to many of our peers in the med tech industry. For fiscal 2020, core revenue increased 3%. We exceeded our expectations and delivered more than $570 million in new product revenue. We achieved a new record level for both gross and operating margins with solid execution. We advanced our growth platforms with organic investments and 3 acquisitions, and finished the year with adjusted earnings of $5.53, an increase of 14% after adjusting for the 2019 divestiture of our surgical consumables business. This was in line with our guidance range provided a year ago, and we are proud we have delivered this level of performance during these unprecedented times. For the year, onetime COVID-related purchases for bed systems and noninvasive ventilators accounted for $180 million in revenue and earnings of approximately $0.75 per diluted share. As we cycle through some difficult comparisons over the next few quarters, we remain confident in the underlying fundamentals of our business, the compelling value propositions we offer across our connected care solutions and our proven ability to deliver enhanced value to patients, caregivers and our shareholders. While Barb will walk through the P&L in more detail, let me provide some perspective on our fourth quarter results and recovery dynamics. As expected, our fiscal fourth quarter reflects the impact from hospital capacity expansion that occurred in the earlier phases of the pandemic. Customers turn to Hill-Rom, and we quickly responded to their urgent needs. As you know, this resulted in Q3 financial performance that far exceeded our internal expectations and affected visibility on normalization and recovery dynamics across our portfolio. Forecasting trends in that environment was more complex and less predictable due to patients shifting profiles, improving treatment options and the ability of providers to rapidly adapt and triage COVID and non-COVID patients. With that backdrop, Q4 performance came in above our projections, with revenue of $705 million and adjusted EPS of $1.17 per diluted share. This reflects normalization of demand for beds, following record Q3 performance, and sequential recovery across most of the remaining portfolio. We are now observing early signs of improved trends as recovery progresses and year-over-year declines are decelerating. We will keep a keen eye on areas that have recently seen rising COVID cases and are experiencing setbacks in the process of reopening, but we have not seen any material impact to date. Therefore, we expect that Q4 represents the trough from a growth perspective as we move into fiscal 2021. Geographically, U.S. core revenue declined 15%, driven by lower capital revenue, like beds and surgical equipment. International revenue, on the other hand, advanced 5%. We are very pleased with the recovery in the emerging markets, where growth exceeded 10%, led by double-digit growth in China and the Middle East. Developed markets like Europe and Canada saw solid gains across the portfolio outside of the Surgical business, where large construction projects continue to be delayed. Now let me briefly review the performance by business at constant currency rates. First, Patient Support Systems revenue declined 13% in Q4. This reflects a challenging comparison to prior year growth of 14% and follows the third quarter peak COVID demand for Med-Surg and ICU beds. As expected, our bed revenue declined by more than 20% overall despite a COVID tailwind of approximately $25 million, driven primarily by elevated demand across Europe. For the year, our portfolio of smart beds grew double digits, including mid-teens growth in the second half. We continue to enhance our leadership and share position with our differentiated ecosystem of smart beds and connected care solutions. The good news is that throughout Q4, our bed orders and backlog in the U.S. accelerated and the remaining PSS portfolio experienced encouraging sequential improvement. This includes the Care Communications business with a sequential increase of nearly 30% versus Q3. As hospital access restrictions have eased, quoting activities accelerated and revenues rebounded to near pre-COVID levels. Q4 Front Line Care revenue increased 1%. Performance was driven by double-digit growth in vital signs monitoring, blood pressure and thermometry as well as the completion of the U.S. stockpile order for noninvasive ventilators. The remaining FLC portfolio was down double digits, but showed sequential improvement of 15%, as U.S. physician office visits resumed. This is a trend that has continued into the start of our new fiscal year. Lastly, Q4 revenue in Surgical Solutions declined 29%, reflecting a difficult comparison, the remaining impact from the surgical consumables divestiture and the impact from capital project timing. With strong sequential growth and improving order funnel and easier comparisons for 2021, we expect gradual recovery in surgical from here. Last November, we unveiled a compelling multiyear plan reflecting durable mid-single-digit revenue growth, double-digit earnings growth and strong cash flow. This was a plan that included benefits from new product momentum, emerging market penetration and value creation from M&A. I am pleased to reiterate with confidence that these key growth platforms remain intact. Obviously, the long-range outlook we provided did not reflect an impact from a global pandemic in the first year of our plan. However, I am confident that as we cycle through difficult comparisons from 2020 and with fiscal 2021 as a new baseline, we are well positioned to deliver on both our long-term aspirations and growth objectives in a post-COVID world. This pandemic has demonstrated that the work we have done to build a strong portfolio provides us with unique solutions and capabilities to tackle accelerated transformation of the global health care environment. We believe Hill-Rom is very well positioned to benefit from these new trends in 2021 and into the future. For fiscal 2021, many uncertainties remain around COVID, including how the pandemic will evolve, how governments worldwide will respond to new policies and when a vaccine will be available. While the pandemic continues to be fluid, we believe the guidance range provided today is both balanced and achievable. For fiscal 2021, we expect revenue to decline 3% to 5% and adjusted earnings of $5.25 to $5.45 per diluted share. After adjusting for the 2020 onetime COVID impact of revenue and earnings of $180 million and $0.75 per diluted share, our guidance range reflects underlying base business revenue growth of mid-single-digits and adjusted EPS growth of at least 10% for the full year. This implied underlying growth is aligned with our longer-term growth aspirations. In closing, as I reflect on the progress of our ongoing business transformation, I am extremely proud of what we have accomplished. Our global Hill-Rom team has displayed a winning spirit, rose to the challenge during these uncertain times. And I would like to humbly thank them for their commitment, resilience and dedication. As I have mentioned, our mission has never been more vital. Our passion is focused on enhancing outcomes for patients and caregivers with connected care solutions that add significant value to the delivery of health care across all care settings, from the hospital to the surgical suite to the physician’s office and at home. We look forward to the future with conviction as we build on a solid foundation in pursuit of our vision of advancing connected care. Thank you, and let me turn the call over to Barb.
Barbara Bodem:
Thanks, John, and good morning, everyone. I will briefly walk through our financial results before turning to our guidance for fiscal 2021. As mentioned, worldwide revenue in the fourth quarter of $705 million declined 10% compared to a record finish last year with revenue of $783 million. John discussed recent business trends, but there are 2 other points I would like to highlight. First, Q4 noncore revenue of $13 million reflects the international surgical OEM business. As previously disclosed, we expect to complete the exit of this business by the end of this calendar year, and we are now retiring the core definition. In addition, during the fourth quarter, we lapped the anniversary of the surgical consumable divestiture as well as the Breathe acquisition, both of which were completed in 2019. So revenue projections going forward reflect organic growth. Moving on. Adjusted gross margin in the fourth quarter of 51% expanded by 110 basis points. This was the result of favorable product mix and operational improvement. For the full year, we achieved a new record gross margin of 51.5%, reflecting an improvement of 200 basis points versus the prior year. This includes the positive impact from onetime COVID revenue of approximately 70 basis points. Moving on to operating expenses. R&D in the quarter increased 2% to $36 million. SG&A increased 8% to $207 million, as we continue to fund investments in our strategic growth platforms and IT transformation while managing our discretionary spending. Our adjusted operating margin in the fourth quarter was 16.5%. For the full year, operating margin improved by 100 basis points to 18.8%. This performance is consistent with our strong multiyear track record of driving annual operating margin expansion. Interest and other nonoperating expenses for the quarter totaled $18 million, and the adjusted tax rate was 20.3%. So this translates to adjusted earnings per share of $1.17 per diluted share for the fourth quarter, which declined 31% versus the prior year. For the full year, adjusted earnings per share increased 9% to $5.53 per diluted share. Excluding the impact of the surgical consumable divestiture, adjusted earnings per share increased 14%. Now turning to cash flow. Cash flow from operations for the year was $482 million, reflecting an improvement of $81 million versus the prior year, which was a 20% increase. Capital expenditures totaled $106 million and as a result, we generated free cash flow of $376 million, which is 15% higher than last year. In terms of the balance sheet and financial leverage, our debt-to-EBITDA ratio at the end of September was 2.9x, and we have returned $129 million to shareholders through dividends and share repurchases during the 2020 fiscal year. Let me conclude my prepared remarks with our guidance for fiscal 2021. Today, we are issuing guidance range that we believe is both balanced and achievable, incorporating various scenarios and uncertainties. This outlook assumes a return towards normalized demand trends in those areas that significantly benefited from the COVID-related activity in 2020, and our guidance also incorporates a gradual recovery from product categories negatively impacted. As mentioned earlier, the ongoing scope and evolution of the pandemic remains uncertain and could present incremental risks as well as opportunities for the company’s business. We are not including any potential benefit for substantial surge in COVID-related purchases, nor are we including significant financial or operational impacts to Hill-Rom or our hospital customers from government policies associated with the pandemic. Our guidance also does not reflect an impact from potential health care, government or tax reform, or from future M&A. So for fiscal 2021 full year, we expect revenue to decline 3% to 5%, both on a reported and constant currency basis. As we have previously mentioned, we are retiring the noncore definition as we expect to complete the exit of the international surgical OEM business by the end of the calendar year. Our guidance includes a headwind of approximately $30 million or 110 basis points related to the year-over-year impact of this exit. In addition, our revenue guidance reflects the headwind from the onetime COVID impact of $180 million in fiscal 2020, which presents a challenging comparison to fiscal 2021. Excluding both the onetime COVID impact and the surgical OEM exit, revenue growth is expected to be in the mid-single digits, in line with our longer term objectives. By business segments, at constant currency rates, we expect Patient Support Systems to decline 6% to 10% due to the COVID headwind. Excluding the onetime COVID impact from surge demand, growth is expected to be in the low single digits. We expect Front Line Care revenue to be comparable to the prior year. As the impact from the onetime U.S. stockpile order of noninvasive ventilators in 2020 is offset by continued recovery related to physician office visits. And finally, we expect Surgical Solutions revenue growth of 3% to 5%, driven by gradual recovery towards pre-COVID level and inclusive of the surgical OEM exit. From a profitability standpoint, we expect some modest pressure to adjusted gross margin and operating margin with both set to be within 50 basis points of the record level set in fiscal 2020. We expect gross margin to exceed 51% and operating margin in the range of 18.3% to 18.8%. We expect R&D to approach approximately 5% of sales, and we expect adjusted SG&A to decline in low single digits and represent approximately 28% of sales. Our SG&A guidance includes investments in key growth initiatives, and approximately $50 million in accelerated business optimization savings from actions we announced in September. We expect other expense, which includes interest of approximately $70 million. And lastly, we expect a tax rate of approximately 19% and share count of approximately 67 million shares. We look to offset stock option dilution with share repurchases just like we have done historically. This translates to an adjusted earnings guidance range of $5.25 to $5.45 per diluted share. On a reported basis, adjusted earnings per share are expected to be down 1% to 5%. However, when excluding the prior year onetime COVID impact of approximately $0.75, adjusted earnings per share growth is expected to be at least 10%. From a cash flow perspective, we expect operating cash flow of $370 million to $400 million, which reflects our earnings guidance as well as outflows related to our business optimization efforts and the timing of receivable collection. Capital expenditures in 2021 are expected to be approximately $100 million, and free cash flow is expected to be $270 million to $300 million. For the fiscal first quarter, we expect revenue to decline 3% to 5% on both a reported and constant currency basis. We expect adjusted earnings of $1.05 to $1.10 per diluted share. There is no prior year impact of COVID. Before I turn the call back over to John, I want to mention that we have provided additional quarterly information on the 2020 revenue and earnings per share impact of COVID in our supplemental presentation posted to our website. This information will help you understand the expected quarterly trajectory of reported revenue and earnings per share guidance and the performance of the underlying business during the recovery. Thanks. And now I’ll turn the call back over to John.
John Groetelaars:
Thanks, Barb. For those of you who have followed Hill-Rom over the years, you know that we have significantly diversified our business. We strengthened our business model with enhanced value propositions and improved our durable growth profile with internal R&D and deployment of capital into M&A. Our continued balanced approach towards growth and investment is leading to an exciting and compelling transformation at Hill-Rom. I will reiterate that our strategy, long-term fundamentals, growth prospects and investment thesis remain intact. Prior to and during the pandemic, our company has established a strong track record of performance. We have consistently delivered on our objectives and met expectations. While the macro environment has proven challenging for most, including Hill-Rom, with shocks to traditional demand and evolving dynamics never seen before, we are entering 2021 with improved visibility and cautious optimism as our business begins to recover. Our commentary today is intended to provide a transparent depiction of current business trends and our future outlook, which we believe will aid investors in their evaluation of Hill-Rom as a long-term investment. With a solid foundation, clear strategy and seasoned leadership team, we will continue to go above and beyond to deliver enhanced value to our customers and shareholders and position our company for sustained success. With that, let’s open up the call for Q&A.
Operator:
[Operator Instructions] I would like to remind participants that this call is being recorded, and a digital replay will be available on the Hill-Rom website for seven days at www.hillrom.com. Our first question comes from Rick Wise from Stifel.
Rick Wise:
It’s good to see the solid finish to the year. Thank you for the clarity around all the moving pieces, it really helps. Maybe, John, just talk a little bit more about your -- the -- not just the guidance for the year ahead, I think that’s clear, but just how you’re envisioning the year unfolding. Solid first quarter, clearly. But maybe help us think about how you’re thinking about the flow of the quarters for the year and what you think could get better as the year unfolds?
John Groetelaars:
Yes. Sure. Thanks for the question, Rick. I’ll point you, Rick, to Slide number 25 in the presentation material. In that slide, you’ll see the breakdown of the COVID benefit for fiscal ‘20. I think that’s a really important foundational set of numbers to understand. So with that in mind, here’s how I’d characterize ‘21. Obviously, Q4 was our trough. We feel really good about broad-based momentum we’re seeing across all businesses and all geographies as we exited the year and entered fiscal ‘21. So that’s a very encouraging sign and something that gives us a tremendous amount of confidence around our Q1 guidance. As we start to come into Q2 and Q3, we’re going to start, especially in Q3, hitting it up against some really difficult COVID-related comps from last year. And so the shape of that recovery curve continues to build momentum in the underlying business. And our emerging market growth continues to be at double digits throughout the year. We will be launching a significant number of new products, north of 10 new products planned for launch this year. So the fundamental drivers of new product growth, emerging market growth and the recovery of our businesses that were negatively impacted are all well in play and going to deliver for us during the year. And we will see that sequential improvement, excluding that COVID impact from last year. So as you look at the second half of the year, we would expect to see growth excluding that COVID benefit and certainly see nice organic growth in the fourth quarter. We got to cycle through some challenging comps on the COVID side of things and on the recovery of our business, which you’re starting to see, as you noted. Compare Q4 to Q1, we’re expecting to see a nice sequential recovery in our business just in that period where there’s no COVID impact. So I think the final point I would make is our growth drivers. As we’ve mentioned in the past, those -- in terms of product categories, those continue to be in the same areas that we’ve seen them. Very excited about the growth driver opportunities in ICU expansion, in care communications. We have several new product launches in that category coming this year. Noninvasive ventilation, remote monitoring and diagnostics, especially with the importance of telehealth and remote diagnostics. We have several exciting new products in our connected exam tools and screening tools, both for vision screening as well as for physical exam. And then in our Surgical Solutions business with the recent acquisition of Videomed and connected video and OR integration. So really, I think the fundamentals are there. The recovery curve is well in place and new product launches, emerging market growth are going to really position us very nicely as we get towards the end of the year and get past these COVID benefit comps that we have to overcome this year.
Rick Wise:
That’s great and lots of clear direction there, John. On the other side, thinking about it, the investor concerns or the kinds of questions I get. A lot of that, obviously, a lot of investor anxiety revolves around the outlook for capital, capital spending at the hospital level. And of course, very specifically, always on the bed business, the PSS side. You’re talking -- maybe talk to us, if you would, about the -- your sense of the capital spending environment and what you’re dialing into your expectations? And when you contemplate the PSS low single digits ex COVID, maybe talk about are people going to be concerned about the competitive environment and impact on Centrella, among other issues? Can you put some of that in perspective for us as well?
John Groetelaars:
Yes. Sure. There’s a lot to unpack there, Rick. So let me take it -- important questions, let me take them to start up with. The environment first, right? The environment is so much better from a CapEx point of view and procedure recovery, physician office visit recovery. And we’re seeing that as we outlined in recovery of our businesses, not just here in the U.S., but globally. So that increased level of certainty allows us to reissue guidance quite candidly. And that’s the fundamental difference between the first wave versus now where we are today. Obviously, I won’t get into the details between the first wave and second wave and what we’re now experiencing with a third wave. But the summary of all that is not just us, but our providers and our customers have a lot more confidence of how to deal with COVID surges, how to treat COVID patients and non-COVID patients and how to triage those patients and effectively keep health care treating patients on both sides of the equation. So overall, very good certainty, very good recovery of procedures. And as a result, the financial profile of our customers and the financial certainty of our customers is significantly improved, particularly in the U.S. Internationally, it was never impacted the same way. And while some CapEx -- in aggregate, CapEx is down from where it was going to be a year ago, it plays to our portfolio very nicely, in ICU, in bed expansion in care communications and in ventilation. So relatively speaking, we feel that the CapEx environment is quite improved from where it was even 3 months ago and certainly significantly improved from where it was 6 months ago. So -- and that’s why we feel confident enough to reissue guidance the way we have. So that’s that part of the question. The second part of the question relates to the bed business. If you look at -- if you take a step back and avoid looking at quarter-to-quarter, I’ll get to that in a second. But if you look at the full year last year, our bed business grew at double digits, right? And now if we look forward, we’re seeing a really nice recovery of orders and our backlog for our Med-Surg and ICU bed offering, and we’re seeing that number sequentially is about 20% improvement from Q4 into this current period. So not only that, but the activity level around quoting and orders is actually near pre-COVID levels for our bed business. So we feel really good about that. And from a competitive point of view, we can maybe get into details at a follow-on question, but we’re feeling really good competitively. This is not a surprise to us. We knew this launch was coming, and we candidly expected to come a lot earlier than it is. And quite frankly, the comparison between our bed offering, which really is more of a patient monitoring and connected care solution versus the Stryker bed offering, is like apples and oranges. And I’m happy to get into the comparison of that, if you want. But we feel really good competitively and are prepared for that introduction.
Operator:
Bob Hopkins on Bank of America.
Bob Hopkins:
So a couple of things. I’m going to keep my questions kind of on the macro level. So just two things I’d love to hear you guys comment on a little bit. One is if you just wouldn’t mind talking about the potential pipeline for deals over the course of this fiscal year. What you’re seeing out there, and what we should expect as a result? And then also, there’s so many moving pieces to the business this year. And I understand things will get a little cleaner as we progress later in the year. But if you are -- so what are the things that we should be tracking on a quarterly basis that will give us a better sense for what’s really going on with the underlying business? I’ll leave it at that.
John Groetelaars:
Yes, great. I’ll take that second part of the question first, Bob. I think it’s really, fundamentally -- and this is why we’re being so clear about the COVID impact. But fundamentally, looking at the recovery curve of our businesses that were negatively impacted and seeing how that recovery is improving sequentially, right? We had reported a negative 10% in Q4. Our guidance for the first quarter is a significant improvement of that, and we would expect that to continue over time. So that’s one thing. The other part is, in particular, the businesses that are recovering that are significant to us are Care Comm and our surgical business, which will -- which are coming back to pre-COVID levels, but they’re not quite there yet. And once they cross over the chasm, I think we’ll be in a really good place to start showing year-over-year growth. So I would be looking at that, Bob. Certainly, we’ll be talking about new product launches as we get closer to them. The other part I would look at is our emerging markets. We do expect, with the investments we’ve made, to continue to see double-digit growth in emerging markets throughout the year and high double-digit growth in China, where we’ve made some significant investments. So we feel particularly good about that part of it as well. Related to your question on M&A, we, as you know, have remained quite busy. We’ve completed 3 deals, smaller tuck-in deals during the last fiscal year. We continue to remain busy, and we’re optimistic that we’ll find some meaningful tuck-in opportunities as we come into fiscal ‘21. We’re very busy on that front, we see a lot of nice opportunities in private -- privately held companies. Then we fit very nicely with our portfolio and our vision of advancing connected care and our ability to do -- to advance in those areas that we talked about in the past.
Bob Hopkins:
Great. That’s it for me.
John Groetelaars:
I think just to conclude that, I think investors should expect us to stick to our financial discipline of our criteria of being growth accretive, being margin accretive and providing an ROIC within a 3 to 5-year time frame.
Operator:
Matt Taylor of UBS.
Matt Taylor:
So I just wanted to clarify two things. One is, when you look at the onetime positive COVID impact here in the fiscal fourth quarter, what was that comprised of? Do you continue to see some of these same trends around the orders of noninvasive dents in beds? Or was the composition any different as you move through the pandemic?
John Groetelaars:
Yes. I would say, Matt, the COVID benefit of $180 million, you see this quarterly breakdown in that one schedule that I pointed to earlier. 80% of it is beds and half of it, half of the total, was international, the other half was in the U.S. So those are probably 2 good kind of ways to think about that $180 million. 80% beds, 20% ventilators and then 50-50 in total in aggregate between U.S. and international. So that’s -- I hope that answers your question. Did you have a follow-on to that?
Matt Taylor:
Yes. No, that’s great. And then...
Barbara Bodem:
Hey, Matt, that’s okay. Yes. Let me just add. In the fourth quarter, we had $35 million of COVID benefit, and $10 million of that was related to the ventilators, $25 million is related to that. Just to clarify Q4.
Matt Taylor:
Okay. And then I just wanted to get some thoughts on the year ahead in terms of what you’re anticipating in different geographies. You called out the trends here in the quarter and the year in terms of how they’re recovering differentially. Can you speak to the outlook for the major regions that you’re exposed to?
John Groetelaars:
Yes, sure. So as I mentioned earlier, emerging markets, we expect double-digit growth. China, we expect very high double-digit growth. Our investments are really starting to come through there. And because of the breakdown I just gave you earlier, that $180 million being roughly half of that being internationally, that was mostly in Canada and Europe. So we will have in that timeframe of Q3 and Q4 some very challenging comps overcome in those regions. So barring some unforeseen demand, which has not into our guidance, we would expect to have some challenges in that Q3 period internationally.
Operator:
David Lewis of Morgan Stanley.
David Lewis:
Can you hear me okay?
John Groetelaars:
Yes, we can hear you.
David Lewis:
All right, John. Sorry about that. Just two quick questions for me, I’ll ask them both upfront. I guess the first thing, John, what’s interesting about the guidance. If I think about your guide for the year and I back out the surgical OEM headwind as well as the COVID-19 dynamics that you’re very nice in providing, it kind of gets you kind of a 4% underlying number for 2021, John, which frankly isn’t that far off of where you were pre-COVID at 4% to 5%. So the couple of questions is your confidence in that sort of underlying performance because it doesn’t seem to imply a lot of sluggishness in the U.S. capital market. I just sort of wonder sort of some of your assumptions and your confidence about that number because it’s, frankly, a lot more robust than we were expecting and how you were thinking about sort of Stryker’s ProCuity, which should get going here in the first quarter of next year in the U.S.? And then for Barb, just thinking about the rate of investment in ‘21 versus ‘19, I noticed that the implied SG&A number is lower. And I just want to kind of understand how you can deliver that level of SG&A improvement in ‘21 over ‘19 on the recovery? And does it factor it enough, frankly, relative investment back in the business to kind of maintain the growth momentum you had pre-COVID? Sorry for the long questions, but those are my two.
John Groetelaars:
Thank you, David. Yes. I think the -- as I’ve mentioned before, on the certainty of the environment and the relative importance of the CapEx that we’re bringing to the marketplace with our beds and our sensors and our communication technology, we see continued strong pipeline of activity. And really, quite frankly, broad-based recovery of the businesses that were negatively impacted. So we’re quite confident about our ability to see that recovery come through and then also take advantage of the investments we’ve made over the years to position the company for sustained durable growth, whether that’s coming from emerging markets or in this case, we are deploying new incremental investments for our Care Comm team, our digital business, to expand, and our Enterprise Accounts team, which is focused in the U.S. to also expand. We do expect our customers to become larger and more significant in terms of large, enterprise-wide purchasing decision. So we’re scaling up in those 2 areas specifically to make sure we’re positioned for ongoing growth as the recovery continues. And I’ll turn it over to Barb for the second question.
Barbara Bodem:
Your question about the level of overall investment in ‘21 versus ‘20 and are we able to sustain that. The answer is yes. So we’re reinvesting incremental investment in ‘21 at a very similar level to what we had in ‘20. And the way that we’re able to do that [Technical Difficulty] and pulled forward the business optimization and just...
John Groetelaars:
Barb, you’re breaking up there. I think you’re breaking up, Barb.
Barbara Bodem:
Oh, I’m sorry. Was it not clear? Let me try again. Can you hear me now?
John Groetelaars:
Yes.
Barbara Bodem:
Okay. So David, I’m sorry to repeat, if you heard it the first time through. But our level of incremental investment in ‘21 is very consistent with ‘20. And we’re able to do that because of the pull forward of approximately $50 million worth of business optimization into ‘21. Is that clear?
John Groetelaars:
Yes.
Barbara Bodem:
Okay, great.
John Groetelaars:
Sorry for the technical question, David. Did you have a ProCuity question as well, David?
Unidentified Analyst:
This is, Marissa, on for David. Yes, we were just hoping you could comment on any trends that you’ve seen or any commentary in the channel if you have seen anything from Stryker’s ProCuity.
John Groetelaars:
Yes. We have not seen any deliveries yet. Obviously, there’s some commentary out there of a pending launch, but we have not seen any deliveries occur at this point in time. So we expect that will happen in the next couple of months, but we’ve not seen anything material in the marketplace today.
Operator:
Michael Polark from Baird.
Michael Polark:
It’s quite the deck. Maybe a few -- appreciate that no COVID surge buying is built into the fiscal ‘21 outlook. Seems like the conservative and prudent thing to do. We have seen, though, in the last week or 2, even the World Health Organization out with predictions about ICU capacity in places in Europe getting really strained. And so would be interested in just kind of a real-time assessment. What are you hearing in some of these pockets where the flare ups are starting to really pick up steam? Are you seeing your customers really strain, gets strained with capacity? Any color would be helpful.
John Groetelaars:
Yes. Sure, Mark, and thanks for the question. The -- if I refer, as I mentioned, is this being the third wave. We expect this third wave to be a lot like the second wave in the summer. However, it’s going to be much more widespread geographically. And that opens up more hospital capacity as a result. We do believe that the -- from what we’re hearing from our customers that they feel confident, that they can manage what is anticipated in terms of hospitalizations, their treatment protocols, their ability to segregate patients, their ability to -- the patient profile themselves is a very different patient than the first wave, and it’s much more geographically dispersed. So I think in the U.S., yes, it’s going to provide some tension, but manageable is the current feeling. In Europe, with the spikes that are going on and the surge going on in Europe, the level of ICU capacity in particular and treatment capacity in certain regions of Europe, we are starting to see pressure building. And as a result, some higher level of interest and demand in some of our product offerings as a result. That goes across from ICU offering to our vital signs business to thermometry. So we’re starting to see some of that in Europe today. But it does seem -- it’s -- again, it does seem much more well-managed and not panic-oriented, but we are starting to see some incremental demand in those areas.
Michael Polark:
Fair to say that hasn’t been fully built into the Q1 framework? Or -- yes. Okay. And maybe, John, you offered to get into a little more detail on the apples and oranges of your bed platform versus the upcoming competitive release. They do make -- your competitor makes some fairly big claims. And I just love a few extra details about how you see what you have and how that differentiates versus what you expect ProCuity to offer to customers.
John Groetelaars:
Yes, I’m happy to take that question. We’ve been building for quite some time, a very differentiated platform on our bed business. In fact, I would actually say we’re turning the corner and it’s really more of a patient monitoring and connected care system today. Given all the technology and sensors and real-time communication capability that we’ve built into the system of the bed as a digital hub, the sensors and then the communication tools that surround it with our Care Comm and mobile communication business. So when you think of what we’ve been able to do and the offering that we’re continuing to enhance, what we effectively have put in place is -- from a -- I guess my best analogy would be cellphones and smartphones. Having connectivity is one thing. Having wireless connectivity is effectively like a flip phone from the ‘90s. Having what we have put together is effectively a smartphone in the current day and age. And what I mean by that is we can visualize waveforms, we can access real-time data, we can incorporate video into a patient and caregiver communication, and it’s a closed loop. So sensors from the bed communicate to the phone and then the phone, you can then communicate with other caregivers and patients directly. So it’s really -- the comparison of apples and oranges is really the basics of connectivity of having a cellphone versus having a smartphone today. Incorporating that camera, so you can do video chats and communication, you can access stock market information, you can access all kinds of other information. And that’s the difference of the robustness of the ecosystem that we have built with Centrella and our Care Comm offering and the Voalte acquisition and the sensors that we’ve incorporated the bed versus the basics of wireless connectivity.
Operator:
Our final question comes from Andrew Cooper from Raymond James.
Andrew Cooper:
It’s been asked already, but maybe just one more on kind of the guide and how we think about 1Q in ‘21 in terms of the COVID impact. You gave a lot of color. But when we think about your comments on bed demand and backlog, as where the order book is building relative to some of the upticks in Europe and things like that, when we think about that $180 million or 90 or so -- I’m sorry, 140 or so that’s bed. How much -- how do you think about what pull forward of demand to meet that surge that might slow orders in ‘21 relative to kind of onetime, but not necessarily impacting the expansions or roughly consider coming in the coming year?
John Groetelaars:
Yes. Maybe I’ll have Barb. Can you take that one?
Barbara Bodem:
Yes, I’d be happy to. No, I’m happy to talk to that. So the key thing that you need to think about is we’re looking at all 2021 is really about the normalization of the bed demand. And we’ve talked about how most of that pull forward we felt was really affected in Q4 of ‘20. And really for ‘21, it’s about normalization of that demand. And as John talked about, we saw nice sequential growth in our order book and are now reaching points where we’re getting close to pre-COVID levels in terms of order and quoting activity in the bed area. The second thing to think about as you look across ‘21 is the gradual recovery of those product lines that were negatively impacted by COVID. And that gradual -- that recovery can be more gradual and will continue across the first 3 quarters of ‘21. So as you think about the calendarization, as you think about the cadence as we go across ‘21, we’ll see that trough in Q4, we’ll see gradual improvement as we get normalization of demand and the recovery across the rest in Q1 and Q2. As you get into Q2 and Q3, we’ll have much stronger COVID headwinds that we need to manage through, especially in Q3. That’s a big headwind in Q3. And by the time we get to Q4, we’ll be bouncing back to growth. The other thing to think about as you think about the course of the year is we will see progressively improving operating margin and gross margin throughout the year, which will also contribute then to a bottom line that will look very similar to the top line improvement.
John Groetelaars:
Is that the final question? Well, thank you everybody for joining our call today. And we’ll see you next quarter.
Operator:
Ladies and gentlemen, this does conclude today’s conference with Hill-Rom Holdings Incorporated. Thank you for participating. You may now disconnect.
Operator:
Good morning, and welcome to Hill-Rom's Fiscal Third Quarter 2020 Earnings Conference Call. During the presentation, all participants will be in a listen-only mode. At the end of management's prepared remarks, we will conduct a question-and-answer session. [Operator Instructions]. As a reminder, this call is being recorded by Hill-Rom and is copyrighted material. It cannot be recorded, rebroadcast, or transmitted without Hill-Rom' written consent. If you have any objections, please disconnect at this time. I'd now like to turn the call over to Ms. Mary Kay Ladone, Senior Vice President, Corporate Development, Strategy and Investor Relations. Ms. Ladone, you may begin.
Mary Kay Ladone:
Good morning, and thanks for joining us for our fiscal third quarter 2020 earnings conference call. Joining me today are John Groetelaars, President and Chief Executive Officer of Hill-Rom; and Barbara Bodem, Chief Financial Officer. Before we get started, let me begin by reminding you that this presentation includes forward-looking statements that are subject to risks, uncertainties, assumptions, and other factors that could cause actual results to differ materially from those described, including any impact related to the COVID-19 pandemic. Please refer to today's press release and our SEC filings for more information concerning Risk Factors that could cause actual results to differ materially. In addition on today's call, non-GAAP financial measures will be used. Reconciliations between GAAP and non-GAAP financial measures are included in our earnings release issued this morning. I would also like to mention that in addition to the press release issued this morning, we have posted a supplemental presentation, which highlights Hill-Rom's performance. These materials can be accessed on the Investor Relations page of our website. So, with that introduction, let me now turn the call over to John.
John Groetelaars:
Thanks, Mary Kay, and good morning, everyone. Hope you're doing well. And thank you for joining the call. I'd like to start the call today by recognizing the dedicated, committed, passionate and mission-driven team that we have here at Hill-Rom. It's truly extraordinary. And I do mean extra ordinary. We were called to fulfill our mission to enhance outcomes for patients and caregivers, and as a team, we unequivocally executed to achieve. Ramping up and shipping two times the normal volume of smart beds, ramping up and delivering seven times the normal volume of non-invasive ventilators, securing our global supply chain, ensuring our workers safety, involving five of our largest manufacturing sites in ramping up manufacturing to meet customer needs, continuing to engage our over 1,200 Field Service employees and rental employees and those involved in logistics and shipping, you name it, our overall operational team delivered excellent. And this group of people, which is approximately 7,000 employees out of our 10,000 employees, really deserve special recognition. Next, we pivoted and accelerated our R&D pipeline during the pandemic, launching five new products and pivoting our programs towards innovations to help patients dealing with COVID. It doesn't stop there. We closed the two acquisitions, and supported our vision of advancing connected care in both patient monitoring and OR data integration. And if all that wasn't enough for you, we actually did this, while all of our office workers moved to remote work-from-home, and we launched a new website for the company, as I said, extra ordinary, incredible execution by the Hill-Rom team. The combination of our exceptional execution, financial strength, and diverse portfolio underscores our commitment to enhancing value for customers, caregivers, and our shareholders today, and over the long-term. Moving to financial highlights for the third quarter, we're pleased to report record results that exceeded our expectations on both the top and bottom line. Core revenue growth was 12% reflecting the durability and strong value proposition of our critical care products and our category leadership in the markets we served. Core revenue includes a contribution of approximately 400 basis points from the Breathe acquisition and benefit of more than $100 million related to other COVID-related purchases. We continue to be pleased with our ability to significantly expand margins, achieving a record adjusted gross margin of 53.8%. With disciplined cost management and expense leverage, we posted an operating margin of 23.7%. This resulted in adjusted EPS of $1.95 per diluted share, an increase of 59%. Before turning to performance by business, I'd like to highlight that growth from new products accelerated again this quarter, resulting in more than $440 million in new product revenue year-to-date, an increase of 40% versus the prior-year. Importantly, this sets a solid foundation for achieving our $550 million in new product revenue, a key objective we set at the beginning of the fiscal year. I'm very proud of how we pivoted our R&D efforts and recently introduced five new products in the areas of remote monitoring, respiratory care, and surgical workflow. These were highlighted in the press release issued this morning. So given our limited time together, I won't walk through them individually, other than to note that they are all representative of how we're advancing our category leadership and plan to accelerate future growth through innovation. Geographically, international performance was strong with core revenue growth of nearly 40% due to a surge in demand for COVID-related products like ICU and med-surg beds, thermometry and vital signs monitoring equipment. As expected, with the exception of Asia-Pacific, all regions generated positive growth, including significant double-digit growth from EMEA, Canada, and Latin America. In the U.S., growth of 2% reflects the puts and takes across our diverse portfolio. Patient Support Systems led the way with core growth of 12% which was offset by lower revenues in Front Line Care and Surgical Solutions. Now, let me touch on our third quarter performance by business at constant currency rate. First, Patient Support Systems revenue increased 21%. Core revenue growth of 23% was driven by a global surge of demand for our ICU and med-surg bed systems, as hospitals expanded capacity in the early phase of the COVID outbreak. The vast majority of the company's COVID benefit that I referenced earlier was from med-surg and ICU beds, which comprised approximately 30% of total company revenue in Q3. That's a full 10 percentage points higher than typical. During the quarter, we worked through a significant backlog in orders that accumulated during the month of March and April, particularly in the U.S., Canada, and EMEA. This resulted in revenue that was nearly two times the level of prior-year. In the U.S., we estimate that approximately 50% of the peak demand for bed was due to market expansion, while the other 50% was pulled forward from our fourth quarter funnel. Global demand for beds is now beginning to normalize. Due to the pull-forward effect, and surge demand previously mentioned, we anticipate near-term transitory headwinds for our bed portfolio. That being said, we remain optimistic about recent customer commentary, and prioritization around ICU bed as a top CapEx investment priority, as they balanced capacity needs to treat both COVID and non-COVID patients. We remain encouraged by the long-term growth prospects of ICU market expansion, which may help overcome some otherwise difficult growth comparisons in coming quarters. While bed revenue was strong, it was partially offset by anticipated headwinds in other parts of the business, including Care Communications, which was impacted by hospital access restrictions to complete installations. The good news is that access restrictions are starting to ease, installations and coding activity is accelerating towards pre-COVID levels, and we are currently building a robust funnel that we expect to benefit from in fiscal 2021. Turning to Front Line Care, third quarter revenue increased 4% reflecting strength in international and one-time non-invasive ventilator orders of approximately $25 million to support U.S. stockpiles. While we experienced strong demand for vital signs monitoring equipment and thermometry, it was not enough to offset the impact of lower physician office visits in the U.S. on the other patient exam and diagnostic tools, including cardiology, and vision screening. Generally, physician offices are now resuming and recovery towards pre-COVID levels is occurring across multiple areas of our Front Line Care portfolio. Lastly, Surgical Solutions revenue declined 37% reflecting the surgical consumables divestiture last year. Core revenue declined 21% as a result of project timing and capital delays due to COVID-19. We expect recovery in the surgical business to be more gradual, as OR capital projects, as you can imagine, are currently being deferred by our customers. With that as a backdrop, I'd like to provide some additional perspectives on our results and visibility to the trends we're now seeing across the portfolio. As you may recall, we have portions of our business that have been favorably impacted, and those that have been negatively impacted by the evolving market trends. The net impact to Hill-Rom in various regions and product categories will largely depend on the scope, intensity, and duration of the pandemic, as well as the shape of the recovery in demand for healthcare and access into acute care facilities. Given all these variables last quarter, we elected to suspend our previously issued guidance. And while we're not reinstating guidance today, as the situation remains very fluid, we're now through three quarters of our fiscal year and we have some visibility into our final fourth quarter. Given the strength of our financial results to-date, including core revenue growth of 8% and adjusted EPS growth of 28% and the evaluation of various scenarios for Q4, we're confident in projecting adjusted earnings of at least $5.40 per diluted share for fiscal 2020. Our confidence is based on various outcomes of the puts and takes across our portfolio. This includes the assumption of normalized demand for med-surg and ICU beds following the Q3 surge, continued growth across multiple product categories in Q4, and reflects no benefits from a second wave. In addition, we anticipate recovery across other areas of our portfolio that were negatively impacted by project delays, customer access, and reduced physician office visits. We are pleased with the speed of this recovery and expect double-digit sequential growth for these products as we exit our fiscal year. So, in summary, amid a challenging environment, our performance to-date demonstrates the advantage of our company's transformation into a diverse and more resilient portfolio of connected care solutions and that is more important than ever. Looking ahead, we will continue to focus on our strategic priorities, advancing our mission and category leadership strategy, executing on our growth oriented M&A strategy and driving operational execution and strong financial performance in the years to come. Thanks and I'll turn the call over to Barb.
Barbara Bodem:
Thanks, John, and good morning, everyone. Let me briefly walk through the P&L before commenting on trends we are seeing as we closeout fiscal 2020. For the third quarter, global revenue of $768 million increased 6% over prior-year revenue of $727 million. On a constant currency basis, revenue increased 7%. Core revenue advanced 12%, reflecting a benefit from COVID-related purchases of more than $100 million, new product contributions, as well as approximately 400 basis points from the Breathe Technologies acquisition, which will anniversary in August. Adjusted gross margin expanded 350 basis points versus the prior-year and peaked at 53.8%, a new record level. This reflects favorable product mix, particularly from higher margin one-time COVID purchases, as well as the impact of new product and portfolio optimization initiatives and the benefit of lower manufacturing and service costs. R&D spending of $34 million was comparable to the prior-year. Adjusted SG&A of $197 million decreased 3% primarily as lower discretionary spending, like travel, meetings, and certain marketing expenses more than offset strategic investments to drive future growth. Given strong adjusted gross margin expansion and expense leverage, adjusted operating margin of 23.7% improved 590 basis points compared to the prior-year, setting a high watermark for the fiscal year. Interest and other non-operating expenses for the quarter totaled $17 million and the adjusted tax rate was 21%. This translates into adjusted earnings for the fiscal third quarter of $1.95 per diluted share, which is an increase of 59% from $1.23 per diluted share in the prior-year. Excluding the diluted impact of the Surgical Consumable divestiture which contributed $0.07 per diluted share last year, adjusted earnings per share increased 68%. Now, turning to cash flow, cash flow from operations for the first nine months of 2020 was $315 million, a 5% increase to prior-year. Capital expenditures on a year-to-date basis totaled $72 million, $21 million higher than the prior-year, driven by IT transformation costs and capitalized software costs related to R&D investments. As a result, year-to-date free cash flow totaled $243 million. Our balance sheet and overall financial position remains very strong. To-date we returned $114 million to shareholders through dividends and share repurchases during fiscal 2020. We ended the quarter with $332 million in cash and our debt-to-EBITDA ratio at the end of June was 2.9 times. The first time it's been below three times since the Welch Allyn acquisition. We continue to operate well within our debt covenants and we have no material debt maturities until 2024. Lastly, given our refinancing efforts last year, we have access to a revolving credit facility of up to $1.2 billion to address any capital needs as necessary. Now, before turning the call back over to John, let me expand on the current business trends as we continue to actively monitor the evolving landscape and track potential implications geographically and within each of our three businesses. As John mentioned, Q3 reflected peak demand overall for 60% of the portfolio, which translated into actual growth of more than 40% for this category of products. As demand for certain products like ICU and med-surg beds begins to normalize, we do expect double-digit growth for other products in this category like thermometry, vital signs monitoring and respiratory products as we exit the year. Collectively for the 60% revenue category, we expect Q4 revenues to be comparable to the strong fourth quarter last year, resulting in growth of nearly 20% for the second half of 2020. This reflect the current backlog and visibility to orders and no benefits from a second wave. The other 40% of our revenue is now showing signs of recovery and is expected to show sequential double-digit revenue growth as we exit our fiscal year as customer access and physician office visits improve. We continue to expect second half revenue for this portion of the portfolio to decline by about 25%. This is in line with the expectations we shared with you last quarter. Given the ongoing uncertainty, scope and evolving nature of the pandemic, we're not reinstating formal guidance. We would also not recommend extrapolating our recent results into projections for the remainder of the fiscal year. However, given our results today, and disciplined management of the business, we can say that we expect full-year adjusted earnings of at least $5.40 per diluted share. We look forward to providing you with additional updates in the future. Thank you. And with that, I'll turn the call back over to John.
John Groetelaars:
Thanks Barb. In closing, we remain confident in the durability of our diverse portfolio of differentiated healthcare solutions. As we move beyond heightened COVID demand, and the transitory benefits, we believe our value proposition got even stronger and remain attractive in the post-COVID environment. And the multi-year growth platforms we've previously discussed can contribute meaningfully to future performance. Our company is better positioned today than during the last period of economic instability. Our core investment thesis remains intact. Our financial strength, consistent cash flow generation, and the execution of our strategic priorities is positioning Hill-Rom for sustained success. As I mentioned earlier, the strong foundation we've built is due to the amazing work and dedication of our Hill-Rom team. Their commitment both to our company, and the patients and caregivers we serve is truly an inspiration. Our employees around the world bring our mission to life every day. I feel fortunate to work with such a great team and together we will continue to build on our momentum as we aspire to deliver on our long-term objectives and create value for our shareholders. With that, let's open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions]. I would like to remind participants that this call is being recorded and a digital replay will be available on the Hill-Rom website for seven days at www.hillrom.com. And first question comes from Rick Wise with Stifel. Please go ahead.
Rick Wise:
Good morning, John, and Barb and thanks for all the excellent detail and the performance in the quarter. So many questions. Maybe I'll start with patient support. John, you can give details about the quarter. But I'm sort of intrigued with your views around market expansion here. I can imagine why you might argue for market expansion. But as part of this question, how does that market expansion characterized in your mind? What's it due to growth? How does this play out over the next couple of years? And maybe you can help us understand on a sustainable basis what this might mean to more normalized go-forward growth for this business?
John Groetelaars:
Yes, thanks Rick. When it comes to our PSS business, and in particular, the bed portion of both med-surg and ICU beds, I think what we saw in Q3 and as we outlined in our prepared comments was in fact market expansion. We took a lot of time to detail out that incremental $100 million of COVID-related business, and saw that roughly, we said about half of it was due to market expansion. So and a big portion of that in Q3 was not just U.S. was International. I can give you examples, I'll give you one example that we talked about last time. In Canada, we sold well over $25 million of ICU and med-surg beds, primarily ICU. And they weren't replacing other beds in that instance. And same with that whole category that we said was market expansion. They were adding new incremental capacity. In that instance, it was done in a hurry, it was done pretty much across the country, and we will well position to support those customer needs in a real hurry. So the fact that we could adapt and respond so quickly to that urgent need in a moment of panic quite frankly led to immediate market expansion in Q3. And that's why I think in other prepared comments, and I'm sure we'll talk about this. But let me try and address it now. We've always said and I've always said that we're going to see a nonlinear recovery, when it comes to this part of our business. We're seeing a nonlinear expansion as it relates to this part of our business right now. There was an incredibly urgent and significant healthcare need. And Hill-Rom was able to deliver for that need to provide immediate market expansion. Now, at the same time, it pulled forward a lot of sales that we had in for Q4. But I think to your question with a long-term outlook, we feel really good about the long-term outlook for market expansion for ICU beds and med-surg beds that have the ability to flex-up and become an ICU bed for a transitional temporary period. Both of those are in our portfolio. In fact, you'll see in our website a new dark frame that we're just out promoting now as a Centrella Bed offering that can be flexed up to become an ICU bed offering to provide for this transitory capacity that may be required. So we think we're really well-positioned, Rick to benefit from this trend. It's a global issue. Many countries require more ICU capacity in the app. We were a clear recognition after the wave that we've just been through that is distinct to happen. And you're seeing a much more measured kind of thoughtful approach around how various healthcare systems do this. However, I would say we've got a lot of -- tremendous amount of feedback; we've kind of do a lot of research on this topic. And our confidence is very high that we're going to see market expansion over the coming years for the ICU bed market.
Rick Wise:
Great. John, you talked about the Care Comm business. And I'm not surprised that obviously that in the period you didn't have the access you wanted to install. But I'm excited to hear that you're building a backlog and you were very positive about the impact on fiscal 2021. Can you talk about what kind of -- I mean, I don't know if you can give us any numbers about where the backlog is. But maybe can you help us think about what kind of incremental benefit could we see from this turnaround in Care Comm as we contemplate the fiscal 2021?
John Groetelaars:
Yes, so our outlook for Care Comm remains really bullish. It's more relevant now and in the future than it has been. We because our Care Comm business is constituted of conventional nurse call and the mobile platform offering, the access into rooms to wire in the systems and install systems and recognize revenue as a result was severely impaired in Q3. As we exited the quarter, things got better. Our outlook in Q4 continues to show a nice route. We believe a very nice recovery as we saw the trend play out in Q3. So we're quite optimistic that that recovery curve is one of the quicker steeper ones to come back partly because the relevance and the importance of these communication tools to healthcare providers and the expanded feature set that we now provide with everything as we mentioned in some of our presentation materials a new partnership with hands-free voice activated feature on our Volt mobile nurse call system, as well as the earlier acquisition of Excel Medical which brings medical device integration and live waveforms, our comprehensive solution set in that [ph], the mobile building around this business continues to provide a fairly dynamic growth vehicle for the company going forward. So the recovery is coming, it feels like it's one of the quicker businesses that will recover, because of the importance of it. And the long-term growth outlook continues to be one of our brightest opportunities in the future.
Rick Wise:
And just last from me, debt now is 2.9 times. Maybe just talk to us about your thinking about M&A. You feel like just because of all the craziness in the world that are more businesses available or more of the kind of acquisitions that you're interested in available now? And maybe talk through with the help of your outstanding business development strategic team, where are your priorities as we think about the portfolio? Thanks so much, John.
John Groetelaars:
Thanks, Rick. Yes, so we continue to be very active in M&A. As we're working through the last quarter and the craziness of the pandemic, we were able to remain very focused with our teams on M&A and continue making good progress. As you heard in this announcement, we closed two small tuck-in acquisitions, one around video integration in the OR, video and OR data integration in the operating room. And then another one around emerging market connectivity solution for our vital signs business, which we're really happy with. Both of those are strategically fit into our strategies very nicely. They both support international as well as U.S. opportunities in the case of the OR integration one. So we remain very active from a valuation point of view and our rigor around the financial discipline. Smaller privately held companies probably represent better near-term opportunities. It's really difficult for larger and certainly larger public companies to meet our financial criteria in today's environment. But it's not that we're not looking. But I think our strategy around tuck-in and bolt-on M&A is a more likely set of expectations in the near-term. And maybe, Barb, if you want to touch on capital allocation priorities, I think it was also part of this question.
Barbara Bodem:
You know, I think you've covered it really well, John, our capital allocation priorities remain the same. First and foremost, we're looking to support the growth of the business and finding the right M&A deal is top of our list. Absent the right M&A we will continue to support our dividend. We'll continue to look at share repurchases as a lever to offset dilution where appropriate. But absent the right M&A beyond our supportive dividends and share repurchases, we're going to continue to pay down our debt. We're really pleased in this environment to see our debt ratio decline to 2.9 which is historically low number for us. So we're going to continue to stay disciplined and look for the right deals and the deals that are going to drive our top and bottom line growth over time.
Operator:
Larry Keusch is on the line from Raymond James with a question. Please state your question.
Larry Keusch:
Thanks and good morning, everyone. Just a couple here. John, I'm wondering if you can perhaps talk a little bit about sort of the trends that you're seeing in the business through the fiscal third quarter and sort of how you're thinking or how July progressed?
John Groetelaars:
Yes, let me probably address that two ways, Larry, one with CapEx and one with our down businesses, the 40% of our portfolio that was negative. I'll start with the latter, in that group of 40% of revenue that was negatively impacted by COVID; it breaks down to three categories, one Care Comm which we talked briefly about earlier. The second one is all of our physician office businesses in Frontline Care everything from vision care to vital signs, and thermometry, well not thermometry, thermometry is in the other part of the portfolio, but all of our physical assessment tools, and then our surgical business as well as some of the safe patient handling equipment in our PSS portfolio. Those are the three big elements and they're all on different recovery curve, I would say. Care Comm, as I mentioned earlier is one of the quicker ones to come back. And we're seeing -- we saw a nice uptick in the trend as we exited the quarter. And our outlook for Q4 is kind of getting back to where we hope to show some growth in that category in Q4, if not, we'll come pretty close. In our Frontline Care portfolio, you can imagine primary care physician office visits were not as high a priority as elective surgeries and the return to healthcare demand. So that that was slow to show recovery in Q3 but did definitely show signs in the month of June. And we're seeing that that trend continue in the month of July. So we're again that's on its way back to pre-COVID type of levels, we believe in the coming quarter. And then the surgical business as well as safe patient handling, which does involve many times in installing infrastructure in the ceilings of the hospital or in the OR given the importance of OR activity and resumption of surgical backlogs and elective surgery, that's one of the reasons we're not seeing, we don't anticipate seeing a significant increase in those businesses from Q3 to Q4. But we do expect and have schedules to see those product lines coming back in our new fiscal year, starting in October. So they're going to come back, we feel very confident they are going to come back. It's just a slower recovery curve in that area. The other area I would comment on is CapEx, and in particular, U.S. CapEx, our international CapEx is really not impacted, in the markets we're in and the products we're in if anything is favorable because of the need for more bed capacity, more ICU bed capacity, and are there parts of our portfolio that are experiencing a tailwind in this environment. In the U.S. is where more of the uncertainty is, and I'm sure everyone's heard the commentary on that from providers as well as other companies in the industry. We're actually very favorably positioned. We know that the top one, two -- couple of top priorities for our customers is workflow and clinical communications with both caregivers to caregiver and caregiver to patient that positioned our Care Comm business pretty well as a priority. And ICU capacity and ICU needs for critical care equipment, whether that's vital signs equipment or for ICU bed. So those are going to have relative high priority, even in a constrained capital environment in the U.S. So it will be certainly a challenging environment for the next couple of quarters until hospitals see the full benefit of government stimulus and support. So far, about $125 billion out of $175 billion has flowed to them. And maybe there'll be more in future stimulus packages. That combined with the return of normal elective surgery volumes and normal consumption of healthcare in the acute care environment certainly helps shore up their financial certainty. The combination of those two events and good food, we anticipate that over the coming couple of quarters that the financial certainty around CapEx will significantly improve in the United States. But in the near-term, our portfolio is well-positioned for their most pressing urgent requirements.
Larry Keusch:
Okay, terrific. That was really helpful. And then just two for Barb. I guess one thing I was thinking about was certainly the record margins that you set this quarter, but as you start to ramp-down some of that manufacturing that was flexed up to meet COVID-related demand, how should we think about kind of margin in the fourth quarter. And I assume that that'll trend back down a bit, so some thoughts around that? And then on the cash flow from Ops, which was up, as you mentioned 5% year-to-date, looks like your GAAP net income was up significantly more in the year-to-date and it feels like at least as I looked at it quickly, it looks like there's a fairly meaningful increase in inventory. So again, how do we think about kind of inventory levels going forward and improvements in cash flow from Ops? Thanks.
Barbara Bodem:
Hey, Larry, thanks for the question. I hope you're doing well. Let me start with gross margin. So gross margin for Q3 was at record levels 53.8% and we're really pleased with that. As we highlighted in our presentation that's online about 180 basis points of that really is related to the one-time COVID sale that we saw in Q3. On a year-to-date basis, if you look at our performance, we're year-to-date for the first nine months at 51.7%. And one-time, we're tracking really well for the full-year. In fact, if you go all the way back to sort of our aspirations at the beginning of the year for our gross margin expansion, we're tracking well against that. As you think about Q4, there are probably two things that you want to consider. One is that, we won't have the one-time COVID benefit. But the second thing to keep in mind is that the benefit that we've been receiving from the divestiture of Surgical Consumables business has given us about a 50 basis points lift each of the quarter so far this year, that's going to anniversary in August. So we will not see the same level of benefit in Q4. So you want to keep in mind those two pieces. But overall, in terms of the expansion of gross margin, we continue to be really pleased with it. It's tracking along our long-term aspiration. Volumes and manufacturing variances to-date and in our expectations are going to have an immaterial impact on the full-year. This is really coming down to our efforts on the portfolio optimization, our M&A, our new product launches, and the overall portfolio mix that's driving the bulk of the improvements, supported by ongoing productivity improvements from our outstanding operations team. So that's how we think about gross margin. As we turn and we talk about cash flow, and we look at inventory, we did have a significant build of inventory in Q3. And really, that was driven by a couple of different things. One of it was sort of a reaction or the result of the fact that we did see parts of our portfolio that 40% of our portfolio we saw softness in demand in the quarter. And we saw that demand. It takes time for the supply chain to matchup with that demand. The other part of the build was a conscious build, to make sure that we have the flexibility to continue to meet customer demands. And given how fluid the market is, we've deliberately held a little bit more to make sure that we're in a position to meet demand as it moves. As you think about Q4, I wouldn't expect a substantial change in our inventory levels, as we think about Q4, but we expect as we head next year, those things will all start to normalize more as we go into 2021. I hope that answers your question.
Larry Keusch:
Yes, that was terrific. Thanks to both of you. Appreciate it.
John Groetelaars:
Yes, maybe just one clarification on that excess inventory of componentry. We don't see any risk to obsolescence in that kind of inventory build of our supply chain.
Barbara Bodem:
Really good clarification. This is deliberate choices about volume, not about any risk of obsolescence.
Operator:
Bob Hopkins from Bank of America is on the line with a question. Please state your question.
Bob Hopkins:
Thank you and good morning. So had some --
John Groetelaars:
Good morning.
Bob Hopkins:
Good morning. I know it's a confusing time; things are kind of all over the place. So I've got a -- just some clarifications on the guidance, and then some longer-term question. First, just to be clear on the -- what you're saying about the fourth quarter, what are you saying about the fourth quarter in terms of absolute dollar revenues?
John Groetelaars:
Well, I'll start with that and then I will turn it over to Barbara. We haven't specified, Bob, explicitly. I think the best we can articulate is on Page 20 of the slide presentation, we've provided where we're saying that 60% of the -- we're providing overall second half outlook of what we believe the revenue of the 60% resilient and the 40% impacted, how they look for the second half and you can certainly do the math and back into what the fourth quarter looks like. But when you do that, you'll see we're projecting a decline in fourth quarter revenue overall, which is heavily driven in fact primarily driven from the surge in bed volume that we saw, and were able to deliver in Q3. And as you know, Bob, customers were desperate to get this product and delivered immediately. Thankfully, we were able to meet those requirements. But as a result of that, we have a nonlinear transition between Q3 and Q4 of our resilient products because we delivered over $100 million of benefits financially around beds, and then another $25 million of non-invasive ventilators that are that that will be a one-time stockpiling order in Q3. So those things don't repeat. And so our attempt to smooth that out over the second half of the year ,and say, look this is what the second half would look like, if you take two quarters and average them out.
Bob Hopkins:
Right, no, I understand. I mean I think everyone gets that there's a lot of moving pieces right now. We're just -- I'm just trying to understand for the purpose of clarity for people, because we're just getting a lot of questions on I realized that gave us some things to work with in terms of math, but it seems like it would be sort of maybe in the low $700 million range for the fourth quarter, when you do all that math is that kind of roughly --?
John Groetelaars:
No, I think what we try -- yes, what we try to do, Bob and I'll let Barb to chime in here, but we try to do is underpin it with the $5.40, right on the EPS side, because there are a lot of puts and takes on the revenue line. And quite frankly, it's quite difficult for us to, that's why we're not providing guidance; we don't have the ability to provide an accurate enough outlook on the top-line. However there's enough other levers in the P&L that we feel we have enough certainty where we're on our fiscal year to say $5.40 EPS for the full-year is something we feel confident is the floor and that would give us, if you exclude the Surgical Consumables divestiture last year, that's 11% growth year-over-year. So again, our ability to deliver in highly uncertain times deliver double-digit EPS for our fiscal year is something we're quite proud of.
Bob Hopkins:
Yes, and that makes total sense. It's just that you are providing information in the slide deck. And I'm just trying to understand what that information implies about the fourth quarter and it looks like to me it's kind of very low $700 million. And I just wanted to see if we were kind of doing the math right.
John Groetelaars:
Barb?
Barbara Bodem:
Well, just to reiterate, when we look at suspended guidance last quarter, it was because it's very difficult to pinpoint the exact net impact on the portfolio of all the puts and takes. And as John has highlighted around the bed orders in Q3 and our ability to deliver on that in Q3 and the subsequent impact on Q4, it's not just about the net impact, it's the timing of the net impact that becomes challenging. And so we obviously are running loads of scenarios looking at where things could be and as we were preparing for today, wanted to make sure we are providing as much clarity as we could. So again, where we came back to was this floor. And it really is a floor on the EPS of the $5.40. Where do we feel confident that we can deliver there? And then providing the thoughts about what the second half will look like on the 60 and 40. And as you're doing the math back, that will give you sort of the range, if you will, and the floor that you can work that to from a revenue standpoint of what we think the quarter is going to look like. But remember that the timing, the timing in particular, it's the net impact of the puts and takes. But it's also the timing and how that’s falling within our quarters, there's more fluid nature to it than what we've traditionally seen.
Bob Hopkins:
Okay, and that's fair. Let me just follow-up on that.
John Groetelaars:
Bob, hey look, I wouldn't -- let me just comment, Bob, I'm not going to object or comment either way to your number of $700 million in the quarter. But let me just say, for the last few quarters, we said please don't extrapolate off of these quarterly results; right this quarter and the prior-quarter. And whatever our results end-up being in Q4, we would probably say the same thing again. So even though you might end up on a number for Q4, you can't extrapolate off of it.
Bob Hopkins:
No, no, I get that. So let me just -- let me take it back up for a second just with one additional question. On the $5.40, I guess two quick things. One is where's their conservatism built into that number? Just maybe some thoughts around the kind of what assumptions are underlie that -- and that $5.40 and where there might be some conservatism. And then I know it's such an uncertain time. But John, maybe if you could just comment on once we get through all this, like what is your view kind of based on what you know right now, just in terms of how you think about the growth outlook for the business, as you see it right now thinking a little bit longer-term, and what -- from maybe a revenue and earnings perspective, just some rough thoughts on how you're thinking about this, this business long-term based on all the new learnings over the course of the last couple of quarters? I'll leave it at that. Thank you.
John Groetelaars:
Yes, thanks Bob. I'll turn the first part of that question over to Barb on the $5.40 and the puts and takes.
Barbara Bodem:
Happy to take it. So I think we talked a little while ago about gross margin and the expectations for Q4. So you should not be expecting a repeat of 53.8% in Q4. But our overall trend towards gross margin expansion have not been significantly out of line then with where we stated our goals for the beginning -- at the beginning of the year. And I think that that we continue to kind of lean into our expectations around gross margin expansion. With regards to operating expense leverage, we saw very good operating expense leverage in Q3. As we saw expenses decline year-over-year because of the impact on the business as we all move to remote working. Now, in Q4, as you think about operating expenses, there are a couple of things that will be a little bit different as you think about Q4. One is as John has talked about, activity has picked up and so our spend level is expected to pick-up as well, just because we're out in the marketplace, and we're reconnecting with customers. So it's a different level of normal activity in Q4, plus the investments that we turned on in Q3, we will continue to find as we go into Q4. But our overall commitment to both the growth and operating margin expansion remain strong. And we believe we're on a good path to be able to deliver on those for the year. The uncertainty around Q4 and where relative to that $5.40 is going to come down to the net impact of the puts and takes on the portfolio and the timing of those. That's really the question and why we're not giving specific guidance, because there are so many moving pieces as you highlighted earlier.
John Groetelaars:
So let me then answer the second part of that question, and I'll point to our actual results first, and say the Hill-Rom today is not the Hill-Rom of yesterday. And the results year-to-date and what we're now projecting for the full-year illustrate that, right. The diversity of our portfolio, the resiliency of our portfolio, and our ability to navigate through this pandemic and the financial uncertainty that go with it and still deliver double-digit EPS growth and revenue growth in some -- at some level, we'll know in the next quarter what that full-year performance looks like. It's pretty remarkable especially compared to our peer group. Long-term, our vision and our direction of going towards a connected care and advancing connected care environment is become more relevant than it ever has been. And the growth vectors will be driven-off of new products which we continue to see nice acceleration in the current quarter. It'll be driven by select investments in emerging markets, and then driving-off of four key product category areas
Operator:
David Lewis with Morgan Stanley is on the line with a question. Please state your question.
David Lewis:
Hi, good morning. Just a couple of follow-ups here. I just, I hate to go back to Bob's question, but I'm going to. So guys for the fourth quarter, various guidance out there in your deck and it doesn't -- it says kind of assessment of kind of $6.95 to $7.10 range for the fourth quarter is sort of the range implied by your deck. And if you look at your earnings guidance, it applies 17% margins-ish on sort of that number. So are you saying $6.95 to $7.10 sort of isn't the range implied by those slides? Or you're sort of saying we don't have as much confidence in the revenue, we have a lot more confidence in the earnings. So I'm still confused and just I want to make sure expectations are very closely set here before we exit the call?
John Groetelaars:
Yes, like I said, because we're not explicitly giving guidance, David we provided -- we did our best to provide as much color as we could. And I think you're seeing that and backing into numbers that I can fill-up. Yes, you're in the right zip code. But we're not going to explicitly affirm it, but you're certainly in the right zip code. And so as Bob, we don't mean to evade the question in fact, we try to do the opposite. We try to provide you as much color as possible on current results and second half year results, so you can get to that kind of the range that you've just outlined. If you have a lot more confidence in our ability with moving levers and everything down the P&L to provide a hard number on the floor for EPS.
David Lewis:
Okay, that gives us a range to work with. Thank you. And so kind of related to that, either for Barb or John, the -- I think investors sort of fear that this business trough dynamic, I think you've been asked this question a lot and sort of 4Q sort of paints that picture as these tailwinds and headwinds cross in sort of any given quarter but to the back half of the year core gross around 2%. Is that a decent way of thinking about the business floor or a decent proxy for the first half of next year or there reasons to believe that in thinking about the peak and the trough third and fourth as an average, that's just not a very good number of 2%?
John Groetelaars:
Yes.
Barbara Bodem:
You want me to take that John or --?
John Groetelaars:
I want you to start, Barb sure, go ahead and start.
Barbara Bodem:
So I think that it's difficult, and as we talk about it, we would not extrapolate purely off of Q3. And as John commented earlier, we wouldn't extrapolate off of Q4. Even taking the average of those two, David could present some challenges. You really have to think about the shape and the speed of the recovery that we're seeing in the underlying portfolio. Much as John talked about it earlier, we're seeing different speeds based on whether you're in care homes versus physical diagnostics versus safe patient handling and surgical. And then we're going to have in the near-term, some of the lumpiness around the U.S. capital market and the impact on the bed sales as a result of the really phenomenal volumes that we had in Q3. So there's a lot of moving lines that are moving at different speeds. And therefore I think even taking just a second half is a troublesome sort of extrapolation, I wouldn't advise doing that. I think that you're going to have to bear with us a little longer as the pandemic rolls out. And we have clear trajectories on where 2021 will be. And the next time we're together, we'll have more information; we will be able to talk more about that then.
David Lewis:
Okay. And just two, two more quick questions for me, I apologize. You mentioned Barb 40% of the business can exit fiscal 2020 with double-digit growth which is encouraging, any sense of a range or floor for sort of the other 60% of the business?
Barbara Bodem:
So we've given you in the second half of the year, we've talked about the 60% and where we see that growing in the 20% range. I think we've also talked about that in that 60%, we continue to see double-digit growth on subcategories around the monetary -- around patient monitoring. Those areas continue to grow as we think about Q4.
David Lewis:
Okay. But that 60%, a view that 60% of the business can exit this year kind of flat. Is that too aggressive?
Barbara Bodem:
We spoke about how we think that year-over-year collectively that growth is going to look very similar to what we saw in Q4 of last year.
John Groetelaars:
Really, the wildcard there, Dave, the wildcard there, David, is the bed business, right. Maybe it was such a surge in Q3, it's relative to last year in Q4, obviously showing the decline in the math that we're providing here. It's that that is the piece, as we talked before that is going to be nonlinear. It's generally positive over a multi-quarter kind of period of time. But quarter-to-quarter in this kind of environment is going to show some positive and some negatives, quarter-to-quarter and just going to be nonlinear. And that's just unfortunate the nature of the pandemic that we're in.
David Lewis:
Yes, totally understand. And just lastly John, on the LRP just more specifically, I mean you've expressed some confidence recently in the LRP. And the first half of the LRP, if you assume that guidance range for the fourth quarter is correct. It's kind of maybe 3.5% core growth here in 2020 did closer to 7% in 2019. So you kind of get 5% growth in the first half of the LRP, to deliver your LRP have to do 5% growth in the back half of the LRP, so if we think about 2021 and 2022, are you now feeling that you can do 5% in the back half of the LRP or it's now just looking like it's more likely you can do that 5% for the next two years, if 2021 comes in lower?
John Groetelaars:
Yes, I would comment this way. One as we just said, the quarter-to-quarter variability in some elements of our business namely the bed business quarter-to-quarter financials and volatility right, so over a longer period of time and because of the environment we're in right now, the end of this year and likely beginning of next fiscal year, it's going to give us some interesting comps to deal with in fiscal 2021. That said, the long-term growth trajectories, the long-term growth vehicles in our business that are shining through in Q3 and will rebound in Q4 for the parts that have been impacted. We feel very confident that those aspirations can be achieved over a multi-year period.
David Lewis:
Okay, very helpful. Thanks so much.
Mary Kay Ladone:
We have time for just two more questions. I know we'll go a little bit longer today. But two more questions, please. Thank you.
Operator:
And we have a question from Matt Taylor with UBS. Please state your question.
Matt Taylor:
Hi, thank you for taking the question. So I just wanted to ask one about the guidance for the 40% of the portfolio that seems COVID pressure. So I'm having trouble understanding the guidance relative to your comments, because you talked in the script about the care comps activity picking up and physician office visits improving. So why would it still be down 25% in the second half, the same as Q3, why wouldn't you see any improvement in Q4?
John Groetelaars:
Yes, good. That's a good question. And the simple answer is tough comps from the prior-year. We normally have a really robust Q4. In the current environment, we don't expect the same kind of seasonality in our business or quarterly phasing in our business because of the situation that we're in. That's why we do see sequential improvement of around 10%. We expect around 10% sequential improvement between Q3 and Q4 on whole. And then with the comment -- the other part of that is that the safe patient handling and the surgical business which is about 15% of total revenue. So 15% of that 40% is really going to be a little bit slower on recovery, because of getting access to install infrastructure.
Matt Taylor:
Okay, okay. And one follow-up on the longer-term ICU opportunity. So Philips has commented for example they think there could be a doubling of ICU capacity over time. Is that a number that U.S. is balanced as well? Do you think it could be greater or less than that?
John Groetelaars:
Yes, we're honing that number as we speak and doing a lot of research. We do believe that it's a well over $200 million incremental opportunity over the next four years. And in terms of the TAM that will be available. So that's on an incremental basis, that's kind of a preliminary number that we're seeing.
Operator:
Matthew Mishan with KeyBanc is on the line with a question. Please state your question.
Matthew Mishan:
Thank you for squeezing me in. Just on the $200 million incremental opportunity that you're talking about. There's a big difference in ICU bed for Tampa and that TAM, is with you are talking about developed European countries versus also including emerging markets like India and China, how do you think about the differences? And are those included in that TAM as well?
John Groetelaars:
Yes, that's exactly the kind of thing we're doing to quantify it because in some of those emerging markets, they'll be happy using a lower end med-surg bed as an ICU bed and can have very different practices. So that that is the work, we need to finalize, but the number I gave you over roughly $200 million or better over the next four years does incorporate that thinking in terms of market dynamics.
Matthew Mishan:
And just to put it all in the context, where are you at on Centrella penetration of the existing base? And did that seriously accelerate over the last quarter or is it still, it's still fairly low?
John Groetelaars:
It’s still fairly low; it's around 15% mark the last quarter will probably give it an uptick of a percent or two, but it's still below 20%, easily below 20% of our Hill-Rom base of business in the United States. So we have a long way to go in terms of penetrating that base and then building our connectivity story of smart bed to smartphone and digital product offerings around that as we go into the future.
John Groetelaars:
Okay, thank you. Well, with that I will turn it back over to Mary Kay and say thank you for the call. We went over a little bit, but given the climate, hopefully everyone hung on to the call. And really want to thank you for your questions today. And I'll turn it back over to Mary Kay.
Mary Kay Ladone:
Thanks, John. Just wanted to say thanks for everyone sorry, we ran a little late today, but happy to answer any follow-up questions during the day. Thanks so much and have a great weekend.
Operator:
Ladies and gentlemen, this concludes today's conference call with Hill-Rom Holdings Incorporated. Thank you for joining.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International’s Second Quarter 2020 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today’s call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or re-broadcasted without Baxter’s permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President and Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Katherine. Good morning, and welcome to our second quarter 2020 earnings conference call. Joining me today are Joe Almeida, Baxter’s Chairman and Chief Executive Officer; and Jay Saccaro, Baxter’s Chief Financial Officer. On the call this morning, we will be discussing Baxter’s second quarter 2020 financial results and full-year 2020 financial outlook. A supplemental presentation to complement this morning’s discussion can be accessed on our website in the Investors section under events and news. This presentation includes related non-GAAP reconciliations. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook for full-year 2020, new product development, business development and regulatory matters contain forward-looking statements that involve risks and uncertainties. And of course, our actual results could differ materially from our current expectations. Please refer to today’s press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today’s call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. On the call this morning, we will be discussing operational sales growth, which adjusts for the impact of foreign exchange and the acquisition of Seprafilm, which closed on February 14 of this year. Now, I’d like to turn the call over to Joe. Joe?
Joe Almeida:
Thank you, Clare, and thanks everyone for joining us today. I hope that you and your families are healthy and safe. Like the last quarter, I want to begin by recognizing all of the healthcare providers and the first responders, who continue to work tirelessly in combating COVID-19. Our deep appreciation also goes to all the clinicians and researchers, who are advancing knowledge, treatment and promising vaccine candidates to address this global pandemic. Three months ago, we were hoping to see some easing in the trajectory of this deadly pandemic by now. Sadly, while the hotspots may have shifted, the infection rates and impact to remain staggering. Baxter’s second quarter performance reflects the evolving impact of pandemic conditions on the global healthcare landscape and on our own operations. As you saw in today’s press release, Baxter reported a year-over-year decline in both net sales and earnings in Q2 2020 while demand for certain pandemic-related treatments and technologies reached historic highs within the quarter. We also saw a negative impact on our results from significantly lower rates of hospital admissions and a reduction in elective procedures. The implementation of various shelter-in-place initiatives globally, as well as patient concerns regarding potential COVID-19 infection risk and the healthcare setting contributed to these trends. During the quarter, we continued to experience significantly heightened demand for our acute therapies products due to COVID-19. According to a number of third-party sources, 20% to 30% of COVID-19 ICU patients will develop acute kidney injuries requiring treatment with a renal replacement therapy, of which week continuous renal replacement therapy or CRRT, is the preferred option. In addition, our chronic renal care business continues to deliver sustained mid-single digit constant currency growth in peritoneal dialysis product portfolio. We continue to highlight the advantages of peritoneal dialysis therapies plus our Sharesource telehealth acknowledge as clinicians and patients look to home-based treatment to limit the risks of potential pandemic exposure. This positive performance in acute therapies and renal care as well as growth in our political nutrition business, partially that year-over-year sales declines in Medication Delivery, Pharmaceuticals and Advanced Surgery. Results for these businesses reflect the negative impact in the quarter resulting from a decline in U.S. hospital admissions of over 20%, any reduction in U.S. surgical volumes up more than 30%. The rate of these declines was similar to what we observed in both our European, primarily Western Europe, in Latin American markets during the quarter. Our Asia Pacific business, particularly our business in China slowly begun to recover in the second quarter, while we do expect sequential improvement in both emissions and elective procedures globally, our current assumption is that both metrics will remain below prior year levels and could be further negatively impacted by COVID resurgences in markets around the world. Sales in the second quarter also reflected all forward of demand into the first quarter, where we saw generally more aggressive ordering and stocking patterns among hospitals and distributors reflecting elevated uncertainty amid the pandemic’s early rapid global spread. While the current environment remains deeply uncertain. As of the end of the second quarter, we have been able to renormalize production and inventory of high-demand products and have reduced the need for around-the-clock manufacturing. We also have been able to wind down our use of supplemental expedited shipping methods, which played an essential role in accelerating product availability early in the pandemic. Baxter’s resilience at this unprecedented moment continues to be bolstered by the diversity and medically essential nature of our products combined with our market leading positions. Similarly, our broad geographic footprint supports balance and stability, helping counter the risks of overexposure to a more limited range of geographies. The continuing momentum of our business transformation also helps to strengthen our market position. Baxter’s enhanced efficiency, speed, and agility are clearly helping us navigate the impact of COVID-19 and there is just one variable we’re addressing. As we anticipate a challenging hurricane season, we’re leveraging our learnings on enhanced operational effectiveness for maintaining steady supply as the season unfolds. Meanwhile, we remain steadfastly focused on driving growth through innovation. Recent weeks have seen the launch of our new EVO IQ Syringe Infusion System in the UK and Australia. FDA clearance of our Altapore Shape Bioactive Bone Graft, and the publication of new positive data in the journal CHEST, involving our Sterling Fluid Management Monitoring System. Looking ahead, additional pipeline highlights include our Novum IQ Smart Pump Technology, Share Source Analytics and additional differentiated generic injectables. In all of these efforts, our people remain our ultimate resource and differentiating strength. I’m working closely with some of the most talented and dedicated colleagues I have known. Our customer satisfaction rates as recently captured in the highest average Net Promoter Scores Baxter has recorded globally further speak to our efforts during this period. Together, this team has helped advance dramatic change and we’ll continue to do so. These include new initiatives to advance racial justice within Baxter and among the communities in markets we serve. I’m proud of what we have achieved to-date across our business in our culture. But even more importantly, I’m energized by our ability to address various markets challenges and accomplish still more for our patients, shareholders, employees, and the diverse communities we serve. Now, I will pass it to Jay for a closer look at our second quarter results and outlook for the balance of the year.
Jay Saccaro:
Thanks, Joe and good morning, everyone. As Joe mentioned, our second quarter performance reflects the resilience of our diversified portfolio, even in an uncertain healthcare landscape. Our unwavering focus is on meeting the needs of patients and providers globally with medically essential products and therapies. Turning to our second quarter of 2020 results. Global sales of $2.7 billion declined 4% on a reported basis, 1% on a constant currency basis, and 2% on an operational basis. Increased demand for our acute therapies portfolio, along with solid performance in Renal Care and Clinical Nutrition were offset by declines in our Advanced Surgery, Pharmaceuticals and Medication Delivery businesses largely driven by the impact of COVID-19 on surgical procedure volumes in hospital utilization. We estimate that there was over $180 million in revenue downside for the quarter related to COVID-19. On the bottom line, adjusted earnings decreased 24% to $0.64 per share, reflecting lower sales and higher margin businesses, incremental COVID-related operations and logistical expenses as well as higher interest expense and the higher tax rate. Now, I’ll walk through performance by our regional segments and global business units. Note that for this quarter, constant currency growth is equal to operational sales growth for all global businesses, except for our Advanced Surgery business, for which we will provide both constant currency and operational growth adjusting for the acquisition of Seprafilm. Starting with our three regional segments. Sales in the Americas declined 5% on a constant currency basis and 6% on an operational basis. sales in EMEA advanced 1% on both the constant currency and operational basis. And sales in our APAC region advanced 5% on a constant currency basis at 3% operationally. Moving on to performance by global business units. global sales for Renal Care were $919 million, advancing 5% on a constant currency basis. Performance in the quarter was driven by mid-single growth in both our PD and HD businesses. PD growth benefited from increased patient volumes globally, including high single-digit patient growth in the U.S. as well as solid performance in our APAC region. Our HD business returned to growth this quarter as we anniversary the prior year sales impact of our Revaclear dialyzers supply constraints. sales and medication delivery of $612 million declined 9% on a constant currency basis. Within the quarter, we continued to benefit from strong execution on our Spectrum IQ and EVO IQ infusion pump placements globally. And as Joe mentioned, we were pleased with the launch of our EVO IQ syringe pump internationally. We also saw solid growth for our small volume parenteral products in the U.S. during the quarter. These benefits were more than offset by the impact of COVID-19 on lower patient admissions and a reduction in surgical volumes, which drove global declines in our IV therapies business, as well as lower sets and access utilization in our Infusion Systems business. As Joe mentioned in the second quarter, we saw the rate of hospital admissions declined more than 20% and surgical volumes come down over 30% as compared to pre-COVID levels. We estimate these lower volumes negatively impacted medication delivery sales by approximately $100 million within the second quarter. pharmaceutical sales were $485 million, down 7% on a constant currency basis, reflecting the expected declines from reduced demand for our inhaled anesthesia products. as a result of lower elective procedures related to COVID-19. We have to estimate this negatively impacted inhaled anesthesia sales in the quarter by approximately $50 million. performance in the quarter was also impacted by increased competition for Transderm Scop. These declines were partially offset by increased demand for our international pharmacy compounding business, along with certain generic injectables. moving to nutrition. [Technical Difficulty] in the U.S., reflecting the lower hospital volumes we’ve discussed. sales in advanced surgery $168 million declining 27% on a constant currency basis and 37% on an operational basis. The acquisition of Seprafilm in February, contributed $23 million to sales in the quarter. Declines in elective surgical procedures drove an estimated negative impact of approximately $80 million for the Advanced Surgery portfolio. Sales in our Acute Therapies business were $186 million representing growth of 45% on a constant currency basis. We estimate that the heightened COVID related demand contributed approximately $50 million to growth in the quarter. Finally, sales in our other category, which primarily includes our contract manufacturing services, where $129 million in the quarter advancing 7% on a constant currency basis. moving through the rest of the P&L. our adjusted gross margin of 41.6% declined by 280 basis points over the prior year, driven by lower sales of higher margin products, as well as increased expenses we have incurred in our manufacturing operations and supply chain related to our COVID-19 response. adjusted SG&A of $577 million decline 5% on a year-over-year basis, primarily driven by our ongoing focus on expense management, reduced discretionary spending resulting from COVID restrictions and lower bonus accruals under our annual employee incentive compensation plans. adjusted R&D spending in the quarter of $118 million declined 16% on a reported basis with reductions in discretionary spend due to COVID-19 being supplemented by our continued focus on operational excellence and the timing of certain project related spend. We continue to prioritize strategic investments to fuel our innovation portfolio. adjusted operating margin in the quarter was 16%, a decrease of 190 basis points versus prior year. net interest expense was $36 million in the quarter and increase of $16 million compared to the prior year, driven by increased interest expense from higher outstanding debt balances, as well as decreased interesting income due to lower interest rates. other non-operating expense totaled $6 million in the quarter compared to $4 million in the prior-year period. the adjusted tax rate in the quarter was 16.2% higher than the previous year, which included a benefit related to favorable tax ruling and higher stock compensation deductions. with respect to cash flow in the first half of 2020 regenerated free cash flow of $332 million compared to $242 million in the prior-year period. And as Joe mentioned, we are currently carrying higher levels of inventory to ensure adequate product availability in advance of hurricane season and amidst the ongoing uncertainty related to COVID-19 demand. We remain very focused on maintaining a durable balance sheet and adequate liquidity in an uncertain market environment. At the end of the second quarter, we had approximately $4.1 billion of cash on our balance sheet, which we believe is sufficient to fund our operations and strategically execute on our capital allocation priorities. While to-date, we haven’t yet experienced significant collection issues. We are closely monitoring the collectability of our receivables in the current environment. At this time, we’ve maintained a temporary suspension of our share repurchase program to drive further financial flexibility in the current market. Within the quarter, we announced an approximate 11% increase to our quarterly dividend payment, reflecting our continued commitment to delivering value to our shareholders. Let me conclude my comments by discussing our outlook for the remainder of the year. for full-year 2020 at this time, we expect reported sales growth between negative 1% and positive 1%. We expect flat-to-low single digit sales growth on both the constant currency and operational basis. In ever evolving landscape, some of the factors impacting this outlook, which we continue to monitor closely around the world, inclusively, patient referral pipelines, and willingness to return to care, pace of elective procedure recovery, impact of COVID-19 on the ESRD population and PD penetration, hospital access for our sales and technical representatives and the impact of [Technical Difficulty] of infection levels globally. As Joe stated earlier, our current outlook assumes a sequential improvement on a quarterly basis in both hospital admissions and surgical volumes, although it’s still below prior-year levels. Regardless of these uncertainties, we remain ready to address critical patient needs by supplying the market with a portfolio of medically essential products and ensuring the safety of our employees. as such in line with our first quarter commentary, we expect to absorb approximately $150 million of incremental operations and supply chain expenses related to our COVID-19 response efforts in 2020. these costs include measures we are taking to protect employees’ safety, bonuses paid to our frontline manufacturing and field service employees, and increased freight-related costs as we prioritize delivery of critical products. We will continue to prioritize our planned R&D investments within the year, year-over-year operating expense reductions will be driven by continued financial discipline, as well as lower travel and meeting expenses. We expect full-year net income – net interest expense increased by over $60 million as compared to the prior year; and for the full year, we also expect other non-operating expense to be negatively impacted by approximately $50 million year-over-year due to the loss of pension-related income from the Q4 2019 transfer of $2.4 billion in pension assets and related liabilities. Given these factors and underlying assumptions, we currently expect adjusted diluted earnings per share, excluding special items between $3 and $3.10 for the full-year 2020. Finally, as we announced last quarter, we’re postponing our Investor Conference until 2021. As we previously discussed, we’ve withdrawn our long-term financial outlook, but remain confident in our ongoing commercial execution strategies and expecting contributions from our new product pipeline. We plan to provide an updated financial outlook at our Investor Conference next year. in closing, in the first half of 2020, each day brought new learnings as to how this unprecedented environment is impacting the patients and providers we serve globally. Our year-to-date top-line growth is fueled by the durability of our portfolio, as well as a pandemic response, which has benefited from strategic vision, financial discipline, and the tireless efforts of our dedicated employees around the world. In this dynamic environment, we continue to be well-positioned for sustained success. With that, we can now open the call for Q&A.
Operator:
Thank you. [Operator Instructions] And our first question comes from Robbie Marcus with JPMorgan. Your line is open.
Robbie Marcus:
Great. Thanks for taking the question. Maybe we could start with the delta in second quarter versus your expectations coming out of the first quarter? And then what gives you the confidence to put out the guidance range that you did? With still seeming uncertainty through the balance of the year, help us understand how conservative this is? How much room for upside or downside is in the guidance range? And just any color you could provide around it. Thanks.
Joe Almeida:
Robbie, good morning. This is Joe. We had expected that – and positively for primarily the U.S. and Europe, the widespread or shelter-in-place initiatives and concerns in the beginning of April really reduced hospital admissions. People were fearful to go to hospitals, but the shelter-in-place put a reduction in place of cases along – if you remember, along the curve for the month of April and May sequentially. Those things combined created pressure on hospital admissions. So, let me explain to the folks on the phone that Baxter is a little different than what you think of our peers are. We are dependent [technical difficulty] by that. Hospital admissions drive another portion of our business. And home care, primarily the dialysis business drives that too. So different than many of the peers that you usually cite, Baxter is not an elective procedure-dependent company. Hence, our resilience, hence, our performance this quarter was slightly below our expectations. But it showed to be more resilient than double-digit decline that you saw in many of our peers who reported already. And the reason for that is that we have business like acute renal care and peritoneal dialysis, which are doing extremely well for different reasons. What suffers in Baxter is the business of operating room procedures, you see, with anesthetic gases. The Pharmaceutical business is down double digits versus prior year. That is mainly driven by anesthetic gases and the lack of use of some injectable medicines that would be used in general – on the general floor for alleviating urosis. Admissions to hospitals saw a double-digit decline in the second quarter. So that created the pressure that you see in our numbers. We also – transposing to your question now, we have done an extensive work on modeling with a significant amount of inputs created our own way of understanding the market. And we see in our model a modest sequential improvement. That’s why we felt a bit more comfortable in giving guidance. But if you notice our guidance, it’s pretty wide. And it contemplates a significant amount of variables that we have in place. But if you boil down to what variables drive Baxter business is the home care business, is admissions into ICU, general admissions into hospitals and the operating room affects our business, primarily the anesthetic gases and Advanced Surgery.
Robbie Marcus:
Okay. So maybe, as we think about that, Joe, and maybe, Jay, you could take it. How do you think about what third quarter looks like and what fourth quarter looks like? And maybe give us some of the puts and takes around the margins, both, you had pretty material R&D cuts. How do we think about gross margin, your spending on research and development? And where you could get some of the savings to offset the incremental $150 million in SG&A?
Jay Saccaro:
Sure. There’s a lot to that question. So I’ll hit each of the pieces. First, as we think about Q3 versus Q4, we were reluctant. We provided a larger range than we normally do at this point in the year on both the sales and the earnings for the company. And we did so because of the very wide dispersion of outcomes that are potential in the marketplace. I’m sitting here, I just saw the headline indicating a 33% decline in GDP for the quarter, which is just a shocking number and reflective of the wide range of uncertainty that we’re currently contending with. And so as a result of that, we put forth a wider range than we normally do. And we also did not share quarterly guidance, because given how things emerge, given hotspots, movements in these – in different pieces that take place, there is an inherent amount of volatility on sales in a given month. And we believe that over a longer duration of time, we have a better ability to predict. What I would say is we expect higher earnings in Q4 than Q3, and probably similar levels of sales performance in each of the quarters. Now as it relates to R&D spending, the R&D spending, we have – across SG&A and R&D, we are seeing some level of savings as a result of the pandemic and as a result of discretionary controls we’re putting in place. But what’s important to note is that we are incredibly focused on advancing the R&D pipeline. So, we will make those investments necessary to preserve this wherever possible. And like I said, and I think you see this in some of our commentary and discussions and progress that we’re making, we’re really happy with the progress in the R&D pipeline. So, while there will be some spending savings, I wouldn’t expect it to radically alter any specific time lines. As it relates to offsetting the $150 million. So, we made significant investments because right now, priority number one is keeping employees safe. Priority number two is getting our product where it’s needed in time. This is a pandemic. It’s moving around very, very swiftly. Hotspots are emerging. Our product has to be available. And so as a result of that, we experienced some significant second quarter costs. Some of those costs will roll out in Q3 and Q4. And we anticipate this $150 million number, a lot of which is just ensuring business proceeds as usual. So now how do you offset that? Well, there are a lot of mechanisms that we will put in place to offset from a spending control standpoint, things like travel, things like other discretionary areas. Robbie, you know as well as I do, this company is incredibly focused on zero-based budgeting and really smart spending on every single dollar. That doesn’t change. The pandemic does change in terms of how we approach our business and affords us some new opportunities, but that philosophy of focusing on every cent is something that will continue to serve us well. And then the big thing is as this pandemic subsides, and we don’t know when that will be, then we’ll recover the majority of the $150 million. But that’s going to be a cost that we’ll continue to watch and we’ll continue to support. And then as things ease at some point here, then we’ll start to recoup some of those expenses.
Robbie Marcus:
Thanks a lot.
Operator:
Thank you. Our next question comes from David Lewis with Morgan Stanley. Your line is open.
David Lewis:
Good morning. Just a couple for me. Maybe, Joe, and then I’ll shift back to Jay. Joe, just – can we just talk about the path for THERANOVA from here? And what you’re expecting now in terms of expectations for additional reimbursement either heading into 2021 or beyond? And then I’ll follow up with Jay.
Joe Almeida:
Okay, David. Good morning. We carried after we received the news from CMS. We had several exchanges with them related to our submission, and we keep them abreast of the – some rapid change environment in the THERANOVA. We will submit the comments to CMS by September 4. And we plan to address CMS’ issues as well as provide new information to them since our January 2020 filing. I would say that the information will include publications of our FDA clearance trial, a randomized controlled trial with the U.S. Medicare patients, also set to be published in September in a peer-reviewed journal. Our FDA market authorization status will be shared with them and an update on our companion of studies. They include posters recently presented at some conferences in June 2020 as well as newly published manuscripts already shared with CMS. We’re confident we can address the CMS issues. This is not our decision, it’s theirs. So I don’t want to speak on behalf of CMS. But in terms of addressing what was present to us, we think we can do it as well.
David Lewis:
Okay. So, your confidence in reimbursement for 2021, is it still would you say relatively high or…
Joe Almeida:
David, I can’t speak on behalf of CMS. My confidence is very high that we’ll be able to address the questions that they posed as well with meta-analysis that we’re doing, but that doesn’t mean that they’re going to make a decision one way or the other, I can’t predict that. But I can tell you from our behalf that we are confident that we can produce all the product – all the data and documents that seems that they are not complete from their perspective.
David Lewis:
Okay, very clear. And then Jay, just two questions from me. One is just on the surgical business, which is the business that’s sort of very similar to other medical device procedure businesses. I’m kind of curious in your guidance, what assumption you made, most of your peers are saying sort of the surgically oriented businesses will grow in the fourth quarter. What’s implicit in your guidance for the fourth quarter there? And just on spending, the $150 million, there was a sense that, that would be sort of correlated to revenue this year, but a lot of that spending got made in the first quarter. So to what extent will that spending be correlated to revenue throughout the year? And how confident are you that those spending dynamics don’t carry into 2021? Thanks so much, guys.
Joe Almeida:
Sure. I will take – I was going to – David, your question was very long. Can you repeat the – I would take the first part…
Jay Saccaro:
The surgical procedures…
Joe Almeida:
Jay would take the second part. The surgical procedures, we see improvement – a slight improvement quarter-over-quarter. We actually – we don’t comment intra-quarter, but today, I’m going to make an exception and tell you that we’re seeing a slight improvement in procedure volume into the [Technical Difficulty] For me to sit here today and affirm that we’re going to have positive growth in the fourth quarter is very difficult. We don’t know what’s ahead of us. I don’t question other companies’ ability to do that. From our perspective, growth is anything above zero, right? So if that is the case, there is a possibility, but I tell you is a possibility. I’m not going to be sitting here today affirming that procedure growth is going to be positive in the fourth quarter. We got to have a better understanding how we are controlling the hotspots in the U.S. and Europe were the major drivers of procedure growth as well as how the vaccine will impact the immunity of large swath of the population that would be ready for surgeries. So, I would say to you, there is a possibility for growth in the fourth quarter, but we are not affirming that in terms of guidance. It’s just an opinion.
Jay Saccaro:
That’s right. With the wide range of uncertainty around it, David, I mean, I think for us, one of the things that we are very respectful of is the large range of potential outcomes as it relates to the pandemic. And so that impacts things like, to Joe’s point, surgical volumes. Our crystal ball is cloudy, because surgical procedures are not scheduled six months in advance. So anybody who has a really good line of sight to that, I would be very thoughtful about those expectations. But as it relates to the $150 million in spending, this too is, to a large extent, related to what happens with the pandemic. To the extent that the pandemic ends and we return to business as usual, then we will have the ability to claw back the majority – the significant majority of this spending. But until such time as we have confidence that the situation is managed, our employees are safe, we’re getting the medically necessary products to our customers, we will have some level of cost resident in our P&L and, not discussed, we will have some level of excess inventory that we carry because we have to protect against things like a wave two or a resurgence or a hurricane season. So, all of these things will kind of impact us, and we’re going to watch carefully. But I think when calling when these things subside becomes very challenging at this moment.
Joe Almeida:
I’m just going to add that to all of you on the call, not only to David’s question, is Baxter has ultimate responsibility to our patients and our customers. So for us, having inventory on the shelf is incredibly important because as we saw during the peak of the pandemic in the Northeast, we were having volumes that were reaching 500% of our ability to produce and having that inventory independent of government stockpiles is important for us to have it. The same applied for IV solutions. All of you’ve probably noticed, there was not a shortage of IV solutions in any markets that we serve. And one of the reasons for that is because we prepared well. As the tropical storm is hitting Puerto Rico, as we speak today, I feel very upset about that. Something we can’t control because the people in Puerto Rico had suffered enough maladies and issues with weather and hurricanes and earthquakes. But nevertheless, we do have sufficient inventory in – on the shelf to withstand any situation that hit us in the Caribbean. So, we will carry that inventory level for a while. We will then reduce appropriately, and we are starting to reduce in some areas. Listen, there is nobody more interested to take the $150 million out of our P&L than I am. And we’ll do it as soon as we can. We have actions in place right now. We have significant actions in place, including some changes in staffing some of our plants that had – needed to increase staff for the peak of the pandemic in the Northeast, and we’ll do it responsibly.
Operator:
Thank you. And our next question comes from Pito Chickering with Deutsche Bank. Your line is open.
Pito Chickering:
Good morning, guys. Thanks for taking my questions. The first one on PD. Can you talk about the PD business a little bit? I believe in early 2Q, it was challenging for patients to get the PD catheter, which could have impacted growth. So, can you talk about how PD growth changed throughout the quarter? And where you exited it on 2Q? And do you think that COVID accelerated the patients’ interest in home dialysis?
Joe Almeida:
Pito, listen, we are very focused on [Technical Difficulty] business that had 5%-plus percent growth in the quarter. The U.S. experienced 5% growth. We had also high growth in Asia. Europe is a spot that has not grown to our expectations. But I think some of that was related to the Middle East, the emerging markets of Europe. Europe – Europe itself actually did pretty well. So, we – first of all, I don’t know if you remember that peritoneal catheters were deemed to be emergency surgery. So, they were being performed in several hospitals in the U.S. The growth of our business is very encouraging. As you know, we ramped up our production of peritoneal dialysis supplies. We are implementing capital right now to shore it up. I think the dynamics of the home therapies is really something that finally is coming to the surface as a great advantage and vis-à-vis in a crisis like we just had. So, we are very excited about this business. I think our partners are excited about this business. And you can see by the growth even in the middle of the worst quarter for this pandemic, the U.S. has 8% growth. So it’s – that’s one of the things I talk about our business is its resilience and its reliance on different sectors of the health care continuum of care that help us mitigate some of the most acute issues of hospital admissions as well as the pandemic effects on the whole – the entire health care system.
Pito Chickering:
Great. And then going back to guidance again, I understand that predicting the bounce back of surgeries is virtually impossible at this point. But can you break out what percent of pre-COVID hospital possible visits you were assuming at the high end and at the low end of your revised guidance?
Jay Saccaro:
Pito, we didn’t hear the exact specific question that you asked.
Pito Chickering:
Okay. Let me restate it, so going back to guidance again, I understand that predicting the bounce back of surgeries is virtually impossible at this point. But can you break out what percent of pre-COVID hospital possible visits you were assuming at the high end and at the low end of your revised guidance?
Jay Saccaro:
Yes. I’ll start – I’ll share some assumptions regarding the higher end in Q4. As we think about – and by the way, the area of most interest is the U.S., because I think this is the most pronounced. But what we’re expecting to see from a procedure rate standpoint is basically flattish in Q4 relative to prior year. From a procedure standpoint, we’ll see some softness in Q3, and then we’ll claw back as we move towards Q4. And then from an admissions rate standpoint, we do expect a sequential recovery, but we’re modeling down several kind of low single digits versus the prior year in Q4. And those assumptions support the high-end of our range. So you can model down from there to see what a low-end assumption would be. And again, it’s – we’ve done a lot of modeling on this in terms of statistical inputs. We have a variety of rich inputs to our model. But again, there is a wide range of outcomes here that makes forecasting at this point challenging.
Pito Chickering:
Great. Thanks so much.
Operator:
Thank you. Our next question comes from Bob Hopkins with Bank of America. Your line is open.
Bob Hopkins:
Great. Good morning, Joe and everybody. First question is on your guidance related to COVID. Thank you for providing that $180 million number for the second quarter. It sounds like that’s the net impact of COVID in the second quarter. I’m just curious for your guidance for the back half of this year, what do you assume the net impact of COVID is on your business and the projections you gave us?
Jay Saccaro:
Yes. And the projections that we shared, it's roughly somewhere around $130 million, $140 million of negative impact related to COVID. So that's the assumption that we put forth. And underlying that assumption or the assumptions that I laid out for Pito in the U.S. and then kind of similar assumptions, although a little bit of a better marketplace in Europe and Asia Pacific.
Bob Hopkins:
Okay. So that $130 million is for the back half?
Jay Saccaro:
Yes. That's embedded in the guidance.
Bob Hopkins:
Yes. Thank you. That’s helpful. And then I just also wanted to see if we can get a little more color on Medication Delivery. It sounds like the pump business did about as you expected. It sounds like the issue with infusion sets. Was that 100% related to what's going on with COVID?
Joe Almeida:
Largely, if not 100% related to the pandemic, to the hospital sensors, okay? We did not see any competitive threat in this – in the pump area. As a matter of fact, I think we did as expected in terms of pump sales that we had predicted internally to the company. We don't disclose that specific target. So as we also have launched pumps outside the U.S. EVO IQ is launched outside U.S., the syringe pump. So we're starting to have a global portfolio of pumps, as you know. And we've been advancing in the U.S., our current SIGMA SPECTRUM. And we're looking forward to hear from the FDA on our new pump platform, which we hope to hear some time in September.
Bob Hopkins:
Great. Thanks very much.
Joe Almeida:
Thanks, Bob.
Operator:
Thank you. Our next question comes from Vijay Kumar with Evercore ISI. Your line is open.
Vijay Kumar:
Thanks for taking my question. Jay, one on, I guess, a clarification on the prior question from Bob. The – I guess, the assumption here is excluding COVID impact, the underlying business is growing mid-singles. So there's no change from your LRP ex COVID. Is that the correct math here for 2Q and back half?
Jay Saccaro:
Yes. It's a – what I would say is relative to expectations and what we previously shared, which is, remember, there were some slight departures between what we shared in January regarding this particular business and the original LRP that we shared a couple of years ago. So relative to guidance that we shared at the beginning of the year, the primary driver of change really relates to COVID impacts. I mean – so that's – and it's substantial. And we've seen an incremental cost, but then also this impact on – in particular on our Medication Delivery business, the combination of those two factors, cost and sales, really, that's the big driver this year in terms of our performance.
Vijay Kumar:
Then Joe, maybe on – a question on LRP here. Ex COVID, right? I mean, when I look at sort of what you guys laid out, has anything changed at all? It feels like since then, things have gotten incrementally positive. I didn't hear talk about the President's initiative on home care. Where are we on that? When you look at the free cash flow year-to-date performance, I'm just curious, has anything changed on free cash flows at all? Thank you.
Joe Almeida:
Hi, Vijay, we – our long-term perspective for our business as we had outlined in our prepared remarks has changed. What we look at the R&D portfolio of the company, there are some puts and takes, but we don't see great change from the original plan that we had in place. There are puts and takes, the things that came out, things that don't – that didn't work, things that are new or work in a put-in. So in terms of innovation, because I think the LRP of the company has two major drivers – I would say, three major drivers. One is the home care push PD. That's a big driver for us. The second one is the whole innovation underlying push the company is undertaking. Remember, we're looking at this year close to sales of new products over the last three years to be close to $1 billion. Even in the year of COVID, we feel very comfortable with the number that is coming out of our innovation. We're very excited about our new pump platform. We're excited about new things we are developing in other areas. Our PrisMax has launched well, and it was a great product for the right time. So that's the second lever. And the third is continuously attacking the cost basis of the company. And for that, there's two areas of focus. One is the digital transformation of Baxter which we started, and creating significant change in how we do business internally and sometimes with our customer as well as a complete revamp of manufacturing, which will be several years to do it, but will create some good opportunities. So those for me are the areas, the underlying conversation for the LRP. This is the conversation we have with the Board, and that's what we would have with our investors. Those are the four areas, three areas with one divided into two, that I would say are the major drivers for the company future.
Vijay Kumar:
Thanks guys.
Joe Almeida:
Thanks, Vijay.
Operator:
Our next question comes from Matt Taylor with UBS. Your line is open.
Matt Taylor:
Hi, thanks for taking the question. So the first question I had was just because there's been a lot of focus on this on the call for the $120 million in costs that you're talking about. Could you just parse out some of the bigger buckets, so it makes it easier for us and the investors to understand how some of that could go away? I know you've talked about overtime labor, PPE and shipping. Are those some of the big ones? And assuming the pandemic ended tomorrow, how long would have take some of those to dissipate?
Jay Saccaro:
Yes. Matt, maybe I'll make some commentary, but we will stop short of doing line item cost review. The – from an overall standpoint, you're right, expedited freight is an important and significant driver. One of the things that we had to do is because we were seeing higher levels of absenteeism, we were also having to hire temporary workers to mitigate that shortfall in employees. And so that was another expense that we've experienced. PPE is another expense. Now this will be more ongoing. So we'll look to manage this as effectively as we can because, frankly, I think that PPE will be here to stay in manufacturing facilities. And then like I said, overtime and incremental bonuses for frontline workers, those others comprise the majority of the spending that we've experienced. It's important, when you get back to our priorities
Matt Taylor:
And then one follow-up on Med Del. You mentioned that pumps are in line with your target. One of your competitors called it a pretty large bolus of placements under EUA. Do you expect to see something like that? And maybe you could also just talk about the potential for a U.S. pump launch for the new platform and the timing of that?
Joe Almeida:
Matt, I can't comment on a competitor EUA status and what they sold or not. But I can tell you that we performed as planned in terms of our pump placements. And we remain very excited with the potential launch of our new pump platform. As you know, it is a brand new platform, very robust in terms of electronics as well as the modality of syringe pump that we never had as a company. So I think the market is ready for something new, something that is designed for the future. And we will accommodate future digital health updates. So we're excited about that. So I can't comment on our competitors, but I can tell you that we are ready to go back to the market with a new product despite the fact, we just launched our version 9, which is a robust and very good pump about 1.5 years, two years ago or actually two years ago into July, it was July 2017 when we launched that – July 2018, I'm sorry, July 2018. So, very excited about new pump platform. So – and not only that, Baxter has a global platform now because the new pump platform for us is going to be a global business, despite the fact that now we went back to the outside markets with an interim product, which is EVO IQ, which is doing very well. So we're going to position ourselves as a strong pump competitor in the future with a platform that is expansible and will allow our customers' future expansion in digital health.
Matt Taylor:
Okay. Thank you, Joe.
Operator:
Thank you. Our next question comes from Joanne Wuensch with Citi Research. Your line is open.
Joanne Wuensch:
Good morning, everybody. I have two questions. Is it possible to quantify how much of the first quarter purchasing impacted the second quarter? And then I'll ask my second question now, as we look forward and think about 2021, I recognize your many, many moving parts, but is there a way to start gating what you think the business may look like and if not in terms of numbers, maybe qualitatively or in terms of products? Thank you.
Joe Almeida:
Joanne, let me take your last question first and Jay will take the first part of your question. In 2021 is a little early for us to give any kind of commentary on 2021. Qualitatively speaking, everything will depend upon how back to normal is going to be. We feel that the peritoneal dialysis momentum probably will continue. And that is a good thing for Baxter. We hope by then, not affirming, but we hope that we have a new bump platform already launched and ongoing, so there are some – and we have some launches of some molecules. So, I think 2021 back to normality is Baxter back to normal. Very difficult to see this at the moment right now, the forecast is a little foggy, but we hope the great companies, which are developing these vaccines and some of the actions taken in terms of palliative health across the globe will help us go back to normal. Jay?
Jay Saccaro:
Sure. Joanne, we estimate around $40 million to $50 million of sales that sort of accelerated in the last couple of weeks of March ended up being pre-buying early buying from Q2 negatively impact in Q2 sales.
Joanne Wuensch:
Thank you very much.
Joe Almeida:
So it is it is just interesting that when you look at our forecast for the year, Baxter, despite the fact that we are negatively affected by COVID in many areas, including in admissions to hospital, just to supplement your question, Joanne, we see a range of outcomes that can give us a slight positive to a slight negative performance versus prior, which in a situation like this is shows the resilience of our portfolio shows that our home care beds are done correctly, and things are placed – our beds are placed in the right places. One last comment I like to reiterate on research and development, is despite the fact there's variations and research and development, and those are our costs that can be postponed. That's absolutely 100% focus in innovation at Baxter. And we have no intentions to let that down one iota. So we may have changes in few millions of dollars between quarters or between 2020 into 2021. We are responsible people here will do the right thing to make sure that our expenses are in control. Everybody knows that, but there is a bigger commitment to innovation and to our research and development groups, which are doing extraordinary job very difficult circumstances to have data completing clinical trials, data submitted to agencies for product approval, like to finish the call by just reiterating that. Thank you.
Clare Trachtman:
We have time for one more question,
Operator:
Okay. And that question from Larry Biegelsen with Wells Fargo. Your line is open.
Larry Biegelsen:
Good morning. Thanks for fitting me in. A quick one on injectables and one on capital allocation. Joe, just on injectables, you’ve talked about that. You're excited about the pipeline there. Any major new launches this year, Sumant has talked about it, an attractive cardiovascular product. And capital – go ahead Joe?
Joe Almeida:
Capital allocation, I'm sorry, I cut you off. I was going to answer your first part of the question. Just finish that. Sorry, Larry.
Larry Biegelsen:
I just wanted to get them both, because we're running out of time. Sorry. So on capital allocation, just thoughts on M&A and in this environment. And when would you reconsider reinstating the share repurchase program? Thanks for taking the questions guys.
Joe Almeida:
Larry, we have a couple of things launched 2021, a large bolus in 2022. So, we're excited about the pipeline. We have not deviated talk about LRP. That's one thing that we have is holding pretty true in the last few years is the pipeline in pharmaceuticals. Despite the fact, we made drop some molecules, we're able to add more. So, there's good momentum there. Remember Baxter, if pharmaceutical injectables is always is renewing itself, as we leave behind the old molecules, they work to be, it used to be the biggest drivers of sales for the company as these products become generic in other companies come in our portfolio is revamping itself to be able to offset that and moving on, if you'll notice we speak none nothing about cyclophosphamide and that's a real testament to our pharmaceutical team that he's starting to launch the products like dexmed or like our pre-mix injectable insulin and all their products that are part of our portfolio. In terms of capital allocation I let Jay comment on share buyback, in terms of acquisitions, we're still very focused. We have several small deals that we had looking at all the time. As you can see by Jay’s prepared remarks, we have over $4 billion in cash in the balance sheet. This is a company that he has a solid, solid financial position and that afford us to continue to look for opportunities. The pandemic has slowed down a little bit because the month of April and May were very hectic across the globe, but we are engaged very much so and continuing to look ahead inorganic opportunities. Jay?
Jay Saccaro:
Sure. On share buyback I think what I would say is, we are very pleased with the durability, the resiliency of our business, the ability to maintain cash. We're over $4 billion. And if you think about it, our earnings well down year-over-year by roughly $0.20, all of that is explained by offloading the pension, which was a smart capital allocation move along with the bond offering that we did. So, if you think about it, those two items, which were really insurance policies for the company cost us $0.20 and explained fully on the year-over-year delta. And so we feel very good about our ability to withstand this pandemic and continue to thrive over the long-term. Having said that, you know, I think it's premature at this moment in time to begin share buybacks. Once again, we'll watch as this evolves. We'll carefully study way to, we’ll carefully ensure that our business continues to withstand as it has thus far. And once we have better line of sight to where this goes, I think we'll be able and willing to reinstate the program, which has been a very important part of our capital allocation approach over the last many years. So stay tuned, but not yet. Thank you.
Operator:
There are no further questions at this time. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating. You may now disconnect everyone. Have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's First Quarter 2020 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today’s call. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcasted without Baxter’s permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Katherine. Good morning, and welcome to our first quarter 2020 earnings conference call. Joining me today are Joe Almeida, Baxter’s Chairman and Chief Executive Officer; and Jay Saccaro, Baxter’s Chief Financial Officer. On the call this morning, we will be discussing Baxter's first quarter 2020 financial results. A supplemental presentation to complement this morning's discussion can be accessed on our website in the Investors section under events and news. This presentation includes related non-GAAP reconciliations. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development and regulatory matters contain forward-looking statements that involve risks and uncertainties. And of course, our actual results could differ materially from current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. On the call this morning, we will be discussing operational sales growth, which adjusts for the impact of foreign exchange and the acquisition of Seprafilm, which closed on February 14 this year. Now I'd like to turn the call over to Joe. Joe?
Joe Almeida:
Thank you, Claire, and welcome to everyone joining us on the call today. I sincerely hope that you, your families and colleagues are all safe and well during this difficult time. As we continue to deal with the evolving impact from the global COVID-19 pandemic, our Baxter team salutes the selfless health care providers and first responders who are rising to the enormous challenges with bravery and compassion. Their dedication inspires us all. This is uncharted to rain for the health care industry and society at large. At the same time, Baxter's path forward is clear. It is defined by our mission to save and sustain lives, just as it has been for nearly 90 years. We are doing everything we can to support patients, the healthcare system, our employees and the communities we serve worldwide. Baxter's medically essential portfolio places on the front lines of this pandemic. We are experiencing extraordinary demand for many products, including our PrisMax and PRISMAFLEX, continuous renal replacement therapy, devices and associated consumables. Our MINI-BAG Plus drug delivery system, the Spectrum IQ infusion system in SAS, plus IV Solutions parenteral nutrition therapies and injectable drugs used in the ICU and across the hospital.
Jay Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, our first quarter performance reflects the value of our medically essential portfolio in the current environment as well as our commitment to meeting the needs of patients and providers globally. Our ongoing business transformation efforts, effective commercial execution and improved balance sheet flexibility position us to more effectively respond to the COVID-19 pandemic with speed and agility. Turning to our first quarter 2020 results, global sales of $2.8 billion increased 6% on a reported basis and 8% on both a constant currency and operational basis, reflecting the underlying strength of our business, coupled with increasing demand for select products resulting from the pandemic. This heightened demand notably accelerated during the last two weeks of the quarter. We estimate that the COVID-19 related demand contributed approximately $45 million to sales in the quarter.
Operator:
Thank you. We will now begin the question-and-answer session. And our first question comes from Vijay Kumar with Evercore ISI. Your line is open.
Vijay Kumar:
Hey, guys, congrats on a really solid quarter here, really impressive considering the environment. I just add back, Jay, on the comments are in 2Q, some helpful comments here. But looking at what other companies are saying, it seems like 2Q is the bottom, and we expect sequential improvement from 2Q. Would that -- is that a fair comment? Is that applicable to Baxter, any comments on how we should think on the trajectory here would be helpful.
Jay Saccaro:
Vijay, yes, I'll start with some commentary and pass it over to Joe. We do see a challenging Q2. Our expectation is that will probably be the most difficult quarter of the year. And then in Q3 and Q4, we anticipate in our -- one of our base case scenarios a level of rebound and acceleration. The only thing to keep in mind with respect to our Q4 is the very strong Q4 that we had last year. I mean, look, there's a lot of uncertainty with respect to how the pandemic will evolve and hospital purchasing patterns towards the end of the year. But I think generally, the way you've described it, is the way we think about it, at least in certain scenarios. Joe?
Joe Almeida:
I think you did a good job, Jay. You covered both parts that I was going to cover.
Vijay Kumar:
And just one follow-up, maybe this is for Joe. Joe, I think in your prepared remarks, you mentioned oXiris rate. And we've been hearing about cytokine storm for the COVID patients. How well -- how should we think about the revenue opportunity for this product, or any comments on either oXiris or sticking to renal? Any updates on AAKHI? I think that would be helpful. Thank you, guys.
Joe Almeida:
Good morning, Vijay. The oXiris has a special filter. We make them in Europe, and it has a heparin coding to it, which makes it ideal for the situation where we're seeing now. We don't have enough data on the COVID or the coronavirus impact on the filter just in the very beginning, the use in the US. It seems to us that it's lasting longer than our current filter because it prevents the coagulation. It usually clogs the CRRT filters a little faster. So we are working with the FDA, and we work internally and with our partners in the industry to collect the data, to do investigational work, so we can propose keeping the product on the market once the crisis subsides and the agency feels that the product may not be of need anymore. So we will do everything we can to register the product in the US with the FDA. It is a product that we've seen outside the US really good results. So we hope that we can prove the point that this is a great therapy for sepsis treatment because the type of filter because the coding. We also -- going to the AAKHI drive. It proves the point that home therapist is ideally position for a crisis where there's so much transmission of virus by a realization and close contact. So I think AAKHI -- no, I cannot comment where the rule is at the moment, but we think that, that is the right move by the government, and we think it's going to end up going through. It's just a matter of time. But that has not stopped Baxter from its investments. We continue to invest. As a matter of fact, yesterday I just had a meeting on a phase two investment for this purpose. Remember that our growth in home therapies is going up. Now, we are -- in the U.S. alone, PD home therapies was about 13%. Now, APD home therapies in the U.S. was about 13% growth. So because that kind of growth, you need to have this kind of investments. So we're optimistic about. So, even if the rule doesn't come as fast as we wish it had come, work with our partners, VIDA and other partners in the U.S. We are advancing the home therapies. And rest assured, we're going to continue to make the investments.
Vijay Kumar:
Thank you, guys.
Operator:
Thank you. And our next question comes from Bob Hopkins with Bank of America Merrill Lynch. Your line is open.
Bob Hopkins:
Hi. Yes and good morning and thanks for taking the question. Just curious, one other follow-up on that second quarter comment and the slower growth that you're expecting there. Is that due entirely to a lower net benefit, Q2 relative to that $45 million that you saw in Q1, or are there other non-COVID related issues that are changing in Q2 versus Q1?
Jay Saccaro:
Yeah. And Bob, I should caveat my commentary around our forecast before we get into -- before we talk specifically about Q2. We didn't give guidance for a real reason, which is, there is a very significant level of volatility that we're seeing with respect to the COVID virus and its impact on our business and demand generally. And in Q1, think about it. We gave guidance with only a few weeks left in the quarter, and we significantly beat the guidance on the top line, which is not a normal situation for Baxter, given the steady and durable nature of our portfolio. So I have to comment and just say, look, this is unprecedented environment that we're operating in. And the other thing I will say is, we talk about our expectations. We have one forecast, but our planning team, led by David Roman, has developed, I believe, six different financial scenarios that could emerge that we need to be prepared for, three lower cases and three shop or two shop cases. So we really are looking at a broad spectrum of things that could occur. And in light of that, that's why we suspended guidance. As it relates to Q2, yes, we believe that there was some incremental benefit in Q1. But then, secondly, Advanced Surgery will have a meaningful decline in the second quarter. In large part because of postponing elective surgeries, as we've all discussed in med tech, that's a real factor. It did not impact us in Q1, but it will certainly impact us in Q2. And I think that's probably the most volatile item. And as we think about elements like recovery and how that's going to occur, we're watching how elective surgeries will resume. But clearly, in April and May, that's a significant headwind that we're facing.
Bob Hopkins:
Okay. Thank you for that. And then just one other thing I'm curious about, especially in light of the hiring that you guys announced. Could you talk about where you might be capacity constrained this quarter? Are there areas in your business that you just couldn't meet the demand because of capacity issues? And more specific about, or just any comments on capacity in the quarter?
Joe Almeida:
Bob, good morning. And we are – if you all remember, about two years ago, we had the Hurricane Maria that taught us quite a bit of a lesson, and we had modified our supply chain to a point that our fluids today don't have any constraint with the exception of our MINI-BAG Plus, but we made arrangements for extra shifts, and we're putting out record amount. And so we predict that most of our fluids, with few exceptions, would be all flow – protective allocation in the next few weeks. The part – the area of our business that really has a capacity constrained based on the type of virus we have today is CRRT. CRRT is made in a couple of different places in the world between the machines and the filters and sets and fluids as well. That's the one that we are capacity constrained. We advised our partners and government agencies of that issue. We are seeing demand that is multiple times what we can produce. And we're working very diligently with our customers to serve our patients best. For the future, that will be an area because the type of therapy and adoption of the therapy that is probably going – is going to grow. We're going to work in diversification of manufacturing sites and put more locations for fluids across the globe. But that is the one that comes to mind at the moment. Also some of our drugs that are being used as a backup, for instance, for propofol. We don't make propofol in the U.S. We make propofol for other parts of the world. But dexmed is used as a backup drug for sedation. And what we're finding is that we are outstripping our capacity and have outstripped our capacity. So we're going to also be making more investments in our Galaxy technology as we move forward.
Bob Hopkins:
Thank you.
Operator:
Thank you. Our next question comes from Robbie Marcus with JPMorgan. Your line is open.
Robbie Marcus:
Great, thanks. And Jay, glad to hear you're sounding pretty well. So glad you recovered okay.
Jay Saccaro:
Thanks, Robbie.
Robbie Marcus:
I was hoping – we've seen some other companies this earnings season, give us a glimpse of what April looked like to give us a view of what maybe the floor on performance could look like in second quarter. I was wondering, if you could offer similar insights here into what you're seeing in April across the different businesses?
Jay Saccaro:
Sure. Look, April is in line with some of our expectations. We predicted that some of the largest impact with respect to the COVID virus will occur in April and May and then start to see some rebound in June and then Q3 and then better in Q4, as I described earlier. That is -- and I want to make sure, Robbie, that you walk away, that is simply one scenario that we're looking at. We are expecting the biggest declines to occur in Advanced Surgery in these months of April and May. And I would say, generally speaking, that's proceeding in line with the expectations, our base case expectations that we've laid out. And so, nothing wild in terms of incremental commentary I can share with you. Other than to say, Advanced Surgery is an important one. We'll want to see that start to rebound. But so far, April was as expected, with so many hospitals really closed to elective procedures, that impact came in, in line with expectations.
Robbie Marcus:
Okay, great. And maybe just as a follow-up here. It seems like you're taking a lot of, I would say -- I would imagine, well received actions with your sales force. This is something I'm paying close attention to, as I think, companies that do the right thing for their employees, can probably rebound a bit faster coming out of this. I was hoping, you could just walk through some of the positive programs you've put in place for your employees? And do you feel like this puts you in a solid position, as you come out of COVID-19 with respect to your sales force and productivity?
Joe Almeida:
Robbie, good morning. We have taken an action with our sales force, for instance, in Advanced Surgery, teaching them skills -- technical skills on other product lines that we have, having them call on surgeons, on catheter insertion. We're making sure that they are occupied. We're having global webinars that they're being conducted by the team. There's a significant amount of activity. And we find that we have a tremendous, tremendous sales force, and we're going to keep them engaged. We have -- as you can see, we have employees in the frontline. Not only the sales force, we have a service group that services all these machines across the globe, and they are every day in hospitals across the globe servicing them. We're treating them as well as our folks in manufacturing and the global supply chain. We gave them an incremental incentive to recognize their effort in such a difficult time. We also have our plans, for the most part, operating 24/7, almost all of our 50 plans with very few exceptions. So we're making sure that we're having their safety first in mind. It's our number one priority is employee safety. And the second priority is with them being safe, they can make product for our patients. So we're now in uncharted waters here, but I think having our employee's well-being first in mind has been from the get-go, what has taken us to the point that we are today. And they all have in their minds, the mission of saving sustaining lives is what drives us. So we're very, very, very grateful to all the 50,000 folks who work for Baxter who are in this battle with us.
Robbie Marcus:
Thanks a lot.
Operator:
Thank you. And our next question comes from David Lewis with Morgan Stanley. Your line is open.
David Lewis:
Good morning and congrats on a very durable quarter. I -- just a couple of quick questions for me, Joe. Maybe I'll start with you. Pump dynamics, Joe, I'm assuming your pipeline was very strong heading into 2020. And I don't think your prior guidance implied any update or upside from your competitors' recall. But just sort of curious what you're seeing competitively and how the balance of sort of new pumps looks relative to replacements and how you think that changes across the year? And then I had a quick follow-up.
Joe Almeida:
David, good morning. We think that you have a bolus of demand that is really difficult to discern between what is just we and our -- and we know the competitive accounts that were going forward, the competitive accounts we think we're going to win. And now we have this bolus of demand coming in with more need for pumps as the patients are requiring a multitude of pumps, more pumps that they would otherwise in situations in the ICU. So, we're trying to kind of separate them and understand. We ramped up our production of Sigma Spectrum in the U.S. tremendously. We put extra shifts, more people. We are procuring raw materials. We're expediting raw materials. We're paying sometimes premium to get raw materials faster. And so we're producing as much as we can. Coincidentally, this week, we just got approval in Canada for our new pump platform, the NOVUM IQ. We also have our international platform for Evo IQ being approved in a multitude of countries and a lot of orders in Australia, and we are getting approvals in Brazil, and we have approval in Colombia. So, we're starting to see that -- and also in the U.K. with NHS. So, we're seeing a lot of movement on the front business of Baxter. We have -- as you know, we have filed for 510(k) for our NOVUM IQ platform in the U.S. We also file for EUA here because we think we can make -- we can bring more pumps beginning in July NOVUM IQ to supplement the demand for our current Evo IQ. So, we're doing everything we can. In terms of competitiveness, it's tough to see the moment how things are going. People are so focused, David, in the current situation. Nobody is thinking about something two months from today. I think the hospitals are stripped for resources and it would not have a conversion at this moment in time. What you have is demand that has spiked up quite a bit, but our folks are really planning for the future. I think our pump platform is shaping up to be a great platform. And then the addition of some monitoring capabilities will make us strong as you can -- if you -- you heard this morning and you read this morning, we had made a couple of investments in algorithm technology and artificial intelligence technology.
David Lewis:
Okay, very helpful, Joe. And then maybe just a question for Jay or for Joe. One of the things that we're hearing in light of COVID as sort of hospital administrators are waking up and asking questions around how much inventory they should have been keeping for critical care products in light of, obviously, in light of COVID. So, I'm kind of curious what you guys are seeing from an inventory perspective and how you think you and customers are going to manage inventory in light of COVID heading into the hurricane season and frankly, heading into next flu season? Thanks so much.
Jay Saccaro:
Yes. That's a -- it's a good question, David. And I think that the whole integrity of the supply chain is a critical focus for companies like us with medically necessary products and for hospitals and distributors that serve them. I mean, so the answer is, it's hard to say at this point. But for us, we want to ensure that we have available supply to meet patient needs under a whole variety of scenarios. And by the way, you raised a really good point, which is going into hurricane season. There is talk of a challenging hurricane season this year. And so, ensuring that, we have adequate supply means, at least for this year, at least until the pandemic situation has stabilized, and we get through the hurricane season, we will be carrying extra inventory of critical products. Now that did not show up in our Q1 results, because of the sales surge that occurred in the last couple of weeks in March. Our days inventory on hand was actually below our expectations. But what will happen as we approach the latter parts of the year is, we will build in those areas that are most sensitive and critical to the current environment. And I think, frankly, the same will be true of hospitals as well. I think, hospitals will evaluate what levels of inventory that they need to carry going into these kinds of crisis. It's clear that certain of them did some inventory build in March, and a lot of that has been consumed already. But, I think, each hospital will have to evaluate this on their own merits. Maybe, Joe, you could add some further color commentary here?
Joe Almeida:
Sure. So, David, what you also will see is stockpiling. From this point on when the demand surge is up a little bit, I think hospitals, I don't know if they will have the capacity to stockpile significant volumes of products. There will some probably, but I think you're going to see governments thinking differently about how they face a calamity, such as this virus. So I think it's teaching a lot of lessons to the whole to the whole supply chain, government, private. A lot of PPPs, public-private partnerships, you're going to see happening in terms of preparedness. So we'll see a lot of that probably in the third and fourth quarter as this is off through the summer and how entities across this spectrum will react.
David Lewis:
Great. Thanks so much. Great color.
Operator:
Thank you. Our next question comes from Larry Biegelsen with Wells Fargo. Your line is open.
Larry Biegelsen:
Thanks, guys. Good morning. Thanks for taking the question. Jay and Clare, I'm glad you're both feeling better. So, first, I just had one on China and one on the P&L. So first, on China, could you talk a little bit about Asia Pacific was obviously quite strong in Q1. Could you talk about what you're seeing there, the pace of recovery and how much of a read-through do you think that is to the rest of the world for your business? And then I have one follow-up.
Joe Almeida:
Larry, we're seeing the -- some normalcy coming back into Asia. But I want to give you some color on Baxter's business being slightly different in China, primarily in parts of Asia than it is in Europe and Americas. We are a heavy PD peritoneal dialysis companies in China, so that's a chronic disease. We saw a stockpiling going on in the first quarter there and then being consumed, but that business is consistent and constant. We're starting to see some hospitals in China going back to normal in terms of surgery, not 100%, but we probably will see through the second quarter, the return to normalcy for great deal of businesses in Asia, with perhaps an exception to Japan. I think Japan still has not figured out. They're locked down. And I think that is going to be a little slower than the rest of Asia. Australia is already thinking about a possible second wave and then working on preparedness for that as far as we can see. So that is the reason why Asia was strong for us in the first quarter. But we see the normalcy coming in, but don't forget our business in Asia, primarily in China is mostly home care peritoneal dialysis chronic business.
Larry Biegelsen:
Thanks for that, Joe. And, Jay, thanks for the helpful color on the P&L and a nice quarter on the margins. Could you maybe help tie it together for us a little bit? There seems to be some puts and takes. Can the operating margin be up year-over-year, given that incremental spending, but the trade-off with lower travel? And the two below the line items, I don't think you touched on where the other income and tax. How should we think about that? Thanks for taking the question, guys.
A – Jay Saccaro:
Yes, Larry, we're talking about severe impacts in terms of incremental spending that will drag down the margin. And so while I'm not prepared to comment on year-over-year margin growth, I am prepared to say that we really can't offset the $150 million in incremental expense from an operating margin through SG&A savings and so on. That's not likely going -- that's not going to happen. So that's -- and again, we view those costs as absolutely essential to the long-term success of our business because for us, we have to be there right now for our customers and our employees, ensuring that we have the right amounts of PP&E that we're compensating employees who need to be at work in challenging situations. All of those factors are, first and foremost, on our mind. And like I said, that will be a drag on operating margin year-over-year. As it relates to in the quarter, tax rate, business mix was sort of favorable from a tax rate standpoint. So we saw a little bit of benefit relative to our expectations. Relative to year-over-year, it was a downside in large part because of some FAS 123 are excess benefits that we experienced in Q1 of last year. And then as it relates to other income, the two factors, the largest one being we've offloaded the pension plan as part of an important initiative that our treasury team undertook throughout last year and culminated in the December transfer of assets. And so as a result of that, we're no longer seeing pension income below the line. And then secondly, we did have a loss. We had -- there was a balance sheet position that we held, I believe, it was your long and a movement caused a loss in that particular item, which contributed to the year-over-year decline in other income.
Larry Biegelsen:
Thanks so much, Jay.
Operator:
Thank you. Our next question comes from Pito Chickering with Deutsche Bank. Your line is open.
Pito Chickering:
Good morning, guys. Thanks for taking my questions. A few questions for you on PD, how much COVID impact was there for new starts for patients both in the U.S. and outside the U. S.? And how is it trending today? And when you talk to dialysis providers, how much pent-up demand are you hearing for patients who want to move into the home? And then I have a follow-up.
Joe Almeida:
Pito, good morning. We saw a healthy level of PD starts, but nothing different than what we had planned. I think what you're going to see is a little bit of a reduction and then a pickup towards the middle of the year because PD is dependent upon catheter insertion. Despite the fact the American Nephrology -- Society of Nephrologists had recommended and had said that this is not an elective procedure and put the procedure as necessary. Some hospitals are doing that. In talking to a colleague of mine in the Northeast, he's chief surgery of a hospital, he said that they were doing -- one of the few surgeries they were doing was catheter insertion, okay? But not everybody had the luxury. Some of the hotspots, I'm sure that other than the PD insertions that were done, for instance, in several hospitals in New York City, because we sold a significant amount of therapy into New York to alleviate the pressure on CRRT for patients in the ICU, it's called the acute PD. We will see probably a small -- a slowdown of PD, and then it will pick up through the rest of the year. The demand is there. The home therapies is the way to go for the right patients. And I think the momentum is not going to be in the long-term altered. It's just now you have this crisis where the insertion becomes more of an issue. You had a second part to your question. What was that?
Pito Chickering:
So the second part was, how much did the supply impact from Revaclear impact the renal business right now? And was there supply constraint, because you're converting manufacturing over into THERANOVA?
Joe Almeida:
Well, it's around $5 million, okay? Around $5 million, the answer on the Revaclear. What we're finding is, our plants producing Revaclear are producing the record level right now, both one in the U.S. and one in Germany. And as we prepare towards the end of the year to convert some of our production lines into THERANOVA, okay? So as a THERANOVA application, the Novum is going through the FDA, and we have -- we're preparing for the launch. We're going to start converting our production lines, and we need to start doing that in Germany. So you're going to see that swap. That was about $5 million.
Pito Chickering:
Great. Thanks so much.
Joe Almeida:
You're welcome.
Operator:
Thank you. And our next question comes from Danielle Antalffy with SVB Leerink. Your line is open.
Q – Danielle Antalffy:
Hey. Good morning, guys. Thanks so much for taking the question and congrats on a really good quarter. And thanks for all you're doing in this crazy environment and helping patients get better. I just -- I have a quick question, a follow-up on PD. It's a non-COVID related question. And just curious on any progress you're hearing being made on the kidney initiative. And how we're thinking now, you're making significant investments ahead of potentially that initiative going into place to build for a higher number of PD patients. Where are we with that? How soon can we know? And how does that change the PD outlook long-term?
Joe Almeida:
Anyhow, good point. We don't see the long-term impact on the AAKHI. You see a pause because I think the administration is quite busy right now with other matters. But speaking to an official the other day that is still front and center for the White House. They want to move forward with this. And I think will be just a matter of time. We have done a significant amount of simulations in Monte Carlos and all kinds of work in understanding capacity demand. And we're ready in July to speak to our Board again on a Phase 2. Phase 1 is already being put in place, okay? So, capacity is being augmented. We're going to start seeing more capacity coming in next year. But then the thing is projecting two or three years down the road, we're going to need to make that investment. So that investment is already planned. We know where it's going to be made for the most part. We have some decisions to make, but we're down that path. So, what you see with this unfortunate COVID-19, it is a slowdown in decision-making, which we think is just a matter of time.
Danielle Antalffy:
Got it. Thank you. I'll leave it there. Thanks so much.
Joe Almeida:
You're welcome.
Clare Trachtman:
Hi Katherine, this is Clare. We have time for one more question. And then following that, I'm going to turn it back over to Joe.
Operator:
Okay. We will -- our next question comes from Matt Miksic with Credit Suisse. Your line is open.
Matt Miksic:
Hi, thanks for squeezing me in. So, I'll just -- I'll keep it to one. Just one of the things that a lot of other companies have talked about during -- as we approach and go through the early parts of earnings season here is just the drops in the second quarter, driven obviously by implants and like surgeries and things like that. I'm wondering if you could talk a little bit about, obviously, much of the exposure that you have at Baxter is not necessarily in things like implants, but in sort of advanced surgical supplies that are used in the OR, maybe talk a little bit about some of the stock in flows. And I think, Joe, you touched on this earlier in terms of some of these key elements of supply being stocked or stockpiled into the back half of next year as governments think differently about these products. But maybe just, Jay or Joe, if you could help us understand some of the flows that would have maybe not impacted Q1 so much and maybe you're going to impact Q2 and how it plays out for the rest of the year?
Jay Saccaro:
Sure. So, Q2 -- let's put it this way. Q1, the $45 million, there was certainly some pre-buy in that number in the sense that hospitals were anticipating a COVID crisis coming to the U.S. And so we did see some advanced purchases in bias of critical solutions and supplies. Now as we -- how much of that has been consumed, we believe the vast majority has been consumed. And we will see continued sales attendant with the crisis that's ongoing in a large component of our portfolio. But we have about 15% of our sales between our advanced surgery business, along with a few other areas like some of our inhaled anesthetics, which are very much dependent on elective procedures taking place in hospitals. And to the extent that those procedures are delayed or curtailed, we will see a negative impact. We expect the biggest, most prominent impact to occur in the second quarter. But again, how does the second wave evolve? How does -- how long is wave one? How severe? How do hospitals react? There are so many variables that are input into our demand signals and so many scenarios that we've developed. That's why we've kind of put guidance on the side for the time being. We'll watch to see how things evolve this year. We'll try to understand better what is the potential wave two and a wave two impact. And how does that materialize? And at that point, I think we'll be in a better position to comment on financial performance. And in particular, financial performance in some of these most impacted segments. Joe mentioned something, which was quite a good point, which is stockpiling that might occur at a national level for various countries looking to shore up supply of life-saving and sustaining products. We will watch that very carefully and look to support them to the extent that we can. So, with that, maybe I'll turn it over to Joe for some closing comments.
Joe Almeida:
Thank you all for coming -- to calling in today and listening to our earnings call. We, at Baxter, are very proud of what we're doing today, and we have done everything we can to attend to patients across the globe. We wish you all to be safe and well. And hopefully, we can return to normalcy for our next earnings call. So, to all of you, thank you very much, and have a good rest of your week.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating. You may now disconnect. Everyone, have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to the Baxter International Fourth Quarter 2019 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcasted without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Katherine. Good morning, and welcome to our fourth quarter 2019 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's fourth quarter and full-year 2019 financial results as well as growth comparisons to restated historical financial results as disclosed in today’s comprehensive 10-K filing. We will also provide our financial outlook for the first quarter of 2020. A supplemental presentation to complement this morning's discussion can be accessed on our website. This presentation including related non-GAAP reconciliations can be accessed on Baxter's external website in the Investors section under Events & News. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development, and regulatory matters, contain forward-looking statements that involve risks and uncertainties and, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable US GAAP financial measures is included in our earnings release and available on our website. On the call this morning, we will be discussing operational sales growth, which for a historical period adjust for the impact of foreign exchange and generic competition for cyclophosphamide in the U.S. Operational sales growth guidance for 2020 adjust for the impact of foreign exchange and the acquisition of Seprafilm, which closed on February 14 of this year. Now, I'd like to turn the call over to Joe.
Joe Almeida:
Good morning and thank you for joining us. Before Jay and I review financials for the fourth quarter and full-year 2019, I want to update you on our internal investigation regarding non-operating income related to foreign exchange gains and losses. As you know, the company and the Board have taken this matter very seriously. We move to address it quickly and comprehensively with the help of independent experienced advisors and forensic accounts. We also communicated proactively to the SEC and has maintained open dialogue with the commission throughout.
Jay Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, our fourth quarter results demonstrate robust operational performance with solid growth across all six global business units and three geographic segments. Throughout the year, we delivered on our goal of growth through innovation and drove further benefits from our ongoing transformation initiatives. Moving into 2020 and beyond, we will continue to execute on our commercial strategies, while also invest in several initiatives to support accelerated growth opportunities.
Operator:
Thank you. We will now begin the question-and-answer session. I would like to remind participants that this call is being recorded and a digital replay will be available on Baxter International's website for 60 days at www.baxter.com. And our first question comes from Pito Chickering from Deutsche Bank. Your line is open.
Pito Chickering:
Good morning, guys. Thanks for taking the questions. First one is on your manufacturing site. You talked about in the script that you guys don't believe in the issues with the supplies. Can you sort of go into more detail around where the majority of your raw materials are coming from? What percent of those are sourced to the China? And sort of why is that sort of not a risk in terms of be able to offset from the other supplier, ? And I’ve a follow-up after that.
Clare Trachtman:
Yes. So just to refresh, I think this is a little hard for you to hear you, Pito. So I think what you’re talking about is the overall manufacturing where we're at, where our raw materials are coming from, how confident are we in the supply chain, is that kind of summarize what you were asking?
Pito Chickering:
Yes. Yes. And I apologize. On the cell phone, obviously.
Joe Almeida:
Okay. Pito, good morning. And our raw materials come from a variety of places around the globe. Let me -- because your question has a specificity for COVID-19, I'm sure and our supply chain. So our electronics come primarily from parts of Europe and China. We're working very diligently and we're getting -- start to get components out of China. We have good safety stocks. We feel comfortable that towards late spring we will have enough -- for most of our products would have guaranteed ability of having products sold across the globe. So I'm not that concerned. So if things become really difficult in China, back to what was in January or February, then the conversation is different. But today, the way we're seeing the shipping lanes are clearing up, we're getting products into our factories, not -- don't feel that we're under tremendous amount of pressure now. What comes to IV bags? IV bags, the products are made for the U.S. are exclusively made in the U.S., meaning the raw materials are made in our plant in Arkansas. The bags are made in the Carolinas and we can also make bags down in Mexico in Cuernavaca. So that is a backup plant that we have set up since Hurricane Maria, and we can get -- we are getting products from there now, we can get products -- more products in the future. So our supply chain is we have probably 20, 25 components and raw material that we're watching very closely. But we have 24 hours coverage around the globe. Our procurement departments are set in many parts of the world. So at this moment, we feel that between APIs, which are also made in India and China, we have a pretty good grip in the APIs about the same of the electronics. You’re talking about late spring. If things get worse in China, that's a different conversation. But it was with what we know right now. We are comfortable with inventory levels and we can supply the demand.
Pito Chickering:
Great. Then the follow-up question is going be a non COVID-19. Can you walk us through the manufacturing capabilities of THERANOVA at this point? How fast can that be expanded? Whether it's new lines of manufacturing sites? And how much would each of those costs and how many units would those create? Thanks so much.
Joe Almeida:
So, Pito, we have the ability to date to make THERANOVA, okay? We can make high single-digit millions of that -- mid single digits in the millions of that, okay? We are starting in October, converting production lines from our current REVACLEAR to THERANOVA, meaning the lines will be able to make either one of them. And I think by the time we finish the conversion for the globe, we're going to be able to supply probably close to 30 million units, 28 million to 30 million units, okay? This is, as we know today. We can always make investment plans for more capacity. As you know or you may not know we manufacture our own equipment, our ,our spindles and spinning equipment and how we bundle the fibers into very proprietary, but great product that we currently design and are not making outside of the U.S. today. So that's our capacity. And we're prepared, by the way, once the period of 2 years of demonstration of the add-on payment, what's called the , I got corrected in Washington last week by somebody at CMS, it's not . We can accelerate investment and we can produce more than $30 million if they need to be.
Pito Chickering:
Great. Thanks so much.
Joe Almeida:
Thank you.
Operator:
Thank you. Rob -- Robbie Marcus with JPMorgan. Please state your question.
Robbie Marcus:
Hi. Thanks for taking the question. So I imagine everyone is very curious about what life will be like under COVID-19. You pulled the guidance, but we are almost completely through the first quarter here. So I was wondering if you could comment on trends you're seeing in first quarter in terms of different positives and negatives in the business and any actions you're seeing from the hospitals in Europe and U.S. as they prepare for what's to come here over in the next few weeks?
Joe Almeida:
Robbie, we will -- let me get part of your question, and Jay is also here, he can chime in. We are seeing buying patterns that you see usually in with this kind of situation. We have only to compare in heavy flu seasons and some of us remember back in 2003 sites, okay? So we have buying patterns that go from people not understanding what's happening, all of a sudden stockpiling going on everywhere, okay? So Baxter is at the front line of treating patients with acute respiratory and acute generalized infection with our CRT contingency in replacement therapy, our fluids, our antibiotics, our pumps. So we feel that right now we are seeing buying patterns that are starting to get more coherent with an outbreak of something like the COVID-19 that we saw probably half way through the first quarter. Because halfway through the first quarter, China was more in focus and what we saw in China. And remember, not only we're in the front lines for treatment of diseases such as this, but also we are in the chronic treatment business, which we need to deliver products, products to people's homes. So we saw in China an acceleration of purchasing for PD, peritoneal dialysis products. And then what we've seen in the U.S. probably it's going to go through the same thing. We're getting calls from state governments, not only the feds, but also the state government, countries asking placing orders for stockpile of products. So we're starting to see the volume of those orders picking up. We're very -- we've been very judicious because we don't have at this moment a capacity restriction, but capacity is all relative. If you go ahead and you start buying significant amounts by unit, by hospitals more than what we can make, we will not be able to supply a business. So we think we're well equipped to supply the world with the products that we need and the products we have. And we are not -- we have few products that may go in allocation, just as production, but we have to date the major IV business. These solutions, we don't have any allocations of that. We're prepared to supply the market and actually activate our backup plans that we have put in place since Maria. In terms of the quarter, we're giving guidance few weeks before we close the quarter. So as I said, we saw different patterns in the first quarter. And I think it shows the resilience of our business through a process like this, because we do have products used in all sorts of different products, different settings from the home to the acute side to the more long-term care, as well as for non-elective and elective procedures. Jay any color?
Jay Saccaro:
Joe, I think that's a great commentary and you described the resiliency and the durability of the portfolio. We have a number of product lines which benefit, I mean, in this kind of scenario, like acute IV, some of the antibiotics as Joe described. And then we'll watch them very carefully, our anesthesia and advanced surgery businesses, which are more related to actual operating procedures that take place in hospitals. So that's one area that we're watching very carefully. But generally speaking, this is a very durable portfolio that we have.
Robbie Marcus:
Great. And maybe just one follow-up. People are starting to worry about the impact to capital equipment sales. So with you set to launch a new pump system, which could actually be in high demand, do you expect any impact to that or to your PD cyclers over the next few weeks and months? Thanks.
Joe Almeida:
Very different dynamics, Robbie. Very different dynamics. First of all, hospitals today in the U.S., the priority is to treat potential patients coming in. I don't think we've changed dramatically their buying patterns for capital in the mid-term, but in the short-term, it may alter their priorities. Not that we're not going to be able to sell the pumps, so we probably will sell them and we'll probably supply product to customers, who today are impacted by the Class 1 recall of our competitor. But that may change a little bit of sequence looking at the priorities that we are currently putting into place. Remember, we are sending service personnel to hospitals, but I don't think we're going to be sending a bunch of people to install pumps now into hospitals. So it may shift a couple of months here and there, but I don't think the pattern of capital by -- as we know today, it will change in the mid-term to the long-term. It will change in the short-term because the priorities of the hospital are to treat the patients. And PD is a different conversation. PD is actually the safe place to be, which is the home, imagine putting patients in a clinic with five or seven other very ill patients with diabetes, sometimes insufficiency and with the kidneys not functioning. And going to a clinic in this type of outbreak it is really dreadful. So I would say that there's a pretty compelling reason for the peritoneal dialysis modality to take shape and be something strong going forward. I'm not saying right now, but I think this actually reinforces the AAKHI prerogative, that the government had on having people treated at home, this is another added benefit of the home treatment.
Robbie Marcus:
Thanks a lot.
Joe Almeida:
Thanks, Robbie.
Operator:
Thank you. Bob Hopkins of Bank of America is on the line. Please state your question.
Bob Hopkins:
Great. Thank you and good morning. I hope everybody is well. Two quick questions. So it sounds like from your commentary that you've got some products where you're seeing increased demand like you do in a heavy flu season and some products, you're seeing decrease in demand, currently. I'm just curious, kind of directionally from where you sit today, is this overall feel like a net neutral to your business as far as you can tell right now?
Joe Almeida:
It's tough to say, Bob. That's the reason why we are not putting long-term -- the 2020 guidance out there because we need to figure this thing out. As I said, the buying patterns are really strange. We're getting orders for our CRT equipment. They are in excess of anything we ever seen, okay? We also have a pretty healthy advanced surgery business. So we don't understand some of the patterns today. I have to imagine with the changes in procedures in hospitals, some of our business will be impacted like anesthesia, for instance, you have less procedures at surgery. And on the other hand, we have significant amount of business in the ICU. So I cannot give you an answer precisely what if this is a net neutral or not. We're going to have to wait. We hope by April -- end of April, when we announce our first quarter results, we have either guidance for the rest of the year or have a better understanding what's happening at the moment.
Bob Hopkins:
Okay. And then one quick follow-up. I'm really curious as to what you're seeing in China in the advanced surgery business. Are you seeing kind of a return to sort of stabilization in procedures in China at this point? Just kind of curious what you're seeing there in that business, in particular?
Jay Saccaro:
That's a very small business for us. So I think on an annual basis, we're talking single-digit millions. So it's very difficult for us to comment on procedure volumes in China, given the small size of that business. And the largest business in China for us is our renal business, which is a different kind of business and really not an illustration of what's happening in hospitals.
Bob Hopkins:
Okay. I was just trying to get a sense for trends in hospitals in China as they hopefully come out the other side of this. Thank you.
Joe Almeida:
Yes.
Operator:
Thank you. And our next question comes from David Lewis with Morgan Stanley. Please state your question.
David Lewis:
Good morning. Thanks for taking the questions. Maybe, Jay, a couple of quick ones for you. We didn't get segment guidance for the first quarter. So I just wonder if you could help us if COVID has been largely limited impact, it sounds more neutral impact so far for the first quarter. Can you just bridge us from the first quarter guidance 5% to 6%, obviously, the fourth quarter, very, very strong, first quarter is anniversarying an easier comp. So just headwinds and tailwinds we should be thinking about to sort of -- to think about the fundamental momentum deceleration in the first quarter. What businesses are stronger, what businesses are weaker, or what dynamics change fourth to first? Just so we can kind of get the bridge, that would be super helpful. Then one follow-up.
Jay Saccaro:
Sure. Overall, looking at the fourth quarter, as we've said in the past and David, you and I have discussed, we were very pleased with the performance across the portfolio. We saw strength in every one of our geographic regions. We also saw strength across the business portfolio in terms of, great -- great medication delivery, sales -- great sales in each of the portfolios. So very strong quarter. There were a couple of one-time components in place in the fourth quarter. So we did see some buying from distributors related to our flu business. We did have some benefit in our advance surgery business relative to competitors being off the market, roughly $50 million. There were some accounting adjustment true-ups at the end of the year, perhaps around $10 million or so. So we don't see a markedly different trend going from Q4 to Q1. We will see -- like I said, given the strength of the medication delivery, that business will come down a little bit, but we still expect to have a solid first quarter in that area. So no markedly different trends. And frankly, if you think about our aspirations that we've talked about over the long-term, this Q1 guide is very consistent with what we've seen and shared in the past. So like I said, there were a couple of specific items that -- because we're not a 9% growth company at this stage. So there's a couple of specific items that accentuated the great performance in Q4 that we don't expect to repeat in Q1, and really that's the primary driver. No real change in fundamentals.
David Lewis:
Okay. And then, Jay, just a related question, both for the first quarter and for the year. So EPS guidance for the first quarter, can you just give us the headwind and tailwinds first quarter '19 to first quarter '20, just given the guidance is relatively flattish. And then for 2020, there may be some revenue impact for 2020, positive or negative. Please help us understand if there is a negative impact, how we should be thinking about the drop through or the kind of spending activities that are going on inside Baxter now to support customers? Thanks so much.
Jay Saccaro:
Sure. As it relates to Q1 year-over-year, you're right. As we look at our Q1 of 2019, we had $0.75 roughly in earnings per share and our current guidance is $0.72 to $0.74. The primary driver is really not related to operational performance. I would say the number one driver year-over-year is tax rate difference. Last year we had a very large FAS 123R benefit in the first quarter of the year. We also recorded certain other income in the first quarter, which you can see in our restated financial tables. If we were to adjust for those items, I think it's roughly a $0.06 impact. So what you would see is the sales growth along with some slight operating margin improvements in the first quarter dropping through, and that's really what drives the performance improvement offset by some of those financial items that I just referenced. As we look to the balance of the year, our number one priority as an organization is to fulfill the mission of the company, saving and sustaining lives. And that means getting product to our customers consistently and reliably. What we're seeing is there are situations where there are some extra costs required from a supply chain standpoint to ensure the continuity of supply, to ensure we're getting critical raw materials out of impacted geographies and we will spend to support that. So I would expect that, we had some very disciplined targets on supply chain spending, but there will be some spending related to supporting our customers and ensuring consistency of supply. And we've got a lot of work that's ongoing in terms of enhancing cash flow. But we will also be really thoughtful about carrying extra inventory in the coming months, because at the end of the day, we have to have sufficient supply to do everything we can to ensure that. And so we will have -- we will carry some extra inventory of critical products and products we think are likely to be stockpiled in the event of a broader scale pandemic. So, David, you can imagine there are a lot of moving pieces as we look at the coronavirus and different manifestations this can take. And so we are prioritizing serving our customers over just about everything else. And we're also focused on ensuring the safety of our employees. So those are a few comments.
David Lewis:
Great. Thanks so much.
Operator:
Thank you. Matt Taylor from UBS is on the line. Please state your question.
Matt Taylor:
Hi. Thanks for taking the question. So I just wanted to clarify two things on your comments on inventory and supply customers currently. Are you starting to run towards higher inventory levels? It didn't seem like it from your commentary. And then, in terms of people stockpiling, are you starting to ration any product, or how are you managing your inventory to make sure that you're going to have enough, that this does get much worse?
Jay Saccaro:
So I'll take the inventory question and Joe can take on the question regarding customer stockpiles. Inventory, we are looking to build inventory levels of critical products wherever possible. Now, in some cases, that's not possible because we are running full tilt today. But in cases where we do have the opportunity to think, first of all, creatively about where we locate our inventory around the globe, but also are we running the facilities that could support inventory build at their highest levels? Matt, we have to be prepared for disruption. We have to be. And so the best way that we know to do that is to build up some extra inventory so that to the extent that disrupting -- disruptions do occur, we are prepared and ready. So that's really our philosophy. You won't -- you'll see it when we talk about Q1 cash flow, but that's something that we're watching very carefully, and we're absolutely willing to do and carry in the short-term until the situation correct itself. Joe, you want to talk about customer stockpile?
Joe Almeida:
Sure. Sure. Matt, we limit our hoarding of inventory because otherwise you're going to have hospital systems in the U.S. going out and buying more antibiotics, more this more that and we are -- we have a control tower approach where we look at everybody's consumptions and we will supply everyone with their needs. What we want to prevent is people buying months of inventory at a time. They don’t even have a place to store, these are bulky items. So we prefer to do our inventory ourselves, we store things ourselves. Our operations today, Bob Reed runs our operations and supply chain for the company and its being very thoughtful about how we -- where we put the products. We are starting production lines as a backup. For instance, we started production line in Mexico for the U.S. that is going to be producing millions of bags for the U.S. We have other things that we are doing just in case. But remember, we want to make sure that everybody gets what they need and not one customer or two customers who put an order first. So we're triaging things. We're making sure that our U.S. system through a heather night is doing a great job in making sure everybody gets what they need. So we're not rationing. We're not allocating everything. What we're doing is just simply making sure the orders are rational and we'll be able to ship them correctly where people need. The same thing with PrisMax. For instance, the PRISMAFLEX, our CRT machines, you have countries book new orders for hundreds of those, so well hang on a minute. Why do you need hundreds? You have less beds in another country, so we're making sure that we made and sold more CRT machines than we ever did in the period time where we need to make sure that we can make them, the component lead times, the components were measured. We're making sure that we get the supply chain coming in right, and the supply chain comes from China and other places we're making sure that we're doing things right. So we're here to serve our customer. Our mission is so important to us. It's sometimes tough to comprehend looking from the outside, from finance community, how much our employees are committed to our mission. And we'll do everything we can to make sure everyone has what they need.
Matt Taylor:
Thanks, guys. Maybe I could just ask one follow-up. And I appreciate all the comments on mission, it is very important right now. The European situation is very fluid. You commented a little bit on China, now that’s returned to normal. That's encouraging. So wondering if you could give us any color about what's going on -- on the ground and your businesses in Italy or other places where we're seeing infections rise and what that might mean for the U.S.?
Joe Almeida:
First of all, we cannot take China's situation for granted because a lot of that has to do with isolation. I think there are papers out there. There's a paper that I read yesterday from the Imperial College in London talking about that communicable nature of the disease can be spread again. So we are not taking anything for granted. We're very cautious. Our daily calls with our locations always stress the safety of our employees first and servicing the patients as well. So when it comes to Italy, we have the special letters that we give to employees because we make products in Italy, primarily in Lombardy area. We have three plants there and we're making fluids and we're making equipment there and we're making sure the plants have -- are staffed properly. And so far we not have had much disruption to those plants and the crossing of the border for supplies are -- is happening. So, so far, so good. And Italy is really the hot spot at the moment, as well as Spain we’ve a factory in Spain primarily supplying the Spanish market and some of the south of Europe market. We also have plants in England. All of all of these plants are operating, as we say, with a sense of normalcy, which is kind of not normalcy because everybody has very heightened attention to everything. And this is just to tell you how committed our people are because they live in their homes and going to work every day in plants in North Carolina, in Alabama, in England, in Australia, everywhere in the world. China -- five plants in China. They all are operating with the normalcy that you would expect under significant stress on the -- by the outside world and by the news channels and everything that’s happening around them.
Matt Taylor:
Thanks a lot.
Joe Almeida:
You're welcome.
Operator:
Thank you. Danielle Antalffy with SVB Leerink is on the line. Please state your question.
Danielle Antalffy:
Good morning, guys. Thanks so much for taking the question. I hope everyone's staying healthy during these crazy times. Just a quick question, a non-COVID-19 related question. On the medication delivery business, very strong operational sales growth in Q4. Obviously, that's not likely to continue, but can you help us understand how sustainable any momentum that you have in the medication delivery business is into 2020 and beyond? And the different drivers of the strong growth that we've been seeing there in the back half of the year?
Joe Almeida:
Danielle, just a little color on the business and Jay, if you want to chime in, please do. We are -- what we have done is transformed the U.S. sales and marketing organization. We have done a very good job in selling pumps and placing pumps last year was a crescendo. This is not something that you start and get done in one quarter. The fourth quarter was the result of months and months of preparation of accounts, of bids that we won. This was not an easy path. So I would say that the pumps, the way they work, they perform in the fourth quarter, they did very well. We are going down the same path and trying to get the same business in 2020 because we think we have a pump platform currently in place. And hopefully, when approved by the FDA, which we don't have a date yet, our new pump platform, we're going to be able to perform as well or even better with the new platform because we'll have a more complete set of products that we currently don't have. We also had good fluid sales. Remember a little anticipation of fourth quarter, not much, but some anticipation of the flu season. At that time, it was not known to the world that the coronavirus was just dangerous. So I will say that this business has tremendous resilience and aided by a new platform and a good solid pump, which is our version 9 of our SIGMA SPECTRUM on the market today. We feel comfortable with the trajectory going forward. Is that going to be easy? No, it's not going to be easy. But I think with the contracts that we have signed, which are more long-term contracts and with the pumps and sets that we have, I think we can continue to aim to perform well.
Jay Saccaro:
Yes and Danielle just to add to that. Well, we appreciated about 2019 was that there were some unique set of circumstances that allowed us to guide to 6% growth. And part of that had to do with an easy comp and some challenges in the prior year and then there were some other factors in play. So we were so thrilled. You can imagine when we actually exceeded the 6% and delivered 7% growth on a full-year basis, and it's really a testament to the teamwork that Joe described earlier. Having said all of that, we don't -- we've always said that 2019 was a bit of an anomaly and we will see a lowering of the growth rate a little bit more in line with what the long-term expectations are for this business. But by no means are we not incredibly excited because we are. But again, we have to appreciate the specific and unique circumstances that allow that 7% growth to occur in 2019.
Danielle Antalffy:
Okay. And then I just have one quick follow-up as it relates to the generic injectables business. And how dependent is the growth on that business on upcoming new product launches? I asked the question just because it feels like there's potential for things to even slow down at the FDA. And I'm just curious as to whether the growth in that business is highly dependent upon products to come or do you feel like you have the portfolio right now to sustain growth there, which has been very strong. Thanks so much.
Joe Almeida:
So just a curious comment on the FDA. I expect the FDA will slow down the approval process because people are now working there mostly working remotely. But interesting, we just got the other day, our PrisMax2 approval just came in and came in a couple months ahead of time. So we made significant -- we made some changes in hardware, improved and some software change that enable an upcoming digital portfolio with the Wi-Fi capability and other things, the true view analytics that is going to be on the machine, so we file for the 510(k), got approval. So we were kind of surprised, it came so fast. Perhaps that was already in the pipeline and got accelerated. But I think we -- I just got news the other day, we just filed for another molecule ahead of time with the FDA. So we can't control and speak on behalf of the FDA. The only thing I can say is that we expect and we should plan for those delays. And we'll keep you posted as we see things, as we're going to know much more probably in a month from now when we're talking to you about April, what is going to happen with all this -- with the environment, with the landscape of hospital purchasing patterns, as well as agents approvals and things like that. But just a curious fact about one file that was sent in ahead of time and the other one was approved way ahead of time. So, it's tough to predict what's coming. Quarter Thank you so much.
Jay Saccaro:
Thanks, Danielle.
Operator:
Thank you. Larry Keusch with Raymond James is on the line. Please state your question.
Larry Keusch:
Thanks. Good morning, everyone. Jay, you in your prepared comments, I believe, talked about the cash situation of the company, the draw down on the European revolver, comments around the U.S. revolver. Could you talk a little bit about how you are thinking about capital allocation priorities as we think about what the stock has done, what asset valuations may be doing out there in the market? So just give us some thoughts around that as you raised, obviously quite a bit of cash to be ready.
Jay Saccaro:
Yes. Thanks, Larry. We have to be prepared for whatever we can anticipate. The coronavirus will -- how that will emerge. And so as a result of that, we've been really thoughtful about having adequate capital on hand. This is the time to have the balance sheet work on our behalf and we want to be absolutely ready to support the company. And so what we did in the first quarter is we have, $200 million plus in borrowings on our European revolver. And that's a facility we used from time-to-time, but we've chosen to leave that $200 million, we have cash to offset the borrowing. And we have nearly $3 billion in cash. We also recently successfully redid our U.S. revolver, which has a $200 million same day withdrawal feature on it and some other contemporary provisions that make it a best-in-class facility. And so we have all of that in place. What we wanted to ensure is that there would be no disruptions to our operations. So our primary objective is to ensure we have adequate liquidity on hand, despite the fact that we have a resilient and durable portfolio. We just -- we want to be ready for all circumstances that might emerge. But then, there are opportunities that could emerge as a result of this. And so we are seeing asset prices come down quite substantially in MedTech. And we've seen the share price of come down quite a lot. So as we think about allocation of capital and capital deployment, then we also want to be ready to take advantage of those kinds of opportunities. We were pleased to close the transaction in the quarter. The Seprafilm deal was a great one, but we do expect perhaps some of the patients that we've had over the last several years with respect to capital deployment, let's see how that fares us in the current market environment, because as I say, we are seeing asset prices moderate down quite a bit relative to prior levels. Joe, do you want to add anything to that?
Joe Almeida:
Yes. First of all, our first responsibility is to ensure that we have liquidity in the company and we've have plenty of that, as -- and we are prepared for anything come all way. But also, I think it's worth noting that we kind of took a long, long pause on speaking about large acquisitions or midsized acquisitions. We could not justify prices. The PEs were so high. And I think sometimes time is on the side of the patient, individual and we are patient here. And I think perhaps having a good amount of money in the bank and asset values are being down, I think maybe as an opportunity for us to continue to look at M&A landscape. But I don't discount the fact that also our stock is that the pricing is very attractive.
Larry Keusch:
Okay.
Joe Almeida:
Thanks very much.
Clare Trachtman:
Katherine, we’ve time for one more question.
Operator:
Thank you. Our next question -- our last question comes from Vijay Kumar with Evercore. Your line is open.
Vijay Kumar:
Hey, thanks, guys. Quick, maybe a guidance question, Jay. Margins for Q1, I think I heard you say a slight expansion. Maybe, is this some incremental investments going on for Q1 and not free cash conversion? Looking at the restated numbers, it's in the 80s. Is that the new normal, or should we expect that free cash to step back to 90s? Thanks, guys.
Jay Saccaro:
So, Vijay, there's some impact in terms of investments in the first quarter related to supply chain and other activities. But this is a very fluid situation and we're watching it very carefully. And like I say, while we are incredibly rigorous on spending across a number of areas, we have to spend to support getting supply to our patients that need it, and our customers that need it. And so we will continue to do that. So this is stay tuned on this, we will have some more commentary when we report Q1 results. As it relates to free cash flow conversion, if you look at our 2019 results, it was off our expectations. I mean, really, there were a few factors in play. One is, we had a higher receivables balance and there were two drivers of that. One is a different business mix than we expected. So we had a little bit more ex-U.S. sales, in sales and higher DSO geographies, leading to a higher DSO. And then second, we had an incredibly strong December and the result of that is those sales were not paid off with account receivable collections. Those account receivable collections occur in 2020. In addition to that, while we saw improvements in days inventory on hand, we were off a little bit, our expectations are days payable. We did not make enough progress in this particular area. And finally, there were some higher cash tax payments than we originally budgeted for. Those are the drivers that led to our 2019 free cash flow performance. What I can tell you is our organization is incredibly focused on enhancing cash flow performance. And the number that you cited is not the new normal. We brought in a new chief procurement officer who was looking across the entire vendor base and restructuring terms and days payable terms across the vendor base. Our supply chain forecasting process started to pay dividends at the end of last year. And as we move to this year, it will pay significant dividends. So we are very optimistic about improvements in free cash flow performance and working capital balance performance. But I do have to take you back to my comments earlier on, which is over the next several months, we are not focused on that so much as we are supplying consistently our patients and if that requires incremental inventory, which it will, we will carry the incremental inventory. So we will have this factor that comes into play over the next couple of quarters. But it's going to match the tremendous progress that we are going to make across the board on free cash flow performance. So with that, I think we can conclude the call. But Vijay thanks very much for the question. We appreciate it and the support.
Vijay Kumar:
Thank you.
Joe Almeida:
Thank you all and be safe. Be protective of your health and we wish you all well. Thank you.
Operator:
Ladies and gentlemen, this concludes today’s conference call with Baxter International. Thank you for participating. You may now disconnect. Everyone have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to the Baxter International Third Quarter 2019 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions]. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time.I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Katherine. Good morning, and welcome to our third quarter 2019 conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer.As you saw in today’s press release, the company recently initiated internal investigations into misstatements in our previously reported non-operating income related to foreign exchange gains and losses. While the investigation is ongoing, we are not able to provide full financial results and will be focusing today’s call on preliminary operating results for the third quarter of 2019. As such, we will not be commenting on any financial measures other than those above the operating income line for the third quarter or any future periods.A supplemental presentation to complement this morning's discussion can be accessed on our Web site. This presentation includes related non-GAAP reconciliations and can also be accessed on Baxter's external Web site in the Investors section under Events & News.With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development, and regulatory matters, contain forward-looking statements that involve risks and uncertainties and, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause results to differ materially.In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our preliminary operating results press release issued this morning and is available on our Web site within our investor presentation. On the call this morning, we will be discussing operational sales growth, which adjust for the impact of foreign exchange and generic competition for cyclophosphamide in the U.S.Now, I'd like to turn the call over to Joe. Joe?
Joe Almeida:
Thanks, Clare. Before we get into a discussion regarding our third quarter performance, I want to address the ongoing internal investigation that we disclosed in today’s press release. First, I want to emphasize that our Board and leadership teams have taken this matter very seriously.Baxter recently began an internal investigation assisted by experienced outside investors into misstatements in our previously reported non-operating income related to foreign exchange gains and losses. These misstatements were in part a result of the company’s historical use of a foreign exchange rate convention that was not consistent with GAAP.Our Board’s Audit Committee is overseeing the investigation with the assistance of independent, experienced external advisors. We voluntarily advised the SEC that the internal investigation is underway and intend to provide them with additional information as the investigation progresses.The investigation is in its early stages and we cannot predict its duration or outcome. As a result, we do not expect to file a quarterly report on Form 10-Q for the period ended September 30, 2019 on a timely basis.Upon completion of the investigation and our evaluation of the materiality of the misstatements, we expect to either amend our periodic reports previously filed with the SEC to include restated financial statements that correct those misstatements, or include in reports for future periods restated comparative financial statements that correct those misstatements.As part of any corrections to previously issued financial statements after completion of the non-operating income investigation, Baxter also expects to correct certain operational items that were immaterial to its previously reported results of operations.These items include the impact of the use of the foreign exchange rate convention to translate the results of the company’s foreign operations into U.S. dollars and the impact of the incorrect accounting for placed equipment that the company leases to its customers.Across Baxter, we’re taking steps to strengthen and enhance our internal controls and look forward to sharing our full financial results as soon as it is appropriate. We will continue to execute against our business strategies targeted to deliver top quartile industry performance and our 50,000 employees remain focused on building our positive momentum and maintaining ethics and compliance in everything we do.Please note that there isn’t additional detail regarding the investigation that we can share beyond what we have provided in our press release. We, therefore, ask that your questions during the Q&A portion of this call be focused on our preliminary operating results, business progress and innovation efforts.With that, I will now turn the call over to Jay.
Jay Saccaro:
Thanks, Joe, and good morning, everyone. Our third quarter results reflect strong performance across our three geographic segments and all six global business units. Given the ongoing internal investigation, we are not able to provide year-over-year comparisons for segments and global business units but we’ll speak to the specific drivers of performance in the quarter.In the third quarter, global sales of $2.85 billion increased 3% on a reported basis and 5% on both a constant currency and operational basis, reflecting strength across our diversified portfolio. Adjusted operating margin of 19.5% was driven by our solid top line performance and ongoing operational efficiencies.Now, I'll walk you through performance by our geographic segments and global businesses. Starting first with our three geographic segments, sales in the Americas totaled $1.5 billion, sales in EMEA totaled $730 million and sales in our Asia-Pacific region totaled $587 million.Moving to performance by global businesses, global sales for renal care were $918 million. Performance in the quarter was driven by strength in PD therapies globally with patient volumes advancing approximately 7% year-over-year and representing the highest quarterly patient volume growth year-to-date.Partially offsetting this is lower sales of select in-center HD products, including the Bloodline’s business exited earlier this year which negatively impacted sales in the quarter by approximately $18 million. Renal care sales were also impacted by the temporary supply constraints associated with the REVACLEAR Dialyzer. The impact was less than $10 million in the quarter.Sales in medication delivery of $701 million represented the focused commercial execution of our U.S. hospital product team. Performance in the quarter benefited from strong sales of Spectrum IQ Infusion System in the U.S. where we continued to increase our install base of pumps and also from improved sales of small and large volume IV solutions globally, as we continue to build momentum. We are pleased with the ongoing improvement in the business, particularly in the United States.Pharmaceutical sales were $527 million in the quarter. Contributing to performance in the quarter was robust demand for our international hospital pharmacy compounding services as well as increased sales of certain generic injectables. Partially offsetting these results were lower sales of anesthesia and critical care products as well as Brevibloc due to increased generic competition. U.S. cyclophosphamide sales totaled $41 million in the quarter.Moving to nutrition, total sales were $219 million driven by improved sales of multi-chamber bags and micronutrients globally. International demand for automated nutrition compounding also contributed to performance in the quarter. Third quarter sales reflect the efforts taken to rebuild our U.S. business coupled with our focus on new product launch execution.Total advanced surgery sales were $216 million in the quarter. Performance was driven by strength of hemostats and sealants which benefited by more than $10 million of sales related to previously discussed competitive supply constraints, which are not expected to continue contributing at this level.Third quarter sales in our acute therapies business of $130 million were driven by increased global demand for Baxter's continuous renal replacement therapies, supported by the launch of new products including PrisMax, Baxter's next-generation CRRT system. Finally, sales in our other category which primarily includes our contract manufacturing services were $140 million in the quarter.Moving through the rest of the P&L, our adjusted gross margin of 45.7% benefitted from strong top line performance as well as positive manufacturing variances. Issues associated with our Dialyzer supply constraints negatively impacted gross profit by approximately $15 million in the quarter.Adjusted SG&A totaled $614 million as we strategically reinvest savings in general and administrative expenses to support our sales and marketing initiatives, while maintaining our disciplined focus on managing discretionary expenses.Adjusted R&D spend in the quarter was $134 million. We continue to fund our product development programs to deliver on our innovation pipeline, while also realizing benefits from our ongoing optimization initiatives to optimize our R&D processes and the organization.Adjusted operating margin in the quarter was 19.5% due to strong top line performance, manufacturing efficiencies and ongoing efforts to improve operational effectiveness across the company.Let me conclude by commenting on the sales and adjusted operating margin outlook for the fourth quarter of 2019. We remain confident in the health of our business and in strength of our commercial execution. Given the ongoing investigation, we are providing limited guidance for the reminder of the year.Specific to the fourth quarter of 2019, we expect sales growth of 3% to 4% on a reported basis and approximately 5% on both a constant currency and operational basis. We expect operating margin to be between 15.2% and 15.9% on a reported basis and between 18.5% and 19% on an adjusted basis.Finally, I want to comment on our 2020 outlook. We’re currently in the process of completing our annual operating plan, and as part of that activity we’re considering several factors and their potential impacts. Some of these items include the proposed Advancing American Kidney Health initiative and the related capital investments to support this along with other government renal policy initiatives.Capital investments and operational improvements we are making to enhance our quality and manufacturing capabilities and the finalization of our agreements with various GPOs and IDNs in our U.S. hospital products business. As a result, it is premature to comment on 2020 guidance and beyond but anticipate providing more detail on our next earnings call.With that, I’d like to turn the call back over to Joe.
Joe Almeida:
As Jay shared, our strategic transformation yielded positive performance across all of our business units and regions in the third quarter. The fundamental health of our business remains strong and reflects our growing momentum.We’re continuing to drive operational excellence and strategically deploy capital to create shareholder value and advanced compelling innovation in our core areas and attractive adjacencies both through robust internal research and development and strategic business development.In renal care, for example, we continue to believe that the Advancing American Kidney Health initiative will offer tremendous benefits to patients with home dialysis embraced as a frontline option. We also continue to nurture our innovation pipeline in this space including advancements in early stage technology that could have a transformative impact on the treatment of end-stage renal disease.In medication delivery, we’re building on our leadership in IV infusion systems and solutions with internal innovation that is complemented by our expected acquisition of Cheetah Medical, the combination of which will fuel the broader impact of our integrated family of pumps, fluids, medications and monitors.In pharmaceuticals, we’ve continued to launch a steady stream of new molecules including the recent introduction of Myxredlin, our new ready-to-use insulin for IV infusion.In sum, our business strategy objectives and capital allocation philosophy remains unchanged. We are focused on addressing the unmet patient and customer needs, building our pipeline and successfully launching products across the globe.At the same time, we continue to actively pursue opportunities to extend our impact through strategic partnerships and business development initiatives. This all supports our goal to accelerate performance and deliver top quartile results for all the stakeholders.Now we’ll open the call up for Q&A, keeping in mind that we’ll be limiting our ability to comment beyond the details we shared this morning.
Clare Trachtman:
Katherine, you can open up the call for Q&A now.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions]. Our first question comes from David Lewis with Morgan Stanley. Your question, please.
David Lewis:
Good morning. I want to get the fundamentals guys, but just real quick, Joe, just in case we won’t be able to get this information. Can you just give us any sense of how the issue was identified and any rough sense of when you hope to complete the investigation? If not, I’ll jump to some fundamental questions.
Joe Almeida:
David, as we said before, the investigation is in early stages. Beyond what we shared in our press release, I cannot provide additional information when the investigation is ongoing. So let’s move to the business fundamentals.
David Lewis:
Okay. So, look, given those FX dynamics, Joe, obviously it’s cloudy in their reporting structure, but obviously underlying comps and currency growth this quarter was solid. So just first question is, can you just give us a sense of underlying trends this quarter, how you felt about those versus plan? As you think about underlying business performance into the end of the year, how do you feel about that sort of relative to plan? And any thoughts you can share about improving revenue performance in 2020? And then I got a quick follow up for Jay.
Joe Almeida:
So, David, let me start with our medication delivery business. This is one that our investors have asked so many questions and paying a lot of attention. That business was able to perform very well. It actually has slightly exceeded my expectations. And I will say that our new pump, our Version 9 of our pump is doing very well, extremely well as a matter of fact. We finish our first full integration of that pump in a two-way system in the hospital system in the Southwest. We have closed many, many deals that I’m very excited about. We also are seeing a very stable business in our IV solutions, the small and large volume parenterals with recovery now on its way and good contracts being signed, some of them surprisingly us being doing very well. And this is a reflection on the performance of the U.S. medication delivery in the U.S. As I said, our head of that business, Heather and her team in the U.S. are doing a wonderful job there. I want to highlight as well that our launch of PrisMax has been well received in the marketplace. It’s one of the fastest launches I’ve seen. As soon as we launched in the U.S., within a couple of days we had purchase orders coming in. The system is really hitting the mark. And I feel the innovation of the company is really starting to bear fruit. So I’m excited about when we talked to you about 2020 about the impact of new products sales into next year. Also when we talk about the regions themselves, we see full recovery in Europe. Europe was a real ladder for us and it’s coming up to be driving well performance and great performance in Asia-Pacific as well led by China. And I want to close by just saying the fundamentals of our PD business and this is one of the business when I first started here that we really were a bit concerned about because we had issues with contracts and we had issues with the ability to supply products. And seeing the patient growth on a global basis is so high in the U.S. nearing 10% gives me tremendous confidence that when we hear back on rule on AAKHI, that can really represent an opportunity for us. So the fundamentals of the business puts me quite at ease in how we are doing in the marketplace, the share that we are expanding and ability to really compete, this is a different Baxter.
David Lewis:
Thanks, Joe. Just two quick follow ups. One is, I know it’s challenging to talk about forward guidance just given the dynamics that are going on. But can you talk at all about you said building accelerated momentum in the business in 2019, how are you thinking about that momentum into 2020? And then for Jay, margins always tick down in the fourth quarter. Can you just bridge us to fourth quarter, any one-time benefits in the third, any headwinds into the fourth and how margin outlook is tracking relative to plan? And any comments you can make on pension which was sort of an inter-quarter announcement that we haven’t yet got clarity on? Thanks so much.
Joe Almeida:
So, David, we don’t have or I don’t have any reason to think about any changes in dynamics that would slow down our ability to do our business in the future. Why is that? Baxter has, for the most part of this, largest markets either driven by contracts which are mid to long term as well as large tenders outside the U.S. and we see a steady position of our products through contracts that give me comfort. Doesn’t make me relax but gives me comfort that we’re hitting the right places. The innovation coming through our new pump platform coming out next year gives me tremendous optimism in terms of how we’re going to be able to face new opportunities in the U.S. We’re also launching – we launched the three-chamber back in Europe for nutrition that is doing very well. Our post-Maria recovery in nutrition which was very slow in the beginning is starting to see some momentum. So I don’t have any reasons today to tell you that I’m concerned about the ability of Baxter to grow its top line.
Jay Saccaro:
Great. David, in relation to your question on margin versus expectation and sequential, I will tell you that Q3 was a very solid margin performance relative to our expectations. We were supported by top line in line with our expectations which was great. But then as a result of savings initiatives and focus on efficiencies, we were able to come in maybe 1% ahead of our internal expectations. Now, as we move from Q3 to Q4 you’ll note that the margin does deteriorate which as you pointed out is largely attributable to normal seasonality. In the case of this fourth quarter, gross margin will come down in large part if our shutdowns occur in Q4 and that has a period of expense impact in the fourth quarter. But then secondly, R&D in the third quarter I believe was a little bit below 5% of sales. We will expect it to go a little bit above 5% of sales in the fourth quarter related to the timing of certain milestone payments attributable to advancing the pipeline. So that’s really the story on the overall margin evolution. As it relates to the pension, the overall goal of the pension approach is to really reduce volatility. As part of the transaction that we engaged in, we have reduced the liability by approximately $2.4 billion. That is very substantial long-term benefits to us in terms of managing the predictability of future financial results. But as it relates to commenting on the 2020 impact in particular because this is in other income line item, I’ll refrain from talking about whether this is a benefit or headwind or tailwind. I’ll stop my comments there and stick to the fact that this is more about a long-term reduction in volatility which we why we pursued this transaction.
Joe Almeida:
Thanks for the questions, David.
David Lewis:
Thanks so much.
Operator:
Thank you. Robbie Marcus from JPMorgan is on the line. Please state your question.
Robbie Marcus:
Hi. Good morning, everyone. Joe or Jay, I was just hoping – we didn’t get constant currency by segment, we didn’t get guidance by segment like you typically have. Any comments you could add to maybe where you’re seeing pluses or minuses versus your internal plan or any deltas we should be expecting after third quarter results here?
Jay Saccaro:
Sure. Robbie, just as a matter of clarification, the reason that we have not provided sales growth by segments or by region is that as part of any correction to previously issued financial statements after we complete this investigation, we do expect to correct certain items that are immaterial to our previously reported results of operations, which include the impact of translating our foreign operations back to U.S. dollars in the exchange rate used. Like I said, this is an immaterial impact but you can imagine how sensitive we are to any minor changes in growth rates that may emerge as a result of comparisons and this kind of situation. So I think Joe – so that’s why for your information, we haven’t shared anything in relation to growth by segment, by region. But I think Joe said it well. Look, we had strength across the portfolio. Our renal care business continues with great momentum. Medication delivery had a very solid performance, in particular in the U.S. as we look to continue to drive performance in that area. The pharmaceuticals business, not only did we couple solid performance in the quarter but we added to that the launch of Myxredlin which becomes an important driver for our long-term growth. So I would say generally speaking we sit here very pleased with the business momentum across the board.
Joe Almeida:
I echo Jay and I’ll tell you – I just want to point to the acceleration in the PD business. The patient growth has been impressive and not surprising because the therapy is a desirable therapy for the home. But this is one of the levers that we have. And the other lever that we have is also the momentum in our U.S. medication delivery business which we started to see the fruits of our change in sales force structure and organization.
Robbie Marcus:
Great. And then a quick clarification, Jay. Might there possibly be cash flow restatements or is this purely just a P&L item?
Jay Saccaro:
So at this point, Robbie, we can’t comment on any – we’re limiting our comments today to operating income. We have an investigation ongoing. Upon the conclusion of that, we’ll be prepared to share further comments. But for purposes with our discussion here, we’re not commenting on anything below operating income.
Robbie Marcus:
Okay. And then just last quickly from me, Jay, we saw some recent news reports that you might be in discussion with a pharma company for a specific drug. Can you just give us your latest thoughts on the use of capital specifically for M&A and what type of deals you’re looking for that might be most appropriate for Baxter here? Thanks.
Joe Almeida:
Robbie, this is Joe. Great question. We don’t comment on any M&A activity that we are contemplating or not. But I think you have a great question when it comes about capital allocation. Capital allocation, as we’ve mentioned, remains unchanged. We are – we always prefer a strategic deployment of capital into acquisitions. We said before that adjacencies are more reasonably priced and easier to integrate and we are very, very open to those. We also have not changed our view on dividends at all. And at the end of the day we’re not going to be hoarding cash. So if we find ourselves with excess cash in our balance sheet, we’ll make a decision to appropriately buy shares back. So I just want to say to you and to the folks on the call that no change has been contemplated neither in sight to our current capital allocation policy. Jay, anything you want to add?
Jay Saccaro:
No. That’s a great summary. The only thing to add is and Robbie of course we have very ample liquidity with significant cash on hand to fund business development or any other activities we are interested in pursuing.
Robbie Marcus:
Thanks a lot.
Joe Almeida:
Thank you.
Operator:
Thank you. Bob Hopkins of Bank of America is on the line. Please state your question.
Bob Hopkins:
Thanks very much and good morning. First question is, I just wanted to clarify something in your 8-K and make sure I’m reading it correctly because it says the FX gains for '14 to '18 list those out. Should we view those as representing the magnitude of the misstatement or could those misstatements be I guess in the end larger or smaller?
Jay Saccaro:
The misstatements could be larger or smaller on then what was reported as gains in the 8-K that we issued.
Bob Hopkins:
Okay, thank you for that. And one of the other things in the 8-K was on Claris. It sounds like the FDA process is going really slower. Jay, can the contingency plans that you guys have talked about prevent the potential for disruption there or just how should we be thinking about that?
Joe Almeida:
Bob, we are just being cautious. We can’t predict when the FDA will come in and re-inspect the plant. We have not been re-inspected yet, and we’re coming towards the end of 2019. We have done everything that we’ve committed to do to date for the FDA. We have improved our operations. We have modified facilities. We have done a lot of different things as we promised. But we can’t predict, so we’re better off just not counting on something. And if it comes, fine. If it doesn’t, at least we’re upfront telling you. But what you need to think about is that we are committed for a backup plan and we’re investing money to have most of these products on a CMO basis if we ever need to activate CMO. So our pharmaceutical group not only is very busy right now with significant amount of new opportunities in pipeline they’ll be formulating and example is Myxredlin, but they also will be working on continue and closely all the CMO opportunities as a backup.
Bob Hopkins:
Okay, so it sounds like the potential for disruption is low there. That’s it for me. Thank you.
Joe Almeida:
I just want to rephrase. I incorrectly used the contract manufacturing organization and I used CRO which is contract research organization. I apologize. Please strike that from the record. It’s C-M-O. I’m very sorry.
Jay Saccaro:
Thanks, Bob.
Operator:
Thank you. Matt Taylor with UBS is on the line. Please state your question.
Matt Taylor:
Thanks. Good morning. So I was hoping you could comment on the PD dynamics and do you think you’re seeing a pickup in the patient volumes because of technology, because of the initiatives that the government has talked about or some combination thereof?
Joe Almeida:
Well, I think that the therapy’s benefit was always very clear but I think that there is an acceptance of therapy probably more widely today than was before. But I have to say that our partners, DaVita [ph] being one of them, have been working very closely with us in a very collaborative manner and that has created the opportunity for us to continue to deploy our resources to train nurses and patients. I also underscore that Baxter has made significant operational changes in making products what we make, how much capacity we’re putting in place giving confidence to our partners that we can actually supply the market versus perhaps back in 2013, '14 and '15 when we had some constraints and allocation of resources. So if now the clinics and the doctors and our partners feel more confident, then that plays a role. But I also think the move into the home is becoming more definitely apparent to our constituents. This is a good result and we’ll be working very hard to make sure that we continue on with these partnerships.
Matt Taylor:
Thanks, Joe. And then just a follow up on med del. So the U.S. number was very strong but the OUS was a little below what the consensus was expecting. Can you talk a little bit about the dynamics OUS if that growth could improve? And then when do you think we’ll start to see more inflection from the new pump launches?
Joe Almeida:
So I think there was some timing on the performance outside the U.S. Also we have focused tremendously in making sure that we have launched our new pump Evo IQ outside the U.S. We had a slow launch of that product in the UK, which is going to be picking up momentum later this year into next year. There was a little bit of weakness that we found there as well. But we had a very good momentum in Latin America, very good momentum and we’re on track on that. And then we also in Canada we just launched our new pump there. So don’t read anything on the OUS numbers. More so you should feel comfortable that in the U.S. we got this thing addressed and we’ve got the numbers right. And we don’t talk about comparison at the moment. We’re not going to be talking about quarter-over-quarter or year-over-year, but I can tell you that based on my expectations this business is doing well. It’s doing well and I’m very happy with the performance that we have demonstrated. At one point in time it was being quite challenged by other constituents. We are on track on that.
Matt Taylor:
Great. Thanks, Joe.
Operator:
Thank you. And our next question is Pito Chickering with Deutsche Bank. Please state your question.
Pito Chickering:
Good morning, guys. Thanks for taking my questions. Two quickies for me. What is the process for getting Theranova approved for the Medicare conditional add-on payment in 2020?
Joe Almeida:
Well, I don’t want to get into the sausage making because there’s a lot being done. We have a full team. But we submit our comments to HHS and we also have submitted our Theranova for the de novo process. So I’m very happy. Our team led by Laura Angelini and Tony Woodson have done a great job in getting this on time to the FDA. Now the comments need to go in and they need to come back with the final resolution about the process itself. Remember, it does not only affect our product but affects other categories of medical devices. But we’re confident. We see some of the early data that was done outside the U.S. on Theranova and we find that to be very compelling. I think HHS saw that as well. So we’re on track, but remember this is not a 2020 conversation. This is a 2021 conversation, okay, because it’s going to take us time by the time we get to the product approved and get the reimbursement confirmed will take about 12 months to start implementing.
Pito Chickering:
Perfect. So assuming that this is accepted for the add-on payment, the providers will start getting paid with that add-on payment in 2021, correct?
Joe Almeida:
That is correct. This is our best estimate right now. If anything changes we’ll let you guys know in one of our calls.
Pito Chickering:
Okay. And then from a manufacturing capacity of the dialyzers, it sounds like there’s some capacity constraints this quarter. Can you talk about what investments you’re making in those facilities and how fast you think those facilities can get ramped up?
Joe Almeida:
Well, listen, we at one point in time a few years ago, say about three years ago, we had two lines within our plant in Alabama that were not operational. We did not enable them to start operating because the capacity versus demand was balanced. As we start getting more success both in the dialyzer business and start selling more product, we activate those lines. Those are complex lines and we had issues in getting them started out. So we will have some investment that we’re making in quality and operations in this plant for the next 12 months. We’re going to increase the amount of investment in that plant to make sure that the lines will be ready to be converted to Theranova if we decide to do so. But we need to do some investments, some expenses that will go up a little bit next year in terms of enabling that plant to be fully capable of making Theranova or Revaclear and then we’re going to decide which is the best mix for our patients and for our customers and also for Baxter in general.
Pito Chickering:
Great. Thank you so much.
Operator:
We have Larry Keusch with Raymond James on the line. Please state your question.
Larry Keusch:
Thanks. Joe, I just wanted to maybe talk a moment about the delivery business. Obviously you did achieve a medical deal, which is interesting. But as we get past this year and we kind of stabilize the business, what’s really the right way to think about the growth outlook and what you’ll be focused on over the next several years?
Joe Almeida:
Well, I had a great discussion with the head of that business, David Ferguson, the other day and for us the vision of that business is preventable harm. How do we create a system that integrate pumps and fluids that you continue to treat the most critical patients in a way that they can recover and exit a critical stage faster even in a septic stage or any acute other stage. So we find that the hemodynamic balance of the patient to be very important, so we started PIVA, which we started our clinical trials a couple of weeks ago. Then Cheetah comes in and gives us more qualitative data in terms of the treatment of that patient. But there are other things that we’re looking around, a series of monitoring technologies that will come to surround our patient in the ICU to be able to get that patient out of the critical condition as fast as possible. And to that we can also think about – don’t think about medication delivery exclusively, think about our acute renal care therapy, our CRRT therapy because that plays a role also not only treating but also helping diagnose and determining when do we start. Because the patient when it gets to the point that you check in the hemodynamic balance, you’re checking the quality of that treatment is also a patient that sometimes has acute kidney injury and is incapable of doing – the kidneys are not operating any more. So all of this together, how do we create a business for critical care patients that prevents harm and improves the ability of that patient to get out of the critical stage. So you’re going to see a lot of this movement from Baxter in this area that was not in the past a priority for us. Because we think having the best pump platform that is coming out next year is one lever. Having the fluids available for the hospital is the second lever. But now how do you create this safety net that can bring the patient to a better outcome faster.
Larry Keusch:
Okay. So just a quick follow up on that, one question. So it sounds like the aspirations are clearly to grow this business in totality sort of faster than the low single digit growth of the markets. Is that fair?
Joe Almeida:
That is fair. Remember, we have a very large and stable business within medication delivery which are fluids and for that we’re working very hard and have worked very hard to stabilize, get the contracts in place, get the supply chain in place. So this was Phase 1 because without that, it’s a nonstarter. So we start doing that and that became our priority. Now the second priority is let’s get a pump platform that has all the pumps that they need and they are connected, they’re two-way communications and how do we make them more intelligent. Third, how do you surround that patient with a safety net that prevents harm and allows the patient to get out of critical care faster? So you see this all comes together but we had to do it in phases, because we had a business that was a little bit in disarray and now we have that business quite organized, quite ready to go. And by the way, when we look at the people selling this, the whole restructuring of the sales force that we’re putting in place not only in the U.S. but other parts of the world because we’re going to have a global pump product – this is not about the U.S. anymore – then makes it the fourth pillar of having this business completely revamped.
Larry Keusch:
Okay, perfect. And then just quickly, Jay, just while you’re moving through the investigation here on the accounting misstatements, I just want to confirm whether you can deploy capital during that period, meaning are you free to do M&A and more specifically are you free to buy back stock?
Jay Saccaro:
So just to be clear, obviously, we commented on this a number of times. The organization here takes the matter incredibly seriously; the management team, audit committee of the Board. There is an ongoing investigation and we intend to move through it expeditiously. As far as capital deployment, on the M&A side, our principles have not changed and we have ample cash to deploy. And so that’s what I would say in terms of our current deployment of capital that would be the priority focus.
Larry Keusch:
Okay. Thank you.
Operator:
Danielle Antalffy with SVB Leerink is on the line. Please state your question.
Danielle Antalffy:
Hi. Good morning, guys. Thanks for taking the question. Joe and Jay, I know you’re not going to provide 2020 guidance and not asking you to, but just at a high level as I look out to 2020, it feels like you have a lot of tailwinds in place, new product launches that you had here in 2019 across most of the businesses. And I know some of the headwinds, I appreciate some of those back half med delivery comps will get tougher you also had in the acute surgery business that supply disruption from a competitor. Just at a high level, can you help frame for us the tailwinds and headwinds from a top line perspective as we head into 2020, especially as you’re exiting the year here what seems like it would be a 5% organic growth rate?
Jay Saccaro:
Thanks for the question, Danielle. Overall, what I will say is we’re pleased with the momentum and the progress that we’re seeing, as I said earlier, really across the portfolio. The third quarter from a sales perspective hit on a lot of different cylinders and furthermore as we looked at the performance of the pipeline and innovation in new products, those were all pointing in the right direction. As far as 2020 goes, as we always do this time of year, we really do hold off on specific guidance for 2020 and specific headwinds and tailwinds. And the reason is we are literally in the process of completing our annual operating plan. In the coming weeks and months we’ll review it with our Board of Directors and walk them through it as we prepare for the new year at which point we’ll share guidance. And then as we think about this year in particular, there are a number of different items that could have an interesting impact on our financials, things like the Advancing American Kidney Health initiative which is an important potential driver for us. We also have to ensure that we have the right capital investments and operational investments in our manufacturing and quality systems. That’s another critical area we are spending a lot of time assessing that. And then finally one of the key areas to our long-term success relates to agreements with GPOs, IDNs and other major customers. And so that’s another area that we are working – our U.S. teams are working very hard on that. And so we have full line of sight to the completed operating plan along with some further information on these numerous critical drivers, it’s a little too early to get into on specifics on 2020.
Danielle Antalffy:
No, but that’s helpful. And just one quick follow up as it relates to capital deployment. We touched on your ability to do M&A while this investigation is ongoing. What about your ability to continue to buy back shares? Can you do that before you file the 10-Q or are you limited in what you can do there?
Jay Saccaro:
So generally speaking, we don’t comment on share repurchases for a lot of different reasons. What we typically do is after having repurchased shares, we make comments on how many shares we repurchased and there are a number of different reasons for that that I think represent good practice. And so as it relates to going forward, stay tuned; we’ll talk about share repurchases on an upcoming call.
Danielle Antalffy:
Thank you so much.
Jay Saccaro:
Thank you, Danielle.
Operator:
Vijay Kumar with Evercore ISI is on the line. Please state your question.
Vijay Kumar:
Hi, guys. Thanks for taking my question. Hello?
Jay Saccaro:
Hi, Vijay. We’re still here.
Vijay Kumar:
Sorry about that. Can you hear me now?
Jay Saccaro:
Yes, we can. We’re good.
Vijay Kumar:
Thanks for taking my question. So one maybe on the fundamental side, Joe or Jay. The 5% operational for Q4 and it looks like sequentially what changes I guess in the model because you do have a tougher comp Q4. I’m guessing some of this is on the pharma side. The Brevibloc headwind goes away. You spoke about Myxredlin. Are those the main drivers here to offset the tougher comp?
Jay Saccaro:
Yes. As we always anticipated, there was an acceleration in Q4 in medication delivery that represents an important driver. The team’s hard at work in terms of identifying new customers, doing a tremendous job on the pump side and also the large volume solution side. So that medication delivery does represent an important component as we look to close out the year successfully. And then we’ll also see some improvements sequentially in nutrition. Again, that’s an important business for us. The team has been hard at work recapturing some of the lost business in the U.S. but along with also successfully launching products. So those would be the couple of things that I would point out. I don’t know, Joe, if you would add anything to that?
Joe Almeida:
I would say, Vijay, that compounding has had an effect on the sequential basis. We’ve been very successful with compounding, but compounding is a business that varies a lot based on what kind of drugs go into biosimilars and mineral compound in business outside the U.S. So biosimilars are very successful outside the U.S. when they go on. On biosimilars, we have not a reduction in profit but we have a reduction in sales just because of the purchase price. The other one is we’re anniversarying dexmed. Remember, this is an $80 million plus business that we’re anniversarying right now. Myxredlin is just trying to pick up momentum. We’re picking up to see sales go up on the ready-to-use insulin product, but the dexmed anniversary and then – so there are some puts and takes in the whole quarter, but it’s not – now I don’t see anything terribly different that would alter the momentum.
Vijay Kumar:
Thanks, Joe. And Jay just on the 2020 commentary that you made on – I think if I heard you correctly, you were talking about CapEx investments. So I just want to put that into context just given that free cash has been growing healthy. Are we looking at a step up in CapEx? Was that the genesis of the comment? And then just on the topic of free cash when you look at deploying free cash, between now and until the investigation gets resolved, can you buy back stock, right, I guess – and I apologize if this has been asked? With that, I’ll stop. Hello?
Jay Saccaro:
Sorry, Vijay. A couple of things. As it relates to your question on capital, my comment about 2020 I highlighted a few drivers, the AAKHI. That initiative is an important long-term growth driver for us. We have not reflected on that particular initiative in our long-term plans but also in terms of our short-term capital plans. So that would be above and beyond our prior expectations in terms of CapEx investments. As it relates to manufacturing quality, one of the things we are intensely focused on is ensuring on the high quality manufacturing and that we have the right investments in quality. And that comes in two forms; OpEx certainly and also some CapEx. So that’s another feature that we’re looking at as we think about our 2020 planning. So those are a couple of highlights. And I’ve just chosen a few things to highlight as we think about our 2020 and which is why really we don’t want to get into more detail on what our expectations are at this stage. As it relates to share buyback, like I say, our policy is simple and straightforward and frankly we really haven’t varied from it over the last many years. We simply do not comment on share buyback until we’ve completed them.
Vijay Kumar:
What I mean Jay was, is there – are you allowed to buy back I guess? I wasn’t asking on --
Jay Saccaro:
So, Vijay, totally understood. But in conjunction with my comment regarding comment on share buybacks, furthermore we don’t comment on our ability to buy back shares. That’s how we do it.
Joe Almeida:
Vijay, this has been a policy that’s been here. Independent of this investigation, we wouldn’t have given you this answer no matter what.
Vijay Kumar:
That’s helpful, Joe. Thank you, guys.
Jay Saccaro:
Vijay, thanks for the questions.
Vijay Kumar:
Thank you.
Operator:
Larry Biegelsen with Wells Fargo is on the line. Please state your question.
Larry Biegelsen:
Good morning. Thanks for taking the question. One on renal, one on nutrition. Joe, on the renal care initiative, what are the next steps there and when do you think you’ll be in a position to tell us more about the impact not just from a capital standpoint in terms of the impact on your PD business? And is the point of care PD systems still a 2020 launch? And I have one follow up.
Joe Almeida:
Larry, all the commentary, ours and a bunch of it, over a 100 comments that went into this system. I think the government original prediction was in November we would hear from the HHS. It can be January. We hope as soon as possible. So as soon as we hear from them, we are internally preparing several different scenarios in terms of growth rates and investments. That’s why we announced $500 million of investment, but there’s some stuff that we can do in the meantime to increase capacity but we’re going to have to invest money. So we have all these scenarios planned ready to go. We’re just waiting to hear what is going to be the rule itself. Is this a mandatory or voluntary? Are there any changes that will make the demand go up or down? Is the population that they’re experimenting with, the change in the policy, the same size that was originally conceived or differently? So there’s so many variables. We are on it and we’ll be ready to talk to you folks as soon as we hear from HHS when the rule is finalized and we’re ready to go. Your question on point of care, point of care we are continuing with the clinical trial. We have more patients enrolled and that’s a great thing for us to understand how to mix – how to compound a drug in somebody’s home. And we’ve been successful in doing that. But don’t get all focused on that alone. We are making investments in some very interesting early technologies and we’re very excited about it. So we’re seeing some other stuff. We’re being first there, getting to know. We’re making investments, sitting on boards of these technology companies. We think the horizon has opened quite rapidly for innovation when it comes to treatment of patients at home. So I would say in about five to seven to eight years, this outlook how you treat patients may change and Baxter will be there because we are embedded in a lot of these new technologies that are being developed at the moment.
Larry Biegelsen:
That’s very helpful. Just quickly for me on nutrition, what’s the outlook there? You talked about new products in the U.S. and Europe, two new products but you talked about a three-chamber bag I think outside the U.S. Do you need that in the U.S. to accelerate your growth? Thanks for taking the questions.
Joe Almeida:
Larry, we do have products in the U.S. that will have multi-chambers. We think the U.S. is a slightly different market than the European market. The European market is a really early adopter of multi-chamber bags. Our multi-chamber bag in the U.S. will come at the right time. As a matter of fact, we have some very advanced plans we have in the product here. The thing that I want you to focus is that the opportunities outside the U.S. that we are very concentrated right now in putting together. There’s opportunities in China, there are opportunities in other parts of the world and we are also developing and feel really good about a new multi-chamber technology that our folks in Belgium are looking and developing. So we’ll continue to complete well. As you know, we are market leaders in U.S. in parenteral nutrition and we’ll continue to firm our position by launching either multi-chamber bags either with fish oil, olive oil, whatever we think is the best combination for the patients here.
Larry Biegelsen:
Thank you for taking the questions.
Joe Almeida:
Thank you.
Jay Saccaro:
Thank you, Larry.
Clare Trachtman:
We have time for one more question, Katherine.
Operator:
Okay. We have one from Matt Miksic with Credit Suisse. Your line is open.
Matt Miksic:
Hi. Thank you. Just a quick one from me. I think we’ve covered a lot of the topics. But I’ve been hopping back and forth between calls, so I apologize if this was answered. But oddly, the topic is FX but not the investigation. Just maybe Jay if you could quantify maybe the impact of what looked like worse FX on some of your businesses if they showed up or in one place and another during the quarter just in terms of dollar terms? I know that’s all netted out organic growth, but any color you can provide just because it did look like it stepped up during the quarter at least relative to estimates.
Jay Saccaro:
Matt, I think you can appreciate our sensitivity with respect to discussions of FX on a business line for regional basis today. So I’ll refrain from answering that question and perhaps at a future date we can get into more detail by line, by business and so on.
Matt Miksic:
I understand. Thank you.
Jay Saccaro:
I definitely appreciate your understanding.
Clare Trachtman:
Katherine, I think we can wrap up the call now.
Operator:
Ladies and gentlemen, this concludes today’s conference call with Baxter International. Thank you for participating and have a nice day.
Operator:
Good morning, ladies and gentlemen and welcome to Baxter International's Second Quarter 2019 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time.I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candace. Good morning, and welcome to our second quarter 2019 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer.On the call this morning, we will be discussing Baxter's second quarter 2019 financial results and our updated financial outlook for full-year 2019. A supplemental presentation to complement this morning's discussion can be accessed on our website. This presentation, along with related non-GAAP reconciliations, can also be accessed on Baxter's external website in the Investors section under Events & News.With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development, and regulatory matters contain forward-looking statements that involve risks and uncertainties and, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause results to differ materially.In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and is available on our website. On the call this morning, we will be discussing operational sales growth, which adjust for the impact of foreign exchange and generic competition for cyclophosphamide in the U.S.Now, I'd like to turn the call over to Joe.
Joe Almeida:
Good morning and thank you for joining us. We’re pleased to share our second quarter results with you today and to discuss our updated expectations for 2019. I will begin with a quick review of our performance in the quarter and Jay will then provide more detail on the financials. We will wrap up with Q&A.Baxter maintained a [responsive trajectory] in the second quarter of 2019 delivering sales growth of 4% on both a constant currency and operational basis. On the bottom-line, adjusted earnings per share were $0.89 exceeding our expectations and up 16% year-over-year. Growth in the quarter was driven by top line sales performance, operational efficiency initiatives, a lower tax rate, and a reduced share count.All six of our global business units contributed positively to constant currency sales growth, powered in-part by our revitalized innovation efforts. On a constant currency basis, global growth and the Renal Care continues to be driven by increasing patient volumes for our peritoneal dialysis products. As expected, results in the quarter were negatively impacted due to the strategic exit of the U.S. in-center hemodialysis Bloodline's business.Performance was also impacted by a recall and certain manufacturing challenges at one of our facilities that produces Revaclear dialyzers used for hemodialysis. This is creating a temporary supply constraint as we have been selectively slowing down production lines at this facility to address this situation. However, Revaclear production is now ramping up and we expect to return to help their inventory levels over the next few months.We do expect to incur incremental costs in the second half of the year as we work to enhance our production capabilities at this facility. I also wanted to take a moment to discuss the recent Advancing American Kidney Health Initiative announced by the White House earlier this month.As proposed, it would have a transformative impact on the treatment of end-stage renal disease or ESRD in the U.S. This is part of an emerging trend taking shape in worldwide as payers, clinicians and patients increasingly embraced home PD as a frontline ESRD treatment option based on key economic therapeutic and lifestyle benefits.Baxter is the pioneer in global market leader in the home PD and we fully support this initiative to broaden the adoption of home dialysis across the United States. As noted in our release this morning, we anticipate capital investments of $500 million to significantly increase our production capacity and meet new patients’ needs in-line with proposed CMS models.These investments will be scaled to align with the patient and market dynamics across the innovation curve, increased demand would in turn help accelerate Renal Care growth and contribute positively to Baxter’s previously communicated financial estimates. We are working to model the anticipated impacts and expect to be in a better position to provide additional information about what this initiative means for Baxter once the role is potentially finalized it later this year.Moving along our medication delivery business, returned to solid constant currency growth globally. We’re now emerging from a challenging performance comparison to spike in demand for large volume IV solutions in the first half of 2018. Growth this quarter benefited from the continued uptake of our new infusion pumps, Spectrum IQ in the U.S., and Evo IQ in selected international markets and related disposables.Increased sales for Mini-Bag Plus in the U.S. and Large Volume IV Solutions internationally also contributed to the growth in the quarter. Mid-single-digit constant currency growth in our pharmaceuticals business was driven by increased demand for Baxter’s hospital pharmacy compounding services, the contribution from recent launches of injectable pharmaceuticals such as dexmed and the Baxter, a MetaBot business.This trend helped offset the expected impact of generic competition in the U.S. for Brevibloc and [cyclophosphamide and] [indiscernible] benefit from new product launches, including the recent approval of approval of Myxredlin, the first and only ready-to-use insulin for IV infusion in a hospital or acute care setting.Baxter's Clinical Nutrition business delivered low-single-digit sales growth globally on a constant currency basis. We’re continuing to rebuild momentum here supporting in-part by the launch of new products, including [OLIMEL N11], higher protein formulation and FINOMEL, our novel fish oil-based triple-chamber container. We’re also positioning for a U.S. launch of Clinolipid Baxter's proprietary olive oil-based lipid emulsion later this year. Advanced surgery delivered high-teens growth at constant currency rates. Performance in the quarter benefited from competitive supply constraints, which resulted in incremental demand for both FLOSEAL and RECOTHROM.Finally, acute therapy has posted high-single-digit constant currency growth, fueled in-part by the ongoing rollout of our PrisMax next-generation technology for CRRT and Therapeutic Plasma Exchange. PrisMax can be found in the intensive care units in more than 20 countries across Europe and Asia-Pacific. There are plans to bring additional markets on board through 2020.As all these highlights reflect, we’re continuing to see Baxter's renewed emphasis on innovation, gaining traction, and delivering results across our businesses. There is a great promise and potential ahead, fueled by our research and development pipeline, and strong balance sheet, and emerging opportunities. Most importantly, our employees, who are inspired and empowered by our mission to save and sustain lives. Our transformation is on track and we remain absolutely focused on delivering sustainable top quartile performance in service of patients, shareholders, and the rest of our broad stakeholder base.Now, I'll pass it on to Jay for a closer look at our financials and outlook.
Jay Saccaro:
Thanks, Joe, and good morning everyone. As Joe mentioned, our second quarter results reflect solid constant currency growth across each of our six business units, and further reinforce confidence in our full-year outlook. I’ll start by discussing our second quarter results before providing our updated financial outlook for 2019. Beginning with the second quarter, global sales of $2.8 billion were flat on a reported basis, and increased 4% on both a constant currency and operational basis, reflecting strength across our portfolio.On the bottom-line, adjusted earnings increased 16% to $0.89 per diluted share. This exceeded our guidance of $0.80 to $0.82 per diluted share, driven by topline performance, ongoing operational efficiencies, and a lower tax rate.Now, I’ll walk you through performance by our geographic segments in global businesses. Note, for this quarter, constant currency sales growth is equal to operational sales growth for all businesses and region segments except for our pharmaceuticals business and the Americas region for which we will provide operational growth in addition to constant currency growth.Starting first with sales growth for our three geographic segments. Sales in the Americas grew 1% on a constant currency basis and 2% operationally. Sales in EMEA grew 6% on a constant currency basis, and sales in our Asia-Pacific region advanced 9% on a constant currency basis.Moving to performance by global businesses. Global sales for Renal Care were $910 million advancing 3% on a constant currency basis. Performance in the quarter was driven by high-single-digit growth in PD therapies globally, partially offsetting this growth was the lower sales of select in-center HD products including the Bloodline's business exited earlier this year, which negatively impacted sales in the quarter by approximately $14 million.Renal Care sales growth in the quarter was also impacted by the recall and temporary supply constraints associated with the Revaclear dialyzer. The impact was less than $10 million in the quarter. Sales in medication delivery of $689 million grew 4% on a constant currency basis, representing a return to solid and balanced growth in both the U.S. and internationally. Performance in the quarter benefited from strength in infusion systems following the launch of Spectrum IQ and Evo IQ.International growth of large volume IV Solutions, particularly in Latin America and the continued momentum from Mini-Bag Plus. We are pleased with the sequential and year-over-year growth acceleration in our medication delivery business. Pharmaceutical sales were $539 million increasing 4% constant currency and 7% operationally.Strong international sales contributed to performance in the quarter, driven by the increased demand for our hospital pharmacy compounding services, generic injectables, including [Baxter MetaBot] and anesthesia products. This growth was partially offset by declines in our U.S. business, which are reflected approximately $40 million of lower U.S. sales of Brevibloc and cyclo, as compared to the prior year period. Sales in the U.S. were also impacted by lower sales of anesthesia and critical care products in the quarter.Moving to nutrition, total sales were $215 million, up 2% on a constant currency basis and reflect sequential improvement in both the U.S. and internationally. We expect sales to continue to ramp throughout 2019 as we worked to rebuild our U.S. business and capitalize on new product launches.Sales of $232 million in advanced surgery increased 17% on a constant currency basis. Strong global growth benefited from our ability to address competitive supply constraints in the hemostat market in the U.S. These supply dynamics contributed approximately 12 percentage points to growth in the quarter.Sales in our acute therapies business were $133 million, representing growth of 8% on a constant currency basis. Growth in this business is now normalized, after a difficult year-over-year comparison in the first quarter, and we continue to see growth globally driven by new product launches and demand for Baxter's CRRT therapies.Finally, sales in our other category, which primarily includes our contract manufacturing services were $122 million, a decrease of 9% on a constant currency basis, reflecting a challenging comparison to the prior year period.Moving through the rest of the P&L, our adjusted gross margin of 44.5% represents a 100-basis point decline compared to the prior year period as benefits from our manufacturing improvements and portfolio initiatives were more than offset by lower U.S. sales of Brevibloc and cyclo and a less favorable product mix.In addition, gross margin was negatively impacted by incremental expenses related to enhancing manufacturing capabilities at our dialyzer facility. Adjusted SG&A totaled $610 million, decreasing 5% on a reported basis, and 1% on a constant currency basis, reflecting the positive contributions from our targeted initiatives to improve operational efficiency. We continue to strategically invest in sales and marketing initiatives, while maintaining our focus on driving increased effectiveness in general and administrative expenses.Adjusted R&D spend in the quarter of $141 million decreased 14% on a reported basis and 10% on a constant currency basis versus the prior year period. We continue to see benefit from our efforts to enhance our processes and optimize our R&D organization, while prioritizing strategic investment in our innovation pipeline. Adjusted operating margin in the quarter was 18%, an increase of 90 basis points versus the prior year.Net interest expense totaled $20 million in the second quarter, an increase of $9 million, compared to the prior year, driven by lower interest income and increased interest expense resulting from higher average commercial paper borrowings during the quarter, and the issuance of our new 1.5 billion of Euro denominated debt. This debt was issued at an average coupon of 75 basis points, and an average duration of 7.5 years.Further income totaled $28 million in the quarter, driven by pension benefits and foreign exchange gains on balance sheet positions. The adjusted tax rate was 10.8% for the quarter, favorable to our expectations, primarily driven by a benefit resulting from a favorable tax ruling along with stock compensation deductions.And as previously mentioned, adjusted earnings of $0.89 per diluted share exceeded our guidance of $0.80 to $0.82 per share. Within the second quarter, we repurchased approximately $123 million or 2 million shares of Baxter stock, which was partially offset by option-related dilution within the quarter.With respect to cash flow, in the first half of 2019, free cash flow of $265 million was in-line with our expectations. In the second quarter, we drove sequential improvement in days inventory on hand and we continue to expect the cash conversion ramp in the second half of the year.Let me conclude my comments this morning by providing our guidance for the full-year 2019 and the third quarter. For the full-year 2019, we now expect reported growth of 1% to 2% globally and are approximately 4% sales growth on both a constant currency and operational basis.Moving to full-year guidance by business on a constant currency basis except where otherwise noted. In Renal Care, we now expect growth of approximately 2%. Strong growth for our PD therapies globally is expected to be partially offset by lower sales in in-center HD, due to strategic exits in our U.S. Bloodline's business, which negatively impacted Renal Care sales in 2019 by approximately $55 million.In addition, the impact of supply disruption from the Revaclear dialyzer is expected to negatively impact full-year sales by approximately $20 million. We expect to return to normal inventory level by the end of the year. In Medication Delivery, we continue to expect sales to increase approximately 6% with sequential improvement in the second half of the year.For our pharmaceuticals business, we now expect an increase of low single digits on a constant currency basis. U.S. cyclo sales are now expected to total approximately $125 million versus our previous assumption of $105 million, adjusting for U.S. cyclo, operational growth is now expected to increase mid-single digits. As a reminder, Brevibloc sales are included in operational growth and are expected to decline approximately $75 million in 2019.Moving to Clinical Nutrition, we continue to expect sales growth of approximately 3%. For our advanced surgery business, we now expect sales to increase high-single-digits given the strong performance year-to-date. Our guidance assumes that competitive supply constraints begin to ease in the third quarter. For the Acute Therapies business, we continue to expect growth of approximately 7% to 8%. Finally, in our other business, we continue to expect sales to decline low-to-mid single digits.Moving down to P&L, we continue to anticipate adjusted operating margin expansion of 80 basis points to 100 basis points with an additional savings in operational expenses being offset by the gross margin impact of mitigation efforts to return our dialyzer manufacturing plant to full capacity by year-end. The full-year estimate of these incremental expenses is expected to total approximately $50 million.We continue to expect net interest expense of approximately $65 million to $70 million, and we now expect adjusted other income of approximately $90 million for 2019. For the year, we now expect an average adjusted tax rate of approximately 16%, reflecting the favorability from Q2. We continue to anticipate a full-year diluted average share count of approximately 520 million shares. Based on these factors, we now expect 2019 adjusted earnings, excluding special items of $3.34 to $3.40 per diluted share.Finally, for the year, we continue to expect to generate operating cash flow of $2.3 billion and free cash flow of $1.6 billion. Specific to the third quarter of 2019, we expect sales growth of 3% to 4% on a reported basis, and approximately 5% on both a constant and in operational basis. We expect adjusted earnings, excluding special items of $0.82 to $0.84 per diluted share.With that, we can now open the call to Q&A.
Operator:
Thank you. [Operator Instructions] And our first question comes from David Lewis from Morgan Stanley. Your line is now open.
David Lewis:
Good morning. Joe, I thought your comments on ESRD are pretty clear. So, maybe I’ll focus on medication delivery and a quick one for Jay. Joe in Med Delivery, obviously you beat our number, there was a pretty significant momentum improvement, you are maintaining guidance. Can you just talk about how you’re feeling about market stability, new customer, new account penetration, and in fact the pump business as we head into the second half of the year and then a quick one for Jay?
Joe Almeida:
Good morning, David. The business as we had predicted had a really tough comp in the first quarter, but we had confidence in our ability to secure current customers that have been with us for many years. So, we have re-signed all GPO agreements and for the most part we have signed a great deal of [IDM agreements] as well. The market is stable. We found opportunities to gain new customers, not only in the acute care market, but also in the OEM or contract manufacturing business that is important to us, help us in our facilities, but also improve the visibility of Baxter product line across all sets of care.When it comes to pumps, we have a very healthy pipeline. There is always pluses and minuses, but I would say at the moment the pluses are winning free handily, the opportunities that we have. But I’d tell you the new management group that we have put in the U.S. has done an extraordinary job in understanding the pipeline and the creation of value. Our spectrum version 9 is a wonderful pump; it’s a really good device with the number one best in-class drug library. And that has been very important to us in terms of having this product showcased for our customers.So, the business as we predicted is healthy. We’re going to continue to make progress and this continues to be our source of investment for ourselves. Our new pump platform is coming along extremely well and we’re very comfortable with the launch time line for it.
David Lewis:
Okay, very clear. And then Jay, just thinking about a couple of items in the guidance in the back half of the year, I mean FLOSEAL was a benefit; to this particular quarter, I’m sort of curious, what your assumptions were for the back half of the year for FLOSEAL? And then with Myxredlin, maybe just talk little briefly about the size of the opportunity there for the company. I think we’ve talked about this product launch for a while. How big is that opportunity and what are the assumptions into the back half? Thanks so much.
Jay Saccaro:
Sure. With respect to our biosurgery business, yes, we did comment on some upside that we experienced in the second quarter. We don’t like to forecast competitor outages, so we don’t maintain long-term assumptions on that. However, if we have very clear visibility to a short-term situation emerging, we will reflect that in our guidance. So, as we think about advanced surgery, there is roughly two months of upside that we’re counting on in our numbers as we sit here today. So, we’ll expect that to continue for a couple of months. If it continues further than that, of course, we will be available to supply our customers, but we’re not counting on anything more than that.We’ve talked previously about how exciting the insulin-Myxredlin launch is. It’s a new presentation of our workforce product for hospitals absolutely thrilled, the size of the market is significant, it’s over a $100 million market, I mean hospitals in the U.S. So, this represents a very viable long-term opportunity for us. As it relates to this year’s guidance, we have single digit millions built-in basically nothing built into our guidance at this point. In large part, we want to be cautious in terms of launch timing, preparing, and having adequate supply available when we actually go to market. So, no meaningful impact this year, but stay tuned as we give guidance for 2020. This will have a more meaningful impact in those numbers.
David Lewis:
Thanks so much, nice quarter.
Jay Saccaro:
Thank you.
Operator:
Thank you. And our next question comes for Robbie Marcus from JPMorgan. Your line is now open.
Robbie Marcus:
Great, and gain congrats on a nice quarter here. Jay, two questions for you. First, maybe we could start on the [P&L performance], really impressive how you were able to offset some of the lower gross margin product strength in the quarter with lower R&D and SG&A, but with R&D taking such a hit and SG&A coming down so rapidly, maybe you could just give us some insight into where that’s coming from, is it more a general efficiency in overhead or you holding back on some projects for the future?
Jay Saccaro:
Sure. Just with respect to gross margins, to your comment, gross margin did come in a little bit below our expectations. Really, there were just a few drives of that. Some of it related to business mix as you pointed out. We had very strong performance in our drug compounding business, but that carries a much lower margin in the corporate average. Now interestingly enough about this business, it is a very high return on invested capital business for us, but the gross margin is lower. So, the fact we overachieved that business cost us about 30 basis points to our gross margin, and then addressing some of the dialyzer manufacturing issues, that’s roughly a 20-basis point impact in the quarter.So, those were two of the more prominent items impacting gross margin for us. Of course, there were always other bits and bytes, but we were able to offset that with continued focus on spending. So, on the SG&A side, we are very focused on improving the efficiency of our back-office operations along with judiciously spending every single dollar. So, we’ve talked in the past about the zero-based spending approach that we have here disciplined around all spending categories along with really thinking creatively about how we organize the back office. That continues to pay dividends today, paying dividends in the quarter, you saw a decline of SG&A of 1%, and again this is on the back of three or four years of continued improvements in this particular area. So, a great performance on the SG&A line.R&D is a little bit different. Some of this relates to timing, some of it relates to the fact that we’ve been able to get after some of the infrastructure cost in R&D faster than accelerations in certain areas and new product spending. And so, we will see some R&D tickup in the second half of the year. What I will tell you is, our overarching principle on R&D is, we want to invest to grow and we are funding programs for success, we are not holding back on any dollars. And I think the press release, Joe’s comments about this spirit of innovation at the company is evident of that philosophy in action. Having said that, we did see savings in this particular area, so stay tuned to the back half. Joe, you want to add to that?
Joe Almeida:
Yes, sure. Robbie, the whole thing about R&D was for us to create efficiency in the R&D line and the spending has not been very different than if you go back to 2016; it’s just a mix, where are we spending and how we are spending the money? So, we abandon large programs that had absolutely no return investment and we invest in significant opportunities in areas of medication delivery, acute Renal Care with our point of care in PD, as well as have some very quick turnaround new products in advanced surgery, some in the nutrition area. So, if you think about, we also have significant arbitrage in labor, because we created centers of excellence across the globe, but also, now we have a very large center in Bangalore, India we never had. So, it is well managed group.Our heads of R&D, led by our GPO leaders and Sumant Ramachandra who has overarching responsibility for the function have been very successful in reallocation of cost. I want to just tell investors, that we’re very focused in innovation and that fluctuation in spending is nothing other than being efficient and timings of the investments, nothing to do with us going and tightening the belt in R&D programs.
Robbie Marcus:
Very clear, and if I could sneak one more in. Just on capital deployment, not surprised that we haven’t seen any M&A here with MedTech valuations where they are, but how are you balancing your capital allocation plans here with Baxter share price at highs and MedTech valuations where they are? Thanks.
Jay Saccaro:
Robbie, it has been a very, very busy first half analyzing opportunities. The way we have allocated capital inorganically is not very different than how we allocate organically. We do have focus in area of monitoring in the areas of acute Renal Care and critical care. We also are very focused in looking at individual molecules. So, what I’m going to say to our investors is, think about Baxter adding value with the small tuck-ins as we look for the right opportunity and valuation for a larger deal. It is very, very rich, right now the market is frothy and we are not going to compromise on the returns of this acquisition.Every acquisition has, they larger they get, the inherent risk is enormous and we all understand that, we all take risk, but there is a point where the cost of investing in that asset and the price valuations are so [out of whack] that you cannot make internal rate of return of low single digits, it doesn’t work, it doesn’t work. And then if anything goes wrong, the FDA comes about and tells that a product that you have has a compound that is made into the product that doesn’t work, now your whole evaluation of that target is under scrutiny, you’ve got to be very careful with this and understand your target.I think Baxter is surprising to our investors. How much opportunity there was and there is and there will be in our base businesses and how we have the opportunity to innovate and continue to maintain number one position in most of our businesses and watch us in the pump business, watch us there because we are coming out with a great platform of pumps and monitoring devices. So, the thing is, let add to those inorganically as tuck-ins, let’s not think about all the time this huge capital investment in allocation into assets that are overly expensive. And I tell you something else, we will continue to acquire our shares prudently, while we see the prices are there, because we are not going to sit on cash as I said to you, cash is not going to burn a hole in our pocket.
Robbie Marcus:
Thank you.
Operator:
Thank you. And our next question comes from Bob Hopkins from Bank of America. Your line is now open.
Bob Hopkins:
Thank you and good morning.
Joe Almeida:
Good morning.
Bob Hopkins:
Wanted to start with a big picture question, Joe, obviously you put up a very solid Q2, sounds like the pipeline is making good progress, obviously also during the quarter you got some nice new, sort of structural tailwinds in some of your business. As you kind of think about all these factors and put them together, do they sort of suggest some upward pressure to your long-range plan from a revenue growth perspective or are they just nice offsets to other headwinds? Just trying to get a sense for the sort of cumulative effect of all these things that are going on right now.
Joe Almeida:
Well, if you think about our long-range plan, when you give a five-year plan, you always going to have put and takes and how you are going to make things happen, okay. You have the best intentions in the world, you have the best plans in the world, not everything works same way on the positive side or negative side. For instance, we didn’t plan to have our insulin product premixed approved as early as we did, we planned actually to have that approval towards the end of the year. That’s a plus for us, but other things worked the other way as well. So, when I look at the major forces that we have going on right now, you have a tremendous momentum in our peritoneal dialysis business. So, you know, just in terms of patient growth, we are experiencing a healthy growth in terms of patient.We don’t even have the executive order from the White House coming in and becoming a rule and there will be a transformation for the renal business, but just that, we experienced high-single-digit growth in patients in PD. So, that has an effect to our plan to offset many, many negatives that can appear in the future. So, I figured this moment that between everything that is happening in the market and the things that happened in Baxter that we can sit here and say well, we told you last year, we reconfirmed today, okay.
Bob Hopkins:
Okay. That sounds fair. But maybe as my second question, I’ll just ask a follow-up to that. I understand the philosophy, but it does seem like there is your philosophy in providing your guidance, but it does seem like, since you gave that guidance, most of the incremental news flow that you have been getting to your business is positives. I mean, I just want to make sure I’m not missing anything. When we think long-term are there other negatives that have popped up that would make you hesitant on this issue, relative to some of these very incrementally positive pieces of news that you’ve gotten over the course of the last couple of months.
Jay Saccaro:
Remember the last time we gave guidance, the dynamic in the Medication Delivery business shifted quite a bit, and we’ve been able to reconfirm our long-term expectations despite that shift as a result of strength in many different areas in the portfolio and general buoyancy of the new product pipeline along with great product progress in areas like PD and successful adoption there. So, I think it’s too early to start changing LRP’s at this point. We will consider doing that at some point in the future, but on balance we were very pleased with the quarter. We were pleased with the signs of operational strength along with some of the longer-term good pieces of news that we’ve been able to either de-risk or add to the story.
Bob Hopkins:
Great. Thanks very much.
Operator:
Thank you. And our next question comes from Joanne Wuensch from BMO Capital Market. Your line is now open.
Joanne Wuensch:
Good morning everybody and very nice quarter. I want to spend a couple more minutes on the renal business and this is sort of a two-part question. The first part is, you’ve been sort of huddling a headwind as you’ve exited the in-center HD business, at what stage does that annualize, we don’t see that anymore? And then the second part is, your 500 million investment, can you just parse that a little bit, what do you think the benefit will be? And then I would assume there is some level of pressure on gross margins, how we can think about that over time? Thank you.
Jay Saccaro:
Sure. I’ll make the comments on the Bloodlines and then Joe maybe you can comment on the excitement around the investment. With respect to the bloodlines, that’s just one component of HD business in the U.S. We do have other as product that we sell in the U.S., but that particular one was a product that we distributed and it was a very low margin business. It was a $55 million impact roughly for this year, and by the end of this year we will be done and it will be ceased to be a headwind the end of this year. As we related to the investment, Joe, you want to make some comments about that?
Joe Almeida:
Sure. We have to the best of our ability scoped our project. Based on the interpretation of the executive order that we have, okay. And that is not final rule yet, and the comments will be complete in about 50 days, and after that the HHS has time to put the rule in place. So, based on what we know and interpreted from the executive order, we have a three-phase investment here. We have an investment where we can supply the market with the growth studies projected in the beginning, because this is the progress, remember this addresses the best market about 50% of the overall served market and then from that 50% there is a ramp, there is a period where clinics are given an opportunity to change their patterns between clinic, hemodialysis, and home therapy.So, based on that we can accommodate with some supply chain that we did extremely well about a year-and-a-half ago by relocating and reregistering products from all over the Americas so we can do that. Then there is a second phase where we do a small investment, more modest than – part of the 500, they give us incremental capacity all the way [indiscernible] starting to invest into a new plant. The investment will be, depends upon the time, sometimes concurrently done, but the effect of the throughput will be felt later – in later years. Remember, this is a seven-year program. So, we feel, as company, our responsibility, moral responsibility to our customers and more so to the patients is to be there for this opportunity. So, we’re going to make everything possible to not be a problem during the ramp up that is so aggressively laid out in the executive order.
Joanne Wuensch:
Thank you.
Joe Almeida:
Thanks, Joanne.
Operator:
Thank you. And our next question comes from Vijay Kumar from Evercore ISI. Your line is now open.
Vijay Kumar:
Congrats on the nice piece here, Joe and Jay. Jay, maybe on the 3Q EPS, if I just look at the OpEx rate, the last two years, EPS has grown sequentially, revenues are accelerating in the back half, sequentially I'm not sure why EPS would be down because it looks like the dialyzer impact on gross margins was felt in 2Q, so maybe can you just walk through that EPS math and maybe some timing element on expense here, which would be impacting 3Q?
Jay Saccaro:
Sure. As we look at the Q2 to Q3 story, there are a couple of factors to keep in mind. One is the dialyzers impacted us about $0.01 in Q2, but as we moved to Q3, that will ramp up a little bit somewhere between $0.02 and $0.03 of impact. The second prominent driver relates to tax rate. We’ll see a really substantial uptick in tax from Q2 to Q3, that’s somewhere around $0.08 or $0.09. So, it really does match some of the strong operational performance.Now, I have to say hats off to the tax team for great work in terms of optimizing the tax rate and allowing us to capitalize on opportunities that emerge and really think about how we organize our operations effectively in a tax efficient manner. So, we saw a benefit in Q1 and Q2, but we don’t expect to see that in Q3 and Q4 to the same extent. So, the tax rate in the third and fourth quarter kicks up to roughly [19-ish percent] from the [12-ish percent] that we’ve had year-to-date. So, that’s really the – those are some of the primary drivers. We’ll see continued operational strength that helps support and offset those items, but that really is the big – those are the big drivers as we move from Q2 to Q3.
Vijay Kumar:
That’s really helpful, Jay. And one quick – on Pharma, I mean Brevibloc was about 700 basis points to 800 basis points impact to revenues first half and despite that you guys did a phenomenal in Pharma rates. And as those headwinds go away in the back half, I'm just curious why, you know, perhaps Pharma couldn’t come in better?
Joe Almeida:
As we look at the pharmaceuticals business to your point, we’ve had a very solid performance in the first half of the year, and a lot of that was driven by great performance in our compounding business outside the U.S. We do expect that – and that business grew in the first half of the year in 20%, very significant. As we move to Q3 and Q4, we don't expect to see that level of accelerated performance in the back half, so that really is the primary driver that takes the former growth rate down.But I will tell you, we’re very pleased with the performance in this area. It's been a great source of over achievement for us and steady growth and, you know, with things like Myxredlin on the horizon, which will benefit future years, along with some of the premixed injectables and the Claris portfolio, which has been selling well here in the U.S. Overall, you know, this has been a very solid performer for us.
Vijay Kumar:
Thank you, guys.
Jay Saccaro:
Thanks, Vijay.
Operator:
And our next question comes from Lawrence Biegelsen of Wells Fargo. Your line is now open.
Lawrence Biegelsen:
Good morning. Thanks for taking the question. Just one on infusion system and one on Asia-Pacific, so Joe, one of your competitors have had some issues with their pump and infusion sets, do you see an opportunity for Baxter to take some share here? And with a new pump platform coming out in 2020, are customers extending the selling cycle to wait for the new platform? And I have one follow-up.
Joe Almeida:
Larry, the opportunities that we’re having are mostly, mostly related to the strength of our version 9 of our pump. Its operability, it’s our drug library, so we have customers who have been our customers for a long time and start with them to renew their like – innovation and evolution of the product and they just buy it. There's always opportunity when there is a problem with a competitor in the market. If that problem is perceived to be more permanent than temporary, so we need to think about, as we look at our Advanced Surgery business, that is going to be a – probably a temporary gain until the competitor comes back on the market, and because our product is so good, the FLOSEAL is the best product on the market.There is opportunity to retake ups, right? So, the same applies for the infusion pumps. You know it depends upon how permanent, how temporary the issue is that competitors are having. But I think the success that we’ve been having is, first of all, a very good sales effort, new team completely focused on pipeline, second is the ability to demonstrate the technical superiority of our drug library, compared to the competitors. To your point on the new platform, no, there are customers who need the product now, they will take the product now.I just want to let you know that LVP, which is a large volume parenterals pump, which is what we have to-date, remember we don't have any other pump, that’s what we have today, the guts of the new pump, all are different, are more modern and will be a horizontal pump. But, but work flow, the drug library, all the features are the same, meaning you have a new product with phenomenal operability, but also has a great pumping mechanism in the new pump platform. We have a great pump mechanism today, Version 9, and the operability is the sane, so the customers have a lot to gain Baxter launches the other pumps, which are part of the same family, with the same interoperability.So, it will be a new platform on the market that has that capability and I think that customers can see that going forward. If they need the pump now, there’s nothing that they are losing on this current version versus the new platform for the large volume parenterals, but what we will bring into the market is not only syringe – patient, patient-controlled [indiscernible] PCA as well as in 12 months from the launch of their first one is ambulatory. So, I hope this answers the answer to your question and put our investor at easy that there is no business being postponed because we don't have the NTP today.
Lawrence Biegelsen:
Very helpful, Joe. And just lastly, Asia-Pacific has been very strong. What’s driving that and how sustainable is that? Thanks for taking the questions.
Jay Saccaro:
Great. We’re really pleased with the performance in the Asia-Pacific region, 9% growth coming – it was really strength across the board. You know we’ve grown a custom to solid performance coming from China in the quarter, you know, 7% plus growth from that particular business. But what perhaps has been more surprising based on historical commentary from Baxter is the fact that we had a tremendous performance in Japan, high single-digit growth coming from our Japanese business, and it’s really a combination of factors in play.Looking at the other areas, you know, solid performance in Southeast Asia, we’ve had a great business in Australia and New Zealand for the med. We’ve been there for many, many years, double-digit growth there, a lot of that benefiting from compounding. But what I will tell you is this is a combination of commercial execution along with the benefits of new product launches. We’ve talked quite a bit about the impact of Kaguya. We are seeing continued momentum in patient gains in Japan and this is, you know that’s a great driver for us. But I think across the region, there is examples of innovation, but like I said, commercial excellence that have really contributed to this performance. On a full-year basis, we’ll expect this to come down a little bit from a growth rate standpoint, but not materially. So, overall, you know, great performance from the team in Asia.
Lawrence Biegelsen:
Thank you very much.
Operator:
Thank you. And our next question comes from Kristen Stewart from Barclays. Your line is now open.
Kristen Stewart:
Hi, and thanks so much for the question and congrats on a good quarter. I was wondering if you could just provide us with an update on the Pharmaceutical business and some of the legacy Claris manufacturing, FDA warning letters, how you’re feeling about that, and how there maybe opportunities to deal with that? Thanks.
Joe Almeida:
Hi, good morning. Our Pharmaceutical business is – our strategy is starting to take shape. It took a little bit. We have built a second-to-none formulation team between India and Northern Illinois, very talented vis-a-vis now our partnership to launch the insulin product, that's Med, and this is just the beginning of our very long pipeline. When it comes to Claris, or what we call [Baxter Metabot] we are doing everything that we have spoken to the FDA and have told the FDA we’re going to do. It’s up to the FDA to lift or to inspect us again, and provide us with their feedback, okay. But nevertheless, we are de-risking any Claris opportunity for future by having ultimate supplies for almost everything that we make there. And also, for the future molecules, we are de-risking that by going to CMOs instead and having Claris possibly as a backup in the future.There is one molecule that I won’t read – speak about, the name of the molecule, but that molecule we're developing in [Metabot], but also, we’re going to have a pilot operation in our Illinois facilities, so we can have possibly a backup. This is more of a longer term. So, we’re doing not only everything that we told the FDA we’re going to do remediate the one letter that was given to us the day that we bought the company, but also, we are doing everything we can to de-risk any future revenue stream. Now, the performance of the business is doing very well, its double-digit growth. That business is resilient, is doing well and is not only U.S., but is also in Europe, that is doing well. So, this is the state of our Pharmaceutical business.
Kristen Stewart:
And just as a follow-up, do you still anticipate that you may be able to move beyond the warning letter issues next year, I think that's what you’ve said before, and do some of the actions that you're taking, what will be kind of the P&L impact of that? Could that put a little bit more pressure on the margin side for 2020? Thanks.
Joe Almeida:
We have done a couple of things. We accelerated the development and placed the molecules from the future that we think in any case we’ll be able to offset any negatives that will come out of a potential and I cannot actually rate likely or unlikely because I’m not the FDA. So right now, our plans are for 2021. If it happens, if we get the clearance and can commercialize products that are new on [file] from the plant, it will be great. We’ll follow our plan. If that has any postponement for whatever reason, we have backup plans that will probably not alter the trajectory of that business.
Kristen Stewart:
Thank you very much.
Joe Almeida:
So, there is upside is that happens, if we are successful in 2021.
Clare Trachtman:
Candace, we have time for one more question.
Operator:
Thank you. And our final question comes from the line of Matt Taylor from UBS. Your line is now open.
Matt Taylor:
Hi, good morning, and thank you for taking the question. I wanted to follow up on a couple things in the renal business. So, I guess first, Joe or Jay, you’re talking about the investments that you’re planning, you know, according to the model that could come out. I guess I was wondering if you could share with us some insight into those plans in terms of the scale that you are currently planning for, meaning if you do invest that $500 million. Could you help us understand what number of additional patients or dollars that would allow you to address? And just give us a little more of the roadmap?
Joe Almeida:
Matt, you think about this. If you read the executive order, is the significant amount of interpretations and things that buried in and that's why they have the comment and that’s why the rule is not there yet. But think about this today, we are 12% penetrated in PD in the United States. Remember this is our home, there’s three pillars to it. Two of them are interconnected, which is a transplantation process and number of available kidneys to be transplanted with a lot of incentives not only – in terms of healthcare insurance for donors and things like that all way to moving from the clinic to the home, two different modalities from human dialysis and PD. Baxter is a leader with close to 70% of the market share in PD on a global basis in U.S. around the same number, okay.So, if its 12% in the U.S. and there's a 50% population that is being targeted for demonstrating, if you look at the targets of the government, it’s not inconceivable to think about double patients just in the period of demonstration within the seven years of the demonstration period. So, it tells you that you would double the incident patients, not the prevalent, but the incident patients going forward. That’s how we have done some of our analysis, but our plans are flexible, so we can flex up the investment if we need to or flex down the investment because it’s progressive.There is Phase 1 with no investment, Phase 2 with some investment, Phase 3, which is to build a new plant, all of them will launch very similarly in time because they have different lead times for execution. But those are designed to support the program as it was designed, but as I said to you, if this rule comes out in November, we will have the ability to adjust our plans, but right now, we want to ensure that the government knows, our investor knows, our patients and customer know that we are committed to the program and we’ll do everything possible to help patients get the therapy that they deserve and for us as a company to grow in this sector, which is so important and has been so underestimated and underpenetrated for so many years, not only in the US, but across the globe.
Matt Taylor:
Thank you. If I could just sneak in one follow-up, you mentioned that lot of the data you presented on Theranova and I was wondering if you have any updated thoughts about giving some differential reimbursement for that product?
Joe Almeida:
Well, we are here waiting for decision from – actually not from HHS, but probably from between the HHS and the scoring process that happens at the budget office. So, we know as much as you do, but we are excited about the possibility and we have several different avenues to get Theranova in the U.S. Most importantly, we have agreed with the FDA on the novel process and this challenge that we have at our plant in the US will be timely resolved, and the plant – one of the issues that we had with the plant, we tried to ramp up the plat too fast because our dialysis volume went up between two different forecast, and when we tried to do the ramp up, we encountered some issues because the plant was underutilized at that moment. But with this, no, not all bad, few things good come out of it, and one of them is that we’re going to be fully staffed and equipped on our order lines plant in Opelika to be able to have the ability to produce Theranova when it’s needed.
Matt Taylor:
Thank you very much.
Joe Almeida:
Thanks, Matt.
Jay Saccaro:
Thanks, Matt.
Operator:
Thank you. And that concludes our question-and-answer session. Ladies and gentlemen, this concludes today's conference with Baxter International. Thank you all for participating. Everyone, have a great day.
Operator:
Good morning, ladies and gentlemen and welcome to Baxter International's First Quarter 2019 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candace. Good morning, and welcome to our first quarter 2019 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's first quarter 2019 financial results and our updated financial outlook for full year 2019. A supplemental presentation to complement this morning's discussion can be accessed on our website. This presentation, along with related non-GAAP reconciliations, can also be accessed on Baxter's external website in the Investors section under Events & News. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development and regulatory matters contain forward-looking statements that involve risks and uncertainties and, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and is available on our website. On the call this morning, we will be discussing operational sales growth, which adjust for the impact of foreign exchange and generic competition for cyclophosphamide in the U.S. With that, I'd now like to turn the call over to Joe. Joe?
José Almeida:
Good morning and thank you for joining us. We are pleased to share our first quarter results with you today and to discuss our updated expectations for 2019. I will begin with a quick review of our performance in the quarter and Jay will then provide more detail on the financials. We will wrap up with Q&A. Baxter opened 2019 with a solid first quarter, delivering sales growth of 2% on both a constant currency and operational basis representing the high-end of our projections. Reported sales declined 2% with foreign exchange negatively impacting sales by approximately 400 basis points in the quarter. On the bottom-line, adjusted earnings per share were $0.76 advancing 9% year-over-year. Growth was driven by top-line sales performance, operational efficiency initiatives, a lower tax rate and a reduced share count. The breadth and essential nature of our portfolio reinforce Baxter’s underlying stability even in the dynamic healthcare landscape. First quarter results benefited from positive performance across our Renal Care, Pharmaceuticals, Advanced Surgery and Acute Therapies businesses supplemented by increased demand for Baxter’s cytotoxic contract manufacturing services. This strength helped offset the sales declines in our Medication Delivery and Nutrition businesses in the quarter as expected. Renal Care continued to perform well and maintain underlying momentum globally. Negative growth in U.S. as expected was due to our strategic exit of the in-center hemo dialysis bloodline business. Demand for our peritoneal dialysis therapies remains strong with patient volumes increasing high-single-digits in the U.S. in mid-single-digits globally. The continuing rollout of our new PD cycles are Amia in North America, Kaguya in Japan and CLARIA in Europe is helping to build this growth. Pharmaceutical delivered a strong mid-single-digit growth globally on a constant currency basis despite announced favorable comparisons from increasing west generic competition for cyclophosphamide and Brevibloc. The strength in this Pharmaceuticals business reflected positive contribution of the Claris Injectables portfolio and our steady launch of new molecules including the recent launches of two pre-mixes in the U.S. Dexmed and epti increased demand for Baxter’s hospital pharmacy component services as well as growth in our anesthesia business also contributed to growth in the quarter. Double-digit constant currency growth in advanced surgery was driven by the U.S. which benefited from last year’s acquisition of RECOTHROM and PREVELEAK. We are continuing to enhance our hemostatic product-line in response to customer needs most recently with the FDA approval of a next-generation faster prep configuration for Floseal. This make it even easier and quicker to employ our leading hemostatic in the operating room and our acute therapies business delivered solid mid-single-digit constant currency growth globally. Recall last year this business benefited from an intense flu season creating the difficult year-over-year comparison. We continue to see strong trajectory here with the launch of our next-generation PrisMAX technology gaining traction in the ICUs in Europe and is up Q1 Asia Pacific as well. This quarter, Baxter and NantHealth also announced that a digital health solution is now available to connect Prismaflex with hospital’s EMR systems. This represents a key enhancement in our digital care portfolio. In addition, a new collaboration with bioMérieux, is focused on identifying biomarkers to diagnose acute kidney injury earlier reflecting our strategies to broaden our impact across the continuum of care. The growth in this businesses was partially offset by the anticipated decline in our Medication Delivery and Nutrition businesses. This past quarter, Medication delivered basic challenging comparisons corresponding to 2018. You will recall that the demand for U.S. large volume IV solutions spiked in the first half of the last year. This was due to hospitals and distributors stocking up in response to industry-wide supply challenges, owing Hurricane Maria, as well as the intense flu season. Performance in this business is expected to improve sequentially over the course of 2019 driven impart by our ongoing recapture and of course original volume per – and the continued uptake of our new pump platform Spectrum IQ in North America and Evo IQ in selected international markets. And as I have mentioned previously, we are rebasing our Nutrition business in the U.S. The upcoming launch of Clinolipid marks our first U.S. launch in our Nutrition business in over a decade and will be an important milestone in our efforts to reactivate growth. Our employee base remains highly engaged and focused on delivery innovation and improves patient outcomes, enhanced safety, facilities to ship of care to the home setting and increases the ready access to generics including drugs in short supply. This will allow us to address many of the present issues facing hospitals today as they look for opportunities to further reduce the – for medication error and decrease costs. In sum, we are encouraged by the underlying strength of the quarter. Our results are built on a combination of enhanced operation efficiencies and in revitalized innovation pipeline as we are well positioned for growth acceleration. Before I pass it over to Jay, I want to provide a quick update on our quality efforts. As you know, we have been operating since 2013 with an FDA warning letter in place for our North Cove, North Carolina and Jayuya, Puerto Rico manufacturing plants. This week we received notice from the FDA has now classified our Jayuya site as Voluntary Action Indicated or VAI. We are pleased with this development which we believe reflects our steadfast commitment to quality of Baxter and acknowledges progress in our efforts to help ensure reliable product supply for our customers. Now, I will pass it to Jay to provide more details on our financial performance and outlook.
James Saccaro:
Thanks, Joe and good morning, everyone. As Joe mentioned, our first quarter results which exceeded our expectations, position us well for accelerating growth throughout the year. I will start by discussing our first quarter results before providing our updated financial outlook for 2019. Beginning with the first quarter, global sales of $2.6 billion decreased 2% on a reported basis but increased 2% on both a constant currency and operational basis reflecting global strength across several of our businesses. On the bottom-line, adjusted earnings increased 9% to $0.76 per diluted share. This exceeded our guidance of $0.66 to $0.68 per share driven by solid operational performance, phasing of certain R&D investments and a lower tax rate. Now, I’ll walk to you through performance by our geographic segments and global businesses. Note, for this quarter, constant currency growth is equal to operational sales growth for all businesses and segments except for our Pharmaceuticals business and the Americas region for which we will provide operational growth in addition to constant currency growth. Starting first with sales growth for our three geographic segments. Sales in the Americas declined 1% on a constant currency basis and were flat operationally. Sales in Europe, Middle East and Africa grew 4% on a constant currency basis and sales in our Asia Pacific region advanced 7% on a constant currency basis. Moving on to performance by global businesses, global sales for Renal Care were $851 million, advancing 3% on a constant currency basis. Performance in the quarter was driven by continued momentum for PD therapies, partially offset by lower sales in the U.S. for select in-center HD products including the recently exited Bloodline business. Adjusting for this impact, underlying growth in the Renal Care business was approximately 6% in the U.S. and 5% globally. Sales in Medication Delivery is $634 million, declined 4% on a constant currency basis in line with our expectation. We are on track with our recapture efforts related to small volume parenterals as our teams continued to reinforce to our customers the safety and efficiency of our SVTs for drug reconstitution. Finally, we are pleased with the market response to both our Spectrum IQ and Evo IQ infusion pumps. As Joe mentioned, we expect growth to accelerate in this business over the course of the year as we anniversary the 1H 2018 stocking impact, executing on SVT recapture efforts, capitalize on our new pump launches and improve product availability internationally. Pharmaceutical sales were $509 million, increasing 6% in constant currency and 9% operationally. Contributing to performance in the quarter were strength in our international hospital pharmacy compounding business, increasing demand for anesthesia and critical care products and robust sales of generic injectable drugs which benefited from the new product launches Joe discussed earlier. Pharmaceutical growth in the quarter was partially offset by approximately $40 million of lower U.S. sales of Brevibloc and Cyclo as compared to the prior year period. Moving to Nutrition, total sales were $205 million, down 5% on a constant currency basis. We continued to focus on returning to positive growth in the U.S. and are gaining traction with our recapture efforts. International sales also declined in the quarter, primarily driven by the phasing of some orders in Asia Pacific and EMEA which shifted from Q1 to later in the year. We remained focused on enhancing performance for our global nutrition business through improved execution and innovation including the introduction of new products for both U.S. and international markets. We expect sequential improvement in growth rates for our nutrition business throughout 2019. Sales of $198 million in Advanced Surgery increased 12% on a constant currency basis. Growth in the quarter was driven by increased sales of hemostats and sealants including a contribution from RECOTHROM and PREVELEAK of approximately $17 million in the quarter. The acquisition of these assets from Mallinckrodt has allowed us to broaden our portfolio of hemostats and sealants, so we can offer surgeons more choices. Sales in our Acute Therapies business were $128 million representing growth of 4% on a constant currency basis. As Joe mentioned, this business faced a challenging year-over-year comparison as Q1 2018 benefited by approximately $11 million due to flu-related sales in the quarter. Adjusting for this impact, growth in our acute business remains strong driven by new product launches, continued focus on geographic expansion, and our clinical education efforts demonstrating the benefits of CRRC for the treatment of chemodynamically unstable AKI patients. Finally, sales in our other category, which primarily includes our contract manufacturing services were $107 million, an increase of 8% on a constant currency basis. Performance in the quarter was primarily driven by increased demand for our cytotoxic contract manufacturing services, and reflects an easier comparison to the prior year period. Moving to the rest of the P&L, our adjusted gross margin of 43.7% declined slightly as compared to the prior year period, as the benefits from manufacturing improvements and portfolio optimization initiatives were more than offset by the lower U.S. sales of Cyclo and Brevibloc and a less favorable product mix. Adjusted SG&A totaled $587 million, flat with prior year on a reported basis and increasing 4% on a constant currency basis. The positive contribution from our targeted initiatives to improve operational efficiency were partially offset by the loss of approximately $7 million and transition service income received from Shire in 2018. In addition, as we continue to ramp up our efforts on accelerating innovation, we are making select investments in sales and marketing to help ensure successful commercial execution of new product launches. Adjusted R&D spending in the quarter of $140 million decreased 17% on a reported basis and 13% on a constant currency basis versus the prior year period. R&D expenses in the quarter were impacted by the timing of certain project-related spend, which is expected to pick up beginning in the second quarter. We continue to prioritize strategic investments in our innovation pipeline and the phasing of this spend does not materially impacts any of our timeline related to new product launches. Adjusted operating margin in the quarter was $17.1%, an increase of 40 basis points versus the prior year. Net interest expense totaled $18 million $18 million in the first quarter, an increase of $6 million compared to the prior year, driven by lower interest income and an increase in commercial paper balances in the quarter. Adjusted other income totaled $25 million in the quarter, driven by pension benefits and a gain on an equity investment, as well as foreign exchange gains on balance sheet position. The adjusted tax rate was 12.7% for the quarter, favorable to our expectations, primarily driven by a benefit of $34 million related to stock compensation deduction as compared to $13 million in deductions to previous year, and as previously mentioned, adjusted earnings of $0.76 per diluted share exceeded our guidance of $0.66 to $0.68 per share. Within the first quarter, we repurchased approximately $600 million or 8 million shares of Baxter’s stock which was partially offset by option related dilution in the quarter. Before turning to the 2019 outlook, I will provide some commentary regarding cash flow performance in the first quarter free cash flow of negative $50 million was in line with our expectations due largely to normal seasonality of the business. We do expect improvement throughout the year, or particularly with respect to the days inventory on hand. Let me conclude by comment this morning by providing our guidance for the full year 2019 and the second quarter. For the full year 2019, we continue to expect flat to 1% reported sales growth globally, 2% to 3% constant currency growth and 3% to 4% operational growth. Moving to full year guidance by business on a constant currency basis, except where otherwise noted, in Renal Care, we continue to expect growth of 2% to 3% with ongoing momentum in PD, being partially offset by lower sales in U.S. in-center HD. As a reminder, the strategic exit made in this business are expected to negatively impact Renal Care sales in 2019 by approximately $55 million. In Medication Delivery, we continue to expect sales to increase approximately 6% with sequential improvement due to the drivers referenced earlier. For our Pharmaceuticals business, we now expect a decline of low-single-digits on a constant currency basis. U.S. Cyclo sales are now expected to total approximately $105 million versus our previous assumption of $95 million. Adjusting for U.S. Cyclo, operational growth is expected to increase low-single-digits. As a reminder, Brevibloc sales are included in operational growth and are expected to decline approximately $75 million in 2019. Moving to Clinical Nutrition, we continue to expect sales growth of approximately 3%. For our Advanced Surgery business, we continue to expect sales to increase 3% to 4% on a constant currency basis. For the Acute Therapies business, we continue to expect growth of approximately 7% to 8%. Finally, in our other business, we now expect sales to decline low to mid-single-digits. Moving down to P&L, we now anticipate adjusted operating margin expansion of 80 to 100 basis points. We now expect net interest expense of approximately $65 million to $70 million and adjusted other income of approximately $85 million for 2019. For the year, we now expect an adjusted tax rate of approximately 17% reflecting the favorability from Q1. We now anticipate a slightly higher full year diluted average share count of approximately 520 million shares driven by increased option exercises in the first quarter. Based on these factors, we now expect 2019 adjusted earnings excluding special items. $3.27 to $3.35 per diluted share. This reflects the benefit of our first quarter over-achievement as well as the anticipated shift in R&D investments to future quarters. Finally, for the year, we continue to expect to generate operating cash flow of $2.3 billion, and free cash flow of $1.6 billion. Specific to the second quarter of 2019, we expect sales to decline approximately 2% on a reported basis, growth of approximately 2% on a constant currency basis and growth of 2% to 3% on an operational basis and we expect adjusted earnings excluding special items of $0.80 to $0.82 per diluted share. With that, we can now open up the call to Q&A.
Operator:
[Operator Instructions] And our first question comes from Robbie Marcus of JPMorgan. Your line is now open.
Robbie Marcus:
Great and thanks for taking the question. There is obviously a lot of investor focus on Medication Delivery and Nutrition. But we are also seeing really good results out of Pharma. So, maybe you could just spend a minute and discuss some of the puts and takes in the quarter in Medication Delivery and what your stand? But also some of the offsets and the benefits you are seeing in Pharma? And any commentary you could give us on expected cadence for the balance of the year given the focus there?
José Almeida:
Good morning, Robbie. I will start and then I’ll pass on to Jay. Well put, investors tend to focus on things that they feel discussed about, which not necessarily is how the management feels. So, probably it answers about 50 questions that I am going to get on the same thing that you just answered. So, I feel comfortable with our ramp up in Medication Delivery. Why is that? First of all, the first quarter last year, we had close to $50 million of net cash purchases. The LVPs and SVPs that were not necessarily needed but were purchased because the hurricane affected, the flu that was very hard and people stocking up all those products. Consequently, the other quarters that we had were – to start with the quarter two, and then culminating with three and four were really, really destocking, severe destocking. So when I compare Q1 this year with Q1 last year, what I get is a negative growth rightly, so. Now, why do I believe that we can get to the guidance in Medication Delivery? Why now I have no indication otherwise? First of all, we have a good pipeline of pumps either conversions or replacements in the horizon. So, we feel good about that. Second, we are, as you know, have signed all the GPO contracts with the extension of supply of our LVPs and SVPs. We are now signing IVNs with some of the GPOs with almost 100% by the end will be signed. And with opportunities to continue to gain potential market shift because the investment that Baxter made in its supply chain culminating with investment in quality that resulted with the FDA issuing a Voluntary Actions Indicated from the inspection that they had in December. Not necessarily I am affirming that the FDA will lift or knock the warning letter that we have in those two facilities but indicates that our efforts have resulted in progress against observations of the past. So, when we show this to our customers and potential customers, we have now redundancy in our supply chain and people should feel comfortable about us. Okay, so the SVPs and LVPs which are part of Medication Delivery including the bumps, we have a plan to get there and right now I have nothing otherwise telling me that the plan is in jeopardy. Okay. When I shift to Nutrition, Nutrition is a longer recapture of the market using products that have different indications for use. The discretion of the nutritionist and the physician changed and once we could not supply them with amino acids off of the hurricane. Practice have changed. We see us continue to make progress is not a 19 story or a 20 story. But I feel comfortable that we have enough gas in the tank with the launch of Clinolipid this year, that we can augment this growth. Let me shift now to the Pharmaceutical business. When I first came to Baxter, I thought Baxter had a hidden gem in its ability to mix APIs in solution, make them stable either at room temperature or frozen and continue to advance in this niche space that has been very good to Baxter. Our pharmaceutical team has executed extremely well not only on new molecules that we are launching, but also in molecules that we purchase through Claris. So we will continue to double down in Pharmaceuticals. We don’t tell everything to everyone that we are doing, but we have a significant amount of development, a very healthy pipeline in Pharmaceuticals and that was by design, put in place to create diversification for Baxter’s base business, and what is doing today is exactly that. I feel very comfortable about acute therapies. I think we are – huge pluses from last year. I see that business is growing. We have an opportunity with this business to get close to double-digits even in phase of a tough comp from last year’s first quarter flu season. We launched PrisMAX. We just got filed with the FDA and the FDA started its period of review of our PrisMAX in the U.S. It’s doing well outside the U.S. Prismaflex which is the generation before that, just got augmented with two way communications with the EMR. I found also Advanced Surgery to be doing a fairly good job in getting market share. We are there. There is a shortage in the market due to a competitor having a recall. We have capacity. Our FLOSEAL is still the best product out there for severe bleeding. So we are still doing well. We took the business from Mallinckrodt the RECOTHROM and PREVELEAK and did extremely well last year with it. So I find the execution of the company going well. So going back to Medication Delivery, what I have in front of me is no Medication that we are not going do what we said we are going to do. So perhaps this can alleviate the same question in in spite the conversions and they may come up for you. And one last comment is on Renal Care, our patient growth has been good, it has been slightly over 5%. U.S. is doing extremely well with 8.5% growth in peritoneal dialysis patient growth. So we feel good about that. We got out on purpose of bloodline. So we made no money on that business. That business was a $40 million, $60 million bucks that was making no profit. As a matter of fact, we are losing money. So, we made the right decision there. So, all in all, I think the company is focused on execution and we are absolutely with a brand new team in the U.S. led by Josette Macauley and by Heather Knight, both of them with great track records. We continue to strive to meet our commitments.
Robbie Marcus:
That’s great color Joe. Maybe, Jay, just one quick question. We saw R&D tick down a little bit and SG&A tick up a little bit in the quarter. But you felt confident enough to raise the bottom-end of the operating margin guidance for the year. Maybe just give us a little color and why it was postponed in R&D? And what the investments are in SG&A?
James Saccaro:
Sure. So, as I referenced during the call, one of the things we are incredibly excited about is a new product pipeline that we have. We are launching probably more products this year than we have in many years, but attending with that, we want to make sure that we have the right commercial teams and commercial investments on the ground to support successful launches. So, this was a rare quarter on the phase of it, SG&A grew 0%. But on a constant currency basis, we did see a few points of growth adjusting for TSAs, maybe 3% growth. And really what it comes down to is, some of those select marketing investments. I'll stop short of delineating actually where those investments took place. But from an investment standpoint again, we just want to make sure that the markets are ready to successfully launch. Now, from an R&D standpoint, it’s always difficult to get the exact timing of specific milestone payments outlined in a quarter we planned. And so, one of the things we found, as we looked at results for this year is certain of our payments were shifting from Q1 and Q2, future quarters and so we expect an acceleration as we move through Q2 to Q4 in terms of some of these payments and frankly, we have reflected in our guidance roughly a $0.03 shift of R&D spending from Q1 to later quarters. It’s not specific to one program. And I think from my standpoint, most importantly, it does not impact the launch timing of any of the products that we put forth. So there is no change to timeline and we can talk more about it. But we are as bullish as we’ve ever been about the pipeline, but we did see some phasing and we did not want to reduce R&D spending on a full year basis. We are going to see that spending come through in future quarters. The only other comment I would make is, or one of the things we’ve been really focused on is improving the efficiency of our R&D spending. So there have been a number of global initiatives in terms of consolidation and simplification and you are seeing some of that yield dividends in the overall performance of the spend category.
Robbie Marcus:
Thanks a lot.
Operator:
Thank you. And our next question comes from Bob Hopkins of Bank of America Merrill Lynch. Your line is now open.
Bob Hopkins:
Hi, thanks and good morning. Just to follow-up on that last train of thought on the pipeline, Jay or Joe. Could you just talk a little bit about key pipeline time lines or launch dates for the rest of this year? Just kind of refocuses on what you think is the most important things as we look forward over the next six to twelve months on the pipeline perspective? And how that drives your confidence not only in the outlook for this year, but in the outlook for acceleration for next year as you’ve expressed in the LRP?
José Almeida:
Well, let’s start with Pharmaceutical. As we have a couple of molecules that we're launching. We are expecting a good size molecule for sometime early next year. So, like about six to 12 months from today. We also have the version 9 of our pump we launched last year, but we have a new pump platform coming out next year and we are going to have two pumps coming out right out of the gate which is a large volume pump and syringe pump, all integrated, 2-way integration with EMR. All the stuff you should have plus the Baxter drug library in the market. We will have later that year which is next year we will have the PCA pump which is a third leg of the stool. And then, in another six months after that, we will have the ambulatory pump. So we have a four pump platform. We also continue to experience a significant uptake in demand for our Kaguya cycler in Japan. That is going well. We just crossed 1000 patient mark and we’ve seen this business for the first time since I’ve got here with growth in Japan. We also have PrisMAX which I just spoke about. PrisMAX for the U.S. is a big deal. We hope to get approval probably within six months to eight months depends upon the FDA review timeframe. And so, we have over 20 products actually coming up for launch in the next 12 months. So, some are small, some are more relevant, some are more long-term, some more durable like the pumps and PrisMAX. We continue to look at a look at a lot of different molecules. And so, we feel comfortable with the Baxter shifting a bit now from its operations excellence and efficiency as you – all of you know we’ve been doing for the last 3.5 years to starting to see the fruits of the innovations coming through.
Bob Hopkins:
Thank you for that. And then, just one quick follow-up for Jay. Jay, can you just comment on the puts and takes impacting the gross margin? This quarter was a little weaker than we anticipated and then, your expectations for how gross margin flows over the course of the rest of the year?
James Saccaro:
Yes. So, from a gross margin standpoint, that was principally in line with my expectations in large part because of the significant headwinds we experienced in some high margin products in the first quarter. And so, if you look at the first half of the year, we have a big drag related to Brevibloc. It’s basically $30 loss in Q1. It’s another $30 million in Q2 and that comes through at a much higher margin than the corporate average. Furthermore, we had a little bit of a FX headwinds. In the quarter, we also have a cyclo headwind year-over-year again in the first quarter. And so, those were particularly pronounced year-over-year headwinds that impacted the first quarter. As we move to the balance of the year, we will see the normal cadence of improving gross margins throughout the year. So, typically, Q4 is our strongest gross margin quarter. Q1 is typically our lightest. So we’ll see that uptake as we normally do. But then we will also have the benefit of a accelerated sales growth in the second half of the year which lends itself to a higher gross margin, both from a mix standpoint, but also from a utilization in our manufacturing facility standpoint. If you look at the first half of the year, our overall guidance operationally is in the 2% to 3% range. As we move to the back half of the year, based on easier comps, but other accelerations as well, you start to see a much faster sales growth and an uptick in overall sales. So, I think, those are few of the drivers that impacts gross margin. But like I said, this is largely in line with my expectations.
Bob Hopkins:
Helpful. Thank you.
Operator:
Thank you. And our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Lewis:
Thank you. Good morning. Just two quick questions from me. The first just one focused on cash flow and capital deployment, maybe Jay, as a question for you, the cash flow got off to a slower start here in the first quarter. So, what’s the pacing? What drove that in the first quarter? What’s the pacing for the balance of the year? And then related to that Joe, I just wonder if you take a second and talk about capital deployment. Obviously, you are still continuing to purchase dramatic amounts of stock. I think $600 million this quarter. What are you thinking in terms of the pace of capital deployment relative to buyback versus M&A for the balance of the year? And I have one quick follow-up.
James Saccaro:
Sure. As it relates to cash flow, cash flow came in, in line with our expectations. Q1 is typically the lowest quarter of the year for a number of different reasons one of which is incentive payout from the prior year, occurs once a year in the first quarter. We also had a large vendor payment that we had anticipated in the first quarter of this year that impacted the number. So, by and large came in very close to our expectations. So, what that implies, David, to your point is a significant ramp as we approach the back – or a portion of the year. I mean, we will start to see improvements in Q2. Now, looking at the balance sheet and so what will happen, what will drive this improvement is operating margin and earnings growth of course. But then you transition to look at working capital. And on the working capital side, two categories we don’t expect to change too much. Our days payable for the first quarter will be in the mid-50s. Our days receivable will be in the low to mid-50s. So those two categories are exactly where we want them to be and we’ll continue to manage those aggressively. Where we expect to see a significant improvement in working capital relates to inventory. This is an area that has disappointed us over the last year. The inventory build up as a result of different sales mix than we anticipated has been a real problem and something that we focused on correcting but it’s not something that corrects overnight. And in the first quarter of the year, the days inventory on hand will end at roughly at 107 days. By year end, we will expect to see roughly a 10 day improvement in that particular area. And frankly, that will drive the lion share of performance in our cash flow – free cash flow for the year. We’ve got a new leader in supply chain, Philippe Reale comes to us and we are excited to have him on board. He has been on board for several months and he has a number of new operating mechanisms. Joe and I are personally involved as well along with our Head Of operations. So, we feel quite good about this and we also knew that this number would be high in Q1. But I definitely and very focused on watching this improves through the balance of the year. Joe, do you want the take the question on capital deployment?
José Almeida:
Yes. Just going back to inventory, a bit of the inventory was planned, because we had – it’s nothing in terms of large volume parenterals in the inventory. Now we carry inventory at the levels that are appropriate to service our customers of today and future customers. So, going back to capital deployment, David, we continue to look at extensively at all kinds of different opportunities. We like some of the stuff that we are seeing. We are looking at molecules. We buy molecules to make more stuff all the way to large stuff we are looking at buying shares back. Until very recent it was a good deal because we thought the multiple was depressed and our treasury group did a great drive. We continue to evaluate the deployment of capital in phase of opportunities that we have in front of us. So we may or may not continue with the program at the pace that we had in this first quarter. We depend a lot of time on what opportunities we have in M&A. As I said before, there is always a good balance between strategy and buying shares. That we couldn’t pass the opportunity in the last six months to buy the shares because we thought the price was adequate and long and behold, I think we made a very good decision in buying that and we will speak to our investors folks who are long holders of Baxter. They probably appreciated the fact that we had an opportunity and took that opportunity. There is nothing would pay back as fast as that did for us and for our investors. But with that said, we will continue to look at expanding Baxter’s technology and opportunities. There is not a week that goes by that I don’t see one or two opportunities. And as I say to folks, it’s the right one. You will be the first one to know.
David Lewis:
Okay and just – thanks, Joe. And then, with my follow-up here I take a step back here. If I think about the debate into this year, it really was focused on the ability to drive earnings and your ability to deliver on Med Delivery. I think in the first quarter you jumped over the hardest margin quarter of the year raising operating guidance and obviously raising earnings. So I think that’s sort of asked and answered. Just to come back to Medication Delivery, Joe, I think you did a nice job sort of outlining how from a share capture perspective, customer recapture you are doing as well as you expected. The key question I think is just, for the Medication Delivery underlying fundamentals the demand equation in the channel and where you see inventories in the channel? How comfortable are you that those signals and what you are seeing in the channel are stable base that you can build on and sort of benefit from this recapture you are discussing? Thanks so much.
José Almeida:
So, David. I can see where our investors feel uneasy looking at a performance of the last year, a couple quarters, some in the first quarter and said how can you get there and it’s one of the things that is our credibility. Right, so, what we are saying to you that we can do that because we can see through it and we have the numbers, we have the reviews. But let me give a little bit more color. The market is quite stable, meaning, there are not shortages out there. There is not a company that is out of the market. There is nothing like that. So, what plays – what is important to our customers that you have continuity of supply that you have inventory, that you have the ability to supply a large swath of products under the Medication Delivery and be safe at the end of the day. So, what Baxter brings to the table are few things. We are a very stable supply chain right now. We’ve modified significantly in the last two years. We invest over $120 million in our factories to improve quality, to improve output. We continue to revamp our management at factory. So, we do have the capacity to-date from Canada, United States, Brazil, Spain and Ireland. We have a network that is flexible enough that can provide products. We launched a new product that has been very instrumental in recapturing this small volume parenterals the Mini-Bag Plus, which is a single pack. We also took advantage of one of the competitors that filled in during the shortage of the small-volume parenterals is on a recall, and the product is not available on the market which brings our products to light as a safe product, Mini-Bag Plus. So we’ve been seeing – signing two, three, four year agreements with hospital systems right now. So we feel that our pipeline is strong enough of deals that we think we can deliver on our promise. Things can change six months down the road. I don’t think as I see today that they will, but things can. What we are doing is making sure that we are signing every single account and we are showing to customers who are not ours today. How Baxter can serve them with value, as well as supply and breadth of products. Remember, we are a company that goes from the pharmacy all the way to the ICU. So we have a breadth of products that can be offered that way. On top of it, we also have one of the best pumps, if not the best, drug library on the market which is using our Spectrum Version 9. So, all of this together, with the new team that we have with experienced people, it’s not a new team, but it’s experienced people, I am very confident that we can get to the end of the year and deliver to our investors what we are going to deliver. If we have any changes to that, we will let you guys know.
Operator:
Thank you. And our next question comes from Danielle Antalffy of SVB Leerink. Your line is now open.
Danielle Antalffy:
Hey, good morning everyone. Thanks so much for taking the question. Just wanted to ask a question about how to think about the different business segments and their growth profile, specifically in Q2? Last quarter you guys did a great job, I thought of calling out some of the quarter-specific headwinds. Can you help us think about how to think about that for Q2? And I guess, specifically as it relates to some of the more controversial businesses like Medication Delivery? And then I have one follow-up. Thanks.
James Saccaro:
Sure. Q1 was interesting, right, because we had a number of headwinds that were specific to the quarter and some of those go away, some of those persist in Q2. And so I referenced earlier Brevibloc, that was like $33 million in the first quarter. It will be around $30 million in the second quarter. So that is a real headwind operational pharmaceutical sales growth that we are mindful of and we have tremendous work coming from this group in terms of all the activity and the new launches. But that’s going to be a specific headwind for the second quarter. We’ve talked in the past about the Bloodline’s headwind which is on a full year basis around $50 million. We will see continued decline related to this particular item impacting our Renal growth in the second quarter. But there are a couple of headwinds that subside. One is, you will see a normalization of the acute growth, because the flu headwind of roughly $10 million moved away in the second quarter. So we will see a solid performance at improved performance out of that group in the second quarter. And then, the IV buy in that we have described in the past which impacted the first quarter of this year again subsides. Now, interestingly enough, that headwind becomes an actual tailwind in Q3 and Q4. Because our Q3 and Q4 were depressed by this amount as Joe referenced earlier. Q2 is fairly neutral. So, as we think about the growth profile in Q2, you will see Renal growth kind of consistent with overall annual growth. We expect to see acute growth closer to the annual rate that should be in line with that. Medication Delivery will increase in the second quarter, but not to the extent that we’ll see in the back two quarters of the year as we look at all of the efforts that Joe described. Many of those benefits accrue to the second half of the year. Pharmaceuticals will have a lower rate for the Brevibloc reason that I mentioned and then we expect to see some Nutrition growth in the quarter as well. Advanced Surgery, again should have a solid quarter largely in line with full year expectations, maybe a little bit better. So that really kind of walks you down the overall components of the growth in the second quarter, like I said, the biggest change in overall growth rate occurs in the second half. So, we go from this operational growth of 2 to 3 accelerating to 4 to 5-ish in the second half of the year.
Danielle Antalffy:
Okay. That’s super helpful. And maybe we can talk about, I thought there were two really bright spots in the quarter, Pharmaceuticals and the Advanced Surgery business and I know you called out contract manufacturing, but also curious how much contribution was from new products for Pharma and Advanced Surgery, because to me it feels like maybe the pipeline is really starting to take hold. Any color you could get there would be great. Thanks so much guys.
James Saccaro:
Yes, we don’t really break out new product contribution by quarter, by business. But what I can tell you is, in the case of the Pharmaceutical business, we were definitely excited with the launch of dexmedetomidine. That has been well received in the market. It’s a novel presentation and that should be a continued solid growth engine for us for the balance of the year. As we think about biosurgery, we did have the benefit in our operational growth numbers of the Mallinckrodt assets. Roughly $15 million of RECOTHROM and PREVELEAK featured in our numbers in the quarter and so that annualizes as a comp moving into the second quarter. So, the growth rate will return to a lower rate. But we did see a very solid benefit in the first quarter in particular in U.S. As we look forward, biosurgery has been an area that has been performing well. The team is executing with the core hemostats and sealants and we are seeing good momentum there. So, we will expect continued positive progress in those areas. And you know, as we think about business development, I do think the assets that we acquired from Mallinckrodt really are a great example of the kind of business development that we can be incredibly successful with. It leverages the same sales call point, same sales team and we are seeing that really resonate well as we look to commercialize that product.
Operator:
Thank you. And our next question comes from Matt Taylor of UBS. Your line is now open.
Matt Taylor:
Hi, thank you for taking the question. So the first question I wanted to ask was just on Renal market dynamics. So I was wondering if you had seen any shift. It seems like that PD volumes are relatively healthy and I was wondering if you could part that how much of that you think is coming from the cyclers - are being helped by the cyclers or if you are seeing any market shift that push patient towards PD?
José Almeida:
Matt, I think, what we see is, the number of patients are related to penetrate. A couple of things. One is the penetration of the therapy. Our renewed partnership with DaVita. And lastly is, also may be related to length of stay in terms of durability of the revenue, right, on therapy. So, I would say, to the number of patients, I attribute it mainly by the excellent relationship that we have with DaVita where we seek the best therapies for the patients and the organizations are aligned and Baxter has – is making investments in its plants to provide more capacity for growth in PD, right now, as we speak, we are investing dozens of millions of dollars in our facilities to be able to support DaVita. We had this agreement with them. So I find this to be the result of that execution.
Matt Taylor:
Okay. And then, flowing at the 50th question here on the delivery. I just wanted to understand the dynamic a little bit better. You called out $50 million of excess purchasing that you had in Q1 2018. And from the outside and it’s hard for us to think about the pace of destocking. Could you offer any specifics on the next couple of quarters to help us model how the comps are going to play into your recapture in the stocking?
Clare Trachtman:
So, Matt, it’s $15 million, one five was the stocking impact for U.S. LVPs in the first quarter of last year. We did see, some elevated purchases in the first couple of months of the second quarter and then, in June of last year is when we started to see the destocking that then occurred throughout the rest of the year. So that’s really how it relates to the progression of kind of that stocking impact for the U.S. LVPs. And again, as Joe was saying, with respect to small volume parenterals, we are on track with that and those will continue to ramp throughout the year as well. So, our recapture efforts are going there. We are doing really well with our Mini-Bag Plus, particularly with single packs. So we will continue to drive those efforts really focused on education, about the safety and efficiency of using Mini-Bag Plus to reconstitute drugs. So our sales reps are armed with that and are out there working with clinicians on that. I think Joe talked about pumps. So we will continue to see both Spectrum IQ and Evo IQ as well ramp throughout the rest of the year. And in addition, our reallocation of volume to international markets will continue to pick up over the course of the year, as well. So, I think those are all the dynamics. Again, it’s more – the growth will be more back-end weighted as we face those easier comps with respect to destocking in the U.S. LVP market.
Matt Taylor:
Okay. That’s really helpful.
Operator:
Thank you. And our final question comes from the line of Matt Miksic of Credit Suisse. Your line is now open.
Matt Miksic:
Hi. Thanks for taking the questions. I’ll spare you the umpteenth Med Delivery question and just ask if you could maybe elaborate on a couple of the other businesses. The first on the PD side. If you could talk maybe just remind us what some of the drivers are of that growth. If there was any macro or economic or reimbursement dynamics that are driving that strength in PD? And then I have one follow-up on Pharma.
José Almeida:
Matt, the government announcement that they would initiate a move to take patients from clinics to home is too new to have caused any significant impact on our numbers. Our numbers, as I said are driven primarily in the U.S. by a strong relationship with DaVita that continues to get stronger. Our availability of products which is most importantly. We are making investments in our plants to supply the market with product. So we will have availability of products for the longer-term. We are investing in technology point-of-care. For instance, our first patient just came off successfully from the three month clinical trial period. We continue to enroll more patients on that technology. So, all in all, the U.S. has done well because our renewed effort in partnership. When I look at the Asia Pacific, the growth in patients would be 6.6%. Don’t forget that Asia, but primarily China, we are 70 plus percent market share holding in China and in China we have twice as many patients in PD that we have in the U.S. And the areas that we need to continue to improve is Europe has always been behind PD penetration compared to the U.S. and parts of Asia. So, all in all, 5.1% growth in patients for PD is a pretty healthy number. And consequently, our outlook for the year is a little more than that. So we continue to see a very strong outlook in the U.S., Asia Pacific, as well as Canada.
Matt Miksic:
That’s great. I appreciate that. And then, just on Pharma, again, impressive growth. Can you talk a little bit about, maybe remind us or update us just to the kinds of additional assets, businesses, size of these molecules, the strategy there and how it compares to sort of the traditional specialty injectable businesses as folks may know it’s – and perspective would be helpful.
José Almeida:
Yes. So, if you compare like Brevibloc, and cyclophosphamide, we will not see drugs like that in our portfolio not to that extent anymore, because those are drugs they were semi-specialty drugs. They were – they had patents and they had things that we had and it was a different Baxter at that time. Our intent in Pharmaceuticals is to launch three to four molecules a year which are injectable mostly, mostly premixes, which is Baxter’s strength, it’s premix. It’s our Galaxy technology that comes to light. We will launch some APIs, primarily when once we get the warning letter resolved out of Ahmedabad. There will be some APIs launched out of that facility. But if you look at our objective is to launch in five areas of care, oncology, anesthesia, antibiotics, specialty antibiotics, and a conglomerate of small parts of therapy, as well as the premixes. So we are going to take those areas of therapy and launch specialty products, three to four molecules a year. Some are going to be $70 million, $80 million, some are going to be $3 million, $4 million. It’s going to be a mix of them. Our objective by 2023 is to more than double the number of molecules that we currently have as we are ahead of plan to get there.
Matt Miksic:
Great. Thanks so much.
José Almeida:
Thank you, Matt.
Operator:
Thank you. That concludes our question-and-answer session. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating. Everyone have a great day.
Operator:
Good morning, ladies and gentlemen and welcome to Baxter International's Fourth Quarter 2018 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer session of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin. Clare Trachtman Thanks, Candace. Good morning, and welcome to our fourth quarter 2018 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's fourth quarter and full-year 2018 financial results along with our financial outlook for 2019. A supplemental presentation to complement this morning's discussion can be accessed on our Web site. This presentation, along with related non-GAAP reconciliations, can also be accessed at Baxter's external Web site in the Investors section under Events & News. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development and regulatory matters contain forward-looking statements that involve risks and uncertainties. And, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our Web site. On the call this morning, we will be discussing operational sales growth which for historical periods adjust for the impact of foreign exchange, generic competition for U.S cyclophosphamide, our acquisition of two surgical products from Mallinckrodt in the first quarter of 2018, and for a full-year 2018 approximately 7 months of sales from the acquisition of Claris in July 2017. 2018 operational sales growth guidance adjust for the impact of foreign exchange and generic competition for U.S cyclophosphamide. Now I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Good morning and thank you for joining us. We are pleased to share our fourth quarter results with you today and to discuss our expectations for 2019. I will begin with a quick review of our fourth quarter performance before sharing my reflections on the year as a whole. Jay will then provide more detail on the financials, including our 2019 outlook. We will wrap up with Q&A. Baxter closed the year with a solid fourth quarter, delivering sales growth of 2% on a reported basis, and 5% on both a constant currency and operational basis. A strategic execution with strong operational performance and disciplined financial management resulted in adjusted EPS of $0.78, up 22% year-over-year. Drivers of growth in the quarter included the company's Renal Care, Pharmaceuticals, Advanced Surgery, and Acute Therapies businesses; increased demand for Baxter's contract manufacturing services also contributed to performance in the quarter. This strength helped offset performance in our Medication Delivery and Nutrition businesses, which was in line with the guidance we shared on our third quarter call. Growth in Renal Care continues to benefit from increased demand for our peritoneal dialysis products globally. In the U.S., we experienced the highest growth for PD patients of the year with patient volumes increasing high-single digits in the fourth quarter. And in Japan, the successful rollout of Kaguya is also contributing to performance with patient growth advancing mid-single digits in the quarter. In Pharmaceuticals, growth in the quarter was driven by strength across the portfolio globally, increased sales of premixed injectables, anesthesia, and critical care products as well as a strong performance in our pharmacy compounding business, all contributed to growth. This helped to offset expected lower U.S sales of BREVIBLOC and cyclophosphamide in the quarter. Advanced Surgery achieved growth of 17% on a constant currency basis in the quarter, including a contribution of approximately $20 million from sales of RECOTHROM which benefit from competitive supply constraints during the quarter. Performance in acute therapies continued to be driven by improving utilization for CRRT globally as well as increased demand for our multi organ support products. Finally, performance in our U.S Medication Delivery and Nutrition businesses has stabilized, and we are in the process of executing on efforts to return demand for impacted products to pre-hurricane levels. In addition, we are seeing closer alignment between end user unit demand and financial unit purchases for a large volume IV solutions. As we discussed last quarter, going forward we continue to expect these businesses to grow in line with their respective market growth rates as well as benefit from new product launches. In addition, last quarter I mentioned that we were taking decisive action to renew strategic momentum in our U.S hospital businesses. To this end, I’m pleased to announce that Heather Knight will join us as the new General Manager for our U.S hospital business effective February 11. I worked with Heather previously, so I know firsthand that she will bring outstanding leadership skills and superior insights on the medical device market. On our fourth quarter performance illustrates important progress in our long-term strategic journey, Baxter's emphasis on increasing innovation, unwavering financial discipline, and driving operational efficiency, all contributed to our ongoing growth. For the full-year 2018, Baxter achieved sales growth of 5% on a reported basis, 4% on a constant currency basis, and 3% on an operational basis. Our overall strength was also reflected geographically, where we achieved mid-single digit constant currency sales growth across all three of our geographic reporting segments
James K. Saccaro:
Thanks, Joe and good morning, everyone. As Joe mentioned, our fourth quarter results demonstrate a strong finish to 2018. Throughout the year we delivered consistent bottom line strength through improved operational performance coupled with the ongoing benefit of our business transformation initiatives. Moving into 2019 and beyond, we continue to be well-positioned to achieve our long-term financial goals. I will start by discussing our fourth quarter and full-year 2018 results, before providing our financial outlook for 2019. Beginning with the fourth quarter, global sales of $2.8 billion increased 2% on a reported basis and 5% on both a constant currency and operational basis. This was favorable to our expectations driven by performance in our Renal Care, Pharmaceuticals, and Advanced Surgery businesses. On the bottom line, adjusted earnings increased 22% to $0.78 per diluted share. This also exceeded our previous guidance of $0.71 to $0.73 per share, driven primarily by sales performance, disciplined financial management and a modest benefit from increased share repurchase activity, which Joe referenced earlier. Now I'll walk you through performance by our geographic segments in global business units. Note, for this quarter constant currency sales growth is equal to operational sales growth for all businesses with the exceptions of our Pharmaceuticals and Advanced Surgery businesses and for the Americas region, for which we will provide operational growth in addition to constant currency growth. Starting first with sales growth for our three geographic segments. Sales in the Americas advanced 4% on a constant currency basis and 3% operationally. Sales in both our EMEA and APAC regions advanced 6% on a constant currency basis. Moving on to performance by global business units. Global sales for Renal Care were $953 million, advancing 5% on a constant currency basis. As Joe mentioned, performance in the quarter was driven by high single-digit growth for PD therapies globally. Partially offsetting this growth was lower U.S sales of in-center HD, primarily related to lower sales of low margin distributed bloodlines. Sales in medication delivery of $660 million were flat on a constant currency basis in line with the expectations we communicated last quarter. During the quarter, we continue to work with distributors as they reduce their inventory levels. We believe that destocking is largely complete and distributor purchases will now more closely align with end user demand. With respect to small volume parenterals, we're on track with our efforts to return demand to pre-hurricane levels, as we continue to reinforce to our customers the safety and efficiency of our SVPs for drug reconstitution. Finally, pump sales came in slightly below expectations. As discussed last quarter, we are seeing a longer sales cycle for Spectrum IQ, given the two way hospital connectivity with the hospital EMR, as well as customer somewhat delaying purchases of new pumps. Despite these dynamics, we gained just under a point of market share in 2018 and expect to gain a similar amount in 2019. Pharmaceutical sales were $540 million, increasing 9% constant currency and 11% operationally. Growth in the quarter benefited from strength in our anesthesia and critical care products, driven by increased sales of Transderm Scop and Sevoflurane. Strong sales of Baxter's injectable premixed drugs also contributed to growth in the quarter benefiting from recent product launches. And finally increased demand for Baxter's Pharmaceutical comp -- pharmacy compounding services also contributed to performance. This growth was partially offset by lower sales of BREVIBLOC and cyclo during the quarter. U.S cyclo and BREVIBLOC sales were $39 million and $14 million, respectively, in the quarter. Moving to Nutrition, total sales were $215 million, down 5% on a constant currency basis. We continue to focus on driving growth recovery through market education and reinforcement of supply availability. During the quarter, we saw a slight pickup in the market and our efforts to regain demand loss as a result of the hurricane are on track. Sales in Advanced Surgery were $214 million, increasing 17% constant currency and 5% operationally. Sales of RECOTHROM and PREVELEAK contributed approximately $21 million in the quarter. As Joe mentioned, RECOTHROM fourth quarter sales benefited from a competitor supply constraint. These issues have since been resolved. Sales in our Acute Therapies business were $137 million, representing growth of 12% on a constant currency basis. Strong performance in the business continues to be driven by increased global demand for Baxter's continuous renal replacement therapies. Finally, sales in our Other category, which primarily includes our contracting manufacturing services were $122 million, an increase of 14% on a constant currency basis. Performance in the quarter was driven by increased demand for our contract manufacturing services. Moving through the rest of the P&L, our adjusted gross margin of 44.3% decreased 10 basis points over the prior year as the benefit of operational improvements were offset by a certain one-time manufacturing cost in the quarter. Adjusted SG&A totaled $597 million, decreasing 4% on a reported basis and 2% on a constant currency basis, driven by our business transformation initiatives targeted with improving operational efficiency, which helped to offset a loss of approximately $9 million in transition service income received from Shire in 2017. Adjusted R&D spending in the quarter of $165 million, decreased 9% on a reported basis and 7% on a constant currency basis versus the prior year as we anniversaried certain milestone and third-party payments made in the fourth quarter of 2017. Strategic investment in our innovation pipeline continues to be a priority. Adjusted operating margin in the quarter were 17.5%, an increase of 210 basis points versus the prior year. Growth was largely driven by operational expansion and continued focus on transforming how we more effectively manage our business. Net interest expense was $11 million in the fourth quarter and adjusted other income totaled $34 million in the quarter, primarily reflecting a benefit from changes in our U.S pension plan and foreign exchange gains on balance sheet positions. The adjusted tax rate was 18.9% for the quarter and as previously mentioned adjusted earnings of $0.78 per diluted share exceeded our guidance of $0.71 to $0.73 per share. Within the fourth quarter we repurchased approximately $1.4 billion or 20.9 million shares of Baxter stock, reflecting our stated intention to strategically repurchase shares trading at a discount to our intrinsic value calculation. Turning to full-year 2018, sales of $11.1 billion increased by 5% on a reported basis, 4% at constant currency and 3% on an operational basis. On the bottom line, adjusted earnings increased 23% to $3.05 per diluted share. On a full-year basis, we generated free cash flow of more than $1.4 billion, marketing an improvement of approximately $200 million or 16% versus the prior year. This is slightly below our guidance of approximately $1.5 billion, primarily due to a higher year ending inventory balance than we expected. Let me conclude my comments this morning by providing our guidance for the first quarter and full-year 2019. For full-year 2019, we expect flat to 1% reported sales growth globally, 2% to 3% constant currency, and 3% to 4% operational. I would like to point out some key assumptions reflected in our full-year sales outlook, which included approximately 200 basis points of foreign exchange impact, and full-year's U.S cyclophosphamide sales of approximately $95 million versus $166 million in 2018. Operational sales growth adjust for the impact of foreign exchange and generic competition for U.S cyclophosphamide in 2019. Operational growth includes the impact and were approximately $75 million related to lower U.S sales of BREVIBLOC as well as approximately $55 million of lower U.S in-center HD sales. Collectively, these two factors negatively impact 2019 growth by approximately 130 basis points. Moving to guidance by business, on a constant currency basis, except for otherwise noted, in Renal Care we expect growth of 2% to 3% reflecting continued momentum in PD partially offset by lower sales of U.S in-center HD, aligned with our stated strategy of enhancing performance by exiting lower margin product lines. In Medication Delivery, we expect sales to increase approximately 6%. We expect our Pharmaceuticals business to decline 3% to 4% on a constant currency basis. Adjusting for U.S cyclo, operational growth is expected to be flat 2018, reflecting the lower BREVIBLOC sales I just mentioned. Moving to Clinical Nutrition, we expect sales growth of approximately 3% as we work to return customers in the U.S back to pre-hurricane prescribing patterns. For our Advanced Surgery business, we expect sales to increase 3% to 4% on a constant currency basis. For the Acute Therapies business, we expect growth of approximately 7% to 8%.Finally, in our Other business, we expect sales to decline low single digits as we don't currently anticipate the outperformance in 2018 to repeat in 2019. Moving down to P&L, we anticipate adjusted operating margin expansion of 60 to 100 basis points. We expect net interest expense of approximately $60 million to $65 million and adjusted other income of approximately $80 million to $85 million for 2019. For the year, we expect an average adjusted tax rate of approximately 18% and a full-year diluted average share count between the range of 515 million to 520 million shares. Based on these factors, we expect 2019 adjusted earnings excluding special items of $3.22 to $3.30 per diluted share. And finally for the year, we expect to generate operating cash flow of approximately $2.3 billion and free cash flow of approximately $1.6 billion. Specific to the first quarter of 2019, we expect sales to decline approximately 3% on a reported basis, growth of approximately 1% on a constant currency basis, and growth of 1% to 2% on an operational basis. And we expect adjusted earnings excluding special items of $0.66 to $0.68 per diluted share. With that, we can now open-up the call for Q&A.
Operator:
Thank you. [Operator Instructions] And our first question comes from David Lewis of Morgan Stanley. Your line is now open.
José E. Almeida:
Good morning, David.
Jon Demchick:
Hello. This is actually Jon Demchick on for David. Thanks for taking the questions. Would love to kind of dive a little bit into the IV solutions part of the medical device -- the medication delivery business and kind of think about what projections you’re expecting for the first couple of quarters through the year, and how you see the alignment of supply to the financials that you're going to see? Like how much visibility you think is there now today relative to the visibility you saw during 2018?
José E. Almeida:
Good morning, John. We never met, but welcome to our call. I’m going to take the first part of the question and then I will pass on to Jay, who will get into more of the financial impact. Listen, we found now that we're largely the inventory in the chain is largely balanced, meaning that while we see financial results or dollars coming in and the inventory levels at distributors, so sales out to hospitals and inventory is balanced. We saw that throughout Q4, we think that we have a stable market right now, and which made us conclude that we have not lost market share. Our market share is stable and some of the OEM contracts that we had spoken about are coming back a little faster, and we have some opportunities. So what you see in the progression of the quarters is that we have a very tough comp in the first quarter because quite a few remember last year there was a significant amount of buy-in, a tough flu season was the reaction to the hurricane in late 2017. So this is a tough quarter for us to compare, but if you look across the other quarters and for the year, Medication Delivery will be a 6% business, which tells you that this is a well-established business, a stable business. And we have plans to continue to convert that. We have the launch of our new pump coming in. The new pump will drive more stats, will drive more volume and the ability to capture those that will be great. The other thing that makes this quite stable is we are two out of three GPOs signed. In one of them, we are 100% re-signed with the IDNs and we feel very comfortable about our position in the marketplace. Now let me pass on to Jay, who will talk a little bit more of the financial impact.
James K. Saccaro:
Yes, just thinking about the IV therapy business, we did have a substantial buy in, in the first quarter of last year. That’s rough -- it was roughly a $15 million positive sales impact in the first quarter. So recognizing this is a low-single digit end user demand that was a -- that was certainly a departure which we’ve discussed in the past. And so as we look at our plans for the U.S business with respect to IV therapy, you will see a decline in the first quarter this year into double-digits. But then as we move to the back half of the year, in the second quarter it’s a more normal quarter, and then in the back half of the year, we do have the benefit of easy comps in large part because -- of some of that inventory coming out of the channel. So really that’s the sequencing that we expect to see during the year.
David Lewis:
Okay. And actually guys this is David. I’m stepping in for John. Sorry about that. So two questions for me, Joe, kind of more strategically. And the first one, obviously, is two focus items for investors. The first is fluids, and I think you’ve addressed that for '19 and the first quarter. The second, obviously, is balance sheet deployment, Joe. How urgent are you feeling about deployment in 2019 to sort of get back to 5%. On one hand, I think about the headwinds in your business BREVI and HD, you can almost get back to 5%, just adjusting for those headwinds versus your '19 guidance. But how important is M&A to you this year to deliver your LRP targets in '20? And then for Jay, just thinking about margins, obviously you’ve talked about a margin opportunity of 300 basis points over the next two years guiding to about 50 this year. How good do you feel about the ability to still deliver those margin targets into 2020, just relative to the '19 guide? Thank you.
José E. Almeida:
Good morning, David. That was well, well orchestrated. So we’ve got three questions out of your call. You said only two, but I will -- those are good questions, so we’re going to answer them properly. M&A, listen, we continue very aggressively looking for opportunities, and I want you guys to think about not on the size base but more so on adjacencies and things that’ll make sense for our company for Baxter. It is -- don’t mistake our aggressiveness in looking for targets with our discipline of really understanding the financials behind the returns for acquisitions, which are unchanged. We are looking for molecules. We have and we require molecules in the marketplace to augment our Pharmaceuticals, we're interested in Critical Care, we’re interested in many other areas that are adjacent to our business. Size is not the priority, but the ability to augment that. Will M&A be a great part of our LRP, we augment our LRP. I still -- I’m still very confident that we have the ability to deliver the LRP. We’ve done M&A at the moment because we have $1.7 billion in new products coming in 2023, and that is still in the plans. If you look at our new product development sales contribution in the second half of 2018, it was great. Now we have some really -- a lot of new products coming in, so we’re confident in that, but I think augmented with adjacencies, M&A, and don't be hung up on size. Some may be a little larger than others, but we’re working intensively. But I want our investors to understand -- I would like to underscore the fact that the returns and the financial returns to our shareholders is very, very important to us, so we would not do a deal that is in the fringes or negatively impact our return to our shareholders. I will pass on to Jay on the balance sheet.
James K. Saccaro:
Yes, great. Great. Yes, in terms of margin, but also in terms of actual sales growth, I do think it's important, David, you referenced something. Our operational sales growth this year is 3% to 4%. As you know, excludes the impact of cyclo, but it does include two important impacts. One is BREVIBLOC, we discussed this extensively, roughly $75 million. But then, we’ve also talked about this idea of historically exiting lower margin businesses. I mean, one of the items we pursued is kind of shrinking certain areas where there was little margin in our in-center HD business. But that’s roughly a $60 million impact. So thinking exclusively about sales growth, the 3% to 4% includes within it roughly a 130 basis points of impact that depress it in 2019 relative to the normalized rate of growth we will expect to see going forward. The second item, as it relates to margin expansion, this is one area we’ve been incredibly focused on over the last several years. And this year we will see further margin growth, but I will highlight that this year we’re faced with a number. Of very significant headwinds on the path to delivering this margin expansion. Cyclophosphamide, that’s roughly 1% of margin impact. BREVIBLOC, that’s -- sorry, BREVIBLOC is roughly 50 basis points of margin impact, and I should say cyclo is roughly 50 basis points. And then foreign exchange is roughly 30 basis points. So if we put these items together, we’re talking about again a 130 basis points of headwinds that we fight through on the way to the margin expansion that we will deliver. This year we had a number of headwinds as well. We’ve discussed those in the past and we were able to again deliver nice margin expansion in the face of that. So we don’t point to headwinds as a reason to not deliver margin expansion, but again it does depress margin expansion relative to the normal rate of growth.
David Lewis:
Great. Thanks so much.
José E. Almeida:
David, any handle off for further questions or should we move on? Right.
David Lewis:
No, I will stop there. Thanks, guys.
José E. Almeida:
Thanks. Thank you, David.
Operator:
Thank you. And the next question comes from Robbie Marcus of JPMorgan. Your line is now open.
Robbie Marcus:
Great and congrats on the good quarter. Jay, maybe I can follow-up on that. The guidance came in, I think, pretty good on the top line, especially considering all the headwinds that weren't factored into street models. But first quarter came in a little bit lighter. So maybe you can walk us through the puts and takes of the cadence through 2019 and maybe some of the product launches or different factors that give you confidence in that second half acceleration.
James K. Saccaro:
Yes, Robbie, you’re correct. This is a meaningful acceleration that we will see towards the back half of the year in the back three quarters, I should say. And there are a number of specific items impacting the first quarter growth. So we pointed to operational sales growth of 1% to 2%. But included in that, BREVIBLOC, the biggest impact that we’re going to see is, I believe, in the first quarter. Its roughly $35 million in sales, roughly 1.3 percentage points of growth. The IV buy-in, so we did see a very significant heightened buying pattern in the IV business. I referenced it moments ago. That’s about $15 million or roughly 50 basis points of growth. And then in-center HD, this exit that we pursued is another factor that’s depressing Q1 sales growth. That’s roughly $15 million. So again, as we look at this first quarter growth of 1% to 2%, we’ve almost 2.5 points of sales growth headwinds that are most pronounced in the first quarter of the year. Now transitioning that to an EPS discussion, quite simply $0.05 of BREVIBLOC, $0.01 of cyclo, $0.03 of FX and by the way FX is more of a first half phenomenon than a second half phenomenon. You put these items together and its significantly impacting the first quarter EPS. Furthermore, we’ve a number of benefits that start to accrue to the second half of the year. We’ve the easier comps in the U.S Medication Delivery business that I mentioned earlier. And then furthermore, we start to see the benefit of some of the new products and the acceleration there. Joe -- with Joe in his script referenced some of the great progress that we’re making and we’re pleased really across the board, but it's not overnight that these products come to bear, and so we do see a bigger impact in the second half of the year, on the way to an even bigger impact in 2020.
Robbie Marcus:
Thanks. That’s really helpful. One other thing I wanted to dive into is, it looks like the pharma business did very well in the quarter, even when backing out the generic headwinds. I think it's a part of the business a lot of people don't understand the underlying drivers. Can you give us a little bit more insight into what’s driving the outperformance there and how to think about the key growth drivers in '19? Thanks.
José E. Almeida:
Robbie, the performance is being driven by several factors. Let me start highlighting the success of the molecules that we’ve been launching internally from Baxter, and those are special molecules, not the molecules themselves, but the delivery of the API. And the second is our premix. So premix is the substitute for when we have shortages. We made great efforts to substitute some of our MINI-BAG Plus product lines in the marketplace by premixes and the premixes are more effective and even safer way of delivering the medication and that is doing extremely well. The growth is fantastic. We are moving up 30% plus of growth in premixes. So I know that we both had Medication Delivery and the recap of and recover of our MINI-BAG plus and MINI-BAGS business. But some of that we actually prefer the conversion into premixes which has been extremely success, but the margins are higher by 20%, 30% and we think that that is the way to go. So our Pharmaceutical business is doing extremely well. We have more molecules coming up in '19 and '20. And we feel that that business is finally taking off, ex this cyclo and BREVIBLOC, which eventually will be something of the past and we can move onto the new Pharmaceutical business which is leadership in generic injectables with novel ways of delivering the medication. Thank you. Thanks, Robbie.
Operator:
Thank you. And our next question comes from Bob Hopkins of Bank of America. Your line is now open.
Bob Hopkins:
Great. Thank you and good morning. Just two questions for me. One is a clarification and I'm sorry if I missed this. But are you guys today explicitly reiterating your 2020 operating margin EPS and rev growth targets that you set last year?
James K. Saccaro:
Yes, Bob, yes we are. There is no changes to those guidance numbers.
Bob Hopkins:
Okay. And then the other thing I wanted to ask about was just Medication Delivery. We have talked about it a little bit here, but obviously that was a division that cause you trouble for two quarters of 2018. And now your guidance for this year is for 6% growth. I realize some of that is easy comps, but it just seem like a little higher guidance than I anticipated given what happened in 2018. And also given your comments about the tough competitive landscape on the pump side. So maybe you could walk through a little bit what gives you confidence in that 6% from a new product prospective, because even comp adjusted you’re projecting accelerated growth here in 2019.
José E. Almeida:
So we're definitely getting some benefits from the recapture or the acceleration campaigns with respect to MINI-BAG, MINI-BAG Plus, and then some stability in the LVPs. So the reality is because of the rebates that took place in a number of our product lines, we are able to see above market growth rates in certain product categories. As we referenced in the call, we were pleased to see some of the progress that we made in those areas in -- fourth quarter of 2018, so very, very solid early signs of the recapture campaign paying dividend. And that will continue to pay dividends. Again, above market growth barring the first quarter issue. So that's one factor. The second factor that comes into play is we do start to see accelerated performance on the new pump -- the version 9 of our spectrum pump, which starts to accelerate towards the back half of the year. We have been pleased with the reception of this pump in the marketplace, well received by clinicians around the U.S., so very positive reception. But the sales cycle has been longer than we expected. So as a result of that, we will start to pay that all off in 2019. We have got a line of sight to the pipeline that gives us confidence that we will be able to do that. So you put those things together and like I say, this is a -- this is one where we have a high level of confidence in the acceleration that takes place. And then furthermore, we do have some easier comps in the second half of the year for -- certainly as we look at performance there.
Bob Hopkins:
Okay. Thank you.
Clare Trachtman:
The only other comment I would make there, too, as well is we’re going to see some acceleration outside the U.S as well as we anniversaried some of the comps. As you remember, we took some of that volume to the U.S and now we have successfully -- we are going to successfully bring some of that volume back to those Latin American markets as well.
Bob Hopkins:
Thanks very much.
Operator:
Thank you. And our next question comes from Matt Taylor of UBS. Your line is now open.
Matthew Taylor:
Hi. Thanks for taking the question. So the first one I wanted to ask about was the Renal business, that was a little bit of a tick up here and you highlighted now you got all your cyclers is around the world and more people are using them. Can you talk about assumptions for 2019 in terms of any pickup that you could see in PD because of the cyclers? And then, I would love to get a little bit more color on how you're feeling about on-demand PD looking into 2020 and what kind of impact that can have?
José E. Almeida:
I will take that. Our Renal Care, 2% to 3% is our guidance in 2019. And I just want to give a little bit color why is 2% to 3% and how do we connect the PD patient growth to it. We consciously are walking away from business that were unprofitable in some geographies, primarily bloodlines and was a large volume of product. So our HD business is artificially depressed because our decision -- we were making no money. As a matter of fact, we are losing money in that business and it was a good thing that we are not going to be in that business anymore. Moving to the PD business, we are still looking between 5% to 6% in patient growth. This is a very healthy business. The best geographies in the world right now are North America as well as parts of Asia, Japan and China. We have very successful launch of CLARIA with SHARESOURCE, relaunched in parts of Europe, very difficult time we had with the privacy issues in Europe and now we overcame that issue in many geographies in Europe, and we’re trying to see CLARIA with Sharesource, which is a different cycler. Similar to the HomeChoice here, the old HomeChoice in U.S., but updated with software for monitoring. So that is now been using several different countries in Europe. We struggled in the beginning with the privacy. We got to understand how difficult it is to operate in Europe with software [indiscernible], there's home monitoring, but now that's going well. I will point to Japan, Japan the Kaguya business in Japan is doing extremely well. We already have a 1,000 patients on therapy there. We expect to really accelerate that business in '19 and '20. So expect 5% to 6% patient growth. Very healthy business in the U.S. Our partnership with DaVita is going well, great partner and great customer.
Matthew Taylor:
Great. Thank you. And any additional color you can talk about in terms of the pipeline with on-demand PD?
José E. Almeida:
Well, we just have few patients lined up to start receiving the therapy. We have one that is started and he is going well so far. Early to say, but it is something -- this is a very classic Baxter stance. And I would say something we do something. We tend not to say stuff and not do it. So we put our patient on therapy like we promised. We are going to work hard on that therapy. It's complex, because you're making the drug in people's homes, but it's going well so far. And I tell you we are going to have several iterations of this technology going forward, because this is going to be almost a comparison to what the electric car was seven, eight years ago. You start and you started evolving and evolving, and we’re going to evolve this technology. We will continue to be the leaders in home therapy for peritoneal dialysis.
Matthew Taylor:
Great. Thank you. And can I just ask one follow-up on the pharma business? You mentioned some of the dynamics before, but I was hoping you could be more specific about kind of the both number of molecules you're launching in '19 versus '20, really thinking about the Claris dynamic there. I mean, should we see some acceleration in terms of the molecules in the growth in '20?
José E. Almeida:
Well, let me -- let's divide this in pieces. We have Claris molecules, which were part of our plan for Claris. And as you know we have the warning letter for the facility, we are doing everything that we are -- we promise to do to the FDA. We will be inspected a couple of times before we can get clearance or VAI for that location. So our focus right now for Claris is to be able to get that facility cleared of the warning letter, and all the efforts that we promised the agency are being done. We also have contingency plan for that plant, because we would like to have Plan B and our Plan B is for most of our products that will be sold in the U.S., we would have CMOs or backups so we can continue operation if something doesn't work. It means that we are working everything that -- every angle that we can to make sure there is no disruption to our plan because the warning letter at Claris. So this is -- this addresses Claris. The other molecules that we have, we have some important molecules launched at the end of '19 and '20, they’re really breakthrough molecules. Not that the molecule itself is breakthrough, but the delivery system of the molecule is a premix and nobody has that in the market. I'm not going to give the name of the molecule, but I'm telling you we have some really interesting stuff going on. The other thing is we have molecules that are launched last year, we have few more launched in this year. The one is a launch last year, I have to say one of them, and I'm not going to give the name of the molecule, is done extremely well with 40% higher sales in our estimates for last year. So that will continue to do well. So our plan for Pharmaceutical is absolutely offset and leaving the past cyclophosphamide and BREVIBLOC and things that were the chief products for the company few years ago were moving into, as we said, we are going to add almost 70 molecules to our portfolio and above double that the ways to deliver those molecules and we are going to do this in a multitude of regions like we promised last year and we are on plan to do it. As I said, we have an important molecule, that hopefully will be launched by the end of '19 and we will announce that properly when that happens.
Matthew Taylor:
Great. Thank you, Joe.
José E. Almeida:
Thank you.
Operator:
Thank you. And the next question comes from Vijay Kumar of Evercore ISI. Your line is now open.
Vijay Kumar:
Hey guys, thanks for taking my question. So couple of, I guess, guidance, housekeeping questions here. Is the guidance assuming any contribution or I guess I should say contribution, the resolution of FDA a warning letter of Claris. And I'm curious, Jay, you mentioned the LATAM business coming back for IV fluids, that happens to be a tender business. I'm just curious have you signed any tenders? Do you have any visibility?
James K. Saccaro:
So from an FDA standpoint, there is no resolution assumed in our 2019 numbers for resolution of the Claris warning letter. Obviously, that becomes an important component of our 2020 numbers. So to the extent that we get that resolved along the time frame we expect, then the long range plan that we have are intact with no change. We are looking for mitigation tactics in the event that, that does not occur. But as we look at 2020, that will be an important component for us to get resolved. As it relates to Latin America, yes, certainly there is a different dynamic in terms of tendering in Latin America versus certain other markets. And so, we have moved some volumes back to Latin America. We have clear line of sight to sales performance and where that's going to go. In some cases tenders have been one, but as opposed to going through that in a lot of detail, what I will tell you is we have a high level or a solid level of confidence in our ability to deliver some of the IV sales in the Latin America business.
Vijay Kumar:
That's helpful, Jay. Just one follow-up on -- the interest expense guidance. It looks like interest expense is going up. Is there any -- I'm just curious, what is the implication for cash balance or capital deployment just because this is ticking up?
James K. Saccaro:
Yes, we have a -- we do have a higher interest expense year-over-year, so that's a few cents of impact. And there is really two factors in play. One is the rising interest-rate environment. But more than that, we have repurchased a significant number of shares. As we said in the past, we have opportunities to buy shares in the market and it's below the intrinsic value, we take advantage of that. In the fourth quarter, we did see a dislocation. We saw fairly meaningful moment in the stock price, but our long-term valuation of the shares was very much intact. We took the opportunity to produce a number of vehicles to repurchased shares. That has a share benefit in terms of share count for the full-year 2019. There is an offset to that, which is increased interest expense. Now as we look at the overall position for Baxter, the net debt situation, we are still significantly below one turn of net debt to EBITDA. And while we’ve said our long-term target is 2X net debt to EBITDA, what I will tell you is I believe we have more -- our main goal is to maintain a solid investment grade credit rating and I do believe we have more flexibility than that as we look at further capital deployment. So it doesn’t -- the share repo that we pursued in the fourth quarter really does not impact our business development or capital deployment strategy to any significant extent going forward, but it's a fair point about increased interest expense.
José E. Almeida:
I just want to, Vijay and folks to underscore what Jay just said, we have said that we were not going to let cash sit in the balance sheet unused. So we are going to return that to the shareholders in a way that we can make the most out of it. So ideally we like to buy more companies and spend money in M&A, but if we don't find the target with the right return, we are going to return money to shareholders in the other two vehicles that we have which are share repurchase and dividend. So I want to make sure that people understand that those three vehicles can be -- are not mutually exclusive. They can be done concurrently, but we will accelerate one versus the other as we progress as I said, money will not sit in the balance sheet unused.
Vijay Kumar:
Thank you, Joe.
José E. Almeida:
Thanks, Vijay.
Operator:
Thank you. And the next question comes from Larry Keusch of Raymond James. Your line is now open.
Lawrence Keusch:
Thank you. Good morning everyone. Joe, I obviously caught the comments related to share being stable in IV solutions. I think one concern that investors have is that as we go through contracting process and contract renewals, given some of the pricing around the spot market et cetera, that pricing overall could start to come down. So I was hoping you could perhaps provide a little bit of color and I guess in that maybe some thoughts around just given the tremendous job that you guys have done with creating redundancies for supply, how that also resonates and factors into some of those discussions.
José E. Almeida:
Listen, we were not the benefactors of the spot market sale, because when we end up having -- before we create all this flexibility in our supply chain in Americas, which today is second to none. We have that ability. It's so strong that we can guarantee with penalties to our customers the contracts that we would supply them product, okay? But when we didn't have -- not have that, the other -- the competitors who are selling their product to our customers, were selling sometimes in the spot market with higher prices. So we are not the ones who mostly benefit from that. So I would say pricing in the markets are established by contracts. We have a stable contracts and a stable share. But pricing is a function of competitiveness and that -- so we will always be competitive in the marketplace. But we have what most companies today competing with those don’t have, we have volume of manufacturing, but we have redundancy plan. Think about where we are now approved to sell into the U.S. We can sell our -- out of our plant in the Carolinas, we can sell in the U.S products made in Ireland, products made in Mexico, and products made in Brazil. So we can with the flip of a switch very quickly build inventory contingencies across the Americas, and I think that is a very important position. So how does the price play in this is that, listen, we don't control price other than negotiations which are given -- who are between us and our customers. We did not benefit from this spot markets. So if you are thinking about seeing a decline in price in our contracts in 2019, those will not be there because we're not the ones who jacked up the price for a spot sale and took advantage of that.
Lawrence Keusch:
Okay, perfect. And just one clarification, and then a follow-up. The clarification is the -- I know you worked hard with the FDA to get clearance for a lot of those facilities to bring supply into the U.S. I just want to make sure that those are permanent approvals to bring supply in. And then the second question, Joe, I wanted to just touch on M&A perhaps in a slightly different way which is, obviously, Amy Wendels come onto the Board of Directors, she is someone that you've worked with for a long time. She has been very, very impactful at Covidien relative to the M&A strategy. And so I just wanted to pick your brain a little bit on the implications of her joining the Board?
José E. Almeida:
Okay. So listen, going back to the first part of the question and in terms of what is permanent. Mexico is permanent. Brazil is temporary right now, going to permanent after a second inspection that we are expecting from the FDA shortly. Ireland is permanent and we are going to eventually hook up Canada as well as soon as we line up inspections from the FDA. But if you think about Mexico, Mexico is permanent for us, that's a humongous amount of volume that we can bring into the U.S and divert into other places in Latin America as we wish. So there is a lot of flexibility. So Mexico brought -- if you think about a 100% flexibility, Mexico brought to us 85% of flexibility to the supply chain. And the other 15% were brought by Ireland and eventually when Brazil gets permanent importation status, which will happen in 2019.
Lawrence Keusch:
Great. And then Amy?
José E. Almeida:
Oh, and the second part, about Amy, well I'm so happy Amy is joining the Board. Amy was a colleague of my at Covidien for many years and work with me for 20 plus years at Covidien. So and -- Tyco Healthcare and Kendall Company. So we go back 1995. She will be instrumental on the Board in helping is not only M&A. Amy is a strategist, is a healthcare strategist. She is excellent in that area and we are very excited that she will be part of helping us with her strategy as well as making sure that our team is in the best shape ever. This is great news for Dennis [technical difficulty].
Lawrence Keusch:
Thank you, Joe.
Operator:
Thank you. And our next question comes from Danielle Antalffy of Leerink. Your line is now open.
Danielle Antalffy:
Hey, good morning, everyone. Thanks so much for taking the question and congrats on a strong quarter. To exit the year, Jay, I know how much you love to talk about cash flow and not to nitpick on the quarter, but cash flow did come in a little bit under the updated guidepost Q3 for the year. Wondering if you could talk a little bit about that and what the drivers for the cash flow guidance for 2019 are? Thanks so much.
James K. Saccaro:
Certainly, Danielle. Thanks for the question. As you know I do always focus on cash flow, it's a critical number for us. From a fourth quarter perspective in 2018, actually -- it actually was quite a good quarter, right? Operating cash flow growth of 50% nearly and free cash flow growth essentially double and we grew $270 million to over $500 million. So very solid performance. But cash flow is admittedly a number that it's very back end loaded. A lot of the activity, roughly 40% of the cash flow in the year comes in the fourth quarter and a large component of that comes in December. And whenever you try to forecast performance in a month, there is a lot of choppiness to that. And so we -- to your point, we did comment a little bit below our expectations. The reality is there were few factors in play. The sales mix came in a little bit different with more drugs and less devices. Some of the devices that we had earmarked to place in Q4 moved to Q1 with no implications to long-term revenues, solid customer demand. But like I say, it's difficult to anticipate exactly when devices will go out the door. And then the final factor which is an interesting one, is some of our sales over performance came in December and whenever that happens you get the inventory benefits to cash flow, but you don't get the payoffs in the receivable collection even if you have a 30 day DSO, you’re collecting -- if you make a sale in December, it's not going to show off until January. And so, you put all these factors in play, I mean, cash flow did come in a little bit below our expectations. But I will tell you anytime, we grow free cash flow 16%, 17%, which is basically what it was for the year, largely in line with earnings growth and I think it's a decent performance. And so as we look forward, we will have a solid -- we have solid line of sight. What I hope that we have made some improvements to our process to get a better handle on December, but we use the word approximate when we talk about cash flow guidance for this very reason, and it tends to be the most volatile number we forecast. But like I say, our conversion ratios are continuing on to a very good extent. This continues to remain a focus for our entire organization. And in fact, later on today, Joe and I have a meeting with our supply chain team, discussing our -- some improvements to our S&OP process. And we brought in a new leader to this area, supply chain, S&OP process is really the sales and operations planning process that we have at the company. So opportunity there, but, by and large, a very solid cash flow year.
Danielle Antalffy:
Great explanation. Thank you so much.
James K. Saccaro:
Thank you Danielle.
Operator:
Thank you. And our final question comes from the line of Matt Miksic of Credit Suisse. Your line is now open.
Matthew Miksic:
Hey, everybody. Thanks for squeezing me in.
José E. Almeida:
Hi, Matt.
Matthew Miksic:
Hey, how are you? And congrats on a really strong end of the year. So I couple of clarifications here just on guidance and one on capital deployment. So maybe for Jay, just a clarification on Q1. The color on the 230 basis points of nonrecurring growth items in that 1% to 2% growth guidance was extremely helpful. If I look at that, right, I just want to make sure we are looking at this the right way, this would put sort of growth -- underlying growth, if you will, closer to 3.5% to 4.5% for the first quarter ex those items. And I’m just wondering, if that’s true, just maybe flesh out the impact on the bottom line. I get about $0.05 to $0.07, but anything you could do to quantify that or color around that would be helpful? And then as I say, one question on capital deployment.
James K. Saccaro:
Certainly. So in the first quarter, you're right, Matt, BREVIBLOC is $35 million. It's like 1.3%. The IV buy-in and in-center HD are another two factors, adding about 1%. So it is a fairly substantial impact. I will stop short of adding those to the reported operational growth number to come up with this fictitious adjusted number. I don't want to do that, but you can certainly do that to get a more accurate long-term representation of what the growth rate will be. We try to be judicious at using adjusted financial measures here. But then from an EPS headwind standpoint, it's actually more than that, because BREVIBLOC is a $0.05 headwind. Cyclo is a $0.01 headwind. Now that's not included in the operational sales growth number, but it is, of course, included in the EPS number. So that's a $0.01 headwind. And then foreign exchange is also a $0.03 headwind. Now we’ve a number of good guys, things like share count and so on. But like I say, those are $0.09 of specific headwinds to the first quarter that, by and large, are the most pronounced in the first quarter of the year. So you point to we do have a bit of a decline in EPS in the first quarter before we see the acceleration. But really, those are the key factors that impact that. I would say that the IV buy-in is also probably about $0.01 of impact to earnings with the in-center HD is less than that because it is a low margin business. So that’s really the overview.
Matthew Miksic:
Okay. Now that's super helpful. And on the follow-up, I guess taking kind of a similar analysis to the full-year, and I understand your organic growth guidance is your organic growth guidance of 3% to 4%. But if we look at the 130 basis points kind of in a similar way, one could argue sort of the underlying growth of your businesses is already kind of tracking into that 4% to 5% long-term growth CAGR that you’ve talked about through 2020, at least and that’s our analysis, of course. But on the strategic front, I just want to confirm and clarify the thoughts on urgency for a deal. I think there's a perception that a deal is maybe more urgent somehow to get to this 4% to 5% growth and -- or whether potential enhancements to the portfolio and growth and so on, strategic investments would be additive to those long-term goals. Just any sort of clarifying thoughts you have on that as we wrap up the call?
José E. Almeida:
Matt -- no Mike. Sorry for that, Matt. I know you’re Matt and now I've called you Mike. Matt, first of all, the worst thing that any of us can do here at Baxter is to rush into a deal just to make sure that it helps us in the short-term. And usually those decisions are bad and ill-conceived ones. We are looking for deals for a while, that’s why we’ve a strong M&A team onboard. But that doesn't mean that we are desperate for a deal, we're not. As a matter of fact, we've turned many deals down. And I can tell you we may -- we did this in the last three quarters. We've turned deals down because financials were not there. We couldn’t make ends meet when we -- but we continue to explore every opportunity. We work very closely with our Board in terms of creating a strategic intent, a strategic drive to bring the deals onboard. It has to be strategic. It has to be accretive. It has to return financially, it has to be a company that will benefit Baxter in the long-term. So if we don't find it, we use the money for something else and benefit the bottom line of the company like we did at the end of '18. But there's no urgency. I want our investors to know that this thing of having to make a deal to make '19 happen or '20 happen, it will help us get even better, but it doesn't mean that we need them. And we will not make stupid decisions to get to the -- to a number just because we have the cash. Thank you.
Matthew Miksic:
Thank you.
José E. Almeida:
Thanks, folks.
Operator:
Thank you. That concludes our question-and-answer session for today. Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone, have a great day.
Operator:
Good morning, ladies and gentlemen and welcome to Baxter International's Third Quarter 2018 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candace. Good morning, and welcome to our third quarter 2018 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; Jay Saccaro, Baxter's Chief Financial Officer; and Brik Eyre, President, Americas. On the call this morning, we will be discussing Baxter's third quarter 2018 financial results along with our updated financial outlook for 2018. A supplemental presentation to complement this morning's discussion can be accessed on our website. This presentation, along with related non-GAAP reconciliations, can be accessed on Baxter's external website in the Investors section under Events & News. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development and regulatory matters contain forward-looking statements that involve risks and uncertainties. And, of course, our actual results could differ materially from current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. On the call this morning, we will be discussing operational sales growth with adjust for the impact of foreign exchange, generic competition for cyclophosphamide in the U.S. and approximately one month of sales from the acquisition of Claris in July 2017, along with our acquisition of two surgical products from Mallinckrodt in the first quarter of 2018. Now I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Thank you and good morning. I will begin with some comments and perspective on our third quarter results. Jay will then walk through the financials and guidance in greater detail and we will close with your questions. Brik Eyre, whom may you know from our many investor conferences, will join us for the Q&A to provide additional insights on our U.S. performance. Baxter reported solid third quarter with sales up 2% on a reported basis, 3% on a constant currency basis and 3% operationally. On the bottom line, adjusted earnings per share were $0.80, increasing 25% year-over-year. Our strong earnings growth demonstrates the continued power of our operational improvement initiatives, and we see more potential for these efforts moving forward. Drivers of growth in the quarter included the company's Renal Care, Pharmaceuticals, Advanced Surgery and Acute Therapies businesses; increased demand for Baxter's contract manufacturing services also contributed to the performance in the quarter. This strength helped offset declines in our Medication Delivery and Nutrition businesses. Growth in Renal Care was primarily driven by increased patient volumes for our peritoneal dialysis products globally. In the U.S. this contributed double-digit PD therapy growth. In Asia Pacific we continue to see strong patient growth in China. And for the first time in years, we're experiencing positive patient growth in Japan following the launch of Kaguya earlier this year. In Pharmaceuticals, growth was driven by strength in the U.S. where we've experienced increased demand for our premixed injectables and extended our portfolio with addition of Claris products. Claris, which we'll now refer to as Baxter Ahmedabad, continues to deliver double-digit performance growth in line with our expectations. Increased sales of anesthesia and critical care products also contribute to the results in the quarter. Advanced Surgery achieved double-digit growth including a contribution of $14 million from sales of RECOTHROM and PREVELEAK. Acute Therapies also reported double-digit sales growth based on global strength across the portfolio. On Monday, this team initiated a worldwide launch of the leading-edge PrisMax system, beginning with 19 European countries. PrisMax is our next-generation technology for CRRT or continuous renal replacement therapy in organ support therapies. It offers ICU practitioners a broad range of advantages designed to make therapies simpler, safer, more accurate and more efficient. This is transformative innovation that builds on decades of Baxter market leadership in the acute care space. The strong results posted by this business was partially offset by performance in our U.S. Medication Delivery and Nutrition businesses, which were frankly disappointing. I can assure you that steps are already being taken to address these issues. It starts with decisive actions to put the right leadership in place, accountable for renewing the strategic momentum and forecast reliability that we and you expect. Overall, we remain on sound footing across a vast portfolio of products with market leadership positions. To be certain, we are in a period of course correction in a few key areas which we often occurs from time to time in a dynamic market like ours. Let me drill down a few key areas starting with supply disruption due to Hurricane Maria. It has now become clear that market dynamics have fundamentally shifted in a few of our market segments in the aftermath of Hurricane Maria, at least in the near to mid-term. While we have resumed production at pre-hurricane levels, the gap in bringing supply back to market ultimately cause a longer-lasting ripple effect for several products line. End customer demand has now fully resumed to prior levels. Specifically, with respect to small volume parenterals which include our MINI-BAG and MINI-BAG Plus lines, we have seen impacts from protocol changes such as moving to IV push for administration of drugs, as well as some moves to competitive products and supply constrained codes. While we expect to regain most of this business, we do anticipate it will take some time, particularly for the portion of the business that has moved to alternative practices for drug administration. We are continuing to reinforce the benefits of MINI-BAG Plus, emphasizing safety and reduced potential for medication errors. We're also reinforcing the availability of supply with our customers. For select U.S. nutrition products, we've seen some market contraction as a result of hurricane-related supply constraints, whether through providers delaying the start of parenteral nutrition and/or reducing dosage. We also experienced some shifts to outsource the nutrition compounding centers and competitive products. It is unlikely we'll regain all our lost sales here, particularly where we've seen market contraction, at least in the near to mid-term. We're in process of rebasing this business and expect to resume U.S. market growth of low single digits in the coming quarters. And while not directly related to the hurricane's impact on our production levels, the historic tight supply in the market for IV solutions has also impacted performance for the Medication Delivery business this year. Sales of large-volume IV solutions spiked in the first five months of the year, driven by increased purchases, given the protracted industry-wide supply challenges, coupled with an intense flu season. Customers rushed to acquire any available IV solutions products. This resulted in growing inventory levels across our customer base. Our forecast was built off this elevated run rate and didn't contemplate the level of inventory destocking we're currently experience as supply constraints have eased. In addition, the timing of having incremental beds in non-acute customer has fallen short of our expectations. It's important to note that the end user demand for our LVPs is up approximately 2% year-to-date. We believe this is slightly ahead of the market which we see as growing approximately 1%. So ultimately, while our overall share has remained stable, the impact from the inventory destocking as well as the timing of bringing on new customers has clearly been slower than anticipated. As a result of these market dynamics, we are resetting expectation for these businesses in 2018. Going forward, our expectation is that the Medication Delivery and Nutrition business will grow in line with our long-term outlook. Taken together, these learnings will help support greater predictability and forecast alignment. We have a unique portfolio of life-sustaining products and we've implemented some necessary changes that we believe will make our prospect both stronger now and over the long run. In summary, our diversified portfolio, accelerating innovation, strong balance sheet and relentless focus on operational efficiency give us the confidence and flexibility to deliver on our long-term financial objectives. With that, I will turn it over to Jay.
James K. Saccaro:
Thanks, Joe and good morning, everyone. As Joe mentioned, although we've experienced challenging market dynamics in select businesses, our third quarter results reflect the benefit of our diversified portfolio as well as our ongoing commitment to accelerating bottom line growth. I'll start by discussing our third quarter results before providing our updated financial outlook for 2018. Beginning with the third quarter, global sales of $2.8 billion increased 2% on a reported basis, 3% at constant currency and 3% on an operational basis. On the bottom line, adjusted earnings increased 25% to $0.80 per diluted share. This exceeded our previous guidance of $0.72 to $0.74 per share, driven by solid operational performance and ongoing benefit from our business transformation initiatives and the lower tax rate. Now, I'll walk you through performance by our regions and global business units. Note, for this quarter, constant currency sales growth is equal to operational sales growth for all businesses with the exception of our Pharmaceuticals and Advanced Surgery business. For these businesses, we will provide operational growth. Starting first with sales growth for our three regions. Sales in the Americas advanced 4% on a constant currency basis and 3% operationally. Sales in Europe, Middle East and Africa grew 4%, both constant currency and operationally. And finally, sales in our Asia Pacific region were flat on both a constant currency and operational basis. As a reminder, in the third quarter of 2017 we recorded $25 million of sales in our international compounding business due to an early contract settlement with one of our Australian hospital pharmacy customers, which impacted growth in the Asia Pacific region by approximately 4%. Moving on to performance by global business units. Global sales for Renal Care were $910 million, advancing 3% on a constant currency basis. Performance was driven by mid-single-digit growth for PD therapies globally, as well as low-single-digit growth globally for our in-center HD business. Sales in Medication Delivery were $652 million, down 3% on a constant currency basis, driven by the business dynamics that Joe walked through earlier. Pharmaceutical sales were $519 million, increasing 5% constant currency and 5% operationally. Sales growth in the quarter benefited from strength in our anesthesia business and increased demand for Baxter's injectable premixed drugs. Sales of U.S. cyclo were $40 million in the quarter and global Claris sales were $38 million. Moving to Nutrition. Total sales were $218 million, down 2% on a constant currency basis. Solid growth in international markets was offset by lower sales in the U.S., which Joe commented on earlier. Sales in Advanced Surgery were $200 million, increasing 15% constant currency and 7% operationally. As Joe mentioned, sales of RECOTHROM and PREVELEAK contributed approximately $14 million in the quarter. Sales in our Acute Therapies business were $122 million, representing growth of 10% on a constant currency basis, continuing the trajectory of delivering double-digit growth, driven by increased global demand for Baxter's continuous renal replacement therapies. Finally, sales in our other category, which primarily includes our contract manufacturing services, were $146 million, an increase of 17% on a constant currency basis. Performance in the quarter was primarily driven by increased demand for our contract manufacturing services, specifically our cytotoxic contract manufacturing services, as well as incremental production volumes for seasonal vaccines. Moving through the rest of the P&L, our adjusted gross margin of 46.3% increased 100 basis points over the prior year, benefiting from favorable product mix and manufacturing efficiencies. Adjusted SG&A totaled $622 million, decreasing 1% on a reported basis and flat on a constant currency basis. We continue to see a positive contribution from our relentless focus on effective expense management and business transformation initiatives, which helped to offset the loss of approximately $10 million in transition service income from Shire and incremental expenses related to our recent acquisitions. Adjusted R&D spending in the quarter of $153 million increased 3% on a reported basis and 4% on a constant currency basis versus the prior year period, as we continue to invest in high-impact programs to accelerate innovation at the company. Adjusted operating margin in the quarter was 18.3%, an increase of 170 basis points versus the prior year. Growth was driven by strong operational expansion as well as continued effective expense management. Net interest expense was $11 million in the third quarter, reflecting higher levels of interest income due to rising interest rates and other income totaled $32 million in the quarter, primarily reflecting a benefit from the recent changes we made to our U.S. pension plan, along with foreign exchange gains on balance sheet positions. The adjusted tax rate was 17.1% for the quarter, which includes a benefit of $9 million from stock compensation. This came in favorable to our expectations, driven primarily by certain discrete items recorded in the quarter. And as previously mentioned, adjusted earnings of $0.80 per diluted share exceeded our guidance of $0.72 to $0.74 per share. During the quarter we repurchased $247 million or 3.3 million shares of Baxter stock. These repurchases were partially offset by option-related dilution in the quarter. Before turning to 2018 outlook, I will briefly comment on our cash flow performance. In the first three quarters of 2018, we generated free cash flow of $873 million with improvement in net income offset by higher inventory levels as we worked to rebuild supply for select products to ensure adequate product availability. Let me conclude my comments this morning by providing our guidance for the fourth quarter and full year 2018. Given the market dynamics we discussed for our U.S. Medication Delivery and Nutrition business, we've lowered our sales forecast for the year. Globally we now expect 2018 full-year sales to increase approximately 5% on a reported basis. We now expect growth of approximately 4% on a constant currency basis and approximately 3% on an operational basis. Moving to full-year guidance by business on a constant currency and operational basis, except where otherwise noted. In Renal Care we continue to expect growth of 3% to 4%. In Medication Delivery, we now expect sales to decline low single digits. We now expect our Pharmaceuticals business to increase high single digits at constant currency. This assumes 2018 U.S. cyclo sales of $160 million, above previous guidance of $130 million. We continue to expect full-year Claris sales of approximately $145 million. Adjusting for cyclo and the first seven months of Claris, we now expect operational sales to increase approximately 7%. Moving to Nutrition, we now expect sales to decline low single digits. For our Advanced Surgery business, we now expect sales to increase approximately 10% on a constant currency basis. This includes a contribution of approximately $45 million related to the acquisition of RECOTHROM and PREVELEAK. Excluding the impact of these sales, operational growth is expected to be approximately 4%. For the Acute Therapies business, we now anticipate growth of 10% to 11%. Finally, in our other business, we now expect growth of high single digits, given increased demand for our contract manufacturing services. Moving down the P&L. We now anticipate adjusted operating margin expansion of approximately 100 basis points. We expect net interest expense of approximately $45 million and other income of approximately $105 million for 2018. For the year, we continue to expect an adjusted tax rate of approximately 17%. For full-year 2018, we anticipate a diluted average share count between 545 million to 550 million shares. Based on these factors, we expect 2018 adjusted earnings, excluding special items, of $2.98 to $3 per diluted share. Finally for the year, we now expect to generate operating cash flow of approximately $2.2 billion, with capital expenditures of approximately $700 million and free cash flow of approximately $1.5 billion, down slightly from our previous guidance due to higher inventory levels. Specific to the fourth quarter of 2018, we expect sales growth of approximately 1% on a reported basis and between 3% and 4% on both a constant currency and operational basis. And we expect adjusted earnings excluding special items of $0.71 to $0.73 per share. That concludes my comments. We can now open the call for Q&A. As a reminder, also on the call today is Brik Eyre, President, Americas, to join us during the Q&A. Candace?
Operator:
Thank you. We appreciate everyone's patience and would like to provide as many of you as possible with the opportunity to ask a question. We'll pause for a moment while the list is being compiled. I would like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. And our first question comes from Bob Hopkins of Bank of America Merrill Lynch. Your line is now open.
Bob Hopkins:
Oh, thank you and good morning.
José E. Almeida:
Morning, Bob.
Bob Hopkins:
So thanks for taking the question. I guess my concern looking at the last two quarters is that at least some of the issues that you're facing seem a bit structural given that you're experiencing share loss and a move to some alternative, cheaper technology. So I guess my question is this
José E. Almeida:
Okay. Bob, I'm going to pick up half of the answer here and I'm going to pass to Brik to get a little bit more color on the question on the share. First of all, there were shifts in the market, because us not having MINI-BAGS and MINI-BAG Plus and amino acids. We actually were the ones teaching our customers how to use alternative methods. Some of them will come back and we expect in 2019 to pick up a portion of that without a problem. The other ones will take a little longer for us to convert, because those are medical practices. You have a significant amount of hospitals in the country and we have large market share. I would say that, we don't see the issues that we experienced in 2018 by rebasing 2018 to affect tremendously growth rates going forward. So as a matter of fact, I would say that the full year of 2018, the results are the base for the LRP that we present in May, which runs from 18 to 23. So using the projected performance of 2018 that we just shared with you, we are not revising our long-term guidance for total Baxter, either the top or bottom line. So there are structural issues that take a little longer to resolve, but we have not lost any customers at this moment. And we may have lost some temporary share in accounts where some fluids are being substituted which we expect from the mid to long term to recapture. I'd like to see if Brik would like to add anything to it.
Brik V. Eyre:
Yeah. Thanks Joe. Bob, let me talk about a couple of segments of the business. So first our small-volume parenterals. So these are 50-, 100-, 150-milliliter bags that are used to administer, infuse medication to patients. In that segment, when there were no products that our customers could find, about 25% of the doses that have historically been used or been administered through infusion using our MINI-BAG and MINI-BAG Plus products, had to find other ways to administer those drugs. A portion of that went through a new practice which is IV push. Now to be clear, IV push happens in every hospital every day across the country, typically in OR drugs, et cetera. But in this particular case when there was no product, specifically cephalosporins, penicillins, those anti-infectives were moved to an IV push. This practice is, the nurse literally takes a syringe and dilutes the drug into 5 ml, 10 ml worth of diluent and then injects it into a port that is at the hand where there's access to the vein. And then they will do that over a period of time. There are some safety concerns, et cetera, that we are talking with our customers, but some customers have moved to IV push. And in so doing, they have to change their protocol. They changed their protocol, they changed their system, et cetera. So while we do believe we will get this back, it's taking a little bit more time than we had anticipated. Other customers went to competitive products. We actually feel very confident that we will get those products back and we're working with our customers now to ensure that they understand that we have capacity, supply, et cetera. Now the other component of this is Nutrition that was impacted from the hurricane perspective. The Nutrition business actually did contract, the market contracted. Whereas Joe mentioned in the opening comments, when customers didn't have product, they delayed start times, et cetera. So believe the overall nutrition market has contracted about 7%. We have also lost some share, because we didn't have product and we are working again with customers to get that share back. So while we don't think it's a long-term piece, certainly over the next few quarters we anticipate seeing a ramp-up of bringing those products back to us. But anything that required a change in protocol will take a little bit more time.
Bob Hopkins:
Thanks for the clarity there. Just a very brief follow-up. Joe, is now the right time to be more aggressive with the balance sheet relating to buyback, given your confidence that these things will be temporary?
José E. Almeida:
I would say that with the capacity that we have and we're going to look at the sentiment of the investors, it's always a good time at this moment to look at some buybacks. But also, we continue to use a significant amount of efforts inside Baxter in the M&A space. So we want to make sure that we have capacity to do all the above, continue to increase our dividends annually and buy back shares and have plenty capacity to go after M&A targets which has a renewed and very focused effort at Baxter.
Bob Hopkins:
Thank you.
Operator:
Thank you. And our next question comes from Vijay Kumar of Evercore. Your line is now open.
Vijay Kumar:
Hey, guys. Thanks for taking my question. And maybe, just going back to Bob's question on some of the disruptions you guys have had. And this is a little unusual for you guys, where the Street's gotten used to stellar execution. So I just want to understand the dynamics, right? So you had – I think Joe you mentioned LVP. So if I'm understanding what happened on the LVP side is customers pre-bought, as in, they built up inventories. One, how long does it take for them to work through those inventories? Should we still be expecting impact in first half of 2019? And then back to, I guess, Brik's sort of – Brik, thanks for that explanation on the push syringe impact. But I would think like, I mean, for 50 ml to 100 ml bags, someone pushing in, using an IV push, that's a lot of inconvenience from a time, use of time perspective in the hospital for the nurse. I'm just trying to think whether all of that comes back, or if the assumptions around why some of that may not come back.
José E. Almeida:
Vijay, good morning. So I'm going to have Brik answer 95% of your question. Just want to go back to the LVP. We now have a very good understanding of what happened in terms of stocking and destocking. As I said, we haven't lost a customer, but what we learned from this whole thing was that there was a pattern of purchases that were, for many years, in place due to product allocation that customers would buy whatever was available for them to buy, because was usually a little less than they would wish to purchase. We have created significant flexibility in the supply chain. And for the first time we are in the market with no allocation which creates flexibility for us not to sell in U.S., but sell the product in other parts of Latin America like we just did the other day in Mexico; extremely well-executed flexibility in supply chain. So we are going into a new era of LVPs where not only our plant in North Cove has done extremely well remediating and improving the output of the plant. So at the same time, we're resolving long-lasting quality issues. Things of the past are being resolved effectively. That plant is also now surpassing capacity plans, because it's doing so well. We have capacity in Mexico, Ireland. So we now have the ability to really put the product to work. And this will be fundamentally important for us to re-sign customers up where we signed in the past. So we talk about execution. We had an execution issue in the short term by having a team that did not understand what was happening with the difference between inventory, end distributor and demand at the end of the day. It didn't change the dynamics. We did not see the signal and we should have seen that and communicated more effectively. So to that end, we are relentless in execution. That's why we made significant changes in the U.S. team and have replaced people, in process of replacing people who did not understand how we operate. I want to pass on to Brik to speak specifically about the push and how this business can come back in terms of market share as well.
Brik V. Eyre:
So Vijay, thank you. I just want to make sure I'm clear. In the package insert for administration of a ceph or a pen, for example, there's a couple ways that they can do that. They can put it into a MINI-BAG and infuse it over 30, 45 minutes of an infusion or – and that would be like 100 ml. Or you can inject it driving push with 5 ml to 10 ml of diluent. And so, they're not doing an IV push of 100 ml. It is 5 ml to 10 ml. Now, they will do that over a three to five minute period of time. It will say in the package insert how long they should wait. The practical reality is studies have shown that a lot of times they don't wait that long to push it and so there could be an overprescription, overdosing and there could be a medication error. And that's one of the things that we're talking to our customers about. So IV push, the issue really is they're comfortable with IV push for certain drugs, but those drugs that can be infused, cephs, pens, et cetera, really the best way to administer that drug is through MINI-BAGS, and that's what we're talking to our customers about. Now I might take just a moment on LVPs to add just a little bit of color. This has been a business that's been highly successful for us for a number of years and it's driven tremendous, tremendous growth. And the vast majority of that comes from new customer sign-ups. As you know, over the last five or six years, we've actually signed up to three- to five-year contracts about 100,000 beds. So tremendous market shifts over the last five, six years in our business from an LVP perspective. And that has been – that coupled with an industry challenge in supply, our customers virtually purchase almost everything we could produce. In fact, these products have been on allocation. So we allocated a number of units that each customer could buy based on historical performance, because we had to do that to make sure that we got product to every customer. As we discussed and as Joe just discussed, as we brought more product from Latin America, we were able to increase the allocation to customers above their historical usage, and ultimately to remove that. As we did that, the demand for our products was tremendous in the first half of the year, particularly in the first quarter as customers were concerned, and distributors as well, were concerned about the hurricane disruption of the market in general, as well as products that have just been on allocation for a long time, exacerbated with a larger flu impact that we had earlier this year. So there was tremendous, tremendous demand for our product. And then our U.S. team took that run rate on product that has always been able to -whatever we manufacture, people purchased over the last five years because of allocation and used that for our forecast the back half of the year. And they did so not realizing that distributors and customers purchase significantly over the end user demand the first half, most notably in the first quarter as I mentioned. Now the good news is that those distributors have worked through that inventory. Caused a significant impact in the third quarter, but we believe that we are close to being back into equilibrium. We've been in contact with our distributors, our wholesalers. We know our end user demand. We get tracings from our distributors. So we really improved our analytical capabilities and certainly we will be at equilibrium over the next couple of months.
Vijay Kumar:
That's extremely helpful, Brik. And maybe, Jay, just on the margin front, that was a stellar standout, right, in terms of the positives. Irrespective of what the top line was, I mean, you guys have executed on margins. But as we – it looks like maybe Q4, maybe there are some below-the-line items impacting. I'm having a little bit of a hard time getting to the low end of that EPS guide range. And when we look at 2019 just qualitatively, should we be assuming some of these revenue headwinds persist? But on the margin front, the guide that you guys laid out at the Analyst Day, nothing changes on the margin front. Thank you.
James K. Saccaro:
Sure. Vijay, let me talk a little bit about Q4 and our expectations there because to your point, while in second half of the year we were pleased to be able to confirm the overall guidance at the high end of the range, you point out very accurately that the Q4 implied guidance is down relative to what we previously shared. There's a few factors in play here, the largest of which is this issue that we've highlighted and discussed extensively about Medication Delivery and Nutrition. Overall, as we think about the impact in the fourth quarter relative to our prior expectations, that's about $0.06 of impact. Now offsetting that is savings initiatives that we have in place, roughly $0.01; cyclophosphamide impacts approximately $0.03. And then there are a couple of financial adjustments, or financial items I should say, related to foreign exchange and tax. We have taken – we reduced our expectations with respect to FAS 123R, so you do see a bit of tax uptick. But in combination, foreign exchange and other financial items impact us roughly $0.04 in the quarter. So in combination, all of those items take us roughly down $0.05 midpoint to midpoint in the fourth quarter. As it relates to 2019, we'll stop short of giving guidance for that today. We do believe that there's real opportunity to recover and I think Brik has discussed that extensively as has Joe. But as far as specific guidance for 2019, we'll stop short of that. We have reiterated confidence in the long-range plan that we shared which shares through 2023 with also 2020 numbers.
Vijay Kumar:
Thanks, Jay.
Operator:
Thank you. And our next question comes from Robbie Marcus of JPMorgan. Your line is now open.
Robbie J. Marcus:
Great. Thanks for taking the question. I wanted to ask about some of the businesses that did well in the quarter, particularly Acute Therapies and Pharmaceuticals. These are ones where we've seen trends progressing positively each quarter. Can you help us understand Pharmaceuticals, what's driving that, how sustainable it is? And then in Acute Therapies, there were some new product launches recently. Can you help us understand the impact from those going forward?
José E. Almeida:
Can you repeat the second part of the question? I understood the Pharmaceuticals. I missed....
James K. Saccaro:
Acute Therapies and new product launches.
José E. Almeida:
Acute Therapies, okay. Robbie, we had an extraordinary performance in the Pharmaceuticals business. Some of that is our capability of producing products that others can't and being there all the time. Cyclophosphamide is one of them despite the fact there's the new competitor that was authorized by the FDA to produce. We haven't seen the product coming out of this manufacturer yet. It's a very difficult product to make. We're not saying that we're the only ones who can because there's another competitor in the market. Sandoz has their product out there. But at the end of the day, we can make oncolytics and cytotoxics extremely well, one of the best in the market. We have BREVIBLOC that we do well and also TDS which we source and be able to have the product for our customers. We don't see these products repeating the same performance all the time because as the nature of the business being when we can produce then people can't, people sometimes come back to the market. BREVIBLOC is one that now has couple other manufacturers on the market, but we are always hedging our capabilities. So the performance of the Pharmaceuticals have been driven primarily by our ability to execute versus others who can't. I will give you a little bit of a mid to long-term view of Pharmaceuticals. It's just our ability to continue to look into acquiring molecules which we've been doing. Second is our commitment to deliver on the LRP that Brik had presented at the Investor Day. We are still on track for all of that. Moving to the Acute Therapies, and then I just want to say that we just launched PrisMax. Great product, launch in Europe. It's going to launch in the U.S. following. We are very excited. We're number one in this therapy around the globe. You can see by the performance of this business and the performance of a competitor that just released earnings the other day, specifically yesterday, that we continue to be very successful in gaining share and also creating adoption for this technology. Just this proves this is a structurally sound business and we're very happy with the execution. I just also want to take the opportunity to mention things are going well to underscore our launch of PD business and a relaunch of our PD business in Japan with great success and a 10% growth overall in China on all of our businesses combined. So we have some really good stuff happening. The unfortunate part is that we've missed some of the market signals in the U.S. that created a headwind for us in Q3. (41:27) create in Q4 and we'll recover probably through 2019 into 2020. So we have some really good businesses within the company. They are really good cash generators and also we have a good and sound pipeline coming out on the company in 2019 and 2020.
Robbie J. Marcus:
Okay, great. And I know there've been a couple questions on Medication Delivery, but just to look at it from a different angle; I haven't heard anything in terms of how infusion systems have done in the quarter year-to-date. Maybe how that's playing out with the systems you launch. And then also can you comment on large volume pricing? You've said that volumes were up 2% year-to-date. How does the pricing situation look for first half and then versus third quarter? Thanks.
José E. Almeida:
Robbie, just want to amend my answer on Pharmaceuticals. There are premixes which are replacements for me – we would sell premixes every day of the week in detriment of MINI-BAG Plus, okay? Because premix carry higher margin and they're up 18%, and they're reflected in Pharmaceuticals. They're not reflected in SVPs. Just want to highlight that because I missed that in my answer to you. So to the folks on the call, premix has done extremely well, just the GALAXY product and those were ones that we told the customers to substitute for when we did not have MINI-BAG Plus available after the hurricane. So this is the positive side that we did not talk about. Let me pass on to Brik to answer the rest of your question.
Brik V. Eyre:
So Robbie, relative to pricing with LVPs, nutrition et cetera, the reality is these are products that are on longer term contracts that have modest price increases built into those contracts. So pricing remains in line with our expectation across all of those product lines. Relative to infusion pumps, we continue to believe that we will pick up approximately 1% of market share this year in the United States with our Sigma Spectrum pump. We have found that as more customers desire to have auto programming, one of the key features of our new pump that we've recently launched, our Spectrum IQ, which we sometimes referred to as version nine and other integrated features, the selling cycle has lengthened a little bit. And so IT is now involved at a much higher level, at a hospital level or at a hospital – in each of our hospitals. And so we did reduce our pump number a little bit in the back half as products slip out into next year. But overall we anticipate picking up the one percentage point as we had suggested earlier on with the new launch of Sigma Spectrum.
Robbie J. Marcus:
Thank you.
Operator:
Thank you. And our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Ryan Lewis:
Good morning.
José E. Almeida:
Morning.
David Ryan Lewis:
Maybe, Jay, just start – morning, guys. Just start, Jay, with you a question on free cash. Just free cash flow growth reversed a bit second quarter to third quarter. So I imagine there's been some supply chain reinvestment. Could you just walk us through second quarter to third quarter? And as you think about, so next year, do you think free cash flow gets back to that historical double-digit growth rate?
James K. Saccaro:
Yeah, look, thinking about overall performance from a free cash flow, year-over-year, I think we're still talking about north of 20% growth, so very solid growth from 2017 to 2018. You'll recall earlier in the year we raised free cash flow guidance. We have subsequently lowered it. And really what that has to do with is a couple of the factors that we discussed during this call. One is to the extent that you fall short on a sales forecast, it's very difficult to adjust your supply chain planning such that there's not an inventory build that takes place. The second thing is we're very pleased with the performance coming out of our North Cove manufacturing facility but that has been overproducing in terms of getting fully back up to speed ahead of our expectations which is another factor contributing a bit to the inventory build. And then as we said earlier, when we look at year-over-year performance, we did make some strategic decisions to make select product inventory builds. So really, those are the three factors that we see. We do not see this as a structural issue. And frankly, once we kind of tighten up our forecast going into next year, this will be an opportunity for us to claw this back. So this year, if we think about the progression of free cash flow, we've gone from $300 million in 2015 to $1.5 billion in 2018. Inherently, and when you see that kind of extraordinary growth, there will be some volatility and some puts and takes. We wanted to make sure we share, obviously, the most updated thinking in terms of where we see this landing. But like I say, I don't believe this is structural issue that we're faced with and we will plan accordingly as we look to next year.
David Ryan Lewis:
Okay. Thanks, Jay. And just maybe two quick follow-ups. The first is for Joe or for Brik. We haven't heard a lot about the SVP manufacturing dynamics in Puerto Rico. How do they trend here in the third quarter and what's the pathway to approval? Then Jay, sorry. Just for the fourth quarter assumptions, we have two different dynamics
Brik V. Eyre:
So let me first talk a little bit about SVP, David. Our production level is back where we want, need it to be, et cetera. We were able to put MINI-BAGs back in the channel kind of mid-July, so mid-summer, and we're starting to see an impact of having that back in the channel which is a good thing as customers can buy from their primary distributors. MINI-BAG Plus just went back into the channel in September. We are healthy on most codes of MINI-BAG Plus. We've got one or two codes that we're still getting healthy on, but the vast majority of our business, we're very healthy now from a inventory perspective and we are working, again, diligently with our customers relative to ensure that they have confidence in our ability to supply.
James K. Saccaro:
And then, David, from a fourth quarter financial forecast, we've spent a lot of time with a bonds up build up, trying to be appropriately conservative as we look across the portfolio. And that includes LVPs. That includes SVP recapture and so on. And so I think we've got the right number as we look to Q4 in the guidance that we shared.
Brik V. Eyre:
The only other thing I might add, David, is we have launched a new product which is sourced out of Castlebar, which is a single-pack MINI-BAG Plus product, which we're really excited about. From an operational efficiency perspective in the hospital, it's been very, very well received. And so this continues to diversify our risk as we have other sites manufacturing this MINI-BAG Plus product that is such a great product for us.
David Ryan Lewis:
Thanks so much, guys.
Brik V. Eyre:
Thank you.
Operator:
Thank you. And our next question comes from Larry Biegelsen of Wells Fargo. Your line is now open.
Lawrence Biegelsen:
Good morning. Thanks for taking the question. One on the P&L, one on capital deployment. So Jay, in the past you've been very helpful in pointing out kind of headwinds in the subsequent year and you guys have been very good at being able to overcome those headwinds on the P&L. So for 2019, you have currency, cyclo BREVIBLOC, maybe on other income and tax, potentially as headwinds. And in the aggregate, by our math could reduce 2019 EPS by about $0.40. So can you walk us through some of the P&L headwinds next year and help us understand if you can still grow EPS at a double-digit reported rate in 2019? And I had one follow-up.
James K. Saccaro:
Yeah, sure. Larry, stay tuned. Come join us on I think January 31 or February 1 for guidance for 2019. At this stage, I think it's premature. What we've said is we've shared financial guideposts for 2020 and 2023. There are numerous puts and takes of which we've confirmed and feel confident in. There are numerous puts and takes as we look at any given year, and our objective is to do as well as we possibly can do in any given year. And so certainly things like new product launches are things that we'll highlight as we come to our earnings call at the beginning of next year. But like I say, it's too premature to give 2019 guidance at this point.
Lawrence Biegelsen:
Understood. And Joe, regarding M&A at our healthcare conference, Jay, not to get you in trouble but you said Baxter is agnostic to deal size which surprised me a little bit. So Joe I thought you had a strong preference for smaller deals because it was hard to get a good ROIC from larger deals. So my question is has anything changed? Thanks for taking the questions, guys.
José E. Almeida:
Thank you. Trying to figure out if Jay and I are on the same page and we are actually. Jay called me right before he said that, said, can I say that and I authorize him to say that without being present. We are looking at any opportunity that we have, either adjacent to the core or completely outside of the core in terms of another leg to the stool. And why do we take the constrain of size? Because that creates an issue in selecting targets. Not necessarily that we will execute on them, but being agnostic of size what, Jay meant to say was that we are looking at every opportunity that will get us what we need to do which is to refresh the portfolio of Baxter to create momentum on the gross margin line, augment growth on the top line and be accretive to the bottom line. We're doing this. And by taking the size from the restriction, we can see better what's available to us. But let me also put a commentary that was implied in Jay's response to your question during your conference. That is, we will push the boundaries of our debt ratio to the limit of investment grade but not go below that. So that creates a size limitation of what we can do okay? Secondly, I have to say to you that what Baxter has done in terms of its business transformation and why we're able to bring to the company when I first started about exactly three years ago yesterday, we had 9% of operating income and now we are above 18% of operating income. That transformation of a company is difficult to achieve. But once you know and learn how to do it, it is paramount on the acquisitions. So if you think about when we talk about sizes and how we do it, it's not about integration per se but it's our ability also to go in with that mentality, with that trademark and get the savings out of the target independently, if the synergies are all in terms of connecting systems and doing the stuff that more traditional people think about. I'm coming from a different angle that said that is doable, but the first thing we'll do, we'll put a business transformational office identical to what we have in Baxter at that company. And we're going to remove the cost in this path that companies usually have in the medical technology and generics pharmaceutical business. So, it's a long answer to you to say that we are looking at multiple size deals. We're looking for in also adjacencies and outside of our space within the healthcare, but also we have the ability to really be a cost-driven organization that can extract value from a target, even if it's not core or highly synergistic to us.
Lawrence Biegelsen:
Thank you for taking the questions.
Operator:
Thank you. And our next question comes from Larry Keusch of Raymond James. Your line is now open.
Lawrence Keusch:
Yeah, hi. Good morning. Just wanted to – we've obviously spent a lot of time on LVPs and SVPs, but wanted to come back to nutrition and just get some thoughts as it relates to sort of the protocols changing in terms of delayed starts for nutritional products. How do you influence that to kind of go back to where it was? Because I guess my concern is that could become a bit more permanent.
Brik V. Eyre:
So, Larry let me take that if I can. Certainly it's more problematic when protocols change. But ASPEN, The American Society of Parenteral and Enteral Nutrition, wrote some guidelines to help people when they were in conservation mode. There are guidelines for feeding. And while these patients are typically really, really sick, they don't have gut function; that is why they're on parenteral nutrition. So, it's very difficult to be able to track specifically what the clinical outcome is to – there are so many different inputs. But if you take a step back, we do know and there's good data that would suggest that outcomes are better when a patient is nourished appropriately and effectively. So, we are working with all of the societies now that there's an appropriate supply to see if we can't help customers go back to feeding protocols that have been established by ASPEN here in the U.S., by ESPEN which is in Europe, to help make sure that patients are fed appropriately. We'll continue to work with those societies, continue to work with our customers. But as you mentioned, when a protocol changes in the hospital, it just takes a little bit more time to get it back. We're working very closely with our customers and they do recognize the importance of feeding. And we just have to make sure that they're confident in our supply chain and the supply chain of the market in total. And to your point and just from a framing perspective, about 7% of the market contracted and we will be working over the next several quarters to bring that back.
Lawrence Keusch:
Okay, perfect. And then two other perhaps quick ones. I think, Joe, you may have mentioned in your prepared comments about some management changes following some of the forecasting missteps, if you will, relative to the business. So, again, I want to make sure I heard that and kind of what the plans are there. And then for Jay, just on the gross margin expansion year-over-year which was clearly impressive, just trying to understand the components that drove that expansion if there any one-timers there. Thank you.
José E. Almeida:
We always look at execution at Baxter in a way that is pretty straightforward. Some stuff we expect from people to accomplish at a certain level. Understanding their market's the first one. So, when people don't understand their markets or they have been complacent in doing their jobs, it's our responsibility as leaders to identify that, either correct with the personnel that we have or just replace. So that's what we did. And we do that all the time in all businesses. We have significant changes. For instance, we made significant change in the international business of Baxter. Was really under-managed to be honest with you, and we brought some really good people in and we start seeing the performance going up. Brik had issues with the performance in the hospital business in the U.S. and we just did the same thing. So it's pretty straightforward. No different than I would have done in any other prior jobs, but we take performance very seriously. We take performance as the number one criteria only second to ethics and compliance.
James K. Saccaro:
As it relates to gross margin, which was a bright spot in the quarter, the lion's share of the improvements relate to cost initiatives and business transformation. As Joe mentioned, the margin journey that we're on is something that initially was focused primarily on SG&A as that was the fastest area to take out. But now under the leadership of Scott Pleau, we've been able to make changes to our operations network, to facilities, to optimizing within facilities. So probably 75% of our margin improvement year-over-year relates to some of these cost initiatives. And perhaps 25% or so relates to mix and operational growth that took place in the quarter. So, on balance, as we look from 2018 to 2023, you can expect to see more progress driving cost out with a lot of that coming from the gross margin line in the coming years.
Lawrence Keusch:
Okay, terrific. Thank you.
Operator:
Thank you. And our final question comes from the line of Joanne Wuensch of BMO Capital Markets. Your line is now open.
Joanne Karen Wuensch:
Good morning and thank you for taking the question. There are a number of new products that you're launching right now in the second half that should benefit you in 2019
José E. Almeida:
Yeah. Joanne, clearly we are looking into 2019 to be a year that we're going to have growth. The question that we're going to tell you how much the growth is going to be is going to be a conversation in January. Those products will contribute and we're counting on them to help because, as you see, some of this change that Brik just mentioned in nutrition is several quarters in the making to recoup that kind of a sales volume. So those new products will be key. We're counting on PrisMax. I think dexmed [dexmedetomidine] is one that we're very excited. Once we launch that, is actually doing very well. We have four new molecules launching next year as well. So one thing we have proven is the ability to really ramp up quickly to big sales on those molecules. If I'm not mistaken, dexmed [dexmedetomidine] peak sales will go into 2019, will get into 2019 pretty quickly. So we need those products. We're counting on Kaguya next year to be a driver in Japan because the profitability, not as much sales growth as much as the profitability. That product has showed that the patient in Japan are highly profitable in terms of our reimbursement. So we are counting on those products without a doubt. And for me, and this is a message that I give to Brik, to Cristiano, who runs Europe, Middle East and Africa, and Andy Frye, it's all about executing on those new products. They have the message. They know what needs to be done and we're counting on them. Thank you.
Joanne Karen Wuensch:
Thank you. And as my follow-up question, you mentioned that you're a little bit more revitalized on the M&A focus and you gave a great answer earlier to what you were looking for in terms of size. But is there anything in particular that has made you revitalized? Is it the business as we're seeing today? Or is it just opportunity or something else? Thanks.
José E. Almeida:
If you think about the transformation, Joanne, I put that in three different phases and some of them are all in parallel. But the M&A was the one and the portfolio revamping and transformation of the portfolio is one that had to come after two things that we had to do. We need to put the house in order in terms of organization structure, finance, balance sheet and culture. Once we get those things done and we have our own organic programs, now we have a team that is working diligently on finding opportunities for us to tag along. So if we don't have those things in place, we couldn't do the other. I couldn't come up six months into this job and say we're going to buy this company and that company. We didn't have the balance sheet. Now we do. Not only that; we have the strategy and we have competent leaders for the most part that we're making sure that we can execute on this. So as we make adjustments to our organization, I have to say that the people and the employees of Baxter have done a significant amount of heavy lifting due to so many headwinds that we had with this hurricane, anticipated and unanticipated, because some of this stuff caught us by surprise. Not because we didn't prepare, but because the long-lasting effect. But the people of Baxter have worked relentlessly and get this done. Now it's time for us to really get the M&A going as these things are starting to get behind us.
Joanne Karen Wuensch:
Thank you. And happy Halloween.
José E. Almeida:
Happy Halloween as well.
Brik V. Eyre:
Happy Halloween.
Clare Trachtman:
Happy Halloween, Joanne.
José E. Almeida:
Thank you.
Operator:
And that concludes our question-and-answer session for today. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating. Everyone have a great day.
Operator:
Good morning, ladies and gentlemen and welcome to Baxter International's Second Quarter 2018 earnings conference call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. As a reminder, this conference call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candace. Good morning, and welcome to our second quarter 2018 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer, and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's second quarter 2018 financial results along with our updated financial outlook for 2018. A supplemental presentation to complement this morning's discussion can be accessed on our website. This presentation along with related non-GAAP reconciliations can be accessed on Baxter's external website in the investor section under Events & news. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product developments, business developments and regulatory matters contain forward-looking statements that involve risks and uncertainties. And, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Thank you, Clare, and good morning to everyone joining us. I'm going to share a few comments on our second quarter performance. Then Jay will walk through the financials and guidance in more detail. And we will close as always by taking your questions. I would like to start by saying how energizing it was meeting with so many of you face-to-face at our investor conference. Thanks also to those of you who attended online or watched the replay. Our team was excited to share the next chapter in Baxter's story, our progress to date and more importantly, our opportunities and outlook ahead. We've set a clear path to deliver approximately 5% compounded annual growth through 2023. We will accomplish this objective by building on the strength of our base business and accelerating innovation. As we shared at the conference, we plan to introduce new therapies and products that I expect to contribute approximately $1.7 billion of sales by 2023. At the same time, we remain relentless focus on enhancing operational efficiency to deliver increased value to shareholders. And we will augment this performance with business development, expanding into new adjacencies and unlocking new markets to drive incremental value for all the stakeholders. Now turning to the quarter. Second quarter 2018 sales were up 9% on a reported basis, 5% on a constant currency basis, and 4% operationally. Second quarter operational sales adjust for the impact foreign exchange, generic competition for cyclophosphamide in the U.S., the Claris acquisition, and our acquisition of two surgical products from Mallinckrodt. The strength in the quarter was driven by double digit growth in our Pharmaceuticals business, which benefited from increased sales of injectable pharmaceuticals in the U.S. and the addition of Claris, which contributed $33 million of sales in the quarter. We also experienced double digit growth in our Advanced Surgery business driven by solid international performance and the addition of RECOTHROM and PREVELEAK, which contributed $17 million of sales during the quarter. Our Acute Therapies business continued to deliver double digit growth for the company. Performance in the quarter was driven by 20% growth in the U.S. where we remain focused on increasing CRRT adoption and securing new customers. Increased demand for our contract manufacturing services as well as solid growth in our Renal Care business also contributed to growth in the quarter. This momentum helped to offset declines in Medication Delivery and Clinical Nutrition. Digging into these specific performance a bit further, with respect to large-volume parenterals, or LVPs, we continue to gain new customers in U.S. following the reallocation of volume from Mexico to the U.S. But the uptick in timing of these additions has been somewhat slower than anticipated. We are confident in our ability to continue to gain additional new customers in the second half of the year. Performance in Medication Delivery was also impacted by the lower sales of small-volume parenterals, or SVPs, in the quarter. While production volumes continue to improve, supply of these products has remained tight. As such, we were unable to restore our distribution partners back to pre-hurricane supply levels for all SVP product quotes during the quarter. Given current production levels, we expect this supply dynamic for SVPs to improve in the coming weeks. For our nutritional therapies, we have experienced a delay in customers returning to their historical purchasing patterns that preceded Hurricane Maria. Our marketing teams are working closely with our customers to reinforce availability of products and recapture those sales. Overall, our sales performance conveys the strategic benefits of our diversified portfolio, helping to ensure that temporary headwinds in certain areas are counterbalanced by performance company wide. On the bottom line, adjusted earnings per share was $0.77, a 22% year-over-year increase. This reflects the impact of our top line growth as well as the ongoing impact of our business transformation initiatives. At the investor conference we emphasized that product innovation is central to our go-forward growth strategy. Some key recent highlights reflect this commitment. Expansion of the company's Medication Delivery portfolio with two new innovative drug infusion pumps. FDA and Health Canada approvals of the Spectrum IQ Infusion System with those IQ Safety Software. Our latest smartphone platform features bidirectional EMR integration and other enhancements to help reduce programming errors and enhance patient safety. CE Marking for the Evo IQ Infusion System in the United Kingdom and Ireland, representing the first in a series of planned regulatory submissions internationally. In Canada, we advanced the launch of a new indication for our oXiris set. oXiris is the first blood purification set that can be used in continuous renal replacement therapy, CRRT, and sepsis management protocols, and it is now approved in more than 30 countries. And we introduced key program updates for our SHARESOURCE remote patient management platform to support greater accessibility and efficiencies in remotely viewing PD, patient data. Another theme at the Investor Conference was addressing our untapped potential in Japan. In Q2, we continued the successful rollout of our Kaguya APD system with embedded SHARESOURCE technology, which targets Japan's unique market needs. Plus, we have recently initiated the launch of our Prismaflex system, which positions Baxter in Japan as the only comprehensive one stop partner in the acute care space. Before closing, I would quickly share a few words about Claris. As you know, last week, the FDA released a warning letter regarding our legacy Claris Injectables' facility in Ahmedabad, India. The FDA initiated a site inspection at the time of the closing of our Claris acquisition, which took place one year ago this week. We have already taken many corrective actions in response to the FDA's original Form-483 observations. We are continuing to undertake actions and facility improvements as we integrate Ahmedabad into our Baxter Quality Systems. The Claris deal is an important platform for the expansion of our Pharmaceuticals portfolio and pipeline. Financial results over the past year have tightly aligned with our expectations, and as indicated in our 8-K, we don't currently expect for the warning letter to have any material impact on our long range financial outlook issued this past May. We are continuing to invest in Ahmedabad to expand local capabilities, technologies and expertise. We have made solid progress and we'll continue working with FDA to ensure all outstanding observations are revolved as quickly and comprehensively as possible. In closing, we are pleased with our second quarter performance, which demonstrated the strength of our diversified portfolio. We remain squarely focused on increasing the innovation and is strategically deploying capital to further accelerate our performance, all in support of delivering even greater value for patients and investors. I will now pass it to Jay for more details on our Q2 results and outlook for the balance of 2018.
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our second quarter results, which represented another solid quarter of continued momentum. I'll start by discussing our second quarter results before providing our updated financial outlook for 2018. Beginning with the second quarter, global sales of $2.8 billion were in-line with guidance, increasing 9% on a reported basis, 5% at constant currency, and 4% on an operational basis. Key growth drivers for the quarter included increased sales of injectable pharmaceuticals, strength in the company's Renal Care and Acute Therapy businesses, as well as solid performance from our compounding and contract manufacturing businesses. And as Joe discussed, growth was partially offset by performance in our Medication Delivery and Clinical Nutrition businesses. On the bottom line, adjusted earnings increased 22% to $0.77 per diluted share. This exceeded our previous guidance of $0.69 to $0.71 per share, driven by solid top-line performance, the ongoing benefit of our business transformation initiatives, a lower than expected tax rate, and other income. Now I'll walk you through performance by our regions and global business units. Note, for this quarter, constant currency sales growth is equal to operational sales growth for all businesses with the exceptions of our Pharmaceuticals and Advanced Surgery businesses. For these businesses, we will provide operational growth, which adjust for the impact of generic competition for U.S. cyclophosphamide as well as the Claris and Mallinckrodt surgical product acquisitions. Starting first with sales growth for our three regions, sales in the Americas advanced 6% on a constant currency basis and 4% operationally. Sales in Europe, Middle East and Africa grew 3% both constant currency and operationally. And finally, sales in our Asia-Pacific region rose 6% on a constant currency basis and 5% operationally. Moving on to performance by global business units. Global sales for Renal Care were $931 million, advancing 4% on a constant currency basis. Performance was driven by solid growth in PD therapies globally as well as increased sales internationally for our HD business. Sales in Medication Delivery were $681 million, down 2% on a constant currency basis. And as Joe discussed, growth in this business was impacted by the timing of adding new customers in the U.S. for LVPs, residual supply constraints for SVPs following Hurricane Maria, and lower international sales resulting from reallocation of solutions volume to the U.S. Pharmaceutical sales were $537 million, increasing 16% constant currency and 11% operationally. Sales growth in the quarter was driven by our injectables business, which benefited from increased sales of BREVIBLOC due to competitive supply constraints as well as strength in our premixed injectables and international hospital pharmacy compounding business. Sales of U.S. cyclo were $45 million in the quarter and Claris contributed $33 million globally. Moving to Clinical Nutrition. Total sales were $221 million, down 3% on a constant currency basis. Strong growth in international markets was offset by lower sales in the U.S., which Joe commented on earlier. Sales in Advanced Surgery were $204 million, increasing 12% constant currency and 2% operationally. Performance was driven by solid growth in international markets. As mentioned previously, we completed the acquisition of RECOTHROM and PREVELEAK earlier this year. We're pleased with the contribution of these products which represented approximately $17 million in the quarter. Sales in our Acute Therapies business were $129 million, representing growth of 10% on a constant currency basis. Growth in the quarter was driven by continued strength in global demand for Baxter's continuous renal replacement therapies. Finally, sales in our Other category, which primarily includes our contract manufacturing services, were $139 million, an increase of 20% on a constant currency basis. Performance in the quarter was primarily driven by increased demand for our contract manufacturing services. Moving through the rest of the P&L, our adjusted gross margin of 45.5% increased 20 basis points over the prior year. Underlying operational expansion was partially offset by a negative impact from foreign exchange and incremental supply chain costs we absorbed during the quarter. Adjusted SG&A totaled $641 million, increasing 7% on a reported basis, and 4% on a constant currency basis. The positive contribution from our focus on effectively managing our expense base was offset by lower transition service agreement income from Shire and increased freight expense as we continue to ensure adequate product availability to meet our customer needs. The acquisition of Claris adds 1 point to growth in the quarter. Adjusted R&D spending in the quarter of $164 million increased 6% on a reported basis and 1% on a constant currency basis versus the prior year period. Adjusted operating margin in the quarter was 17.1%, an increase of 70 basis points versus the prior year. Strong operational expansion of over 150 basis points in the quarter was also partially offset by the loss of transition service agreements income and foreign exchange. Net interest expense was $11 million in the second quarter, reflecting higher levels of interest income due to rising interest rates. Adjusted other income totaled $31 million in the quarter primarily reflecting a benefit from the recent changes we made to our U.S. pension plan and foreign exchange gains on balance sheet positions. The adjusted tax rate was 17% for the quarter, which includes a benefit of $15 million from stock compensation. And as previously mentioned, adjusted earnings of $0.77 per diluted share exceeded our guidance of $0.69 to $0.71 per share driven by solid top line performance, our business transformation initiatives, a lower than expected tax rate, and other income. During the second quarter we repurchased $259 million or 3.8 million shares. These repurchases were partially offset by option-related dilution in the quarter. Before turning to our 2018 outlook, I will briefly comment on our cash flow performance. In the first half of 2018, we generated free cash flow of $541 million, an improvement of $50 million versus the prior year, driven by underlying operational performance as well as improvements in DSO and in DPO metrics. Let me conclude my comments this morning by providing our guidance for the third quarter and full year 2018. Globally, we now expect 2018 full year sales to increase approximately 6% on a reported basis given the strengthening dollar. We continue to expect growth of approximately 5% on a constant currency basis, and 4% to 5% on an operational basis. Operational growth excludes the impact of foreign exchange, U.S. cyclophosphamide sales from the first seven months of Claris, and sales from RECOTHROM and PREVELEAK. Moving to guidance by business. On a constant currency and operational basis, except where otherwise noted, in Renal Care, we continue to expect growth of 3% to 4%. In Medication Delivery, we now expect sales to increase approximately 4%. We now expect our Pharmaceuticals business to increase 5% to 6% constant currency. This assumes 2018 U.S. cyclophosphamide sales of $130 million, slightly above previous guidance of $120 million. We continue to expect full year Claris sales of approximately $145 million. Adjusting for cyclo and the first seven months of Claris, operational growth is now expected to increase approximately 5%. Moving to Clinical Nutrition, we now expect sales growth of approximately 2% as we work to return customers in the U.S. back to pre-hurricane purchase levels. For our Advanced Surgery business, we continue to expect sales to increase 8% to 9% on a constant currency basis. This includes the contribution of approximately $40 million related to the recent acquisition of RECOTHROM and PREVELEAK. Excluding the impact of these sales, operational growth is expected to be between 3% and 4%. For the Acute Therapies business, we now anticipate growth of approximately 10% given the strong first half performance. Finally, in our Other business we now expect growth of 4% to 5%, given increased demand for our contract manufacturing services. Moving down to P&L, we continue to anticipate adjusted operating margin expansion of 80 basis points to 100 basis points. We expect net interest expense of approximately $50 million and adjusted other income of approximately $95 million for 2018. For the year, we now expect an averaged adjusted tax rate of approximately 17%, which reflects the lower rate we reported during the first half of the year, and a continued benefit from stock compensation in the second half of the year. For full year 2018, we anticipate a diluted average share count of approximately 548 million shares, which reflects the benefit of ongoing share repurchases, offset by option-related dilution. Based on these factors, we expect 2018 adjusted earnings, excluding special items, of $2.94 to $3.00 per diluted share. Finally, for the year, we now expect to generate operating cash flow of approximately $2.25 billion, capital expenditures of approximately $700 million, and free cash flow of approximately $1.55 billion. Specific to the third quarter of 2018, we expect sales growth of approximately 3% on a reported basis and between 3% and 4% on both on constant currency and operational basis. And we expect adjusted earnings, excluding special items, of $0.72 to $0.74 per diluted share in the third quarter. With that, we can now open the call up to Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. So that we may be respectful of everyone's time, please limit your comments to one question with one follow-up question if necessary. We appreciate everyone's patience and would like to provide as many of you as possible with the opportunity to ask a question. We'll pause for a moment while the list is being compiled. I would like to remind participants that this call is being recorded, and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. And our first question comes from the line of Bob Hopkins of Bank of America. Your line is now open.
Bob Hopkins:
Okay, thanks. Can you hear me okay?
Clare Trachtman:
Yes.
José E. Almeida:
Yes, we can.
Bob Hopkins:
Great, great, great. Thanks a lot for taking the questions. I just wanted to start out with a question on revenue growth in the quarter. And I think I basically heard three areas where things were a little slower. On the LVP side, you talked about getting new customers, on the Med Delivery side about tight supply, and on the Nutritional side about delay and sort of post-hurricane situation there. Can you just kind of qualify those three things and their impact on the quarter, and then talk a little bit more specifically about when you expect those things to be fully resolved? It sounded like they'd be fully resolved by Q3 or during Q3, but I just wanted to be sure. Thank you.
José E. Almeida:
Thank you, Bob, and good morning. I'm going to break the question into three areas so it becomes easier for us to speak about. LVP is a large volume parenterals. We have categorically not lost one point of share or one customer. We just were slower to convert new beds. We are converting new beds. As a matter of fact, we convert significant amount of beds, but late in the quarter, did not feel the effect. We also had just taken a large OEM customer from a competitor, and we did this just now in early July, okay. So we were not fast enough coming off the hurricane. We got our volume repositioned. We got our supply chain with significant amounts of flexibilities, and we do have now the ability to direct our volumes not only to the U.S. but at anyplace in the world that we need volume. So that I feel very comfortable. Our team's just taking a little longer, and I feel that we're going to be able to get there in the second half. Just so you know, there was about 16% of growth in the first half of the year in LVPs. So you know, 16% growth in the first half of the year. We slowed in the second quarter, probably some bleed of inventory, and now we're slow, and we were slow in picking up new customers, but categorically speaking, we have now lost one customer and one point of market share. When it comes to SVPs, or small volumes parenterals, but – do you mind to mute your line? There's a – thank you.
James K. Saccaro:
Perfect
Clare Trachtman:
Thank you.
José E. Almeida:
Thank you. The SVPs. We are in tight supply level, recovering now quite fast. So these are Mini-Bags and Mini-Bag Plus. These products are designed to reconstitute pharmaceutical APIs, okay. So we were now in channel, meaning Cardinal, Owens, and Medline, people who distribute our products, now we have Mini-Bags into that channel. Mini-Bag Plus is not yet there. It's going to get there in September, meaning that when it gets in the channel, you get volume because some of these customers will not buy directly from us. But we had to take them off the channel because we are in short supply. So we also are putting these products in more than 100% allocations and we hope by the end of the year, early next year, Mini-Bag Plus and Mini-Bag will be off allocation. So a point on allocation. LVPs are 100% out of allocation. No more allocation for LVPs. Let's now cover the Nutrition. The Nutrition side is the part we had the worst supply issues during the hurricane, those amino acids and other nutrients. Those are slow – we're feeling those are slower to pick up. Those are practice changes in hospitals. We are market leaders and we feel that they will probably be the slowest ones to pick up on the ramp-up curve. It's the smallest business that we have among them all, but we feel confident that in the next six to eight months, we'll be able to get back into a course. It's a slower process to recover than the SVPs and the LVPs. I hope that has clarified some of the questions that you and some of your colleagues may have in this area.
Bob Hopkins:
Yeah, definitely helpful. Just curious, Jay, if there is any kind of quantification of these three issues. And to sort of summarize all that I just heard, it sounds like the majority of all of these issues will be resolved this calendar year?
José E. Almeida:
Bob, this is Joe. It is correct. In terms of quantification, we prefer not to get into the number of customers and things like this. I just gave you just a bit of a reference. We will probably convert approximately 4,000 beds in the second half of the year, okay. And we did about the same number in the first half, but most of that happened in the first quarter, not the second quarter. But just giving you the numbers for reference, and we'll stop here.
Bob Hopkins:
Great, thank you very much.
José E. Almeida:
You're welcome.
Operator:
Thank you, and our next question comes from Vijay Kumar of Evercore ISI. Your line is now open.
Vijay Kumar:
Hey, guys. Thanks for taking my question. So maybe I'll start one on the guidance here, maybe just one clarification on some confusion on organic operational numbers in the Q. Operational was in line with how you guys were expecting, right? It's just cyclo came in a little bit better for the difference in how we do the math right. I wanted you to clarify that. And the guidance now for the year, given the 3Q operational growth guidance, that implies a big step up, high singles for Q4. Can you just walk us through on what changes in Q4?
James K. Saccaro:
Yeah, just to give a little context on our overall sales performance in the quarter, generally speaking we were pleased. Our operational guidance, which excludes the impact of cyclophosphamide and it also excludes acquisitions that we've undertaken, was 4%. The guidance that we provided was 3% to 4%. So sales came in strong. I think probably the most important aspect of Joe's commentary was the diversified nature of the portfolio that we have and the fact that we were able to offset some short-term challenges with strength elsewhere in the portfolio. Now, moving to the back on an overall annual basis, our guidance operationally is 4% to 5%. And again there is a meaningful step up in the fourth quarter. The third quarter we guided operationally to 3% to 4%. Now, you'll recall last year we had a settlement with a compounding customer, which was about $20 million or 1 percentage point of growth. So that's one of the elements that takes – this Q3's a little bit more challenging for us, driving this 3% to 4% growth, which, again, organically we're in line with our expectations. And then going to Q4, we do have the $70 million hurricane impact that's included in our numbers last year. So you will see, the fastest growth of the year we expect to take place in the fourth quarter.
Vijay Kumar:
Got you. And then just one on margin stuff, Jay. So the guide for the year is – call it low 17s, right, and if I go back in a long-term guidance rate, so we're looking at north of 20% for 2020. So that would imply a 300 basis points margin expansion between 2019 and 2020, right. So that's a step up in margin expansion. When you're looking at 2019, 2020 versus 2018, I mean, maybe just talk about what would cause some optimism on the margin expansion side for 2019 and 2020. Thank you.
James K. Saccaro:
Yeah, look. We are extremely pleased with the margin progression of the business and this is very much in line with the expectations that we've outlined, and this is tracking very well. You'll recall, Vijay, at the spin-off we had a 9% or 10% margin. We outlined specific plans to take that to 17% over the course of three years, but we also recognized in the 2018 timeframe, there would be a number of headwinds that we would experience with respect to things like cyclophosphamide, the sunsetting of transition service agreement. And so if you were to adjust for those items, the 80 basis points to 100 basis points that we expect this year is a number that's much higher than that. And so as we get some of these factors behind us in 2019 and 2020, we have clear line of sight, plans and expectations to drive the margin consistent with what we shared targeting the 20% to 21% by 2020. I'll remind you that when we put together the long range plan, there is no sort of unidentified item in the plan in the sense that every single cost program is delineated and specific included in our numbers, so there's no unidentified go-get that we have to get after. It is simply about executing the plans that we've laid out, managing against that.
Vijay Kumar:
Very helpful commentary, Jay. Congrats on a nice Q.
James K. Saccaro:
Thank you.
José E. Almeida:
Thank you.
Operator:
Thank you. And our next question comes from Robbie Marcus of JPMorgan. Your line is now open.
Robert J. Marcus:
Oh, great, thanks for taking the question. I wanted to talk maybe if you can about the Pharmaceutical businesses. That was one of the standouts there. Particularly, cyclophosphamide revenues going up for the year and a difficult comp in the U.S. business as there was the Transderm Scop benefit last year. So maybe talk about some of the underlying trends there and how sustainable that is.
José E. Almeida:
Robbie, the strategy in Pharmaceutical is one to use the strength of the company in its formulation and drug-delivery technologies, and it always comes back to our ability to make products consistently like cyclo, like BREVIBLOC, and other drugs that are – the generics and the competition is coming, but people have a hard time consistently making this product. So hence the strategy that we've placed in front of you guys in our Investor Day in May. It's important that we continue to expand our Pharmaceutical business in tough-to-make molecules, cytotoxics, oncolytics, because despite the fact that other people have the desire to get in, they don't make it consistently. So right now, there is another competitor in cyclophosphamide in the market. In BREVIBLOC, there's one coming in the month of September, and we plan another one coming in cyclo at the end of the year. As you can see, we continue to sell cyclophosphamide. We haven't seen the one that was approved come into the market. I think it's just a matter of time, but we have the advantage of having a consistent production of this product, and I think our team here in the U.S. has done a wonderful job really creating the commercial opportunities to make this business more reliant on us than other people, and more resilient. As you can see, this business – we had spoken about this cyclophosphamide issue two years, three years ago, and we're still making the product and making a lot of money when we sell it, and we will continue to do it as long as the competitors are not getting or hesitant in getting the market. But I want the folks to understand that Baxter has unique capabilities and that's the reason why we're doubling down in Pharmaceuticals. We – now, at this moment in time, we are planning for a second cyclo to come in – I'll say third, because Sandoz is already on the market. Another two coming in, one just came in, another one at the end of the year, and BREVIBLOC coming in September. Those numbers are baked into our forecast and estimates.
Robert J. Marcus:
Okay, great. And then maybe just a quick follow-up for you or maybe for Jay. At the Analyst Day you laid out your capital allocation plans, but even just since a few months ago, continue to generate strong free cash flow. That guidance is moving higher. Your stock price continues to move higher and so do other asset prices. So maybe in that context, give us your latest thoughts on how you plan to use your capital and maybe timing or expectations around that. Thanks a lot.
José E. Almeida:
Thank you, Robbie. Listen, our intention is, it's very easy to buy shares back and we have the cash and we've been doing a good job at that. But our intention, working very hard, is actually to deploy capital in acquisitions that will positively impact the business. And we have three thresholds that we have to cross when it comes to acquisitions. One is sustainable revenue growth. It has to be accretive to Baxter's growth at minimum, the strong market position and leadership, and accretive to Baxter current margins, and clear path to drive margin improvement. So – and this is not about size. It can be a niche or it can be a large market company. We are looking at a significant amount of opportunities as we speak to expand Baxter's adjacencies and even looking at other opportunities that are at the moment variable. So we want to make sure that we deploy the capital with the returns that the market can count on Baxter to return. Our execution is starting to get really good. Even with the setback that we had on the 483 of Claris, we're executing on that business extremely well. Not only that, we not only covered a vast majority of the things that the FDA wrote us up for, but also, have improved significantly the operation and capacity at the plant and you can see, we're up 20% on sales that came into Baxter as an acquisition. The same thing with Mallinckrodt. So we're starting to get the execution in Baxter now with an SG&A between 21% and 22% and probably next year going sub 21%. We will be able to integrate much better acquisitions in our systems and everything else. So we need into to find a good opportunity for Baxter. We're looking forward to do it, and we have the capacity and the capability to do so.
Operator:
Thank you. And our next question comes from Larry Keusch of Raymond James. Your line is now open.
Lawrence Keusch:
Thanks, good morning, everyone. So, maybe, Joe, just to start, if my math is correct here, it looks like the U.S. growth accelerated in the 2Q from the 1Q, so maybe just some thoughts on the U.S., how the environment feels?
José E. Almeida:
The environment is not bad. I think you still have low single digit growth, but consistent growth. We see no less admissions. You always have the seasonality in the mid of the summer, people will not voluntarily sometimes go through full procedures, and this is not a heavy time of the year primarily for most of the Baxter products which are related sometimes to flu and heavy hospitalization in general. But we see the U.S. market as a healthy, healthy market, with – continuing to see consolidation on the provider side, and I think a lot of movement in the payor provide area. So – but in terms of population, being treated is a healthy market and it's a good market to be part of.
Lawrence Keusch:
Okay. Perfect. And then just the other question is clearly, new products are important for the second half of the year. I think that's embedded in your guidance that you'll start to see some revenues here. Can you just again give us some thoughts on the status of those new products? What are the drivers? And I would assume that it would be mostly weighted towards the fourth quarter. Thank you.
José E. Almeida:
Yes. Let me start with the Kaguya launch in Japan. We are excited about that. We're slightly ahead of our plan, to the point that we had actually to accelerate some purchase of production equipment at our partner to be able to supply the market. So it is a super exciting market, Japan, because it's a high paying market with very, very low penetration of peritoneal dialysis, so we're starting to see some good movement there. We just launched our Spectrum V9 in the U.S. We've converted one account, and a significant prospect of accounts coming up. So this is – our U.S. team, our Scott Luce and his team in the U.S. need to execute now in the second half, bringing new customers and some conversions to the table. On the V9, Evo IQ, and – it's out new pump outside of the U.S., the first time in I think 15 or 17 years since we launched a new product outside of the U.S. when it comes to pumps. We're going to not only secure our current base of products in the UK, Australia, New Zealand and Ireland, but we also plan to gain market share there. So we have now an install base of COLLEAGUE pumps, a name of the past that is still being used outside the U.S. And this product was launched in partnership with a company outside of the U.S. We were able to bring this product to the market with Baxter trademark points, meaning some of the features that we have in our pump is built into their product in 18 months. So we're excited about that as well. We have PRISMAFLEX in Japan. We're now a comprehensive player in Japan. We also have Prismax in Europe in Q4, and more stuff coming in 2019. So we're excited about – this is a Baxter that we haven't seen in many years with so many launches. Now it's on us to execute.
Lawrence Keusch:
Okay, terrific, thank you.
José E. Almeida:
Thank you.
Operator:
Thank you. And our next question comes from Danielle Antalffy of Leerink Partners. Your line is now open.
Danielle Antalffy:
Hey, good morning, guys. Thanks so much for taking the question. Just wanted to follow up on Robbie's question regarding potential capital deployment and M&A. There's a lot of possible assets out there and potential adjacencies where you could fill some product gaps or potentially go even bigger. And I was just hoping to get a better sense from you guys on what does make the most sense strategic strategically as it relates to adjacencies? So some examples from the Analyst Day is you're getting back into nerve repair. Is it kind of building out specific areas like that? I mean, can you give any more color on where the priorities are as it relates to parts of the business from a BD perspective?
José E. Almeida:
We have presented to you the adjacents that make sense to us, right? So we're strong in hospital. We're strong in home. So we have the channels. We have the key account management, but also, in terms of bringing synergies to the market, we have the capability now with one of the industry's lowest SG&A, okay. So I feel that we bring that part and we also bring the commercial ability to grow businesses. We like parts of surgery, but more so we like hospital supplies. We also like some niche products into the doctor's office and areas that may bring some of our expertise in all these settings. So we now have some very interesting things that we're looking at. Some a little different than others, but it's not a lack of desire and a lack of opportunity. Now – and then boils down to value, and hopefully we can cross that bridge because value is one of the things that we continue to be focused on, despite the fact that we need to meet three criteria that I just outlined before at Robbie's question.
Danielle Antalffy:
Okay. That's fair, and just one follow up question on the long range plan as it relates to sales growth guidance and operating margin expansion. I mean, in this quarter you saw another nice step up in operational sales growth. Seems like you're heading in the right direction. Just wanted to get a feel from you on your confidence in achieving the long range plan based on these results, as this is the first quarter you've reported since updating that in May. Thanks so much, guys.
José E. Almeida:
Thank you. Long range plan, as it says, is long range, so we still – we remain confident in our ability to meet those numbers, first of all. For several reasons I outlined a series of new products we're launching and our effectiveness in doing so. We also have market share leadership in many areas of care that we participate. So one quarter doesn't give you the right picture for the long arrangement, because if you think about the mix of products that Baxter's going to have in 2023, it's going to be different than what we have today. So it's going to be focused on 100 plus molecules in pharmaceuticals. It's going to have significant presence in the ICU. It's going to be in the specialty monitoring with our pumps. So things that we don't have today. So our confidence in achieving the plan on the base business is solid. We have no questions about that. The part that we need to execute and we need to launch, and I'm feeling confident because the amount of products coming onto market is the technology and the innovation. And the third piece of it is really capital deployment, so we can get that thing done correctly and continue to augment, because I'm starting to feel more confident in our ability to take really tough stuff like Claris and turn things around, and actually use that asset as well as tuck-in acquisitions. But I feel comfortable with a solid confidence on our LRP.
Danielle Antalffy:
Thank you.
Operator:
Thank you. And our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Ryan Lewis:
Good morning. Maybe just one quick one for Joe and then a follow up financial question for Jay. Joe, just coming back to Medication Delivery and the comments around customer acquisition speed, is the ability to acquire new customers or supply those new customers, is that being impacted in any way by better supply by competitors or any changing pricing dynamics in the saline market?
José E. Almeida:
We'll start, David, from the end of your question. No, no price dynamics. These are long-term contracts. As a matter of fact, of the three GPOs that are in the market today, the largest ones, we have two already re-signed with us, and we're going to continue to re-sign customers under them, extending the longevity of these contracts. So – and the prices built in is a modest increase just to maintain with inflation or maintain up to a certain index. So it's not the pricing that will change the dynamics, at least in the next four to five years, because the contracts are five, and some have extensions built in that go up to seven. The availability of other competitors, I would assume that one of the competitors, which had a significant issue with capacity will come back to the market. I don't doubt that, but the contracts are locked, so for us, right now, we're picking up beds that are available, but also importantly is to supply what most of you probably did not recognize is the large OEM opportunity that is out there, and we've just signed one not too long ago that brings a significant volume into Baxter from somebody else. And one that is locked is locked for many years. So – and everything, David, has to do with consistency of manufacturing and distribution, and I feel absolutely comfortable with our plant in North Cove doing a wonderful job, really a wonderful job. A plant manager came in, Jon Rushford, about a year ago and has really transformed the culture of that place. Secondly, getting the network in Latin America now to be flexible that I can ship into the U.S. if I need or I can revert back into Latin America or go to Europe if I need, and vice-versa. That creates a unique advantage to Baxter. Not putting any of our competitors down, but we bring a different dimension of supply stability and partnership to this market.
David Ryan Lewis:
Okay, Jay. Very clear, and then – sorry, okay, Joe. And Jay, just a couple of dynamics.
José E. Almeida:
I'm surprised that you confused our accents. Jay has a New York accent and I have a Brazilian accent.
David Ryan Lewis:
Well, I hold you both at the high esteem; you're the same in my book. So a couple things, Jay, just on numbers here. So number one, just – you're seeing a benefit, obviously, of some customer or competitive disruption in BREVIBLOC and the OEM business. We have that as sort of two points in terms of growth impact this year. Kind of – is that close, Jay? And when can we think about those dynamics beginning to reverse? And just a second, broader question, Jay, on guidance. Into the back half of the year, the 4% to 5% number, at the low end you have to have some modest acceleration to get there, obviously more at the higher end. Are you as confident at the higher end of the range here of 4% to 5% now as you were to begin the year? Those two. Thanks so much.
James K. Saccaro:
Yeah, certainly. On the guidance question, we are very confident in the guidance in the second half of the year. I think there's a few factors in play that sort of distort the quarters a little bit, one of which is the compounding that I referenced, one of which is the hurricane that I referenced. If you were to adjust for those items, really the piece that starts to contribute meaningfully are some of these new product launches, along with some of the customer gains that we started to see in the Medication Delivery business. So I think overall we feel quite good about it, and it's one of these areas where our line of sight to delivering the plan is as consistent as it's been. On the BREVIBLOC item, certainly that was a contributor in the quarter. We saw maybe $15 million plus in terms of incremental BREVIBLOC sales above plan. We do expect this to subside, as we have a competitor entering in September. So – and there are some use cases for this particular product which we believe will abate over time, but that's been a factor – that was a factor in the quarter.
David Ryan Lewis:
And Jay, just the OEM quantification on the OEM benefit?
James K. Saccaro:
We don't really get into -
David Ryan Lewis:
And on the revenue?
James K. Saccaro:
Yeah, in terms of OEMs – oh, I'm sorry. So there's two different pieces, right. Joe referenced this concept of OEM, which is sales of IV bags to other institutions that are not necessarily hospitals, right. We're going to stop short of quantifying that particular item because from our standpoint, we don't want to get into specific customer dynamics. As it relates to our other business, which did experience solid growth in the quarter, there were a number of factors going on with respect to what we call our B2B business, which is really contract manufacturing for others. We were able to generate a number of new customers, and then also we saw incremental volumes being sold to current customers. So again, good performance for us in the quarter from the "Other" business. It's something that we'll see some continued performance in that regard going forward.
David Ryan Lewis:
Great, thanks so much.
Operator:
Thank you. And our next question comes from Isaac Ro of Goldman Sachs. Your line is now open.
Isaac Ro:
Good morning, thank you guys. Joe, I wanted to come back to your earlier comments on the IV solutions' dynamic there, and the reason for asking is the marketplace – clearly, you guys have been able to bring back some capacity. You mentioned the long-term contracting, but I'm curious if given the supply shocks that we saw last year, if the nature of some of these contracting terms have changed at all to maybe incentivize vendors to ensure capacity or supply – I'm sorry, supply in future crises. And to be fair (55:47) that might be an advantage you can take to the market; is that something that's helped you win business? And to the extent that you might have new competitors coming in down the road to help you maintain that share and pricing that you talked about? Thank you.
José E. Almeida:
Isaac, it's very relevant. As a matter of fact, I don't – I think all of our future contracts, there will be some kind of clause that has guarantee of certain volume or more penalties if you don't provide the volume. And we like that, and now we're in a comfortable position because I think spot market sellers are very opportunistic, but they may not be able to provide for the longer term. I think with us on the LVPs and the SVPs, we are getting to a lot of contracts that have that language. I feel very comfortable on the LVPs. The SVPs, we're going to get more comfortable towards the end of the year and towards the mid to late 2019, we're going to have more Mini-Bag Plus capacity in a different location, as well – in two different locations; one coming up this December coming from Europe, and then one in the Americas, new capacity for Mini-Bag Plus that can be out there between Mini-Bag Plus and Mini-Bag. So for us, having capacity and long-term contracts assure us in a tough, tough situation that happens more often than people think, which is tough – flu season is already hitting places like Brazil right now. We need to have solutions, and last year it was a good lesson, I think, for the industry and for us in terms of how to be more prepared and have contingencies in place. We've been working very hard as well with the FDA to get redundancy for emergencies and things like that. But that plays a role in the contract because having that clause in the contract makes our customers more at ease with – in a situation of a crisis and allows us also to plan for the longer term.
Isaac Ro:
That's helpful, thanks. Maybe just a follow-up on Claris. If I look at your comments in the 8-K regarding timeline, it looks like we have something like 6 months to 12 months before we'll get the next FDA inspection. Could you maybe just walk us through the top handful of priorities that you guys need to execute upon during that window to make sure that the next inspection goes well? Thank you.
José E. Almeida:
Well, we will not do anything much different than we've been doing in the last 12 months. We are relentless working in correcting all the observations by the FDA and things that we – as our Baxter quality system calls for, that was different before. So we are converting their documentation systems. We have rebuilt a significant amount of the plant. We have new air handling systems. We have a bunch of different things that we've been doing and preparing that plant really to be a great plant for Baxter. It is already doing well in terms of exceeding our expectations in sales in the short-term. But we have a backup plan if we cannot get to the new molecules fast enough. We're looking for CMOs that will be able to come in and get the APIs in so we can finish the product someplace else. So we do have backup plans for that, but I have to say that our quality team led by Jackie Kunzler, our operations team by Scott Pleau, they are squarely focused in making sure that that plant will do the best it can to have a successful series of inspections by the FDA. Because it's not one inspection, you have to have a series of successful inspections so we can get into the launching product phase of the acquisition.
Isaac Ro:
Got it, thank you, guys.
José E. Almeida:
Thank you.
Operator:
Thank you. And our final question comes from the line of Joanne Wuensch of BMO Capital Markets. Your line is now open.
Joanne Karen Wuensch:
Thank you very much for taking the question. I'll keep it brief. First of all, Jay, can you quantify the impact on the P&L or the operating margins in the quarter from the recent acquisitions of Claris and also the Mallinckrodt products? And then second one is a larger picture for you, Joe, is emerging markets. Anything new in terms of the approach there, or can you give us an update on that area? Thank you.
José E. Almeida:
Okay. Let me take the emerging markets first, and Jay will close the call answering your question. We right now are looking at emerging markets of close to 5% our outlook for the year with a significant – and good growth in China, close to 8%. Eastern Europe, over 6% and Emerging Asia, close to 5%. I think – don't forget, we call emerging markets, but those are 23% of our sales, okay. So they're not as emerging as one may think. I'm particularly happy with China. I think China is a place that we haven't spoken much about. We talk a lot about Japan, but China is a country that within our long range plan we will exceed $1 billion, and we feel excited about that business. So I think the two-invoice system in China and how some changes in regulatory in China are not concerning, but are watch outs, but I think those are the things that the industry and us will overcome. It's still a significant opportunity. It's still a great market, and I think Baxter is well positioned because it has a strong team in China. So great leadership there. As a matter of fact, we're going to be there next week doing a Growth Summit to make sure we can get even more growth and new white space opportunities within our Chinese group. So now, Jay?
James K. Saccaro:
Yeah, great. Thanks, Joe. Overall we're pleased with the performance, as Joe mentioned earlier, of both of the acquisitions, the Claris acquisition and the Mallinckrodt. In the quarter, those two acquisitions contributed approximately $0.02 and maybe improved the operating margin of the company about 10 basis points, although there may be some rounding in that. It's a small amount. But from an overall standpoint, sales moving ahead in line with our expectations, and then the EPS impact very much in line with how we thought about these transactions earlier in the year.
Joanne Karen Wuensch:
Thank you very much.
José E. Almeida:
Thank you, Joanne.
Operator:
Thank you. And that concludes our question and answer session for today. Ladies and gentlemen, this does conclude today's conference call with Baxter International. Thank you for participating. Everybody have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's first quarter 2018 earnings conference call. Your lines will remain in a listen-only mode until the question and answer segment of today's call. As a reminder, this conference call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thank you, Candace. Good morning, and welcome to our first quarter 2018 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's first quarter of 2018 financial results, along with our final outlook for 2018. A supplemental presentation to complement this morning's discussion can be accessed on our website. This presentation, along with related non-GAAP reconciliations can be accessed on Baxter's external website in the Investors section under Events and Presentations. As a reminder, Baxter will be hosting an investor conference on May 21 in New York City with presentations beginning at 8:00 a.m. Eastern Time. At the conference, we will be providing an update on our strategic roadmaps and long-term financial aspirations, along with showcasing our promising new product pipeline at our Innovation Hall. The Innovation Hall will be open before and after the presentation. Registration information and additional details can be found in the Investors section of baxter.com on the Events and Presentations page. With that, let me start our prepared remarks by reminding everyone that this presentation including comments regarding our financial outlook, new product development, business development and regulatory matters contains forward looking statements that involve risks and uncertainties and, of course, our actual results could differ materially from our current expectations. Please refer to today's Press Release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I'd like to turn the call over to Joe.
José E. Almeida:
Good morning, everyone, and thank you for joining us today. I will start with a brief look at our first quarter performance. Then I will share a few thoughts about our ongoing transformation in advance of our upcoming investor conference. Jay will then take a closer look at the Q1 financials and provide an update on our guidance for the rest of the year. We will close with Q&A. Baxter kicked off 2018 with strong results, delivering solid top-line performance and maintaining the momentum we have built over the course of our business transformation. Sales in the first quarter increased 8% on a reported basis, 4% on a constant currency basis, and 3% operationally. As a reminder, first quarter operational sales adjusted for the impact of foreign exchange, generic competition for cyclophosphamide in the U.S., and the Claris acquisition. On the bottom line, adjusted earnings per share was $0.70 increasing 21% year-over-year. This growth reflects positive contribution of our top-line performance, continuous operational efficiency improvements, a benefit from recent change to our U.S. pension plan, and a lower tax rate. In line with our outlook, first quarter sales were negatively affected by approximately $25 million, due to the temporary manufacturing disruption in Puerto Rico related to Hurricane Maria. As we indicated on our Q4 call, these facilities were already ramping up to pre-hurricane production levels in January. This significant milestone, coupled with the FDA's granting of regulatory discretion for temporary special importation of certain products has facilitated our return to a minimum of 100% custom allocation for all major product categories connected with our Puerto Rico operations. We'd like to recognize the critical collaboration and support of FDA in helping us address product supply and relay our continued gratitude to our customers and patients as we worked to resolve the supply challenge. At this point, we do not expect any further revenue impact due to the Hurricane Maria. In addition, we continue to identify opportunities to strengthen and optimize our global manufacturing supply network. In the quarter, following a receipt of permanent approval from FDA, we increased shipments of large volume IV solutions from Mexico to the U.S. to address increased U.S. demand. Going forward, we will look to reallocate additional IV solutions borne from select South America manufacturing facilities into the U.S. This action will allow us to complete remediation activities and modernize production processes at a certain manufacturing facilities in U.S. and Puerto Rico. The reallocation of this volume will help us ensure that we have appropriate supply levels to service both existing and new customers in the U.S. market during the period of remediation and modernization and beyond. Innovation is essential to our growth equation and, as our Q1 highlights reflect, we're focused on driving growth both organically and inorganically for optimal impact. Last month, we completed our acquisition of RECOTHROM and PREVELEAK from Mallinckrodt, bringing additional depth to our advanced surgical portfolio of hemostats and sealants. These two products are already enhancing our portfolio by offering surgeons additional Baxter options when intraoperative bleeding may occur. In addition, our advanced surgery team recently began the launch of TISSEEL Prima in Europe. TISSEEL Prima is a significant enhancement of our market leading TISSEEL fibrin sealant, now offering surgeons greater speed, precision, and control during application through a fully assembled redesigned syringe. Taken together, these developments reflect our broader commitment to driving surgical innovation and the importance we place on advanced surgery as a core growth opportunity. In Japan, our renal care team began the launch of Baxter's KAGUYA peritoneal dialysis technology. KAGUYA is very similar to our AMIA APG system, while also incorporating several distinct features reflecting local needs and patient demographics. Currently, nearly all of Japan's end stage renal disease patients are treated through in-center hemodialysis. And we believe KAGUYA represents an important option to facilitate more patients choosing pediatherapy as their preferred treatment choice. Early feedback has been positive. All in, our Q1 results and efforts we've made to strengthen both our innovation pipeline and our manufacturing operations reflect the swift, steady progress we have made on Baxter's strategic transformation. We remain focused on our mission to save and sustain lives. And on our top quartile performance goals. At the same time, our objective is to accelerate growth by extending Baxter's impact across the healthcare spectrum, supported by the evolution of our new product pipeline. We look forward to sharing more information in just a few short weeks at our upcoming investor conference, where we'll outline the next chapter in our strategy and what's in store across our businesses. And now, I'll pass it over to Jay, who will walk you through the quarter's financial in more detail.
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned we're encouraged by our first quarter results, which represented a strong start to the year. I'll start by discussing our first quarter results before providing our updated financial outlook for 2018. Beginning with the first quarter, global sales of $2.7 billion exceeded guidance increasing 8% on a reported basis, 4% at constant currency and 3% on an operational basis. Key growth drivers for the quarter included strong demand for the company's continuous renal replacement therapies, due to an intense flu season, increased sales of injectable pharmaceuticals and advanced surgery products, as well as IV solutions and peritoneal dialysis therapies. As previously mentioned, disruptions to our Puerto Rico manufacturing facility negatively impacted first quarter sales by approximately $25 million. And as Joe mentioned, we do not expect any further impact to revenue moving forward. On the bottom line, adjusted earnings increased 21% to $0.70 per diluted share. This exceeded our previous guidance of $0.60 to $0.62 per share, driven largely by operational performance and a lower than expected tax rate, due to certain discrete items we recognized during the quarter. Now, I'll walk you through performance by our new regions and global business units. Note for this quarter, constant currency sales growth is equal to operational sales growth for all businesses with the exception of our Pharmaceuticals business. For this business, we will provide operational growth, adjusting for the impact of generic competition for U.S. cyclophosphamide and the Claris acquisition. Starting first with sales growth for our three regions. Sales in the Americas advanced 4% on a constant currency basis and 3% operationally. Sales in Europe, Middle East and Africa grew 3% constant currency and 2% operationally. And finally, sales in our Asia-Pacific region rose 3% on both a constant currency and operational basis. Moving on to performance by global business units. Global sales for Renal Care were $868 million, advancing 4% on a constant currency basis. Performance was driven by solid global growth in both our PD and HD businesses. Sales in Medication Delivery were $676 million, flat on a constant currency basis. Performance was driven by continued strength for U.S. large-volume IV solutions as we were able to clear a number of backorders in the quarter, given the additional volume from Mexico. Growth in the quarter was offset by lower sales internationally and the impact from Hurricane Maria. Pharmaceuticals sales were $496 million, increasing 13% constant currency and 6% operationally. Sales growth in the quarter was driven by strength in our U.S. injectables business, which benefited from increased sales of BREVIBLOC due to competitive supply constraints. Strength in our international hospital pharmacy compounding business also contributed to growth in the quarter. Performance was partially offset by the benefit we would recognize last year for Transderm Scop as well as the impact of Hurricane Maria. Sales of U.S. cyclophosphamide were $42 million in the quarter and Claris contributed $36 million globally. Moving to nutrition, total sales were $223 million, flat to prior year. Growth in international markets was offset by the impact of Hurricane Maria on U.S. sales. Sales in Advanced Surgery were $182 million, increasing 4% on a constant currency basis. Performance in this business continues to improve with sales for our core hemostats and sealants advancing 6% in the quarter. As mentioned previously, we completed the acquisition of RECOTHROM and PREVELEAK late in the quarter. Sales in the quarter were immaterial for these products. Sales in our Acute Therapies business were $129 million, representing growth of 14% on a constant currency basis. Contributing to growth in the quarter was strength in global demand for Baxter's CRRT therapies as well as a benefit from an intense flu season, which contributed approximately 7 points of growth in the quarter. Finally, sales in our other category, which primarily includes our contract manufacturing services, declined 12% to $103 million on a constant currency basis. Performance in the quarter was impacted by the timing of certain items compared to the prior-year period. Moving through the rest of the P&L, our adjusted gross margin of 43.8% declined 60 basis points over the prior year. Underlying operational expansion of more than 100 basis points was more than offset by a negative impact from foreign exchange, the impact from lost sales due to Hurricane Maria, and incremental supply chain costs we absorbed during the quarter. Adjusted SG&A totaled $587 million, increasing 6% on a reported basis and 1% on a constant currency basis. The positive contribution from our relentless focus on effectively managing our expense base was offset by lower transition service agreement income from Shire and increased freight expense as we work to ensure adequate product availability to meet our customer needs. The acquisition of Claris also added 1 point of SG&A growth in the quarter. Adjusted R&D spending in the quarter of $137 million increased 6% on a reported basis and was flat on a constant currency basis for the prior-year period. R&D expenses in the quarter were impacted by the timing of certain project-related spend, which is expected to pick up in the second quarter of 2018. Adjusted operating margin in the quarter was 16.7%, a decline of 10 basis points versus the prior year. Strong operational expansion of approximately 300 basis points in the quarter was more than offset by the loss of transition service income, foreign exchange, and the impact of Hurricane Maria on lost sales and increased supply chain expenses. Net interest expense was $12 million in the first quarter. Adjusted other income totaled $18 million in the quarter, primarily reflecting foreign exchange gains on balance sheet positions and a benefit from the recent changes we made to our U.S. pension plan. These changes to our U.S. pension plan included separating out the current plan into two plans for active and nonactive employees, as well as announcing a prospective freeze for the active plan effective December 2022. The benefits of these changes is primarily recognized in other income due to the adoption of new accounting guidance which requires the recognition of service costs for active employees in operating income and all other components of pension expense in other income. Previously, all of pension expense was reported as part of operating expenses. Results for 2017 have been restated to reflect the change. The adjusted tax rate was 14.5% for the quarter, which reflected a benefit of $13 million from FAS 123-R stock compensation guidance as well as certain discrete items we recognized in the quarter that favorably impacted the rate. And, as previously mentioned, adjusted earnings of $0.70 per diluted share exceeded our guidance of $0.60 to $0.62 per share, driven by operational performance and a lower tax rate. During the first quarter, we repurchased $522 million, or 7.7 million shares. These repurchases were somewhat offset by option-related dilution in the quarter. Before turning to our 2018 outlook, I will provide some commentary regarding our cash flow performance. In the first quarter, we generated free cash flow of $292 million, an improvement of approximately $210 million versus the prior year. Growth was driven by underlying operational performance along with continued focus on improving the company's working capital performance, most notably in our days payable. In addition, cash flows during the quarter benefited from a $70 million payment for the settlement of certain claims related to the acquired operations of Claris. Let me conclude my comments this morning by providing our guidance for the second quarter and full-year 2018. Globally, we now expect 2018 full-year sales to increase between 7% to 8% on a reported basis, approximately 5% on a constant currency basis, and between 4% and 5% on an operational basis. Operational growth excludes the impact of foreign exchange, sales of U.S. cyclophosphamide, sales from the first seven months of Claris, and sales of RECOTHROM and PREVELEAK. Moving to guidance by business, on a constant currency and operational basis, except where otherwise noted, in Renal Care we continue to expect growth of 3% to 4%. In Medication Delivery, we now expect sales to increase 7% to 8%. We now expect our Pharmaceuticals business to increase 1% to 2% constant currency. This assumes 2018 U.S. cyclophosphamide sales of $120 million versus previous guidance of $95 million. We expect sales of Claris to contribute approximately $145 million. Excluding the impact of these sales, operational growth is expected to increase approximately 1%. Moving to Nutrition, we continue to expect sales growth of 4% to 5%. For our Advanced Surgery business, we expect sales to increase 8% to 9% on a constant currency basis. This includes a contribution of approximately $40 million related to the recent acquisition of RECOTHROM and PREVELEAK. Excluding the impact of these sales, operational growth is expected to be 3% to 4%. For the Acute Therapies business, we now anticipate growth of 9% to 10%, given the strong first quarter performance. Finally, in our other business we continue to expect low-single digit declines in sales. Moving down the P&L, we continue to anticipate adjusted operating margin expansion of 80 to 100 basis points. We expect net interest expense of approximately $65 million and an adjusted other income between $55 million and $75 million for 2018. For the year, we now expect an average adjusted tax rate of approximately 19%. The tax rate reflects the lower rate we reported during the first quarter. For full-year 2018, we anticipate a diluted average share count of approximately 550 million shares. This reflects the benefit of ongoing share repurchases. Based on these factors, we expect 2018 adjusted earnings, excluding special items of $2.85 to $2.93 per diluted share. Finally, for the year, we now expect to generate operating cash flow of more than $2.2 billion, capital expenditures of approximately $700 million, and free cash flow of more than $1.5 billion. Specific to the second quarter of 2018, we expect sales growth of approximately 9% on a reported basis and 5% on a constant currency basis. Operationally, sales in the second quarter are expected to increase 3% to 4%. And we expect adjusted earnings, excluding special items, of $0.69 to $0.71 per diluted share. With that, we can open up the call for Q&A.
Operator:
Thank you. We will now begin the question and answer session. And our first question comes from David Lewis of Morgan Stanley. Your line is now open.
Varun Kuchibhatla:
Oh, hi. This is Varun on for David. I just had a quick question on second quarter guidance. Just kind of walking through, so you did 3% in the first quarter and your guidance is maybe 3% to 4% operational ex-cyclo for the second quarter. Just given the easier comp and maybe the hurricane gives you one point and you've got Transderm as well; maybe that's another point. Just wanted to understand if there's maybe something that we're missing that kind of leaves the growth rate next quarter at only 3% to 4%. Thank you.
James K. Saccaro:
No, certainly, look, as we look at the growth rate moving into the balance of the year, it's largely consistent with what we've said in the past. For us, as we look at the second quarter, there was about a point of impact related to the hurricane that we saw in the first quarter. So, you could adjust for that to see a growth rate more along the lines of 4% and like as we said, the balance of the new products' impact as we look at 2018, will come in the second half of the year. So, one of the reasons why we've been able to guide to 4% previously and now 4% to 5% relates to the benefits of the new products that we'll be launching this year. But a lot of that impact, as I say, comes in the second half of the year, through things like KAGUYA along with the version nine of the SPECTRUM pump. So, really that's what drives the acceleration in the back half of the year relative to Q2.
Varun Kuchibhatla:
Thank you.
Operator:
Thank you. And our next question comes from Vijay Kumar of Evercore. Your line is now open.
Vijay Kumar:
Hey, guys. Congratulations on a really strong quarter here. So Jay, maybe one starting on the guidance on – I just wanted to understand if the organic core was raised by 100 basis points because we had the Mallinckrodt deal close. When I look at your acquisition contribution, it really didn't change. So I'm just trying to understand what's the core operational increase for the year.
James K. Saccaro:
Yeah, just to give you a little background on the core operational growth of 4% to 5%, there are three items that that excludes. First, it excludes 70 basis points of Claris. So, basically seven months of Claris sales are excluded from the operational sales growth. The second item that it excludes is the cyclo impact, which on a year-over-year basis, we now expect to be around 70 basis points. And finally, the Mallinckrodt acquisition is also excluded from operational growth. And that's about 40 basis points of impact. So that's the drivers of the difference between constant currency growth and operational growth. Really, the primary reason why we've raised operational growth from the 4% to 5% was the solid Q1 performance, and we expect that to kind of hold throughout the rest of the year. That was really the driver that led to the increase.
Vijay Kumar:
No, that's helpful, Jay. And then one on margins, maybe. I think you mentioned FX and hurricane in Q1. When we think about that back half, right, and again, I think if I recall the comments you made on the prior call, pension was supposed to be a headwind. And given now it looks like cyclo's coming in better; pension was actually positive in the Q, I'm just curious on the EPS guidance and margin assumptions, given the Q1 strength we've seen.
James K. Saccaro:
Yeah, we did see a little bit of overperformance relative to our Q1 margin, so, definitely pleased with that performance. I would tell you that pension is in line with our expectations and really, because of the accounting change in relation to how we think about the different components of pension, most of the benefit that we're seeing year-over-year takes place in other income or below the operating margin line. It's our expectation that Q1 will roughly be the lowest margin of the year. The 16.7% will be lower than what we'll expect to see in the balance of the year. We have a lot of, a number of good elements coming through in the back three quarters, in particular, no hurricane impact. Furthermore, we'll start to see the impact of some new product launches, as I mentioned earlier, but the big headwind that we have relates to cyclophosphamide in the latter part of the year because we are still anticipating a decline in that, which will impact margins a little bit. Having said that, like I say, we do expect a bit of a step-up from Q1 levels to the balance of the year.
Vijay Kumar:
And maybe if I can squeeze one in for Joe. Joe, just on cap deployment, any thoughts, updated thoughts on how you guys are thinking about the cap deployment front?
José E. Almeida:
Vijay, it hasn't changed. We are very focused on three things. We continue to look to deploy cap rate dividends; share buyback, I think we've been very outspoken about that. And M&A. If we don't find the right M&As and we accumulate cash in our balance sheet, we'll buy share back. And our plan is always to continue to increase our dividend year-over-year. So, our capital plan is preset and unchanged from that point of view.
Vijay Kumar:
Thank you, guys.
José E. Almeida:
Thank you.
James K. Saccaro:
Thanks, Vijay.
Operator:
Thank you. And our next question comes from Robbie Marcus of JPMorgan. Your line is now open.
Robbie J. Marcus:
Great, and congratulations on a good quarter.
José E. Almeida:
Thanks, Robbie.
Robbie J. Marcus:
Jay, maybe I could start. You raised EPS guidance well above what you beat in the first quarter. Maybe you could give us a different breakdown of the different buckets of where it's coming from over the balance of the year.
James K. Saccaro:
Great. And Robbie, congratulations on your new assignment there. Overall, the EPS guidance was raised, the midpoint was raised roughly $0.13. Of that, $0.09 of it relates to Q1 overperformance. And from our expectation, the $0.09 breaks down roughly $0.06 of operational performance, and there are a number of components of that where we saw strength, and then about $0.03 of financial, and that includes positive things like the tax rate, share count and a number of other items included in that. So that's really the Q1 overperformance. Looking to the balance of the year, the two primary changes that we made to the guidance relate to cyclophosphamide. We've added roughly $25 million of cyclo, which is around $0.03, and then we also have adjusted our bottom line to reflect the contribution of Mallinckrodt, which we expect to be approximately $0.01 positive. So, on balance, it's a roughly $0.13 raise. We've seen $0.09; we've got another $0.04 to go.
Robbie J. Marcus:
Great. And maybe just to follow up. The two businesses that stand out most to me in the quarter are Renal Care and Pharmaceuticals. These are businesses that are experiencing different growth rates than what we'd seen in the past. So maybe you could just give us some pointers of what happened in the quarter and how sustainable this is going forward. Thanks.
José E. Almeida:
Robbie, let's start with Renal Care. I think the change from last year to this year which we feel confident is propelling momentum, we have a new agreement with DaVita in the U.S. that has been positive for the company. I think with DaVita undertaking this large and vast market of potential PD patients, and I think for the patient, both companies are engaged in advancing that modality. And I think, now with the lawsuit and the issues behind us, I think what we see now is the true growth of the market and the potential that we can achieve together. The second one is the Pharmaceutical business. I think what you see there is a lack of competition for cyclophosphamide. That's one thing. I think, if you look at the performance of Claris, that's coming slightly better than we thought. And we continue to plan to launch the molecules that we had planned in the past. So, another item that we'd like to comment is BREVIBLOC. BREVIBLOC is a drug that now has competition in the marketplace. However, we secured a customer base that continues to provide us with the business. And this has to do with a competitor who should be in the market and was not. Coming later on the year and we think if they don't come, we'll let you know. Now, if they continue to have problems, BREVIBLOC will continue to grow. If they come as we plan, which is in the guidance, actually, we'll also experience that competition. So, the Pharmaceutical business is strong despite the fact that BREVIBLOC has a competitor and it will continue to do well.
Robbie J. Marcus:
And do you guys mind just clarifying what your timelines in guidance are for cyclo competition and for BREVIBLOC? Thanks a lot.
Clare Trachtman:
Sure, Robbie. It's Clare. With respect to BREVIBLOC, we do expect incremental competition starting in this quarter, in the second quarter. For cyclophosphamide, we're assuming the similar run rate in Q2 as we had in Q1, with competition entering in the second half of the year.
Operator:
Thank you.
James K. Saccaro:
Thanks, Robbie.
Operator:
And our next question comes from Isaac Ro, Goldman Sachs. Your line is now open.
Isaac Ro:
Good morning, guys, thank you. Could you give us a little bit of detail on your expectations for gross margin progression for the rest of the year? Appreciate the comments on what went on this quarter. Kind of curious, as those roll off, how the impact of new products can kind of help sort of the gross margin tailwind? And just net of those two factors, what you guys expect as we exit the year on the gross margin level?
James K. Saccaro:
Yeah, overall, we've seen strong performance from our manufacturing team. Over the course of the last several quarters, all of last year, as well. And that has paid off in part in our ability to raise gross margin guidance. In the quarter, we did have some negative FX impact. We also had the impact of certain supply chain expenses. As we look to alleviate and address some of the tight supply situation we were seeing across a number of our product lines in part related to the hurricane, in part related to the intense flu season, there was a lot of incremental freight that we experienced that impacted our gross margin. So, looking at gross margin, I would say that Q1 should be the lowest quarter of the year, despite the fact that we will see cyclo erosion in the back half of the year. So, we had a 43.8 roughly number. We do expect that to go up in Q2 and Q3 which will be the highest levels of the year and then it will be down a little bit relative to Q2 Q3 levels in the fourth quarter. As I said, as the most intense period of cyclo competition emerges. And so, on balance, like I say, we'll expect roughly flat to last year, recognizing that Q1 is below the full year level from last year.
Isaac Ro:
Okay. That's helpful. And maybe as a follow-up, are there any implications to the cadence of tax rate for the rest of the year, based on those moving parts? Just curious if the quarter-to-quarter tax rate could see some volatility as well. Thank you.
James K. Saccaro:
Certainly. The tax rate, we were pleased with a number of items. Obviously on the FAS 123R is just an element that happens each quarter. But there were a couple of settlements that impacted our tax rate in the first quarter of the year. We are not expecting or banking on those kinds of settlements moving forward. So, we do expect the full-year rate to be in line with what I mentioned on the call, better than the original guidance, but in line with what I mentioned earlier in my statements. And the result of that is there is a fairly significant step up from Q2 to Q4 related to tax. And so, we'll expect to see that in line with our expectations and like I say, we're not banking on significant items to occur in the balance of the year.
Isaac Ro:
Makes sense. Thank you.
Operator:
Thank you. And our next question comes from Danielle Antalffy of Leerink Partners. You line is now open.
Danielle Antalffy:
Hey, good morning, guys. Thanks so much for taking the question. Congrats on a great start to the year. Jay or Joe, just wanted to – not trying to front run the analyst meeting. So just want to focus on the back half of the year. And you mentioned operational sales growth acceleration from a slew of new products. Wondering if you could give us a little bit more color or remind us what some of those products are and in what businesses and how meaningful they could impact sales growth re-acceleration in said businesses.
James K. Saccaro:
Yeah, certainly. And Danielle, it's important to point out that while new products will play an important role in the back of the year, we also do benefit from an easy comp in fourth quarter in particular related to hurricane. So, I think that's one element to point out. But looking at – and we're very excited about the innovation pipeline. We'll be sharing a lot of detail with all of you at our Investor Day on May 21. Related to the back half of the year, I think really the two most prominent launches and the two most important, as we think about our long-term expectations for the company, relate to the version nine of the SIGMA SPECTRUM pump. This has an important innovation with respect to auto-programming, two-way wireless connectivity. So we think it's an important new feature that we added to the pump. And it's one that we're quite excited about. So that should drive some solid infusion systems growth in the back half of the year. The second piece relates to KAGUYA. This is our cycler in Japan. And for us, this is a great step forward from a technology standpoint for Japan. It includes our SHARESOURCE technology. And we look forward to continued, or growth in that market for the foreseeable future. And that becomes an important long-term item for us. I would say those are the two most prominent. But beyond that, there are a number of smaller launches along with geographic expansion that also feature in the second half numbers.
Danielle Antalffy:
Okay. That's helpful. And one follow-up on the gross margin line of questioning. We're hearing a lot out of this earnings season rising commodity prices and could this be peak margins? I mean, obviously, you guys have a lot of fat to trim elsewhere, outside of the supply chain. But how are you guys thinking about the rising commodity prices and impact to gross margin and where do you see offsets to that? Thanks so much.
James K. Saccaro:
Certainly. Overall, gross margins for the quarter were largely in line with our expectations. All of the impacts – again, we did not see a significant variance from what we expected. The biggest item that was a negative related to this freight. But that was not actually freight pricing; rather volumes of expedited freight related to addressing customer shipments. Certainly, this is a real area of focus for us, but our supply chain team, our purchasing team, along with our manufacturing team are incredibly focused on offsetting whatever impacts we see in raw material prices, like resin or oil, with hard savings dollars in other areas to keep us at or better than our budgeted expectations. Part of the reason why we did so well in Q1, along with things moving forward relates to strong performance from our manufacturing and supply chain team. We expect that to continue and we expect to work to offset these cost changes for input materials to continue.
Danielle Antalffy:
Thanks so much.
Operator:
Thank you. And our next question comes from Joanne Wuensch of BMO Capital Markets. Your line is now open.
Matthew Henriksson:
Yeah, thank you. This is actually Matt Henriksson in for Joanne. Congrats on the great quarter.
James K. Saccaro:
Thank you.
Matthew Henriksson:
My first question is on a little more color on KAGUYA. How do you guys see the PD market opportunity in Japan? And is there any numbers that you guys could provide?
José E. Almeida:
Hi, good morning. We feel that the market is very under penetrated. To date, there's only 3% of the population eligible for dialysis that isn't peritoneal dialysis. And one of the biggest impediments was the fear of peritonitis and contamination. What KAGUYA does, it has automatic assembly of the connecting tubes in the catheter. So is hands free. This device, we just got reports that we are really doing extremely well in our pre-launch efforts in Japan. It looks like it's taking off. So, the market in Japan is a highly profitable market, but was also under penetrated. So, with this launch, we hope that we can unlock the market by providing technology that puts at ease the fear of contamination and peritonitis. So, it's a milestone launch for Baxter.
Matthew Henriksson:
Oh no, that's very helpful. Thank you very much. And then my follow-up question is kind of going back to capital allocation. You guys have talked about acquisitions being an important factor for revenue growth going forward into 2020 and beyond. But you also don't like to have the large transformational acquisitions. Is there any commentary that you guys can give us on the Goldilocks kind of size of an acquisition that gives you that revenue growth without being too large?
José E. Almeida:
I like it term Goldilocks. So, thinking about what -- I kind of pictured that right away instead of the acquisitions we have in mind. We don't put the size as much as what are the adjacencies to our business that lend themselves for acquisitions, okay? We are not pursuing white space acquisitions, meaning large acquisitions that have very little synergistic value for the company. But we are pursuing acquisitions, anything from $50 million to $3 billion, $4 billion, okay? So that's the space that we can play. We have the balance sheet to do so. But as I say all the time, it's all about the return, the returns, our ability to integrate successfully, preserve the culture. All the good things that I think we have done with Claris, for instance. Mallinckrodt was a small acquisition, but an integration similar. So, it's gone extremely well. So, we are pursuing very hard acquisitions. We have a very good team in place. So, the sizes are not what guides us, but the opportunity to really create value for our shareholders. As I said, double digit internal rate of return, 500, 600 basis points better than our cost of cap including debt. Cost of debt, I say about having an ROIC, the three to five years gets the company average. And we've been doing a good job with returning investor cap and return on assets. Company has done a good job in creating momentum on those two indexes. And more so create long-term growth that is in markets that are equal or better what Baxter currently competes on. So, I would say that, stay tuned. But if we don't find those acquisitions for whatever reason, they don't pan out, we have the balance sheet at our disposal to continue to buy aggressively shares back.
Matthew Henriksson:
That's very helpful and congrats on a great quarter again.
José E. Almeida:
Thank you.
James K. Saccaro:
Hey, thank you very much.
Operator:
Thank you. And our next question comes from Larry Keusch of Raymond James. Your line is now open.
John Hsu:
Good morning, this is John Hsu on for Larry. Joe, maybe if we could start just following up on your comments on M&A. That was obviously very helpful. But regarding no white spaces, one thing that we saw recently is you obviously closed the acquisition of those Mallinckrodt assets, which I believe gives you a new leg in the basic side of the BioSurgery market. And you obviously have leading share on the advanced BioSurgery side. So, does your future M&A contemplate opportunities to build out on the basic side? And if so, could you help us kind of size what that opportunity looks like?
José E. Almeida:
You're talking about building on the Advanced Surgery side? Okay. So, we do find ourselves with several opportunities. We still need to create a global portfolio that is more uniform, okay? So, we're doing that through organic opportunities. So, we have an active – several new products being developed. But we still have need to accelerate entering the market in some geographies for some products. So, you're going to continue to see an active pursue from Baxter in populating each portfolio across the globe. So we can have similar offerings, even if there's regional only, that will fulfill the whole gamut of hemostat and sealants that go, like you said, from your basic hemostat all to more complex variations of flow seal. And that allows us to provide the physicians with what they need to stop the bleeding and heal the patient.
John Hsu:
Okay. Great, that's really helpful. And then for the follow-up, how do we think about the flu impact in the 1Q, or kind of the one-time benefit there?
James K. Saccaro:
Yeah, the primary area where the flu impacted was our Acute business, where we did see outstanding growth. And what I will tell you is the remainder of our business, we did not see a significant change to our core hospital products business as a result of the flu, in large part because of some of the supply constraints that we had in place, but related to the Acute business it was roughly...
Clare Trachtman:
It was about $8 million of a benefit in the quarter, $7 million to $8 million of a benefit in the U.S. from the flu in our Acute business.
John Hsu:
Okay. Perfect. Thanks so much.
James K. Saccaro:
Thanks, Clare. Thank you.
Operator:
Thank you. And our next question comes from Bob Hopkins of Bank of America. Your line is now open.
Bob Hopkins:
Oh great, thank you. Just have two quick questions. First, on the medical delivery side, just curious if you can give us an update on Mexico and bringing incremental supply to the U.S.? And is that the reason why things get better in the back half, because you just have more capacity?
James K. Saccaro:
Yeah. Certainly, we do expect to see incremental volumes in the back part of the year, but there was also a hurricane impact in our Medication Delivery business in the U.S. in the first quarter north of $10 million. So that was a key driver that we expect to subside in Q2 to Q4.
José E. Almeida:
Yeah, Bob, also now thinking about it strategically, how we provide product for the U.S. business. The U.S. market needs permanent volume increase from Baxter. So, we decided to supplement our volumes of large volume parenterals, which are the bags that go from 250 mL to 1 liter, with 100 million units coming from Mexico on a permanent basis. So what this does for us is threefold. First of all, it eases the fear of us ever getting into a situation where the company has been in the last few years where we had struggled with allocations and things of this sort. Second, allows us to go in and pursue new customers. And thirdly, and as important as the other two is the fact that we can have time to modernize and remediate our facilities in the U.S. and Puerto Rico. So, having this change in how we allocated volumes across the globe is very important. What people sometimes don't remember is Baxter is a global company with the ability to make products in many countries of the world to supply any geography that we need. And unfortunately, we had different thinking some time ago where we restrict ourselves to geographies. Not anymore. We have the ability to shift products from Brazil into the U.S., from Colombia into the U.S., from Castlebar in Ireland into the U.S., and vice-versa. And we also monitor volumes and demand across the globe. So, this is a new company that will be there for our patients and customers as they need our solutions.
Bob Hopkins:
Terrific, thank you. Thank you for that. Very helpful. And then, Joe just wanted to ask one sort of big picture question on the upcoming Analyst Day. Maybe just broadly speaking, how confident are you that there's an organic kind of new product portfolio pipeline at Baxter that can lead to better revenue growth going forward?
José E. Almeida:
Bob, I feel very confident. If I have to put this in baseball terms, and I hope all our audience today understand a little bit of baseball, but I would say that we are at the top of the third inning when it comes to innovation. So, while we have set up ourselves well that we have the right research and development team in place right now, we have the right structure in place, and we have really solid strategies by global business unit today. So if I look at the pipeline, every business of ours has a ten-year pipeline. We have technology development teams in place, we have associating ourselves with universities as the case of our center for the metric hydration you guys going to see in May. That has a lot to do with the collaboration between Vanderbilt University and Baxter. So, I feel the company has turned a corner in how it learns to innovate. And when I say we're at the top of the third inning because there's a bright future ahead of us and I think we have now the ability to accelerate, combined with the fact that we're leading out the organization with an SG&A now sub 22%, so we can now not only deliver the profitability to our investors, but also fund some of the innovation that is very needed.
Bob Hopkins:
Great, thank you very much.
James K. Saccaro:
Thanks, Bob.
Operator:
Thank you and our next question comes from Larry Wong (51:18) of Wells Fargo. Your line is now open.
Unknown Speaker:
Thanks, it's Lee (51:23) calling in for Larry. Thanks for taking my question. I just want to start with just a question on the SUPRANE. There was a generic FDA approval couple of months ago, but it doesn't look like it's launched. Can you just talk through how you think about the generic risk? I understand it's not easy to get a generic product in the marketplace, and how you think about the generic risk in your 2018 guidance. And then I have a follow up.
José E. Almeida:
We have no impact of this generic SUPRANE in the marketplace and the impact that we have in 2018 is none, is nil. So our conclusion goes along with what you just said. It's not an easy product to penetrate the marketplace and we don't think that, at the moment in time, there's any threat to our 2018 numbers. Neither we have seen anything that concerns us.
Unknown Speaker:
Great. Thanks. And then my follow-up is, so in your Analyst Day you plan to give an update, I think, on your 2020 outlook and provide longer term guidance beyond 2020. We have some aspect of your 2020 outlook from prior calls and prior Analyst Day. Would you say you're confident at this point that you would be able to overachieve your 2020 outlook at this point, just based on everything you've done through 1Q 2018?
José E. Almeida:
This is like getting a preview of a movie that has now gone to the theaters, in the Internet, when somebody filmed that illegally in the movie theater. I'm not giving you that one. Wait for it. It's not too far in the future. It's three and a half weeks, we'll be very happy to give you that insight when we are all in New York at the Sierra Hotel.
Unknown Speaker:
All right, understood. And if I squeeze one more in, is there any update on the Claris 483?
José E. Almeida:
We have complete all the items that we have committed to the FDA that we're going to complete on time. We submitted that to the FDA. We can't speak on behalf of the FDA. But we can speak on behalf of Baxter that we have done everything that we've promised to do. And we continue to do because that's not an end game. You don't just do what the FDA asks you to. We continue to improve, find opportunities to improve our operation (54:10), and from our estimation, our plant has improved significantly. But we're not the FDA, as I said, and I cannot comment on their behalf. But we at Baxter continue to be satisfied with the level of improvement that we have seen at our facility.
Unknown Speaker:
Great. Thanks very much.
José E. Almeida:
Thank you.
Operator:
Thank you. And there are no further questions at this time. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating and have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Fourth Quarter 2017 Earnings Conference Call. Your lines will remain in a listen-only mode, until the question-and-answer segment of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Canda. Good morning, and welcome to our fourth quarter 2017 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer, and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's fourth quarter 2017 financial results, along with our financial outlook for 2018. As a reminder, we have posted a supplemental presentation to compliment this morning's discussion. This presentation, along with the related non-GAAP reconciliations can be accessed on Baxter's external website in the Investors section under Events and Presentations. As previously mentioned, we've reorganized our commercial structure to boost performance, optimize cost, increased speed in the decision making process and drive improved accountability across Baxter. To that end, we will be modifying how we report our quarterly financial sales in segment analysis. This new structure will reflect the current makeup of our commercial operations, and while we recognize these changes will impact their model, we believe this presentation will provide you with more granularity regarding our topline performance by global business units end reason [ph]. To aid you in this transition, this morning we posted reclassified sales schedules for the global businesses for the last three years inclusive of 2017. These schedules can be found in the Investor Section of baxter.com. The regional segment structure will be included in our 10-K filings with the SEC. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development, and regulatory matters contain forward-looking statements that involve risks and uncertainties and, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now, I'd like to turn the call over to Joe. Joe?
José Almeida:
Good morning, and thanks for joining us today. I will start with a brief look at our fourth quarter performance, then I will share some thoughts on 2017 as a whole and how we are well positioned to sustain this momentum into 2018 and beyond. Jay will then take us closer look at our 2017 financials and outlook for 2018. We'll close with Q&A. Baxter finished the year with another solid quarter delivering fourth quarter sales growth of 5% on a reported basis, 3% on a constant currency basis and 2% operationally. Operational sales adjust with an impact of foreign exchange, generic competition for U.S. cyclophosphamide, the Claris acquisition and the previously communicated select strategic product exits the company has undertaken. On the bottom line, adjusted earnings per share was $0.64 upto 1% year-over-year driven by strong operational performance, the ongoing impact of our business transformation efforts in a lower tax rate. This performance more than offset the impact in the quarter from Hurricane Maria which reduced our results by approximately $70 million on top line and approximately $0.06 on the bottom line. For full year 2017, Baxter achieved top line growth of 4% on a reported constant currency basis and 5% operationally. Adjusted income from continuing operations up $2.48 per diluted share, an increase of 27% and free cash flow of more than $1.2 billion. Before we discuss some key highlights for 2017, I wanted to take a moment to update you on our operations in Puerto Rico. We've been intently focused on addressing the supply situation in U.S. and the aftermath of the hurricane and the challenging impact it has had on our customers. Our primary goal as always is to ensure we can address the needs of patients and healthcare providers and we have mobilized quarterly [ph]. All of our Puerto Rico facilities are now connected to the electrical grid and we've been ramping up production to pre-hurricane levels. Our expectation is that we will be able to return to more normal supply levels over the coming weeks and as such we expect the residual sales impact of approximately $25 million in the first quarter of 2018. In a related matter as you are likely aware, an aggressive flu season in U.S. coupled with industry-wide supply changes has heightened demand for Baxter's large volume IV solutions which we produce outside of Puerto Rico. As I mentioned in our last earnings call, we have received further FDA approval to import large volume IV solutions from our plant in Cuernavaca, Mexico to help address increased demands from our customers and potentially served new customers in the future. Now turning to some 2017 highlights. Claris acquisition represents an important example of our commitment to enhancing our portfolio and pipeline in our core growth businesses like generic injectable pharmaceuticals. We are rapidly integrating the Claris team, bringing these operations fully online with Baxter's quality systems and looking forward to continued momentum and commercial growth over the long-term. And earlier this year we announced an agreement to acquire two hemostat and sealant products from Mallinckrodt, RECOTHROM and PREVELEAK; both compelling for post additions to our advanced surgical portfolio. From an R&D perspective, we enter into some promising partnerships designed to augment our portfolio and potentially lead to transformative patient care technologies, our organic R&D pipeline is also advancing the several high potential developments. In the U.S. market we received FDA guidance clarifying the regulatory pathway for new home-based peritoneal dialysis or PD, solution generation system that may allow even more patients to experience the benefits of home therapy. And we have initiated the U.S. clinical trials of HDx therapy enabled by TheraNova; a Baxter technology now available in many global markets that is designed to closely mimic the natural clearance of certain molecules during dialysis. Outside the U.S. we begin to limited launch of PrisMAX, our latest technology advanced for acute care therapies in Europe. We anticipate full European launch later this year, also in acute therapies we launched a labeled expansion for oXIRIS, blood purification set in selected markets outside the U.S. This marks the first three-in-one set for use in continuous renal replacement therapies or CRRT and sepsis management protocols. We continue to advance customer focus enhancements with high value technologies across our core portfolio, including our AK 98 hemodialysis system, our FLOSEAL and TISSEEL Hemostatic agents and the SIGMA SPECTRUM infusion system. In 2017 also marked a one million PD treatment used in our proprietary share source telemedicine technology, shared source is foundational rather to the success of our newest automated PD cyclers, AMIA in the U.S. and HomeChoice CLARIA in international markets. Last week we announced FDA approval of Bivalirudin used Baxter's proprietary frozen GALAXY container technology, making it the first and only presentation of this generic cardiovascular inject with a convenient source and premixed solution. These internal and external investments designed to accelerate future growth are balanced along with our commitment to return significant value to our shareholders. Through this end in 2017 we increased our annual dividend rate by 23% but also repurchasing more than $560 million worth of shares. Overall, we are energized by what we accomplished for our stakeholders in 2017 and it has all been made possible by our 47,000 employees globally who are absolutely committed to our mission and the success of our transformation. As we look to our expectations for 2018, increased operational efficiency remains essential and we will continue to identify opportunity to improve operating leverage, at the same time we intensely focus on accelerating top line performance. We know by enhancing our product mix we can drive sustainable gross margin improvement for the company. As schedule [ph] continue to ramp up, our emphasis on new product innovation and business development support this objective. We look forward to updating you on this strategic initiatives, particularly many of our existing and exciting pipeline programs at our upcoming investor conference on May 21 in New York City. In summary, while we have a lot of hard work ahead, as we continue to position for the future, I'm confident that we are up for the task. Now I'll pass it to Jay for deeper dive on the fourth quarter performance and outlook for 2018.
James Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our fourth quarter results, which represented a strong finish to a great year. I'll start by discussing our fourth quarter and full year 2017 results before providing our financial outlook for 2018. Beginning with the fourth quarter, sales increased 5% on a reported basis, 3% of constant-currency and 2% on an operational basis. Key growth drivers for the quarter included a continued momentum across our U.S. fluid systems and renal businesses, as well as strength internationally in nutrition and increased demand for our cytotoxic contract manufacturing services. As previously mentioned, disruptions to our Puerto Rico manufacturing facilities negatively impacted fourth quarter sales by approximately $70 million. On the bottom line, adjusted earnings increased 12% to $0.64 per diluted share. This exceeded our previous guidance of $0.56 to $0.59 per share, driven by operational performance, disciplined management of expenses and a modest benefit from foreign exchange gains on balance sheet positions. Now, I'll walk you through performance by business. I'll speak to growth figures on an operational basis to provide a clearer understanding of underlying performance. As a reminder, operational growth excludes the impact of foreign exchange, U.S. cyclophosphamide, Claris, and select strategic product exits. Global sales for Hospital Products were $1.7 billion, advancing 1% operationally. Breaking this out by business, sales in Fluid Systems were $632 million, up 2% operationally. Performance was driven by strength for large volume IV solutions and IV access set in the U.S. Growth from the quarter was offset by lower sales internationally and impact from Hurricane Maria. Integrated Pharmacy Solutions, or IPS, sales were $602 million, flat to prior year on an operational basis. Sales growth in the quarter was negatively impacted by $56 million from Hurricane Maria which offset increased sales of our premixed injectable drugs in the U.S. and from nutritional therapies internationally, as well as strengthen our hospital pharmacy compounding business. Sales of U.S. Cyclo was $43 million in the quarter and Claris contributed $30 million globally. Moving to Surgical Care, which includes anesthesia and advanced surgery; total sales were $363 million, increasing 3% operationally. Growth in the quarter benefited from increased sales in inhaled anesthetics internationally, and U.S. sales of BREVIBLOC. Also contributing to performance was growth in advanced surgery of 3%. Sequentially, advanced surgery grew 5% as we are beginning to recognize many of the actions we have implemented to improve performance in this business. Fourth quarter surgical care was impacted by lower sales of Transderm Scope as a result of increased competition. Finally, in Hospital Products, sales in our other category were $108 million, increasing 1% driven by favorable demand for the company's cytotoxic manufacturing services. Turning to our Renal business; sales were approximately $1.1 billion, up 4% operationally. Sales in the quarter benefited from solid performance across all lines of the business. Chronic renal therapies, inclusive of PD, in-center HD and renal therapy services rose 3% globally and our Acute Renal therapy's business delivered high-single digit growth globally, driven by balanced growth in the U.S. and internationally. Walking through the rest of the P&L, our adjusted gross margin of 44.3% declined 20 basis points over the prior year; operational expansion due to positive mix, select pricing and business transformation initiatives was more than offset by the impact on lost sales due to Hurricane Maria and a negative impact from foreign exchange. Adjusted SG&A totaled $628 million, increasing 2% on reported basis but declining 1% on a constant currency basis. The positive contribution from our relentless focus on effectively managing our expense base was offset by lower transition service agreement income from Shire and more than two percentage point contribution from foreign exchange. Adjusted R&D spending in the quarter of $182 million increased 20% versus prior year, reflecting our stated intention to accelerate investments in our core growth businesses. Growth in the quarter also reflect the timing of some milestone payments to partners. Foreign exchange contributed 5 percentage points to growth in the quarter. Adjusted operating margin in the quarter was 15.1%, a decline of 30 basis points versus the prior year. Strong operational performance in the quarter was more than offset by the loss of transition service income, foreign exchange and the impact of Hurricane Maria. Net interest expense was $14 million in the quarter. Adjusted other income totaled $24 million in the quarter, primarily reflecting a benefit from foreign exchange gains on balance sheet positions. The adjusted tax rate was 17.7% for the quarter, which reflects approximately $8 million of benefit from the new stock compensation guidance. And as previously mentioned, adjusted earnings of $0.64 per diluted share exceeded our guidance of $0.56 to $0.59 per share, driven by operational strength, expense savings and the gain on foreign exchange balance sheet positions. During the fourth quarter, we repurchased approximately $290 million, or approximately 4.5 million shares. These repurchases were somewhat offset by option-related dilution. Now turning to full year 2017. Sales increased 4% on reported basis; 4% at constant currency and 5% on an operational basis. On the bottom line, adjusted earnings increased 27% to $2.48 per diluted share driven by operational strength, the ongoing benefit from our business transformation efforts and a favorable tax rate. Moving quickly through the rest of the P&L; our adjusted gross margin of 44.8% increased by 90 basis points over the prior year reflecting favorable product mix, improved pricing in select areas of the portfolio and manufacturing efficiencies. Adjusted SG&A totaled approximately $2.4 billion, decreasing by 4% and adjusted R&D spending totaled $617 million, an increase of 9% versus the prior year. Adjusted operating margin for the year was 16%, a 240 basis point increase versus the prior year and at the high end of our expectations. Net interest expense was $55 million, and adjusted other income totaled $47 million. The full year adjusted tax rate was 18% which included the benefit of approximately $56 million related to new stock compensation guidance. And finally, adjusted earnings of $2.48 per diluted share exceeded our guidance of $2.40 to $2.43. Before turning to our 2018 outlook, I will provide some commentary regarding our cash flow performance. On a full year basis, we have generated free cash flow of more than $1.2 billion, an improvement of more than $300 million versus the prior year. Growth was driven by underlying operational performance and lower CapEx along with the continued focus on improving the company's working capital performance. Let me conclude my comments this morning by providing our guidance for the first quarter and full year 2018. As previously mentioned, we have updated our external sales reporting structure and I will provide guidance consistent with this new format. Globally we expect 2018 full year sales to increase between 6% to 7% on a reported basis and approximately 4% on both a constant currency basis and an operational basis. I would like to point out some key assumptions reflected in our full year sales outlook which include approximately 250 basis points of favorable foreign exchange contribution. Approximately $25 million of negative sales impact from Hurricane Maria in the first quarter. Approximately $145 million from Claris sales is compared to $57 million in 2017. Full year U.S. cyclophosphamide sales of approximately $95 million versus $185 million in 2017. We have for the most part anniversary select strategic product exits we have undertaken and leveled while we will continue to optimize the portfolio, we will no longer be adjusting sales for these exits. And finally, this guidance does not include any contribution from the two hemostat and sealant products from Mallinckrodt. We continue to expect this transaction to close in the first half of the year. In terms of our new external reporting structure we will no longer be classifying sales by the two segments of hospital products and renal. Sales will now be broken down into six global businesses and the segment analysis we provide will be reported by our three regions; Americas, EMEA, Europe, Middle East and Africa and Asia Pacific. As Clare mentioned, we have posted schedules on our website reclassifying sales into the new global business unit structure. Sales guidance has been provided in the new structure on a constant currency basis starting with Renal Care which includes our peritoneal dialysis, in-center hemodialysis and renal therapy services; we expect growth of 3% to 4%. Our next global business, medication delivery which includes infusion systems, large and small volume IV solutions, and our reconstitution product such as Mini-Bag Plus, we expect to see this area to grow 6% to 7%. The pharmaceutical business which includes our broad generic injectibles portfolio, anesthesia and critical care products and our hospital pharmacy compounding services conducted outside the U.S.; performance in this business is expected to be flat to 2017 given some sales we recognized in 2017 that are not expected to repeat in 2018 along with increased competition for select products. Moving to our next global business, nutrition, which was previously part of integrated pharmacy solutions; we expect sales growth of 4% to 5%. For our advanced surgery business we expect sales to increase 3% to 4%, for the acute therapies business we anticipate growth of 8% to 9%, similar to 2017 levels. Finally, in the other business which primarily includes our contract manufacturing services, we expect low single-digit decline as 2017 sales benefited from a customer stockpile order and we're projecting also lower manufacturing revenues from Shire. Moving down to P&L; we anticipate adjusted operating margin expansion of 80 to 100 basis points. We expect net interest expense to total between $65 million to $70 million and adjusted other income between $50 million and $60 million for 2018. For the year we expect an average adjusted tax rate of approximately 19.5%, the tax rate reflects approximately one percentage point benefit from the new U.S. tax reform legislation and a lower benefit from stock compensation. For full year 2018, we anticipated diluted average share account of approximately 550 million shares; this reflects the benefit of certain ongoing share repurchases. Based on these factors, we expect 2018 adjusted earnings excluding special items of $2.72 to $2.80 per diluted share. Finally, for the year we expect to generate operating cash flow of approximately $2.1 billion. We expect CapEx of approximately $700 million and as a result we anticipate free cash flow of approximately $1.4 billion. Specific to the first quarter of 2018 we expect sales growth of 5% to 6% on a reported basis and 1% to 2% on a constant currency basis; operationally sales in the first quarter are expected to be flat to up 1%. And we expect adjusted earnings excluding special items of $0.60 to $0.62 per diluted share. With that, we can now open up the call to Q&A.
Operator:
[Operator Instructions] I would like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. And our first question comes from Mike Weinstein of JP Morgan. Your line is now open.
Michael Weinstein:
Let me start with this fourth quarter. If I back out the Puerto Rico impact from the quarter, you're at $0.70, you're at $2.80 run rate. How do I think about that as I go into your 2018 guidance because obviously your earnings power is a lot higher than just the headline numbers suggest here.
José Almeida:
Mike, your math is not totally incorrect but there is a caveat to it. The second phosphamide is a huge reduction, close to $100 million reduction year-over-year; we're expecting new entrants as we don't have a crystal ball but we have our best intelligence, so we are estimating that we're going to have one or two entrants in 2018 and that is one of the reasons by which we have a significant reduction in the EPS on the run rate basis; we're compensating that with other things, not just Claris. And also we had one-time reduction in the -- like you noted, Hurricane Maria provides a positive momentum in 2018 versus 2017 but the biggest difference is the $100 million with cyclophosphamide.
Michael Weinstein:
You bought back more stock this quarter than you had been buying back and I was wondering if you could just talk a little bit about that and then in the broader context of capital allocation going forward. Obviously, there has been a lot of discussion last several quarters about M&A and the opportunity for you guys to do some bolt-on transaction using Claris. Last year you had the Mallinckrodt deal that's pending but you have a balance sheet that enables us to do both, bolt-on M&A and buybacks. It looks like you've stepped up your activity this quarter, how should we think about it for '18? And are you assumingly incremental buybacks in your guidance? Thanks.
James Saccaro:
Overall, if you look at 2017, we've purchased the company for approximately $600 million, we also repurchased approximately $600 million worth of shares and so if you put that in the context of free cash flow of $1.2 billion, we essentially deployed all of it. Now our objective is not relative to a free cash flow number but I can tell you that we intend to be active, both on the business development front and on the buyback front. I talked to you in the past about how we think about buyback; we have an internal model which calculates the value of the shares, and as we look at the share price we look at opportunities to purchase shares relative to that looking for a discount. I mean, typically the share is traded at a discount so we are active buyers in the marketplace. We expect to continue to do this through 2018 and we also expect to continue to do a number of bolt-on transactions, of course and Joe will speak to this in a moment; for us we have to be very disciplined about business development and so it's not just about doing deals, it's about doing very positive deals for our company. Similar to this Mallinckrodt deal. As far as the guidance, we have embedded some incremental guidance, we've been repurchasing shares in the quarter, this current quarter we expect about $500 million worth of buyback currently planned although I expect this is not the final number, it will be different than that and it will be based on the mechanics that I described earlier. Joe, you want to talk about business development?
José Almeida:
Sure. So going back to the team of capital allocation, I think Jay described pretty accurately our ability to do all of those things together. Our intention is to look at our businesses on an adjacency basis and do those incremental deals at a higher volume and velocity, meaning, more of them and a little faster as we continue to refine our M&A group, our M&A group is now complete, we have very strategic group in place, we have a pretty well defined boundaries where we want to go and I never take no, never considered that larger acquisitions are completely off the table, they are just difficult to come by and they are much more difficult to-date to get decent returns on those. But we -- as we look opportunistic at many different things, our focus in M&A and strategy are the cases it's going to continue to do that. But we can do the three things that we have planned all along; we continue to buy shares, we're going to continue to pay the dividends and increase dividends every year like we have done in the past, and do the small deals or deals which are complimentary in high volume and velocity.
Michael Weinstein:
I don't want to go through all the different businesses and the guidance for 2018 is relative to our expectations; but I don't want too many surprises, I thought that you're probably being a bit conservative and advanced surgery given the product flow there in the R&D, then put it in the work side, I'd love to hear your thoughts on that. And as well maybe the same comment on the renal side where there is a lot going on and really all three or four different parts of that business. Thanks.
José Almeida:
Thank you, Mike. I have to think that we are good forecasters of our business and this is the beginning of the year. We always have the ability to -- for the most part to do what we saw we're going to do. So when we give a number to this suite there is something we have confidence that we can achieve. Clearly, the year always hold surprises, we had a huge one with Hurricanes visit. But the company has enough in the back to be able to provide [indiscernible] results till we're be dead. I would say that we good growth in most of our business and we are continue to do geographic expansion product launches. So the ability to can't exceeded directly related to execution on the new products in second half of the year when we come in with the new pump version for SIGMA SPECTRUM, launch of our new peritoneal dialysis automated device in Japan in geographic expansion. So if we can execute on those things, everything goes right, we'll let you guys know and we will change our outlook for the year but at the moment that's what we see with a significant amount of puts and takes including cyclophosphamide.
Operator:
The next question comes from Larry Keusch of Raymond James. Your line is now open.
Lawrence Keusch:
I just want to quickly start-off on IV solutions; I know that you made the comments that you expect to be back in -- I think more normalized supply in the U.S. over the coming weeks. What gets you there? Is it a combination of the ability to import and Puerto Rico continuing to ramp up? And then if you could sort of segment that between large volume IVs and Mini-Bags?
José Almeida:
Larry, we can split the conversation into two pieces. The piece that got affected by the hurricane is a small volume parenteral that we'll call the SCP, those are we call Mini-Bags, Mini-Bag Plus. And pre-filled bags in small amounts for nutrition, amino acids, dual chamber bags and other things like that. So we have two different distinctive situations; let's -- let me talk about the small parenteral bags. We are producing at a pretty good clip at our plants in Puerto Rico, we supplemented that production with volume that is coming from Ireland, our Casabar [ph] facility. And we'll continue to make progress and we think by the end of the first quarter, though the production -- the inventory levels will be at a place that we can put this behind us. As we speak today, the allocation that we put out it is 100%; so people can buy Mini-Bags and Mini-Bags Plus today, we just changed that at 100% of the average purchasing volume of six months ago. So -- and we will get this completely normalized by the end of the first quarter, probably earlier than that. So we also have contingency plans which will put towards the end of '18, mid '19 more capacity for Mini-Bag Plus for two reasons. One is, we have the ability to sell as much as we make, it's better for the market and more profitable for Baxter; so we're shifting that mix to benefit all the stakeholders including ourselves in terms of profitability. The second part of the conversation is that large volume parenteral that has nothing to do with the hurricane, that has to do with increased demand and the inability of some of the manufacturers in the marketplace to make the product. We obtain permanent importation licenses and product registration for Mexico, we walk away from some of the business that we had in Mexico which can be taken over by a local competitors and is moving their volume permanently to the U.S. The second thing is, yesterday we just got approval from importation permits for Brazil, so now the product is going to be coming into the U.S. and we -- so by the end of this next six months, we will have a network of global factories that cost effectively can bring products into the U.S. in any situation, even to guarantee future contracts with our current customers and potential new customers.
Lawrence Keusch:
And then one other one, maybe a little bit longer in nature; I think Joe that you've been focused on Japan as an opportunity, it sounds like you guys are fairly under indexed there relative to other large multinational U.S. company. So just briefly, how do we think about the opportunity there in Japan and what are you doing?
José Almeida:
In Japan; the first opportunity for us is to capitalize in the tremendously under penetrated peritoneal dialysis business. Japan has a very, very, very rich reimbursement for PD and we make significant amount of profit from that modality but the volume compared to the rest of the world is quite small. So by launching the new Kaguia [ph] cycler in Japan we'll be able to satisfy some of the market needs for instances; more connectivity of the tubing [ph] in this machine is done automatically, hence free. So there are some peculiarities that Japan requires to adopt technologies different, we as a company have done not a great job in Japan once we separate from Baxalta because Baxalta was the bulk of the business in Japan. And our business now will focus on augmentation of the PD, launching new advanced surgery products in Japan, as well as augmenting the pharmaceutical capabilities in Japan. So this is more of a long-term roadmap but I tell you that is one that has our focus and in fact now is the -- present for Asia, Japan falls under him and we have significant plans for talent improvement to be able to get those things there.
Operator:
And our next question comes from Vijay Kumar of Evercore ISI. Your line is now open.
Vijay Kumar:
Maybe on the Q1 guidance on -- the revenue guidance; so some of the questions I'm getting is, if sequentially you had capacity coming back from Puerto Rico, right, was this guide a little bit tad below or what was the sweetness modeling on some of the line items?
James Saccaro:
Just a couple of things to point out in relation to Q1 sales growth which to your point Vijay is below the run rate we expect for the balance of the year, solid operational performance but Puerto Rico does impact us by one point of growth. And then the other comment I would make is, our -- last year we had a bolus of sales related to a product called Transderm Scope, and year-over-year that's about 1% headwind. So those two items collectively drag down the growth little bit below what we expect moving forward. The other thing that happens as we approach the latter part of the year is, we start to benefit from some of the new products launches. Joe mentioned, Kagulia [ph]; we're also extremely excited about the version 9 spectrum pump which we anticipate launching towards the end of the first half of the year, and so that starts to benefit and accelerate some growth. So two very specific items and then certain benefit from new products is really the story on Q1 relative to rest of your sales guidance.
Vijay Kumar:
Just a couple of quick guidance follow-ups; one, into the segment details, this is extremely helpful, the historical numbers you gave out but on that medication delivery but it's capacity is coming back from Mexico repurposing capacity rates, if I'm looking at year-on-year, flattish to maybe up slightly. So one, I'll be fair to assume -- this guidance has six to seven Delaware does not assume incremental shares and I have one follow-up on that free cash. Thank you.
James Saccaro:
As we look at 2018 performance for medication delivery, we are going to benefit certainly from the reallocation of sales back to the U.S. from IVs, from some of the markets that Joe mentioned early on. So that's certainly is a tail-wind for us. What I will tell you is over the last several years, we benefited from a number of items including the relaunch of Version 8 pump which featured prominently in our numbers, for a number of quarters. We also benefited from negotiation of selected grim [ph] that we have in place with GPOs. So there is -- we've always anticipated and we've model long-term that there would be a deceleration into grow, and particular in the U.S. overtime but this guidance is largely consistent with our expectations and does reflect some benefit of the reallocational products.
Vijay Kumar:
The free cash guidance, so that's -- call it double-digit growth or '17; but if we're looking at their 2020 targets of $2 billion, so that is how free cash flow accelerates back the high-teens. Was there any timing impact for '18 when you look at the free cash number?
James Saccaro:
What I will tell us is, relative to the guidance that we shared in July our confidence in our long-term ability to generate cash flow has increased in the sense that we had a great 2017 performance ahead of our expectations, so solid performance on free cash flow. Not really timing items, specifically I think we were pleased to exceed $1.2 billion, $1.4 billion will reflect in continued performance with respect to working capital management which we are driving relentlessly along with continued operating income growth. So stay tuned, we'll watch this one closely, it's always very difficult at the start of the year to predict cash flow, it's a highly volatile number, it's the most -- frankly, the most challenging one for us to predict on a full year basis. So stay tuned, we'll watch this one carefully as we go on but I will tell you, the performance of our team on the supply chain side on accounts payable, receivable side; very good performance and we're tracking where we want to be on the free cash flow side.
Operator:
And our next question comes from Matt Taylor of Barclays. Your line is now open.
Matthew Taylor:
The first question I wanted to ask was -- just around the injectibles outlook in Claris; I guess you gave us a number for Claris, I was hoping maybe you could supplement that with some color on what you're expecting from your internal program and maybe any update on the Claris 43 and how you're doing with the remediation there?
José Almeida:
We are continuing to pursue internal development. We are launching a coronary drug, just got approved. We have other drugs planned to be launched here, either frozen or not frozen dump made by Galaxy. We continue to launch products outside Claris, outside the U.S. for Claris and the 43 is quite simply, we have done to date everything that we said we were going to do, we're still not finished, we have couple of more things to do but we're still in the timeline in some of the things we're doing ahead of our timeline. We are optimistic that what we're doing is going to resolve the issues outlined in 43 but we are not the agencies, so we cannot speak on behalf of the agency, we do everything we can to satisfy what we said to the agents we're going to do and we feel comfortable that we're doing, now rest is with the FDA to make that determination but we work very hard and we have integrated significant amount of quality systems into the best of quality systems and if you went to the [indiscernible] today, you would see a significant amount of physical improvement in things that we've done to correct issues that we personally as a company have found and stuff that the FDA has found on top of our findings.
Matthew Taylor:
And I want to give you a chance to -- without bias can you maybe talk about some of the tailwinds from a product standpoint in 2018, and specifically we'd like to hear from you products that you think can make a difference that you believe are underappreciated by investors?
José Almeida:
I'll focus on three or four errors. First of all, I think our ability to provide the market with LVPs and SVPs add to volumes that the market not only needs but potentially have comparative -- going to competitive accounts is a potential upside, we don't know if that's going to materialize the competitive accounts but we know that we now have solid factories being completely focused in the U.S. market. BAX is largest manufacturer solutions in the world and having no use of that capability in the past was a mistake, now we're full engaged in using this capability and flexibility across the globe; so that is a positive. I think the new version of our pump, SIGMA SPECTRUM, coming out now in the second half of the year is a good thing; the pump has really new features and new things that we think are needed in the marketplace and the people waiting for it, so our ability to launch that well offers the possibility to be positive for us. The third one is the launch of the Kaguia [ph] in Japan, I think that is a positive. In geographic expansion, lastly is, we're trying to get products approved, we just got one approved in China the other date after earlier this week we just got a monitor 1898 [ph] approved in China for sale, way ahead of time. So our people are trying to work very diligently in new products to be able to get those things to augment our objective in the mid-term which is to get the company to a 5% topline growth.
Operator:
And our next question comes from Danielle Antalffy of Leerink Partners. Your line is now open.
Danielle Antalffy:
Just at a high level, if you think about beyond 2018 and what in the pipeline -- and Joe, maybe this is a question for you as well, what do you see is the key pipeline initiative that are going to drive accelerating growth beyond the 4% operationally or projecting in 2018, number one? And then Jay for you, number two, the incremental leverage you can pull on the P&L to drive positive leverage in the out years considering it feels like a lot of low hanging fruit might have already been picked here?
James Saccaro:
I'll start by talking about the operating margin leverage that we have and then Joe, perhaps you can talk about some of the exciting pipeline products that start to accelerate growth as we move past 2018. And by the way, it's a bit premature to talk about '19 and '20 as we sit here on February 1, so that's a risk of doing that. I think we are very pleased with the transformation efforts on the cost side. Danielle, your question is good one because to a large extent we have taken a lot of low hanging fruit and reflected that in our numbers over the last couple of years in terms of implementing zero based budgeting, certain other tactics that we've employed. As we look at 2019-2020 and beyond, there are certain more complicated or bit more challenging programs that we have on the back office with respect to G&A and perhaps it's better to say longer lead time items, as we look to transform our back office to streamline shared service centers, we've made tremendous progress, our functions have done really amazing work, but our expectational long is that those would not have an impact in 2016 or 2017 but would start to playout as we're seeing in 2018 and then 2019 and 2020. So that's one area I would say, and then the other thing that's going to be very interesting as we move to 2019 and 2020 is, our manufacturing team has done a great job in terms of controlling cost, now obviously that team has been very focused on responding to things like natural disasters and tight supply situation, so they've been very focused on that but at the same time they've been very focused on optimizing on manufacturing network and optimizing operations within our manufacturing network. And so moving to 2019 and 2020, we continue to expect very solid performance coming out of that team along with a restored supply situation. Now with respect to acceleration of growth on the top line and products that are going to drive that, Joe, maybe you could take that one.
José Almeida:
Our mid-term goal for the top line is 5%, we work very hard to get there and to get there is the ability to launch those new products, little better than we have planned and there is opportunity for that. So the first one as I said is optimization, the supply chain have in the right part and in the right place in U.S. if you're confident on that. The second is the launch of the product in Japan, the Kagua [ph] in cycle. The third is geographic expansion, get this thing right. Fourth, the pump, the SIGMA SPECTRUM, remember our medication delivery guidance for global growth is between 6% and 7% for 2018 which is pretty good growth. Then, let's look at little bit more on the mid-term, let's talk about '19 and beyond. TheraNova is a game changer in-center HD, so having that thing -- having the product completely approved in U.S., have the clinical trials in and have the ability to drive adoption in the U.S. is key for us to continue to grow. Launching PrisMAX which is our new acute renal care, CRRT monitor in the U.S. will drive continuously more growth in U.S., we're already market leaders in acute renal care with the CRRT modality, this is over $1 billion in market, we only have this modality which is CRRT was continuous renal replacement therapy has only 50% or less of the overall market, so the conversion is great. Also, getting in other modalities in the acute renal care is a desire of ours; and please don't forget that some of these acquisitions that we're making, we will have organic impact in the company once the anniversary meaning they have -- their own growth, we're not buying businesses, they have 0% growth, if we're buying business they have the ability -- like Claris, that's 12% to 14% growth happening in 2018. So there is opportunity going forward, we're ceding the way to be able to get to 5% and like they said, with the significant smaller cost base for the company to operate brings a very desirable form to the table.
Operator:
And your next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Lewis:
Just thinking about the pacing of 2018 numbers, I think so description of first quarter topline; just in the bottom line Jay, I think our math has 50 bips of margin maybe for the first quarter? Can you just talk a little bit about the factors impacting the bottom line for the first quarter? And then, as you think about the third quarter, that's either tough comp this year, should we also expect growth to be a little low in the third, kind of similar to the first?
James Saccaro:
Yes, I think that in the first quarter to your point we're seeing the lowest level of sales growth of the year and then also as we look at the bottom line there, there are a number of factors in play that impact bottom line growth; the first one being Puerto Rico, that's a couple of cents of margin impact that we expect to see and that's probably the most prominent. On the operating margin line, the Puerto Rico impact is roughly 40 basis points. Some of the other should -- the TDS sales item, that does not really have a bottom line impact, so I would say that if you adjust for that along with a tough TSA comp which represents about 50 basis points impact in the first quarter, remember, we -- that ceases to be an issue for us in the second half of the year. Those two items really explain why the margin would be the lowest growth rate in the first quarter relative to the other quarters in the year and we start to see acceleration there. So really those are the two items explaining about roughly one point of the growth. As we look to the balance of the year, we do expect to see solid performance throughout and so 2018 -- the third quarter does represent the tough sales comp but importantly, we'll start to benefit from some of the new product launches, so the version 9 of the SPECTRUM pump just starts to feature in our Q3 results. So I think that on balance we feel quite good about the quarterly forecast; Q1, a little bit of a slower start but again, that is entirely explained by things like Puerto Rico and TDS and then, as we move through the rest of the year, the story becomes consistent with the full year picture. The one item I would say in Q3, we do have $20 million compounding settlement in our 2017 results, so we'll probably talk about that but beyond that I think it's fairly steady progress.
David Lewis:
And Joe, just two strategic questions for you. I guess the first is, one that is breaking out of this global business structure, it occurs to me that some of the businesses you're breaking out actually have dramatically faster end market growth rates. I mean as you think about this new structure, are you starting to be of the view that the weighted average market growth rate for this business is frankly closer to 5%, relative to 4%?
José Almeida:
I think our weighted average market growth rate for the overall business is 3% but the ability to perform at 5% has to do with new product launches and the ability to focus, so hence the organizational restructuring. We were not focused and now deploying capital some time ago to the right business, despite the fact our intention was that but the organization structure was not prepared. What it has allowed us to do is two-fold; get people paid on global growth or certain franchise, second, allow us to really put people in those business with more specializing given exempt of pharmaceutical for instance. We have a big mountain to climb with $100 million in headwind on cyclophosphamide. Now having execution of Claris and our own organic molecules is key; to do that you got to have people who understand the generic pharmaceutical business, this is not a hospital product, this is not the same people who will do design infusion lines and infusion pumps, it's completely different. So we brought and are bringing people who have the ability to bring this business to the next level. So this reflects more of how we want to beat people, how we want people to focus and also to get to our 5% objective on the top line.
Operator:
Our next question comes from Larry Biegelsen of Wells Fargo. Your line is now open.
Larry Biegelsen:
I wanted to start with the operating margin guidance and the goal for 2020, I think of 20% Jay. So this year I think you're guiding to 80 basis points to 100 basis points of operating margin improvement, I guess that implies that you need about 150 basis points per year in '19 and '20 to reach the 20%. So why only 80 basis points to 100 basis points this year and that acceleration? I think earlier in prior calls, I think there was an impression that you could do a little better than 20%, do you still feel that you can exceed that number and I have one follow-up.
James Saccaro:
I'll talk about 2018. As far as 2020, we remain very confident in our ability to drive the business going forward. So I would insert a brief commercial for our May Investor Day, we look forward to updating our long-term financial projections for both 2020 and beyond which the whole team is really excited about that. As it relates to 2018 guidance, there is actually three items that I think are worthwhile pointing out that provides some color because on the one hand you could say 80 basis points to 100 basis points and that's what we expect but there is three headwinds to point out. First, cyclophosphamide is approximately 70 basis points of impact in this year, so that's an assumption that we've made, we'll see, we'll monitor this very closely but that's a very big drag on 2018. And frankly, as we look at margin performance over the next three years, we're modeling the largest single impact occurring in 2018. The second item is we have approximately 40 basis points of impact from TSA income loss. So again, that's an item that is explicit to 2018 that does not impact future years. The final thing I would comment on is, we have adopted the new guidance for pension accounting and what that means is, a number of items have moved below the line and there are certain items maintained above the line. This will be spelled out in detail in our 10-K but at the highest level reflecting this guidance is about 40 basis points drag on our results in 2018. We'll footnote this and describe in a lot of detail as I say in our 10-K, there will be also be some additional information available related to 2017 impact but if simply put in our 80 basis points to 100 basis points, this 40 basis points of headwind is related to the new pension accounting. So as we think about what those drivers add upto, that's about 150 basis points of drags that we work through this year on our way to achieving the 80 basis points to 100 basis points of margin improvement. We don't expect similar magnitude and so it becomes -- we can sit here confidently and say we feel very solid about 2019 and 2020 performance.
Larry Biegelsen:
Lastly for me, Joe, any update on emerging market performance?
José Almeida:
Yes, we had a pretty good performance in emerging markets. We had about 6.7%, close to 7% in emerging markets for the year. We also had China over 6% which is great for us. I just want to underscore that emerging markets like medical devices qualify does not apply to Baxter, we've been in those markets for a long time. So China for us is a good growth market, has a good GDP growth and that represents an opportunity for us to geographically expand new product lines there, as well as Brazil and Mexico, Columbia; I see those as probably the most prominent and then Southeast Asia. So, we do emerging markets commentary on calls for actually you folks, the analysts. Internally we have three different regions in the world; Americas, Europe and Asia, and we don't specifically monitor emerging markets anymore. We monitor specifically China which we think has continued to perform well and it's a very profitable and large market for us. And if you qualify emerging markets like -- you speak as about 22% of our overall sale; so it's very much larger than for many of our peers. So that's why we don't focus on that.
Operator:
And our final question comes from the line of Joan [ph] of BMO Capital Markets. Your line is now open.
Unidentified Analyst:
Joe, big picture medtech [ph]. You guys are probably closest to the ground at what's happening in the hospital as it relates to volume, price and flu. Can you just give us some of the brief overview of what you're really seeing out there?
José Almeida:
We're projecting low single-digits for hospital procedures and admissions in general, that's what we see in our -- when we connect the dots of our businesses. We also see a renewed interest in the capital investment from hospitals, at least, one of the large hospital enough for profit groups announced that they will revitalize plans for investment and that is good for the market. And we see also in general, consumption at a stable tools like a positive level. So it is altogether a unique situation for the country, for the U.S. is specifically where we see the healthcare markets reacting well to new tax legislation and so forth. The flu season is clearly picking up a significant money, [indiscernible] is already high for all accounts and there is some -- there is always slight positive impact because couple of our businesses and products that are used for situations where patient is in ICU with distress and multi-organ failure; so there is a pickup for our business when there is a good flu season, flu season is at all-time high.
Unidentified Analyst:
A follow-up and more specific question; every year I feel like we start-off with a relatively high cyclo competition headwind and then window it down throughout the year. Why is $100 million the right number for 2018? Thank you.
José Almeida:
Because we do model quite extensively and very precisely the impact of one entrant, two entrants, three entrants, four entrants; we do this because as a matter of fact we are sometimes on the other end, we're coming in as the second or the third entrant, so we know what the number is. So we have modeled based on the number of applications out there for cyclophosphamide that that is the impact. Now if people can pull it, pull-through, they don't have the regulatory capability; clearly, there is an upside for Baxter and we'll let you know as we give updates to our quarterly forecasts and update guidance if we see that there is no entrant, we will update and increase that if that's the case. And as I always say, we're very transparent about cyclophosphamide and it's always a positive for the company because there is more cash in our blanket. And it's a drug that is proven through many that it's not that easy to make. You know, cytotoxic drugs are very difficult to make and Baxter has a state-of-the-art facility that is not only used by us but used by many different pharmaceutical companies because the difficulty of doing it. So the desire to do it is not that -- doesn't relate to the ability to do it and recently one potential manufacturer got two warning letters in their facility in India [ph], so that probably put a stop on their ability to produce. But there are others out there then we have models, so if they come to the market we estimate it very precisely, $100 million of impact.
Operator:
Thank you. And that concludes our question-and-answer session for today. Ladies and gentlemen, this does conclude today's conference call with Baxter International. Thank you for participating and have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Third Quarter 2017 Earnings Conference Call. Your lines will remain in a listen-only mode, until the question-and-answer segment of today's call. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Canda. Good morning, and welcome to our third quarter 2017 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer, and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's third quarter 2017 financial results, along with our updated outlook for 2017. As a reminder, we have posted a supplemental presentation to compliment this morning's discussion. This presentation, along with related non-GAAP reconciliations can be accessed on Baxter's external website in the Investors section under Events and Presentations. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development, and regulatory matters contain forward-looking statements that involve risks and uncertainties and, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now, I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Thank you, Clare, and, good morning, and thanks for joining us today. I will get started with an overview of our third quarter results, then I will share some key highlights for the quarter that reflect Baxter's accelerating momentum around innovation and drive towards sustainable top-quartile performance. I will also briefly address our response to the natural disasters that have recently devastated parts of the Americas and Caribbean, and the related projected impact on our operations in the fourth quarter. Finally, I will pass it over to Jay who'll walk through our third quarter results and financial outlook in more detail. We'll close with Q&A. As you saw in our press release, Baxter delivered solid third quarter results on both the top and bottom lines. You'll recall that we closed our acquisition of Claris Injectables on July 27, our third quarter performance includes $27 million in sales from Claris. Sales growth in the quarter was 6% on a reported constant currency and operational basis. Operational sales are adjusted for the impact of foreign exchange, generic competition for U.S. cyclophosphamide, the Claris acquisition, and the previously communicated selected strategic product exits the company is undertaking. In the third quarter, we realized our strongest growth of the year, driven by continued strength in the U.S., particularly in Fluid Systems, pharmaceuticals, including Claris, and renal therapies. Internationally, we saw improved performance across both the Hospital Products and Renal businesses. On the bottom line, adjusted earnings were $0.64 per diluted share, increasing 14% over the prior-year period. This reflected solid top-line growth and improved gross margins driven by favorable mix in the quarter, as well as positive contributions from our ongoing business transformation efforts. Our company-wide results for the quarter reflect our focus on disciplined execution to drive an improved operational performance. We will continue to implement actions to support our business transformation, while also investing in the businesses, both organically and inorganically to drive innovation and growth. The Claris acquisition represents an example of this commitment. This acquisition allows us to build a broader presence in the generic injectable pharmaceuticals market. The early market response has been positive, with customers welcoming this addition to the expanding Baxter portfolio. We will continue to build on our momentum and commercial synergies as we launch additional molecules going forward. The molecules being advanced in the generic injectables pipeline represent a combination of internal development and external strategic partnerships. Our top priority during these early months of integration is to bring Claris fully online with Baxter's systems and processes. We have focus on bringing Claris up to Baxter's global quality standards and have taken actions to support this critical objective. We have made progress since the acquisition closed and we'll maintain this emphasis in the months ahead. M&A deals like Claris will continue to play an important role in building out our portfolio and pipeline across our key growth categories and adjacencies. Our third quarter highlights also demonstrated transformative and accelerating tempo of innovation of the company. During the quarter, we upgraded the SIGMA Spectrum Infusion System with the launch of DeviceVue Advanced Asset Tracking System. Baxter is the first and the only smart infusion pump manufacturer to offer a tagless, end-to-end acid tracking application designed in consultation with our customers to drive operational efficiencies and help maximize the clinical value of their pump investments. In our chronic Renal business, we have now enrolled the first patient in our U.S. clinical trial for HDx therapy enabled by TheraNova. This is a crucial step in bringing the benefits of TheraNova to patients in the U.S. market. TheraNova technology is designed to closely mimic the natural kidney through clearance of certain molecules during dialysis. It is already available in several markets worldwide, including Colombia, where we have just launched a second trial of the technology. In acute therapies, we have just launched the first 3-in-1 set for use in continuous renal replacement therapy, CRRT and sepsis management protocols. This is a label expansion for our oXiris blood purification set and adds to Baxter's multi-organ therapy offering, utilizing the Prismaflex system. The oXiris label expansion takes effect in more than 30 countries in Europe, as well as geographies in the Middle East and Africa. These highlights represent the small fraction of our activity and ongoing investment focus on supporting new products, the indications and new research. These investments are critical for fueling our continued growth hand-in-hand with improved efficiencies, (7:27) and disciplined execution. Before turning it over to Jay, let me take a moment to address the natural disasters that have overwhelmed parts of the Americas the Caribbean in recent weeks. We mobilized quickly in the aftermath of each of these catastrophes through a combination of product donations, financial assistance, on-the-ground support, and employees going above and beyond to help maintain patient access to our life-sustaining products and therapies. This work continues. In an update to the press release issued October 12, the FDA has granted two new approvals for regulatory discretion to temporarily import certain drugs from our facility in Canada and Mexico. We now have four sites approved to help address demand in the U.S. market. As it relates to product supply from Puerto Rico, we have targeted recovery strategies in place and are continuing to do everything we can to help mitigate patient and provider disruptions. As mentioned in the press release, even with the contribution of special import approvals from other sites and expected increased production in Puerto Rico in the weeks ahead, we will not be able to fully bridge the gap in demand in the fourth quarter. Accordingly, we currently project that aftermath of Hurricane Maria will negatively impact fourth quarter revenue by approximately $70 million. However, we expect the related effect on adjusted earnings will be offset through positive performance in other areas of the business. In terms of projected recovery dates, a limited number of products won't return to healthy inventory levels until the first quarter of 2018; however, we currently expect that a number of product families will return to normal supply by the end of this year. We fully understand and regret the hurricane-related inventory impact affecting our customers. Restoring reliable product supply remains our collective priority. Disruptions like this, in whatever form they may take, are an inevitable part of doing business. What matters is our ability to prepare, move fast, and then react swiftly while maintaining our commitments to our stakeholders. Everyday we're focused on achieving our mission for patients, strengthening our fundamentals as a company, and driving greater value for investors, employees, and the communities where we make a difference. Tenacious execution is the path forward and there's no letting up the pace. With that, I will pass it to Jay, for a deeper dive on the third quarter performance.
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our third quarter results, which represented our highest quarterly growth rate for the year. Sales in the quarter increased 6% on a reported constant-currency and an operational basis. Top line growth exceeded our expectations on both the constant-currency and reported basis, driven by better-than-expected contributions from Claris and cyclophosphamide, as well as a favorable foreign exchange benefit from a weaker U.S. dollar. On the bottom line, adjusted earnings were $0.64 per diluted share. This exceeded our guidance of $0.58 to $0.60 per share, and reflects solid top-line performance and improved gross margin, driven by favorable product mix, as well as the ongoing impact from our business transformation efforts. A modest benefit from other income and a lower tax rate also contributed to the results in the quarter. Now, I'll walk you through performance by business. I'll be speaking to growth figures on an operational basis to provide a clearer understanding of underlying performance. As a reminder, operational growth excludes the impact of foreign exchange, U.S. cyclophosphamide, Claris, and select strategic product exits. I will point out that top line performance in the quarter was not materially impacted by any of the natural disasters experienced during the third quarter. Global sales for Hospital Products were $1.7 billion, advancing 6% operationally. Breaking this out by business, sales in Fluid Systems were $610 million, up 7% operationally. Performance was primarily driven by robust sales of IV solutions in the U.S. Moving to Integrated Pharmacy Solutions, or IPS, global sales were $627 million, increasing 8% operationally. Contributing to performance in the quarter were increased sales for premixed injectable drugs and a one-time benefit from an early contract settlement with one of our hospital pharmacy customers outside the U.S. Sales of U.S. Cyclo were $47 million in the quarter and, as mentioned previously, Claris contributed $27 million globally. Moving to Surgical Care, which includes anesthesia and BioSurgery; total sales were $338 million, increasing 6% operationally, contributing to performance in the quarter with low double-digit growth for anesthesia and critical care products, driven by positive demand for inhaled anesthetics internationally, as well as increased U.S. sales of BREVIBLOC, a fast-acting IV beta blocker. As a reminder, in the third quarter of 2016, international anesthesia sales were negatively impacted by an austerity adjustment. Globally, BioSurgery sales increased low-single digits in the quarter. We expect growth in this business to continue to improve as a result of our efforts to enhance commercial effectiveness and reinvigorate the portfolio with a number of new product launches expected next year. Finally, in Hospital Products, sales in our other category were $122 million, declining 2%. Turning to our Renal business, sales were $1 billion, up 6% operationally. Sales in the quarter benefited from solid performance across all lines of the business. Both our peritoneal and in-center hemodialysis businesses advanced mid-single digits globally. Notably, the in-center HD business reported positive international sales growth for the first time this year, reflecting our efforts to stabilize and improve performance in this business. The Acute Renal business delivered high-single digit growth globally in the quarter, driven by mid-teens growth in the U.S. and mid-single digit growth internationally. Walking through the rest of the P&L, our adjusted gross margin of 45.2% represents an improvement of 30 basis points over the prior year and was driven by improved pricing in select areas of the portfolio and the benefit from our business transformation efforts aimed at simplifying the portfolio to drive efficiency and reduce costs. This improvement was modestly offset by a negative impact from foreign exchange. Adjusted SG&A totaled $633 million, increasing 4%. The positive contribution from our relentless focus on effectively managing our expense base was offset by lower transition service agreement income from Shire in the quarter. In addition, we continue to make select investments in sales and marketing in key areas of the portfolio to support our growth initiatives. Adjusted R&D spending in the quarter of $150 million increased 16% versus the prior year, reflecting our stated intention to accelerate investments in our core growth businesses. Adjusted operating margin in the quarter was 16.3%, an improvement of 30 basis points versus the prior year, and favorable to our expectations, driven primarily by improved gross margin. Net interest expense was $14 million in the third quarter. Adjusted other income totaled $12 million in the quarter, reflecting a benefit from foreign exchange gains on balance sheet positions. The adjusted tax rate was 18.9% for the quarter, which reflects a benefit from the new stock compensation guidance. And as previously mentioned, adjusted earnings of $0.64 per diluted share exceeded our guidance of $0.58 to $0.60 per share, driven by operational sense, other income benefit and a lower tax expense. During the third quarter, we repurchased approximately $180 million, or approximately 3 million shares. These targeted repurchases were more than offset by option-related dilution. Before turning to our updated outlook, I will provide some commentary regarding our cash flow performance. On a year-to-date basis, we have generated free cash flow of $933 million, an improvement of more than $500 million versus the prior year, and already exceeding the 2016 full-year total of $905 million. Growth has been driven by strong operational performance and lower capital expenditures, along with continued focus on improving the company's working capital performance. Let me conclude my comments this morning by providing an update on our outlook for the remainder of 2017. We expect 2017 full-year sales to increase approximately 4% on a reported basis, and approximately 4% on a constant currency basis. And after adjusting for U.S. cyclophosphamide impact, select strategic product exits, and removing the benefit from Claris, we expect underlying operational growth of 4% to 5%. I would like to point out some key assumptions reflected in our full-year sales outlook. These include approximately $70 million of negative sales impact from Hurricane Maria, approximately $57 million in Claris sales, and full-year cyclophosphamide sales of approximately $190 million. Looking at the sales outlook in more detail, we now expect growth in Hospital Products business of approximately 4% on a constant currency, and 4% to 5% on an operational basis. This outlook reflects the full impact of Hurricane Maria, with approximately 80% of the lost sales realized in the IPS franchise. The remainder of the impact is reflected in the full Fluid Systems franchise. Within Hospital Products franchises we now expect Fluid Systems constant currency sales growth of 5% to 6%, and approximately 7% on an operational basis. For the Integrated Pharmacy Solutions or IPS franchise, we expect constant currency sales growth of 3% to 4%. Operationally, IPS sales are expected to increase approximately 2%. As I just mentioned, IPS includes a negative impact from Hurricane Maria of approximately $55 million. Within Surgical Care, we continue to expect sales growth of approximately 4% on a constant currency basis and 4% to 5% operationally. And finally, for the Hospital Products business, we expect BPS and other to increase in low-single digits. For the Renal business, we continue to expect full-year constant currency sales to increase approximately 3% growth, and growth of approximately 4% operationally. Moving down the P&L, we expect an adjusted operating margin of approximately 15.5% to 16%. We expect net interest expense to total between $55 million and $60 million, and adjusted other income of approximately $35 million for 2017. For the year, we now expect an average adjusted tax rate of approximately 18%. For full-year 2017, we anticipated diluted average share count of approximately 555 million shares. Based on these factors, we now expect 2017 adjusted earnings, excluding special items, of $2.40 to $2.43 per diluted share. Finally, for the year, we are once again increasing our outlook and now expect to generate operating cash flow of approximately $1.85 billion, and free cash flow of approximately $1.2 billion. Specific to the fourth quarter of 2017, we expect sales growth of approximately 4% to 5% on a reported basis, and approximately 2% on a constant currency basis. Operationally, sales in the fourth quarter are expected to increase 1% to 2%. I did want to note that operational sales growth includes approximately three points of negative impact due to Hurricane Maria. And we expect adjusted earnings, excluding special items, of $0.56 to $0.59 per diluted share. This includes a $0.06 negative earnings impact from Hurricane Maria, which is mitigated by an increase in our sales projections for U.S. cyclophosphamide and a lower-than-expected tax rate for the fourth quarter. With that, we can now open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. And our first question comes from Matt Taylor of Barclays. Your line is now open.
Matthew Taylor:
Hey, good morning, and thanks for taking the question. I guess, the first thing I wanted to clarify is, it seems like when you're talking about your recovery efforts in Puerto Rico that there should be very little spillover into the first quarter. Is that right in terms of what you're currently projecting? And what's the risk that some of these efforts take a little bit longer to kind of shore up your supply?
José E. Almeida:
Matt, good morning. We have three factories in Puerto Rico. And I think our lowest percentage of operating capacity right now is at probably around 70% to 80%, okay? So, we will have very little impact in the first quarter. We're going to have on-hand inventory of those products towards the end of January, meaning on-hand, I mean product in the inventory that can be shipped. So nothing that we know today would prevent us from having inventory position be well-positioned by the end of January. That doesn't mean that you're not selling the product, meaning that we have a pretty good inventory levels at that moment in time. So, I will say the impact in the first quarter is small. But I want to make sure that people understand that the infrastructure in Puerto Rico is devastated. So we are operating under emergency situation with generators, and we have water in our plants and everything else. So the plants are fully operational, but we need to make sure the federal government continues to provide the support for the recovery of the island. We have one of the plants already going on to the grid, hopefully by the end of this week. So, as we continue to see progress, our confidence becomes even stronger. But based on what we know today, very little impact in the first quarter.
Matthew Taylor:
Okay, Joe, thanks for that. And then, I wanted to ask one on the Renal business. If I look at the guidance for the year, it looks like you're projecting a little bit of a pick-up in the fourth quarter, and this is the first quarter the HD business has grown in a while. Can you talk about what you're expecting going forward, and if we could see more of a pick-up, I guess, in the HD business, with you participating in tenders, or what's going on there?
José E. Almeida:
Yeah, we are expecting low single digits in the HD business. But one thing that we have done is, we anniversary some issues that we had in dialyzers on a global basis, primarily outside the U.S., where we encountered significant competition and price erosion that has been anniversaried, but also, we're the second largest manufacturer of dialyzers in the world, so we have the ability to compete very effectively outside the U.S., and I think this is one of the changes in mindset from the old Baxter to the new Baxter. You operate where you can and make sure that manufacturing is a strategic weapon for the company. So, when we look at the market, we can provide the market with the great products outside the U.S., in a very cost-effective manner and also profitably. So, we want to make sure that we participate. You know previously here in the company we probably did not have that window into the opportunity. So what you're seeing right now is the pick-up of our dialyzer business outside the U.S. markets and the stabilization of our monitor sales, as well. So, we feel cautiously optimistic and happy with the turnaround in the HD business.
Matthew Taylor:
Okay. Great, Joe. Thanks for the color.
José E. Almeida:
You're welcome.
Operator:
Thank you. And our next question comes from Bob Hopkins of Bank of America. Your line is now open.
Robert Hopkins:
Hi. Thanks very much. First, just a clarifying question. I'm sorry if I missed this, but, Jay, in terms of the EPS impact of currency in 2017, can you tell us what the impact is in 2017, and your thoughts on how currency is shaping up as we look forward?
James K. Saccaro:
Yeah, I mean, as we think about the second half of the year relative to forecast, while we have seen a fairly meaningful sales improvement relative to foreign exchange, the actual drop-through has been fairly low. So, maybe a penny or two on the bottom-line. And I bet – I would characterize that as a result of a couple of things. One is, given that a lot of this strength comes from Euro strength, we have a very large European cost base in place. So, we don't see a great benefit from the translation back of dollars of increasing Euro performance. Now, we are working on our European cost base, and that will improve over time, but, the benefit of a stronger Euro is a bit muted. The other factor that comes into play when we think about foreign exchange is we have had – we have put on hedge positions over the last six quarters, hedging out Euro and other currencies, and so, we have a little bit of an offset. As the Euro strengthens, our translation improves, but that's offset a little bit by lower gains in terms of foreign exchange on the hedge positions that we have. So, in combination, I would say that while we did see a sales impact, we didn't see an intended drop-through to the bottom line, for the most part. And looking out to 2018, clearly there is some currency strength that we're evaluating that could have an impact, but there are a lot of different factors in play as we look to 2018.
Robert Hopkins:
Great. That was very thorough. Thanks, Jay. And then, Joe, just I was wondering if we can get an update on your latest thoughts on capital allocation? And specifically, how you're thinking about the growing free cash flow and cash that you have? If deals do not materialize, are larger buybacks what we can expect as the most likely use of cash? Or are there circumstances where you'd let cash build? Thank you.
José E. Almeida:
Bob, we always prefer to invest the money back into the company. In this case, the cash flow of the company into acquisitions. When it is not possible, we're going to buy shares back, okay? But I want to make sure there is not an exclusivity to my statement, meaning that those are not mutually exclusive. We will do both of them because I think our cash position and our ambitions in terms of targets, we can do both, buy shares and continue to pursue M&As. I would say that large acquisitions are very difficult to combine, and the return-on-invested capital that they bring along is marginal. So, we are focusing on molecule purchasing. We have a lot of those in process right now, tuck-ins, product lines from companies are divesting, things such as this to augment our growth in the long-term, and augment our four pillars of growth in our business, which is the pharmaceutical business, the critical care, the surgical, as well as parts of our renal area, primarily areas that will be beneficial to us outside the U.S. in terms of buying clinics and things like that. So, if we find acquisitions in these areas where we're going to execute and we have a brand-new M&A team and we see some really good momentum there. But, it is not exclusively one or the other. Be sure that we will continue to apply our cash flow, our growing cash flow to share buyback and to deliver value to our shareholders. I would say maximized value for our shareholders.
Robert Hopkins:
Great. Very clear. Congrats on a great quarter. Thanks.
José E. Almeida:
Thank you.
James K. Saccaro:
Thanks, Bob.
Operator:
Thank you. And our next question comes from Mike Weinstein of JPMorgan. Your line is now open.
Michael Weinstein:
Good morning. I want to try and run through a couple of items. So, first, in the quarter, what was your ability to capitalize on B. Braun's manufacturing challenges in the Solutions business? And then, could you just spend another minute on the IPS out-performance this quarter going into, obviously a more challenging fourth quarter because of the hurricane? Thanks.
José E. Almeida:
Mike, I would say that one thing that we have changed at Baxter is our view of supply chain. And this has changed significantly in the last six months. And the reason is that we not only now are preparing to come into the U.S. with significant volume in LVPs to help assure our current customers that they will have LVPs. So, we do have that capability coming from other plants in the Americas, and that has already advanced to a point that we're going to start seeing that volume coming into secure volume and help guarantee volume for our current customers in the first quarter of 2018. But, also, volume that will serve to consistently meet the necessities of customers that are not ours in a situation like B. Braun. So, we are selling every LVP that we have today. I know the situation in the U.S. is not desirable from the point of view of the providers with the current – the competitor that you just mentioned having quality issues or supply issues. I don't know which one is what, but I know that we are doing everything we can. But in the future, to be able to capitalize on this, we are bringing significant volume into the U.S., now that it has been redirected permanently, permanently from other parts of the world to the U.S. in a very cost-effective manner and also it is approved by the agency. In terms of the fourth quarter, I think Jay was clear about the upside that we have in cyclophosphamide, as we don't see a third competitor or fourth competitor coming to that market, so, we'll be able to offset the Hurricane Maria impact. But once you clear that impact, we also are making provisions so we can have enough SVPs. So, let me clarify what SVP is. It's small volume parenterals, and that's the product made in Puerto Rico. Puerto Rico does not make one-liter bags, does not make 500-mL neither 250-mL bags. Okay? So, separate both of them. I think there's some misinformation going around, spread by other competitors about what makes what and who makes what. So, we want to make sure that people know. We also are augmenting volume and production of SVPs coming out of Puerto Rico to be able to satisfy not only current customers, future customers. So, we see the Solutions business in the U.S. as a good business; therefore, we made some permanent decisions in allocation of capacity back into the U.S. to augment current contracts and future contracts.
Michael Weinstein:
Okay. And just to clarify, there was a piece in the IPS Business internationally this quarter that you said was one-time. Could you just maybe explain what that was, and how much it was? And then, Jay, just a tax rate question, you're guiding to a lower tax rate, initially it was after the fourth quarter at 18%, can you just speak to the sustainability of that in 2018? Thanks.
José E. Almeida:
So, Mike, what happened was, that was a one-time contract – contractual payment due to us outside the U.S. in a compounding pharmacy area, and there was $20 million this quarter. Okay?
Michael Weinstein:
Got it.
José E. Almeida:
That's what we highlighted, we're not going to repeat, but was a contractual paid to us. And I'll pass it on to Jay to answer the second part of your question.
James K. Saccaro:
Yeah, certainly. The tax rate has trended favorably relative to our expectations. In the third quarter relative to out-performance, tax rate contributed about a penny. And then, again, in the fourth quarter, we're seeing some positive performance from tax rate. The biggest driver of this relates to FAS 123-R, which is the new stock compensation guidance. At this point, it's difficult to forecast the long-term impact of that, because to a large extent, it's dictated by auctions exercise and the nature of those auctions, in terms of their value relative to what's anticipated by the Black-Scholes model. So, it's hard to say what the tax rate impact will be in 2018 based on these items, but we're certainly pleased with the performance that we've seen in 2017 related to this item.
Michael Weinstein:
Understood. Thank you.
Operator:
Thank you. And our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Ryan Lewis:
Good morning. Joe, I wanted to follow-up on one of Mike's questions on Fluid Systems. Our sense at our conference was increased enthusiasm for the ability to add capacity in the back half of this year to provide more capacity to customers next year. And you mentioned this could be a tailwind through the first quarter. Could this actually turn out to be relative to some of the destruction when your competitors, a tailwind longer, or have a longer duration into 2018 than just the first quarter?
José E. Almeida:
David, I think we don't know the extent of other people's problems, and unlike other competitors, we will not speculate what their problems are. But, what we can say is what we are preparing to do. We are preparing to bring to the U.S. a strong volume of LVPs in the first quarter. It's starting in the first quarter, coming from one of our factories in the Americas that is approved to ship into the U.S. already. And that will not only help secure volume for our current customers, but also open our ability to compete for secured volume for other customers, which currently are not our customers. So, I'm not saying that we're going to be able to do it. I'm saying that we have the opportunity in front of us. And knowing our Baxter U.S. team, led by Scott Luce, I would say that I have full confidence that team can deliver on the opportunities.
David Ryan Lewis:
Okay. Maybe just two quick follow-ups. So, Joe, obviously last quarter you provided an LRP, and a general association of growth for sort of 4 percentage growth for the LRP. Can you just give us a sense kind of roughly, Is that a good proxy for how we should think about 2018 growth rates? And then for Jay, just on Claris, I mean you're pretty confident at our conference around this. But the warning letter sort of came out here intra-quarter, more details of that letter. Are you comfortable with sort of where you are from a mediation perspective on Claris? And do you forecast any additional costs that we may not know about heading into 2018? Thanks so much.
José E. Almeida:
David, what we said in July about the LRP has not changed. But we would like not today to provide guidance into 2018. So, we will be tuning first week of February, we'll tell you all about 2018. But today, I think we should focus on the third quarter of this year, which we finished, and the quarter coming up, which we're currently on the fourth quarter of 2017. Let me comment on the first part of the question of Claris, and I think Jay can talk about the cost, if there's something to add. We have already responded and are on schedule to deliver on every promise we made to the agency to address their concerns on every observation. So, to summarize, we are on the good path of addressing, from our perspective, the issues that have been raised by the agency. Okay? We knew some of those issues ahead of time. And we already had plans, before we closed this deal, that we're going to put Baxter quality systems in place. We had no doubt about that. We are doing everything we can accelerating the pace to put those in place. We feel that the value of the acquisition is still very much on target, and the value proposition has not changed, which is quality, low cost, and availability of product. And I think the amount of the resources that we have deployed to Claris to resolve these issues and improve their quality systems has been second to none. Baxter does a great job in mobilizing and addressing a crisis, and they did a pretty good job. So now we feel very comfortable that everything that we're doing, we're seeing the effect and we've seen the effect in a positive manner. Remember I speak from our behalf, not on behalf for the agency. Second thing, the amount of money that is going to be used to remediate the quality issues that we have, that we already had most of this cost predicted, we don't think at this point in time, I'll pass on to Jay, there will be something of large extent. Because, first, we know some of them are not expensive to fix. It's just procedural things that we have to do, but I will pass it on to Jay if he has anything else to add.
James K. Saccaro:
Really not much. I mean, we have no material changes to our financial cost projections for the business. I think Joe summed up the situation very well.
David Ryan Lewis:
Thank you very much.
Operator:
Thank you. And our next question comes from Isaac Ro of Goldman Sachs. Your line is now open.
Isaac Ro:
Good morning, guys. Thank you. I wanted to ask a couple of questions about the growth strategy. First, just kind of looking internally; not a lot of attention on the call today regarding Claris, in terms of the pipeline. Can you maybe just give us an update on kind of where you stand, bringing some new products to market. As I recall, it was more of a 2019-2020 story, but just looking for an update on how we should think about the contribution to organic growth?
José E. Almeida:
Innovation is picking-up momentum at the company. I would say that bringing Sumant on board was a big victory for us, and he's starting to make a big difference in how we see innovation. I would say it is playing 19-20 is more of a play there. But we're making everything we can today. Actually, just look at our R&D spending. It was a little up on a sequential basis, and the reason for that is, we're going after some more clinical trials, something the company has shied away in the past of doing. So we're going more after clinical trials, like TheraNova. We have clinical trials in a couple of different places. We are spending more money in our infusion systems. As you know, we have a new version to be submitted to the agency and then to be released hopefully next year, of our spectrum, SIGMA Spectrum. We have new platforms coming up in 2020. We have our new CRRT machine coming to the U.S. in 2019. We have new filtration systems going in for different types of toxins. Going to be launched in 2019 and 2020. So we have the momentum going. I think the biggest challenge that we have is to make sure that we balance the spending in R&D with the spending in the infrastructure of R&D. So, as we continue to modernize and bring the right people to the company to help cement this innovation, we don't get ahead of ourselves in creating more R&D centers, which we're not going to do. As a matter of fact, we're going to reduce the amount of spending in infrastructure and increase the spending in product development. So, we just want to keep transparency and give you, on a quarterly basis, an update of some of our advancements in innovation, which is the next thing for Baxter to be successful, is to combine the significant transformation of the business costs with the innovation, to deliver the best benefit for our shareholders.
Isaac Ro:
Great, thanks. And maybe just a follow-up on the inorganic side for growth. You mentioned earlier that large transactions are difficult and, of course, the overall environment for asset prices continues to go up. So, I'm curious if you could talk a little bit about the extent to which your strategy for M&A is evolving, and in particular, sort of the opportunities that you see maybe outside the U.S. that are perhaps less obvious to those of us in the U.S. market? Thank you.
José E. Almeida:
M&A follows a strategy. We don't have an M&A strategy per se. We have a strategy for every business of the company. And M&A is following that. In the past, we had those two not very well coupled and now we do. Our strategy for the company is expansion inorganically, not only in the U.S., but across all regions. In Europe, as well as Asia with focus in China. And we have the people being put in place to be able to scout those opportunities. We have an M&A team that is focused in bringing more deals. I'm seeing more deals now in the pipeline than I have seen before, but not deals that are – more relevant deals. Deals that have higher probability to be executed in a very large and very fast, by the way, process going on in our pharmaceutical groups, our pharmaceutical group led by Bob, Robert Felicelli. Now, it's time to accelerate and we have identified a significant amount of opportunities in their group for growth. So, inorganically, by the way. And so, now I feel a bit more comfortable that we have the right structure and the right strategy for the company to execute on inorganic opportunities.
Isaac Ro:
Got it. Thank you.
Operator:
Thank you.
James K. Saccaro:
Thanks, Isaac.
Operator:
And our next question comes from Matt Miksic of UBS. Your line is now open.
Matt Miksic:
Hi, good morning. Thanks for taking my questions and congrats on a terrific quarter. So, I wanted, Joe, maybe just first to follow-up on that last comment. You've made a few comments on strategic investment perhaps preferring kind of tuck-in smaller molecules, as you've talked about. And I'd love to understand, you know, there's clearly opportunities in your – across your operating structure to sort of drive leverage, Claris and molecules is one, and your specialty injectable platform. Surgical call-points is another. And on the Hospital side, on the Surgery side for product lines or things like that, I'd just love to get a sense of which elements of Baxter's infrastructure, operations, call points, sales force, I don't know, distribution, adjacencies, do you see as opportunities to leverage? Because I assume if you're looking at product lines, that's one of the key elements of the opportunities. And I have one follow-up.
José E. Almeida:
Our call points go from Hospital to Home. In the Hospital side, we have, in the U.S. and large geographies around the globe, a very good, I would say, probably one of the best key account management groups in the industry. So, our ability to put things in contract, private label products, primarily drugs for GPOs, becomes a real strength when you're looking at these small molecules and how you bring them online. So, look at Claris. With Claris benefited from Scott Luce's opportunities in the U.S. Scott runs our business in the U.S. sales for the Hospital business and immediately got some accretion going on with the Claris molecules in the U.S. So, that is a sweet spot for us. We will shy away, at least in the beginning, to go into spaces that you have to create a brand new sales force with no synergies because the value of those acquisitions are quite dilutive to begin with. Then you look at the Home. We have a sales force to call on home in our Renal business, our PD business, with significant penetration in the U.S. So, the ability to put more on their bag is important to us, and is also an opportunity. So, the call points in Surgery, for instance, we have – we are in the ORs, but we need to find the sweet spot in the ORs with our sales reps can be relevant. So, we're not going to look into generic instrumentation and laparoscopy stuff because those things the market is saturated with that. There are companies that own that space and we have no value there. But we add value to niche operations, niche spaces of therapies or procedures that we can probably have our sales force scanned it back. So, we will see some movement in terms of inorganic opportunities in the future that capitalize on our sales force and the hospital surgery-wise, where we put more products in their bags and they will probably do a great job on that.
Operator:
Thank you. And our next question comes from Larry Biegelsen of Wells Fargo. Your line is now open.
Larry Biegelsen:
Good morning, guys. Thanks for taking the question. So, Joe, emerging markets account for about 20% of your sales, but they don't get a lot of attention on these calls, and the growth has been sluggish, I think, in the first half of the year in emerging markets for your business. What was growth like this quarter in emerging markets? And what's the outlook there? And I had a follow-up. Thank you.
José E. Almeida:
Larry, just want to clarify. What is called emerging markets is 23% for Baxter. So, you can see Baxter different than other companies, that are called peers, have a pretty high penetration in those markets. Most of the products we sell in emerging markets are not devices, per se, they are renal and they are fluids, okay? So, when we look at market growth rates, and you said sluggish in the first half, we were just growing in market rates for the markets we compete. We had a pretty strong third quarter with, for instance, China at 7%, okay? That was a pretty good market growth for us. We do have depressed numbers in emerging markets because it's the place we exited the most of our IP business. So, places like Turkey, like a reduction in volumes in the Middle East, Venezuela, parts of Latin America, as well as parts of Greece, that we took volume down. India, we got out of 100% of Fluids business in India. That's where you see a depressed number. When you remove those, you still are pretty good, strong underlying. So, having a 7% growth in China, it is a great growth for us, because in China we are in peritoneal dialysis, nutrition, and IV fluids and anesthesia gases, okay? So, these are the businesses we have there. We do a great job. We have market share leadership in almost everything we participate in China and China is completely – is going through a complete transformation where we're going to bring more value-added fluids to the market instead of just your regular dextrose and saline. So, I feel really strong about China in our LRP crossing the billion-dollar mark, which I think is a challenge, but is going to be a doable – doable challenge to the Chinese team.
Larry Biegelsen:
Joe, just to clarify. So, when the business exits, and this year we should see an improvement in your emerging market growth rate, it sounds like. And then just one for Jay. You know, year-to-date growth is about 5%. You did 6% in Q3 operational growth, it looks like adjusting for the $70 million from Puerto Rico. It's about 4% in Q4, and that's off of a little bit of an easier comp year-over-year, I believe. So, maybe if you could help us just kind of bridge Q3 to Q4, what do you expect to decelerate a little bit, that would be helpful? Thank you.
James K. Saccaro:
Certainly. The primary driver, as you noted, of the sales deceleration in the fourth quarter relates to the $70 million impact from Hurricane Maria. But beyond that, as we think about comparison Q3 to Q4, as Joe mentioned in his answer to a question, we did have about $20 million related to a contract buyout, which we don't anticipate repeating in the fourth quarter. That was more of a one-time item, per se, or a specific to the third quarter, I should say, item. And so, if you adjust for that the growth rate essentially comes down a point. We had anticipated that. It was no surprise, but it was part of the forecast that we put together. So, what I would say, generally, is we – when we guided in July of this year, we said overall the business is a 4% grower from 2017 to 2020. In many cases, there are quarterly fluctuations. The first quarter was above that rate, the second quarter was below, the third quarter was above, and the fourth quarter we expect to be in line, but for the Hurricane Maria impact. So, I think largely we're growing a little bit faster than our end markets. And then what we do is we go through a bottoms-up forecast process and isolate things like austerity measure impacts and one-time buyouts, and so on, and put together the forecast. So, really, that's the essential commentary, I think, thinking about the fourth quarter, but no material change in trends, per se. Continue to grow in line with our long-term expectations.
Larry Biegelsen:
Thanks for taking the questions.
James K. Saccaro:
Certainly.
Operator:
Thank you. And our next question comes from Danielle Antalffy of Leerink. Your line is now open.
Danielle J. Antalffy:
Thanks so much. Good morning, everyone. Thanks for taking the question. Joe, I just wanted to ask about the impact of the Renal business from the Fresenius-NxStage deal. How do you think that changes the competitive dynamics, and does that change Baxter's overall view of home hemodialysis?
José E. Almeida:
I think the market dynamics will not change in the long term. Okay? I believe that the leadership positions that we have today become the same going forward three, four years out when you think about innovations that we are bringing to the marketplace in PD with point of care, and also the CRRT business with us launching our new Prismax platform in the U.S., as well as extracorporeal stuff that we're going to be launching in the U.S. So, I would say that, I can't comment on why people do things. They are not related to Baxter. So I'm not making a judgment on why one company bought another one. I just don't see the reason why that would affect our market in the short and long term, primarily because, to date, we have market share leadership in CRRT, and we're not letting up on innovation. And in PD, the same thing. So, we want to make sure that our investors understand that we have a very strong pipeline going forward, and the acquisition or the merger of these two companies are quite immaterial to us at the moment, the way we see it.
Danielle J. Antalffy:
Okay, thanks for that. And just sticking to renal, I was hoping you could talk about how to think about the drivers of the Renal business in 2018. Not asking for guidance, but you're continuing to roll out AMIA. You will anniversary some of these less favorable tender exits. So, just wondering, do you view 2018 as a growth acceleration year, or do we really have to wait for the on demand PD system in 2019 before we see the Renal business pick up? Thanks so much.
José E. Almeida:
I just want to start with the end. I will not – I want our investors to understand that the POC, point of care is not a driver of our business, neither is something that will transform the business and change the growth rate of the business in any way, shape, or form. Remember, we are the market share leaders in PD around the globe. And so, for that purpose, the growth rates of the market are primarily dictated by the growth of the disease and our growth. So, I would say that you will continue to see a growth in patients. The patient growth has been healthy for us, and we think we'll continue to become healthier as we move forward. And the HD negative tenders that we either did not participate or had a significant price impact, we will anniversary. So, the Renal business is in good shape, and we will save some of the news for 2018 for February when we give guidance.
Danielle J. Antalffy:
Okay, that's fair. Thanks so much.
Operator:
Thank you. And our final question comes from the line of Larry Keusch of Raymond James. Your line is now open.
Lawrence Keusch:
Thanks, guys. Thanks for squeezing me in. Joe, so, maybe this is getting a little bit in the weeds. But I'm very curious about this Sepsis opportunity that you sort of started to talk about and some of the clinical trialing going on. Could you just shed a little bit of light on sort of the way to think about either the opportunity or the timeline here? And then I had one quick one for Jay.
José E. Almeida:
Larry, what we find is, extracorporeal technology has evolved, and our know-how in membranes and filtration systems help us get there faster. So, if you combine the fact that a patient who is in continues renal replacement therapy in an ICU, will have the probability of developing multi-organ failure. Starting with the kidneys and you go to lung, liver. We are developing filtration systems or membranes specifically for that. So the Sepsis one is, there are some toxins that our oXiris product will filter. And is successful in Japan, which is making this changes and creating the momentum across the globe, all the way coming to the U.S. We have a lung product that we currently distribute today, which is very effective. We also have MARS. Which is used – I was at Emory University the other day, and extensively used there for treatment of liver toxins. And is used in conjunction with our current CRRT product, which is in the market, Prismaflex, today. So, we really like that space. We have a new general manager for this business on a global basis. As a matter of fact, I'm going to see some revised plans this week in terms of how to expand this technology a little faster and a little deeper into markets. But we're excited about those extracorporeal technologies using the current technology that we have for CRRT, but also banking on Prismax, which is the new platform coming out today – coming out in the U.S., probably sometime in 2019.
Lawrence Keusch:
Okay, perfect. And then, Jay, just quickly. Obviously, working capital improvements have been a big opportunity for you guys. So just, again, remind us where you've been making the improvements in working capital, and just any thoughts on opportunities as you look forward?
James K. Saccaro:
Sure. Really, working capital and I would say, generally speaking, cash flow performance has been a core area of focus of the entire organization. And I think we're really pleased with the progress. On the working capital front, frankly, it's been all three areas that have been squarely in our focus. Inventory management, days payable, and DSO. And in the third quarter, we had good performance across all three. I think the quarter ends with days payable of 49, days sales outstanding of approximately 55 days, and inventory on hand in the 90's. Now, certainly, we want to make sure we have adequate inventory on hand and, I think with the hurricanes and so on, that number may be a little bit low relative to standard levels. So, we'll look to rebuild the days inventory on hand. But overall, very pleased with the progress. We have initiatives across each of those three areas, along with a clear focus on CapEx with a zero-based budgeting process for CapEx. And it's just nice to see them all paying dividends.
Lawrence Keusch:
Okay. Very good. Thank you.
James K. Saccaro:
Thank you.
Operator:
Thank you. And there are no further questions at this time. Ladies and gentlemen, this does conclude today's conference call with Baxter International. Thank you for participating and everyone have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Second Quarter 2017 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candice. Good morning, and welcome to our Second Quarter 2017 Earnings Conference Call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's second quarter 2017 financial results, along with our updated outlook for 2017. In addition, as previously mentioned, we will be providing an updated financial outlook for 2020 as compared to the expectations we laid out at our investor conference in May of 2016. As a reminder, we have posted a supplemental presentation to complement this morning's discussion. This presentation, along with the related non-GAAP reconciliations, can be accessed at Baxter's external website in the Investors section under Events and Presentations. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development and regulatory matters contain forward-looking statements that involve risks and uncertainties. And, of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Good morning, everyone, and thanks for joining us today. I will get started with a brief look at our second-quarter results. Then I will share some highlights reflecting the progress and potential of our ongoing business transformation and conclude with an update to our 2020 guidance. After that, I will turn the call over to Jay, who will walk through our second-quarter results and financial outlook in more detail. We'll close with Q&A. Baxter delivered another solid Quarter 2 with top-line sales growth of 1% on a reported basis and 2% on a constant currency basis. Operationally, Baxter's sales increased 3% which excludes the impact of foreign exchange, generic competition for U.S. cyclophosphamide and the previously communicated strategic exits the company is undertaking. Key top-line drivers included strong U.S. performance in Fluid Systems, nutrition and anesthesia, as well steady global growth in PD and acute renal therapies. On the bottom line, adjusted earnings were $0.63 per diluted share, increasing 37% over the prior year period. This reflects solid top-line growth, improved gross margins and a steady impact of our ongoing business transformation efforts. A little over a year ago we outlined our roadmap for achieving sustained top quartile performance. As part of this transformation, we created a foundation that is redefining how we do business and deliver value for our patients, employees and shareholders. To date, we have made great progress rather in executing this transformation and our focus on positioning the company for continued success. I will share a few recent highlights that support this objective. We expect to close our proposed acquisition of Claris Injectables imminently. This acquisition broadens our presence and prospects in generic injectable pharmaceuticals and provides expanded capabilities in one of our core growth areas. Claris brings us a product portfolio of more than 50 products on the market and the robust pipeline of more than 100 new products in development. We will continue to augment this business with strategic partnerships like the agreement we signed in the quarter with the result life sciences to accelerate the development of more than 20 generic injectables. During the quarter, we also announced research and clinical development collaborations with leading institutions. Mayo Clinic and Ramot at Tel Aviv University and Tel Aviv Sourasky Medical Center to transform patient care with new technologies and products across an array of therapeutic areas, including renal care and surgical care, respectively. We also received FDA guidance in the quarter clarifying the regulatory pathway for a new home-based PD solution generations system. This technology has the potential to remove some existing barriers to home-based dialysis, enabling more patients to experience the lifestyle benefits of home therapy. We will continue expanding our research and development pipeline with significant investment targeted to new product developed and additional collaborations to accelerate growth through 2020 and beyond. And while the pipeline continues to expand, we are also maintaining a steady tempo of new product launches, new indications and geographic expansions across our global portfolio. Our progress and pace have also been reinforced by continuing evolution in our operating structure and leadership. Over the last few months, we have partnered built our – built outs, rather, our leadership team with some familiar names in the new positions and some talented new players joining the company. With Paul Vibert's recent retirement, we are in process of simplifying our geographic structure into three regions – the Americas, including North and South America; EMEA, or Europe, Middle East and Africa; and Asia Pacific. Brik Eyre is now serving as President of our Americas region. On boarding this week is Andy Frye, our new President of Asia-Pacific. He joins us from DKSH Healthcare, one of the largest service providers in Asia where he served as the Global Head of Healthcare. Cristiano Franzis has been named our new President of EMEA effective September 1. Most recently Cristiano served as President, Minimally Invasive Therapies Group, EMEA, for Medtronic. Giuseppe Accogli now has an expanded role as President, Global Businesses, responsible for driving global growth through strategy, product development and marketing for the business franchises within Hospital Products and Renal. And Sumant Ramachandra joined us in June as our new Chief Science and Technology Officer. Sumant was most recently Senior Vice President and Head of R&D for Pfizer Essential Health. This leadership team is aligned, energized and ready to lead the charge forward. In light of our progress, trajectory and potential, we are now prepared to update our 2020 guidance. We are projecting sales to grow approximately 4% on a compounded annual basis from 2016 to 2020. We expect a 2020 adjusted operating margin of approximately 20% and adjusted earnings of $3.25 to $3.40 per diluted share. Finally, we expect to generate free cash flow of approximately $2 billion. We are pleased with these increases and will continue to evaluate opportunities to accelerate this performance both organically and inorganically. We continue to see business development playing a crucial role in building out our portfolio and pipeline. Focused on key growth categories and adjacencies, this will be enabled by our healthy cash flow, allowing us to deploy capital to create value on both the top and bottom line. In parallel, we will remain relentless in our efforts to increase efficiency, process improvements, more expanding and the engagement of all Baxter employees who have been fundamental to our transformation to date and we will continue to fuel reinvestment and margin expansion in future quarters. In sum, we have arrived at the next phase of our transformation journey and just like before, persistent, discipline, execution points the way forward. We have a sound strategy in our leadership teams fully engaged to help us realize our goals. Most importantly, we have exceptional talent across the entire company that embraces our mission to save and sustain patients' lives and advance our aspirations to deliver top quartile performance for all of our stakeholders. Together, we are ready to set our sights higher. With that, I will pass it to Jay for a closer look at our financials.
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our second quarter results, reinforcing our confidence that we are on the right path to achieve our goal of sustaining top quartile performance. Sales in the quarter increased 1% on a reported basis, 2% constant currency and 3% operationally, in line with our expectations. The results were really driven by strength across many of our U.S. businesses and improving operational growth internationally. On the bottom line, adjusted earnings were $0.63 per diluted share. This exceeded our guidance of $0.55 to $0.57 per share and reflects solid execution on the top-line, the ongoing impacts from our business transformation efforts and a modest benefit from other income and a lower tax rate. Now I will walk you through performance by business. I will be speaking to growth figures on an operational basis to provide a clearer understanding of underlying performance. As a reminder, our operational basis presentation excludes the impact of foreign exchange, U.S. cyclophosphamide, and selected strategic product exits. Global sales for Hospital Products were $1.6 billion, advancing 4% operationally. Breaking this out by business, sales in Fluid Systems were $607 million, up 6% operationally. Performance was primarily driven by strong sales of IV solutions in the U.S. Moving to Integrated Pharmacy Solutions or IPS, global sales were $568 million, increasing 4% operationally. Contributing to performance in the quarter was increased demand for the company's nutritional therapies in the U.S., driven by a temporary market disruption for select nutritional products. Sales for premixed injectable drugs also increased in the quarter, driven by recent launches and incremental pull-through of other premixed injectable products in our portfolio. Moving to Surgical Care, which includes anesthesia and biosurgery, total sales were $352 million, increasing 3% operationally. Performance in the quarter was fueled by strong U.S. growth for anesthesia and critical care products, driven by increased sales of Brevibloc, a fast-acting IV beta blocker, and Transderm Scop. We did experience a slight benefit in the quarter as the alternate supplier for Transderm Scop returned to the market a bit later than expected. Globally, biosurgery sales slightly declined during the quarter. Mid-single digit growth of core hemostats and sealants was more than offset by the impact from lower sales of non-core products, such as PERI-STRIPS and ACTIFUSE. Finally, in Hospital Products, sales in our other category were $110 million, declining 10%. Growth in the quarter was impacted by lower demand for our contract manufacturing services in our Bloomington, Indiana, facility and lower manufacturing service revenues from Shire. Turning to Renal business, sales were $968 million, up 3% operationally. Sales in the quarter benefited from solid sales of peritoneal dialysis and acute renal care products. The in-center hemodialysis business advanced low single digits globally, driven by strong sales in the U.S., partially offset by lower sales internationally. The Acute business delivered mid single-digit growth globally in the quarter, driven by increased sales internationally. Growth in the U.S. slowed in the quarter given a difficult year-over-year comparison as sales in Q2 2016 benefited from a temporary market disruption for continuous renal replacement solutions. We expect growth in this business to return to double digits in the back half of the year. Walking through the rest of the P&L, adjusted gross margin of 45.2% represents an improvement of 140 basis points over the prior year, driven by improved pricing in select areas of the portfolio, favorable manufacturing performance and a benefit from our business transformation efforts aimed at simplifying the portfolio to drive efficiency and reduce cost. Adjusted SG&A totaled $603 million, decreasing 9% on a reported basis. The primary driver of the improvement was our ongoing focus on effectively managing our expense base to eliminate costs and reduce inefficiencies. Transition service agreement totaled – income totaled approximately $16 million in the quarter, a reduction of approximately $10 million compared to the second quarter of 2016. We expect transition service incomes to total approximately $20 million in the second half of 2017. Adjusted R&D spending in the quarter of $155 million increased 3% versus the prior year. This reflects our stated intention to increase investments in R&D to drive innovation and augment top-line growth. Adjusted operating margin in the quarter was 16.1%, an improvement of 380 basis points versus the prior year. Operating margin compared favorably to our expectations, driven by improved gross margin and disciplined expense management. Net interest expense was $13 million in the quarter, as was adjusted other income, which totaled $13 million in the quarter. This reflected a benefit from foreign exchange gains on balance sheet positions. The adjusted tax rate was 16.9% for the quarter, which reflects the benefit from the new stock compensation guidance, along with select discrete items. And as previously mentioned, adjusted earnings of $0.63 per diluted share exceeded our guidance of $0.55 to $0.57 per share, driven by operational strength, other income benefit and a lower tax expense. During the second quarter, we repurchased approximately $45 million or approximately 750,000 shares. These targeted repurchases were more than offset by option-related dilution. Before turning to our updated outlook, I will provide some commentary regarding our cash flow performance. On a year-to-date basis, we've generated free cash flow of $488 million, an improvement of more than $400 million versus the prior year, driven by strong operational performance and lower capital expenditures, along with continued focus on improving the company's working capital performance. Of particular note, we ended the quarter with DSO of 53 days and days payable of 52 days. Let me conclude my comments this morning by providing an update on our outlook for 2017 and 2020. Starting with 2017, we expect full-year sales to increase approximately 3% on a reported basis and approximately 4% on a constant currency basis. And after adjusting for the U.S. cyclophosphamide impact, select strategic product exits and removing the benefit from the proposed Claris acquisition, we expect underlying operational growth of approximately 5%. All three of these sales ranges represent an increase from our prior guidance. This growth reflects approximately $55 million in incremental sales from the Claris acquisition, which, as Joe said, we expect to close imminently. We now expect growth in the Hospital Products business of 4% to 5% on a constant currency basis, and 5% to 6% operationally. Within Hospital Products, we now expect Fluid Systems constant currency sales growth of 5% to 6% and 7% to 8% on an operational basis. For the Integrated Pharmacy Solutions business, we expect constant currency sales growth of 4% to 5%. We expect full-year sales for cyclophosphamide of approximately $160 million as compared to our previous guidance of $135 million. Our updated assumption is that additional competitors will enter the market during the fourth quarter of 2017. And as I just mentioned, we anticipate that Claris will add approximately $55 million of revenues to IPS. Operationally, IPS sales are expected to increase 4% to 5%. Within Surgical Care we now anticipate sales to grow approximately 4% on a constant currency basis and 4% to 5% operationally. And finally, for the Hospital Products business we now expect DPS and other to increase low single-digits. For the Renal business, we expect full year constant currency sales to increase approximately 3% and growth of approximately 4% operationally. Moving down the P&L, we now expect an adjusted operating margin of approximately 15.5% to 16%. We expect net interest expense to total approximately $60 million and other income of approximately $20 million for 2017. For the year, we now expect an average adjusted cash rate of approximately 19.5%. For full year 2017 we anticipated diluted average share count of approximately 555 million shares. Based on these factors, we now expect 2017 adjusted earnings, excluding special items, of $2.34 to $2.40 per diluted share. Finally, for the year, we are increasing our outlook and now expect to generate operating cash flow of approximately $1.8 billion and free cash flow of approximately $1.1 billion. Specific to the third quarter 2017, we expect sales growth to increase approximately 4% on a reported basis and increase approximately 5% on a constant currency basis. Operationally, sales in the third quarter are expected to increase approximately 6%. Claris is expected to contribute approximately $20 million in sales to the third quarter. And we expect adjusted earnings, excluding special items, of $0.58 to $0.60 per diluted share. Before opening up the call to Q&A, I'd like to expand a bit on our updated longer-term financial outlook. Since we provided our updated projections last May, we have been very focused on opportunities for improvement. Our solid operational performance to date has positioned us well for continued success. As Joe stated, we expect sales growth of 4% compounded annually. While our sales outlook has not changed, I do want to point out a couple of factors. Top-line performance in 2016 came in better than we had projected in May 2016. And the guidance provided last year did not incorporate the select strategic exits we undertook this year. These two factors offset the expected benefit from the Claris acquisition. In addition, as we approach 2020 we expect sales growth to be north of 4% on annual basis as we benefit from the actions we've taken to optimize the portfolio and drive increased productivity from our pipeline investments. The adjusted operating margin of 20% compares favorably to previous guidance of 17% to 18% and reflect continued momentum from our business transformation efforts as well as improve manufacturing performance. In 2020, we expect adjusted EPS of $3.25 to $3.40 per share, representing a mid-teen increase from the prior guidance of $2.75 to $3 dollars per share. Our EPS outlook does not assume any meaningful share repurchases. We've only modeled repurchases to offset dilution, holding our share count flat to 2017 levels. In addition, we've not included any additional meaningful business development initiatives beyond the Claris acquisition in these projections. For me, one of the most important numbers Joe mentioned earlier is our increased cash flow outlook. We expect to generate more than $2.6 billion in operating cash flow by 2020. We will further reduce CapEx spending which is expected to be less than 6% of sales by 2020, resulting in free cash flow improving approximately $250 million to approximately $2 billion in 2020. And to rephrase my earlier comment, this is an unlevered view of our business. It does not reflect any meaningful deployment of the balance sheet other than the repurchase of shares to offset dilution. Similar to our previous guidance, this plan was built from the bottoms up. We're pleased with this update but as always, we'll look for ways to enhance this performance. And 2020 by no means represents the peak, or rather just another step in our journey. We expect to host an Investor Day during the second quarter of 2018 where we will provide a review of our business strategies, product pipeline, innovation, along with a more extended financial outlook. With that, we can now open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. I would like to remind participants that this call is being recorded and additional replay will be available on the Baxter International's website for the 60 days at www.Baxter.com. And our first question comes from Vijay Kumar of Evercore ISI. Your line is now open.
Vijay Kumar:
Hey, guys. Congratulations on another impressive quarter here. So maybe one on the LRP and I'm curious the revenue outlook of 4%, that wasn't changed. I mean, just given the underlying momentum we're seeing in the business, I'm curious why that was maintained and does the LRP contemplate any increase in gross margins?
James K. Saccaro:
Sure. Vijay, thanks for the question. So just commenting on your second question first with respect to gross margin performance over the LRP. In last year's iteration of our financial projections, we shared an operating margin of roughly 17% to 18%, we've increased that to 20% in our current look at 2020. But to decompose the 17% to 18%, we were really in the range of 44% to 45% on a gross margin standpoint. R&D was roughly 5% and then SG&A was 22%. As we moved to this year's LRP, there are a number of areas of improvement. One of the biggest relates to gross margin where we now expect roughly a 46% gross margin in 2020. There are a number of contributing factors to this. I said in the past I've been very pleased with the manufacturing performance under the leadership of Scott Pleau. That team has been incredibly focused on driving cost savings and improvements in the manufacturing network. So we expect to see some of that. But on the gross margin line we'll also benefit from mix as we move forward as we did exit some lower margin sales and then furthermore as we look at the inclusion of Claris in our projections. To complete the picture, R&D is basically unchanged versus the prior iteration and SG&A improves another hundred basis points, again, driven by continued and relentless focus on cost. So that's really the picture from a margin standpoint. As it relates to sales projections, yes, I think it's safe to say we've been very pleased with the sales performance of our business, right? And as we look at the LRP, really the biggest changes for us are a couple of fold. One, we've included Claris so the IPS business now will grow faster than we previously expected but then we did exit certain strategic lower margin sales areas. And so we do have an impact on Fluid Systems and on the Renal business. Those business growths are down a little bit from the prior version of the LRP. So as we sit here today, obviously we're looking to accelerate wherever possible. And in fact, Joe's comments and my comments around innovation, as we look over long-term, we're looking to accelerate the pace of innovation and pull-forward where possible. But as we sit here today, we feel comfortable with the 4%.
Vijay Kumar:
Absolutely. And then just one follow-up, guys, on just maybe the guidance for the current fiscal. You look at the one half versus second half mix the last couple of years, it's been somewhere in 40% to 45% in one half versus 55% to 60% in the second half. I know you have a number of items hitting you in the back half, including the TSA transition. The guidance basically implies the mix is more 50-50 this year. Can you walk us through that, Jay?
James K. Saccaro:
Certainly. We would normally expect to see an uptick in the second half EPS just based on natural business trends. And that's something that we've seen over the last several years. There are several factors that we have to be mindful of. First of all, transition service income. We expect Shire to wind down their need for our services, and right now that's a $0.03 headwind first-half to second-half. Secondly, we did from a cyclo-performance standpoint, we have roughly $0.04 of deterioration, $0.03 to $0.04 of deterioration first-half to second-half. Third, we are going to be accelerating some R&D investments, I think these are very strategic and important. And as we get to your first question in relation to how do we accelerate sales growth, it's very much about pulling forward timelines as much as possible, something our team is really focused on. R&D tics up roughly $0.03 in the second half of the year. And then finally, the way the tax rate works with the benefits related to FASB 123(NYSE:R), typically those benefits are concentrated in the first half of the year, and so we do see the tax rate ticking up $0.03 to $0.04. And finally, we have other income and interest which is $0.01 – or there's a $0.01 impact in the second half of the year. So as we look at the first half to the second half, there are roughly $0.14 to $0.15 of headwinds as we analyzed it, that we fight through to give the guidance that we've shared with you today.
Vijay Kumar:
Great. Thanks. Congratulations.
Operator:
Thank you, and our next question comes from Mike Weinstein with JPMorgan. Your line is now open.
Michael Weinstein:
Thanks for taking the question. Maybe if I can stick in two questions here. For one, can you talk about the Claris accretion to your 2020 guidance with what the expected EPS contribution would be? And then second, just want to make sure I'm reading the cap allocations slide correctly on the dividend? So is the assumption that the dividend payout ratio is still 35% or something below that?
James K. Saccaro:
Yes. From a Claris standpoint, we expect roughly $0.05 of accretion in 2020, a little bit north of that. And then from a dividend payout ratio, our expectation is to maintain over the long term this targeted payout ratio of 35% of adjusted net income.
Michael Weinstein:
Okay, Jay, it was helpful.
James K. Saccaro:
As you know, we are not doing today-
Michael Weinstein:
And, Joe, we just want to get your kind of latest thoughts on business development. On the last quarter call we talked about the potential for larger acquisitions, and it felt I think to the Street, as if the likelihood of larger transactions may be diminished over the course of the quarter. So can you just give us your latest read on kind of what's out there and what's the likelihood of different sizes occurring?
José E. Almeida:
Sure, Mike. Just augmenting Jay's previous answer on Claris, we are giving this guidance on Claris for 2020 as Claris is today. Claris for Baxter is the foundation of getting us to a significant number of molecules in other areas. So when we speak about Claris itself as Claris is today as it transitions over there, there's significant amount of investment that we are going to be making in new molecules that we'll be adding to the pharmaceutical business of Baxter, which we plan to be much bigger than just Claris. On the business development, we have a significant capacity in our balance sheet, organic and inorganic, meaning we are generating a significant amount of cash. I think Jay has spoken about our conversion ratio is really good. It is one of the best I've seen, the team has done a great job. So our natural generation of cash flows well we can borrow put us in a very good position. So what is the difference between where I am right now and a big acquisition and several tuck-ins that will get to the value that we had spoken last quarter but in a different way. Clearly, there is custody of large targets as we all know. So, and also when you look into the financials and how that works with a company, you have an inherited risk pertinent to these kinds of transactions. They are much greater than several smaller transactions. So as we look at how to pursue our inorganic pathway here, first of all, put a strong team in place. And I just bought my old team back, almost the whole team back from my old job into Baxter. And that team will be now responsible for M&A. The second thing is that for me it doesn't matter. If you do a large deal, it's going to take us a while to digest and will probably take us a while to continue down the path of further acquisitions versus smaller deals. So as we evaluate both, we have – we're open for both. It's not that one is losing to the other; it's what are the opportunities that we'll return to our shareholders what we want the shareholders to have. Remember, we want internal rate of returns. They are significant above our weighted average cost of capital, and in the double digits. We want ROIC three years to five years to have close to the company average. So we have put some limits in how we're going to use our shareholders' money. The other alternative that we have, we have said that money's not going to burn a hole in our pocket. So if we do have excess cash, we will buy shares back at our discretion when we think is the most effective way of doing so. We're opening both channels and we can do both at the same time because of the amount of cash that we have. So as we pursue diligently and with significant amount of grit our M&A path, we also will be returning money to the shareholders in terms of shares buyback. So I want to leave those channels open. And size of acquisition is less important than about the strategic fit of those companies within our portfolio.
Michael Weinstein:
Understood. I'll let some others jump in. Thanks, Joe.
Operator:
Thank you. And our next question comes from Matthew Taylor of Barclays. Your line is now open.
Matthew Taylor:
Hi. Thanks for taking the question and good morning. So I wanted to follow up on some of the thoughts on the Claris accretion and maybe just spin this into a discussion around how you think the mix could improve with your injectable initiative in general. Could you give us some thoughts on the different partnerships that you have, Claris and in your internal programs? And what do you think the margin structure of that business could look like over the course of the LRP because, as you know, not all injectable businesses are created equal?
José E. Almeida:
Yes. We feel that we have three pathways here. We had our internal programs, which I thought were good but not at all sufficient. Those are good molecules. Our internal program, when we first arrived at Baxter, were related to things that are difficult to create. In solutions, we stabilized. We're looking at our GALAXY technology in Round Lake, Illinois, to make them. And our pace was one of not great speed, okay. So that program could not only – would not get us what we want. Claris adds a piece to the puzzle, which is the ability to do the filling operations and packaging, also the procurement of APIs and manufacturing of APIs in a very cost-effective way with good quality product. We are expanding now with the ScinoPharm and as well as Dorizoe partnerships to be able to get more volume of molecules. But this is not volume of a million-dollar molecule. We're looking at molecules that are more relevant to the portfolio, therefore creating good accretion to the gross margin. If you think about this business, this is a business with a low SG&A. So it's all about gross margin here And gross margin is providing the market with effective supply chain that creates a cost advantage for us in the market and for the customer. So with 45% and Jay said 46% by 2020, we feel this business has a bigger capacity to deliver on a gross margin, but more so, Matt, is down the P&L with very low SG&A, okay. So we are actively, actively pursuing more partnerships and with all kinds of different companies, either for distribution of the drug, for augmentation of portfolio, for the design of these generics, which is the case of hard-to-make oncolytics with ScinoPharm or just capacity to develop the API new formulation with Dorizoe. So it's all in – when you put together, it is a business. It's a core growth business for us, which is the definition is, has better gross margin, better growth rates, change to vector growth and also impacts our operating income and our EPS.
Matthew Taylor:
Thanks, Joe, some helpful perspective. And I just wanted to follow up on the Fluid Systems business. That continues to perform very well. I know you've been saying it kind of gets the trophy every quarter for best-performing business. And I just wanted to understand some of the dynamics there between, I guess, the competitive environment and share gains, how you're doing on pricing, and some of the pull through. If maybe you could touch on those things to understand how much longer you can continue to grow above market like this?
José E. Almeida:
Well, if you think about the Fluid business in general, we came back to the market with an effective pump strategy. We have probably 22%, 22.5%, 23% market share in pumps and where we are today, and I'm talking about the U.S. per se. So let's focus on the U.S. as the Fluids business outside the U.S. is completely different characteristics and profit profile. So the pumps in the U.S., the SIGMA SPECTRUM, we have a nice momentum on product development. We're going to be launching the new revised version of SIGMA with auto-programmable functions and other features next year. And then we have a pathway all the way to a new platform not too far in the future. That is the foundation of creating momentum in terms of our Fluids business. Fluids themselves is all about capacity and quality. And right now I feel confident that we're working very hard on both fronts. So we have product availability as much as we can and we're augmenting capacity, we're validating new lines in our North America planned footprint. So the ability to provide product to the market at a higher rate is one that will determine in the future our ability to continue to grow. Remember those products are not sold in the spot market. Those are created through contract and those are long-term contracts. So as long as Baxter has the capability to continue to provide those long-term contracts where price escalation is built-in. Second, we have invested in the right capacity, meaning what is the right capacity – it's capacity in the right places and we are. And we maintain the quality required by the FDA. We will be continue to deliver on this business. Clearly there is a point where there is a reduction in growth just by the sheer volume of products that we make. We're number one in the market in terms of solutions. So we would expect this business to taper off a little bit in growth but our expectation is, as we continue to augment capacity, we continue to gain market share. And I think this is something that our team here in North America is doing a significant amount of work and will continue on to be able to provide products to our customers.
Matthew Taylor:
Great. Thanks for the thought.
Operator:
Thank you. And our next question comes from Larry Biegelsen of Wells Fargo. Your line is now open.
Larry Biegelsen:
Good morning. Thanks for taking my questions and I'll echo the earlier sentiments on another good quarter, guys. Let me start with the 2020 margin – operating margin target. Could you talk about how you thought about that target in 2020? Is there some conservatism baked in? Is there room for further expansion beyond the 20% in 2020 – beyond 2020, I'm talking about and how should we think about the path to 20%? Should we think about it linear between 2017 and 2020? And I did have one follow-up. Thanks.
James K. Saccaro:
Okay. Larry, thanks for the question. Overall, from a margin standpoint, the first comment I would make is we do not believe that 20% is the peak. In fact, as we share our guidance in May of next year we'll extend beyond 2020. And you heard Joe make some earlier comments about a business' life, our injectables business, there's incredible excitements around that in part because of the higher margin those businesses carry than the Baxter corporate average. So as we move from 2020 to beyond, we start to get lift from mix and innovation really, really accelerating and helping the margin improvement. In terms of how we develop the target as a conservative or not, it's the same methodology that we've used over the last three years for developing our long-range financial planning commitments. Specifically, we have programs earmarked from a bottoms-up standpoint that sum total to 20%. In the past, I've talked with investors about outside-in and comparing to competitors and using that as a basis. But for us, we've never done that. We've always done bottoms up initiative by initiative. And so we know exactly how we're going to get from where we are today, 15.5% to 16%, to the 2020 target of 20%. And, in fact, as we leave this call, Joe and I will be going to a zero-based budgeting meeting where we will be reviewing many of the savings initiatives that support this 2020 objective. As far as the linearity of this, I don't want to get into guidance discussions for 2018 at this point. What I will tell you is, it is now like there's 300 basis points of improvement in a particular year. It is fairly balanced. But again, I'll stop short of giving annual targets for margin improvement.
Larry Biegelsen:
That was, I guess, on the guidance. My follow-up question was just on the 4% CAGR. What's the – on this revenue, what's the definition of that? It includes Claris, but it doesn't include other business development. And I did hear you say, Jay, that you expect, or maybe Joe, accelerating above for as you come to 2020, my question was going to be around how to think about 2018, anything different from 2017? Should we be thinking about it in a similar way? Not sure if you're willing to kind of give us some of the puts and takes at this point. Thanks.
José E. Almeida:
Hi Larry. The way we think about the top-line is the following. Our weighted average market growth rate, or WAMGR, is about 3%, okay. So we have a 4% plan which is significant amount of new product launches, geographic expansion, things you're putting in to grow above market. Primarily not growth categories, oaky, as we outlined in our presentations in the past. We call core growth. When you look at how to get to 5% is basically execution, excellence on those initiatives and the risk in those initiatives. So the more we de-risk our initiatives, the more we fill our bullpen of new opportunities, we can possibly get to 5%. It's a stretch, it's not easy, and I'm not saying we're going to get there, but we have a lot of Baxter people probably listening to this call, we are getting ready to get there because we're executing., we're doing everything we can. We brought good people from the outside with excellent people from inside, and we're mixing our teams with very good execution people. So we have a possibility to get there. But right now we feel that with all we have on the table, 4% is adequate for our shareholders to model our growth going forward. But we're working hard to get to 5%
Larry Biegelsen:
Thanks for taking the questions, guys.
James K. Saccaro:
Thank you.
Operator:
Thank you. And our next question comes from David Lewis with Morgan Stanley. Your line is now open.
David Ryan Lewis:
Good morning. Just two questions. One short and one longer-term. Jay, maybe you for the short-term question. I think about the second quarter and back half of the year from an organic growth perspective. So momentum slowed a little bit in the second quarter, but your guidance implies a fairly material acceleration in organic growth into the third quarter. And then you have the easy comp in the fourth quarter. So I think about the 5% guidance at the top end. It looks like if you can do the third quarter, frankly, you'd more than do that in the fourth quarter. So could you just help us understand the acceleration into the third quarter, and how you think the third quarter will play out in terms of your back half of the year growth guidance?
James K. Saccaro:
Sure. One important point relates to Claris, and so as we think about the growth rate for the third quarter, there is some benefit from Claris, roughly $15 million in the third quarter. Or actually is it $15 million or $20 million do we say?
Clare Trachtman:
$20 million.
James K. Saccaro:
$20 million, sorry. $20 million in the third quarter, so that's one item. As far as other areas, there is some acceleration outside the U.S. and part of the business outside the U.S. relates to tenders. So as we look at some of our regions, our EMEA region, our Asia-Pacific region, we do see a sequential growth from Q2 to Q3 based on the timing of tenders, which is a little bit different than we've seen in prior quarters and years. So really that is one of the factors that drives this acceleration into the third quarter. And then, of course, we had a solid Q4 last year. So that factors into our math.
David Ryan Lewis:
Okay. That's helpful. But can you sustain those levels, sorry Jay, into the fourth quarter? But then the comp gets a little easier. It just feels like whatever you deliver in the third quarter, you should be able to do consistent growth in the fourth quarter just based on the easier comparable.
James K. Saccaro:
Again, we also have cyclo which tails off a little bit in the fourth quarter, so that's a factor as we look at pure constant currency growth. So that's another element to consider. I think as we look at the second-half growth, we feel confident in our ability to achieve it. There are some nuances between Q3 and Q4 related to timing of tenders' performance in Q4 cyclo. But on balance, I think it's consistent with what we've expected. And like I said, we feel confident in our ability to deliver it.
David Ryan Lewis:
Okay. Thanks, Jay. And then two long-term questions first. Jay, I'll start with you and then finish with Joe. So, Jay, I don't know if you can give an EBITDA margin guidance update on this call. I think you initially had said 24% to 25%. Obviously, the EBIT margins are fantastic. So if you think about EBITDA in 2020, just given the tremendous improvements you've had on CapEx and the impacts on depreciation, how do we think about EBITDA guidance in 2020? And then for Joe, I think all these questions about organic growth on the call are trying to get to sort of one question which is if you can do 6% operationally in the third quarter, are you really saying you're going to see some deceleration in the business intermediate-term before you get acceleration into 2019 and 2020, or are we just making more of this than we should be and these numbers may be a little conservative? Thanks so much.
José E. Almeida:
So let me start with your question and Jay will talk to you about EBITDA. One of the growths in the quarter-to-quarter basis is about comps from the previous quarter. We need to look at sequential and we also need to look at sustainability. So we feel comfortable with the long-term being 4% because we look at how our programs are being factored into the growth and also the tenders that we have. Remember we have a static business in terms of products that we sell. And if we're out of a tender, we're out of a tender. This is the issue that we had in Europe in the last 18 months is we're out of spme tenders because we didn't want to bid. When we get back in, it guarantees the business for the longer term. So I feel comfortable that we are – that the 6% is to be delivered in the quarter. But going forward, we want to make sure that we are at about 4% level. And this is because we are looking at more sequential growth and sustainable growth. We will have quarters that have higher growth and lower growth like we just had this quarter because of discontinuation of business. But in the mean we want to have that 4% there and target 5%. The delivery of our second-half, we'll not be giving no guidance today and affirming the numbers. If we couldn't do it, I'm confident about our ability to deliver on that as we speak today. However, that should not be something that the analysts should be thinking about for us going forward, okay. Because it is quarter-by-quarter, we look at more long-term. So the 4%, David, may have – has an acceleration towards the end of the period that we provide you guidance with the 2020. We will have an acceleration so we can make that number happen based on the numbers for 2018 and based on the discontinued products that we have. I just want to also tell that – say that these numbers, organic, is completely unlevered but we continue to pursue tuck-in acquisitions that will help us on an inorganic side for the next 12 months, but also they will bring pipeline into the company and will help us with organic going forward. So it is a combination but right today we're sticking to the 4%.
James K. Saccaro:
David, the EBITDA margin in 2020 is approximately 26%.
David Ryan Lewis:
Okay. Thank you very much.
José E. Almeida:
You're welcome.
Operator:
Thank you. And our next question comes from Isaac Ro of Goldman Sachs. Your line is now open.
Isaac Ro:
Good morning, guys. Thank you. First question on the long-term guidance. I was just trying to go through some of the moving parts that were yet uncovered and one was on share count. I just want to confirm that you're assuming that you believe perhaps in a share repurchase offset – options solutions but not assuming that there will be a meaningful net reduction in share count through 2020. Is that sort of the right way to think about it?
James K. Saccaro:
That's exactly right. In our modeling, we've held share counts flat to 2017 levels.
Isaac Ro:
Okay. Great.
James K. Saccaro:
And underlying that is an assumption about a certain amount of buyback. But the result of that, given the very strong cash flow generation of the company, is a serious positive net debt or net asset position as we look at cash relative to growth stat.
Isaac Ro:
Right. Great. That's what I was getting at. Thank you. And then a follow up on just a couple of the product specifics. Biosurgery, you guys mentioned the slight decline there. But I think you also talked a little bit about how your pretty strong pipeline is in 2018. So I'm just trying to handicap how we should think about the recovery to growth. Is it going to be sort of a sharper inflection towards this time next year or could we see an improvement sooner than that?
José E. Almeida:
So we have a significant amount of activity going on at the end of this year and into 2018 for biosurgery. What is affecting us today is the performance of the Synovis acquisition products. They were made by the company a few years ago. Those are products that are legacy, there are very little improvement to those products to be made, and what we are focusing on our hemostats and sealants, the base business of Baxter which just in one category, just the FLOSEAL alone is growing 7%, okay. So that is good growth there. So for us to return to a market growth rate, this is what we expect to do in 2018, okay. And then we look forward to some augmentation inorganically speaking into that business that will help us deliver more pipeline in some adjacencies into the surgery business. I'm quite confident in the delivery of this new products. They are not homeruns, they're singles and doubles, but just reignite the innovation that the company has not delivered in the past years. And just the new management into that business is really instilling the innovation part quite a bit. That's why we're having so many things happening next year. We have launch of new forms of FLOSEAL, new applicators, new geographic expansion. So will get back into this game in a good way and beginning to see that transformation in 2018 in terms of getting to market growth.
Isaac Ro:
Got it. That's very helpful. Thank you, guys.
José E. Almeida:
Thank you.
James K. Saccaro:
Thanks, Isaac.
Operator:
Thank you. And our next question comes from Bob Hopkins of Bank of America. Your line is now open.
Robert Hopkins:
Thanks. Good morning. Can you hear me okay?
Clare Trachtman:
Yes.
Robert Hopkins:
Great. Good morning. So just two quick things since a lot of questions have been asked. Joe, I was wondering if you could talk a little bit more about some of the leadership changes this year referring to on this call. Just in terms of kind of when that happened and maybe a little bit more on the folks that you're bringing into the company? And then I have one quick one for Jay to follow up. Thank you
José E. Almeida:
Yes, Bob. We had an organization that was – had international businesses all concentrated under one person. When this person retired was an opportunity for us to really take a look and say, I don't like to concentrate 60% of our business with very different profiles under just one person. So bringing Americas under Brik, very experienced leader with Baxter. And Cristiano Franzis who worked with me before, and Andy Frye, who comes from a large distributor in Asia, and before that Abbott, who give us a great execution lever to focus on those regions instead of just have one person looking at everything but the U.S. It's just a philosophy and a proven theory that I have that when you divide the world in the right regions, you have people focus on those regions, not only the top-line, but also the EPS per region. The other, Sumant is a great technology and research and development leader, comes into the company with significant experience as we have ambitions to continue to grow our pharmaceutical business. Sumant brings a wealth of knowledge and experience into this area. And I think the Street's familiar with him, and he worked for Hospira before and then Pfizer. We are really excited about that. And Giuseppe moving up to have a global role in terms of managing our product franchise in terms of innovation as well as upstream marketing, and working closely with our M&A group to make sure that we have the right inorganic opportunities in place, makes this team pretty strong. On top of that, we brought Dennis Crowley who used to work for me before in M&A. Dennis really brings a strong background in acquisitions with him. There are a couple more team members that came to Baxter. So we're augmenting where we need. You never say you're finished. There is no finishing line when you manage a company. But we think today that we confidently have a strong team amongst our peers.
Robert Hopkins:
Great. That's helpful. Thank you. And then just to finish, Jay, previously in your LRP you gave specifics on 2018 and 2020 for top-line growth. And we've talked a lot about top-line growth here. But I'm just curious if maybe you could talk a little bit more about the cadence of operational revenue growth over the course of the LRP. And you've mentioned growing above 4% in 2020. Is there a more specific target for 2020 that you'd be willing to disclose here? And I guess just a question on cadence.
James K. Saccaro:
Yes, again, for us, the relevant number is the 4% over the period. As we approach the back part of this long-range plan horizon, you start to see the impact of innovation and annual rates ticking the 2020 rate is a little bit above the 4%. And then as we look at 2018, there are a few different factors in play that impact that. You have the full – a annualization or some – a part of your benefit from Claris, but you also have an assumption around cyclo competition that we will be taking. And then also the impact of innovation in 2018 is not as great as it is in the latter part of this plan period. So a number of different factors. We'll stop short again today of giving annual revenue guidance because, again, there's a lot of puts and takes as we approach 2018.
Robert Hopkins:
Great. I appreciate you taking the questions. Thank you.
Operator:
Thank you. And our next question comes from Joanne Wuensch of BMO Capital Markets. Your line is now open.
Joanne Karen Wuensch:
Thank you very much for taking my questions. Many have been answered already. Briefly, could you please give us an idea of how the cyclophosphamide competition you expect will be annualizing over the next couple of years? You briefly mentioned the impact in 2018, but you have a better line of sight on the competition than we do.
James K. Saccaro:
By 2020, we have a fairly small cyclo business, so we expect this winding down very significantly from the current level to a 2020 number, and that occurs – starts to occur at the end of 2018 – or 2017 as a result of incremental competition on-boarding. But I will tell you this is one that we have frankly been surprised by over the last several years. The level – the number of competitive entrants has been fewer than we originally modeled in 2015, than we modeled again in 2016. So it's best for us to keep watching this one. We'll provide an update on cyclo guidance on our January earnings call certainly, and again as we approach the balance of this year in next quarter's call. But it's hard to say what's ultimately going to happen. What I can tell you is we have a fair amount of competition that's assumed by 2020 with a fairly de minimis business left in cyclo at that point.
Joanne Karen Wuensch:
That's helpful – and that's my follow-up question. There's no doubt you have a lot of cash that you can deploy, and yet I feel like investors are waiting for you to do so. What does it take internally for you to pull that trigger? What kind of conversation does it – has to happen? Thank you.
José E. Almeida:
We have a lot of conversations. What it takes is to have the right strategic target. You've got to make sure that you are returning money to the shareholders. You can't just make an acquisition and think that internal rate of return of 7% is good enough. Maybe it's good enough for a few investors. For the majority of investors, that is below our long-term WACC, and that is not something that responsibly we will do. We will select the right targets. We are doing it as we speak a significant amount of work. But I said to you, we're going to deliver value no matter what, either through acquisitions and as well to share buybacks. So I feel comfortable on both ends of the scale. We didn't discard large acquisitions at all, we're just going now after everything that we can look at that makes sense for Baxter, okay. With a better team in place, we're looking at a much more agile process to get to our targets and as well as the amount of balance sheet capital that we have today, the ability to raise capital organically to get there, we will return money to the shareholders. So it's a win-win because we have two good avenues and we can do both at the same time.
Joanne Karen Wuensch:
Wonderful. Thank you so much.
José E. Almeida:
You're welcome.
Operator:
Thank you. And our final question comes from the line of Danielle Antalffy of Leerink Partners. Your line is now open.
Danielle J. Antalffy:
Yes. Thanks so much. Good morning, guys. Thanks for taking the question, and congrats on a great quarter. Jay, I was hoping you could give a little bit more color on what's driving the operation – the increase in EPS guidance? How much of that is coming from FX in the back-half of the year versus Claris versus better operational performance? And then I have one follow-up.
James K. Saccaro:
Sure. The prior guidance, the midpoint of the range was roughly $2.24, and as we think about the current midpoint, it moves to $2.37. There's a few drivers. The over-performance that we experienced in Q2 contributes roughly $0.07. The tax rate, improvements in tax is roughly $0.03. Cyclophosphamide is a couple of pennies of impact. FX is $0.01 and Claris is $0.01. So if you add those up, it's roughly $0.14 versus the midpoint of the last guidance range. About half of that speaks to the Q2 performance with the residual relating to other aspects of the business.
Danielle J. Antalffy:
Okay. That's helpful. And then my follow up is on long-term perspective. Some of the higher profile pipeline products, specifically the on-demand PD products. Just wondering how you see products like that coming to play and driving that 4% CAGR through 2020. How do we think about the on-demand PD product for your Renal business? Is that something that takes penetration in your view from 12% to 14% in the U.S. today to some number significantly higher? Is it more a pricing play? How do we think about that impacting the Renal business and how much that contributes to your long-term guidance? Thanks so much.
José E. Almeida:
You're welcome. Our on demand product is on track. We see this as access to PD. We have modeled the penetration and how it's going to behave in the marketplace. I think it's a little too early for us to give you that information as we are starting our clinical trials next year. And we will be having this product on the market probably by 2020 once the clinical trial is finished. The plans that I've seen, I've seen a rapid succession of improvements to the product which makes me very happy in terms of R&D. I feel that it continue to improve the product as it launches. Our philosophy today versus the old one is we launch products faster with possibility of improvement as we go along to provide more value to the customer instead of getting and waiting for the optimal product with the most features to come out because what we find is highly featured products are not the way forward for an efficient health care system. So we want to make sure we have in the product what is needed and not what all the features that we could engineer and put into to the product. So we are confident that this product is going to do a few things for us. One is increase the penetration of PD for the ease-of-use. Not everybody will like to receive a pallet of product every month. The second thing is it's a product that eventually can customize the solution concentration. This is not how we come out to the market with but it's eventual you can get there. Thirdly, is also a cost savings for the company in terms of the logistics costs and moving fluid around. But we're bettering that alongside our AMIA introduction which happened last year. So what happens is a sequential of innovation for PD and our end objective is to make sure that as many patients that can receive PD are receiving PD in their homes. That is our main objective because we know the therapy is equally efficient as HD but also provide a better life experience for the patient who then can work during the day and to be productive during the day. So we are little too early to give you the numbers. When we're ready, when we're close to the end of the clinical trial, we'll have more numbers in terms of penetration and how we're going to do this introduction. But we're very confident in talking to the FDA. The FDA is working with us, very interested as a matter of fact, how they can help move this technology forward. Thank you.
Danielle J. Antalffy:
Okay. Thanks.
Operator:
Thank you. And that concludes our question-and-answer session for today. Ladies and gentlemen, this does conclude today's conference with Baxter International. Thank you for participating, and have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's First Quarter 2017 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. As a reminder, this conference call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candice. Good morning and welcome to our First Quarter 2017 Earnings Conference Call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's first quarter 2017 financial results along with our updated outlook for 2017 before taking your questions. As a reminder, we have posted a supplemental presentation to complement this morning's discussion. This presentation can be accessed on Baxter's external website in the Investors section under Events & Presentations. In addition, I would like to remind you to please limit yourself to one question during the Q&A session so we can accommodate others in the queue. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product development, business development, and regulatory matters contain forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now, I would like to turn the call over to Joe. Joe?
José E. Almeida:
Good morning, everyone, and thank you for joining us today. I will get started by sharing some comments on our first quarter performance, then I will turn it over to Jay who will walk through the rest of the P&L and provide an update on our guidance for the year. After that, we'll close with Q&A. We opened 2017 with a strong quarter, reflecting continued progress across our three strategic vectors of portfolio management and innovation, operational excellence, and capital allocation. On the top line, Baxter delivered sales growth of 4% on a reported basis and 5% on a constant currency basis. Operationally, Baxter's sales rose 7%, which excludes the impact of foreign exchange, generic competition for the U.S. cyclophosphamide market, and the previously communicated selected strategic product exits the company is undertaking. The results were driven by strength across our U.S. businesses as well as growth in peritoneal dialysis, acute renal therapies and nutrition (03:27) globally. On the bottom line, adjusted earnings were $0.58 per diluted share. This reflects solid execution on the top line as well as the sustained momentum of our business transformation efforts. Now, I will walk you through performance by business, and I will be speaking to growth figures on an operational basis to provide a clear understanding of underlying performance. Global sales for Hospital Products were $1.6 billion, advancing 10% operationally. Breaking this out by business, sales in Fluid Systems were $585 million, up 13% operationally. Performance was driven by IV solutions strength in the U.S. along with increased sales of IV access sets, reflecting the ongoing pull-through from our growing SPECTRUM pump installed base. Moving to Integrated Pharma Solutions or IPS. Global sales were $552 million, increasing 4% operationally. Contributing to performance in the quarter was increased demand for the company's nutritional therapies globally in four (04:43) premixed injectable drugs enhanced (04:47) drug reconstitution systems in the U.S. We are continuing to bolster growth in the IPS business through both organic and inorganic opportunities, particularly in the generic injectable pharmaceuticals. We remain on track to close our acquisition of Claris Injectables in the second half of 2017, which will greatly expand our marketed portfolio and pipeline. And in the first quarter, we announced a new strategic agreement with ScinoPharm, one of the world's leading API manufacturers to help develop, manufacture and commercialize five injectable drugs used in a range of cancer treatments with an option to partner on an additional 15 molecules. In addition, we are preparing to launch several proprietary premixed injectable molecules in 2017 through our internal research and development pipeline. As we have stated previously, we plan to continue expanding our presence in the generic injectable space. Moving to Surgical Care, which includes anesthesia and biosurgery, total sales were $334 million, increasing 11% operationally. Performance in the quarter was fueled by strong U.S. growth for anesthesia and critical care products, driven primarily by increased demand for Transderm Scop due to a temporary supply disruption in an alternate product during the quarter. Increased sales of Brevibloc, a fast-acting IV beta blocker, also contributed to the growth in the quarter. The biosurgery business advanced mid-single digits on a global basis driven by double-digit growth internationally of our core hemostat sealant (06:32). As we have previously mentioned, we have increased our investment in this business in an effort to turn around performance. We expect to begin recognizing the benefit of these actions towards the latter part of this year and beyond. Some recent highlights include the acquisition of Wound Care Technologies Incorporated, the manufacturer of the DERMACLOSE Continuous Tissue Expander. DERMACLOSE is a highly innovative device used to facilitate the suturing and stapling of the skin around moderate to large wounds and represents our entry into a complementary product category. We are also focused on enhancing growth organically. Early this month, we unveiled customer-centric enhancements to both our FLOSEAL and TISSEEL hemostatic agents. They are designed to improve safety for patients and ease of use for clinicians. And in March, we announced the publication of two compelling analyses in the Journal of Medical Economics supporting FLOSEAL as a cost-effective hemostat that may contribute to broader cost savings at hospitals as compared to other options. Finally, in the Hospital Products sales in our Other category, we were $108 million, up 18%. Growth in the quarter benefited from continued demand for our contract manufacturing services, including our expert thesis (08:05) cytotoxic manufacturing at our Jülich, Germany facility. During the first half of 2017, we expect higher growth for this business as we continue to anniversary the impact from one of our customers bringing manufacturing in-house. Turning to our Renal business, sales were $896 million in the first quarter, up 2% operationally. Globally, peritoneal dialysis achieved mid-single digit operational growth, reflecting an increasing patient base and ongoing market momentum of our new Automated Peritoneal Dialysis or APD cyclers, AMIA in the U.S. and HOMECHOICE CLARIA for international markets. The success of AMIA and HOMECHOICE CLARIA APD is due in large part to our proprietary shares towards (08:54) telemedicine technology, which recently surpassed 0.5 million patient treatments. In a related development, Baxter also received approval in the quarter for a new KAGUYA APD system in Japan, which we expect to launch later this year. Japan is a market in which we are looking to broaden our presence across the portfolio. Renal growth in the quarter was impacted by a mid-single digit decline in in-center hemodialysis globally. Positive performance in our U.S. in-center agency business was offset by lower sales internationally due to continued competitive pressures on dialysis. We continue to focus on enhancing the profitability of this business while also stabilizing the growth profile. The acute renal business delivered solid mid-single digit growth globally in the quarter. As we have previously mentioned, we believe the acute market holds substantial opportunity for us, and we are pleased to report that our next-generation leading-edge PRISMAX acute care technology now has been deployed for patients' use in several European locations as part of an initial limited distribution. Clinician and patient response to-date has been favorable, and we look forward to the full European commercial launch in 2018. In summary, our companywide results for the quarter reflect our focus on disciplined execution to drive improved operational performance. Certainly, our business transformation efforts have been central to margin expansion and we are by no means finished. We are pursuing several new fronts to accelerate these efforts, which we expect will generate incremental savings going forward, a portion of which we intend to redeploy back into the businesses to drive innovation and growth. The most important point to stress in closing is that we are on a continuing journey, and our results this quarter reinforce our confidence that we are on the right path to achieve our goal of sustained top quartile performance. With that, I will turn it over to Jay.
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our first quarter results, reflecting continued momentum towards delivering on our long-term financial goals. Sales in the quarter increased 4% on a reported basis and 7% operationally, which was ahead of our expectations, driven by favorable performance in the Fluid Systems and anesthesia businesses. Volume and mix were the primary drivers of growth in the quarter with price contributing approximately 1%. Walking through the rest of the P&L, adjusted gross margin of 44.3% represents an improvement of 200 basis points over the prior year, driven by improved pricing in select areas of the portfolio, favorable manufacturing performance, and a benefit from our business transformation efforts aimed at simplifying the portfolio to drive efficiency and reduce costs. Adjusted SG&A totaled $560 million, decreasing 10% on a reported basis. The primary driver of the improvement was our ongoing focus on effectively managing our expense base to eliminate costs and reduce inefficiencies. Transition Service Agreement income totaled approximately $20 million in the quarter compared to approximately $28 million in the first quarter of 2016. TSA income from Shire will continue to decline as the need for these services ramps down, which is expected to be by mid-2017. For the year, we expect TSA income to decline by approximately $45 million versus 2016. Adjusted R&D spending in the quarter of $130 million decreased 4% versus the prior year. As Joe mentioned, we expect to continue to ramp up our investments in R&D to drive innovation and augment top line growth. Adjusted operating margin in the quarter was 16.4%, an improvement of 590 basis points versus the prior year. Operating margin compared favorably to our expectations driven by improved gross margin and disciplined expense management. Interest expense was $14 million in the first quarter. Adjusted other expense totaled $2 million in the quarter, reflecting a lower benefit from gains on balance sheet positions as compared to the prior-year period. In addition, performance in the first quarter of 2016 benefited from dividend income from Baxalta and gains on the sale of select investments. The adjusted tax rate was 18.5% for the quarter, which reflects a benefit of $0.03 related to the adoption of new stock compensation guidance. And as previously mentioned, adjusted earnings of $0.58 per diluted share exceeded our guidance of $0.50 to $0.52 per share driven principally by operational strength. During the first quarter, we repurchased approximately $50 million or approximately 1 million shares. These targeted repurchases were more than offset by option-related dilution. Finally, before I turn to our updated outlook for 2017, I will provide some commentary regarding our cash flow performance in the quarter. During the first quarter, we generated free cash flow of $83 million driven by strong operational performance, disciplined management of capital expenditures, which declined approximately $60 million to $123 million, along with continued focus on improving the company's working capital. This performance enhances our confidence that we are on track to achieve, if not exceed, our full-year objective of approximately $1 billion of free cash flow. Let me conclude my comments by providing an update on our outlook for 2017. Starting with sales, on a reported basis, including the impact of foreign exchange, we expect full year 2017 sales to increase between 1% to 2%, and on a constant currency basis, 2% to 3%. And after adjusting for the U.S. cyclophosphamide impact and select strategic product exits, we expect underlying operational growth of 4% to 5%. All three of these sales ranges represent an increase from our prior guidance. This growth does not reflect any benefit from the proposed Claris acquisition, which, as Joe mentioned, we expect to close in the second half of 2017. Following completion of the acquisition, we'll provide updated expectations. We now expect growth in the Hospital Products business of 2% to 3% on a constant currency and 4% to 5% on an operational basis. Within Hospital Products, we now expect Fluid Systems constant currency sales growth of 4% to 5% or 5% to 6% on an operational basis. For the Integrated Pharmacy Solutions business, we expect constant currency sales to decline low-single digits. We expect full-year sales for cyclophosphamide to total $135 million as compared to our original guidance of $115 million. Our updated assumption is that additional competitors will enter during the third quarter of 2017. On an operational basis, IPS sales are expected to increase approximately 4%. Within Surgical Care we anticipate sales to grow approximately 3% constant currency or 3% to 4% operationally. And finally, for the Hospital Products business, we now expect IPS (16:50) and Other to increase high-single digits. For the Renal business, we continue to expect full-year constant currency sales to increase 3% to 4% or 4% to 5% operationally. Moving down the P&L, we now expect an operating margin of approximately 15.5% or approximately 200 basis points of improvement versus 2016, reflecting a strong first quarter performance and a lower impact from cyclophosphamide. As mentioned last quarter, we expect to provide updated long-term financial guidance on our second quarter earnings call. We expect interest expense to total approximately $60 million and other income of approximately $15 million for 2017. For the year, we expect an average adjusted tax rate of approximately 21%. This is a slight increase in previous guidance driven by the geographic mix of earnings. For full year 2017, we anticipate an average share count of approximately $555 million (sic) [555 million] (18:00). Based on these factors, we now expect 2017 adjusted earnings, excluding special items, of $2.20 to $2.28 per diluted share. And finally for the year, we continue to expect to generate operating cash flow of approximately $1.75 billion, and as I mentioned earlier in my prepared remarks, free cash flow of approximately $1 billion. Specific to the second quarter of 2017, we expect sales to increase approximately 2% on a constant currency basis and to be comparable to the prior year on a reported basis. Operationally, sales in the second quarter are expected to increase approximately 3%. And we expect adjusted earnings, excluding special items, of $0.55 to $0.57 per diluted share. With that, we can now open the call up for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. I would like to remind participants that this call is being recorded, and a digital replay will be available on Baxter International website for 60 days at www.baxter.com. And our first question comes from Matt Taylor of Barclays. Your line is now open.
Matthew Taylor:
Hey. Good morning. Thanks for taking the question. I guess, the first question I had, I wanted to understand in your guidance what you're assuming for some of the new things like Claris, the ScinoPharm partnership, and the contribution from the molecules that you talked about launching, which is all the injectable stuff.
James K. Saccaro:
Sure. Good morning, Matt. Thanks for the question. With respect to Claris, we have included no impact from that transaction. We expect that the transaction will close in the second half. Upon closing the transaction, we will provide updated guidance, both from a sales and an EPS standpoint. As it relates to ScinoPharm, there is really no material impact in 2017. The large majority of those molecules will launch in 2020, so we have a few years before we start to experience the benefits from that important partnership. And then finally, from the other injectable products, we haven't broken out the specific sales related to the Carrera (20:56) molecules. What we have said is we expect the original set of molecules to generate approximately a little north $200 million in annual sales, but that ramps up over a number of years. In 2017, the impact is still modest. So, what I would say overall is we're very excited about the generic injectable space. It's an area where we believe Baxter can win and do very well, but we're really setting the stage for that success in the first half and second half of 2017.
Matthew Taylor:
Okay, Jay. Thanks for that. And then I just wanted to see if you could give us a little bit more color about what's going on in the Renal business. That's an area where we had expected you might do a little bit better this quarter with the launch of AMIA and continue to see a little bit below market growth there. So, what can get that to pick up, and I guess, what's causing kind of the lower-than-average growth in that segment now?
José E. Almeida:
Matt, the performance of our Renal business in the PD, peritoneal dialysis, and acute renal care is doing very well. And because we are market leaders in both of them, our growth for the vast majority dictates the growth of the market. We have added a good number of patients for the PD business. And AMIA has been a tremendous success in the U.S. As a matter of fact, the growth is at or above what we have said before in terms of market. The issue that we have is simply in-center HD and is focused in Europe for the vast majority. We have had a decent amount (22:38) of competition – price competition actually in Europe on the dialyzer, and we have plans to come back at that with growth opportunities in Asia to offset that. And our issue in Renal is primarily Europe in-center HD, and we are attentively looking at that. Just a note on the general business of Baxter, for Europe, we have made significant changes in management and as well as country management. We are revamping that organization and looking forward to the new folks to make an impact. So, that's the area of focus that we have right now. But in terms of the Renal business, not only we are very happy with the PD business and acute renal care. Matter of fact, the acute renal care, we are taking market share in the U.S. as we speak. We continue to convert at a large rate hospitals in the U.S., and the profitability, most importantly, has increased significantly in the renal business. So, we're quite happy with that. So, the focus, as I said, is in fixing Europe in-center HD.
Matthew Taylor:
Great. Thanks and congrats on a nice quarter.
José E. Almeida:
Thank you.
James K. Saccaro:
Thanks, Matt.
Operator:
Thank you and your next question comes from Vijay Kumar of Evercore ISI. Your line is now open.
Vijay Kumar:
Hey, guys. Congrats on a really impressive quarter here. Maybe the first one, a big picture question for Joe. We've had a number of deals hit the tape recently, a lot of consolidation. And just given your thoughts on portfolio optimization rate (24:26), some of the valuations we've seen here are pretty healthy. I'm just curious how you're thinking of acquisitions, tuck-ins versus even possibly divestitures. Thank you.
José E. Almeida:
Vijay, good morning. My perspective has not changed about where Baxter stands. We're open to the tuck-ins, and we're doing them, and we're working very hard to get even more opportunities. We have a good pipeline in our pharmaceutical business between partnership and some tuck-ins and even in our advanced surgery, our biosurgery business. With the performance of the company and the work that Jay and Cathy Skala have done in our business transformation process and how quick we are integrating and simplifying our back office, I feel more confident that Baxter could do a 20%, 25% of our market cap deal without a problem, okay? It doesn't mean that we're going to do it, but my confidence has increased in the management of the company in really pulling off something that would be a good deal for our shareholders in terms of bringing synergies to the bottom line and a good accretion to the top line.
Vijay Kumar:
That's helpful. And then maybe one follow-up for Jay. Jay, I mean, operating margins was impressive, right? It really was. But when you look at the guidance of 15.5% versus what you did in the quarter, right, it sort of implies maybe 15-ish in the back half. Maybe the delta is some of this is TSA, maybe cyclo. I'm just curious. Is there anything else going on in the operating margin line? Thank you.
James K. Saccaro:
Great. Yeah, from the first half to the second half, there were a couple of drivers that impact the operating margin and EPS. And just to run through those, one is cyclophosphamide. From first half to second half, we expect $40 million run rate decline, and so that's about $0.06 of impact. We also expect a ramp down in TSAs of approximately $30 million. So, that's roughly $0.04 of impact. And then the other important thing that we're doing in the second half of the year is we're accelerating some investments in R&D. It's important for us to really set the stage for accelerating growth in the future that has been a core area of focus for us over the last eight quarters. And so, for us, we are ramping up some spending, about $40 million or roughly $0.07 of impact related to first half to second half increases in R&D spending. The final point I would make with respect to second half EPS, not operating margin, is the tax rate because the primary source of benefit related to the new stock option exercise and stock issuance guideline is a first quarter impact. The tax rate picks up in the second half of the year roughly $0.03. So, interestingly, if you total all of this, we're talking about $0.20 of impact in the second half of the year or roughly $110 million, $120 million worth of pre-tax impact in the second half. So, that's really the drivers as to why we're not seeing the standard rates of growth that we've seen previously in the second half of this year.
Vijay Kumar:
Thanks, guys. That's helpful.
Operator:
Thank you and our next question comes from Mike Weinstein of JPMorgan. Your line is now open.
Michael Weinstein:
Joe, you keep raising that percentage. Today, you said 20% to 25% of market cap, the upside size of M&A versus 15% to 20% prior. Is that where your head is at now, that bigger deals are making more sense than maybe 12 months ago?
José E. Almeida:
Mike, you have a good memory, and I'm happy you listen to what I say. We do have more confidence in Baxter. First of all, as a new CEO last year, you're just getting to know the company. You're getting to know the management and its capabilities. No, we have a solid team, a very, very good team, and the execution has been great. So, that gives me confidence that we can do something bigger if the opportunity arises and things are in the right place, and there is value for our shareholders and never compromising what we think is our primary reason in doing deals, which is deliver more value to our shareholders. So, basically, our confidence goes up, the percentage goes up, and I think it's really reasonable to assume that if there's an opportunity, Baxter has the balance sheet, has the borrowing capability, and we feel comfortable with it.
Michael Weinstein:
Okay. Just a couple of quick financial follow-ups, if you don't mind. So, one, you didn't raise your operating cash flow guidance even though you raised effectively your net income guidance by $50 million, and you had a very strong cash flow quarter. So, maybe if you could just shed some light on that. And then second, can you just give us more on what's going on in the SG&A line than what we have so far and maybe give us a sense of head count changes or anything else you can share? Underlying SG&A expense was down 10.5% this quarter. That's obviously pretty dramatic, and it's hard for us outside the company to see some of those changes that are going on.
James K. Saccaro:
Sure. First, as it relates to cash flow, great performance in the quarter, and it was definitely a little bit ahead of our expectations. It was certainly ahead of last year, but as you'll remember, Mike, we did have a tax payment last year that distorted the Q1 result. But importantly, the pieces that I think we're pleased with, days payable, we held flat, but days inventory on hand, we improved 16 days roughly year-over-year. DSO was down nine days year-over-year, so this relentless focus on working capital balances is paying dividends, and the teams are hard at work driving a result in this regard. The other piece of this relates to CapEx where we continue to focus on driving savings where possible, taking a zero-based approach to CapEx and capital spending. The reason we haven't raised guidance, in my prepared remarks, I said our confidence in our ability to beat or exceed guidance has increased. So much of our free cash flow is concentrated in the fourth quarter of the year that it's very difficult to have a line of sight to exactly how payables and receivables will land at year-end. And given the back-end load of cash flow, it's a very volatile number. So, I think for us, we have an improved line of sight, increasing level of confidence. We'll watch this throughout the year, and perhaps if things continue along the current trend in Q2 or Q3, we'll be able to update guidance and provide some updated numbers in that regard. As it relates to the SG&A initiatives, yeah, I will tell you, we as a team are very proud of the progress that we've made in the transformation of Baxter. We started this in the second half of 2015, you recall, really accelerated the efforts in earnest in 2016. And our business transformation office led by Cathy Skala is focused on a number of important initiatives. One of them relates to zero-based budget. And I will say that in 2017 in the first quarter, we benefited from a lot of the zero-based efforts that we put in place last year related to organization efficiencies, related to spending initiatives. So, really, the primary driver of the benefit in the first quarter was driven by many of these savings initiatives that we initiated last year. And then the other thing that we've done is for the back-office functions, principally finance, IT, HR, we started an initiative to drive and improve the efficiency of those functions. The most notable area to-date, the most achievement in this area has been led by our IT team. So, Paul Martin, our CIO, and his entire organization have been incredibly focused on creatively driving down the cost of the IT infrastructure. And so, that was one element of driving improvement in the first quarter. So, those are a few of the highlights I would say. We'll stop short of getting into specific head count. We have delineated this program in detail in our 10-K where we talk about the spending requirements to the program but also the overall savings programs, and I would say that this is very much tracking in line or ahead of expectations at this point.
Michael Weinstein:
Perfect. Thanks, Jay.
Operator:
Thank you and our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Ryan Lewis:
Good morning. Thanks for taking the questions. Maybe a quick one on long-term guidance for Joe or Jay. So, as it relates to long-term guidance next quarter, you've been pretty transparent about that. I think investors are very focused on margins, Joe. And I think given your comments on your comfort and transformation, it sounds like we get a material update as it relates to margins. But I wonder if you could talk about organic growth transformation for a second. Have you seen enough from some of the pipeline developments in biosurgery and the continued traction in Renal and Fluid Systems to kind of have a fundamentally different view for how this business can grow in the future from an organic perspective?
José E. Almeida:
David, I would say that all of the efforts that were put into innovation and the better deployment of R&D dollars and portfolio management are all starting to give us more comfort that our top line growth can be augmented organically towards the end of 2017 into 2018. Those are not overnight programs. Those are programs that take a significant amount of time if you know our products. Even our hemostats, those are long-term studies that need to be done. But as what I have seen so far coming out our R&D reviews and portfolio business reviews that we're going to start getting momentum towards the end of this year, beginning next year with the things that we started since we started as CEO. I would say that there are some very notable upticks in areas like PD with AMIA and HOMECHOICE CLARIA. We are seeing the launch of some technologies across the board that were not before emphasized by the company such as our extra portfolio (35:48) technologies as well as acute renal care new technology we match (35:51). So, I would tell our investors that there's a significant focus in innovation, but innovation is the part that takes a little longer, and we see that hitting most in 2018. Our story is one of providing value to the shareholder. We went very hard at our cost structure as well as our efficiency selling products in the market, and you can see that. The Claris acquisition will bring some really good molecules, between 150 to 175. I gave the team led by Robert Felicelli a specific goal that by 2021, we need to have more than 300 molecules in the marketplace as well as understanding and potential pipeline of biosimilars. So, we are just in the beginning of our journey to develop a really strong top line organic growth company. And in the meantime, to deliver value to our shareholders, we're hitting everything that we can in terms of making this company the most efficient and effective in everything we do.
David Ryan Lewis:
Joe, very, very clear. Maybe just a quick couple of follow-ups for Jay. Jay, just second quarter numbers seem a little conservative. There's some modest comp- adjusted deceleration. It is your toughest comp of the year, but the question is just, is there anything momentum perspective in your mind that really changes into the second quarter or is that just the comp? And then Fluid Systems, really significant upside relative to our number. Can you just give us a snapshot of what's happening with momentum right now between pumps, disposable pull-through, and price? Thanks so much.
James K. Saccaro:
Sure. First, as it relates to Q2, to your point, David, it is the most difficult comp of the year. Q2 last year, we had 12% growth in the U.S., so a really strong performance. And we had a very strong pump placement quarter along with strong sales in our Surgical Care area. So, from a comp standpoint, it's a challenging one. I would say there's two other factors in play that are factors that are well understood from our perspective. First is Fluid Systems in the U.S., 20% growth. We do expect that to come down over time as we anniversary certain agreements and as we start to get to a more steady-state approach from a pump placement and sets growth standpoint. So, that 20% growth is not a number that we expect to see for the continued future. That will moderate down. And then the other factor is, as Joe referenced in his comments regarding sales, we did have a bolus of sales related to a product called Transderm Scop, about $20 million or so of sales in the first quarter. We expect the alternate supplier to be back on the market. In fact, they are on the market, so those sales will moderate down. That benefit will be more muted as we look to the second quarter. So, what I will tell you is, it is, however, consistent with our original expectations from a sales growth standpoint. As it relates to the Fluid Systems business, 20% growth in the U.S., zero percent, international. If we were to exclude strategic exits, we would see 3% international growth, 12% growth overall, or 13% on an operational basis, excluding the strategic exits. Really, the way to think about that, our infusion systems was high single-digit growth, and really, with the pumps – it wasn't really a pump story. It was more about the sets associated with the pumps because we had good pump placements in Q1 of last year. And so, we saw double-digit, near-teens growth from a set standpoint. Our whole theory in terms of our pumps business is as we grow the installed base, these sets ride along at a higher margin and helps transform the margin profile of the company. That clearly played out with the Q1 result with the double-digit growth in sets. And then the IV business in the first quarter in the U.S., we saw very significant growth, north of 20%. And that was very much a mix of volume along with some pricing. So, again, it was ahead of our expectations overall. We're pleased with the progress there and continue to focus on driving sales of the SPECTRUM pump because that's such an important aspect of our overall business.
David Ryan Lewis:
Great, Jay. Thanks so much.
Operator:
Thank you. And our next question comes from Larry Biegelsen of Wells Fargo. Your line is now open.
Larry Biegelsen:
Good morning. Thanks for taking the questions. I wanted to ask about the Renal pipeline and then one on M&A. So, Joe, you've talked about being excited about the acute renal pipeline in new areas, but I don't think you've given us much color on that. And also, can you talk about the point of care PD regulatory pathway? How close are you to getting FDA signoff on that trial? And then I just had one follow-up.
José E. Almeida:
Hi, Larry. The Renal pipeline is one of the richest that we have right now. And we reorganized our company that put squarely under the general managers and presidents of the businesses, the research and development management with people that we brought from other companies to Baxter. It has enhanced significantly our ability to not only develop, put products in the market but also accelerate the clinical studies that we're doing. So, I'll give an example. We're very excited about THERANOVA. We're going to be investing in the next few years $25 million in clinical data because we are convinced and have sufficient data in hand right now that proves this product is superior to any dialyzer in the market today. When it comes to acute renal care, we have great products for the sepsis treatment. We're going to continue to double down (41:56) in places like Japan and bring that technology on a global basis. And then let me talk about the point of care. A lot has been said by a bunch of different people about point of care and PD and all of this stuff. And Baxter is probably the only company that has the capability to vertically integrate all of these technologies. And to that end, we will be putting our first patient on point of care treatment towards the end of 2018. So, we have a very strong belief, and our pathway is now determined that we can do that. So, that is a great achievement to the chronic renal team that has put that together. So, as I say to the folks at Baxter, go compete for the dollars, go show the best ROIC, and Renal has done a great job so far. I hope the other divisions will follow through, go fight for that dollar that we have available for product development and clinicals.
Larry Biegelsen:
Joe, that's very helpful. Just one clarification on that and one follow-up. The first patient on point of care by the end of 2018, is that the first patient in your clinical trial or is that when you're basically saying that you can launch?
José E. Almeida:
Clinical trial. Will be first – a little – I would say fourth quarter of 2018 we'll have a (43:16) first patient clinical trial. And from that point on, we're going to roll it out as soon as we can in terms of getting the population defined by the agencies in terms of clinical trial. And the launch, we'll be looking at probably towards the end of 2019.
Larry Biegelsen:
That's very helpful. And then just on M&A, can you talk about the M&A pipeline and why we haven't seen more activity besides the Claris deal? And given the change in the deal size that you talked about earlier on this call, have your targets or areas of interest changed or evolved since you last provided the update? Thank you.
José E. Almeida:
Larry, this is a very dynamic marketplace. There's a lot of things happening. We have a relentless focus in inorganic opportunities. But inorganic opportunities is now what will drive our company solely. So, we do a very good balance between how much time we spend in looking new opportunities, how much time we spend managing Baxter's current businesses and making sure that all the businesses are performing well. We are every month looking at least 10, 12 opportunities. Some fall off for financial reasons. Some of them have changed in dynamics and performance and situation. With the expansion of our reach in terms of size, it brings a bit more opportunity to the table in terms of evaluating. This doesn't mean that we're going to do the deal, but this means that we're going to evaluate. And one thing Baxter is starting to do very well, we're very fast at evaluating the deal coming to the table, have enhanced significantly our internal capabilities, which are under Andy Kidd who runs the strategy for us and BD&L (45:12) and David Roman who is in strategy as well here. So, these teams have been put together, a significant amount of horsepower. So, we are doing everything we can, but the first thing is if it strategically makes sense, it needs to make sense for our shareholders. The money, when we look at this, this is not our money. We're just here taking care of the money for our shareholders.
Larry Biegelsen:
Thanks for taking the questions.
José E. Almeida:
Welcome.
Operator:
Thank you and our next question comes from Bob Hopkins of Bank of America. Your line is now open.
Robert Hopkins:
Thank you and good morning. So, I want to ask a quick question for Jay and then a follow-up for Joe. So, Jay, just to start out, obviously, a lot of people looking forward to next quarter when you will give us an update on the long-range plan. In anticipation of that, are there things that you think we should be focusing on in terms of major puts and takes to the long-term plan, things that you'd want to highlight that investors should be considering as we think about the long term relative to your previous guidance obviously?
James K. Saccaro:
Look, I don't know that we would – we have items that are new items to point out with respect to our long-term guidance at this stage. The biggest note I would make is we are certainly ahead of our expectations, and the guidance that we give for this year in 2017 currently sits at $2.20 to $2.28. I believe that's above the 2018 guidance we shared in July of last year. So, a lot of work, a lot of strong momentum. That's probably the biggest change that we've seen in our overall guidance. In areas like working capital or CapEx, we've also seen some improvements, so those would be a couple of other items that we're hard at work in our long-range financial planning process isolating. Beyond that, there's no major dynamic change. We are excited about some of the portfolio items that Joe highlighted in his comments earlier and some of the work that our teams have done from an R&D standpoint, so that should feature – but again, the biggest impact, those will come a little bit later in the long-range plan.
Robert Hopkins:
Okay. And then for Joe, just on this M&A commentary, I was wondering if you could kind of talk a little bit about your priorities, and two, I guess, two specific questions. One, as you consider M&A, would you consider something that's a little bit more of a white space? And then secondly, on the wound management side, I was wondering if you could just talk about that transaction a little bit more and your interest broadly in wound management as a category. Thank you.
José E. Almeida:
Hi, Bob. We have four areas that we consider core growth in our portfolio. It doesn't mean that we don't pay attention neither invest in those other areas. We do and we pay a lot of attention to those. But Renal is about new therapies and end-to-end care of our patients. Then we have critical care, which is an augmentation of what we already have between acute renal care as well as our IPS, our fluid management business. Then we have the Baxter Pharmaceutical business, which is to go into generics and eventually into biosimilars, okay, all injectables, cytotoxic molecules, oncolytics, so that's in Baxter Pharmaceutical. And then you have advanced surgery, which is to complement our product. So, the way we think about this, by defining broader categories within Baxter, allows us to look at spaces that is less singularly focused on product but more focused in areas of care. So, in process of looking at this, we really stumble at opportunities and encounter opportunities that has a little bit of white space in them. At the moment, we are looking at augmentation to support areas of growth for us, not specifically and exclusively in white spaces. We're not there yet. We have our venture capital group here at Baxter where we look at opportunities in white space, but those are at the venture capital level. So, this should give you a bit more color on how we think about deals. The second in wound management specifically is a natural adjacency of our biosurgery business, which is an adjunct, that knowledge in the OR, are opportunities such as this one we just acquired. It's a small business but goes nicely into our wraps bags (50:08). The wound management per se in terms of traditional wound management, specifically is not an area of interest. As I said, we may come across a company that we like overall products but has that as a small business. It's a different conversation. But to have us specifically targeting wound management is not something that is in the cards at the moment in time. This has to do with wound closure, which is very adjacent to our hemostat and sealing business.
Robert Hopkins:
Terrific. Thanks very much.
José E. Almeida:
Thank you.
Operator:
Thank you and our next question comes from Danielle Antalffy of Leerink Partners. Your line is now open.
Danielle J. Antalffy:
Hi. Good morning, everyone, and thanks so much for taking the question. Congrats on a good quarter. Jay, I wanted to ask you about fiscal 2017 guidance and the incremental guidance on EPS beyond the Q1 outperformance. What segments do you expect to drive incremental strength versus prior expectations there?
James K. Saccaro:
Sure. So, as we look at the updated guidance, the midpoint of the range increases about $0.10, and principally, $0.07 of that has arrived in Q1. We expect another $0.03 related to cyclophosphamide. So, really, those are the drivers as we look at the margin improvement on a full-year basis. The Q1 driver, clearly Fluid Systems, had a stand-out quarter. That was an important aspect along with some SG&A savings that contributed ahead of schedule to drive the $0.07. But really, as we move forward, the big change to guidance relates to cyclo. As we look at other factors like foreign exchange, sundry, interest, tax, and share count, they all essentially net out to zero. So, the big drivers are the two that I've mentioned.
Danielle J. Antalffy:
Okay. That's helpful. And then just longer term, if we think about Claris and what that brings to the generic injectables business, how does that change the growth profile of that business? That's a global market that I think is growing in the 9% to 10% range. So, curious if you think Claris is something that gets you to within that market growth range, above that market growth range? And then, Joe, you mentioned augmenting existing businesses. Do you feel like generic injectables is now set with Claris and you'll look elsewhere to augment your businesses? Thanks so much.
José E. Almeida:
Danielle, if you look at our long-term objective is to be at mid-single digit growth rate, okay? And the only way to get there in the markets that we are today is to go into a business like the generic injectables, which will change the weighted average market growth rate of our company. So, I would say that Claris will have an impact likely in 2018, and then when you go in 2019 and 2020, they will bring probably 50 to 100 basis points of incremental growth to the company because it's not Claris itself, but it's everything else that will be attached to Claris. Claris has great manufacturing capabilities. In our integration plans, we are already starting to expand a couple of their buildings to put more capability like dual chamber bags and other things there. And so, we are looking at that as a platform. So, I would say that with comfort that 50 to 100 basis points in the midterm growth rate is acceptable. We're looking at Brik Eyre and Robert Felicelli (53:55) to really deliver on those numbers and also to augment our molecule pipeline.
Danielle J. Antalffy:
Okay. Thanks so much.
José E. Almeida:
Thank you.
Operator:
Thank you. And our next question comes from Matt Miksic of UBS. Your line is now open.
Matthew Miksic:
Thanks so much for taking our questions. So, I wanted to follow up, Joe, I know you've gotten a couple of questions on M&A and strategic thinking on acquisitions. And I guess, one of the questions that we get and we hear in the press, particularly following some of the recent deals, this sort of this idea of scale or leverage on a platform or leveraging your distribution. And you could say the small wound care, wound closure acquisition you talked about sort of fits that on a smaller scale, and specialty injectables kind of in place and your ability to sort of continue to add molecules there, you're talking about a larger deal, I guess. To what degree does growth, does scale, does leverage, does distribution overlap kind of play a role in your thinking? And then I have one follow-up.
José E. Almeida:
Matt, you have to think about what are the major prerequisites for something to get into the funnel. And one of them is be within those four pillars I mentioned before. The second thing is to make sure there is category of leadership in the products that people make and sell. Then once you pass through those broad lenses, it's about what can Baxter do to be a better owner for that business. And if you look at our contract capability in the U.S., (55:45) growth in the U.S., this is phenomenal job (55:47) doing this. So, that is a positive. Baxter is a hospital company, and we are a supply company. We are in every hospital in this country. So, we should have the ability to bring synergy (56:01) in terms of distribution as well as how we manage sales and marketing within the regions of the world because we are effective and very efficient in doing it. Above and beyond that, the scale of products and the ability to synergize by channel, you have the whole efficiency of cost to maintain the infrastructure, the pure G&A, which I think now we are in a position to really bring a lot of synergies to the table that about a year-and-a-half ago, we were not. So, that gives me confidence that once and if we find the right opportunity for Baxter and our shareholders, we will have the channel synergy as well as the cost synergy. Now, remember, we always have this conversation about improving our weighted average market growth rate, and that's the only and sole focus of going into businesses on an inorganic manner and to get businesses that have markets that they serve that will be complementary to ours and the growth will be accretive to us. So, once we get those things on the table, we can make our decisions more clearly.
Matthew Miksic:
Now, that's very clear. Thank you for that. And then I had one follow-up on just one of your business lines. The pump business – and I apologize I've been hopping back and forth between a couple of calls, so if this has been asked, just let me know. But your thoughts on sort of the health of that general business. You've obviously done quite well in that in terms of regaining share. Where should we think about that business going from here? And is there anything else in the product pipeline that we should be looking forward to to kind of sustain this growth rate that you've been able to put up?
José E. Almeida:
Sure. We'll forgive you for flipping calls back and forth like that (58:12).
Matthew Miksic:
Thank you.
José E. Almeida:
So, this is a platform for Baxter. Baxter had this product line for decades in several different shapes and form. We are here to stay. We have this SPECTRUM platform today in the U.S. and Canada, which is doing very, very well. Most importantly is not only the pumps but also the ability to place the sets. And the sets are what continues to deliver on profitability and revenue growth. We have a couple more generations of our SPECTRUM pump coming up in the next couple of years, and then we're going to launch a new global platform that includes different types of pumps that were currently in development. We're outside the U.S. We have a partnership with a foreign manufacturer where we're going to be augmenting our product lines in Anglo-Saxon speaking countries, so we have the ability to replace our old platform called COLLEAGUE, which is still being sold outside the U.S. in a few countries with a much more modern. But the beauty about our platform on a global basis is our drug library is second to none. And having that being retrofitted in any platform, including the one that we are developing with a foreign partner at the moment, is really important. So, our teams are working very hard. We have augmented our research and development teams across the globe. We have strong center in the U.S. We have centers now in India. We augmented not only with third-party design houses but also our own people in our R&D centers in India. So, we are ramping up to really make this business a leading business in the industry that it competes.
Matthew Miksic:
Thank you.
Operator:
Thank you and our next question comes from Glenn Novarro of RBC Capital Markets. Your line is now open.
Glenn John Novarro:
Hi. Good morning. Thanks for taking the question. Joe, I wonder if you can comment on Surgical volumes in the first quarter. One of the companies that we covered last week came in with better volumes, and they thought maybe the uncertainty about healthcare reform may have pulled forward some volumes into the first quarter. And I looked at your Fluid Systems, up very strong. So, maybe comment on what you saw in terms of volumes. And do you think there was any pull forward in cases? And then I had a follow-up.
José E. Almeida:
Glenn, I don't think there was any pull forward. I think our cycle of sales and growth that Jay had explained here, it had to do a lot with the placements of products that we had early this year and also in the last year-and-a-half. So, we see the U.S. supply business as steady, as low single-digit growth, but it is growing. And we don't see at the moment anything that would create major disruption to the system. Clearly, healthcare reform is up there. And now, they were looking at tax reform and how things are coming along, but I think in businesses like ours where the significant infrastructure products that are used for day-to-day operation of a hospital or a care center or patient care like our PD business, we see that the market in the U.S. is still a good market. The increase of growth is about 2%, 3%. So, we find no disruption in the near term or foreseeable future to that market.
Glenn John Novarro:
And then just as a follow-up, can you talk about your emerging market growth in the quarter? And the reason I'm asking is your international results came in a little bit below our expectations, and I know you've exited some business lines, but I'm just trying to search for why international may have come in a little bit lower. Maybe it's emerging markets. So, can you talk about emerging market growth? And has emerging market growth been meeting your expectations, exceeding expectations, or coming in light? Thank you.
José E. Almeida:
Glenn, once you take out the businesses that we exited, which are all in emerging markets, so we are talking about India, you're talking about Venezuela, you're talking about Turkey. Our growth was 6%, and emerging markets is 20% to 22% of our overall sales. You have an impressive growth in Latin America ex Venezuela of 10%. We had good growth in China, 5%. Remember, we are not in physician-preferred medical devices in China. We are local manufacturer of fluids in China for PD and so specialty fluids or IV as well as nutrition. So, 5% is a good growth in China for those products. Emerging Asia, 5%, and East EMEA (01:03:45), which is all the Eastern Europe, Middle East, and Africa is about 4%. So, I'm quite happy with that. We had to exit those businesses because the profitability profile of them were way below what we had set as acceptable for our company. But ex those businesses, we are pretty good there. The issues that we have in international, some parts of Europe which are underperforming, as I said, we're taking measures to replace management but also to extend product line offerings and clinical trials to get new products in the market there.
Glenn John Novarro:
Okay. Great. Thank you for the color, Joe.
José E. Almeida:
Thank you, Glenn.
Operator:
Thank you. And that concludes our question-and-answer session for today. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International’s Fourth Quarter 2016 Earnings Conference Call. Your lines will remain in a listen-only made until the question-and-answer segment of today’s call. [Operator Instructions] As a reminder, this conference call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter’s permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candice. Good morning, and welcome to our fourth quarter 2016 earnings conference call. Joining me today are Joe Almeida, Baxter’s Chairman and Chief Executive Officer, and Jay Saccaro, Baxter’s Chief Financial Officer. On the call this morning, we will be discussing Baxter’s fourth quarter and full year 2016 financial results along with our outlook for 2017 before taking your questions. Please note that we have also posted a supplemental presentation that complements this morning’s discussion. This presentation can be accessed on Baxter’s external website in the investors section under events and presentation. In addition, I would like to remind that you please limit yourself to one question during the Q&A session, so we could accommodate others in the queue. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters, contains forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today’s press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, on today’s call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now, I’d like to turn the call over to Joe.
Joe Almeida:
Good morning, everyone, and thanks for joining us. I will start today with some comments on our fourth quarter performance and will also share some perspective on the year, on how we’re building our momentum in 2017 and beyond. Jay will then take a closer look at our financials and outlook for 2017, and I will close with the Q&A. As you saw in this morning’s press release, Baxter finished the year with another strong quarter. We delivered fourth quarter sales growth of 2% in both constant currency and reported basis. Adjusting for generic competition for cyclophosphamide in the U.S., sales increased 3% in the quarter. Key drivers included strong performance in U.S. Fluid Systems and anesthesia along with continued momentum in peritoneal dialysis and acute renal care. Globally, price contributed approximately 1 percentage point to growth in the quarter. On the bottom line, adjusted earnings were $0.57 per diluted share, an increase of more than 30% versus the prior year. Growth in the quarter reflects solid sales, improved gross margin and the benefit of our ongoing business transformational efforts. Now, I will discuss performance by business and franchise on a constant currency basis to provide a clear look at underlying operational performance. In the quarter, Hospital Products sales totaled to $1.6 billion globally, increasing 1%. Adjusted for cyclophosphamide, sales improved 2% globally, in line with our expectations. Taking a closer look at fourth quarter performance by franchise, our sales in Fluid Systems were $614 million, up 8%; performance was driven by favorable pricing and volume for IV solutions in U.S. along with incremental placements of the SIGMA SPECTRUM infusion system and the related pull-through of access sets [ph]. Fluid Systems sales growth in the quarter was negatively impacted by 1 percentage point of strategic exits of IV solutions in selected markets outside the U.S. Integrated Pharmacy Solutions or IPS, fourth quarter sales were $563 million, a 4% decline; adjusting for cyclophosphamide, sales decreased 2%. The performance in the quarter was impacted by lower sales in nutrition globally, given an increased competitive environment, lower pharmacy compounding sales and higher sales deductions. Surgical Care sales of $349 million were 1% in the quarter, mid single-digit growth in our anesthesia business, offset by lower sales in biosurgery. While we are disappointed with biosurgery performance, we continue to view this business as a core growth platform and have significantly reallocated investments to biosurgery to improve performance. In addition, we’re pleased to welcome Wil Boren to the new role of President, Biosurgery. Wil is a 20-year healthcare veteran with extensive global leadership and surgical care experience. We’ll benefit from his experience and expertise as we expand our presence in this high-potential market. Finally, in Hospital Products, fourth quarter sales of a $104 [ph] million in other declined 6% year-over-year, reflecting lower manufacturing services revenues from Shire. Adjusting for this impact, sales growth in the quarter was comparable to the prior year. Moving on to the Renal business, global Renal sales for Q4 were $1 billion, reflecting 5% growth. We continue to see strong momentum in peritoneal dialysis with growth of 7% globally, driven by patient growth of 6% along with favorable pricing and product mix in the U.S. where we now have nearly 1,500 patients on AMIA. Fourth quarter Renal results also benefitted from our high single-digit growth in acute renal care. Our PRISMAFLEX system continues to lead a rapidly growing market for continuous renal replacement therapy or CRRT. In-center hemodialysis performance declined slightly in the quarter while we are pleased to see growth stabilizing following a number of actions we have taken to enhance performance. Growth improved 2 percentage points sequentially and importantly, profitability continues to improve in this business. In the fourth quarter, we launched our novel and proprietary HDx therapy enabled by our THERANOVA dialyzer, which has the potential to raise the standard of treatment and improve outcomes for end-stage renal disease patients. With that, let’s shift focus to the full year. This call marks my first anniversary as Baxter’s CEO. I found that at a [ph] company with the solid foundation and good people, the goal quite simply has been to convert this potential to consistent top quartile performance to do it fast and do it well. Our full year results demonstrate our progress towards this objective of mid single-digit sales growth, adjusted income of $1.96 per diluted share and free cash flow greater than $900 million. Our business transformation has focused on three clearly defined strategic levers, portfolio and innovation management, operational excellence, and capital allocation. We rolled out this strategy at our 2016 Investor Conference along with our Baxter 2020 financial targets. And it has been about execution discipline. This passionate portfolio management has meant taking a hard look at where we drive the greatest value expectations [ph] and the business across our vast portfolio and global footprint, and then invest according [ph] to the strengthened top line growth and ROIC. We have made some very candid assessments that have been crucial to optimize our portfolio, go-to-market strategy and commercial mindset. Some of these decisions will impact our top line growth in 2017, but position Baxter for accelerated growth as we redirect resources to higher growth, higher margin opportunities. Just like our portfolio, our research and development pipeline must drive clear value for patients and the business. In 2016, we accelerated R&D productivity and shifted differential investment to our core growth areas and some compelling strategic bets. These actions will create a foundation for ongoing growth. We have also made excellent progress establishing a more efficient organizational structure and disciplined cost management strategies. And while these actions have meaningful -- have rather meaningfully contributed to margin expansion in 2016, we’ll continue to identify new initiatives through our business transformation office to drive operational efficiency across our organization. Executing our capital allocation strategy through appropriate investment in our business and return value to shareholders is pivotal to deliver sustained top quartile performance. In 2016, we successfully completed the disposition of the Baxalta retained stake and have opportunistically restructured debt. Among other steps, [indiscernible] increased value. Rewarding shareholders is essential to this equation, which we emphasized through a 13% dividend increase and opportunistic share repurchases of approximately $300 million. Finally, we initiated the acquisition of Claris Injectables, providing key platform for the future growth. So, we sum, it has been a year of rapid and meaningfully strategic execution across the board in advancing both the top line and bottom line. Am I satisfied? No, but we are off to a solid start, and there is more to come. And with that, I will turn it over to Jay.
Jay Saccaro:
Thanks, Joe, and good morning, everyone. And as Joe mentioned, we’re pleased with our fourth quarter results demonstrating continued progress towards achieving our long-term financial goals. Sales in the quarter increased 2% on both the reported basis and constant currency basis, in line with our expectations. Walking through the rest of the P&L, adjusted gross margin of 44.5% represents an improvement of nearly 200 basis points over the prior year, driven by improved pricing in select areas of the portfolio and favorable manufacturing performance in the quarter. Adjusted SG&A totaled $619 million, decreasing 8% on a reported basis. The primary driver of the improvement was our ongoing focus on controlling expenses and the benefit from lower pension expenses. TSA income totaled approximately $23 million in the quarter compared to approximately $30 million in the fourth quarter of 2015. As mentioned last quarter, TSA income from Shire will continue to decline as need for these services ramps down, which is expected to be by mid-2017. Adjusted R&D spending in the quarter of $152 million decreased 4% versus the prior year. Adjusted operating margin in the quarter was 15.4%, an improvement of 470 basis points versus prior year. Operating margin compared favorably to our expectations driven by improved gross margin and disciplined expense management. Interest expense was $13 million in the fourth quarter. Adjusted other income totaled $19 million in the quarter, primarily resulting from gains on the sale of select investments and the foreign exchange benefit on balance sheet position. The adjusted tax rate was 24.5% for the quarter. This rate was higher than expected and reflected finalization of the effective tax rate for the full year, which reflects incremental profitability generated in higher tax jurisdictions in 2016 as compared to 2015. As is previously mentioned, adjusted earnings of $0.57 per diluted share exceeded our guidance of $0.49 to $0.52 per share. Relative to the midpoint of our range, this favorability was driven by approximately $0.06 of operational strength and a $0.02 benefit from other income. This was partially offset by approximately $0.02 due to higher tax rate. During the fourth quarter, we opportunistically repurchased approximately $250 million or approximately 5 million shares during the quarter. These repurchases were partially offset by option-related dilution. Before I turn to our outlook for 2017, I wanted to spend some time discussing our cash flow performance. In 2016, we generated free cash flow of $905 million, an improvement of more than $550 million versus 2015 and ahead of our most recent guidance of $650 million for 2016. This improvement was driven by strong operational performance, disciplined management of capital expenditures, which declined by nearly $200 million, along with the implementation of new programs focused on improving the Company’s working capital. These new initiatives around days payable and days receivable contributed to the strong cash generation in the fourth quarter. We also took the opportunity in the quarter to repatriate approximately $1 billion in overseas cash to the U.S. We were able to bring this cash back to the U.S. in a tax efficient manner via the partial repayment of an intercompany loan as well as repatriation of previously tax earnings in certain foreign jurisdictions. Let me conclude my comments this morning by providing an update on our outlook for 2017. Starting with sales, on a constant currency basis, we expect 2017 full year sales for Baxter to increase approximately 2% and after adjusting for the U.S. cyclo impact and the select strategic product exits we’ve discussed, we expect underlying operational growth of approximately 4%. This growth is in line with our long-term projections and does not reflect any benefit from the proposed Claris acquisition. With respect to Claris, we expect the acquisition to close in the second half of 2017, and we’ll provide updated expectations following the completion of the acquisition. On reported basis, including the impact the foreign exchange, we expect full year 2017 sales to be comparable to the prior year. We expect growth in the Hospital Products business of 1% to 2% or approximately 3% to 4% excluding cyclo and strategic exits. Within the Hospital Products franchise, we expect sales growth of 2% to 3% for Fluid Systems; adjusting for strategic exits, we expect growth of 4% to 5%. For the Integrated Pharmacy Solutions franchise, we expect sales to decline low single digits. We expect full year sales for cyclo of $150 million as compared to $210 million in 2016. Our assumption is that additional competitors enter the market during the second quarter and third quarters of 2017; after adjusting for cyclo, sales are expected to increase 3% in IPS. Within the Surgical Care franchise, we anticipate sales to grow approximately 2% to 3%, both the anesthesia and biosurgery businesses are expected to grow in that range. And finally, for the Hospital Products business, we now expect BPS and other to increase low to mid single-digits. For the Renal business, we expect full year sales to increase 3% to 4%, driven by continued growth across the segment; adjusting for select strategic exits, sales are expected to increase between 4% to 5%. Moving down to P&L, we expect an operating margin of 15%, approximately 150 basis points improvement versus 2016. This is ahead of our long-term outlook we provided in May 2016, and reflects the benefit of all the actions we’ve taken to optimize our cost structure. We expect to provide an update to our long-term guidance on our second quarter conference call. We expect interest expense to total approximately $60 million and other income of approximately $20 million for 2016. [Ph] For the year, we expect an average adjusted tax rate of approximately 20.5%; this reflects a benefit of $20 million or approximately $0.03 related to the adoption of the new stock compensation guidance. For full year 2017, we anticipate an average share count of share count of 550 million shares. Based on these factors, we expect 2017 adjusted earnings, excluding special items, of $2.10 to $2.18 per diluted share. Finally, for the year, we expect to generate operating cash flow of approximately $1.75 billion and free cash flow of approximately $1 billion. Specific to the first quarter of 2017, we expect sales growth to increase approximately 2% to 3% on a reported basis and 3% to 4% on a constant currency basis. Adjusting for the impact of cyclo and selective strategic product exits, we expect underlying constant currency sales growth of 5% to 6%. And we expect adjusted earnings excluding special items of $0.50 to $0.52 per diluted share. With that we can now open the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions] And our first question comes from Mike Weinstein of JP Morgan. Your line is now open.
Mike Weinstein:
First off, congratulations on another fine quarter. Let me ask you couple of questions on the guidance, if I can, Jay. So, your 20 -- let me step back. Your margins over the last two quarters have obviously been exceptional; you’ve made a ton of progress; your EBITDA margin was 15.4% this quarter, 16% last quarter; your 2017 guidance is for 15%. So, tell me why is 15% the right number for 2017, given the second half of 2016 performance?
Jay Saccaro:
Yes, great. First of all, normal seasonality; we typically do better from a margin standpoint in the second half of the year versus the first half of the year. So, there are number of factors that driven that in terms of seasonality of sales and normal hospital buying patterns. But, we do see some normal historic uptick in the second half of the year margin relative to the first half, and that was certainly the case in 2015. But interesting, maybe I’ll make a few comments in terms of overall guidance as we think about 2017 operating margin. Really, there are a number of factors that play, one of them is we do have a cyclo headwind moving into next year, right. So that’s about 80 basis points of impact on operating margin, or call it $0.13 of headwinds; from a foreign exchange standpoint, we have another roughly 30 basis points of headwind; and from a TSA standpoint, we have about 50 basis points of headwind. So, when you sum these up, we’re talking about headwinds of roughly 150 basis points or actually as we calculate it other way, maybe $0.35 of headwinds. Now, converting that to performance, we expect to see adjusting for that roughly 300 basis points of margin improvement, gross of those headwinds that takes us from on full year basis what was 13.6% to roughly 15% for 2017. So, there are couple of factors that match the quantum of the overall margin improvement. If you think about it from an overall EPS standpoint, like I said, we have about $0.35 of headwinds, we’re doing a lot of work on the SG&A line, and we’re going to see normal operational growth and portfolio optimization that contribute that allow us to offset that but it is a fairly substantial increase.
Mike Weinstein:
Okay. And Jay, just two follow-ups. So, if I look back at the Analyst meeting in June, your 2018 margin guidance was 14% and 15%. Your cash flow guidance was for $1.8 billion operating cash flow, $1 billion of free cash flow. You’re going to hit those targets and not exceed them in 2017. So, the question is, are the 2018 targets that you laid out last June now basically no longer effective or operational? And then, second question is, are you assuming any share buybacks in your guidance for 2017? Thanks.
Jay Saccaro:
Yes. So, as we think about the projections that we shared in May, I mean I will tell you on the operating margin side and certainly on the free cash flow side, we’re extremely pleased with the performance so much so that we’ve pulled forward 2018 basically one year to 2017 from a margin standpoint, from a free cash flow standpoint. So, we have to update those numbers. My full expectation is, we will be able to overachieve those numbers, clearly based on the 2017 performance. But from an overall process standpoint, we feel through a bottoms up long range financial planning process, our teams have initiated that work; it’s work that we’ll conduct over the next several months or review the output with our Board of Directors. And then, I certainly look forward to sharing it with our investors at the July earnings call, in part because I do believe that there will be upside to the numbers that we’ve shared. As it relates to share buyback, we are assuming share buyback to offset dilution. So, there is a few hundred million dollars of buyback embedded in our guidance. As we’ve said, our standard approach; we don’t commit the specific amount; a lot of it depends on the evaluation of the share price relative to the intrinsic value of our Company. In the fourth quarter, we saw a great opportunity because from an intrinsic value standpoint, the share is traded at a higher discount than normal, so we repurchased $250 million in shares. We’ll look to do that again to the extent to the opportunity presents itself in 2017. But, from a planning standpoint, we basically have share buyback offsetting dilution.
Operator:
Thank you. And our next question comes from Matt Taylor of Barclays. Your line is now open.
Matt Taylor:
Good morning. Thanks for taking the question. So, just a follow-up on the margin piece; you outlined a number of the headwinds. I’d love to understand the components of margin expansion. If you could just kind of walk us through portfolio management, new products, cost savings, things like that so that we can understand the bridge that allows you to make such a nice jump over some of these hurdles in 2017.
Jay Saccaro:
Yes, great question. I did focus on headwinds in the first answer. As I said, we have about $0.35 worth of headwinds or 150 basis points. But, the work that we’re doing in a number of areas has paid remarkable dividends in 2016, and we expect very big impact in 2017. The area that I’ll point out from an SG&A standpoint, we expect about 120 basis points, 130 basis points of net improvement or roughly $0.18 related to the cost savings initiatives that we’ve put in place. Now, we’ve talked a lot about this concept of zero base budgeting and how from an organization standpoint and from a spending standpoint we’ve been incredibly disciplined looking at every dollar consumed by our Company. That featured prominently in our results in 2016. But, it allows us to do in 2017 is improve our SG&A once again by a 120 basis points, 130 basis points and $0.18, and that’s net of inflationary increases that we normally see from a payroll standpoint. So that one factor is a very big impact and frankly it offsets the number of the headwinds that we’re facing. But then, the next piece relates to normal operational growth. If you think about the normal operational growth that we talk about, roughly 4 plus percent, that will contribute because we’ve walked away from sales that are at the zero margin really. That drops too at a higher level than the standard corporate average. And when we start to see growth in those core growth areas, which attach to them, have a higher margin than the corporate average, it has the great impact on the operating margin. So, with the operational growth of our business, it’s roughly 170 basis points of positive impact, we’ll see roughly north of $0.30 of benefit from the operational growth of Baxter. So, taking a step back, we have a number of headwinds that we’re fighting through but we have two very important tailwinds. One is this SG&A focus that we have as an entire organization and two is the drive to accelerate the growth of the business and the natural improvement that drives towards the bottom line.
Matt Taylor:
Great and then just one follow-up, I’d love to hear kind of your updated thoughts on the Claris acquisition and the injectables space in general. Can you talk about how that’s core to your strategy and does Claris gets you where you need to be in injectables or there are other assets that you could add there or other whitespace is kind of higher priority?
Joe Almeida:
Matt, the strategy we outlined is very clear. We are going to be into the injectables. It’s difficult to make a market. Claris is a step in the right direction. Between Claris and Baxter portfolio in the next three to five years, we’ll be launching 100 different new molecules for us. Into the market, we also have plans to sign several different collaborations and partnership agreements; coming up probably the next 30 days, we’re going to probably have one or two. And we are planning to have 100 more molecules on top of that. So, expect more to come. We also have segregated our organization within Baxter to make sure that we have the right people in place to create a competitive advantage that this market requires which is cost, quality and speed.
Operator:
Thank you. And our next question comes from Vijay Kumar of Evercore. Your line is now open.
Vijay Kumar:
Hey guys, congratulations on another impressive performance here. Maybe, I’ll start with one high level question on the revenue guidance. Jay, I mean, if you look at the 2% constant revenue growth, I think there has been some question about what is the true underlying growth for Baxter ex-pricing? Can you just comment on volume versus price dynamic for that 2%?
Jay Saccaro:
Yes. I mean, the 2% is principally volume-related; there is a small impact of price included in that. But, by and large, it’s a volume related number. We’ve historically talked about this notion of organic or long-term sustainable growth of 4% with our expectations that we look to accelerate beyond that over time. So, as we sit here today, the 4%, when you adjust for cyclo and the strategic exit, we’re kind of broadly consistent with that.
Vijay Kumar:
Great, and maybe one for Joe. Joe, when you think about the top [ph] in cash generation, it really is a remarkable rate. You guys, I think in the last year set out the target $500 million, almost double the free cash. One, why is that $1 billion free cash I think for 2017 a right number; were there any timing related impacts in the fourth quarter period which sort of affects the comp? And two, what’s the use of cash? If I do the math, 5 million shares repurchased for 250; that gets average share price of 47.50. Your stocks right now are at close to those levels. So, how should we think about M&A versus share repo? Thank you.
Jay Saccaro:
Sure. Let me talk about cash flow performance in 2016 and the guidance for 2017, and I’ll turn it over to Joe to talk about uses and M&A versus share buyback. But I will tell you, one of the areas -- there are a lot of things that went very well that we are very pleased with, in 2016, but one of the areas was -- really a bright shining star was free cash flow performance. We did significantly over achieve the guidance that we shared in Q3. And inherently, as we think about cash flow it is difficult to forecast cash flow for a couple of reasons. One is, a lot of cash flow is typically generated at the very end of the year. And then the second point is, because we have such large working capital balances today, because free cash flow has historically been such a small number, small improvements in working capital balance have a very-leveraged effect on free cash flow. And we clearly saw that play out. But, I’ll tell you, we were thrilled with the progress. From a working capital standpoint, we really pursued the transformation on three areas, days payable; days sales outstanding; and days inventory on hand. And in every single area, our Baxter team exceeded our expectations. So, from a days sales outstanding, we’re down two days year-over-year. We have several countries that have historic decade low DSOs. So, the team in Spain has done just an extraordinary job. Our DSO in Spain is a 100 days. I went to Europe in 2007; I haven’t seen the DSO at that level in the ages. And really the focus of the DSO effort was we did not want the Baxter team to stand in a way of a collection, right. We did not want to be a bottleneck. And I think our teams in Mexico, Italy, Spain across the board just did fabulous job in that regard. From a days payable standpoint, we improved one day year-over-year. And this is a program that I previously referenced that we have not really seen such dividends earlier on this year, because we had started it this year but again one day, we have more to do in 2017, great performance there. And then another one, and you’ll see this when we see the balance sheet. On the face of the balance sheet, inventory comes down more than $100 million as days inventory on hand declined 10 days; a remarkable performance by our supply chain team, really solid work there. So, all three dimensions of working capital, we had outstanding efforts. From a CapEx standpoint, CapEx came in a little bit lower. But, if you notice our guidance, we actually guided slightly higher CapEx next year versus this year. There were a couple of programs that had slightly, nothing material, but shifting spending from December to January or Q1 along with placements of some products. Again, no material impact to revenue growth or anything like that, but we did see some shift from 2016 to 2017, very modest. So, I would say that CapEx, the benefits that we saw came earlier in the year and this was a little bit more about timing. And then from a working capital standpoint, those were benefits that frankly I was banking on in 2017 that we were able to materialize earlier on. As we look at 2017, we’re seeing 10% cash flow growth. We’ll see continued improvements in days inventory, days sales, days payable. We will also have embedded in our numbers roughly a $150 million in restructuring payments, restructuring outflows that take place in 2017. So, there are some headwinds that we’re facing, but we feel very confident in the $1 billion and we look forward to working hard to achieve that number. For us, I think this has been a real area of focus, because as we thought about the valuation of our company internally, really free cash flow conversion from sales, free cash flow conversion from EBITDA, that’s a very important metric, and we’ve strived hard to improve that. So, it’s nice to see that that improvement in 2016. We did by the way with the overachievement of $650 million by $250 million, we really did self fund the share buyback in 2016. So with that, I’ll turn it over to Joe to talk about how we’re going to use the cash.
Joe Almeida:
I think the great use of cash is to provide opportunities for the Company to deliver on a top quartile total shareholder return. So, for us, it’s not a matter of one versus the other; it’s we can do them all. We can allocate cap with the dividends, our long-term objective is 35%; we’re going to continue to pursue that. We will buy shares back opportunistically because we’re not going to hold cash in our balance sheet. But more importantly is with this cash flow performance associated with a clean balance sheet and a very, very low net debt over EBITDA, we can now contemplate inorganic opportunities that we probably were a little shy in looking into in the past. So, as I said in the previous meeting this year, 15% to 20% of our market cap is reasonable to think about acquisitions and their level. We have several opportunities that we’re evaluating. And the transformation of our portfolio in a higher weighted average growth market rates business is our objective.
Operator:
Thank you. And our next question comes from Brooks West of Piper Jaffray. Your line is open.
Brooks West:
Good morning, guys. I’ve got two franchise level questions; first, on the IV business. Can you comment on where Baxter with the upgrade cycle for SIGMA SPECTRUM? And I know there has been some competitive disruption there. So, I am wondering if there is more share to be had in the actual pump market. And then secondly, it sounded like you have a little pricing leverage within that business; wondering if you could just talk about some of the pricing dynamics within the injectables. And then, I’ll go ahead and ask my second one, just on biosurgery, Joe. I think you’ve got a new leader there. You are guiding for that business to improve. I am just wondering is it execution, is there a product pipeline to call out, are you looking at deals there, if you could give us some details on how that business should start to turn around? Thanks.
Joe Almeida:
Sure. We do have several improvements to our pump portfolio coming about for the U.S. We just recently also signed a development partnership deal with a very reputable company outside the U.S. that will be augmenting our outside U.S, portfolio. If you remember, Baxter still holds a significant amount of channels outside the U.S. under the Colleague pump. And as we space Colleague pump out, we’re going to come up with a new platform soon to be able to substitute that. And then that partnership is going to grow into new areas of different applications of pump and things of this sort. So, we have two efforts that I feel very confident about. One is the internal launch and connectivity improvement and programmability of our pumps. As you know, we have best in class 2016 pump in the market; SIGMA SPECTRUM is really doing well. And then now, we’re going to go with the international effort with another platform. So, I feel quite confident in our way to approach this market. When it comes to price dynamics, we don’t comment on price dynamics. I can tell you that our price has been a modest contributor to our growth. We spoke -- Jay spoke earlier today about 1%. We have long-term contracts with our hospitals in the U.S. and these contracts are solid and are being executed. Our responsibility at the moment is to actually make sure that we have plenty of supply and we’re investing money in our operations in North Carolina to the tune of $100 million to make sure that we continue to provide quality products to the market and also creating a North American network with more capacity coming out to Canada and Mexico. When it comes to biosurgery, I have to say that our execution has not been the greatest, but with Wil Boren onboard, he quickly is going to be able to turn this business around. We’re looking at a nice licensing agreement right now. And we are renaming this unit within our Company to advanced surgery. So, he’s going to open opportunities for adjacency and acquisitions in the area. So, you don’t only have adjunct therapy, but now you’re going into specialty areas of surgery, which I find very refreshing. So, it’s all about execution with the new president in place. We segregated this business on a global basis, a truly vertical business across Baxter, removing from the traditional international organization and lastly is augmentation of licensee deals and doubling of research and development. So, we have lot of faith in Wil, and I’m sure he will be able to turn this business around.
Operator:
Thank you. And our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Lewis:
Good morning. Just a couple of financial questions for Jay and then one strategic one for Joe. So, Jay, just real quickly, a couple of things. IPS performance was a little lower in the fourth quarter and that sort of relative to our model, looks a little lower in 2017 as well. So, on an underlying basis, is there something in IPS that happened in the fourth quarter that kind of bleeds into 2017? And then operationally, for the guidance for the year, just the pacing of the quarters; first quarter starts out very strong and then obviously that’s slows a little bit across the next two quarters. Is there anything going on there other than just comparables? Obviously your second quarter and third quarter were the toughest comps of the year. And then a quick follow-up for Joe.
Jay Saccaro:
Okay. Let me hit the second one first. We do see some of the strongest growth in our Fluid Systems occurs in the first half of the year. As you recall, we signed a number of agreements and the last of which was really signed I believe in the second quarter of last year. So, we start to annualize those benefits in the second half, thus there is slight deceleration in sales growth from really the first quarter and maybe second quarter to the rest of the year. So that’s really the seasonality factor. As we think about IPS, I would point out that in the U.S. in the hospital business, we don’t really do a lot of discussion around selling days, but we did have a couple of days less from a selling days standpoint, which is call it 3% or 4% of impact. And in particular in businesses like IPS, it can have a material impact on the growth rate. So, I would point to that. I think there is not really other trends going on in that particular business. We continue to be very excited about it. IPS, as you know, includes nutrition, GPI or injectables business, which so far the injectables, we’re very optimistic about that space.
David Lewis:
Okay. And then, Joe, just if I go back to the analyst day and think about strategic priorities, you have this -- 40% of the Company’s dialysis and you have a product suite there that’s delivering and obviously good guidance for 2017. You spelled out the importance of generic injectables in getting that platform for Brook’s [ph] group and that happened. Now, with Wil being on board and kind of renaming that group, is the one area where the greatest opportunities sort of transform the growth rate of the Company? Is that really in this advanced surgery, biosurgery space? That seems to me sort of one hole, post the analyst day that could be filled with sort of strategic action? Thank you.
Joe Almeida:
David, that points to a great area of opportunity I think inorganically. And now with our balance sheet and our performance in cash flow, I feel more confident in how we go about these businesses because it gives us more flexibility. I think when you start going away from classifying your business as products or narrow areas, it opens strategic opportunities, the adjacencies. So, in the surgery business, I think that is the case. I would like to underscore that renal, despite the fact that we are market leaders in peritoneal dialysis and we’ve been gaining market share in the U.S. and other markets in acute renal care, which is our CRRT versus our competition because our technology is far superior. I would say that there is still opportunity in peritoneal dialysis for growth in emerging markets with technology that currently does not exist there. So, I feel that we’re always going to have that nice business, 5% to 6% growth in renal; this keeps churning and churning and delivering on cash. And Giuseppe Accogli has done a great job with his team, turning the in-center hemodialysis business around and with the adoption of AMIA with the stellar [ph] medicine platform, I feel really confident about that business. So, as we see the opportunities in adjacencies, I still think there our base renal business continues to churn and a great deal of cash and helping the Company finance expansion in that area and other areas.
Operator:
Thank you. And our next question comes from Larry Biegelsen of Wells Fargo. Your line is now open.
Larry Biegelsen:
So, Joe, emerging markets are about 25% of Baxter sales. Can you talk about what you’re seeing for Baxter in emerging markets; what was growth in Q4; what’s your expectation for 2017? And, I have one follow-up.
Joe Almeida:
Our emerging markets totaled 3% growth in the fourth quarter, but I’d like to qualify that that all of our exits are happening in that market. We’re exiting some of the business in India, Turkey and Venezuela and they’re depressed. I’d like to point out that in Greater China, we’re up now to 6% with plans to get to high single-digit growth. We see our peritoneal dialysis business recovering in China, which is very important to us. We also see a recovery in Latin America. And some of the underlying growth here will be primarily in biosurgery and peritoneal dialysis, areas we are going to focus. As you know, we exited and we’re going to be exiting a lot of the IP business in some of the markets that we’re not making any money, but the other way, we’re losing money. So, I feel that we have now investment plan for China which will bring that business close to a $1 billion in few years. And we are very, very bullish about Latin America and our expanded investment there. So, I will say that for the shorter or for the mid-term to long-term growth rates, we’re looking at low -- high single digits for that region; so, once we get over this comp, 12 months of us exiting the business in India, Turkey and Venezuela.
Larry Biegelsen:
Thank you. That’s very helpful. And then just back to Claris, I know there was a question asked on that earlier. But, can you tell us what the sales were for 2016 and the growth? And I’m asking because the IMS data implies for at least the U.S. that growth was north of 50% through the first three quarters of 2016. And just I wanted to confirm that if it closes later this year to about $0.01 to $0.02 benefit in 2017. Thanks for taking the questions.
Joe Almeida:
So, we are planning to close Claris as fast as we can, but more -- the realistic approach is probably the second half, July, August. We’ll more clarity. We’re talking about couple of cents a share for this year, and the Company has north of $100 million in sales. So, you can do some of the math. I would think that we will come out with very transparent guidance on how is that going to impact 2018. So, you can put in your long range plan what that will do for us. And we’ll keep you guys posted on the acceleration programs that we’re putting in place for additional molecules for this market.
Operator:
Thank you. And our next question comes from Bob Hopkins of Bank of America. Your line is now open.
Bob Hopkins:
Just a quick question first for you, Jay, on the guidance. I know we talked about this a little bit already in terms of how Q1 starts and then the rest of the year. But, what I’m curious about, if you could just talk about what drives the improving underlying growth in Q1 versus Q4. Because I think in Q4 you said you’re going to 3% and then you’re expecting 5% to 6% underlying in Q1. Is that just comps or what drives such an acceleration from Q4 to Q1?
Jay Saccaro:
Yes. It’s interesting. There is definitely a comp in play. As we look back to last year, we had a strong Q4, and then Q1 was not quite as relatively strong as Q4. But then, and I don’t want to get into this whole billing day thing, but it is a factor that comes into play, in particular in the hospital business globally. We lost a couple of billing days, which was several points of growth; and I believe in Q1, we actually gained 1 billing day. So that swing factor actually modulates the growth rate to some extent. Those are really factors that are in play.
Bob Hopkins:
Okay. So, it’s less fundamental issues, more sort of calendar issues, it sounds like and just in terms of Q4 to Q1.
Jay Saccaro:
Exactly.
Bob Hopkins:
And then, Joe for you, again for everybody, congrats on a great 2016. You’ve talked a lot about M&A already on this call. But, I was wondering if you could just, in broad terms, set expectations for us for M&A in 2017. How likely are deals, how confident are you that there are attractive of assets out there that could be priced at levels that you find interesting in 2017?
Joe Almeida:
Bob, it is quite a task to answer your question because it’s opportunistic and our efforts are relentless. So, eventually we’re going to get to the right target; we’re working very hard. As you know, we’ve rebuilt our M&A team completely from the scratch. We have very good people on board. But we are financially disciplined. So, our ability to strategically identify targets is there, but things have to work. And some assets are expensive, and we want to make sure that we can extract value because our first priority is to really return the top quartile total shareholder returns. So, we’ll do that. We have plenty of targets, a good team in place, good direction where to go. We need to find the opportunity where this target becomes available or is interested, and the price is something that will be attractive for the Company. We are always speaking about three to five years Company average ROIC return; we’re talking about internal rate of return greater, by far exceeding cost of capital all debt and equity included. So, we will continue down this path. But we are excited about the position that we have in our balance sheet. But that does not create a bias for us to act without thinking about the financial returns.
Operator:
Thank you. And our next question comes from Matt Miksic UBS. Your line is now open.
Matt Miksic:
So, I just wanted to -- I know there have been a couple of questions on Claris and on some of the other efforts that you’re making across the portfolio to improve performance. And we thought the Claris deal was right on target with the injectables strategy that you laid out last year. One of the things, it’s come up a couple of times in the call is that we think you’re doing particularly well, and love to hear some thoughts on 2017, is the impact on product line rationalization particularly by geography. You’ve mentioned some of the changes here in the back half. I was wondering, Jay, if you could talk a little bit about the size or the scale of that contribution to your operating -- your underlying 300 basis-point operating improvement you’re talking about before headwinds. And I have one follow-up.
Jay Saccaro:
Yes. I mean, it’s interesting because for us over the last year and a half, and we’ve really intensified the focus over the last six months, we’ve been focused on rationalizing the portfolio and challenging every single sale. And I think we’ve done a nice job looking at the fully loaded and variable profitability of every product line in every country in which we operate. And as part of that, we identify a set of sales which didn’t quite make sense for us on a going forward basis. And so, we walked away; the impact next year is around $100 million in sales. That was really a zero margin contribution. And so, the simple fact of walking away from those sales is roughly 10 to 20 points of margin improvement due to those strategic exits. Now, it’s important to note, as we sit here today, I think we have cleansed the portfolio to the extent it needs to be cleansed at this stage. Of course things change. So, it could be a foreign currency evolution; it could be pricing pressure in a particular emerging market which would cost us to relook at this. But again, as we sit here today, I think we feel very confident that all the sales that we have contribute positively to the economics of Baxter. But now, it’s about from a portfolio management standpoint, not so much walking away but shifting our R&D investments and our SG&A investments towards those areas that we think are promotionally sensitive where Baxter has a proprietary right to win where we have higher margins and that will be the next leg of the journey as we think about margin improvement related to portfolio management.
Matt Miksic:
That’s great. And a follow-up, again, this is a theme that’s come up in a couple of other questions on pricing. But, just given the sensitivity and the focus on this particularly drug pricing which is away from your core lines of business. It would be helpful to understand -- I think we understand that the majority, vast majority of growth is driven by volumes. But, we often think in terms of things like price net of mix or price and mix as the other variables plus or minus around that growth rate. Are you living in a sort of negative price world with some positive mix or the other way around or how should we think about it?
Jay Saccaro:
Yes. I think, what I would say is as we look at 2017, to be clear we have roughly 30 basis points of pricing in our numbers. So, it’s not a substantial number from an overall pricing standpoint. And really that’s not new price increases that we’re anticipating, so much as it is previously agreed to agreements that we have in place with our major customers with normal price increases attached to them. So, really that’s the environment that we’re operating in. As we’ve said, when we look at our long range plan, we see a fairly mutual price environment; there is some benefits and some areas where we’re seeing pressure. We’ve commented historically about price pressure in the area of dialyzers, but we’ve also commented about things like the launch of AMIA, and what that does as a new therapy and ability to charge a higher price because of the great value that we’re providing with that product. So, it’s a difficult question to answer, but what I can say is we’re not really counting on much price. We think the environment is fairly neutral and it’s a little bit different in some of the other dynamics that are in play with other areas in healthcare.
Operator:
Thank you. And our next question comes from Glenn Novarro of RBC Capital Markets. Your line is now open.
Glenn Novarro:
First, Jay, did you give us targets for gross margin and R&D ratio for 2017?
Jay Saccaro:
We did not share those targets. I think from a gross standpoint, we’re looking at roughly 50 basis points of expansion next year; mind you some of the foreign exchange impact and some of the cyclo impact in particular impact that line which is why we’re not seeing more expansion. And from an R&D standpoint, we’re looking at mid single-digit increase. And it’s interesting because our R&D team has done a very nice job looking at infrastructure cost and controlling cost, and diverting spending to new product development. And so, while we’re only increasing mid single-digit, the actual amount spent on project is going up fairly substantially. So, we’re very pleased with that. And then from an SG&A standpoint, we expect again, there will be a decline in SG&A down low to mid single-digits and that’s in large part driven by the zero base budgeting techniques that we’re applying across the portfolio.
Glenn Novarro:
Okay. And then let me just follow up on that SG&A comment just because one of the questions I often get from investors is, how sustainable or how much runway is left in terms of bringing down SG&A. In other words, has all the low-hanging fruit been removed? So, maybe some thoughts, either for you Joe or Jay in terms of the sustainability of the SG&A decline over time. Thanks.
Joe Almeida:
Glenn, we are in the middle of doing it. We still have few programs that are in process of being contemplated. And what I’m finding here at Baxter that I did not find before in my previous experience is that the business transformation office has changed the way we look at things and how we spend money and the effectiveness of our spending patterns. So, we are now a Company that is for the vast majority a six-layer Company with very few exceptions. We are a Company that understands category management. But every meeting that we go, we go to a two-hour business transformation meeting every month, we just identify significant amount of savings in the future of programs are not contemplated. So, this is a journey; this is not a project.\ So, do we have more? Yes. Is it more elasticity? Yes. Do we want to see the SG&A lower? Yes. What is the right SG&A for this Company? Well, we’re going to talk more about what we think the margins are going to be in 2020, later this year. So, then, you can estimate what the SG&A is going to be as a target. But, we’re not satisfied; we’re happy with the progress and the people at Baxter have done a great job embracing this very difficult way of managing business in terms of expense.
Operator:
Thank you. And our next question comes from Joanne Wuensch from BMO Capital Markets. Your line is now open.
Joanne Wuensch:
Thank you very much for taking the question, very nice quarter. Joe, you’ve been there for about a year now. What would you say were your key highlights and takeaways? And a year from now when we’re all together, what do you really want to make sure that have seen happen this year?
Joe Almeida:
Joanne, I was surprised by a culture that was ready to be changed. People here were looking for a change. And so, some of the things that we were doing in terms of portfolio management, reallocation of R&D resources, completely revamping of our marketing organizations, how we are organized, our BDNL, [ph] our M&A groups. This has been a significant change in how people used to do business. And folks here have adopted and really didn’t use to be in getting on with the program. So, I will highlight that of everything we’re doing, we couldn’t have done it without the great employees of Baxter. On looking forward, if I am sitting a year from today, what I’d like to see, I’d like to see this biosurgery business start to transform itself and look some opportunities outside. I’d like to see us with probably another 100 to 200 molecules in our pipeline above what we have today. I’d like to see us with a well-defined pump technology, which is not only U.S. but is a global one that has the ability to meet industry levels of pump platforms that we need to have. So, I have significant expectations. And lastly is to make sure that we don’t lose the sense of urgency and speed by which we transform the Company.
Joanne Wuensch:
As my follow-up, there has been a lot of questions already on M&A, we throw around a lot of different names amongst yourselves. But what is your current thinking about adding another leg to the stool or is it really just adding in things to your current structure? Thank you.
Joe Almeida:
We will continue to look at adjacencies. You’ve got to be able to walk before we go into the triathlon here. So, a white space and a brand new leg to the stool becomes a high order for a company that has not done many M&As and in the areas that they did were always on adjacencies. So, we’re going to look into adjacencies we have not looked in the past. However, to have a complete new leg of the stool, I think is a little premature for us to speak about.
Operator:
Thank you. And our next question comes from Larry Keusch of Raymond James. Your line is now open.
Larry Keusch:
So, Joe, for the year on a constant currency basis, it looks like you did 6% growth in the U.S. and about 3% overseas. So, I wanted to just pick your brain a little bit on how you think about accelerating the overseas growth, because I think it’s probably bit below what you’re anticipating in your LRP, and just want to see if you could expand upon that a little bit?
Joe Almeida:
Larry, couple of things; the overseas will be impacted by two or three factors. Let me start by saying that once we anniversary the exits of $137 million in sales that we are exiting in Turkey, India and Venezuela for the most part, you gain a good -- 1.4%, 1.5% or 150 basis points of incremental growth right on that. Second thing is, we must improve performance in Europe. We’re making some changes in Europe to make sure that we get the right people in place, so we can get performance. It has been a while, and despite the fact Europe is a slow growth market and it’s a difficult market for the most part, the developed part of the Europe, not the emerging part of the Europe, which would be the Eastern Europe, Middle East and Africa which in 2017 we expect a good growth from it. And I want to make sure that we have the right structure in Europe. We’re making changes to that effect and also getting the biosurgery out of the Baxter’s structure on a fully vertical organization and couple of licensing deals, and I think we can accelerate that. So, our objective for outside the U.S. is make sure that we return to 4.5% to 5% growth rate in the midterm.
Larry Keusch:
Okay, perfect. And then, the other question is just thinking about your pump business specifically. How are you thinking in sort of 2017 outlook relative to the potential for a pause in spending at the hospital level, given some of the uncertainties around ACA?
Joe Almeida:
Listen, it’s very uncertain right now with this whole review and replace, what would be actually the replacement policy and what is going to be in place to bring coverage to people that maybe out of coverage. So, I think hospitals always take a pause at big capital items and investment in expansion. I would say that the capital plans that we have -- the capital products that we have, rather, are small capital investments that the hospital needs to make. Those are pumps, they need the pumps; these are not big diagnostic machines. So, I would say that if there is effect and it’s a cascading effect, we’re probably at the tail end of it and we’re still little of that if any into 2017. I would say that we have performed tremendously well with our SIGMA SPECTRUM pump in the U.S. in the last two years. Clearly we’re going to see this playing [ph] out into 2017 because the number of accounts that we took from competitors. But that is independent of the fact that the capital policy for hospitals based on the environment -- the political environment and the mandates that’s coming down. So, let’s separate them. I think Baxter will have a good performance in 2017, maintaining its base and selectively expanding its base in hospitals with more beds in the U.S. because we took a significant market share in the last two years. So now, it’s to maintain, slight grow and make sure utilization on those pumps are done correctly.
Operator:
Thank you. And our next question comes from the line of Danielle Antalffy of Leerink Partners. Your line is now open.
Danielle Antalffy:
Thanks so much for taking the question and congrats on a great quarter. Jay, I was hoping you could give some color on some of the various topline headwinds as we head into 2017, all the headwinds and tailwinds as well. Just thinking about your underlying growth projection or guidance for 4% is below the 5% you delivered in 2016; just looking to get some color on the puts and takes there. Thanks so much.
Jay Saccaro:
Yes. I mean, 2016, we did benefit from a Fluid Systems performance that I would say is above the long-term steady state, in part because we had the benefit of the first quarters, really the first early stages of the CIGMA SPECTRUM re-launch and in part because of all the work we did in terms of volumes and contracting in our Fluid Systems business. So really the biggest driver of the deceleration excluding the onetime impact relates to the slowdown, expected slowdown I should say in our Fluids Systems business. As we move to 2017, I think there are just a few important points, right. We’ve got a cyclo impact that’s about a $100 million; we’ve got a strategic exits impact that’s about a $100 million; and then the rest of the portfolio is kind of largely in line with our long-term expectations. So, no radical departures but the stabilization of the Fluid Systems level, which was -- Fluid Systems business, which will continue to grow and a little bit faster in the first half of the year, that’s the biggest driver of the change of growth rate.
Danielle Antalffy:
Perfect, that makes total sense. Thanks for that. And then, any major tenders, I guess specifically in the renal business that we should of be cognizant of over the next 12 months that are coming up?
Jay Saccaro:
We have nothing major at this stage from a significant tender standpoint to point out. We do have a lot of our business that goes through tenders outside the U.S., some of them are large tenders; some of them are small tenders. But as we sit here, nothing major to point out to you that would be an area of concern for us.
Joe Almeida:
I just want to augment Jay’s questions quickly is, we’re seeing 5% to 6% increase in patients in PD which is a great indicator for us into 2017.
Operator:
Thank you. And I’m showing no further questions at this time. Ladies and gentlemen, this concludes today’s conference call with Baxter International. Thank you for participating. Everyone, have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Third Quarter 2016 Earnings Conference Call. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candice. Good morning, and welcome to our third quarter 2016 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer, and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's third quarter financial results and updated outlook for 2016 before taking your questions. I would just like to remind you that during the Q&A session, please ask just one question and one follow-up, so that we could accommodate others in the queue. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters, contains forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now, I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Good morning, everyone, and thanks for joining the call today. I will begin this morning by sharing some comments on our performance and progress. Then, I will turn it over to Jay who will take a closer look at the financials and provide an update on our outlook for the remainder of the year. After that, we'll open up for Q&A. We're pleased with our performance in the third quarter. We continue to see momentum building across the organization as we implement the strategies outlined at our Investor Conference to enhance financial performance through reshaping our portfolio, transforming our cost structure, and effectively deploying capital. As you saw in our press release, Baxter delivered third quarter sales growth of 4% on a constant currency basis and 3% on a reported basis. These results were driven by continued strong performance of Fluid Systems in U.S. and Peritoneal Dialysis in acute renal therapies globally. Adjusting Baxter's results for the impact of cyclophosphamide in last year's $20 million order of PROTOPAM, sales in the quarter increased 6% globally. On the bottom line, Baxter delivered adjusted earnings of $0.56 per diluted share. This reflects the benefit of solid sales growth along with our ongoing focus on expense management and operational excellence. Now I'll take you through the performance of our businesses and franchises where I will address sales growth on a constant currency basis to provide a clearer picture of underlying operational performance. Global sales for Hospital Products totaled $1.6 billion, increasing 3%. Excluding cyclophosphamide and PROTOPAM, Hospital Products sales advanced 7% globally, reflecting 13% growth in the U.S. and 1% growth internationally. Now, to break our Hospital Products at a franchise level, sales in Fluid Systems totaled $576 million, up 11%. These results reflect continued strength in the U.S. driven by favorable demand and pricing for IV solutions along with the strong growth in extra sets resulting from the ongoing successful launch of SIGMA SPECTRUM. Note that this quarter, we anniversary the launch of SIGMA SPECTRUM which is continuing to drive solid performance and increased market share. Next, Integrated Pharmacy Solutions or IPS. Sales were $563 million, decreasing 4%. Excluding cyclophosphamide and PROTOPAM, sales increased 6%. Growth in the quarter was driven by U.S. nutrition which benefited from a strong sales of vitamins and amino acids as well as our recently launched premixed generic injectable, cefazolin and VANCOMYCIN saline. In addition, this quarter, we launched NUMETA G13E in Europe. These expand our NUMETA pediatric line with the only ready-to-use triple-chamber IV nutrition product for pre-term infants. NUMETA utilizes Baxter's proprietary olive oil based lipid which has been shown to be immunoneutral thereby reducing the risk of inflammation for the patient. Baxter is the only manufacturer to utilize olive oil based lipids as part of our multi-chamber nutritional product offering. Moving to Surgical Care which includes our anesthesia and biosurgery products, third quarter sales totaled $320 million, global growth in the quarter was flat to the prior year with mid-single-digit growth in biosurgery, offset by lower sales of anesthesia products. Anesthesia was impacted by the timing of certain government austerity measures in Europe and the timing of certain shipments internationally. Our industry-leading inhaled anesthetics portfolio continues to represent a solid platform for future growth and global expansion. Finally, in Hospital Products, BioPharma Solutions, our contract manufacturing business, generated sales of $122 million, an increase of 15%. This growth reflects the benefit of an easier comp for the prior year, along with increased customer demand for products produced in our cytotoxic manufacturing facility in Germany. Turning next to our Renal business. Renal sales were $977 million globally, up 6%. This reflects ongoing momentum in peritoneal dialysis or PD, which delivered double-digit growth in the U.S. and high-single-digit growth internationally. PD growth is being driven by an expanding patient base, favorable price in the U.S., and the ongoing launches of our new APD cycler, AMIA in the U.S., and HOMECHOICE CLARIA outside the U.S. These systems feature our innovative SHARESOURCE technology which was also recently approved in Japan. SHARESOURCE will be a defining feature for our new (07:38) APD cycler in Japan, which we expect to gain local market approval shortly. Additionally, Q3 results reflect the positive impact of our acute renal business which delivered double-digit growth globally. This reflects growing global demand for continuous renal replacement therapy or CRRT, which we're well positioned to address with our market-leading PRISMAFLEX platform. Acute care is a fast-growing market where we have a substantial opportunity to serve patients and clinicians with high-value products, so this will remain a growing area of emphasis as we look ahead. Growth in Renal was somewhat offset by performance in in-center hemodialysis. We're taking a deliberate approach to improving profitability in our HD business. As you may have seen in our press release yesterday, we launched our novel and proprietary HDx therapy, enabled by our differentiated THERANOVA dialyzer. HDx therapy with THERANOVA has the potential to improve outcomes and raise the standard of treatment for end-stage renal disease patients. It has just launched in France, Australia, New Zealand, and will launch in several other Western European markets before the end of the year. That's a brief snapshot of our Q3 results. I would like to close my comments by putting our quarterly performance in a broader strategic context. At our Investor Conference in May, we identified three critical drivers that would elevate our performance to top quartile levels
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our third quarter results demonstrating continued progress towards achieving our long-term financial goals. Operationally, sales increased 4% in the quarter, and on a reported basis, sales grew 3%. Growth came in at the high end of our expectations, driven primarily by favorability in PD and nutrition therapies. Walking through the rest of the P&L, adjusted gross margin of 44.9% represents an improvement of more than 100 basis points over the prior year, driven by a positive sales mix, improved pricing in select areas of the portfolio, and favorable manufacturing performance in the quarter. Adjusted SG&A totaled $611 million and decreased 9% on a reported basis. The primary driver of the improvement was our ongoing focus on controlling expenses and the benefit from lower pension expense. TSA income totaled approximately $25 million in the quarter compared to approximately $30 million in the third quarter of 2015. TSA income from Shire will continue to decline as a need for these services ramps down, which is expected to be by mid-2017. During the third quarter, we did report a charge of approximately $130 million for restructuring activities, of which approximately $100 million was related to employee termination costs which are expected to generate over $100 million of annual savings once fully implemented. As Joe mentioned, these actions were initiated earlier this month and were contemplated in the long-term financial guidance we provided in May. We will continue to optimize our cost structure as we move forward. Adjusted R&D spending in the quarter of $129 million decreased 8% versus the prior year. While we did benefit in the quarter from the discontinuation of selected programs, we expect to begin redeploying net spend in areas like biosurgery and premixed injectables beginning in the fourth quarter. Adjusted operating margin in the quarter was 16% and compared favorably to our expectations, driven by positive product mix, lower R&D spend, and the benefit of our initiatives to control spending and reduce expenses. This represents a 480-basis-point improvement over the third quarter of 2015. Interest expense was $14 million in the quarter. During the quarter, we took advantage of favorable market condition and executed a $1.6 billion, three-tranche debt offering consisting of 5, 10 and 30-year notes. Proceeds from this offering were used to retire a series of existing bonds maturing in the near to intermediate term as well as pay off all of our outstanding commercial paper. As a result of this transaction, Baxter's bond maturity profile increased from an average of 9 years to 15 years, and our average coupon rate declined by nearly 1%. Adjusted other income totaled $4 million in the quarter, primarily resulting from a foreign exchange gain on a balance sheet position. The adjusted tax rate was 22% for the quarter, slightly higher than expectations, driven by earnings mix. And as previously mentioned, adjusted earnings of $0.56 per diluted share exceeded our guidance of $0.43 to $0.45 per share. Relative to the midpoint of our range, this favorability was driven by approximately $0.11 of operational strength and a $0.02 benefit from interest and other income. This was partially offset by approximately $0.01 due to a higher share count and tax rate. Along with our equity-for-equity exchange, which we executed in the latter part of the second quarter, during the third quarter, we opportunistically repurchased $40 million or approximately 1 million shares during the quarter. These repurchases were more than offset by higher-than-expected option-related dilution, given Baxter's stock performance during the quarter. Let me conclude my comments this morning by providing an update on our outlook for 2016. Starting with sales, on a constant currency basis, we now expect 2016 full-year sales for Baxter to increase approximately 4%. And after adjusting for the U.S. cyclophosphamide impact, we expect underlying operational growth of approximately 5%. On a reported basis including the impact of foreign exchange, we expect sales to increase approximately 2%. We expect growth in the Hospital Products business of 3% to 4%, or approximately 5% excluding U.S. cyclophosphamide. Within the Hospital Products franchises, we expect sales growth of low double digits for Fluid Systems, driven by continued strength in the U.S. business. For the Integrated Pharmacy Solutions franchise, we expect sales to decline versus the prior year including the impact of U.S. cyclophosphamide. We have adjusted our full-year sales forecast for cyclo and now expect full-year sales of $210 million with the assumption that no additional competitors enter the market during the fourth quarter of 2016. After adjusting for cyclophosphamide, sales are expected to increase 2% to 3% in IPS or 4% to 5% excluding the impact of both cyclo and PROTOPAM. Within the Surgical Care franchise, we anticipate sales to grow approximately 1%. And finally, for the Hospital Products business, we now expect BPS and other to increase low single digits. For the Renal business, we now expect full-year sales to increase 4% to 5%, driven by continued growth in our PD and acute businesses, offset by lower sales in our in-center HD business. Moving down the P&L, we now expect an operating margin of approximately 13%. A 100-basis point improvement versus our previous guidance and a 200-basis-point improvement relative to our original guidance. This increase is driven by improved sales and ongoing disciplined management of expenses. We expect interest expense to total approximately $70 million. For 2016, we expect other income of approximately $55 million, which does reflect a benefit of approximately $10 million in the fourth quarter related to the disposition of an equity investment. For the year, we now expect an average adjusted tax rate of approximately 21%, driven by the expected mix of earnings. For full-year 2016, we anticipate an average share count of 550 million shares. Based on these factors, we now expect 2016 adjusted earnings, excluding special items, of $1.88 to $1.91 per diluted share as compared to our previous guidance of $1.69 to $1.74 per diluted share. Finally, for the year, we expect operating cash flow of approximately $1.45 billion and CapEx of approximately $800 million, resulting in approximately $650 million in free cash flow. This represents an increase of 30% from our original guidance of $500 million. We're applying the same discipline to managing capital expenditures as we are to our expense base, which has resulted in a benefit of approximately $100 million in lower CapEx for the year. In addition, we have initiated programs focused on improving our days payable and days receivable ratios which will benefit operating cash flow going forward. Specific to the fourth quarter of 2016, we expect sales growth to increase approximately 2% on both a reported and constant currency basis. The growth does represent the deceleration from previous quarters, given our previously announced decision to exit select markets outside the U.S. The collective impact of these exits impacts the top line by approximately 1 percentage point. In addition, lower cyclo sales compared to the prior year also negatively impact the top line by approximately 1 percentage point in the quarter. Adjusting for these two factors, growth in the quarter would be approximately 4%, which is in line with our long-term projections. And we expect adjusted earnings excluding special items of $0.49 to $0.52 per diluted share. This guidance reflects increased investment in R&D and incremental investments in SG&A. With that, we can now open up the call for Q&A.
Operator:
Thank you. So that we may be respectful of everyone's time, please limit your comments to one question with one follow-up question, if necessary. We appreciate everyone's patience and would like to provide as many of you as possible the opportunity to ask a question. We'll pause for a moment while the list is being compiled. I would like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. And our first question comes from David Lewis of Morgan Stanley. Your line is now open.
David Ryan Lewis:
Good morning. Just two quick questions. One on margins and one on CapEx. So, maybe just starting with margins for a second. Just, if I think about the fourth quarter, Jay, I think your guidance of $0.49 to $0.52 kind of implies something around 14% margins. So, two things, what would drive that depression sort of sequentially? And obviously, if you do 16% here in the third quarter versus your sort of 14% to 15% outlook for 2018, how are you feeling about those long-term margin targets, so fourth quarter and obviously the 2018 outlook? And then, I've quick follow-up.
James K. Saccaro:
Great. Good morning, David. So, as far as the fourth quarter goes, overall, we were obviously very pleased with the margin performance in the third quarter. So, 16% represents the highest quarterly margin target that we've achieved since the spin-off. As we move to Q4, we do expect a slight downtick in the operating margin of the business, and really there is a couple of drivers to that. One is we are going to be accelerating some R&D investments in both biosurgery and premixed injectables, as I mentioned. So, that will be one factor that increases the R&D spending relative to our current level. And then, the second item relates to SG&A. We do expect a slight uptick as well in SG&A in the fourth quarter as a percent of sales. There's a couple of factors going on there. One is we do have historic seasonality. So, if you look at Baxter over the last many years, we normally have an uptick in spending in the fourth quarter, we do expect that to repeat. And then, the second factor that's going on with respect to SG&A is one of the topics we discussed in our May Investor Conference relates to what we call local initiatives. The idea that given the diverse geographic portfolio that we have in place and the product portfolio, we really have a tremendous opportunity to accelerate growth by unlocking some of the entrepreneurial spirit outside the U.S. but frankly, that comes with it an SG&A cost. And so, over the course of the last quarter, we have approved a number of investment initiatives which we believe will benefit 2017 and 2018, but do have a slight cost associated with them. So, for these reasons, we do expect a slight downtick as it relates to the overall margin, but again, feel very confident in the operational performance. As we look to 2017, I think it's too early to get into forecast for 2017. What I can tell you is, in our May Investor Conference, we shared a series of projections for 2018 and 2020. And it is clear, the data points that we have point to accelerated performance relative to those expectations, so we have a higher level of confidence in our ability to achieve those numbers and exceed those numbers today than we did when we shared them in May of 2016.
David Ryan Lewis:
Okay, Jay, very, very helpful. And just one quick follow-up. I think, for me, you hinted this last quarter about the cash flow numbers here, specifically CapEx guidance was fairly kind of remarkable. So, can you help us understand what's driving an $800 million number? I think you gave us $750 million number as the long-term target. So, that's sort of materially, sort of ahead of plan. How much of that is timing? Or does $800 million represent sort of the new normal as we cycle into 2017? Thanks.
James K. Saccaro:
Sure. One of the numbers I think the team is most proud of is the free cash flow performance. As I mentioned in the script, we're increasing it from $500 million to $650 million. And really, there's a couple of different components to that. One is operating cash flow, we're raising approximately $50 million, and this is an area where I believe there will be more substantial benefits from some of the programs that we've initiated this year in future years. So, we're spending a lot of time as a team on working capital, days payable, days sales outstanding, and inventory. How can we drive that down? And those are balances that you don't switch on overnight, but over time with rigor and focus, you can drive a real result in these categories. So, we don't really have much benefit this year but 2017, 2018, 2019, you'll expect to see some meaningful working capital improvements. Where we were able to drive an impact this year, and frankly I believe this will be sustainable, is in CapEx. We did a couple things this year which I think provided a very real benefit. First, we did a zero-based budget for CapEx, which we review quarterly with our senior leadership teams. So, our top executives at the company sit down on a quarterly basis and the result of that is twofold. One, we did cancel a number of low value-adding programs; but second, for every single program that we had, the challenge to the team was how can we do this more cost effectively. And the results were very, very impressive. So, the second piece relates to an incentive change that we put into place at the beginning of the year. For our top employees, we have a short-term incentive plan for the top several thousand employees. And last year, there was no cash flow component to this. This year, recognizing the challenge that we face with CapEx being 9% of sales, we installed a free cash flow trigger for our short-term incentive plan. By focusing on free cash flow now, we have our entire organization geared and charging towards driving improvements in this important metric. So, while that's harder to quantify, I believe that that's paid a real dividend in our numbers and creativity as we think about addressing CapEx spending. But frankly, this is one area where I believe we've achieved a new normal and will continue to drive performance from here.
José E. Almeida:
I'd just like to add one component to Jay's great answer, is that this is a sustainable level of capital. So, this is not one-year conversation. We have changed how we look at capital, how we invest in different places in the world, and also our new technologies, our point-of-care which is solution making on demand, and also how we service emerging markets with on-demand manufacturing of solutions for 100 to 120 patients will change how structurally we seek capital.
David Ryan Lewis:
Great. Thanks, guys.
José E. Almeida:
Thank you.
Operator:
Thank you. And our next question comes from Matt Taylor of Barclays. Your line is now open.
Matthew Taylor:
Hi. Thanks for taking the question. I wanted to just touch again on the margins and talk a little bit about some of the components that are contributing to the good leverage that you saw in SG&A and gross margin. Could you just articulate what you've sort of done and seen in the plan so far, and then the initiatives that are yet to be really tapped that we could see leverage from in 2018 and beyond?
James K. Saccaro:
Sure. Yeah. Clearly, this was a fabulous quarter for our operating margin, and I would say it was – contributing to it were gross margin, SG&A leverage and some R&D leverage. From a gross margin standpoint, let's start with that. There were a number of factors in play. We've talked a lot about this concept of portfolio management and business mix and upgrading the business mix. And as we look at the Q3 results from Baxter, you start to see that story playing out. So, for example, we saw very strong performance in our U.S. Hospital business in the sets area and access. Our sets in the United States grew approximately 20%. That simple business mix factor contributed to our margin, and as we increased the installed base in the United States of SIGMA SPECTRUM, we'll continue to benefit from this mix factor as it moves forward. From an international standpoint, you'll see that we had lower Fluid System sales. But in areas like Renal, in particular, where we had double-digit acute growth and PD growth where we've been very focused on accelerating growth, those are two good margin areas that provided uplift from a business mix standpoint. And finally, from a business mix standpoint, you heard Joe comment earlier in this call about how we're going to manage in-center HD for profitability, very focused on driving this. So, while that business had lower sales, it had a business mix and from our standpoint, focus on profitability. Those are three examples from a gross margin standpoint where business mix played an impact. The second comment related to gross margin is manufacturing and performance. Overall, we had solid manufacturing performance. We had good volumes in Q2 and Q3. The result of that is a P&L benefit from a manufacturing standpoint. We'll expect to continue driving manufacturing performance going forward, this is a real area of focus for us. How can we effectively utilize our facilities? In Joe's prepared remarks, you heard him referenced, we've closed or sold a number of facilities over the course of this year, that leads to better leveraging of the network. The final piece related to gross margin is this idea of how can we think creatively about our business arrangements, either through pricing or being thoughtful about the services that we provide. A simple example of this is we're really focused in our U.S. Renal business on limiting the amount of overnight shipping that occurs. For us, that has historically been a real cost that we've borne, and it's impacted our margin. By focusing on that, we're able to drive a better margin. So, those are the three drivers that have impacted our gross margin. Moving to R&D, we made a couple of tough decisions over the course of this year with respect to project, a project like VIVIA. And so, as a result of that, we saw a lower R&D spending in the quarter. Now to my earlier comment, I do expect an uptick in this as we start to reinvest in some exciting new areas for us that have nearer-term paybacks than the VIVIA project. But in the quarter, this idea of rigorous capital allocation did play out in the R&D spend. And then finally, from the SG&A standpoint, I would make a couple of comments here. First, this idea of zero-based spending, challenging every single dollar that we have in place, that's something that the company has adopted from a process standpoint. So, as we went through our budgeting process this year, we had a very rigorous zero-based spending approach, a zero-based organization approach in place applying these techniques to our cost structure. But I think beyond that, culturally, the entire organization is incredibly aware of spending and driving results. The number of ideas that we're generating from our organization at large, with respect to the simplification, with respect to savings ideas, is remarkable. And that simple phenomena has played out in our SG&A numbers for the quarter.
Matthew Taylor:
Thanks. Maybe just one follow-up. You've had a lot of momentum in the pumps. Can you talk a little bit about how durable that could be as you continue to kind of gain back share there, and whether that's going to create any headwind for you in 2017 as you try to grow over these strong placed (33:43) numbers?
José E. Almeida:
We had a very good performance in SPECTRUM since its launch about a year ago. We gain market share. We're back to number two position in the market. And clearly, that was a very rapid penetration. We don't see the same rate of penetration going forward, but we continue to see us gaining market share in this large volume pump market in the U.S. We're also very committed to this pump business and technology, and we will be continuing to invest resources in developing not only the portfolio for the U.S. but also for outside the U.S. But to the point of comparables, we are coming to the point we are anniversarying our pump launch, so clearly we cannot expect this business to continue to deliver growth in the 20-plus percent every quarter.
Matthew Taylor:
Great. Thanks for the comment.
Operator:
Thank you. And our next question comes from Vijay Kumar of Evercore. Your line is open.
Vijay Kumar:
Hey, guys, congrats on a great quarter. Maybe one near-term and one medium-term question. Obviously, phenomenal 3Q numbers. When you look at the fourth quarter numbers, right, an organic of 2%, that's a sequential decel, I'm just going to – what kind of cycle assumptions do we have? Can you just give some clarity on the top line, please?
James K. Saccaro:
Yes. So, overall, there is essentially two drivers of the deceleration in the fourth quarter. One is cyclo. While we don't – we're not anticipating an incremental competitor in cyclophosphamide, we do expect lower levels than prior year. It's down about $20 million or roughly 1 point of growth, to $45 million in the quarter. So, that's a deceleration that we've expected and kind of consistent with how we thought about things. As we look at the other area that has impacted our Q4 result, we have always talked about this idea of rigorously going through our portfolio and ensuring that every single sale that we make is one that contributes positively to the economics of Baxter. And so, in support of that, we did walk away from roughly $130 million in sales on an annual basis, which amounts to roughly 1 point of growth impact in the quarter. Now, the good news is this has limited to no impact on the bottom line. The sales were essentially breakeven, and we've been able to eliminate all the costs associated with those sales. So, while on the bottom line there's no impact, it does impact the top line a bit. If I were to adjust for these two factors, the 2% growth would be more like our normal expected run rate growth of 4%.
Vijay Kumar:
Great, Jay. And then, maybe a quick follow-up on – sticking to the theme of top line. And I guess one of the feedback we get from investors is, look, I mean the company has – they've done a phenomenal job on the cost side, on the margins and EPS growth. At the end of this – the products, there's always – it's hard to model a company when you have so many SKUs. What gives you the confidence that Baxter could be 4% to 5%, when you look at the next two to three years, can you talk about when we can annualize some of the in-center HD business on the Renal side and some of these growth initiatives can kick in? Thank you.
José E. Almeida:
Vijay, this is our challenge, and I think we are on our way to create that environment. First thing we did was completely reallocate capital. If I showed today to you the dollars invested by franchising the company versus 12 months ago, you'll see a significant difference. We are doubling down in areas like biosurgery, it's going to take us a couple of years to pick up momentum there because we fell behind in a lot of different things, but we are looking at some M&A augmentation for the short term. We also are doubling down in the PD business, the peritoneal dialysis business. I have great confidence that we're going to unveil a very different model of doing business in some parts of the world. We're working with payers at this moment, and I think that will be a very interesting way of expanding the use of PD, which has proven to be, economically and from the access point of view, a better way forward for the patient and for the system. And with SHARESOURCE, we're going to continue to invest there. I see us very focused on the M&A area associated with organic growth in our generic injectable business. We think we have a platform opportunity at the moment, plus our internal growth engines in terms of new molecules, which we're accelerating. So, all of this gives me the confidence that we can achieve 4% to 5% in a couple of years. I tell you, we are trimming our portfolio. We're removing a significant amount of unprofitable dollars, which will boost our 2017 bottom line, but cleaning up the portfolio and simplifying Baxter is also part of the playbook. So, the playbook is innovation, really good capital allocation practices, use our capital dollars in the way that was different in the past. As you can see, our free cash flow numbers will allow us to generate more profitability for the company. And lastly, when we talk about transformation, it's not just cost reduction and reduction of personnel, but is also the complete restructuring of the company in terms of its processes. Baxter grew up to be a very complicated company with a lot of SKUs, and we're working very hard to the Office of the Business Transformation to redo that. So, that accumulation of factors give us pretty good odds of hitting the numbers, we just need to continue forth with a lot of tenacity to achieve what we set forth to do.
Operator:
Thank you. And our next question comes from Mike Weinstein, JPMorgan. Your line is now open.
Michael Weinstein:
Thank you. Good morning, and congrats as well on the quarter. Jay, I wanted to just clarify, in the footnotes on some of the charges that were taken this quarter. It talks about $25 million of costs to implement business optimization programs, and that includes consultants and employees' salaries. So, just maybe walk through why are those costs backed out of adjusted earnings?
James K. Saccaro:
Yeah, I mean. Look, Mike, there are a couple of major programs, kind of onetime programs that we have ongoing which we don't expect to be permanent costs in place. And so, for example, we have a, what we call, our Project Touchstone which is related to the implementation of a global business service center. It really is not part of our ongoing operations. We do not have the expertise to do this ourselves. So, we have brought in some consultants to assist in this process, and we have some employees dedicated to this process – to the project, I should say. At some point, once implementation is complete, those costs will all go away and they will benefit future periods, not current period. So, that's just one example of a number of programs that we have in place which are not really a part of our ordinary operations, which we've chosen to special out.
Michael Weinstein:
Got you. Maybe I should go to (42:07) Joe on this. Joe, if I think about the pushback I hear from people just kind of on how the story has evolved here, it really revolves around just the idea that the success the company is seeing is almost like a playbook of what we'd saw earlier from spec pharma companies where they took some otherwise mature, older products, raised some prices and cut some costs. And that drove a rise in profitability in the short-term. How do you evolve the story from being one of growth and earnings growth off of the instant price increasing and cost cutting at the front end to one that's a more sustainable top and bottom line story?
José E. Almeida:
Mike, we don't have the portfolio of a spec pharma company. So, our playbook is not quite the same. Do we have...
Michael Weinstein:
Yeah, I did say – I said the comments are really focused on the price increases in the Fluid Systems and the PD businesses.
José E. Almeida:
So, I was going to add that our pricing to date is slightly over 1.1% of our growth. So, it's a fraction of the overall growth. Do we have price increases? We do have price increases like many companies. But its sustainability, what I see in the long term, is neutral to a slight positive on pricing. So, I want to make that very clear. The other thing is how do you sustain that top line with transforming the gross margin contribution in participating markets that have higher growth rates than our current one is using the playbook we're using today. So, going into premixed and going into perhaps the manufacturing of very difficult to make KPIs, give us gross margins much, much different than we current today have in terms of average for the company. So, we will double down on that. So, Jay's comments in the very beginning about redeploying of R&D in the fourth quarter is actually doubling down in all the programs that we have in bringing new molecules to premixed using our capability of, we call, the GALAXY. Looking into adjacencies and doubling the amount of R&D in biosurgery is another sustainable way of being in this business. Creating local initiatives that we are and right now we have more than probably 70 local initiatives in all countries. Remember, Baxter is 60% outside U.S. sales, and we had put in place a franchise system as a company that completely took away the ability of our local and regional businesses to operate a little bit more independent. And we have great opportunities and we totaled (45:18) significant amount of money in the next three to four years that will sustain our top line, revamping our R&D organization to be more focused by business than focus in overall company. So, there's significant amount of things we're doing that are not related directly to price, but eventually plays a role in pricing because your mix will be different if products have higher margin and will change the profile of the company. It's not an easy thing to do, but we're working very hard to do it right. Hence, one of the things that we haven't rushed into doing was acquiring companies, we want to make sure that we have the discipline to acquire the companies, where it matters and be strategically accretive to our business.
Michael Weinstein:
Understood. Thanks, Joe.
Operator:
Thank you. And our next question comes from Bob Hopkins of Bank of America. Your line is now open.
Bob Hopkins:
Hi, thank you very much. Can you hear me okay?
Clare Trachtman:
Yes, we can, Bob.
Bob Hopkins:
Great. Congratulations on a great margin performance. So, I wanted to focus both of my questions on the margin performance. And Joe, maybe I'll start with you, and then a question for Jay to follow up. So, Joe, I was just wondering if you could kind of characterize the outperformance on margins from a big picture perspective. What I'm curious about is how much of this outperformance is basically pull-forward of margin opportunities that you anticipated in the long-range plan, versus finding new areas of savings that were not originally anticipated in the LRP? So, I'm just kind of curious how much of this is pull-forward versus finding new opportunities.
José E. Almeida:
Well, Bob, you answered 50% of your own question. We got accelerated programs in place, and we're getting faster results on our zero-based organization, zero-based budget and zero-based spending, okay, so we pull things forward. But we also have come across a significant amount of opportunities that we initially did not anticipate. So, I see us building a lot of confidence in probably over achieving our targets, and I say that with no hesitation. I would say also that there is a portion of our restructuring that is more complex, which is the outsourcing and labor arbitration that is involved in changing our back-office profile. But based in what I did in my past and looking at what we're doing today, there is a vast difference in our approach, and I truly believe that our people will be able to do what we set forth to do at the savings that we've set or even better. So, things are coming together very well. One thing I want to give credit to Baxter and the Baxter management and Baxter employees is once we set our compass to the right direction here, they really execute very quickly, I was surprised how much momentum we got out of simplification and savings. So, the folks of our company have done a phenomenal job embracing this change, and those are not easy changes to make. So, in summary, we are happy with the result and satisfied by the way. And it does give us confidence that probably we will over achieve on our long-range plan targets.
Bob Hopkins:
Thank you for that. I appreciate that. And then, Jay, a little more short-term oriented question around the fourth quarter guidance. You characterized the fourth quarter margin guidance as a slight downtick from Q3, but unless I'm doing my math wrong, it looks like operating margins will come down 200 basis points to 300 basis points in Q4 versus Q3. So, I guess I'm just curious, one, do I have my math right? And two, were there any onetimers in Q3 in that 16% or is that a clean number? And then, maybe if you could just talk a little bit more about the increase in spending in R&D from Q3 to Q4. Thank you.
James K. Saccaro:
Yeah, I mean, look, 16%, great quarter, we were really happy with it. The full year, we expect, to be around 13%. And so, while there weren't onetimers in place, we do expect to see a, what I call, downtick, you call 200 basis points to 300 basis points of deterioration in the fourth quarter, which I think is fair. And as I said, there's a couple of factors, right? It's probably split roughly evenly between R&D and SG&A. From an R&D standpoint, one of the areas we really want to accelerate and we recognize investments today will yield dividends in a couple years relates to biosurgery. So, we've started to accelerate spending there. There were a number of programs that will begin in earnest in the fourth quarter that will facilitate that. And then to Joe's comment earlier, this point-of-care, another very exciting development for us. It's got a lot of benefits for the patients. It's a great program for us. It also allows us to run a capital-light model relative to the historic way of delivering PD solutions to patients. So, very exciting developments, but they have a cost associated with them. We do expect to see that impact on margin by 1 point roughly. And then, SG&A, it's maybe a little bit more than that. For us, Q3 was a low level of SG&A spending. The Q4 number, we're expecting to move back up to roughly the Q2 level. We would historically expect to see a Q4 uptick. Q3 is typically a lower SG&A spend quarter in part because of the August month, which is a holiday in many parts of the world. So, for us, we're being prudent and thinking about an uptick in spending to occur in the fourth quarter. But then to the last point, we've got to accelerate the top line. That is a clear charge of our entire company and that takes some investment as well. We have empowered our international organization to begin spending on a number of initiatives. There's no impact on the sales line related to these of note in 2016. But these investments will start to pay dividends and self fund in 2017 and 2018. So, very exciting development there. Good investments to make. We track and monitor these investments on a monthly and quarterly basis, but in combination, these elements lead to a deterioration, slight deterioration from this 16% level. Having said all of that, to Joe's point, we shared some projections in May of 2016, for margin in 2018, we said 14% to 15%; in 2020, we said 17% to 18%. We have a higher likelihood of over achieving those numbers as we sit here today. That's clear.
Bob Hopkins:
Very helpful. Thanks, guys.
Operator:
Thank you. And our next question comes from Brooks West of Piper Jaffray. Your line is now open.
Brooks E. West:
Hi. Thanks. Can you hear me?
James K. Saccaro:
Yes. Hi, Brooks.
Brooks E. West:
Great. Good morning. So, I had a question, trying to tease out organic growth opportunities more on the Hospital Products side of the business, and I'm specifically looking at the difference in performance between the U.S. and international businesses. So, Jay, I wonder, can you – do you have a sense for the underlying growth rate if you back out either the product lines or the geographies that you're exiting in that business? And then secondly, if you look at organic growth opportunities within Hospital Products, can you talk about even just getting the entire portfolio approved in all geographies, can you help us understand kind of the organic growth opportunity within, and I guess I'm thinking more injectables and nutrition? That's question number one.
James K. Saccaro:
Yeah, sure. Look, the overall Hospital business – as far as the exits that took place, it actually was slightly tilted towards Renal. So, we looked at the India business, we made some decisions related to IVs and PD. In Turkey, we looked at our clinics business along with the IV business there. But on balance, I would say slightly more of an impact in Renal than it was in the Hospital business. And to be clear, we've had outstanding performance in the U.S. Hospital business, right? The 6% growth has been quite good, and internationally the growth is below that. And so, you ask a great question which is, how do we accelerate growth outside the U.S.? The U.S. has benefited from a number of factors which are not quite present internationally. We've had the benefit of a new product launch, the SIGMA SPECTRUM pump. We've had very solid performance coming from our nutrition business, and we've seen sort of adequate performance coming out of our Surgical Care business. But the real standout performance comes from the U.S. Fluid Systems business. Outside the U.S., we have not had the benefit of a product launch like we've had in the U.S., and so for us, how do we address some new products perhaps from a business development standpoint outside the U.S., for example, in the Fluid Systems business? That's a real challenge and opportunity for us as we look to accelerate performance outside the U.S. In addition, our nutrition business, which in the quarter in the United States grew in double digits, grew in low single digits outside the U.S. And so, for us, another real area of focus has been accelerating the nutrition performance outside the U.S., and that will continue to be an area where we'll invest some of the investment initiatives are targeting nutrition growth outside the U.S. So, those are a few of the factors. I mean it's kind of a difficult question to answer in a sense that it really is multi-product, multi-geography but it's safe to say that accelerating performance – Renal outside the U.S. has seen outstanding performance. 5% for the quarter, that was a very solid performance for us. Accelerating the Hospital outside the United States becomes a core area of focus for us, in particular, as we move to 2017.
Brooks E. West:
That's helpful. And then, I guess as a follow-up, you've talked about M&A but really haven't pulled the trigger on anything yet. And I know Joe mentioned earlier some of that is internal timing, but can you talk about the barriers that you see to doing M&A? I mean, is it scarcity of assets? Is it pricing? What's the opportunity and what's really holding you back from pulling the trigger? Thanks.
José E. Almeida:
We have targets that are probably in the number of between 10 and 15 that we have in front of us at any given time. So, it's not a scarcity of targets. And now, we have a strategy that is driving our seeking companies and seeking businesses and technologies. So now, we have the right construct here which is a strategy-driving M&A. We are extremely disciplined when it comes to how we look at our shareholders money. And the ability to drive value is fundamentally important to us. So, at the moment, we are looking at three specific targets that we think have good value for the company. The competition sometimes is irrational about how people are paying for some of the targets. And we don't go there. We don't want to be part of that group. We want to make sure that everything that we pay for has a way of paying back to the company and to the shareholders. So, we are very diligent. I meet with the team every month, every other week we've got updates. We just hired our new head of M&A. He started with us about a week and a half ago. Very talented. We'll not – I want our investors to understand that we are very focused on that, but we will never forget our responsibility in managing our shareholders' money. We don't see it is as our money, it's our shareholders'. So, we're going to make sure that investments we make are very well thought out. I also challenge our team internally to think a little broader when people look at acquisitions and make sure that we understand all the value is being captured. So, this has been a learning curve for Baxter. We have not done that in the past and I think it is a good practice. So, as we get more mature, we're probably going to see some things happening in the future.
Brooks E. West:
That's helpful. Thanks, guys.
James K. Saccaro:
Thank you.
Operator:
Thank you. And our final question comes from the line of Larry Biegelsen of Wells Fargo. Your line is now open.
Larry Biegelsen:
Good morning. Thanks for taking the question. I heard the comment earlier about getting to 4% to 5% growth in a couple of years, but I just wanted to focus first on 2017. Can you talk about some of the headwinds and tailwinds investors should think about? We estimate that cyclo and exiting low-margin sales could be about a 200-basis-point headwind next year. Are in the right ballpark? And the 2016 to 2018 sales CAGR you provided at the May Investor Meeting was 3% to 4%, I believe. Is there any reason why you can't do 3% to 4% in 2017? And I did have one follow-up. Thanks.
José E. Almeida:
We're not going to talk about 2017 today. What I want to tell you is that we will remove sales from the top line, which are unprofitable today. And that is our responsibility. So, we do have the long-term objective of growing the business and the underlying business will grow 3% to 4%. The thing is, we will need to remove some sales. We're doing business in locations that we should not be doing business. We've been there for a long time but has not panned out to be a good business. And the worst thing that we can have is to keep a business afloat that is on the marginal contribution is eroding value to the company. So, we will take the measures that we want to take and make sure that anything that we do will have the intentions of making the company stronger in the future. So, for us, to deliver our bottom line, we will have to take some of this business off line, and I have no problems with that. But at the same time, we are very focused in investing in the right R&D programs to be able to create the momentum to bring the top line to the 3% to 4%, eventually 4% to 5%. So, this is our job, number one right now is to work on top line growth, but we will revamp and repurpose our portfolio, so we are not here sitting three, four years from today with massive unwanted businesses that we should have taken action before.
Larry Biegelsen:
Very clear, Joe. Just a follow-up on capital allocation. You've talked about bringing your net debt-to-EBITDA level to about 2 times in the next couple of years. Is there any timeline on when you expect to be at 2 times? And how do you strike the balance between waiting for the right deal to come along versus returning cash to shareholders via share repurchases? Thanks for taking the questions.
José E. Almeida:
Thank you. We're very happy with our progress on free cash flow. And we see with better management of our capital, we will see probably a better performance than we have spoken to our investors back in May. With that said, it gives us a good ability to deploy this capital in acquisitions. So, we will have not a timeline fixed to get to a 2.0 times. We will get there when we get there. I tell you, it can be in one shot. It can be in several shots. But we are really focused in bringing our balance sheet to a place that we can either do two things, choose to deliver capital to our shareholders in form of buyback, and I think that is a very possible avenue, combined with a healthy M&A strategy because we are very happy with how our free cash flow and our capital spending is progressing.
Larry Biegelsen:
Thanks for taking the questions.
Operator:
Ladies and gentlemen, this concludes today's conference with Baxter International. Thank you for your participation, and have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Second Quarter 2016 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer session of today's call. As a reminder, this call is being recorded by Baxter, and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candice. Good morning, and welcome to our second quarter 2016 earnings conference call. Joining me today are Joe Almeida, Baxter's Chairman and Chief Executive Officer; and Jay Saccaro, Chief Financial Officer. On the call this morning, we will be discussing Baxter's second quarter financial results and updated outlook for 2016 before taking your questions. I would just like to remind you during the Q&A session, if you could please limit yourself to one question so we can accommodate others in the queue. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters, contains forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now, I'd like to turn the call over to Joe.
José E. Almeida:
Good morning, everyone, and thanks, Clare. This is our first earnings announcement since our May Investor Conference, and the strategies we outlined at the time are clearly gaining traction. We're making steady progress in our efforts to enhance our financial performance through our disciplined focus on portfolio and innovation management (sic) [portfolio management and innovation] (02:15), operation excellence and capital allocation. As you've seen in our press release, Baxter delivered a strong top-line and bottom-line results in the second quarter, exceeding expectations. I will share a few comments on our progress and then turn it over to Jay, who will provide more details on the quarter and our updated financial outlook. After that, we will open the call for Q&A. So let's get started. Baxter's worldwide sales grew 6% on a constant currency basis and 4% on a reported basis. Sales growth was driven by strong performance in the U.S. Fluid Systems, U.S. peritoneal dialysis and global acute care renal therapies. On the bottom-line, Baxter delivered adjusted earnings of $0.46 per diluted share, reflecting the benefit of better-than-expected sales growth, favorable product mix and the positive impact of our continuing business transformation efforts. Now, I'll briefly walk you through the performance of our businesses and franchises where we speak to sales growth on a constant currency basis, excluding foreign exchange, to provide a clearer picture of underlying operational performance. Global sales for Hospital Products totaled $1.6 billion, including 7%. Excluding U.S. cyclophosphamide sales, Hospital Products sales increased 13% in the U.S. and 9% globally. Now to break our Hospital Products at the franchise level. Sales in Fluid Systems were $586 million, up 15%. Growth continues to reflect the strong launch of the SIGMA SPECTRUM infusion system in the U.S., where we continue to gain market share, plus favorable demand in pricing in the U.S. for IV solutions. Moving to Integrated Pharmacy Solutions, or IPS, sales were $563 million, increasing 4%. Growth excluding cyclophosphamide was up 8% both in the U.S. and globally, driven by solid performance across nutritional products, pharmacy injectables and hospital pharmacy compounding services. With Surgical Care, which includes our anesthesia and biosurgery products, sales totaled $347 million, up 5% year-over-year. We continue to view biosurgery as an attractive opportunity for growth through both innovation and geographic expansion. In the quarter, biosurgery sales increased mid-single digits globally. Sales continues to be impacted by lower sales of selected non-core biosurgery products, ACTIFUSE and PERI-STRIPS, which depressed growth in the quarter by approximately 2 percentage points. As we discussed at our May Baxter Conference, we continue to focus on strengthening this portfolio through the introduction of new products and delivery devices, expanded indications and continued geographic expansion. During the quarter, we expanded the launch of HEMOPATCH, our advanced surgical patch to Brazil, Mexico and New Zealand. HEMOPATCH provides surgeons in these markets a new ready-to-use option that has broad indications as an advanced surgical patch. Our line of inhaled anesthetics continued to lead the market globally with second quarter sales up 7%, globally driven by double-digit growth internationally, where we continue to leverage our array of high-quality well-trusted anesthetics, as a platform for continued geographic expansion. During the quarter, revenues in the biopharma services partnering business totaled $124 million, a decline of 5%, as expected. As previously mentioned, growth in the business has been impacted by customer electing to take manufacturing in-house. Next, turning to our Renal business. Global Renal sales were $965 million, up 4%. Performance was driven by double-digit growth in our U.S. peritoneal dialysis business, where our highly innovative AMIA APD cycler featuring SHARESOURCE two-way online connectivity continues to build momentum in the marketplace. There are already more than 500 patients on AMIA in the U.S. to-date, which have provided well over 30,000 treatments taking advantage of our cloud-based platform for remote patient therapy management. In addition during the second quarter, AMIA with SHARESOURCE was also approved in Canada, representing a new frontier for growth. Renal growth in the quarter also benefited from the strong growth in acute business driven by increased market adoption for continuous renal replacement therapy, or CRRT, as a treatment for acute kidney injuries. Performance in the quarter also benefited from the strong flu season and competitive supply issues. We're very excited about the opportunities for this business, which remains one of our fastest-growing areas, and an active area of focus moving forward. Our leading PRISMAFLEX platform was recently approved in China, and we've initiated launch of our PrismaLung low-flow carbon dioxide removal device in France, Germany and Sweden. Growth in the in-center HD business declined in the quarter as we continued to take a targeted approach to how we manage this business, including being selective about what markets and tenders we need to participate, aimed to support our objective of improving profitability of this business. Before concluding, I will share a quick leadership update. Over the past few weeks, several outstanding executives have joined Baxter's senior leadership team. These include
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our second quarter results. It's another important building block as we look to achieve our long-term financial goals. Operationally, sales increased 6% in the quarter, and on a reported basis, sales grew 4%. Growth came in two points above our expectations, driven primarily by favorability in Fluid Systems, acute renal and anesthesia. Walking through the rest of the P&L, adjusted gross margin of 43.8% also compared favorably to our expectations and was driven by a positive sales mix and improved pricing in select areas of the portfolio. Adjusted SG&A totaled $663 million and decreased 11% on a reported basis. This represents a 440-basis point year-over-year improvement. The primary driver of the improvement was our ongoing focus on controlling expenses and the rebasing of our cost structure. SG&A also benefited from lower pension expenses and TSA income from Baxalta-Shire. TSA income totaled approximately $30 million in the quarter, compared to $20 million in the second quarter of 2015. TSA income from Shire will continue to decline as the need for these services ramps down. We expect TSA income in the second half of 2016 to be approximately $50 million compared to $65 million in the second half of 2015. Adjusted R&D spending in the quarter of $150 million increased 1% versus the prior year. As we had previously announced, we discontinued our investment in the VIVIA home hemodialysis program in the second quarter, but plan to reinvest that spending into new programs in PD, biosurgery and other initiatives to fuel future growth. Adjusted operating margin in the quarter was 12.3% and compared favorably to our expectations driven by increased sales, positive product mix and continued discipline around expense management. This represents a 530-basis point improvement over the second quarter of 2015. Interest expense was $11 million in the second quarter, reflecting the benefit of lower debt balances resulting from the utilization of the Baxalta retained stake to retire approximately $3.7 billion of gross debt. Interest expense in the quarter was also impacted by a one-time reclassification of capitalized interest from Other to interest. During the second quarter, Baxter completed its disposition of the retained Baxalta equity through a contribution to its U.S. qualified pension plan of approximately $700 million and an equity-for-equity exchange which reduced Baxter's outstanding share count by approximately 11 million. Adjusted Other Income totaled $13 million in the quarter and included a foreign exchange gain on balance sheet positions of approximately $3 million and dividend income of approximately $7 million associated with our former Baxalta equity stake. The adjusted tax rate was 20% for the quarter, and as previously mentioned, adjusted earnings of $0.46 per diluted share exceeded our guidance of $0.38 to $0.40 per share. Relative to the midpoint of our range, this favorability was driven by approximately $0.06 of operational strength and a $0.02 benefit from interest and other income. This was partially offset by approximately $0.01 due to slightly lower than expected cyclophosphamide sales in the quarter. Let me conclude my comments this morning by providing an update on our outlook for 2016. Starting with sales, on a constant currency basis, we now expect 2016 full-year sales for Baxter to increase between 3% and 4%. And after adjusting for the U.S. cyclophosphamide impact, we expect underlying operational growth of 4% to 5%. On a reported basis, including the impact of foreign exchange, we expect sales to increase 1% to 2%. We expect growth in the Hospital Products business of 3% to 4% or 5% to 6% excluding U.S. cyclophosphamide. Within the Hospital Products franchise, we now expect sales growth of low-double digits for Fluid Systems, driven by continued strength in the U.S. business. For the Integrated Pharmacy Solutions franchise, we expect sales to decline low-single digits, including the impact of U.S. cyclophosphamide. We have adjusted our full-year sales forecast for cyclophosphamide and now expect full-year sales of $190 million with the assumption that additional competitors enter the market during the fourth quarter of 2016. After adjusting for cyclophosphamide, sales are expected to increase 2% to 3% in IPS. Within the Surgical Care franchise, we anticipate sales to grow 1% to 2%. And finally, for the Hospital Products business, we now expect BPS and other to decline low-single digits reflecting a change in our manufacturing service agreement with Shire. Selected products we had previously been manufacturing on their behalf will now be transitioned to self manufacture by Shire. With the Renal business, we now expect full-year sales to increase 3% to 4% driven by continued growth in our PV and acute businesses, offset by lower sales in our in-center HD business. Moving down the P&L, we now expect an operating margin of approximately 12%, a 100 basis points improvement versus our original guidance, reflecting increased sales and ongoing disciplined management of expenses. We expect interest expense to total approximately $80 million. For 2016, we expect Other Income of approximately $40 million. For the year, we now expect an average adjusted tax rate of approximately 20.5% to 21%. We expect the tax rate in the second half of the year to increase as the first half benefited from certain discrete items. For the full year, we anticipate an average share count in the range of 545 million to 550 million shares. Based on these factors, we now expect 2016 adjusted earnings, excluding special items, of $1.69 to $1.74 per diluted share as compared to our previous guidance of $1.59 to $1.67 per diluted share. Finally for the year, we expect operating cash flow to exceed $1.4 billion and CapEx of approximately $900 million, resulting in more than $500 million in free cash flow. Specific to the third quarter of 2016, we expect sales growth, excluding the impact of foreign currency to increase 3% to 4%. At current foreign exchange rates, we expect reported sales to improve 2% to 3%. And we expect adjusted earnings, excluding special items, of $0.43 to $0.45 per diluted share. With that, we can now open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. I would like to remind participants that this call is being recorded, and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. And, our first question comes from the line of Bob Hopkins of Bank of America. Your line is now open.
Robert Adam Hopkins:
Hi. Good morning. Can you hear me okay?
José E. Almeida:
Yes, we can.
Clare Trachtman:
Yes, we can.
Robert Adam Hopkins:
Hey, good morning. So congratulations on a really strong second quarter. I'll limit myself to two questions. The first one for Joe, I was wondering since it's such a topic of consideration for investors, I was wondering if you could just give us an update on kind of the outlook for the balance sheet and M&A; what's the environment look like right now? Obviously you've been disciplined to date, but just curious if you could give us an updated outlook for, again, the balance sheet and M&A across the businesses? Thank you.
José E. Almeida:
Bob, good morning. We don't comment specifically on targets as we want to make sure that that we'll get there first and don't get to pay too much for them. But we're very disciplined in that area. We've been looking at significant amount of opportunities. I just revealed yesterday we have probably more than 15 different opportunities in our pipeline. But I have to say that we also walked away from four deals in the last 90 days. They were too expensive. And we've got to make sure that we have the discipline to execute. We could execute those deals internally. We had absolutely the right teams to get them done, but the price was too high and somebody else was willing to pay more money for that asset. If we don't see a way there, we're not going to be competing on the price and innovation, prices of deals. They are now warranted. I'd tell you, our focus is acute and we have – having Andy Kidd as part of my operating team also raise the profile of the M&A jobs in our company and we're working very hard to find those as we continue to progress in creating operational opportunities for the company as well as organic opportunities. Our balance sheet is pristine at this moment in time, and so, one thing about M&A, it doesn't preclude us from buying shares back, and shares back doesn't preclude us from doing M&A. I think we need to have a balanced approach and we can do probably both of them if we do it correctly.
Robert Adam Hopkins:
Great. Thank you for that, Joe. And then, Jay, one question for you. I was just wondering if you could give us a sense of the really strong top-line growth that you're generating. Can you give us a sense as to how much of that roughly is coming from price? Of the 6%, 7%, is that one point or two points from price this particular quarter? And then maybe a quick comment also on just how we should be thinking about the sustainability of Fluid Systems growth, especially in the U.S. Thank you.
James K. Saccaro:
Yeah. Generally, you're right; it was a great quarter from a sales perspective if you look at businesses like the U.S. Fluid Systems, as you pointed out, and we saw north of 30% growth in the U.S. Just thinking about that business for a second, there is really two primary components to it. One is the infusion systems business, and that's really driven by sales of the SPECTRUM pump, along with sales of the attendant sets. So once you install a pump, you have the sets that ride along with that. Our sets growth in the quarter was north of 20%, and then the infusion systems' overall growth was north of 30%. And then, on the other side, we have the IV therapy business in this particular area, and that also grew north of 30%. In the case of IV therapy, it was a balanced mix of price and volume that drove the growth. The other area where we saw some pricing in the portfolio is in the area of U.S. PD where we did see some opportunities to capture value. But beyond that, it's a fairly stable pricing environment. I wouldn't say that there are massive or very significant changes to price beyond those two areas that I referenced.
Robert Adam Hopkins:
But is that one point to two points of the total 7% roughly the right way to think about it this quarter?
James K. Saccaro:
We don't really do price volume on the entire portfolio for a number of different reasons, but I think that the two areas where price was most pronounced would be in the PD arena and then also in the U.S. infusion systems business, in the Fluid Systems business. The only thing I would add is we do see some pockets of price pressure in the portfolio, and so in some instances, there are offsets to price increases that we see. In certain markets, for example, where we see dialyzer pricing or other particular product areas, there are certain areas where we do see price pressures, so it is a balance. It's hard to answer the question across the board.
Robert Adam Hopkins:
Great. Thank you.
Operator:
Thank you. And our next question comes from Vijay Kumar of Evercore. Your line is now open.
Vijay Kumar:
Hey, guys. Thanks for taking my question. Congratulations on a really strong quarter. So maybe one high-level question on the guidance. When you look at the back half right, just given the one half performance, it seems to be a tad light in the back half, especially when you look at cyclo your assumption is now in a cyclo to impact in 4Q versus I think what we had originally thought as a 3Q impact. So can you maybe just walk through what changes one half versus back half as we think about the top-line?
James K. Saccaro:
Yeah, sure. I think from the first half to the second half, there are a number of drivers of change. One is we do have a cyclo impact in particular in the fourth quarter we'll expect to see around $40 million of year-over-year decline related to cyclo on the sales line. As it relates to other areas in terms of sales growth, we are taking a very disciplined approach across the portfolio. So as we look at areas that don't earn the right economic return for us, we will very much walk away from particular tenders or businesses. And so in the fourth quarter of this year, there is probably another $30 million to $40 million of low-margin sales that we choose to forego. And then the other comment I would make on the third quarter relates to PROTOPAM last year. We did have a PROTOPAM order in the third quarter of last year that makes a tough comparable. That was about $20 million. So if you adjust for those items, I think the sales is more explainable. Overall, as we think about the guidance on EPS in the second half, if you were to go back to last quarter's earnings call, the implied second half guidance was $0.85 to $0.91 in earnings per share in the second half. As we think about today, our current view is $0.87 to $0.92. So essentially, we've raised the midpoint of the second half guidance by about $0.015 and which you have to realize is there're a couple of drags on the second half number. The tax rate is slightly higher than our expectations, in part because of profitability coming in higher tax jurisdictions, so that's about one point, and the share count is a little bit higher, I should say $0.01 and then the share count is a little bit higher as well in the second half of the year so that's about $0.01. We do see a benefit of cyclo of about $0.01, but the ongoing organic base performance that we anticipate improving in the second half is about $0.03 relative to the last time we shared guidance. So overall, I think it's a story of continued momentum, but there are some factors that do slow second half relative to first half.
Vijay Kumar:
That was helpful, Jay. And just maybe a follow-up on gross margins. You mentioned sales mix and pricing. As you sort of look at on a medium-term basis, right, if you look at the white space in general, a lot of your peers talk about anywhere from 50 bps to 200 bps of pricing headwinds. How should we think about pricing at the corporate level for Baxter on a medium-term basis? Should we think about a net neutral? And in the Q, gross margin, obviously the other part was mix, right? So as we roll forward the model how sustainable is some of those underlying strong gross margin trends we're seeing? Thank you.
James K. Saccaro:
Sure. I mean from an overall gross margin standpoint, clearly, we were pleased with the results in the quarter. And as we think about what drove margin in the second quarter and what drives it to the balance of the year, gross margin that is, there is the price, net price positive impact that we've seen in the quarter, so that's one element. Now, importantly, we've signed many of our agreements, we've concluded many of the agreements in a variety of our businesses. So as we move to next year, we don't expect to see the same level of price or economic value captured that we've experienced but there are still some opportunities for pricing. The other element in the second quarter that was, from my standpoint, very exciting was the area of mix. And so I commented earlier on 20% growth in sets. Sets carry a higher margin than the corporate average. We talked about the acute business which was just a star performer in the quarter. That too carries a higher margin than the corporate average. We also saw good growth coming out of anesthesia and nutrition. This idea of accelerating growth of our higher-margin products that's something that we expect to continue for the balance of this long-range planning period, and that will be one of the contributors that takes us to our aspiration of the 17% to 18% operating margin by 2020. The last comment I would make is generally speaking, we saw very solid volumes in the first and second quarters and its accelerated sales growth does have a positive absorption impact on the entire manufacturing and distribution network, which allows us to benefit from higher margins by absorbing more costs. So it really was a confluence of events. We do expect to see continued margin improvements moving forward.
Operator:
Thank you. And our next question comes from Mike Weinstein of JPMorgan. Your line is now open.
James K. Saccaro:
Hi Mike. You may be on mute.
Michael Weinstein:
Hi. Can you hear me okay?
José E. Almeida:
Yes. Now we can.
Clare Trachtman:
Now we can.
Michael Weinstein:
Much better. Thanks, guys, and congratulations as well on a very nice quarter. So there is a couple of items I just want to follow up on. One, it looks like the cash flow guidance for the year has been relatively unchanged and started the year despite obviously very significant provisions to the EPS expectations. Jay can you just spend a minute on that? And then the second one, I just want to follow up on the price discussion thus far. Thanks.
James K. Saccaro:
Great. From a cash flow standpoint, you'll see in the 10-Q when we report it. We're finalizing cash flow for the quarter with PwC working very closely. But we're pleased with the second quarter performance. What I would say as we look for the full year cash flow forecast is the probability of achieving our forecast has increased based on the two quarters that we have under our belt. I'm very pleased with the performance. At the Investor Day, we talked about a number of important initiatives that we're embarking on. We just started a days payable project, and one of the comments I made at the Investor Day is the ratio between days payable and days receivable, days sales outstanding doesn't quite work for us. It's a real opportunity. And I will tell you, the early signs are that some of these projects are going very well. But the reason that we haven't changed guidance on cash flow is a lot of our cash flow is back-end loaded due to normal seasonality patterns, and until I get a little bit better line of sight to how Q3 emerges and expectations on Q4, it is a bit premature to raise the cash flow guidance. But I will tell you that the probability of achievement has increased. The other thing I will say is we have been really focused on CapEx, so this is an area where we believe that there is opportunity for us. The 9% of sales is something that we're striving very aggressively to improve. We have long-term plans to do so, but that's another area that as we move towards the end of the year that may be another area that we update. So on balance, I feel quite good about how the cash flow story is shaping up for our company. And frankly, from a free cash flow standpoint, this is a real opportunity for us, not only this year, but moving forward.
Michael Weinstein:
And then on the pricing discussion, if I look across the portfolio, I was hoping you could maybe just provide some more insight into the contribution from price in different businesses. And obviously it's most pronounced in Fluid Systems, but the ability to take price in PD is something that's relatively new for the company. The growth in the anesthesia business this quarter was particularly strong. Are you getting price there? If you could just help identify maybe the level of price you're getting in some of these businesses within Hospital Products? And where you're able to take price today that maybe you weren't 12 months ago? Thanks.
José E. Almeida:
Mike, we have contracts that are signed very recently in the last 12 months, they're three to five years, they have price clauses built into them. Okay? If we look at their trajectory area of growth like Fluid Systems going forward, we're going to continue to see growth in that business. Perhaps the rate is not the same as we took a significant amount of market share lately. But that is built into the contract, so I feel comfortable about that. The point that you underscored by AMIA. Our PD business for many years has not experienced new technology, and we have this breakthrough technology with AMIA that really had stunned the market. We have significant amount of providers coming to us, and the price of the product is coherent with the technology and the benefit of things to our patients. So we've seen some really good momentum, and we see a lot of interest, not only from the providers, but from the payer side in this program, because of telemedicine and the innovative aspect of AMIA. So we have slowed down the price erosion in dialyzers. So all-in-all, the company is looking at price neutral to slightly positive going forward versus any negative price pressure or erosion. So just, again, price neutral to positive going forward.
Michael Weinstein:
And, Joe, that comment is about your dialyzer business, or is that a broader comment?
José E. Almeida:
No, this is about the whole company. The whole company, I see the company when you look at all the price point analysis and what is built into contracts, the pressure in dialyzers, the EMEA launch and some of the new product launches we have, I would say Baxter will have price neutral to positive going forward, at least for the next foreseeable future.
Michael Weinstein:
And Joe that's a comment beyond 2016, right, because in 2016...
James K. Saccaro:
Yes.
Michael Weinstein:
...the price contribution is more meaningful?
José E. Almeida:
Yeah, this is beyond 2016. As I said, some of these contracts are long into the future, so this goes into 2017, as well.
Michael Weinstein:
Perfect. Thank you, Joe.
José E. Almeida:
You're welcome.
James K. Saccaro:
Thanks, Mike.
Operator:
Thank you. And our next question comes from Brooks West of Piper Jaffray. Your line is now open.
Brooks E. West:
Hi, guys. Thanks for taking the questions. I had a question on the growth trends in the U.S. versus international. It seems like you had pretty meaningful outperformance in the U.S. this quarter, and I'm just wondering are you seeing something in the OUS markets that's changing? Is this just a one quarter phenomenon? I wonder if you could spend a little time on that? And then secondly, just curious what you're seeing in the OUS markets between emerging market performance, Europe, et cetera? Thanks.
James K. Saccaro:
Sure. Overall, the U.S. did benefit from two very – well, two very significant product launches, more so on the SPECTRUM side than the AMIA side. But in the U.S., we are seeing the continued adoption of our SPECTRUM Version 8 pump, which is really a great innovation but also very exciting for, you know, from an overall financial standpoint. And then the U.S. PD business also benefits from AMIA and also some of the execution that we're seeing overall in the U.S. PD business. And then finally, the acute business has seen outstanding growth in the U.S., in part benefiting from a flu season that extended and was a bit more acute than we previously expected. So there were a number of factors that set the conditions up for success in the U.S. that allowed us to overachieve our expectations and deliver the 10% growth. Outside the U.S., we reported 3% growth internationally, and what I would say is emerging markets, roughly mid-single digits growth. We did have lower growth in China in the quarter, so low-single digits. In large part, you'll recall we exited certain tenders for PD where the margins weren't attractive to us. So there was that overhang on our overall business in emerging markets and in China. We do expect to sunset that after this quarter, so we'll see an acceleration we expect to see in emerging markets in the Q3, Q4 timeframe. So those would be a few of the overall comments I would make on that.
Brooks E. West:
That's helpful. And then on the biosurgery business, if I could. It looked like a nice step-up in performance there. I'm wondering is that just getting the portfolio straightened out? Is it underlying volumes? Any detail there would be helpful. Thanks.
José E. Almeida:
A couple of things. One was focus; make sure that we are on a global basis focusing on that business. We have great portfolio, and I think other things are taking precedence. The second thing was we have launched HEMOPATCH as well, and our efforts there is trying to ramp up. I have to tell you that we are in process of very – in final stages of hiring a President, a Global President for Biosurgery, which creates a vertical for this business on a global basis and it creates a very different focus in our company for biosurgery, which is a very different product than the rest of our portfolio and requires a significant amount of detailing into accounts. So that associated with us doubling the amount of R&D going into biosurgery is – and also two or three potential small adjacencies that can go into this business, it will revitalize our biosurgery business and put us on track to overperform.
Brooks E. West:
Great. Thanks, guys.
José E. Almeida:
Thank you.
Operator:
Thank you. And our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Ryan Lewis:
Good morning. Two quick questions for Joe or Jay. The first one is on U.S. Fluid Systems. So I'm looking at that performance here in the quarter, and it looks like about half the organic growth for the business is coming from just the U.S. Fluid Systems business, about 3.5%. So Jay can you sort of walk us through sort of anything you tell us on the mix of capital and consumables? And sort of how that contracting sort of falls forward into 2017 and what you think the structural growth rate for this business is on a longer-term basis? And I had a quick follow up on guidance.
James K. Saccaro:
Yeah. I mean, look, overall, Fluid Systems business we anticipate over the next five years to be a 3% to 4% grower, although when I look at this particular quarter and it's a very solid data point in terms of growth and adoption that we were pleased with. Thinking about the performance of the business, it's important to decompose it into a couple of different segments, right? One is the IV business and we are working very hard to bring additional volumes to the market. We're very focused on delivering. So as we think about the sustainability of this particular aspect, this should be a steady grower for the next several years, in part because of the contracts that we've discussed, but also in part because of continued volume that we look to bring to the U.S. In the other roughly half of the business, the infusion systems area, there is two component pieces to this. The larger one today relates to pump sales, so we've had great success with pump business and we continue to perform in line with the expectations, or better than with the expectations that we've shared with investors over the last year on pump placements. But then, the other benefit is as we place pumps, going with those pumps is a non-capital sale and that's the set piece, right? So our sets were up as I said earlier north of 20% in the quarter, just a very solid element. This becomes more of an annuity or an ongoing stream of business that's related to pumps, and so I would say that's a more sustainable business than the capital sales, which are a little bit lumpier in nature, if you will. Overall, though, we feel confident that the business will grow; I believe north of 10% on a full-year basis globally; and then moving forward for the next five years, this 3% to 4% kind of mid-single digit type growth is what we can expect to see from Fluid Systems.
David Ryan Lewis:
Okay, Jay, very, very, helpful. And then second is just to reconcile kind of the fourth quarter number. My way of thinking about it is, maybe you print a 2%, 2.5% constant currency for the fourth quarter, and then we sort of add back a point and a half from cyclo, and a point and a half from the discontinued operations you talked about. And that kind of gets you back to sort of 5%, 5.5%, which is sort of consistent with the first half. Is that sort of a decent way of thinking about the fourth quarter?
James K. Saccaro:
That's exactly how we look at it. So we had about a point and a half of cyclo. I wouldn't characterize it as discontinued operations, but for us we're going to be very disciplined about sales, we will forego sales in certain instances that don't make sense. That's about a point and a half of impact. In that case though, that's a very low-margin impact. As you know, the cyclo on the other hand is a higher-margin impact.
David Ryan Lewis:
Great. Thank you very much. Great quarter.
James K. Saccaro:
Thank you.
Operator:
Thank you. And our next question comes from Matt Miksic of UBS. Your line is now open.
Matt Miksic:
Hi. Thanks for taking our questions. So one follow-up for you Jay on gross margin. So very strong in the quarter at least relative to our estimates. I'd love to get some additional, anything you can quantify around some of the puts and takes there, biased to a business line or product line. I mean, based on David's question, it looks like even though sets for example has started to pick up growth, you're not quite growing as fast as capital and infusion systems. So is that reflecting some of the strength here? Is cyclo some of the strength? Just maybe take through the business lines and can you talk a little bit about that, and then I have a follow-up for Joe.
James K. Saccaro:
Sure. Just from a gross margin for the quarter, actually cyclo was below our expectations by a little bit, and there were a variety of reasons, but it was not meaningful. But when you talk about missing cyclo sales relative to expectations by $5 million to $7 million that has an impact on both gross margin and EPS. So the margin that we saw was even in excess from a pure operational standpoint. But, look, there are two primary factors, right? One is price. So we did see some price benefit in the quarter. But another, and again this is the more sort of exciting area as I look at the business, is a area of mix. So when you have our sets business, our acute business which is a $400 million business, our anesthesia business which is I believe north of $700 million, our nutrition business which is also a very healthy size business for us. When you have roughly 20% of your portfolio growing at a faster rate than the corporate average, and when that has a much higher average margin than the corporate average, it really is a benefit that you see on the gross margin line. In our case, that's something that we experienced in the second quarter. Now, turning to the rest of the year, we do expect to see some of that continued benefit from the accelerated growth of those higher-margin businesses, but then there is also a secondary impact which I referenced earlier which is as your plants fill up with incremental volume, there is additional absorption that's occurred. The manufacturing network becomes more utilized, so you do see an attendant absorption benefit on the cost profile, which also impacts margin. So second quarter great; you see price and mix playing coming to bear. Moving forward, we'll have price, mix and volume. That's why we've been able to increase the guidance in the second half of the year.
Matt Miksic:
Great. Thanks. And the follow-up for Joe, you had mentioned when we were out to see you just these initiatives of reinvigorating the entrepreneurial spirit of some of the teams across Baxter as one of the things you've been focusing on, and I'd love to get your perspective. If you could spend a few minutes just on the progress there, and just specifically on what we'll see from that? The types of benefits you hope and expect to see in terms of growth and margins, and when maybe we start to see some of that flow through?
José E. Almeida:
We have a pretty structured program. We have somebody in charge of that who reports directly to Paul Vibert, our President of International. Couple are notable. As we just launched a pain pump in Italy, in Europe, that was a local initiative. The Elastomeric business is active outside the U.S. and we didn't have the right product for parts of Europe. We just launched that, so good pickup in margin and sales for the group. We also have a plan to bring China to $1 billion by 2021, which is now much shorter than that in our LRP. So that brings growth up to the – to close to 10%. So we're very excited about that. That was all done local, China for China; significant amount of change in direction and mix of products with parts of the business refocusing nutrition for China, which is a great opportunity and introducing biosurgery in China, which we don't have today. So these are just two examples. I can give you a great example in Brazil and Colombia, where we're relaunching our Ringer product and – with big sales in three years of $15 million, they're highly profitable. So we have significant amount of programs going on in the company to sustain organic growth driven by more discipline in cadence of launching products. They had products available for the rest of the world. We didn't do particularly a good job in launching products on a global basis, and we reinvigorate that, and we have so many good products with good invention and innovation in-house. So those are really exciting and they're creating momentum in the company.
Matt Miksic:
Thanks.
Operator:
Thank you. And our next question comes from Glenn Novarro of RBC Capital Markets. Your line is now open.
Glenn John Novarro:
Thanks for taking the question. It's more of a macro question. Your Fluid Systems, your Hospital Products business all grew very strongly in the U.S. and very specific to the company in your execution. But I was wondering if in the second quarter you saw any favorable macro trends? In other words, did you see any pick-up in hospital admissions or surgical volumes? I wonder if you can speak to and address the health of the U.S. market in general, Joe? Thank you.
José E. Almeida:
Thank you, Glenn. We see a slight uptick in the procedure volume, probably 3% or 4% growth in the U.S. This is a good thing for us with the Fluid Systems being driven primarily by that. Also a good flu season helped. It was important this year; more use of fluids and pumps. We see the environment in the U.S. is stable, not with a trajectory of growth that we probably saw before, but with growth as we see unemployment still subdued and below, sub-5%. So it is a good trend for the country.
Glenn John Novarro:
Okay. And...
José E. Almeida:
And they're continuing.
Glenn John Novarro:
And just on an unrelated, just I wanted to get back to Bob's question on M&A, I believe it was handled at the Analyst Day or one of the previous calls, you talked about Integrated Pharmacy Solutions and that's a business on the M&A front, I believe you used the words you wanted to double down. And you also just mentioned on this call that there were four deals that you just passed up on in the last 90 days. So were some of these deals in the Integrated Pharmacy Solutions? And why has the dynamic become so competitive of late? Thank you.
José E. Almeida:
You're welcome, ahead of answering my question. I will say to you that there are very few areas of growth if you think about the healthcare and about the targets. The multiples in EBITDA are skyrocketing in some areas. Go figure out why. I just saw a couple of deals, one that just got concluded in the U.S. on the front-end generics company, the multiples are extremely high for a capability more than anything else because the company did not make any products. So we have those capabilities in-house. We look at some of these deals and we don't see the price, the coherence between price and value. And I think when we don't see the coherence and it does meet our expectations – we have a very established guidelines with our board that reflect our best interest of our shareholders – I would say we will not step into those deals. We walked away from another deal that had a significant difference between us and a foreign party was trying to buy the company. There is not a deal that is important enough that will make us spend our shareholders' money in vain. So we're going to continue to pursue the couple of deals on the table right now that we think are actionable. We are pursuing them but we are going to always keep our eyes on value.
Glenn John Novarro:
Okay. Thanks, Joe.
José E. Almeida:
Thank you.
Operator:
Thank you. And our next question comes from Danielle Antalffy of Leerink. Your line is now open.
Danielle J. Antalffy:
Thanks so much. Good morning, everyone, and congrats on an excellent quarter. Jay, I was wondering if you could talk about Brexit and the impact both on sales overall but specifically as it relates to FX, your exposure to the U.K.?
James K. Saccaro:
Great and thanks for the question. Overall, from a volume standpoint, we don't expect an impact from some of the macro challenges we're seeing in Europe. Most of our product lines are more steady stream from a unit standpoint, so we don't really anticipate an impact in that sense. From a foreign exchange standpoint, really, we have a number of hedges and opportunities that we have. So as it relates to the U.K., we have roughly 5% of our sales in the U.K. We do have a manufacturing plant in the U.K. that provides natural hedge against fluctuations in that currency. And then in the eurozone area, we have a number of plants, so as the euro moves, we do have natural offsets to sales – the currency fluctuations in that market as well. But the other thing that we do is we use synthetic hedges or derivatives, principally options, to hedge foreign currency exposure. And we have a well-disciplined approach where we hedge out up to five or six quarters. We hedge roughly 20% per quarter, and we use options, which really caps the downside associated with those instruments. Now, for us, as we evaluated the Brexit situation leading up to that particular event, we actually did a couple things. We increased our exposure or increased our derivative positions on the pound and increased our derivative positions on the euro as well as an insurance policy to ensure that there would be no adverse impact this year or next year. And so the result of that is, despite the movement in the pound and the euro, we really offset some of the translational impact of the P&L with gains associated with those derivatives that we've put in place, and we're very pleased with the situation that we're currently in. The other item that we did is, as the yen strengthened, we did take the opportunity to increase some of our exposure, again, using options so that the downside is limited to the yen. So we hedged some of our incremental yen positions at basically ¥100 to $1. Again, a trade that we were pleased with and situated us well for both this year and next year from a foreign exchange risk standpoint.
Danielle J. Antalffy:
Okay. That's really helpful. And if I could follow up one more macro question following up on Glenn's question about U.S. volumes. Ex-U.S., there is a little bit more uncertainty, turmoil, if you want to call it that in emerging markets also in Europe. Just wondering what you're seeing from a volume trend, procedure volume trend ex-U.S. and whether that's offsetting some of the strength we're seeing here in the U.S.? Thanks so much.
José E. Almeida:
There is a very high diversity of scenarios. So you have China with pretty stable market regarding our products, the products we serve the Chinese market in terms of pricing, but you always have the trend of risk of price controls and things like that. We've always seen China with a pretty stable outlook as well as some parts of Latin America, even Brazil depending on – independently of the currency situation. You still have Brazil with good prospects for growth, Colombia, Mexico. I will say when you move away from emerging markets, developed markets such as Australia have very strong growth, good performance. And we see our markets there for areas like hospital admissions, but we see that via our compounding business there, that is doing very well, no issues. I would say Europe is always a point of attention with very slow growth in most of the five large countries in Europe with some exceptions in parts of probably England and Spain, we see a little bit of growth there. But it is a market that we are being very careful with how we compete, we are very disciplined in pricing, but we see that market a bit more tenuous than the rest of the developed markets.
Danielle J. Antalffy:
Very helpful. Thank you.
José E. Almeida:
You're welcome.
Operator:
Thank you. And our next question comes from Larry Keusch of Raymond James. Your line is now open.
Lawrence S. Keusch:
Okay. Thanks. Good morning, everyone. Joe, I wanted to come back to emerging markets. I think if I have got the math right, you've probably done somewhere in the 4%-ish range growth in the first half of the year. I think on the first quarter call you were talking about more like 9% to 10% growth for 2016 after you do some adjusting for the Renal situation in China. So I want to see if the thoughts around that kind of high-single digit growth, 9%, 10% are still in place? And if so, what gets you from that kind of 4%-ish range to 9%, 10% for the year?
José E. Almeida:
The 9%, 10% for the year is towards the back end of the year. Then we also have China being the biggest driver. So think about the size of China for our business is over $600 million in sales, and that drives a lot of the numbers when you look at emerging markets and primarily Asia. China, there was – we walked away from an unprofitable bid last year for PD patients. And because we lost those patients, the impact was felt this year in the first and second quarter anniversaried – just anniversaried. So we're going to see a recovery in China by the third and fourth quarter, which subsequently will create the momentum for the growth rate that we have outlined.
Clare Trachtman:
Yeah. Overall, Larry, what I would say is that, we expect emerging market growth for the full year in line with the guidance that we provided at our May Investor Conference of around 5% to 6%. So that's the outlook for the full year. As Jay referenced earlier, there are certain markets and products that we're going to be exiting or not participating in those tenders. A lot of those are in emerging markets, and that in fact will be in the fourth quarter. So that will depress growth in the fourth quarter in emerging markets. But overall, we'll grow in line with that guidance that we outlined in May.
Lawrence S. Keusch:
Great. Okay. Terrific. That's very clear. And lastly, just on CRRT, obviously the growth has been very impressive. I was wondering if you can deconstruct that a little bit as to what's really driving that? Is that market share gains? Is it increasing use of the therapy? And how do we think about the runway for that growth? How sustainable is it?
José E. Almeida:
It is all of the above. So the way to deconstruct – see the underlying growth for acute renal care, which uses CRRT technology to be at 10%, 11% growth business. And we have benefited from a couple of things. One is we've been gaining market share from other modalities on top of the growth of usage of that technology. Now, we can see there by the sales of equipment by sales of capital. So when we have the sales of capital being increased, we know that the pull through will happen, but we need to be at the hospitals to make sure that that technology is used instead of flat or something else. So it's a very good underlying market growth. Second is, there was a supply issue in the marketplace, primarily in the U.S. And Baxter is always there for our customers. We're able to supply products for our patients and by doing so, we were able to help our hospitals as well as create some momentum and potential conversion opportunities of those accounts, because not all of them probably will go back to the original manufacturer who was in that quarter and shorten the market. So we'll be able to pick that up in the near future. So it is a great business for us, hence our ability to continue to tag other technologies like PrismaLung and the other things we spoke in May at our Investor Day because it's a real door-opener into the ICU for us.
Clare Trachtman:
The only other thing I would add, too, is the first half of the year really benefited from a strong flu season that we don't expect that to repeat in the second half of the year. So that's why the growth in the acute will kind of come down to the levels that Joe referenced earlier in terms of the underlying market growth rates.
Lawrence S. Keusch:
Great. Okay. Terrific. Thank you.
Operator:
Thank you. And our next question comes from Joanne Wuensch of BMO. Your line is now open.
Joanne Karen Wuensch:
Hi. Terrific quarter and good morning. When I take a look at your third quarter guidance and full-year guidance and we back into the fourth quarter, it looks like you're looking at about 2% ex-FX. Some of that I suspect is cyclo. Some of that is probably flu because it's not going to be there, but how would we sort of peel away that somewhat lower organic revenue growth rate versus what you just delivered in the second quarter?
James K. Saccaro:
Sure. There is two factors. One is cyclo, which is about one and a half points. This year, the biggest year-over-year impact will be in the fourth quarter as we assume the entrance of a couple of new competitors to that business. So that's about $40 million or a point and a half. The other item is, it's more of a sales than a profit impact, but we regularly look at our portfolio and we'll walk away from certain sales that are below a margin threshold. And in the case of Q4, as we planned and expected, there are certain things that we are walking away from that will impact the fourth quarter by about 1.5 percentage points as well. So in combination, those two items yield roughly three points of growth to the fourth quarter.
Joanne Karen Wuensch:
That makes sense. Thank you. And then as my follow-up question, the U.S. Fluid Systems number is so wonderfully strong. How do we get that going outside the United States? Not that I'm asking for more, but just asking. Thank you.
José E. Almeida:
Well, we have a very nice base of pumps installed outside the U.S. still, with significant amount of channels and we through partnerships right now and a strong group work with our partner, we will be able to launch products in the future. Not too far, then we will start replacing our fleet outside the U.S. and continue to grow with more variety and different types of pumps that we need to sustain that business. I think that was the key. As we look back and thought about the priorities, U.S. is still a big priority business in terms of pumps. But as we have seen the SPECTRUM growing and have new versions coming up in product development, it's for us now to focus outside the U.S. with our global product line and I think we have better strategy in the products line now to do so, so we'll be coming out soon with new products that will create momentum outside U.S. and protect our base.
James K. Saccaro:
And Joanne, the only other comment to add is in the second quarter, growth was adversely impacted because we had a shipment to a particular country, Canada last year, of pumps. So it was a bullish order that we had that impacted growth several percentage points in the Fluid Systems business. So that negative 1% – we actually saw mid-single digit growth in IV therapy, which was a solid performer in the quarter, but we did have the overhang of that one order.
Joanne Karen Wuensch:
Thank you so much.
Operator:
Thank you. And our final question comes from the line of Matt Keeler of Credit Suisse. Your line is now open. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker) Hey, guys. Thanks for taking the questions. Just a couple of quick ones. First, now that the retained stake utilization has been completed, were there any changes versus your prior thinking to the P&L guide?
James K. Saccaro:
To what?
Clare Trachtman:
Our P&L guide. Any changes to our P&L guidance.
James K. Saccaro:
Oh, yeah, no, we're broadly in line. I mean, look, we were very pleased with the execution of the retained stake. Frankly, the tax, treasury and legal team here at Baxter worked very hard in the face of the Shire transaction to execute on those transactions in a timely manner, exactly as we expected it. And so from our standpoint, broad brush, we had anticipated about $0.15 of impact this year, we'll experience $0.15 of impact this year, and we're very thankful and appreciative of all the hard work that allowed us to get to that stage.
Clare Trachtman:
Matt, are you there?
James K. Saccaro:
I think we lost him. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker) Oh, yeah, I'm here. Sorry, guys. Just the – just to wrap it up, the reallocation of spend from VIVIA to PD and biosurgery, any more color you can give us on where that spending will go? And is there any impact there to the either revenue or expense guidance for the year?
José E. Almeida:
A couple of examples; we have several, but we'll give three to you. One is we're going to be launching the variant of our pump sets outside the U.S. that we need. So some money is going there. And we're doubling the R&D dollars going into biosurgery. We've just launched several different programs in biosurgery. And lastly, our point of care is now being fully funded as we're planning to come into the U.S. in about three years with a new point of care to provide patients with on-demand manufacturing of peritoneal dialysis solution in the home. So good use of that money. That's one of the reasons that didn't flow through – will not flow through the bottom-line. We just have better uses for that money, very consistent with our capital allocation policy, as well as we see great opportunity across the board in many organic opportunities. And one last to mention is IPS. Actually we accelerated all the molecules that were out slated for 2019, 2020, 2021 to come earlier and that program costs money and we're funding that as well with some of the PTO money. So a great organic opportunities in the company. We could not pass the opportunity of putting money in the right places.
Clare Trachtman:
Thanks, everyone.
Operator:
Ladies and gentlemen...
Clare Trachtman:
Go ahead and conclude the call.
Operator:
Ladies and gentlemen, this concludes today's conference call of Baxter International. Thank you for your participation. Have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's first quarter 2016 earnings conference call. Your lines will remain in a listen-only mode until the question and answer segment of today's call. As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Candice. Good morning, and welcome to our first quarter 2016 earnings conference call. Joining me are today Joe Almeida, Baxter's Chairman and Chief Executive Officer, and Jay Saccaro, Baxter's Chief Financial Officer. On the call this morning, we will be discussing Baxter's first quarter financial results and updated outlook for 2016 before taking your questions. I would just like to remind you that during the Q&A session, if you could please limit yourself to one question and one follow-up so we can accommodate others in the queue. With that, let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product developments, and regulatory matters, contains forward-looking statements that involve risks and uncertainties, and of course our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Before I turn the call over to Joe, I would like to remind everyone that we will be hosting an investor conference on May 9 in New York City. At the conference, we will be providing an update on our strategic and financial aspirations, along with showcasing our innovative new product pipeline at an innovation fair. More details, along with the link to register for the event, can be found on the Investor Relations section of our website. Now I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Good morning, everyone, and thanks, Clare. As you saw in our press release this morning, we reported a strong first quarter, with both the top line and bottom line results exceeding our expectations. I will provide some brief comments performance before turning it over to Jay for additional details and an update on our full-year outlook. After that, we'll open the call for Q&A. So let's get started. Worldwide sales grew 4% on constant-currency basis and decreased 1% on a reported basis. Operational growth was at the high end of our guidance, and we're pleased with the sequential quarterly improvement in sales growth for total Baxter within both the Renal and Hospital Products segments. Sales growth was primarily driven by strength in U.S. Fluid Systems and PD businesses, along with strong performance in acute renal therapies. They delivered adjusted earnings of $0.36 per diluted share, exceeding our guidance range of $0.28 to $0.30 per diluted share. These results reflect a positive sales mix, continued spending discipline, and some favorability from foreign exchange versus previous guidance. Let me summarize performance by franchise. Please note that I'll be speaking to sales growth on a constant-currency basis, excluding any foreign exchange impact for each of the businesses and franchises, to provide a clearer picture of Baxter's underlying operational performance. Starting with Hospital Products, global sales totaled $1.5 billion and increased 4%. As planned, first quarter sales of U.S. cyclophosphamide totaled $60 million and were similar to the prior period. As a result, sales of cyclophosphamide did not impact the growth rate for the quarter. Within the Fluid Systems franchise, sales totaled $524 million, up 11%. Growth in the franchise was driven by strength in the U.S., supported by the continued successful launch of the SIGMA SPECTRUM infusion pump, as well as favorable pricing and demand for IV solutions in the U.S. We have successfully renegotiated all of our large GPO contracts, including the recent agreements with HealthTrust. These contracts build upon our partnership with U.S. customers that will ultimately allow us to serve more patients and position Baxter for continued growth. Sales in the Integrated Pharmacy Solutions franchise totaled $556 million, an increase of 3%. After adjusting revenues for a government preparedness order last year, sales in the category increased 6%. Growth was driven by strength across the franchise, including the traditional products, pharmacy injectables, and hospital pharmacy compounding services. This category also includes cyclophosphamide, which as planned did not impact growth in the quarter. Key to growth in our IPS business is broadening our product offering. Last week we launched vancomycin saline in the company's proprietary GALAXY flexible container, which enables unstable molecules to be premixed and ensures key sterility (5:34) and operational efficiency at the point of care. Vancomycin saline is the second of nine molecules that we'll be introducing over the next few years, and we recently submitted our third molecule for review with FDA. We also continued to expand our nutrition portfolio globally and recently announced the approval of our NUMETA G13 in the U.K. and Denmark. These markets represent the first of 20 countries where we look to launch this year. NUMETA G13 is a triple chamber parenteral nutrition product focused on meeting the specialized needs of preterm infants. Expanded formulations of NUMETA will help address an underserved market segment. Within Surgical Care, which includes our anesthesia and biosurgery products, first quarter revenues totaled $305 million, declining 2%. Sales in the quarter were impacted by lower sales of selected noncore biosurgery products and weaker-than-expected international biosurgery sales. Partially offsetting this impact was midsingle-digit growth of both U.S. surgical sealant and hemostasis products, as well as international anesthesia products, where we continued to expand the market and capture share. Baxter is now the market leader globally for inhaled anesthetics. Surgical Care remains an attractive area, and we are prepared to accelerate performance through innovation. In the first quarter, we received approvals for expanded indications for HEMOPATCH in the EU and FLOSEAL in Japan. Both offer great utility among surgeons using these hemostatic agents. Finally, sales in the Other category, which is primarily our pharma partnering business, totaled $92 million. As expected, sales declined 14% resulting from a large customer electing to self-manufacture products that were previously contract manufactured by Baxter. Turning to Renal. Global Renal sales totaled $898 million, up 5%, and we're pleased to see growth accelerate within this business. Performance in the quarter benefited from low double-digit growth in our U.S. peritoneal dialysis business as we build on the momentum from the recent launch of our new AMIA PD cycler. The launch is trending better than our expectations, with more than 500 AMIA cyclers sold and more than 100 patients in treatment. The feedback we've received from clinicians and patients has been overwhelmingly positive, particularly with respect to the benefits associated with our SHARESOURCE two-way remote connectivity platform. We look forward to continuing to expand this launch and increasing the adoption of home therapies in the U.S. A standout from the quarter was global growth of nearly 20% of our acute business, driven by increased adoption of extracorporeal therapies, including Baxter's continuous renal replacement therapy for acute kidney injuries. In addition to underlying market growth, Baxter's CRRT business continues to gain market shared globally. And in chronic hemodialysis, we experienced low single-digit growth, a positive reversal from the trend we experienced last year. With good momentum from our first quarter performance, the Baxter team is looking forward to our upcoming investor conference on May 9 in New York. We've recently completed a deep-dive portfolio analysis across all businesses, which has informed us how we must channel our investments moving forward. We're well-positioned to leverage our greatest opportunities and prepare to retool where necessary. I would also point out that we will be hosting an innovation fair prior to the start of the formal presentation showcasing our exciting new product pipeline. I look forward to seeing many of you on the 9th. With that, I will pass it to Jay for more details on the financials and updated outlook for 2016. Then we'll have some time at the end for questions. Jay?
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, we're pleased with our first quarter results. Operational sales growth of 4% came in at high end of our guidance range, and including foreign exchange, sales declined 1%. Walking through the rest of the P&L, adjusted gross margin of 42.3% compared favorably to our expectations and was driven by a positive sales mix, improved pricing, and a lower negative impact from foreign exchange. Adjusted SG&A totaled $620 million and decreased 17% on a reported basis. On a constant-currency basis, adjusted SG&A declined 13%, reflecting our ongoing focus on controlling spending and rebasing our cost structure. SG&A also benefited from lower pension expenses and TSA income from Baxalta of approximately $25 million in the quarter. Adjusted R&D spending in the quarter of $136 million declined 5% versus the prior year on a constant-currency basis. Adjusted R&D spend declined 2% as we continued to balance investments in key programs to support future growth while reducing infrastructure-related expenses. Adjusted operating margin in the quarter was 10.5% and compared favorably to our expectations, driven by the positive gross margins and the operating savings I just referenced. Interest expense was $28 million in the first quarter. During the quarter, Baxter retired approximately $3.7 billion of gross debt through the utilization of a portion of our retained Baxalta equity in two debt-for-equity exchanges. Following these exchanges, the company's gross debt now totals approximately $3.4 billion, and our net debt totals approximately $1.15 billion. At the end of the quarter, Baxter held 30.5 million Baxalta shares, and we intend to utilize this remaining equity through a contribution to our U.S. qualified pension plan and an equity-for-equity exchange, which was launched last week. We expect to complete utilization of all remaining Baxalta shares during the second quarter. Other income totaled $27 million and included a foreign exchange gain on balance sheet positions of approximately $10 million, and dividend income of approximately $10 million associated with our Baxalta equity stake. The adjusted tax rate was 19.8% for the quarter. And as previously mentioned, adjusted earnings of $0.36 per diluted share exceeded our guidance of $0.28 to $0.30 per share. To decompose this favorability, it was driven by $0.04 of operational strength, $0.02 of benefit from other income, and a lower foreign exchange headwind, which contributed approximately $0.01 relative to original expectations. Let me conclude my comments this morning by providing an update on our outlook for 2016. Starting with sales on a constant-currency basis, we now expect 2016 full-year sales for Baxter to increase approximately 3%. And after adjusting for the U.S. cyclophosphamide impact, we expect underlying growth of approximately 4%. On a reported basis, including the impact of foreign exchange, we expect sales to increase approximately 1%. We expect growth in the Hospital Products business of approximately 3%, or approximately 5% excluding U.S. cyclophosphamide. Within the Hospital Products franchises, we now expect sales growth of high single digits for Fluid Systems, driven by the continued strength in the U.S. business. For the Integrated Pharmacy Solutions franchise, we now expect sales to decline low single digits, including the impact of U.S. cyclophosphamide. Our full-year sales forecast for cyclophosphamide of $180 million remains unchanged, and is based on the assumption that two additional competitors enter the market in 2016, the first by mid-year and the second during the latter part of 2016. After adjusting for cyclo, sales are expected to increase low single digits. Within the Surgical Care franchise, we now anticipate sales to grow 1% to 2%, reflecting the softness we experienced in the first quarter. The growth trajectory for this category is expected to improve as we build upon new indications and geographic expansions. And finally, for the Hospital Products business, we expect the Other category to increase 6% to 7%. For the Renal business, we continue to expect full-year sales to increase approximately 3%, driven by continued growth in our PD and acute businesses and a stabilization in our in-center HD business. Moving down the P&L, we now expect an operating margin of approximately 11.5%, a 50 basis point improvement versus our original guidance, reflecting favorable sales mix, disciplined management of expenses, and a lower headwind from foreign exchange. We expect interest expense to total approximately $80 million. For 2016, we expect other income of approximately $35 million. For the year, we now expect an average adjusted tax rate of approximately 20.5%. This represents an increase from our original guidance, and it's driven by incremental strength we're observing within our U.S. business. For 2016, we anticipate an average share count of approximately 545 million shares. Based on these factors, we now expect 2016 adjusted earnings, excluding special items, of $1.59 to $1.67 per diluted share, as compared to our original guidance of $1.46 to $1.54 per diluted share. Finally, for the year, we expect operating cash flow to now exceed $1.4 billion. We expect CapEx of approximately $900 million, which results in more than $500 million in free cash flow. Specific to the second quarter of 2016, we expect sales growth, excluding the impact of foreign currency, to increase approximately 4%. At current foreign exchange rates, we expect reported sales to improve approximately 2%, and we expect adjusted earnings, excluding special items, of $0.38 to $0.40 per diluted share. With that, we can now open up the call for Q&A.
Operator:
Thank you. We will now begin the question and answer session. I would like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International website for 60 days at www.baxter.com. And our first question comes from Mike Weinstein of JPMorgan. Your question, please?
Michael Weinstein:
Good morning, guys. So first question – the strength in the Fluid Systems business in the U.S., could you maybe try and break that out between the pump business and the medication delivery piece?
James K. Saccaro:
Sure. We did report a very solid first quarter in Fluid Systems, with approximately 28% growth. And really there were a number of drivers of that. We are seeing continued strength in infusion systems, which is growing north of 30%. A lot of that has to do with pump placements – or pump sales, I should say – along with the attendant sets. But, having said all of that, we also had a very solid quarter in IV therapies, benefiting from both volume and pricing. So in short I think it's a combination of factors that led to the solid performance.
Michael Weinstein:
And maybe can you do the same for the U.S. dialysis business? Could you just talk a little bit about the difference between the underlying PD business and the other businesses?
James K. Saccaro:
Yeah, overall Renal in the United States in the quarter grew approximately 8%, and we did see even faster growth in the PD business. As Joe mentioned in his prepared remarks, we're off to a great start with AMIA. It's a fabulous, innovative new product for us. It's been very well-received. And so that's one of the factors. But I think beyond that, we are seeing volume and price growth in this important area, and we're pleased with PD performance, which really drives the lion's share of the growth in the quarter.
Clare Trachtman:
The other piece, Mike, was the acute business, which had very strong growth as well in the quarter.
Michael Weinstein:
Okay. And then one last follow-up; I'll let some others jump in. The cash flow improvement is obviously important and impressive. Can you just talk a little bit about the plans to rein in CapEx spending, where you stand with that? You're still at $900 million for this year. Without getting ahead of us with the analyst meeting upcoming, can you just talk about where you are in trying to bring in the overall CapEx budget? Thanks.
José E. Almeida:
Sure.
James K. Saccaro:
Sure. Look, I think both Joe and I would very quickly acknowledge that 9% of sales for a company of our nature is too high. There are elements that we have to consider as we think about the Baxter business, but there is a clear opportunity for us over our long-range plan horizon to improve CapEx spending and to reduce it to a number that is below the 9%. One thing I would point out, Mike, that we didn't really discuss in detail on the fourth quarter call, is when we were meeting with you all in May, we highlighted $900 million on average for CapEx over the long-range plan, but we did say that the early years would be above the $900 million, implying a number closer to $950 million in the first year of the plan. But we were very pleased with some of the zero-based activity that we did on the CapEx budget to reduce CapEx spending to start the year. And then as we move forward, this is going to be a continued area of focus for us, and our full intent is to drive this down over the plan.
José E. Almeida:
Just to complement Jay's answer, Mike, it's not only the zero budget that we did, but also using innovation to replace large capital spending programs that we have. We're looking forward to talk to you folks next week about point of care, and this is one of the ways to reduce large capital spending, primarily for the PD business.
Michael Weinstein:
Perfect. Thank you, Joe.
James K. Saccaro:
Thanks, Mike.
Operator:
Thank you. And David Roman of Goldman Sachs is on the line with a question. Please state your question.
David H. Roman:
Thank you, and good morning, everybody. I wanted to start on the Surgical Care business. In your guidance, you've contemplated an acceleration throughout the year from the negative 2% up to the 1% to 2%. Could you maybe just help us understand how much of the drag in the business is coming from discontinuation of noncore product lines versus any other factors that may be negatively influencing that business? And then what specifically drives that turnaround expected throughout the year?
José E. Almeida:
David, good morning. The Surgical Care, when you get towards the second half of the year, the comps will help that business, because we're anniversarying some of the negative trends in that business. I would like just to take the opportunity to make the point that this business has two very distinctive areas. One is our hemostatic sealants, which are doing well. We need to do a better job in the international market, and plans are in place for us to accelerate that with more indications and more focus by a couple organizational change we're going to be undertaking. But more so is to highlight there are a couple categories in that biosurgery business or businesses that were purchased a few years ago that are really laggards and businesses that probably don't fit in our portfolio. Very small product lines, but they are the ones which are dragging the comp on this business. So I want to just reassure our investors that we have a significant amount of focus in this technology. Our base business – FLOSEAL, TISSEEL, COSEAL – those are great products and doing very well. And we are looking at a couple of those laggards then to see what we're going do with them.
David H. Roman:
Okay. And then maybe just a follow-up. In your prepared remarks, Joe, you brought up that you'd renegotiated all of your GPO contracts, I think in reference to parts of the Fluid Systems business. Could you maybe just put that into perspective for us? What does that mean in terms of the growth rates of these franchises? Does the renegotiated contract provide greater visibility and sustainability of growth? Are there price escalators in there? How should we think about those, just with some context around the overall business performance?
José E. Almeida:
David, I cannot comment on the particulars of the contract. I just have to underscore the fact that we're very happy with the signing of our latest contract with HealthTrust. It's a great opportunity for the company. We are market leaders in IV fluid systems, and we're going to continue to be the leader in this market by providing enough capacity to the marketplace. We're being very smart about how to optimize capacity from all of our North American plants to make sure that we have enough capacity for the U.S. market and will not disappoint our customers. This is part of signing the contracts. It's a cycle between three and five years that we always have, and our team here in the U.S., Brik Eyre and Scott Luce, have done a superb job really working with the GPOs and having them see how much of a value Baxter as a partner is. So this is – but I cannot get into the pricing and arrangements and volume that we have in those contracts.
David H. Roman:
Understood. Thank you very much.
Operator:
Thank you. And David Lewis of Morgan Stanley is on the line with a question. Please state your question.
David R. Lewis:
Good morning. Maybe one for Jay and then, Joe, maybe a two-part strategic question for you. So, Jay, I mean, for us, the standout in the quarter obviously was SG&A, and I guess if we update for the quarter, your target of 11.5% for the year looks very achievable. Is there a reason why the cost controls, down 13% constant currency in the first quarter, won't hold throughout the variety of the year? Because it seems like if you build on this SG&A momentum, 11.5% looks conservative to us.
James K. Saccaro:
Yeah, David, maybe I decompose the SG&A performance in the first quarter and then talk about the annualization of that. There are really four main elements that contribute to the $100 million decline constant currency year over year in SG&A. One is TSAs of approximately $25 million, one is pension of approximately $20 million, and then there are two other elements, which I referred to as some of operational controls, that we put in place
David R. Lewis:
Okay. Very helpful. And then, Joe, you're obviously having some early operational success here specifically on margins. So I wonder – kind of two-part question. The first is have your thoughts around pursuing sort of larger M&A this year changed in light of slightly better revenue and operating margin trends? And the second question, somewhat related, is your prior management team seemed to be de-emphasizing generic injectables, but my sense is this management team seems to be reemphasizing generic injectables. So, one, larger M&A this year; and, number two, in that broader medical management business, is generic injectables more of a focus for this team than it was the prior team? Thank you.
José E. Almeida:
David, this is a clear area of focus for us. We talk about M&A, and obviously M&A is opportunistic, but transformative M&A is not in the cards as we speak right now. So we're looking at strengthening our current core businesses, and by doing it, we're going to go into adjacencies. So why is injectable generics a good area of focus? We have a tremendous technology galaxy in house. We have a good program. We have several molecules for the next three to four years to come. They are in the pipeline, and we're going to accelerate them as much as we can, as those need to be approved by the FDA. But, in terms of technology, we do a great job on that. So the logical extension of that would be to go in an area that is strengthening those core competencies. Now, I cannot speak from prior – about the prior management's strategic decisions, but when I look at this, I see that as a natural migration of our business. Now, the competencies to manage a business like that are slightly different, and we're going to make sure that we have that in house. We're going to acquire that to be able to be even more successful. But this is an area of tremendous attractiveness for us, and I want to make sure that we are focused on that. But with all that said, the opportunistic nature of acquisitions will drive how we're going to approach this market.
David R. Lewis:
Okay. Very clear. Thank you so much.
Operator:
Thank you. And Bob Hopkins at Bank of America is on the line with a question. Your question, please?
Robert A. Hopkins:
Hi. Thanks and good morning. Can you hear me okay?
José E. Almeida:
Yes, we can, Bob. Good morning. How are you?
Robert A. Hopkins:
Great. Hi. Good morning, Joe. Thank you very much for taking the question. And congrats on the good early start. So two questions, one first for Jay or for Joe. On the Renal side, you had a really good growth quarter here this quarter. And so I guess I'm a little surprised that you're not taking the guidance up for Renal – or at least I don't think I heard that. So can you just talk about the Renal growth in the quarter and why you don't think you'll see better than 3% growth over the course of the rest of this year?
James K. Saccaro:
Yeah, I mean, look, overall we were definitely pleased with the overall performance in Renal in the quarter. And I think of particular note, the acute business, as Joe mentioned in his prepared remarks, standout quarter. We continue to be very excited about adoption there. We also had a very solid PD quarter as well. But one quarter doesn't a year make, so for us, we're mindful. We have a reasonable forecast in place for the remaining part of the year. And we do have some tougher comps, particularly in the fourth quarter, where in the fourth quarter of 2015, we had a very strong performance in the Renal business. So that's one where I think there's some tougher comps, and we'll continue to watch this. But as we look at the long-range plan that we've shared, acceleration in the Renal business is a very important component of our long-term success. So I can tell you that the first quarter was one that was definitely pleasing to us.
Robert A. Hopkins:
Okay. And then – all right, because I just wanted to make sure there wasn't something that falls off in the back half, or some unanticipated hurdles that you want us to be aware of. And so for the second question, for Joe, just to follow up on the previous question about generic injectables. Just curious, as you look around the world, are there a wide range of assets available in that area? I just want to have a better understanding of how much opportunity you think is out there in the world of generic injectables? Are there a lot of assets for you to look at?
José E. Almeida:
Bob, for me, it's not about a number of assets, but the quality of the assets and also, what kind of APIs you're looking to participate. So we are refining the strategy to make sure that we don't have – we're not after generic, easy-to-make APIs and things that are small. We're looking for high-quality opportunities, partnerships, different to manufacturer APIs, create a little bit of differentiation for us. We don't mind to go into the more common APIs. But you have to have a construct where your business has some barriers for entry in the areas of technology and know-how of manufacturing. So we're looking at the whole spectrum of business. So, again, it's not about the quantity of targets, but the quality of targets.
Robert A. Hopkins:
Great. Thanks very much.
José E. Almeida:
You're welcome.
Operator:
Thank you, and Larry Keusch of Raymond James is on the line with a question. Please state your question.
Lawrence Keusch:
Yeah, hi. Good morning, everyone. Joe, unless I missed it, I didn't really hear much of an update on the emerging markets performance for the quarter. So if you could spend a couple moments just walking us through how things are progressing in those emerging markets?
José E. Almeida:
Sure. Emerging markets are doing well. We're very happy with the performance in Latin America. Like many companies, we have, in China, seen a overall decline of growth rates. If you equalize for a Renal adjustment that we had in China, our growth rate, you should be seeing towards the end of the year close to 9% to 10%. Okay? So our emerging markets is a healthy business. We right now are focusing in what we call the singles and doubles opportunities, and we just established our – we repurposed our R&D center, which is a global center in China now, to be China for China. Also very interested in the RTS, our renal clinics in South America. We have some expansion opportunities there. So our emerging markets is doing well, but we want more from it. We're not – we're satisfied, but we're not happy – we're happy but not satisfied, the other way around. We're happy but not satisfied with the performance. And we have some good opportunities ahead of us. We're going to be investing specifically in areas such as China, some parts of Southeast Asia. There's also selected markets in Latin America. As currency weakens in some countries in Latin America, offers an opportunity for potential acquisitions there at a reasonable price, with a good return on investment.
Lawrence Keusch:
Okay. And did you mention what the emerging markets growth was for the quarter?
Clare Trachtman:
Larry, it was about 3% in the quarter.
Lawrence Keusch:
Okay, perfect. And then, Joe, just one other, I guess, sort of strategic tactical question. There's this thought out there that connectivity between devices and software, between the pharmacy, nursing station, the patient room, is becoming more important, certainly up at the C-suite level. I'm just curious if, a), you do think that's a trend that will continue to increase, and maybe just spend a moment on how you guys think you are positioned there, and are you looking at both organic and inorganic opportunities there?
José E. Almeida:
It is a trend we'll continue. The ability to reintegrate the EMRs with the general floor in ICU connectivity, and connect the patient data with libraries and (35:54), I think it's very important. The importance is not proportional to the adoption. There is a need, but the adoption is not as clear path and immediate as one may make you believe. So, from our perspective, we have a significant effort in connectivity, wired and wireless. And we have two new versions of our pumps coming up in the next three years, but we're also working diligently on a global platform that we're going to probably have more news in about six months down the road. But we have a significant effort. It's a great opportunity for us. And as we continue to gain market share in our infusion systems, you will see us coming up with new pump versions that will enable that feature. Enabling of the feature doesn't mean that the adoption is going to be there. It just makes sure that the hospital or the hospital system has the ability to connect with the EMR. Not everyone is ready, but we will be ready, as our customers become more diligent about using this feature. I just want to underscore the fact that our AMIA and CLARIA PD cyclers, both of them operate with a very sophisticated cloud-based system for communication between clinician and patient. So we're already there; we have the technology, and we see the future of Baxter connectivity is enabling our SHARESOURCE technology for also infusion pumps and other devices that may be needed, including our home hemodialysis system, our VIVIA program.
Lawrence Keusch:
Okay, great. Very helpful. Thank you.
Operator:
Thank you, and Matt Miksic of UBS is on the line with a question. Please state your question.
Matt Miksic:
Hi. Thanks for taking the questions. A follow-up, if I could, on the Renal business. And in particular, I think we all on the call and investors following the company understand the profitability opportunity, margin opportunity for pump as you place the pumps and win more business, win more share back, and drive more consumables. There's a – I think a – we perceive, anyway, an opportunity to take up margins in that business over time. Would love to understand how maybe some of the same dynamics could play out for Renal, what you see there in terms of improving margins over time, if there's new product cycles or consumables or some geographic trends, would be very, very helpful. Then I have one follow-up.
José E. Almeida:
From my perspective, we think that there's upside potential in the margins for Renal. And there are different areas. First of all, you saw the performance of the in-center HD business this quarter, and that's the result of stabilization of our dialysis business, primarily in Europe. And as we have new technology coming about, terra nova, we'll – hopefully will be able to see that trend be steady. So you have natural momentum off that. The second part is access to the patient. In selected markets in the world, Baxter will make an attempt to connect direct with the patients. I have a great example in Canada, where the government is really into the PD business. They think PD first is a good policy, not only for the patient, but also for the system in terms of reimbursement and cost for the system, 60% penetration in Canada. So there are other opportunities in North America. (40:00) not happy not accessing the patient in North America, so we will have creative ways of connecting to the patient through payers, through providers, to be able to increase the penetration of PD, therefore increasing the future margins of this business. I have to say that when we look at the acute renal business, that is a phenomenal business for the company, where we're probably going to launch a platform in critical care based on extracorporeal therapies to accelerate even further the growth of that business, with improved margins.
James K. Saccaro:
And just to add to that, as you look at the Renal margins over the last year, there's a couple other considerations, less strategic but impacting the numbers. One is we have been investing in a number of R&D programs over the last year, so, VIVIA, AMIA, along with PrisMAX, which are three major platform developments. Those run through the Renal segment's margins. So that's a factor that will go away over time. Related to that, we'll have the benefit of new product launches at a premium price, which will allow us to take margin up in that sense. And then the final point I would make, just tactically speaking, is you'll recall at our investor conference last year, we did comment that there was 150 basis points of incremental manufacturing costs that we'd experienced in the short term as we looked to address regulatory opportunities for us. That impacted our numbers in the second half of last year and all of 2015, and a large component of that related to the Renal business. We do expect some of these costs to sunset over time. So in addition to the strategic component that Joe walked you through, I think there are a number of tactical elements that will also support margin in this business.
Matt Miksic:
Thanks for that. That's helpful color. On a separate topic, R&D, you'd set some expectations for sort of setting the right level for R&D in 2016, and love to understand how you feel about that now. And maybe how some of your thinking strategically, whether it's hard-to-manufacture injectables, plays into sort of how you see that moderating or playing out over time as part of your P&L?
José E. Almeida:
R&D is a key component for Baxter in terms of innovation and growth. And that's why we're going to be able to show you guys on May 9 our efforts. We're not going to show you everything, but we're going to show a portion of what we think the future holds for Baxter and a significant amount of R&D innovation that is coming through the pipeline. So our commitment to R&D is very strong. We have done and continue to do efficiency programs in R&D, in terms of consolidation of sites and infrastructure. Infrastructure does not provide innovation. What provides innovation are people in the right places developing products for unmet needs and also applications for the specific markets. And so what you see in terms of reduction in R&D is more of a realignment of resources across the globe, and the right focus and the right products. We're starting to do capital allocations, so we're going to see some movement in R&D. We're going to see some projects that will be slowed down, some that will be doubled down to be able to accelerate. In terms of hard-to-manufacture APIs, we have some capability in-house, but we always have at our disposal the ability to partner with companies across the globe and acquire companies across the globe. As you know, our balance sheet has good capacity, and we'll be putting that to work for the shareholders' interest. And one of them is the ability to capitalize on our injectable core competences.
Matt Miksic:
Thanks so much.
Operator:
Thank you, and Joanne Wuensch from BMO Capital Markets is on the line with a question. Please state your question.
Joanne K. Wuensch:
Good morning, and thank you for taking the question. A big-picture one and then a specific one. The big-picture one is can you give us an idea of what you're seeing in the United States and outside the United States as it relates to sort of hospital volumes and your relationship with those hospitals? Thank you.
José E. Almeida:
Joanne, hospital volumes in the U.S. are healthy. We also need to decompose the growth that we have, because we've been gaining market share in some of our categories, primarily infusion systems. So when you pull that aside, the market share aside, the hospital business in the U.S. is still healthy. Price pressures are always there. But we have much less of physician-preferred products, so we'd only speak (45:11) from products that have high pressure on pricing coming from IDNs and GPOs. We have products that are used on every day, saving lives and sustaining lives of patients, and those products are very stable in terms of pricing, but also the volume is healthy. Despite the fact that on top it we're gaining market share in many, many categories.
Joanne K. Wuensch:
And then outside the United States?
José E. Almeida:
Outside of the United States, you'll see price pressures in some categories in Europe. Europe is still a low-growth business, not only for Baxter but across a large spectrum of health care. And we see some opportunity in Latin America, and we see some opportunity in China for volume pickup.
Joanne K. Wuensch:
All right. And then my specific question, with VIVIA starting its U.S. IDE, can you give us an update on how that product is doing outside the United States and the timing of when you expect it in the U.S.? Thank you.
José E. Almeida:
VIVIA is doing well. We have several patients in Europe. It's a technology that continues to evolve. This is a very unique technology. When you compare it to competitors that say that they have home therapies, they have hemodialysis therapies that are done in the home no different than they're done in the center. Our therapy is done overnight in the home, allowing the patient full functionality during the day for working, productive life. So if you think about – this technology's complex, and we keep improving its reliability and its ability to continue to perform in people's homes without a great deal of interference or intervening from clinicians. So the work in Europe is doing well. In the U.S., we're enrolling patients. We have one patient enrolled; we continue to enroll. We have a clinical trial. I think we're a little early to predict the end of the trial and approval in the U.S. We're in constant contact with the FDA. We have a good trial program in place. We'll keep you guys updated as we see needed and we make some progress in terms of enrollment.
Joanne K. Wuensch:
Terrific. Thank you so much.
José E. Almeida:
Thank you.
Operator:
Thank you, and Danielle Antalffy of Leerink Partners is on the line with a question. Please state your question.
Danielle J. Antalffy:
Good morning, guys. Thank you so much for taking the question. Joe or Jay, I was wondering if you could talk about full-year guidance and the drivers of improvement there. I mean, obviously some of the 2Q outperformance flowed through, but you are raising the midpoint of the range even higher than the beat. So wondering if you could walk us through some of the variables that are driving better guidance.
James K. Saccaro:
Great. Thanks for the question, Danielle. As we pointed out at the beginning of the year, our guidance range was $1.46 to $1.54, implying a midpoint of $1.50 per share. And we updated it to $1.59 to $1.67, with the midpoint being $1.64. So it's essentially a $0.14 improvement in terms of EPS. There are a number of factors that contribute to that. One is foreign exchange. There's approximately $0.06 of benefit from foreign exchange that we expect to see in the remaining part or over the course of the year. The second piece, though – and frankly, this is the one that I think we're happiest about – relates to operational performance. Our expectation now is that operationally, we will be $0.06 better than our original expectations. And then there's a number of other puts and takes. Interest and other income related to equity gains and balance sheet gains is approximately $0.04, and that offsets tax rate and share count, which is a negative – roughly negative $0.03 or $0.04. So those are the primary drivers of the performance, but I would highlight that from our standpoint, as we think about the work that we're doing both on the cost side and the pricing, mix side, a lot of those margin improvement efforts that we're undertaking, those are reflected in the $0.06 of operational overachievement that I highlighted.
Danielle J. Antalffy:
And if I could just follow up quickly on the $0.06 of operational improvement, I mean, obviously margins a bit better. How much of it is due to better execution on the sales side of things and/or improving end user markets?
James K. Saccaro:
I would say it's clearly a mix of components that lead to the $0.06, and there's definitely some spending controls that we expect to see as we move forward that contributes a portion. But from an end user market strength, from a pricing and mix strength, that is probably the slight majority of the (50:15) improvement we expect to see over the year.
Danielle J. Antalffy:
All right, thanks. That's very helpful. Have a good day.
Operator:
Thank you. And Rick Wise of Stifel is on the line with a question. Please state your question.
Rick Wise:
Good morning, everybody. Good morning, Joe.
José E. Almeida:
Good morning.
Rick Wise:
Joe, start off with just a big-picture question for you. I know we're going to hear a lot more about it at the analyst meeting. But maybe just share with us some of your early thoughts and your evolving thoughts in these early days. You clearly are busy, you're talking about some management changes, looking at the laggards, et cetera, but do you feel like you're sort of in the place you expected to be? I'd be curious to hear how your thoughts are changing. Is there more opportunity to drive growth in OpEx than you expected? Is there more opportunity to add incrementally than you expected? Just that sort of at-the-margin, your early thoughts. Thanks.
José E. Almeida:
Rick, as always, we are happy but not satisfied. So there was a lot of work being done by the company before I got here, but I think we're refocusing around a few themes. The first one is a true strategy with disciplined capital allocation. So what programs really going to make through the company and give us big needle-movers. The other thing is to impart the organization to develop what I call the singles and doubles, and have more of a global entrepreneurial approach to the singles and doubles so we can benefit from all of them, instead of funneling everything through a very complex and centralized capital allocation process. So we're doing that. We understand the categories of investment. We understand what buckets, and this is what we're going to talk to you guys next week. In terms of our cost opportunity, I just appointed a Chief Transformation Officer for the company. He's been with the company for a while, very well-respected, understands the company deeply. He reports directly to me, and underneath this person, Robert Felicelli, we have all the cost transformation, to simplify the company, to understand our back office and how to make more effective and more efficient areas of spending. We're going to talk more in depth next week – zero-based budget, zero-based spending, zero-based organization. We're going very hard at this, because I think there is an opportunity to free up some real good cash and turn this back to the investors, but also a bit of that turned back into investment programs, to make our company grow faster. So I'm excited. I think the people here are wonderful. We have great talent, and we're highly motivated to deliver to our shareholders and patients.
Rick Wise:
That's great. Just a quick follow-up on a more detailed light, (53:18), maybe for Jay. You talked about the early success with the AMIA cycler and 500-plus cyclers sold to date. Just a two-part question there
James K. Saccaro:
Yeah, sure. First of all, AMIA is a very new product from our standpoint, so this is a completely new, innovative product that we put on the marketplace. And because of, not only the user interface, which has a high level of simplicity, but also because of the SHARESOURCE technology that Joe referenced, there's a lot of excitement amongst treaters, patients, around the AMIA cycler. So the receptivity for this has been great. Our team in the U.S. has been doing a great job promoting and moving this product forward. What's happening as a result of the increased value that we're providing is, there is a margin opportunity for us on this product. But what I would say is, over time, we will expect to significantly migrate towards AMIA. We're focused on new patient starts, as opposed to flipping existing patients. That would be too disruptive. But over time, this will be a larger part of our U.S. business. Frankly, in the short term, it's not going to be a – in 2016, it will not be a huge impact on our overall sales, but over the course of this long-range plan, I do expect this to feature very prominently for our company.
Rick Wise:
Thank you.
Operator:
Thank you, and we have time for two more questions. We have Matt Keeler from Credit Suisse on the line with a question. Please state your question. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker) Hey guys, thanks for taking the question. Just first on the retained stake, can you remind us what the gating factor is to getting approval to use that to fund the pension? And are you still confident you'd be able to do that?
James K. Saccaro:
Yeah, I mean, look, we are very pleased with the progress on the retained stake. This has gone, I would say, according to our plan. I think frankly, our treasury, tax, and legal teams have done just a fabulous job managing and organizing what is a highly complex process in a condensed timeframe. We've completed two major transactions – I referenced them
José E. Almeida:
The second half of the year. I just want to underscore again, our core biosurgery business is doing very well. We have to adjust; in second half, we will have those products anniversarying. Those are laggard (57:00) products; they're not part of our core business, but they were added to the portfolio a few years ago. We just need to find a disposition for these two small products, and they are probably distracting our sales force from even further accelerating. On the development side, we have HEMOPATCH. We have other things that are going on. Launches, we're going to increase our penetration outside the U.S. by creating more indications. We have a healthy pipeline; we have a new oxidized cellulose product that is now being launched in several parts of the world, including Europe. So it's a very exciting franchise that momentarily is having these issues with those two products, but as I said, second half, we'll be anniversarying those numbers. Matt J. Keeler - Credit Suisse Securities (USA) LLC (Broker) Thanks so much.
Operator:
Thank you. And our final question comes from Josh Jennings of Cowen & Company. Please state your question.
Joshua Jennings:
Hi. Good morning. Thank you. I was hoping to circle back to the Integrated Pharmacy Solutions business and focus on the organic growth trajectory there. I believe you've talked about six or eight molecules being launched, yet you just announced the vancomycin launch. Can you just help us frame the organic opportunities with these new molecules? Are these singles, doubles, triples? And just how it can offset headwinds that we're expecting for cyclo over the next 19 months.
José E. Almeida:
We have a first phase, which is about eight molecules, but altogether we have much more than a dozen molecules that will come in the next three to four years, probably close to 17, 18. We have all singles, doubles, and triples. We have a third one coming up, I would say probably it's between a single and double, we have a large one in about a year and a half coming down the pike. So we are working very hard to offset, clearly, the cyclo effect, but I want to make sure that you understand that those are the organic products of the company. We also will be very diligently looking for partnerships and acquisitions to supplement that business, because we think there's a great deal of opportunity for the company there as an adjacency.
Joshua Jennings:
Great. And if I could just follow up on cyclophosphamide, clearly understand you expect one competitor midyear, another competitor closer to the end of the year. Do you have any deeper understanding of what has been the delay for your competitors? Through last year, only one competitor getting into the market, and now waiting till midyear or the end of the year for a second and third generic competitor. But – sorry to ask you about competition, but just curious if you had deeper understanding about what's been the hold-up for those generic entrants. Thanks a lot.
José E. Almeida:
We know as much as you do. The company, we put very little resources in trying to understand every single detail about our competitors. It can be regulatory issues. It can be all kinds of different things, ability to manufacture. So at this moment in time, we take advantage of no competitors in the markets. It's a good cash generator for the company. But we understand and we have forecasted the decline of this business, as we have communicated to you. If we don't see any major activity in the future, we'll be the first ones to tell you that the numbers are not changing, or changing by how much. We're going to be very transparent that cyclophosphamide is not a strategic part of the company. What it is, is a good cash generator, and we're going to use that cash to put that to good use, as I said, in getting into the injectables and double down, triple down, in that business. But anything we know, we're going to make it very clear to you what it is, how much affects us, so there's full transparency in our earnings about this product.
Operator:
Thank you. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for your participation.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Fourth Quarter 2015 Earnings Conference Call. Your lines will remain in a listen-only mode until the question and answer segment of today's call. [Operation Instructions] As a reminder this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Stephanie. Good morning and welcome to our fourth quarter 2015 earnings conference call. Joining me today are Joe Almeida, Baxter's new Chairman and Chief Executive Officer and Jay Saccaro, Chief Financial Officer. On the call this morning we will be discussing Baxter's fourth quarter financial results and outlook for the remainder of 2016 before taking your questions. With that, let me start our prepared remarks by reminding everyone that this presentation including comments regarding our financial outlook, new product development and regulatory matters contains forward-looking statements that involve risks and uncertainties and of course our actual results could differ materially from our current expectations. Please refer to today's press release in our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now, I'd like to turn the call over to Joe. Joe?
José E. Almeida:
Thanks, Clare. Good morning, and thanks for joining us. Before commenting on our performance in the fourth quarter, I wanted to share a few initial impressions of what I have observed during the past several weeks and why I'm excited about the opportunities that lay ahead. Clearly we're building on a very strong foundation. Baxter has established one of the most trusted and respected brands in the healthcare industry, and over this rich history, we have built a durable portfolio of market leading projects with broad geography reach that spans more than 100 countries. Clearly, we have an outstanding base for expanding margins and accelerating performance. And following last year's spin-off of Baxalta we can now devote our attention to the strategies and investments that will drive profitable growth across the business and create value as we aspire to deliver top quartile 5total shareholder returns for our investors. The initial steps are already well underway which is reflecting Baxter's fourth quarter results. As you saw in this morning's release, we delivered adjusted earnings of $0.43 per diluted share, exceeding our guidance of $0.30 to $0.32 per diluted share. Operating income of 10.7% compared favorably of our guidance of 9.5% to 10%. After adjusting for the impact of foreign exchange and a generic market entrant in the U.S. for cyclophosphamide, we reported sales growth of 4% in the quarter, also ahead of our expectations. Key growth drivers in the quarter included strong performance in our US fluid systems franchise where our newly launched SIGMA SPECTRUM infusion pump continues to build momentum as well as increase the demand and favorable pricing for our IV solutions. Performance was also augmented by strength in our U.S. peritoneal dialysis business which report the highest quarterly growth of the year. The U.S. PD business is seeing very promising early results on the recent launch of our AMIA APD cycler which features our SHARESOURCE two-way connectivity platform, and we look forward to expanding this launch in 2016. So overall, a positive quarter and a great base to build on for the future. As for what the future looks like, we are in process of developing a strategic framework that will shape our priorities and direct our approach and investments moving forward. I'm confident this framework will drive a sustainable growth for Baxter and create enhanced value for our shareholders. Simply put, our objective is to further accelerate and increase the impact of our margin improvement plans to support our goal of top quartile shareholder return. To successfully achieve this outcome we will execute on three distinct strategic factors, including portfolio optimization, operational excellence, and capital allocation. In terms of portfolio optimization, we have taken this passionate approach to portfolio management which we include – categorize our businesses based on the existing financial profile and future potential. And accordingly, we will reallocate investments based on the ability to drive innovation. In addition, we're intensifying our focus on both R&D velocity and productivity to support our top and bottom line growth initiatives. The second area of strategic focus is operational excellence. We are aggressively examining our cost structure in terms of how we do business from manufacturing and operations to commercial and corporate infrastructure. I'm confident we can take additional cost out of our business without compromise our commitment to quality and safety. Related to this, we also ensure our capital expenditures are optimally allocated to projects that enhance bottom line growth and support long-term value creation. And the final strategic focus area for us is capital allocation where we are committed to deploying capital in a manner that creates value over both the short and long-term. We'll be sharing more information about our strategy at our upcoming Investor Day on May 9 in New York City. At that meeting, we will provide more specifics around our objectives along with our three and five-year aspirational financial targets. We know there's a lot of hard work in front of us, but our team is energized and well prepared for the road ahead. And with that, I will pass it to Jay for more details on our fourth quarter performance and outlook for 2016. Then we'll have time at the end for questions. Jay?
James K. Saccaro:
Thanks, Joe, and good morning, everyone. As Joe mentioned, adjusted earnings in the quarter of $0.43 per diluted share exceeded our previously issued guidance of $0.30 to $0.32 per diluted share. Sales growth in the quarter benefited from strong operational performance in our fluid systems, PD, and acute businesses, as well as operating expense savings resulting from our disciplined management of costs and the restructuring initiative we announced last quarter. In addition, other income from foreign exchange related gains and a favorable tax rate both contributed to our performance in the quarter. Now, let me briefly walk you through the P&L by line item before turning to the financial outlook for 2016. Starting with sales, worldwide revenues of $2.6 billion increased 2% on a constant currency basis. This performance compared favorably to our Q4 guidance of a 1% sales decline with better than expected sales growth observed across the portfolio, particularly in our fluid systems, integrated pharmacy solutions, and renal franchises. Including the impact of foreign exchange, sales declined 7% on a reported basis, and excluding the impact of both foreign exchange and U.S. cyclophosphamide, Baxter's sales rose 4% globally. Sales in the U.S. increased 1% on a reported basis and after adjusting for cyclophosphamide, U.S. sales advanced 7%. International sales on a constant currency basis increased 2% and declined 12% on a reported basis. Turning now to the drivers of business performance in the quarter, please note, I will be speaking to sales growth on a constant currency basis excluding any foreign exchange impact for each of the businesses and franchises to provide a clearer picture of Baxter's underlying operational performance. Starting with hospital products, global sales totaled $1.6 billion and increased 2%, and after adjusting for U.S. cyclophosphamide, sales for the hospital products business increased 5%. Within the fluid systems franchise, sales of $569 million advanced 12%. Performance in the quarter was driven by growth of more than 20% in the infusion systems business, supported by the successful launch of our next generation SIGMA SPECTRUM Pump and the related access sets pull-through. In addition sales of IV solutions in the quarter benefited from favorable pricing and demand, particularly in the United States. Sales in the integrated pharmacy solutions franchise totaled $595 million and were comparable to the prior year period. Excluding U.S. cyclo sales, revenues in the category increased 8% driven by strength across the franchise, which includes our nutritional products, pharmacy injectables, and hospital pharmacy compounding services. Fourth quarter U.S. cyclo sales totaled $65 million representing a benefit of approximately $10 million versus our previous guidance. For the full year, U.S. cyclo sales totaled approximately $270 million. Fourth quarter revenues in surgical care which includes our anesthesia and biosurgery products totaled $346 million and were comparable to the prior-year period. Performance benefited from low single digit growth of our anesthesia business and core surgical sealants and hemostasis products which both increased in line with surgical procedure volume growth. This performance was offset by lower sales of select non-core biosurgery products. Finally, sales in the biopharma solutions and other category which is our former partnering business, totaled $109 million and as expected declined 22%. As we previously highlighted, this decline is driven by a large customer electing to self-manufacture products that were previously contract manufactured by Baxter. As we mentioned last quarter, this category also reflects sales for products Baxter is manufacturing on behalf of Baxalta, which totaled approximately $13 million in the quarter. Turning to the renal business, global renal sales totaled $984 million, representing an increase of 1%. Performance in the quarter was driven by high single digit growth in our U.S. peritoneal dialysis business. As Joe mentioned, we're very excited about the prospects for this business which will benefit from the recent launch of our new AMIA PD cycler. In addition, we experienced low teens growth globally in our acute business driven by underlying market growth and an increased adoption of continuous renal replacement therapy as a treatment option for acute kidney injuries. Growth in the renal business was offset by lower sales in our in-center chronic hemodialysis business resulting from our previously discussed decision to forego certain lower margin sales opportunities along with competitive pressures for dialyzers. Turning to the rest of the P&L, adjusted gross margin for the quarter was 42.6%, slightly ahead of our expectations driven by favorable products mix in the quarter. Adjusted SG&A totaled $672 million and decreased 17% on a reported basis. On a constant currency basis, adjusted SG&A declined 11%, reflecting the benefit of the initial actions we have taken to rebase our cost structure and reduce discretionary expenses, and the impact from transition service income we received from Baxalta during the quarter which totaled approximately $30 million. Adjusted R&D spending in the quarter of $158 million increased 2% versus the prior year. On a constant currency basis adjusted R&D expenditures increased 9% as we balance increased investments to support our new product pipeline with efforts to optimize our overall R&D spend. Consistent with our portfolio optimization priorities, during the quarter we made the decision to discontinue the development of select programs and as a result absorbed approximately $15 million in expenses related to these decisions. Adjusted operating margin in the quarter was 10.7% which compared favorably to our guidance of 9.5% to 10% driven by the positive gross margin mix and SG&A savings I just referenced. And as Joe mentioned earlier, we'll continue to streamline our operations and control spending to drive ongoing margin expansion. Interest expense was $32 million in the fourth quarter. Last week we executed our first transaction with respect to the retained Baxalta stake. In this transaction, we exchanged approximately 38 million Baxalta shares or approximately 28% of the total original equity stake to retire $1.45 billion of indebtedness under one of our bank lines. Over the next several months, we'll look to further deploy the remaining Baxalta equity through a combination of additional debt for equity and equity for equity exchanges as well as make a contribution of at least $600 million worth of equity to our U.S. qualified pension plan subject to final regulatory approval. Our goal is to exit our retained equity position prior to any shareholder vote for the Baxalta Shire transaction to minimize the risk of any potential negative tax implications, and we have an agreement in place with Shire and Baxalta to assist with the orderly disposition of the stake. For 2016, we expect these retained stake-related actions to benefit our earnings by approximately $0.15 per diluted share. In terms of key balance sheet items, after giving effect to the extinguishment of the bank line, our current gross outstanding debt balance is approximately $5 billion, and cash on hand at the end of 2015 totaled approximately $2.2 billion. Other income totaled $36 million and included a foreign exchange gain from hedges on balance sheet positions of approximately $20 million, and dividend income of approximately $10 million associated with our Baxalta equity stake. The adjusted tax rate was 16.6% for the quarter. This compared favorably to our guidance and contributed approximately $0.02 to our earnings per share in the quarter. The lower tax rate was driven by the extension of the R&D tax credit, a slight shift in our sales mix and certain other adjustments. And as previously mentioned, adjusted earnings of $0.43 per diluted share exceeded our guidance of $0.30 to $0.32 per share. Let me conclude my comments this morning by providing an update on our outlook for 2016. Starting with sales on a constant currency basis, we expect 2016 full year sales for Baxter to increase 2% to 3%, and after adjusting for the U.S. cyclo impact, we expect underlying growth of 3% to 4%. On a reported basis, including the impact of foreign exchange, we expect sales to decline approximately 1%. This is driven by growth in the hospital products business up 2% to 3% or 4% to 5% excluding U.S. cyclo. Within the hospital products franchises, we expect sales growth of 6% to 8% for fluid systems driven by strength in the U.S. business partially offset by the international business where we continue our efforts to optimize our geographic footprint for this franchise. For the integrated pharmacy solutions franchise, we expect sales to decline mid-single digits including the impact of U.S. cyclo. For full year 2016, we anticipate at least two additional competitive entrants, specifically one to enter mid-year and the second to enter towards the latter part of 2016. As a result, we expect U.S. cyclophosphamide sales to total approximately $180 million, representing a $90 million year-over-year decline. Sales for the category after adjusting for cyclophosphamide are expected to be comparable to prior years. I would also remind you that in the 2015, we recognized approximately $40 million in government sales for PROTOPAM. Given the purchasing pattern associated with this product, we do not anticipate any sales in 2016 in IPS. Within the surgical care franchise, we anticipate sales to grow 2% to 3%. And finally, for the hospital products business, we expect the other category, which includes our biopharma solutions franchise, to increase low-double digits as we anniversary the impact of our customer transitioning their manufacturing in-house. This also reflects an incremental year-over-year benefit of approximately $25 million associated with contract manufacturing revenues from Baxalta. For the renal business, we expect full year sales to increase approximately 3% driven by continued growth in our PD and acute businesses and a stabilization in our in-center HD business. Moving down the P&L, we expect an operating margin of approximately 11%, which compares favorably to the guidance we provided at our 2015 May Investor Conference of approximately 10%. We expect interest expense to total approximately $90 million. This reflects the recent extinguishment of our bank line along with additional debt repayment based on further utilization of the retained stake. For 2016, we expect modest other income of approximately $10 million. This represents a year-over-year decline of approximately $150 million. In 2015, we benefited from certain balance sheet hedge gains and select equity gains related to our Baxter Ventures portfolio, neither of which is planned to repeat in 2016. For the year, we expect an average adjusted tax rate of 19.5% to 20%. This represents an increase from 2015 driven primarily by the change in earnings mix. For 2016, we anticipate an average share count of approximately 540 million shares. This reduction is driven by equity-for-equity exchanges that we anticipate to execute as part of our retained stake strategy later in second quarter. Please note that our interest expense and share count guidance reflects a preliminary base case retained stake execution plan and is subject to change as we reassess the optimal size and mix of our remaining transactions as market and other conditions evolve. We anticipate providing updates to our guidance and/or additional detail around the actual impacts of our retained stake transactions as appropriate as we move forward. Based on these factors, we expect adjusted earnings excluding special items of $1.46 to $1.54 per diluted share for 2016. Finally, for the year, we expect operating cash flow of approximately $1.4 billion and CapEx of approximately $900 million resulting in free cash flow for 2016 of approximately $500 million. This is also favorable to the guidance we provided in May. Specific to the first quarter of 2016, we expect sales growth excluding the impact of foreign currency to increase 3% to 4%. At current foreign exchange rates, we expect reported sales to decline approximately 2%, and we expect adjusted earnings excluding special items of $0.28 to $0.30 per diluted share. With that, we can now open up the call for Q&A.
Operator:
Thank you. I would like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International's website for 30 days at www.baxter.com. Our first question comes from David Roman with Goldman Sachs. Your line is open.
David Harrison Roman:
Thank you. Good morning, everybody.
James K. Saccaro:
Good morning.
Clare Trachtman:
Good morning.
José E. Almeida:
Good morning, David.
David Harrison Roman:
Hi, Joe. Good to hear your voice again here. I want to just start with one strategic question and then one follow up on the financial side. And, Joe, I imagine you'll get into this in more detail come May, but maybe you could just start from a top-down perspective in where are you ultimately hoping to take Baxter. As I sort of think about the profile of the business today, relatively low-single digit top line growth, room for margin expansion, how do you want the business to be perceived, and where do you ultimately want to take the story over time?
José E. Almeida:
David, I don't want to preempt our meeting in May, but I will give you a few things that we're considering very seriously. First of all is taking from the top, we need to alter the weighted average market growth rate of our businesses. By doing that, we will look at some organic programs that can help us get into some adjacent markets and also some acquisitions. When also we look at execution, we need to continue to improve our execution on a global basis and make sure that we are in the right businesses around the globe. Being global is not to be all over the place, so we need to make sure that we're focusing in countries and geographies for businesses that make sense. So all this work is in process as we speak. When I look at on the cost base and expense, we want to take the company to a rebase exercise, cost rebase, and find out what is the appropriate level of support that we need to maintain our company and provide for continuous improvement and operational excellence programs that will deliver better results than we have spoken about in terms of operating income back in May last year. So we are working very diligently right now in creating this strategic framework. We're working on our portfolio initiatives. But we understand some of these initiatives on the top line take a little longer, and I have no issues augmenting that with some acquisitions, and I have no problems accelerating our cost reduction rebasing the cost of the company to be able to create momentum until we can get the innovation machine reignited again.
David Harrison Roman:
That's very helpful. Thank you. And then just on the financial side. Jay, maybe you can sort of help us talk through the difference between the 10% operating margin guidance that you provided at last May's analyst meeting and the 11% that you're presenting today for 2016? What are some of the factors that influenced the 100 basis point better performance?
James K. Saccaro:
Great. So there are a number of different variables that have impacted our performance since we sat together in the May. I'll highlight maybe the four most significant. As David pointed out, we guided to an operating margin of 10% for 2016. Obviously, we're very pleased to report our expectations now are an 11% operating income margin. One of the key drivers relates to foreign exchange. The foreign exchange environment since May has moved very significantly. We can talk later about EPS impacts, but from an operating margin impact relative to our May expectations, we're down about 1.4% in terms of margin impact due to foreign exchange. As you'll recall, in the second half of the year, a lot of the emerging markets currencies moved while the developing markets currencies stabilized, and for us because we don't hedge emerging market currencies it did have a 1.4% impact on our overall margin. We did have higher than expected cyclo in 2016. So as I pointed out in my prepared remarks, we'll achieve about $180 million of cyclo sales in 2016. That's roughly 1 percentage point higher than we expected. We also have positive pension. There are a number of impacts that we have with respect to our pension, some of which we had anticipated in part related to the contribution of the retained stake, but some of which we did not anticipate, and that's about 60 basis points of improvement as we move to 2016. But I will tell you the area that's most important as we look at the stability of the operations from my perspective relates to the operational performance and OpEx savings which contribute about a point of margin improvement relative to our May investor conference expectations. So those are the four factors. With cyclo and pension, essentially offsetting FX and then the over achievement really, in my view, coming from operational strength.
David Harrison Roman:
Thanks for all the detail.
Operator:
Our next...
Clare Trachtman:
Go ahead, Stephanie.
Operator:
Our next question comes from David Lewis of Morgan Stanley. Your line is open.
José E. Almeida:
Good morning, David.
David Ryan Lewis:
Good morning, Joe, just a couple of questions here. I'll start with strategic for Joe and then a follow-up maybe for Jay. Joe, just – I know we're not going to get a lot of commentary before May, but just very broadly, I know you've only been there a short period of time, kind of a couple of questions for you. The first is how do you see the balance of pursuing large M&A in the near term versus delivering your organic margin plan? And if you think specifically about your hospital business and the four segments there, do you have a sense of which segments are likely to see further investment versus which ones are likely to be optimized for return or cash? And then a quick follow-up for Jay.
José E. Almeida:
Yeah, David. We almost there are completing that analysis. We've put our portfolio through about five different filters, and we actually have a pretty good idea of the things that we will invest for top line growth versus ROIC and ones that are strategic bets and ones that we're going to manage more for cash. I would say to you. I'm going to give a few examples. We have a very good IPS business, the integrated pharmacy solutions is a very good business, and it's something that we probably can double down as an example. We will be making organic investments, possibly inorganic investments. I just want to circle back to your comment about large size M&A. When we go down this path and we look at inorganic opportunities, size is not what matters but the ability, the ability to change the weighted average market growth rate of our businesses is key to us. And those acquisitions will be singles and doubles. They will not be big things in one shot. We're going to make right decisions with our shareholders' money. And we need to balance that well, but we need to make sure also that we can successfully integrate and generate a step change in how we grow that business that we acquired. So we'll be focusing great deal of our attention in the value the business brings to us strategic, but IPS is a good place to start.
David Ryan Lewis:
Okay. That's very helpful. And then Jay, just on fluid systems, it was the driver obviously in the quarter and it does seem to be the principal driver for next year's acceleration. Can you give us a component right now, what principally is driving the success? I know it's capital and consumable, but can you give us a sense of how large of a role capital sales are playing in 2016 and any sense of backlog in terms of sustainability of those capital sales over the next couple of years? Thank you.
James K. Saccaro:
Yeah, sure. I mean, look, fluid systems really has two primary drivers of growth in the fourth quarter, and then also as we move to next year we'll see similar levels of performance based on those two drivers. And the first one, I would say, is the infusion systems business. In particular, in the U.S. we had well north of 20% growth in our infusion systems business. And breaking that down, there's two components of that. One is the sale of the SPECTRUM Pump, which has recently relaunched, and that clearly is capital related. But as I think about the long-term sustainability of the business, really we were very pleased with the sets associated with that. And so we had very strong performance in set sales as well, well into double digits. So those were the two drivers on the infusion systems side. From an IV therapy standpoint, we've commented previously about the marketplace conditions, some of the actions that we've taken and also continued demand for this important product. And so we did report very solid growth in the IV therapy business as well, well into double digits. And so in combination these items contributed to -- in the U.S. and my growth rates are in relation to the U.S. -- the fluid systems growth that we reported of 27%. So clearly this was a bright spot for us. We do expect this to continue, but of course not at the Q4 rates. So we'll see some moderation as we move to the 2016 plan. So overall very pleased with it. Some of it is related to capital spending but, as you know, most hospitals have lacked for many years an attractive alternative from a pump standpoint for a variety of different reasons. So we do believe there is some level of pent-up demand. We have a fairly good line of sight to the sales plan for 2016, so this is an area that I think is really one of the growth drivers for Baxter in 2016 and beyond.
David Ryan Lewis:
Great. Thank you very much.
Operator:
Our next question comes from Mike Weinstein with JPMorgan. Your line is open.
Michael Weinstein:
Thank you, and good morning, everybody. Jay, just want to circle back to a couple of the line items in the guidance. The share count guidance seems to imply that you're going to use $1 billion of the retained – the remaining Baxalta stake in the stock for stock exchanges. Is that about right in terms of – is that about what you're applying in your assumptions for 2016? And if so, why is that the right mix in terms of what remains?
James K. Saccaro:
Yeah, Mike, maybe I'll take a step back and address the retained stake overall to address your question in totality. From the retained stake standpoint, there are two things that are very clear to us today
Michael Weinstein:
That's a great overview, Jay. Thanks very much. And, Joe, let's just talk strategy for a minute. So you touched on a number of the themes that you talked about in San Francisco including portfolio optimization and, improving R&D productivity, improving the overall growth mix of the business, and being in the top quartile of shareholder returns. The big part of that is putting this Baxalta stake in ultimately your balance sheet to work to create value. You talked about doing more likely a series of smaller deals to achieve those objectives. As you think about that, is the number one priority to accelerate the overall mix of growth in the company's end markets, or should we look at it as more ROIC driven, more margin driven? Maybe just help us think about if you're looking – if you have targets and if you're looking to do something in particular for the company, is it accelerating the top line? Or how do we think about that mix?
José E. Almeida:
Well, we're going to, Mike, take a look at, we have three to five years horizons. Right? So what can we do to change the trajectory of the company's top line growth and bottom line? What comes first? So we need to – we already have embarked on this extensive operational excellence program to cut cost. We're going to double down on that and become a little bit more aggressive. That will create some momentum as we continue to look for the opportunities at the top line. When you talk about the capital allocation at top line, we have about four, five businesses that we probably get a significant amount of investment from the company on the organic arena. I'm going to talk more about that in May. I don't want to pre-empt that now. But also we're going to invest inorganically in opportunities for those businesses. When we talk about how to hit it well, we want to change – we want to buy business that they're growing faster than our current based business. That is a pretty obvious thing. The second thing is if we can combine that with good synergistic deal, we'll do it as well. And why do I put a bracket around very large deals? Because very large deals are very difficult to find. We can keep looking for a deal like that. It will take a couple of years versus just creating a really good strategy by looking at adjacencies and pairing (38:20) good businesses with acquisitions that makes sense. I don't discard size being large, but I'd just say, it's much more difficult to encounter that than something else that will create value almost instantly and you can execute a little faster. So I'm looking at this whole thing as a journey where we make sure that our cost is in place while we augment our internal innovation and supplement internal innovation with some really well thought out acquisitions.
Michael Weinstein:
Perfect. That's helpful, Joe. Thanks. I'll let someone else jump in.
José E. Almeida:
Thank you, Mike.
Operator:
Our next question comes from Bob Hopkins with Bank of America. Your line is open.
Robert Adam Hopkins:
Oh, thank you, and good morning.
José E. Almeida:
Good morning, Bob.
James K. Saccaro:
Good morning.
Robert Adam Hopkins:
Good morning, Joe. Great to hear your voice. A couple of quick questions. First of all, to start out with, with Jay on the operating margin guidance for 2016, you're exiting the year at just below 11% and you're guiding for 2016 at 11%. And it sounds like cyclo pension FX are kind of a wash. So can you give us a sense as to what kind of underlying operating margin improvement you're assuming for 2016 relative to where you're exiting the year?
James K. Saccaro:
Yeah, there is an important point to make which is – and you know this about our business, Bob. We have seasonality, which typically the second half of the year is stronger than the first half. And the fourth quarter is typically one of the strongest margin quarters that we have, in large part because of incremental sales performance that naturally occurs. And so as we think about margin performance next year versus this year, I do think it's important to look at the entire year holistically. And if you think about the full year for 2015, we're at about approximately 9% margin going to the 11% that we've guided to. So it is a fairly substantial step change improvement in margin. The other point I will make is our Q1 guidance does have the lowest margin of the year. Again, in part driven by the fact that Q1 sales are typically the lightest because of all of the fixed costs we have in place, there is some absorption that does not occur due to the lower level of sales. So I think those are a couple of important points. By and large we're very pleased with the margin improvement that this plan indicates. The second half of the year was very important for us, in large part because it gave us confidence that we could give solid guidance for 2016 and that we could operate effectively on a standalone basis. But I do think it's important to consider the seasonality and the trending in margin when we think about 2016.
Robert Adam Hopkins:
Right. So maybe just year-over-year then, ex the things that are affecting margins like cyclo pension and FX, what kind of year-over-year underlying margin improvement are you assuming with the 11%?
James K. Saccaro:
Yeah. So essentially we're talking about, as I said, 200 basis points from 2015 to 2016. And let me highlight a few items for you that impact that. Cyclo is about 80 basis point or 90 basis point drag relative to 2015. PROTOPAM is another item that we've discussed previously, which is approximately a 30 basis point item. Foreign exchange is about a 1.6 point on a year-over-year basis margin drag. So it's a very substantial – relative to May, it's less. On a year-over-year basis, it's even more than that. The pension, again, is about a point of improvement year-over-year. But then there are a number of other critical items, and again, these are the ones that I'm happiest to point out. SG&A savings, we're talking about a two percentage point improvement in SG&A. R&D savings, we're talking about a 60 basis point improvement. And then operationally, because many of the initiatives that we're putting in place from a mix volume standpoint along with some of our pricing and economic value capture initiatives along with general business growth yields approximately a little more than one percentage point of margin improvement. So I walked you through a number of items there, and there's a lot of moving pieces that take us from the 9% to 11%. But as I say, there are a number of important ones that we can point to operationally that are really driving this improvement that I think, based on the second half of this year, we have confidence in as we move forward.
Robert Adam Hopkins:
Great. And thank you for that. And then, Joe, just real quickly, one of the questions that we're getting a lot from investors is, you're articulating a plan to drive faster growth for the company on the top line basis. And people are I think very curious as to how the balance will look, what the balance will look like in terms of the need to invest in the business incrementally to drive that top line growth versus what investors are looking for in terms of operating leverage in the business as you look forward over the next couple years. So how do you respond to that kind of question about the need to invest to get top line growth, but the desire for people to see real operating leverage progress here?
José E. Almeida:
Bob, we need to look this in phases. We need to bring the leverage at the same time that we invest, meaning we need to accelerate some of our cost reductions. Secondly, our spending in R&D today is adequate for the portfolio as we see in the near and midterm. Meaning we don't need to spend more money than we're spending today as a matter of mix. And if we need to spend more money, we need to self-fund that and make sure that does not impact our earnings. So this is not an investment story where we have an R&D budget that is completely underfunded to deliver an innovation. We just need to do a better job in allocating capital to the right franchise that have the chance to grow faster. So I had mentioned for instance IPS. We'll double down in IPS to be able to get more molecules to the marketplace, so we're working on plans like this very rapidly. But that is a reallocation of resources. I want to make sure our investors are clear that as we work to accelerate our cost reductions to provide for improved bottom line, we will create a mix change in how we spend money to be able to invest in the right things and concurrently look at some good acquisitions that will come in and create a momentum and change in our weighted average market growth rate.
Robert Adam Hopkins:
Great. Thank you very much.
José E. Almeida:
Thank you.
Operator:
Our next question comes from Matt Miksic with UBS. Your line is open.
Matt Miksic:
Hi. Thanks for taking our questions. So wanted to just one clarifying question, Jay, on Q1 guidance. You mentioned the sort of puts and takes and I think some seasonal effects that maybe show for a little – the weakest quarter of the year in terms of margins and a touch below where we were expecting. Was there anything else other than just absorption, or was there any FX impact there that you can quantify?
James K. Saccaro:
Yeah, sure. Just a couple of comments in terms of Q1. Historically for Baxter, Q1 has been the weakest quarter of the year with approximately 23% to 24% of full-year sales occurring in the quarter and 2016 is no different for us. The result of that of course is you have a lower drop through both in terms of margin and then ultimately in terms of EPS. And then there is another factor which is, we do have a slightly larger FX impact in the first quarter than we do in later quarters in the year. So roughly 40% of the FX impact on a full-year basis occurs in the first quarter of the year. So really those would be the two items that I would point to. There's nothing specific beyond that as we look at sales and performance in 2016.
Matt Miksic:
That's great. Thank you. And then one follow up on one of the things that's driving much of your growth in the current portfolio of businesses is around pumps. And really impressive number in Q4. Stepping back and thinking about that business, as we all know, it has had its challenges in the past as a category. And I just look to get an update on how you feel you're positioned with the new business coming in from SIGMA with some of the new FDA actions and guidelines on cybersecurity and some of the competitor that have had problems with that sort of new category requirement. How you're positioned going forward to help sort of mitigate the risks of other kinds of problems that you've had in the past as a group in pumps, not just Baxter, obviously.
José E. Almeida:
Matt, this is Joe. I can only speak about the Baxter product. In terms of the industry, you outlined well. There's always a concern. But this is not only – the only programmable pump that you have in that category. You have (48:28) pumps, you have all kinds of different things that fall into that category. But speaking specifically about our business, we have launched a really good product. And you can attest to – the testament to it is the sales growth and how we are gaining back market share and how that business is doing well. The team is executing very, very well. Our objective is to continue to improve the operation ability of the pump. We have new versions coming up in a couple more years. We have two more versions of the same platform. We are very excited about the prospect to create some new features within this pump, and we think in terms of cybersecurity, our pump has performed well. You can't in this area always guarantee 100%. We're doing the best we can to make sure that the platform we have is safe and secure for the clinicians who are programming it for the patients who are receiving the fluid.
Matt Miksic:
That's great. Thank you.
Operator:
Our next question comes from Larry Keusch with Raymond James. Your line is open.
Larry S. Keusch:
Oh, hi. Good morning, everyone.
José E. Almeida:
Morning, Larry.
Larry S. Keusch:
Good morning. Joe, I'm wondering if we could start out perhaps just talking a little bit about how you see the health of the emerging markets as you look into 2016. And I'm not so much talking about FX rates, but just more about just the baseline fundamentals within the various regions.
José E. Almeida:
Well, as you read the same headlines I do read, there is a contraction in some of the major – the larger emerging market economies. Very different in nature between China and Brazil and Russia, but nonetheless, we do 25% of our business in those regions. I think one particular thing about our business is that we are not a physician preferred product in those regions, and we are a hospital necessity. So we're talking about infusion, we're talking about dialysis, and those products are needed. So we have seen price pressure in those markets, but we probably saw that ahead of many people because of the nature of the products. So we feel that the risk of those markets for Baxter deteriorating further is pretty low. With all that said, is our responsibility to look at our portfolio in those countries and make sure that we're selling the right products to the right markets. And we're going through that process as we speak. But in terms of the headlines for Baxter is those are necessity products in hospital settings, and we've seen most of the contraction already. I'm not saying that we're not going to have them in the future, but we are not a physician preferred product company in those markets. So I feel very comfortable that our strategy at the moment is solid. But going forward, rest assured we're going to look at every region and every country to make sure that the business we have are profitable and have good prospects going forward.
Larry S. Keusch:
Okay. Terrific. And then I wanted to, Joe, perhaps get at again the growth question a little bit differently. And I think in your prepared comments you talked about reigniting the innovation engine at Baxter, and so you talked about sort of reallocating resources to drive inorganic and you talked about potential – excuse me, organic means, and then potential organic opportunities. But I guess as you've been there, and I know it's a short time, what do you really need to do to change, again, the ability of Baxter to innovate? Do you need to change the culture? Do you need to hire folks into these various categories to really drive the innovation? What needs to happen to get that engine ignited?
José E. Almeida:
So just a comment on how new I am. I can tell you I know where the cafeteria is because I eat there almost every day. So the culture of the company is one of innovation for many years. I think by not having Baxalta as part of Baxter today really puts the spotlight how we take those franchise that have been trusted in a long-term franchises around the globe and make them more innovative, create adjacencies within our own capabilities, our four walls here for organic growth. And the culture that I'm passing on to our employees is very clearly is about having a strategic direction, and that's about 10% of the conversation. 90% of the conversation is execution. So it's making sure that once we make the allocation of capital to the right programs, that our people deliver on time or better than that. And that's all about execution. So that's what I'm watching very closely, because I think we have very, very smart people at Baxter. I'm not surprised, but I'm very pleased with what I found here, and I want the folks of Baxter to understand that from this point when we get this strategy going, it's all about execution. And I think I have everybody behind me when it comes to that.
Larry S. Keusch:
Okay. Terrific. Thanks very much for the comments.
José E. Almeida:
Thank you.
Operator:
Our next question comes from Joanne Wuensch with BMO Capital Markets. Your line is open.
Joanne Karen Wuensch:
Good morning, and nice quarter. And it's good to hear your voice on a conference call again, Joe.
José E. Almeida:
Thank you.
Joanne Karen Wuensch:
Couple of things. First of all, we haven't heard in a while where you are on home hemodialysis and if you can give us an update on that, that would be great. And then in no particular order, second question, is there a way to quantify the $600 million in FX – not FX, pension impact on gross margins? And last but not least, M&A clearly is going to be a theme here. Big picture thoughts on adding additional legs to the stool and how you think about that. Thank you.
José E. Almeida:
Thanks, Joanne. How are you? Listen, I'm very, very excited about home hemodialysis, first of all. It is what I call blue ocean for the company. It is a great clinically needed innovation. It is not a easy market to get in because the technology has to be absolutely perfect for bringing this therapy to the home. But we think we have the right technology and working very hard to refine technology. Right now we already have kicked off our U.S. clinical trial for VIVIA, and we're excited about that. In Europe, we have early patients and we're learning very quickly about our VIVIA platform, and the use of this device is proving to be well received in Europe. So we like our technology. It is an area that I will call is a strategic bet and why is it strategic? Because it's high end market growth, potential for good revenue per patient, but more so the therapy itself is absolutely fantastic for the hemodialysis patient to be able to do this at home. So we're going to continue to improve our technology, and we will try to put some momentum behind accelerating the U.S. trial as much as we can and work with the agencies and CMS and see if we can get this technology at a different level.
James K. Saccaro:
Joanne, you asked a question about pension and quantifying, and you commented on $600 million. I think – I hope I didn't say that. That's an overstatement in terms of the impact on operating margin. On plan, it's about 60 basis points, which is closer to $60 million of unplanned benefit. But maybe taking a step back to talk about the overall impact of pension, overall we expect approximately a $0.14 benefit year-over-year from pension. $0.07 roughly of that relates to the retained stake contribution that we plan to make in the coming month or so. And then the remaining portion, there's a few different pieces. First, the actual discount rate used to measure the liability has increased, and the result of that is approximately a $0.035 benefit. Second, as we've evaluated our accounting for our pension plan, we made three adjustments. One is we updated the mortality table that we're using. The second is we are now employing the recently approved methodology for accounting for discount rate and that's a benefit. And then the return on asset assumption is an item that we've lowered. So those three accounting changes that we've made impact us positively by about $0.02. And then we have some amortized losses that are rolling off. So that's about $0.01. So in combination, we're talking about a $0.14 year-over-year impact, and importantly this counteracts some of the negatives like the lack of sundry income that we experienced in 2016 along with the significant headwind on foreign exchange. But overall, the pension impact is in that order of magnitude.
Joanne Karen Wuensch:
Thanks. And the last question, add a leg of the stool.
José E. Almeida:
We will continue to work on inorganic and organic areas. I would say to you that a leg of the stool may be just enhancing a franchise that we have. We spoke about IPS and very, very excited about that. I like our specialty injectable business today, and I think augmenting that can become a real good business. And in terms of white space is a little early. We need to kind of get our capital allocation going well, and once we have that well segmented within our population and our management objectives then we can do a white space analysis, and we will proceed on going down that path. But we really have enough opportunities right now to augment the current businesses. And their adjacencies as well. Thank you.
Joanne Karen Wuensch:
Thank you.
Operator:
Our final question comes from Glenn Novarro with RBC Capital Markets. Your line is open.
Glenn John Novarro:
Hi. Good morning, guys. Two questions
José E. Almeida:
Glenn, how are you?
Unknown Speaker:
Good.
José E. Almeida:
So, listen, the utilization that we see, I just want to clarify, the next year's growth is 2% to 3%, Right?
Clare Trachtman:
For surgical care.
José E. Almeida:
For surgical care. So the utilization remains at a good point in U.S. I would say the U.S. has shown really good resilience, and we're happy about that. There's a couple things about the surgical business, one that our anesthesia gases are performing very well, and we need to do a better job in our biosurgery business. We're going to be coming up with some specific actions in terms of execution, but also how we're going to manage that business on a global basis, as well as that is an area that we probably should be looking to augment our portfolio. It's a great area of opportunity. Baxter has fantastic franchises within that category, and we want to make sure we don't miss the opportunity to take advantage of the market growth. So speaking about the PD business, we are growing our patient basis. So that is market share growth. And I'm going to tell you our new technology, new platform AMIA is fantastic, and we're having some really early successes and we're looking for a very good 2016 in that arena.
Glenn John Novarro:
Okay. Great. Welcome back, Joe.
José E. Almeida:
Thank you, Glenn.
Clare Trachtman:
Thank you. This will conclude...
Operator:
Thank you...
Clare Trachtman:
Yeah, Stephanie, we'll conclude the call.
Operator:
Thank you. Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you all for participating. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Third Quarter 2015 Earnings Conference Call. [Operation Instructions] As a reminder this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Stephanie. Good morning and welcome to our Third Quarter 2015 Earnings Conference Call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International. Jay Saccaro, Chief Financial Officer; and Scott Bohaboy, Corporate Vice President, Investor Relations, and Treasurer. On the call this morning we will be discussing Baxter's Third Quarter Financial results and outlook for the remainder of 2015 before taking your questions. Before we review our financial performance in the quarter, I'd like to mention that this morning we issued an 8-K detailing the 2014 and 2015 quarterly income statements for Baxter on a stand-alone non-GAAP basis. Today's review of the results for the third quarter of 2015 and outlook for the remainder of the year will reflect comparisons to the 2014 ongoing baseline detailed in the 8-K filing. With that let me start our prepared remarks by reminding everyone that this presentation, including comments regarding our financial outlook, new product developments, and regulatory matters, contains forward-looking statements that involve risks and uncertainties. And of course our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition on today's call non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I'd like to turn the call over to Bob Parkinson. Bob?
Robert L. Parkinson, Jr.:
Thank you, Clare. Good morning and thanks to all of you joining us. We're very pleased to report strong performance for the third quarter, our first as a stand-alone leading medical products company. These results clearly demonstrate the momentum our organization has established following the spin-off of Baxalta, momentum upon which we will build to further accelerate profitable growth in the quarters and the years ahead. As you saw in our press release this morning for the third quarter, Baxter delivered adjusted earnings of $0.41 per diluted share, significantly exceeding our guidance of $0.29 to $0.31 per diluted share. On a constant currency basis worldwide sales increased 2% and also exceeded our guidance. After adjusting for foreign exchange and the impact of increased U.S. competition for cyclophosphamide, sales advanced 3%. Results in the quarter benefited from a favorable product mix, lower operating expenses, and other income resulting from foreign exchange related gains. As you know at our – excuse me – at our May Investor Conference we outlined a number of initiatives focused on expanding margins and accelerating profitable growth. These measures are gaining traction, as evidenced by our strong third quarter performance. While these are still early days, the initial results reinforce our confidence that we're clearly on the right path to achieve our financial objectives, which will create value for our shareholders, patients, employees, and other stakeholders. And as we've repeatedly stated our aspiration remains to exceed the profitability targets that we had laid out at that Investor Conference. As you'll recall we're executing a three-pronged strategy to accelerate profitable growth, focused on rebasing our cost structure, optimizing our existing products and services through rigorous portfolio management, and finally, expanding our offering of high valued differentiated products through execution of our robust new product pipeline. I want to share a few highlights from the quarter in each of these areas to demonstrate the substantive progress that we're making on this journey. So let me start with cost structure. Back in May we acknowledged the compelling need to rebase our structural cost to better align our expense base with the resource requirements of our new stand-alone enterprise. During the quarter we took an important step in this regard, initiating a global workforce reduction program, representing approximately 5% of all non-manufacturing payroll. This action is expected to generate approximately $130 million in annual savings once complete and is one of the first that we've taken to address our cost structure. As we move forward, we'll continue to evaluate our support levels to ensure that they're appropriate. In addition post separation we've implemented an array of expense controls targeting discretionary spending categories that will reduce our ongoing spend moving forward. Collectively, these actions will ensure that we enter 2016 with a leaner cost base that supports our new business profile and financial goals. And I can assure you that our aggressive focus in this area will continue in the months to come, as we pursue additional opportunities to increase efficiency and reduce structural cost. The second area that we emphasized in May was successfully managing and optimizing our existing product portfolio to improve operating performance. And as we've previously mentioned, we're taking a very disciplined approach with respect to our top line growth opportunities to ensure that they're aligned with our margin improvement objectives and deliver appropriate returns. This year there have been certain international tenders that we have opted not to pursue, because they would not deliver benefits aligned with our profit improvement goals. More broadly we're applying this same discipline to each the product areas and geographies we serve. And we'll evaluate our presence in select markets to ensure it's aligned with our targeted return profile. And going forward you can expect regular updates on the progress being made in this important area. We know emerging market performance has been the key topic of discussion for investors. These geographies play an important role in our growth strategy. And while we're certainly not immune to the macro challenges in play, we're confident that the medically essential nature of our products, combined with the breadth of our portfolio, will continue to position Baxter well over the long-term, despite some near-term volatility. During the quarter the company's emerging market sales rose mid-single digits on a constant currency basis, largely aligned with the long-term guidance that we provided in May. And finally, I want to highlight some key developments in our new product pipeline. Innovation has and will always remain a cornerstone of our success. And we're committed to a future of ongoing advances in areas of clear medical need. Looking out over the months and years ahead, we'll launch a number of highly advanced new products, make significant life-cycle improvements to existing offerings, and expand penetration of our current products into new geographies. Some of our recent achievements include FDA clearance for AMIA, our new automated peritoneal dialysis system with SHARESOURCE, our two-way web-based remote connectivity platform for home parents. AMIA is the only system approved in the U.S. that incorporates innovative patient centric features, such as voice guidance, a touch screen control panel, and SHARESOURCE. SHARESOURCE provides physicians with the ability to remotely access their home patient's historical treatment data and deliver individual treatment settings. We're initiating the launch of AMIA with SHARESOURCE and anticipate having units in the market before year end. Also the recently CE-marked HOMECHOICE CLARIA APD system is successfully launching in markets across Europe. CLARIA builds on the strength of our market leading HOMECHOICE cycler, now incorporating advanced technology and the benefits of the SHARESOURCE web-based remote connectivity, among other patient- and other provider-centric enhancements. Moving to our Hospital Products business, we continue to successfully expand the launch of our next generation SIGMA SPECTRUM infusion pump across the U.S., Canada, and Puerto Rico. Demand for the newly enhanced SPECTRUM technology remains strong and is trending better than our prelaunch expectations. Also in the third quarter Hospital Products announced FDA approval of Cefazolin 2-gram injection in our proprietary GALAXY Container. Cefazolin has been on the FDA's drug shortage list and in a variety of presentations due to high demand. This is the first of nine molecules that Baxter is developing and expects to launch over the next several years. And we recently submitted the second molecule for a review with the FDA and expect to launch this molecule in early 2016. As these highlights demonstrate we're making meaningful advances across our overall margin improvement framework, and this is only the start. So with that let me now turn over to Jay for a closer look at the third quarter performance and also outlook for the remainder of the year. And then prior to taking your questions I'd like to take a moment to make some closing comments. So, Jay, please.
James K. Saccaro:
Thanks, Bob, and good morning everyone. As Bob mentioned, adjusted earnings in the second quarter of $0.41 per diluted share exceeded our previously issued guidance range of $0.29 to $0.31 per share. Performance in the quarter benefited from the disciplined management of discretionary expenses, a favorable product mix, which included better than expected cyclophosphamide sales, and other income from foreign exchange related gains. On a GAAP basis, income from continuing operations of $2 million included net after tax special items totaling $223 million or $0.41 per diluted share, primarily for costs associated with the company's spinoff of Baxalta, business optimization initiatives, debt extinguishment, and intangible asset amortization. Before I walk you through the P&L I wanted to take a moment to make some comments regarding our historical financial statements, which we detailed this morning in our 8-K filing. First, I want to start by acknowledging your patience with respect to these statements. Given the highly integrated nature of the BioScience and Medical Products businesses pre-spin, the preparation of the historical filings required significant time. Second, I wanted to highlight that these statements have inherent complexities associated with them when comparing current results with those of prior periods. More specifically, for the most part prior periods do not reflect income we received from Baxalta related to transition service agreements and deferred country closings. In addition given the highly integrated nature of our businesses, we were not able to clearly isolate select expense categories between Baxalta and Baxter in the discontinued operations presentation. And lastly, the historical P&Ls included payroll expenses for certain positions initially determined as backfills for employees that transitioned to Baxalta. Upon further evaluation post-spin, some of these roles have since been eliminated and will not be replaced. Investors should consider all of these factors when comparing Baxter's current results to historical periods. Now let me briefly walk you through the P&L by line item before turning to the financial outlook for the fourth quarter of 2015. Starting with sales, worldwide revenues of approximately $2.5 billion declined 8% on a reported basis. On a constant currency basis, sales increased 2%, which compares favorably to our guidance for the quarter of comparable sales to the prior year. Excluding the impact of both currency and increased competition for cyclophosphamide, Baxter's sales grew 3% globally. Sales in the U.S. declined 1% on a reported basis, and after adjusting for cyclophosphamide, U.S. sales advanced 3%. International sales on a constant currency basis increased 3% and declined 12% on a reported basis. In terms of individual business performance, within Hospital Products, global sales of approximately $1.5 billion declined 7% and on a constant currency basis sales rose 2%. Adjusting for the impact of U.S. cyclophosphamide and foreign exchange, Hospital Products sales increased 4%. Within the Fluid Systems franchise, sales of $526 million declined 3% and on a constant currency basis sales advanced 5%. Performance in the quarter was driven by double-digit growth in the infusion systems business, supported by the successful launch of our next generation SIGMA SPECTRUM pump as well as a favorable customer mix for U.S. IV solutions. Sales in the Integrated Pharmacy Solutions, or IPS franchise, totaled $590 million and declined 8%. On a constant currency basis, sales grew 1%. Excluding the cyclophosphamide impact, sales in the category increased 9%, driven by strength across the franchise, which includes our nutritional products, pharmacy injectables, and hospital pharmacy compounding services. IPS and performance in the quarter also benefited from a U.S. government order for the pharmacy injectable PROTOPAM. During the third quarter, U.S. cyclophosphamide sales totaled $80 million as compared to our previous expectation of approximately $50 million. To date there remains one competitor in the U.S. market, but we continue to expect additional competition to enter, although the timing of these entrants remains uncertain. Revenues in Surgical Care, which includes our anesthesia and biosurgery products, were $322 million in the quarter and declined 5%. On a constant currency basis, sales grew 2%, driven by strong performance globally in the anesthesia business and growth of core surgical sealants and hemostasis products, including our market leading FLOSEAL Hemostatic Matrix. This performance was offset by lower sales of select non-core biosurgery products, including PERI-STRIPS, where prior year's sales benefited from a competitor being out of the market, who has since returned. Finally, sales in the biopharma solutions and other category, which is our pharma partnering business, totaled $106 million, and as expected declined 19% on a reported basis or 12% on a constant currency basis. As we have previously discussed, this decline is driven by a large customer choosing to self-manufacture products that were previously contract manufactured by Baxter. I'd also note that this category now reflects sales for products Baxter is manufacturing on behalf of Baxalta, which totaled approximately $14 million in the quarter. Turning to the Renal business. global Renal sales totaled $943 million, reflecting a decline of 11% on a reported basis. Excluding the impact of foreign currency, sales grew 1%. Performance in the quarter was driven by mid-single digit growth in our peritoneal dialysis business and high-single digit growth in the acute business. This growth was offset by lower sales in our chronic hemodialysis business, resulting from our previously discussed decisions to forgo certain lower margin sales opportunities, the implementation of select austerity measures in Western Europe, and a particularly competitive environment for dialyzers. Turning to the rest of the P&L. Gross margin in the quarter was 43.8% and compared favorably to our expectations, driven primarily by positive product mix in the quarter. SG&A totaled $670 million and decreased 15% on a reported basis. On a constant currency basis, SG&A declined 6%, reflecting the benefit of the initial actions we have taken to re-base our cost structure and reduce discretionary expenses, along with transition service income we received from Baxalta in the quarter. Further actions to optimize our support structure needs are somewhat constrained in the short term by the transition service agreements we have in place with Baxalta. These agreements extend over the next 18 to 24 months. And as we pursue additional opportunities to streamline our ongoing functional support requirements, we must be mindful of the services we're providing to Baxalta. R&D spending in the quarter of $140 million decreased 5% versus the prior year. On a constant currency basis R&D expenditures increased 2%, as we have balanced increased investments to support our new product pipeline with efforts to optimize our overall R&D spend. Operating margin in the quarter was 11.2%, which compared favorably to our guidance of 9% for the second half of 2015, driven by the positive gross margin and operating expense savings I just referenced. As Bob mentioned this quarter we implemented a global workforce reduction program, which will generate approximately $130 million in annual savings when fully implemented. This program is a component of our comprehensive strategy to improve profitability and significantly expand operating margins by 2020. As we move forward we'll continue to streamline our operations and control spending in support of this objective. All of our cost structure initiatives remain on track. And we are confident in our ability to achieve the 2020 operating margin target. Interest expense was $34 million in the third quarter, compared to $31 million last year. During the quarter we successfully executed a tender for $2.7 billion of outstanding bonds. The benefit of this reduced debt level was more than offset by lower levels of capitalized interest in the quarter. At quarter end our current gross outstanding debt balance was approximately $6.7 billion and consisted of approximately $4.8 billion of bonds and other term debt, approximately $1.5 billion of outstanding balances on our revolving bank line, and approximately $400 million of commercial paper. As previously communicated we'll look to further delever our balance sheet in the months ahead as part of our strategy to optimize the retained equity stake. In addition to these activities we expect our retained stake utilization plans to include equity for equity exchanges as well as a contribution to our U.S. qualified pension plan, subject to regulatory approval. Cash on hand at the end of the quarter totaled approximately $2 billion. Other income totaled $39 million and included a planned gain related to the sale of select equity investments of approximately $20 million and an unplanned foreign exchange gain from hedges on balance sheet positions of approximately $20 million. The tax rate was 20.8% for the quarter. And as previously mentioned adjusted earnings of $0.41 per diluted share exceeded our guidance range of $0.29 to $0.31. Let me conclude my comments this morning by providing an update on our full year sales guidance and outlook for the fourth quarter. Starting with sales on a constant currency basis. We now expect sales for the full year 2015 to increase approximately 1%. And after adjusting both periods for the cyclophosphamide impact, we continue to expect underlying growth of approximately 3%. This is driven by growth in the Hospital Products business of approximately 1%, or 4% excluding cyclophosphamide. Specific to the franchises within Hospital Products we now expect sales growth of 4% to 5% for Fluid Systems, reflecting the strong performance from infusion systems and U.S. IV solutions. For the Integrated Pharmacy Solutions franchise we now expect sales to decline low single digits. As you know this category includes cyclophosphamide. For the full year 2015 we now estimate U.S. cyclophosphamide sales to total more than $250 million, reflecting the $30 million third quarter benefit and an additional benefit of approximately $25 million in the fourth quarter, relative to previous guidance. Growth for the category after adjusting for cyclophosphamide is expected to increase mid-single digit. With the Surgical Care franchise we anticipate sales to grow approximately 3%. This growth is somewhat slower than our original expectations and reflects lower sales of non-core biosurgery products. And finally, for the Hospital Products business we now expect the other category, which includes our biopharma solutions franchise, to decline mid-single digits. As I mentioned earlier this category now includes sales related to contract manufacturing agreements we have in place with Baxalta. For the Renal business we now expect full-year sales to increase approximately 1%, as we remain focused on maximizing the profitability of this business and maintaining a disciplined approach with respect to international tenders. In addition as a reminder, the Renal business is more exposed to the current volatility in emerging markets than other areas of our portfolio. While over the long term we feel very confident that we're well positioned to capitalize on the growth opportunities within these geographies, near-term performance will be impacted by softness in these markets. Moving to the fourth quarter of 2015. We expect sales growth excluding the impact of foreign currency to decline approximately 1%. And after adjusting for U.S. cyclophosphamide to increase 1% to 2%. At current foreign exchange rates we expect reported sales to decline approximately 9%. For the fourth quarter we expect an operating margin between 9.5% and 10%, which again compares favorably to our previously issued second half guidance of 9%. The sequential decline from the third quarter reflects incremental operational improvements and additional savings from our cost reduction initiatives being more than offset from the impact of lower sales of higher margin products like cyclophosphamide and PROTOPAM, as well as the negative impact from foreign exchange. We expect interest expense to total approximately $35 million and other to be an expense item of approximately $5 million in the quarter. We continue to expect a tax rate of approximately 20% and an average share count of 550 million shares. As stated in our press release we expect adjusted earnings excluding special items of $0.30 to $0.32 per diluted share. Relative to our previous guidance earnings in the quarter reflect the benefit of incremental sales for cyclophosphamide, offset by a negative impact from foreign exchange. Before we open up the call for Q&A I'd like to turn the call back over to Bob for some closing comments. Bob?
Robert L. Parkinson, Jr.:
Thanks, Jay. So before we do open up for Q&A I'd like to spend just a minute addressing Baxter's path forward. Certainly, our biggest milestone in 2015 was the successful completion of the BioScience spinoff, resulting in the establishment of two leading global healthcare companies. The spinoff positioned both Baxter and Baxalta with improved focus and an ability to innovate and operate more effectively, which will create enhanced value for all of our stakeholders. I would tell you I couldn't be more pleased with the progress the Baxter organization has made following the spinoff, and my confidence in our future has never been stronger. Our third quarter results I think demonstrate the commitment of all of our employees around the world and the clear alignment that exists throughout the organization on achieving our strategic, operational, and financial objectives. Given this momentum which has been established I'd like to touch on the search process for a new Baxter Chief Executive. As I mentioned last quarter this is a front burner topic for the board. I would tell you we're making very good progress in the search for my successor. As I think you can understand due to the confidential nature of the search we can't comment now on timing or other specifics this morning. Turning to capital allocation and in particular our use of the retained Baxalta equity stake, where our primary objective remains maximizing the after-tax value of the stake. Consistent with our previous statements we intend to use the stake in a highly tax efficient manner to optimize our capital structure, which will provide additional flexibility to support organic growth initiatives and pursue external business development opportunities. Regarding M&A. While we did not include any benefit in the financial projections that we provided in May, going forward we expect M&A to be a key component of our strategy to accelerate profitable growth. Over the next 12 months as we enhance our balance sheet and progress on our post-spin margin improvement initiatives, we will have significant flexibility to evaluate opportunities that are more transformative in both scope and scale, but still align with our business model and leverage our broad channel strength and geographic presence. In closing our aspiration remains to be a truly great company in service of our mission to save and sustain lives. And I'm confident that we're on our way to achieving this goal. So with that I think we can now open up the call to questions, Clare. Okay?
Clare Trachtman:
Stephanie, would you open?
Operator:
Thank you. We will now begin the question-and-answer session. I would like to remind participants that this call is being recorded and additional replay will be available on the Baxter International website for 30 days at www.baxter.com. And our first question comes from David Roman with Goldman Sachs. Your line is open.
David Harrison Roman:
Thank you. Good morning, everybody. I wanted to ask one strategic question and one financial question. And maybe, Bob, I'll pick up on where you ended the call with respect to M&A. I think at the time of the Analyst Meeting back in May, the communication was that unlikely to see M&A for at least 12-plus months. And now it sounds like M&A is becoming a more important part of the potential forward path. And understandably it might not happen immediately. But can you maybe just sort of talk us through the evolution of the thought process around M&A? And give us some flavor for why M&A has become a – potentially moved up the priority scheme? And then what type of deals you might be considering?
Robert L. Parkinson, Jr.:
Well I think a lot of this, David, is about timing. At the May conference I commented on two constraints in the short term, certainly within let's say the first 12 months. One was some financial constraints certainly as we navigated our way through the retained stake and so on. But the second one being organizational. Completing the innovation of Gambro, our ability to continue to support the Baxalta spinoff, which requires a significant organizational commitment on Baxter's behalf going forward. Relative to the organizational constraint, frankly things have moved ahead even better than we had anticipated I think on all fronts. So I think our organizational capacity to contemplate being more proactive, perhaps maybe even a little sooner on M&A, is better today than what maybe we had anticipated in May. And it's not going to be long before we've worked through this retained stake and so on. And as I commented in my prepared comments we're going to have significant flexibility. So we've advanced our thinking on things that we might want to do on the M&A front. I'm not going to be real specific in terms of size. But possibly we could be thinking bigger than maybe what we've characterized in the past. What we do know is we have such a strong presence in the acute care hospital channel, wherever you go in the world. The Baxter brand is well recognized. It's respected. And so the opportunity to do some things that fill out that channel more effectively, we're very interested in. So beyond that I'm not going to be any more specific than that. But hopefully that gives you maybe a little bit more color as to how I think things evolved since we got together last May.
David Harrison Roman:
No, that's definitely helpful. Thank you for – and then just...
Robert L. Parkinson, Jr.:
Sure.
David Harrison Roman:
On the financial side obviously the second half of 2015 is coming in better than you had communicated, some of which is tied to a slower run down in cyclophosphamide than might have been previously expected. But how should we think about what we're seeing in the back half of 2015 as it relates to the initial targets you provided for 2016 back in May? How much of what we're seeing is sustainable versus more one time in nature?
Robert L. Parkinson, Jr.:
Jay, you want to handle that?
James K. Saccaro:
Sure. Just making a comment in terms of third quarter performance. We over-achieved the midpoint of our guidance by $0.11. And there was really three primary drivers which contributed to that. One was cyclophosphamide. A second item related to some other income driven by foreign exchange and the timing of investment gains. And then the third piece relates to savings related to the cancellation of (30:51) spending controls that we put in place as well. So those really are the three primary drivers of the over-achievement in Q3. As we move forward, what I would say, is the one that was most important to us was the operational performance related to the spending controls that we put in place. And we're not updating 2016 guidance at this stage. But what I will tell you is we're very confident in our ability to execute, particularly on the cost side and also on the margin side as we move forward. We'll update guidance in January. But at this stage, I think this first quarter was a very important building block for us to put in place that gives us a high level of confidence as we move forward through the rest of the plan.
David Harrison Roman:
Okay. Got it. Thank you very much.
Robert L. Parkinson, Jr.:
Thanks, David.
Operator:
Our next question comes from Matt Taylor with Barclays. Your line is open.
Matt C. Taylor:
Hi. Thanks for taking the question. So you had good performance. You outlined the three factors. I guess could you expound a little bit on the third one that you talked about in terms of the savings cancellation? And I was just wondering if you could help us put that into context with your prior guidance. How much of the upside was driven by that? And then how much does that change your margin expectations maybe relative to the LRP? What wasn't in the guidance before?
Robert L. Parkinson, Jr.:
Yeah, I think the biggest factor was really the timing of the action. So as we think about the performance in Q3, we had approximately $25 million, maybe a little bit more than that, of savings related to two areas
Matt C. Taylor:
Okay. That's helpful. And then I guess another piece that you've talked a little bit about that wasn't in the plan numbers is an opportunity on price, maybe in the PD business or in the IV solutions business. Could you talk a little bit about the opportunities in each of those two businesses, and I guess why you feel like pricing may be a lever that you can pull over the next 12 months?
Robert L. Parkinson, Jr.:
Now I don't, Matt, I don't think there's anything new there from what we've messaged previously on that. And so for a number of reasons, including competitive reasons, I don't think I'd want to expand on that any further this morning.
Matt C. Taylor:
Okay. All right. Thanks a lot for the comments.
Robert L. Parkinson, Jr.:
Thanks, Matt.
Operator:
Our next question comes from Bob Hopkins with Bank of America Merrill Lynch. Your line is open.
Robert Adam Hopkins:
Hi. Thanks. Can you hear me okay?
Robert L. Parkinson, Jr.:
Sure, Bob, go ahead.
Robert Adam Hopkins:
Great. So I wanted to follow up with a couple questions on the operating margins. So I'll just rattle off a few things here. So in the quarter, how much of the roughly 200 basis points of operating margin beat was due to the $30 million in better cyclo sales? And in terms of the fourth quarter guidance, which looks like it's down by about 150 basis points, could you just break that out a little bit more? Because it seems like cyclo is only coming down by $5 million. So just want to understand the kind of Q3 to Q4 dynamic there a little bit in a little bit more detail.
James K. Saccaro:
Sure. Just one clarifying comment before I address the rest of the question. Cyclo is actually down from Q3 to Q4 sequentially $30 million, so in Q3 we achieved roughly $80 million. We expect to achieve roughly $50 million in Q4.
Robert Adam Hopkins:
Got it.
James K. Saccaro:
As it relates to the operating margin of 11% in the quarter, there were really two drivers of that. One relates to the cyclo over-performance, and that was about 1 point. And the second relates to the timing of the spending savings that we were able to initiate. And that was another roughly 1 point of margin. So if you adjust for those two items, those were the two drivers of the over-performance. Now turning sequentially from Q3 to Q4. We're guiding to 9.5% to 10%. And so relative to the 11.2% that we experienced in Q3, there are a number of drivers. First, we have about 1 point of cyclo deterioration from Q3 to Q4. Second, we have about 1 point of foreign exchange deterioration from Q3 to Q4. The other comment is in Q3 we had a large order of PROTOPAM. And while that's not necessarily a one-timer, it is a periodic order that we receive, and we don't forecast one for Q4. And that's roughly 0.7 points of margin that we're going to lose from Q3 to Q4 that we expected and planned for. But as we think about our performance moving forward, there are two drivers that we're going to continue to experience benefits from, general operational improvements of about 80 basis points and operational OpEx savings will also continue to accelerate as well. So as we think about it, that's what drives the 11.2% to roughly 9.5% to 10%.
Robert Adam Hopkins:
Great, Jay. That's very clear. Thank you. And then one big picture question regarding the request last night from a couple senators for the FTC to investigate saline business broadly among the big three competitors there. I'm sure there's probably not much you can say about that. But I just wanted to make sure I had a good understanding. In the current LRP, this business is a decent chunk of the overall whole. What kind of – I mean I assume you've been assuming pretty decent price increases in that business in your LRP. Could you just confirm what kind of price increases you've got assumed in the LRP for saline going forward?
James K. Saccaro:
Yeah. Overall in the long-range plan we had fairly modest price increases across the portfolio. In some product categories we had low increases. In other product categories we actually had price declines. Bob, you want to add anything?
Robert L. Parkinson, Jr.:
So thanks for asking the question, Bob. And again I'm somewhat limited in terms of what we can say. But maybe some thoughts I would share. I think everybody appreciates the fact that IV solutions are probably one of the best medical values in healthcare today. We've used the analogy of the cost of an IV as less than a cup of coffee or a bottle of water that you'd buy at 7-Eleven. Right? I will tell you all we've made extraordinary efforts to maximize the availability of product to address the shortage, including significant investments to identify and secure additional sources of supply. By the way this includes working with the FDA to get one of our foreign plants in Spain approved to import product from Spain to help mitigate the shortage situation. We continue to work with them on other international sourcing locations as well. The average price for IVs has increased at a fairly modest level over the past. Okay? And Jay commented on our views going forward. So I would just conclude by saying look, we're confident in our practices. I would characterize them as reasonable, appropriate. But again just to reiterate, we're taking every step we possibly can to make product available to address the shortage. So beyond that I won't expand any further, Bob. But thanks for asking the question.
Robert Adam Hopkins:
Great. Thanks for taking the questions.
Robert L. Parkinson, Jr.:
Sure.
Operator:
Our next question comes from David Lewis with Morgan Stanley. Your line is open.
David Ryan Lewis:
Good morning.
Robert L. Parkinson, Jr.:
Hi, David.
David Ryan Lewis:
Bob, just to start with you really quickly here. Emerging market commentary kind of across the coverage universe this quarter has varied amongst companies. I think you commented that your EM business was generally in line with what you talked about back in May. Can you sort of talk about how you saw the business in May? What you're seeing here in the third and early fourth quarter? And how you describe your EM business here from a growth perspective? Is it stable? Is it slowing? Is it accelerating?
Robert L. Parkinson, Jr.:
Yeah. So thanks for asking the question, David. Yeah, I characterized it as generally in line. Frankly, it's a tad softer than what we had messaged in May, although it's hanging in there pretty well and probably stronger than a lot of other companies. And I think that speaks to, as I mentioned in my prepared comments, the "essential nature" of our products and so on. But look, the reality is – and we all know what's going on – emerging markets are a real challenge right now. And I'm not going to project a significant turnaround in the near term. But I do think the guidance that we provided over our LRP in terms of revenue growth will be achieved over the 5-year period of time. I would tell you the one business that has been particularly hit by that has been kind of the traditional in-center hemodialysis business, which we saw a disproportionate impact of the softening of the emerging markets. But just so you don't misinterpret my comments, emerging markets – continued investments in emerging markets given the nature of our products will continue to be an important aspect of our growth prospects over the LRP.
David Ryan Lewis:
Okay. And maybe just, maybe two quick ones. Bob, just one more strategic view.
Robert L. Parkinson, Jr.:
Yeah.
David Ryan Lewis:
You mentioned the word transformative in your M&A commentary. Is transformative M&A possible during the CEO transition? And then second one just for Jay. In Fluids Systems there's a lot of strength there. Jay, was that systems or disposables mix? What was the bigger driver? And specifically can you flush out what was it about the disposable mix that drove the acceleration? Thank you.
Robert L. Parkinson, Jr.:
So I would say in the first part, transformative is a relative term. But obviously we're open-minded to things that are material. I will tell you that I've had dialogue with our Board on some things that we might want to consider doing, relative to the timing of this as it relates to succession. I guess we need to define the succession timing first and then go from there. But the succession has not gotten in the way of us having strategic dialogue with our Board in this regard. And I'm confident that based on the timing of the succession that that dialogue will continue, David. Okay? Jay, you want to do the second one?
James K. Saccaro:
Yeah, sure. And as it relates to the infusion system strength, really the key driver of that was the sale of the SIGMA SPECTRUM Pump in the U.S. We did see mid to high single-digit sales growth of access. But from an overall driver standpoint we're pleased with the progress that we're making on the infusion pump launch. That's going very well. And that was the key driver in the quarter that led to the double-digit growth.
David Ryan Lewis:
Great. Thank you.
Operator:
Our next question comes from Mike Weinstein with JPMorgan. Your line is open.
Michael J. Weinstein:
Thank you. I just want to go back to maybe the first couple questions on the call. So just to flesh out the quarter. So, Jay, if you broke it down, the different upside drivers in the quarter between cyclo delay, the gains, FX, and other that were in the other income line PROTOPAM shipment this quarter, and then maybe the continuing ops, how would you break that down?
James K. Saccaro:
Sure. The PROTOPAM piece was actually included in our original guidance. So that was not an upside to the guidance. But that was about $0.025 roughly of EPS that we had expected. The important thing about PROTOPAM is like I said in my comments earlier, it is not a one-time order. These are periodic orders that we receive. We just don't receive them every quarter. So it was an expected driver of performance in the quarter. Relative to our $0.30 midpoint, as you said there were three upsides. One relates to cyclophosphamide. We had about roughly $30 million of unplanned upside in that category. One relates to other income. We had forecasted certain other income for the second half of the year, but we did over-achieve that, largely driven by balance sheet positions that we had in place in overseas entities driving foreign exchange gains. And that was about $0.03 of over-achievement. And then finally, the OpEx savings that I described earlier was about $25 million, between $0.03 and $0.04 of impact in the quarter. And as I said that was a very important component for us to put in place early on this margin improvement journey.
Michael J. Weinstein:
Okay. So the – you would characterize it as $0.03 to $0.04 is what you would view as being ongoing?
James K. Saccaro:
Yes. Exactly. Those – that would be more ongoing.
Michael J. Weinstein:
Okay. Perfect. And then just to make sure we're thinking about the Baxalta stake correctly. Jay, is your priority still, besides the pension, the revolver that comes due in December?
James K. Saccaro:
Yeah, maybe just taking a step back. Thanks for the question, Mike. I'll make some further comments on the retained stake, so everyone is on the same page. The strategy with the retained stake remains the same. Our objective is to maximize the after tax value. We have a private letter ruling from the IRS, which supports essentially three mechanisms for us to utilize that stake over the next 18 months in order for us to achieve that tax free status that I described. One is an equity for equity exchange. One is an equity for debt exchange. And one is a contribution to our pension plan. As it relates to progress that we're making in the quarter, we are continuing our discussions on the pension with Department of Labor. And we're very confident that we'll receive the appropriate approvals that will allow us to make a pension contribution. And we were pleased with the progress in the quarter. As it relates to equity for debt, you're right. We did file – Baxalta on our behalf filed an S-1 in the quarter, which we have earmarked for a piece of debt that expires in December. The reason I like that debt is because it's a very low-cost way for us to use the retained stake in the sense that there are no premium or breakage fees associated with retiring that piece of debt. So it really does help achieve our objective. To the extent that the market conditions are right, and we feel like we have a transaction window that's appropriate for us to take advantage of, we do expect to target that piece of debt with a portion of the Baxalta equity stake. More broadly we will think about equity for debt and looking at the overall bond complex in the form of a secondary offering with a modified debt tender later on. So overall that all continues as we expect moving forward. And we do – we'll evaluate conditions as we move forward to see if there is an opportunity for us to target that piece of debt prior to December.
Michael J. Weinstein:
That's very helpful. Thanks, Jay. Thanks, Bob.
Robert L. Parkinson, Jr.:
Thanks, Mike.
Operator:
Our next question comes from Matt Miksic with UBS. Your line is open.
Matthew S. Miksic:
Thanks. Thanks for taking the question. So one follow-up for Bob on your questions about M&A and strategic investment. Not to beat a dead horse, but I did just want to touch on one aspect of your meeting in May. It was talking about accelerating profitable growth. And so if we think of assets or transformative or mid-sized acquisitions or – and so on, should we be thinking about something that is a synergy play on your platform and with cost synergies involved? Or should we be thinking of something that is in fact going to help sort of drive growth your – as well?
Robert L. Parkinson, Jr.:
Yeah. Matt, I'm not sure I can expand a lot beyond what I said in answer to one of the earlier questions on this, but maybe to reiterate a point. The priority would be things that as I said before flesh out our acute care hospital channel. So that's another way of saying commercial synergy, where one plus one is greater than two. Clearly structural cost would be part of it as well. And targets that we would look at would be meaningfully accretive. But it would be both a commercial synergy play leveraged in the acute care channel, and depending upon on what the target may be, a structural cost as well.
Matthew S. Miksic:
And one if I could follow-up on a question earlier on pumps.
Robert L. Parkinson, Jr.:
Sure.
Matthew S. Miksic:
If you could talk a little bit about the success that you've had there? That process is of course winning contracts, placing channels, and enjoying and driving the pull through of utilization. Could you talk a little bit about maybe where you are this year? If there is a point where you've sort of either hit changing comps or change in mix? Or just some color on the process of that roll-out? And then I have one more follow-up for Jay.
Robert L. Parkinson, Jr.:
Yeah. So the momentum on the SIGMA launch as I commented is building. We're very pleased with the market response to date. Just to ground everyone you'll recall in our Investor Conference and the LRP projections, we assumed that we would regain approximately 5 of 10 share points in the U.S. launch lost over the last number of years, because of the colleague challenges and so on. All I would say, Matt, on that is given the early impact of the relaunch, we are highly confident that we will be able to regain at least those 5 share points in the LRP. And I think our longer term aspiration of recovering all of that share loss, if not more, is certainly very, very viable. Admittedly there's a little bit of pent-up demand. And so we want continue to gauge that and monitor the sustainability of that. But again all I can just really say qualitatively or subjectively is we're very, very pleased with the market response to SPECTRUM. The product is performing very well. And really beyond that I'm not going to expand. Hopefully that helps.
Matthew S. Miksic:
Sure. Well congrats on the progress so far.
Robert L. Parkinson, Jr.:
Yeah, thanks.
Matthew S. Miksic:
And then, Jay, a comment. You mentioned a couple times the gains, FX gains, as being one of the positives. I was wondering if you could highlight – those sounded like balance sheet or asset-related gains below the operating line. Could you talk a little bit about the impact of the sort of FX gains that dropped through the P&L in terms of the offset, either natural hedges or otherwise? If you have a net feel for what the impact of FX was to the P&L?
James K. Saccaro:
Sure. So to your point the gains that I was pointing to are really other income related gains related to balance sheet positions held in overseas entities that are mark-to-market as part of our standard process on a monthly and quarterly basis. As it relates to overall impact of FX, I did mention that sequentially from Q3 to Q4, excluding the area of sundry, we are seeing some deterioration in foreign exchange. So sequentially from Q3 to Q4 we have about $0.04 of impact that we expect to see. And that's about $0.01 to $0.02 worse than our expectations, driven by its deterioration in a number of currencies. We've seen a lot of volatility in emerging markets in particular. From a hedging standpoint overall, for the developed market currencies we do have an approach where we look to hedge a portion of our exposure with the use of options. And then for those currencies that we don't, there are a lot of emerging market currencies today that we don't actually hedge in, because it's not economic to do so. In the case of those markets there are some natural hedges that we have in place. As you know we have manufacturing facilities in 40 countries around the world, or 40 manufacturing facilities in 25 countries around the world. And so as a result of that we do have some natural expense offsets to the sales that we have in place. And that we don't have that many products that are truly global in nature, creating additional foreign exchange exposure. So we will continue to be exposed to foreign exchange. It's an area we watch very closely. We do see this $0.01 to $0.02 impact. But there are active hedging programs that we have in place. And there are some balance sheet programs we have in place. And then there are also the natural hedges that I just mentioned.
Matthew S. Miksic:
Great. Thanks so much.
Robert L. Parkinson, Jr.:
Thanks, Matt.
Operator:
Our next question comes from Larry Keusch with Raymond James. Your line is open.
Lawrence S. Keusch:
Okay. Thanks. Good morning, everyone.
Robert L. Parkinson, Jr.:
Morning, Larry.
Lawrence S. Keusch:
Bob, I was wondering if you might take a stab at just giving us some thoughts around the environment in the U.S. and Europe. I know you already talked through emerging markets, but how about in some of the other geographies?
Robert L. Parkinson, Jr.:
Yeah. I mean ironically probably the U.S. market is as stable or strong as any geography in the world right now. You saw that with our performance in the first half of the year in the U.S., where we're seeing some recovery. We're seeing some expanded expenditure on capital goods, which helps our pump business. And we would project that that's going to continue. Europe clearly continues, developed Europe continues to be a challenge. We don't see any significant improvement there. I don't see any significant deterioration as well going forward. And then emerging markets I think both Jay and I have commented on this morning. It's really kind of an unknown in the near term. Although clearly long term all of these countries are increasing the amount of spend to healthcare. And that particularly plays to our strength in terms of the essential nature of our product. So beyond that I realize that's all very qualitative. I don't know if there's anything, Larry, specifically within that you'd like me to comment on.
Lawrence S. Keusch:
No. That's helpful. I just had two other questions for you. You did mention in the prepared comments about some competition in dialyzers. Again I recognize that's not necessarily new. But if you could sort of speak to that and weave in there sort of where we are on the dialyzer capacity expansion? And then the other quick question for you was if I sort of just do the very high level math on the operating margin for the second half, it implies somewhere around 10.5% or so. You guys had been sort of focused on 11% for 2016. So how should we think about that 100 basis point improvement in 2016 from the initially targeted 9% in the second half of this year?
Robert L. Parkinson, Jr.:
Okay. Let me comment on the dialyzer competition maybe a little bit more broadly on the Renal performance. And then, Jay, if you would pick up on the second part of the question. So first of all just kind of stepping back, we continue to believe the ESRD patient growth globally is growing around 5%. Our performance to date is impacted really by a number of factors. First of all as I commented in the prepared comments, we've decided to forgo some lower margin tenders, which has impacted us in the short term. We continue to manage through conversion of distributors that Gambro had to going direct, which is the right thing to do strategically and long term, but in the short term can be somewhat disruptive. And then of course I think a more competitive environment in the in-center chronic business than what we had anticipated. Although in fairness I would say in our modeling, we've always assumed some modest price erosion over the long-range plan for dialyzers. In terms of expanded capacity, that won't come on until late 2016 in our investment in Opelika, Alabama. We also as I think you know are expanding capacity in the production of PD solutions in China and Southeast Asia and so on. So the combination of the capacity expansion as well as an array of new product launches. AMIA, I talked about the approval in the U.S., which is very exciting. I mean that really builds on the HOMECHOICE, which is a $1.5 billion system globally today, so that's big. PrisMAX, the CLARIA launch in Europe, and then of course VIVIA for home HD. So whether it's capacity expansion or new product flow, that's what's going to accelerate the Renal growth going forward. I'm confident that as we move into 2016 we're going to ramp up the year-to-year growth in the Renal business. But the reality is that the chronic in-center business, particularly in dialyzers, continues to be very competitive. We anticipated that, that perhaps to a greater degree than we had anticipated, but we're looking forward to the capacity expansion. So that's about as much color as I can provide there. Jay, you want to handle the other?
James K. Saccaro:
Sure. On the operating margin, we did guide to 9% for the second half, and we're pleased that the second half is running better than that. As it relates to 2016, we actually guided to a 10% margin for 2016 and 11% in 2017, essentially 100 basis points of margin improvement per year. It's important to note that in 2016 we also expected about 100 basis points of deterioration due to cyclo. So in fact the organic or the true growth in margin in 2016 was really 200 basis points. But like I said, our guidance for 2016 was 10%. Based on our performance in the second half thus far, we're pleased. And we have confidence in our ability to achieve the projections that we've shared. At this stage we're not making any changes to guidance moving forward. There's a lot of moving pieces, things like foreign exchange, pension, operational improvements, et cetera. And we're actually going through a budgeting process as we speak to firm up our 2016 expectations. You can expect to hear an update from us on our January earnings call.
Lawrence S. Keusch:
Okay. Great. Thank you.
Robert L. Parkinson, Jr.:
Thanks, Larry.
Operator:
In the interest of time we'll take two more questions. Our next question comes from Rick Wise with Stifel. Your line is open.
Rick Wise:
Good morning. Hi, Bob. Just I wanted to follow up on the question on operating margins if I could. And maybe push you a little further. I mean just when companies I've noticed over the years start down this path of focusing more intently on cost reduction and efficiency, sometimes they can even surprise themselves. Maybe a couple things. The – for example the global work force reduction, how quickly will that $130 million savings hit the P&L? And maybe, Jay, talk to us about the possibility of other discretionary spending cuts? I mean just remind us what some of the opportunities are. Is it in supply chain? Is it back office? Is it IT? Just help us understand the larger directional picture if you would.
Robert L. Parkinson, Jr.:
So let me maybe comment, Rick – this is Bob – on kind of to set this up a little bit with some statistics. And then Jay can pick up the second part of your question. First of all in terms of timing the actions that we discussed this morning are going to largely be completed by the end of this year. So this is pretty immediate. As you gathered from our prepared comments this is the first part of what will be other actions that we will take over time. One thing we have to continue to be sensitive to, as Jay commented earlier, is the organizational support requirements for the Baxalta spinoff and so on. So we want to be cognizant of that as well. But we do think there are meaningful actions going forward. And of course what we didn't comment on was the completion of the Gambro integration, which continues on track as well. So in aggregate fairly meaningful undertakings, the impact of which will be near term the – maybe to give you some specifics on the reduction, which we characterize as about 5% of non-manufacturing jobs. This translates into about 1,400 jobs globally, about 70%. Our existing head count, about a third of which are cancellation of open positions, roughly two-thirds of the reductions are outside the United States. And really spread around the world fairly evenly. So hopefully that's helpful. Jay, you want to pick up on the second part of the question?
James K. Saccaro:
Yeah. And just to elaborate a little bit further. I mean overall we commented at our Investor Conference outlining 430 basis points of very specific cost improvements, 90 of which comes from Gambro, 80 of which comes from manufacturing, 50 of which comes from the pension, and 210 basis points related to G&A. And so by no means were we surprised by the size, scope, or scale of the restructuring that we announced. And so far everything is moving forward very much in line with our expectations from a cost standpoint. One of the areas to your point that we're very focused on relates to discretionary spending. And we believe there is some opportunity to look hard at certain categories. We're using some zero-based techniques and looking at very detailed spend levels in areas like travel, consulting, and some other discretionary spending, like marketing and professional services. And so as we go through our budget that's a clear area of focus for us. We think we have the opportunity pegged appropriately in terms of the impact on our long-range plan financials. But I can assure you with respect to all of these actions and the overall plan, the three components of the plan that Bob described earlier, we are looking to do better than we've outlined. And we're attempting to do that at each step. And so cost is squarely in that focus. But I wouldn't say we've been surprised by our performance at this stage.
Rick Wise:
Great. I'll leave it at that. Thanks for the color. Appreciate it.
Robert L. Parkinson, Jr.:
Thanks, Rick.
Operator:
Our last – our final question comes from Joanne Wuensch with BMO Capital Markets. Your line is open.
Joanne K. Wuensch:
Oh thank you very much for including me, and very nice quarter. In Renal did I understand that you're largely done with the Gambro integration?
Robert L. Parkinson, Jr.:
No. We still have work to do. I think we're approaching the conclusion of it. Jay, you want to comment?
James K. Saccaro:
Yeah, sure.
Robert L. Parkinson, Jr.:
Specifically on the dollars.
James K. Saccaro:
Well by the end of this year we expect to have achieved approximately $200 million in savings. And then in 2016 and 2017 we expect $100 million in incremental savings. Really the drivers of the remaining piece relates to certain manufacturing, a consolidation of activity, certain warehousing, and distribution consolidations. And then finally, there are some IT savings. As we roll out Baxter platforms across the Gambro network, there will be some G&A savings. And we still have a few IT implementations to go. Those are the primary drivers of the remaining $100 million in savings.
Joanne K. Wuensch:
That's very helpful. As a follow up as we think about 2016, can you remind us where FX may or may not impact different items on the income statement, other than obviously revenue? But how is it going to roll through, so that we don't get to 2016 guidance and suddenly have either other income or margins significantly different than expectations?
James K. Saccaro:
Yeah. As we look at FX in 2016, what we had assumed in May was essentially a constant FX environment in the sense that we assumed flat currencies over the long-range plan period. To the extent that there are departures from that, we'll first look to hedge using various techniques that we've discussed. There will be the benefit of natural hedges in place. But as we saw in Q4 based on the change in foreign exchange from Q3 – from June to today, let's just put it that way, we did see a negative impact of around $0.01 to $0.02 in the fourth quarter. So this will be one of the important assumptions that we update as part of our January guidance, along with many other items that we look forward to discussing with investors.
Joanne K. Wuensch:
Terrific. Thank you so much.
Robert L. Parkinson, Jr.:
Thanks, Joanne.
Operator:
Thank you, ladies and gentlemen. This concludes today's conference call with Baxter International. Thank you for participating. You may all disconnect.
Operator:
Good afternoon ladies and gentlemen and welcome to Baxter International's Second Quarter 2015 Earnings Conference Call. As a reminder this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Clare Trachtman, Vice President, Investor Relations at Baxter International. Ms. Trachtman, you may begin.
Clare Trachtman:
Thanks, Stephanie. Good afternoon and welcome to our second quarter 2015 earnings conference call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International; Jay Saccaro, Chief Financial Officer; and Scott Bohaboy, Corporate Vice President, Investor Relations and Treasurer. On the call this afternoon we will be discussing Baxter's second quarter financial results and outlook for the remainder of 2015 before taking your questions. I'd like to take a moment to highlight that our second quarter results are inclusive of the BioScience business as the official spinoff of Baxalta occurred subsequent to the close of the quarter on July 1. Going forward, the financial outlook and results for Baxter will be reported on a standalone basis excluding the BioScience business. On the call today we will focus the discussion on the performance of new Baxter, as Baxalta will host a conference call tomorrow to provide additional highlights on their performance in the second quarter and outlook for the remainder of the year. We plan to post standalone new Baxter financial schedules for the quarterly periods of 2014 and the first half of 2015 to our investor relations website prior to our third quarter earnings release to enable year-over-year comparison. So with that, let me start our prepared remarks by reminding you that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters contains forward-looking statements that involve risks and uncertainties. And of course our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, on today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this afternoon and available on our website. Now I'd like to turn the call over to Bob Parkinson.
Robert L. Parkinson, Jr.:
Thank you, Clare. Good afternoon, and thanks to all of you for joining us. Today's call is a transitional event for Baxter. It comes on the heels of our successful spinoff of Baxalta. The excitement level continues to build with the new Baxter as we embark on our journey as a standalone entity and begin to implement a number of the new strategic initiatives and margin improvement actions that will accelerate our profitable growth in the years ahead. For the second quarter, Baxter delivered a strong performance with adjusted earnings of $1 per diluted share, exceeding our previous earnings guidance of $0.92 to $0.96 per diluted share. Worldwide sales also exceeded our guidance, increasing 3% on a constant currency basis, and after adjusting for the impact of increased U.S. competition for cyclophosphamide, sales advanced 4%. Certainly our biggest milestone for both the quarter and the year was the successful completion of the BioScience spinoff, resulting in the establishment of two leading global healthcare companies. The smooth transition that we've seen following the spin is a credit to the comprehensive planning and disciplined execution carried out by employees and leaders across both businesses. And our strong second quarter results provide both Baxter and Baxalta with positive momentum as we continue our commitment to enhance value for all of our stakeholders. As we laid out at our Investor Conference in May, accelerating profitable growth is critical to Baxter's future success and is an objective that the entire management team is focused on. We are not only striving to meet our profit growth goals, but frankly, we're aiming to exceed them. Rebasing our cost structure, optimizing the existing portfolio, and launching numerous high-value differentiated products are the three focus areas that we will execute against over the long-range plan to drive the financial goals that we provided in May. Many of these initiatives have been launched and are gaining traction. So with this as a backdrop, I'd like to highlight some of our recent achievements. First, addressing our standalone cost structure is crucial to meet our goal of increasing earnings at a rate meaningfully faster than sales growth, and we're making progress on a number of fronts. The Gambro integration program continues to advance. We're on track to capture $100 million of cost synergies in 2015, and as we exit the year, we'll have successfully achieved two-thirds of our $300 million 2017 cost synergy target. And more broadly, a comprehensive cost rebasing plan for Baxter is now under way, and we're executing on key opportunities to reduce structural costs and increase efficiencies across the global enterprise. Now that the spin's complete, we've started to implement a number of substantive measures and look forward to sharing more information on these initiatives as we progress. With respect to portfolio management, during the quarter we took steps to optimize our global supply of IV solutions to address demand, while also improving profitability. In May we received FDA approval establishing our Sabiñánigo, Spain, facility as an approved manufacturing site for saline for the U.S. market. The FDA is also in the process of reviewing our application to source saline from our manufacturing site in Cuernavaca, Mexico. As all of you are aware, saline has been listed in Drug Shortage Database as maintained by the FDA over the past two years. So introducing a new supply from Spain and potentially Mexico to the U.S. market will provide us greater flexibility to respond to market demand. It also reflects our commitment to ensuring that we are optimizing our global supply and allocating or reallocating products to markets that generate enhanced returns aligned with our margin improvement goals. Finally, I want to share some recent highlights from our new product pipeline. As you heard, the leadership team emphasize at our Investor Conference, innovation is Baxter's lifeblood and fundamental to sustained growth. We have an exceptional pipeline that's well balanced among highly advanced new products, meaningful improvements to our existing offerings, and expanding our portfolio into new geographies. All are focused on improving the quality of care, while addressing key areas of medical need. So some recent milestones include, in our hospital products business, the full-scale launch of the next generation SIGMA Spectrum infusion pump is now under way in the U.S., Puerto Rico and Canada. And I'm pleased to report that demand is strong. The Spectrum platform has been honored with the best in class customer satisfaction award for four consecutive years, and the latest generation pump includes several innovative features, including an enhanced master drug library, which helps to reduce pump-related adverse drug events and improve patient safety. Customer response has been very positive, and the SIGMA Spectrum is currently being used or in the process of being placed in six of the top seven hospital systems in the United States as ranked by the U.S. News & World Report. In our renal business, we initiated the launch of our AK98 in-center hemodialysis monitor in several markets in Eastern and Central Europe, the Middle East and Africa. The AK series is our flagship in-center HD monitor, and this latest version offers advantages in usability and reliability while reducing the total cost of operation. In the U.S. we completed a 510(k) submission with the FDA for AMIA, our next-generation peritoneal dialysis cycler now integrated with our SHARESOURCE web-based connectivity platform. AMIA incorporates user-friendly features like a graphical touchscreen interface along with secure two-way connectivity that lets healthcare providers mobilely monitor treatment and adjust prescriptions as necessary. And finally, I'm also excited to share that the FDA has approved Baxter's investigational device exemption for our VIVIA home-based hemodialysis system. This milestone helps clear the way for the final U.S. study. And as we've previously shared, the VIVIA technology has the potential to transform home hemodialysis and allow more patients to benefit from high-dose HD in their homes. These are just a few of the new products that we'll bring to market over the next several years. Our pipeline is well-positioned to make a meaningful impact on both near and longer-term performance, and I look forward to providing more details on the progress and potential of this pipeline going forward. So with that, I'll now turn the call over to Jay for a discussion of our second quarter results and outlook for the remainder of the year, and then I'd like to make some closing comments before then opening up the call to Q&A. Jay, please.
James K. Saccaro:
Thanks, Bob, and good afternoon, everyone. As Bob mentioned, adjusted earnings in the second quarter of $1 per diluted share exceeded our previously issued guidance range of $0.92 to $0.96 per share. GAAP earnings of $0.60 per diluted share included net after-tax special items totaling $218 million or $0.40 per diluted share primarily for costs associated with the company's planned separation as well as business development initiatives and intangible asset amortization. These charges were partially offset by a benefit related to a legal settlement. Now let me briefly walk you through the P&L by line item before turning to the financial outlook for the third quarter and second half of 2015. Starting with sales, worldwide revenues of approximately $3.9 billion declined 6% on a reported basis. On a constant currency basis, sales increased 3% which compares favorably to our guidance for the quarter of approximately 1%. Excluding the impact of increased competition for U.S. cyclophosphamide, Baxter's sales advanced 4% globally. Medical Products sales were in line with our expectations while strong growth across the BioScience portfolio contributed to the overachievement. Sales in the U.S. increased 1% or 5% after adjusting for cyclophosphamide. International sales on a constant currency basis increased 4%. In terms of individual business performance, within Medical Products, global sales of approximately $2.5 billion declined 9% and on a constant currency basis, sales were comparable to the prior year period. Adjusting both periods for the impact of U.S. cyclophosphamide, Medical Products sales rose 3% on a constant currency basis. Within the product categories, renal sales totaled $949 million, reflecting a decline of 9% on a reported basis, excluding the impact of foreign currency sales increased 3%. Performance in the quarter was driven by mid to high single digit growth in our peritoneal dialysis business and double digit growth in the acute business. This growth was offset by lower sales in our chronic hemodialysis business resulting from our previously mentioned decision to forego certain lower margin sales opportunities as well as the impact from increased austerity measures in Western Europe. Within the fluid systems franchise, sales of $518 million declined 3% and on a constant currency basis sales advanced 3%. Performance was driven by the relaunch of the SIGMA Spectrum pump in the U.S. during the quarter and strong demand and favorable pricing for IV fluids. Sales in the integrated pharmacy solutions franchise totaled $548 million and declined 16%. On a constant currency basis, sales declined 8% as strength in our hospital pharmacy compounding service business was offset by lower cyclophosphamide sales in the U.S. Excluding this impact, sales in the category advanced 1%. This growth was somewhat dampened given the tough year over year comparison as growth in the second quarter of 2014 was the highest quarterly growth for the year as product availability improved for certain nutritional products that had previously been supply constrained. Revenues in surgical care, which includes our inhaled and aesthetics and biosurgery products were $333 million in the quarter and declined 4%. On a constant currency basis, sales rose 4% driven by strong performance globally in the anesthesia business and solid growth of our core surgical sealants and hemostasis products including our market leading flow seal hemostatic matrix. This performance was partially offset by lower sales of select non-core bio surgery products. Finally, sales in the biopharma solutions and other category, which is our pharma partnering business, totaled $116 million, declining 6% on a reported basis. Sales increased 2% on a constant currency basis driven by increased international demand from our contract manufacturing partners. Global BioScience sales totaled approximately $1.4 billion in the quarter and declined 2% on a reported basis. On a constant currency basis, BioScience sales advanced 7%. Additional details on the BioScience performance in the quarter will be available on the Baxalta earnings conference call tomorrow morning. Turning to the rest of the P&L, gross margin in the quarter was 50.7% compared to 50.3% last year. Positive mix, select pricing improvements, and foreign currency hedge gains more than offset the impact from increased generic competition for cyclophosphamide and incremental manufacturing investments made in the quarter. SG&A totaled $951 million and was comparable to prior-year levels. On a constant currency basis, SG&A increased high single digits. Growth in the quarter reflect continued investments in promotional and market activities to support new product launches in BioScience, certain costs incurred to establish the regional commercial organizations for Baxalta, and adjustments to bad debt reserves in emerging markets. R&D spending in the quarter of $292 million increased 1%. On a constant currency basis, R&D advanced mid-teens and was driven primarily by increased investments in the BioScience business. Interest expense was $30 million in the second quarter compared to $42 million last year as we benefited from a favorable rate and debt mix, and higher capitalized interest. Our second quarter ending debt balance included approximately $5 billion of debt issued by Baxalta in June, which upon the spin has moved to their balance sheet, as well as the retirement of $1.1 billion of commercial paper. Subsequent to the second quarter, we successfully tendered for $2.7 billion of outstanding bonds. Both the commercial paper reduction and bond tenders were paid down with proceeds from the $4 billion cash dividend that Baxter received from Baxalta in June. Other income totaled $15 million and included planned gains related to the sale of select equity investments. The tax rate of 23.2% for the quarter was slightly above expectations driven by the one-time impact associated with completing select tax audits, primarily outside the United States. And as previously mentioned, adjusted earnings of $1 per diluted share exceeded our guidance range. Let me conclude my comments this morning by providing an update on our full-year sales guidance and outlook for both the third quarter and second half of the year. But before I do that, many of you have inquired about restated historical quarterly income statements. We do plan to post adjusted non-GAAP financial statements to our website prior to our third quarter earnings call to provide investors with historical baseline financials for new Baxter. This timing allows for the completion of the final carve-out process and associated discontinued operations presentation of the BioScience business, as well as the confirmation of the baseline run rate associated with the transition services agreements we have set up with Baxalta for which billing will commence in the third quarter. Now, turning to our guidance and starting with sales, on a constant currency basis we continue to expect sales for the full year 2015 for new Baxter to be comparable to 2014, primarily due to the impact of generic cyclophosphamide. Adjusting both periods for this cyclophosphamide impact, underlying growth is approximately 3%. By franchise, we continue to expect renal sales to increase approximately 3% and surgical care sales to advance 4% to 5%. For fluid systems, we expect sales growth of approximately 3%. We now expect sales in the integrated pharmacy solutions franchise to decline mid-single digits. As you know, this category includes cyclophosphamide. For 2015, we now estimate U.S. cyclophosphamide sales of $190 million to $200 million. This is an increase from our previous guidance and reflects a benefit of approximately $20 million in the second quarter and an incremental $20 million to $30 million benefit in the second half of the year relative to our original guidance. While we continue to expect additional competitors to enter the market, the timing of these entries remains uncertain. Growth for the category after adjusting for cyclophosphamide is expected to increase mid-single digits. And finally, we expect the other category which includes our biopharma solutions franchise to decline approximately 10%, as a major customer elects to self-manufacture products that were previously contract manufactured by Baxter. Moving to the second half of 2015, our outlook remains consistent with the guidance we provided at our Investor Conference in May. We expect second half sales growth excluding the impact of foreign currency to be comparable to the prior year, and after adjusting for U.S. cyclophosphamide, to increase approximately 3%. At current foreign exchange rates we expect reported sales to decline approximately 9%. We anticipate the gross margin for new Baxter to be approximately 42% and we continue to expect an operating margin of approximately 9%. As previously mentioned, the 9% initial operating margin reflects the impact of stranded costs and incremental pension expenses following the spinoff of Baxalta. It also incorporates investments we've made to enhance our manufacturing and quality systems. For the second half, we expect interest expense to total approximately $70 million as the benefit of our reduced debt levels is more than offset by lower levels of capitalized interest. We expect other income of approximately $15 million, reflecting a benefit from the sale of select equity investments in the back half of the year. Given the geographic mix of our earnings for new Baxter, we expect a tax rate of approximately 20%, and for the balance of the year we expect an average share count of approximately 550 million shares. As stated in our press release, we expect adjusted earnings excluding special items of $0.58 to $0.62 per diluted share. Specific to the third quarter, we expect sales growth excluding the impact of foreign currency to be comparable to the prior year, and after adjusting for cyclophosphamide, to increase approximately 3%. At current foreign exchange rates we expect reported sales to decline approximately 9%, and we expect earnings from continuing operations excluding special items of $0.29 to $0.31 per diluted share. Before we open up the call for Q&A, I'd now like to turn the call back over to Bob for some closing comments.
Robert L. Parkinson, Jr.:
Thanks, Jay. As part of our roadshow efforts following the May Investor Conference, we had the opportunity to meet with a significant number of both current and also potential investors. Given that this today is really the first public forum that we've had since the Investor Conference, I wanted to take just a moment to address and expand upon three key topics that emerged during many of the meetings. The first topic relates to our margin profile. The second relates to our plans for capital allocation and the last topic centers on management succession. So starting with our margin profile, I can tell you the confidence that we have in the margin expansion targets we provided in May has only been enhanced in the subsequent weeks. Momentum is building across the organization, and as some of our recent highlights suggest, we're already making progress on a number of our margin improvement initiatives. Enhancing profitability is the top priority for new Baxter, and while our short-term profitability is impacted by certain discrete factors, we know what these are and will be addressing them along with our broader cost structure in the months ahead. The spinoff of Baxalta has provided us an opportunity to clearly evaluate our entire cost structure, and we're committed to aggressively addressing our cost position to ensure that it's aligned with our new business profile. We've demonstrated that we can achieve these targets as we've been successful in executing against the cost reduction initiatives identified as part of the Gambro acquisition, and as mentioned, are on pace to achieve our $300 million target by 2017. And to be clear, the margin targets that we presented in May are not an end state. Both Jay and I emphasized in our prepared comments at the Investor Conference that we expect margin expansion to continue well beyond 2020. As we progress, we'll continue to look for additional actions to not only accelerate profitability but drive overall margin improvement beyond the targets identified. Turning to capital allocation, and in particular, our use of the retained Baxalta equity stake. The decision to retain the stake affords us the opportunity to restructure our balance sheet in a highly tax-efficient manner. As we've shared previously, we intend to use the proceeds of the stake to further reduce debt, repurchase Baxter shares and to make a contribution to the domestic pension plan pending regulatory approval. Over the next 18 months, we'll leverage a combination of these activities to arrive at an optimal mix that maximizes the value to Baxter and our shareholders while minimizing the fees and other execution costs resulting from these activities. By reducing debt, we will create capacity for additional borrowing as appropriate to pursue organic and inorganic growth opportunities while remaining within our targeted leverage ratios. As you may have seen this afternoon, we declared our first dividend as a standalone company. The payout ratio is in line with the target that we shared in May of approximately 35% of adjusted net income and places us at the high end of our peer set. Going forward, we expect to grow our dividend distribution commensurate with earnings growth, and we remain committed to returning meaningful value to shareholders through dividends and share repurchases. Regarding M&A, while it's not included in our initial financial projections going forward, we do expect M&A to be a key component of our strategy to accelerate profitable growth. In the near term, our M&A activities will be somewhat constrained by both organizational and financial capacity. Over the next 12 months, however, as we enhance our balance sheet and progress on our post-spin margin improvement initiatives, we'll have significant flexibility to take full advantage of opportunities that are aligned with our business model and augment our channel strength and geographic presence. The last topic I wanted to address this afternoon and expand upon relates to the subject of succession planning. Given my tenure as CEO, which now is well over 11 years, and my age, this was a very natural question that arose in most of the road show meetings. When I came forward to the board over a year ago to recommend that we consider the spinoff of BioScience, the board discussed succession planning and concluded that an undertaking of this magnitude would be enhanced by my continued involvement throughout, to maintain stability within the organization, ensure that the timetable of the spinoff and all associated activities were achieved, and set the stage in the best possible way for both companies to be successful. At that time, I committed to the board that I would agree to serve as CEO of new Baxter long enough to ensure that our goals were clearly defined, that the entire organization was aligned with what we needed to accomplish and that our progress toward our goals and our confidence in attaining them if not exceeding those goals was evident. While the board naturally is always working to ensure a plan of succession, with the spinoff successfully completed, the board is again actively taking up the subject of my succession, and as part of that process has formed a working group of the board to manage the search process and has retained a search firm to assist in this regard. The board knows that I'm available as support in the succession process in every way and I'm willing to serve in whatever capacity the board feels will provide value. While a specific timetable has not been established, we did want to take advantage of this opportunity to update you on the topic, and of course we'll share information as appropriate going forward. So in closing, this is truly a new day at Baxter. The road ahead offers significant opportunities, and we have the strategies in place to leverage these opportunities to deliver enhanced value for all of our stakeholders. The recent spinoff creates the potential for us to have an even greater impact on the lives of our patients as we accelerate performance globally. We're already making it happen along the key trajectories that I've outlined here. Yet through it all, we're staying true to the same fundamentals that have made us a recognized and trusted global market leader for over 80 years
Operator:
Thank you. We will now begin the question and answer session. Our first question comes from Bob Hopkins with Bank of America Merrill Lynch. Your line is open.
Robert Adam Hopkins:
Thank you. Can you hear me okay?
Robert L. Parkinson, Jr.:
We can, Bob. Go ahead.
Robert Adam Hopkins:
Great. Thanks. So I just want to take the opportunity, Bob, to follow up on your comment about succession and your comment about you want to wait until progress is evident. Is it reasonable to assume that by early 2016, we're going to know what kind of progress or that progress would be evident? I'm just trying to put some timeframes around your commentary around succession.
Robert L. Parkinson, Jr.:
Yeah, I appreciate the follow-up question, Bob, and again I don't want to be specific in terms of dates. The reason I did mention what I did is it's fair to characterize this to say what I would call a front burner issue with the board. I mean, the fact of the matter is our board has had in place through the governance committee an established succession plan process for a long time. And in fact, just to provide a little color for everyone, we had discussions on this going back over the last few years. But clearly as we approach the spinoff, we kind of took the notion of succession and set it up on the shelf a little bit. I will say the decision to spin off BioScience clearly wasn't a result of any succession planning, but the reality is as a result of the spinoff, it did answer the succession question for that big piece of the business. It also allows the board to go forward now and evaluate succession in the context of a medical products/medical device company which in terms of experience and so on, can be a much more focused search I think. So now, given the fact that the spin has taken place, recognizing the progress and the momentum that's building at new Baxter, as I said, this has now become a new priority. And as I said in my prepared comments, with that, the board has formed a working group to manage the process, retained a search firm. I don't want to get into all the specifics of that including timing other than to say I wouldn't have raised it in this sense if now that the spin has been completed, we've got renewed enthusiasm, energy and focus and alignment behind what we want to do at new BAX and now is appropriate for the board to reengage on this and that's why I wanted to comment on this this afternoon.
Robert Adam Hopkins:
Great. That's very helpful. So I think I'm hearing, what I think I'm hearing from you, it doesn't sound unreasonable that something could happen in 2016 just kind of hearing the things that you just mentioned.
Robert L. Parkinson, Jr.:
No. That's not unreasonable at all.
Robert Adam Hopkins:
Okay.
Robert L. Parkinson, Jr.:
Yeah. It's not unreasonable at all. The fact of the matter is, we retained a search firm shortly after the spin. We didn't do it before then because there's no secrets in the world. Stability in this organization is important and we intentionally, as I said, kind of put that on the shelf until the spin was completed. But shortly thereafter we formalized it, and particularly with our employees, I always try to be forthright and transparent in communications and that's another reason why I wanted to communicate it today, so they have some expectation in that regard.
Robert Adam Hopkins:
Great. And then just one really quick one for Jay. Given your back half guidance, can you just give us a sense as to the revenue contribution from cyclo in the back half and then the total debt of new Baxter in the back half that drives that interest expense number you mentioned? Thank you.
James K. Saccaro:
Yeah, certainly. As far as cyclo in the second half of the year, we currently expect approximately $70 million in the second half of the year which is a slight increase over our prior guidance. And then as far as the new Baxter debt balance in the second half of the year, we completed a debt tender successfully as I commented on in my prepared remarks. At this stage, we're not reflecting any utilization of the retained stake beyond that. But overall from a debt standpoint, post-spin we're anticipating approximately $6.3 billion in debt, which reflects the benefit of utilizing the cash from the cash dividend from Baxalta to retire certain debt and commercial paper. So that's the current expectation.
Robert Adam Hopkins:
Great. Thank you very much.
Operator:
Our next question comes from Matt Taylor with Barclays. Your line is open.
Matt C. Taylor:
Hi. Thanks for taking the question.
Robert L. Parkinson, Jr.:
Sure.
Matt C. Taylor:
I wanted to ask a question I guess about the overall guidance and any thoughts you have on margins. I mean specifically on the guidance, you gave a second half number. Can you put that in context in terms of what that implies for earnings power for the year? And then also, talk about some of the levers that you have year-over-year and whether there's been any change to your thoughts on margin expectations for next year?
James K. Saccaro:
Yeah. I would say our margin expectations for the second half of the year, first let's start with that, are very consistent with what we shared in the Investor Conference. So the 9% operating margin reflects our expectation around start point, and there are a number of factors that are impacting that 9%. As we move forward, we are increasingly confident in our ability to achieve our long-term margin projections. Having said that, I don't think it's appropriate at this stage to modify our target for next year. As you know, we expect 100 basis points of improvement relative to the second half. So 10% margin for next year and that would include approximately 100 basis points of negative drag from cyclo. So really the organic improvement would be approximately 200 basis points relative to the second half of this year. As it relates to the full year comparables and the earnings power, given the complexities of a mid-year split, we're really not in a position at this stage to comment on new Baxter as a standalone enterprise. We reported Q2 as a consolidated enterprise. We expect later in the year as we approach the Q3 earnings call, we'll have the ability to report Baxalta not only from a discontinued operations basis, but also at that stage reflect the transition service agreements and the actual consumption of transition services by Baxalta. We'll start billing for that, those services that we provide next month. So from an overall standpoint, the first half of the year really is a Baxter consolidated view until we modify that later in the year.
Robert L. Parkinson, Jr.:
Matt, this is Bob. Maybe just to add some higher-level color. It's really too early subsequent to the Investor Conference for us to modify either our outlook for this year or next year. But I think probably as you gathered from our commentary in our prepared remarks, we increasingly are confident in our ability to achieve what we disclosed to everybody and what we project at the Investor Conference. I think the momentum is building and just to reiterate our aspiration, if we can do better, we're totally committed to do that over the next five years in the LRP and certainly subsequent to 2020. So good momentum building, but it's too early in the game to, I think to modify any of our financial projections.
Matt C. Taylor:
Okay. Thanks a lot for the color.
Robert L. Parkinson, Jr.:
Sure.
Operator:
Our next question comes from David Roman with Goldman Sachs. Your line is open.
David H. Roman:
Thank you, and good afternoon everybody.
James K. Saccaro:
Hi, Dave.
David H. Roman:
Hey, Jay. Hey, Bob. I wanted just to start with a couple questions just on the business. If you look at very specifically I guess the fluid systems franchise, it looks like in the U.S. that business continues to do a little bit better than one might expect your end markets to be growing at right now. Can you just sort of talk about the key drivers underpinning the strength in the U.S. and to what extent these type of growth rates are sustainable?
Robert L. Parkinson, Jr.:
Well just maybe high-level comment, then I can maybe tee it up for Jay for more specifics. Some of the strength that you're seeing demonstrated is really a result of some pricing power, pricing latitude in the U.S.. The underlying volume is I think pretty consistent with what we've been generating. As you now, it's a fairly low growth market on a volume basis but what you're seeing the strength from is really, in the core solutions business is really pricing, but then of course we're starting to pick up momentum more broadly with the relaunch of the SIGMA Spectrum. And I will tell you, again, and you know this, Dave, but for the others that are calling in, we projected in the long range plan to recover 5 of the 10 share point loss within the LRP. And early days with orders we have in hand and what we expect this year, I would anticipate that we're going to get at least 1 share point of 5 back before the end of the year. So that's part of the momentum that's building there and that's contributing to the strength as well. Jay, I don't know if there's any.
James K. Saccaro:
No, nothing to add.
Robert L. Parkinson, Jr.:
Specifics you want to add to that. Those are the key components, David.
David H. Roman:
Okay, that's helpful. Then maybe turning just to the surgical care franchise. That's a business that looks like it's maybe doing a little bit better but obviously an area that is fairly intense on the pricing competition side. Do you think this is a business that we can see accelerate on a go-forward basis, particularly as sort of evidence continues to come through on better U.S. hospital volumes and surgical volumes, or just a franchise that's sort of permanently constrained to sort of a lower single digit growth rate?
Robert L. Parkinson, Jr.:
So two different pieces here and again I'll ask Jay and Clare and Scott to add commentary as appropriate. For the biosurgery, what historically we've classified as the biosurgery business, two different stories
James K. Saccaro:
No. That's good answers.
Robert L. Parkinson, Jr.:
Okay.
David H. Roman:
Okay. Thank you very much.
Robert L. Parkinson, Jr.:
Sure, Dave.
Operator:
Our next question comes from David Lewis with Morgan Stanley. Your line is open.
David Ryan Lewis:
Good afternoon. Just Jay, a quick question on the Baxalta stake. I know you talked about the balance sheet moves here in the back half of the year. But obviously a lot of what you've talked about implies you sell a material portion of the Baxalta stake before the end of 2016. So, are there any special dynamics underpinning the timing of that sale process? Meaning should we expect it to be more immediate post the spin or closer to the end of 2016? And then I have a quick follow-up.
James K. Saccaro:
Yeah David, if you think about our objectives with the Baxalta stake, it's really to maximize the value of the stake to Baxter. And as part of that, we're going to look to carefully evaluate the different levers that we have and be opportunistic in terms of timing and amounts in each. And so I wouldn't say specifically there is a specific time that we're targeting. We're probably not going to do anything in the first 60 days, allow the Baxalta stock price to stabilize and we would probably not wait until we get too close to the 18 month timeframe because as you know there are very significant tax benefits to achieving our objectives within the 18 month timeframe. Beyond that, we expect to start certain transactions this year and then we'll do a number of other transactions next year, but we haven't reflected the benefit in reduced share count or reduced interest expense for late-year transactions that we're currently contemplating. The key inputs as we think about this, with respect to the pension, we're going to carefully evaluate the prevailing interest rate environment because we don't want to oversize the pension contribution depending on the size of that liability. We're going to carefully evaluate the evolution of the Baxalta stock price and then the receptivity to, the anticipated receptivity from Baxter debtholders and Baxter shareholders to the different tactics that we're pursuing. So those are some of the key inputs that we're evaluating as we look at timing and sizing of the different transactions. At this stage I wouldn't expect one very large transaction but more multiple transactions.
David Ryan Lewis:
Okay, that's very helpful color, Jay. And then, Bob, I just want to come back to renal for a second here. I feel like it's sort of a tale of two cities. You have great enthusiasm around CRRT and some positive secular tailwinds and you have the more traditional HD business which is perhaps a little sluggish. So, what assumptions are you making for price erosion in the traditional HD business? You talked about some of those in this quarter. How much of this is coming from true austerity, how much is coming from direct decisions you're making about mix, and how much is just coming from frankly competitors using price as a weapon in the channel? Thanks.
Robert L. Parkinson, Jr.:
It's probably some of each. Thanks for the question, Dave. And I'll play it back in and I'll ask the team to contribute as appropriate. It's kind of a tale of three cities, maybe. One is the acute piece in the hospital, which continues to grow very nicely, double digits and higher margin. And we continue to increase our focus on that. The traditional in-center hemodialysis business, which I'll come back to in a second, and then the third leg of courses is peritoneal dialysis which continues to be an attractive growth vehicle and also an area that has pricing latitude going for it as well. So the area that I think used the word sluggish is probably a fair way to describe the traditional in-center hemo business, although I would say that having the full product line, we're seeing that manifest itself in helping us on the PD business as well. So I think increasingly going forward, we have to look at this business in its totality. So on a constant currency basis it grew 3% in the third quarter. As you know we're projecting the long-term growth to be in the 5% to 6% range and that will be driven over time by capacity expansions later in 2016 with dialyzer expansion and then augmented by PD capacity expansion largely in Asia subsequent to that. And then augmenting that of course are the new products which we're very excited about. So let me come back then to the traditional in-center piece. It is a combination of things. We are being more discerning relative to the profitability of that business. I think we commented in the first quarter about some tenders that, candidly, we walked away from because of the returns. It is a price competitive business, and we have assumed, in answer to your question specifically, price erosion for that segment over the LRP on the very low single digits, but I think a practical recognition of the continued competitive nature of that. And then there are austerity measures, one of which was recently implemented in France, where as a matter of policy, they've said we want to extend the useful life of monitors from seven years to 10 years. So that obviously has an impact on revenue of monitors, and I would emphasize, our profitability on monitors is at the low end, and whether it's an old monitor or a new monitor, they chew up the same number of dialyzers, and frankly it reduces our CapEx to some degree as well. So net-net, I'm not sure on the bottom line how significant that is, but it is a contributing factor to the top line. So I touched on a number of things there. I think I've answered each of your specific questions. I'll stop there. Does that address your questions, David?
David Ryan Lewis:
Yes, Bob. Very helpful. Thank you.
Robert L. Parkinson, Jr.:
Okay.
Operator:
Our next question comes from Mike Weinstein with JPMorgan. Your line is open.
Michael J. Weinstein:
Thanks. So, Jay, a quick one first. The FX hedges you mentioned on the gross margin line, how much did they contribute in the quarter? And then, Bob, I just want to follow up Bob Hopkins' discussion with you on succession. So it sounded like a few weeks ago, let's call it late June, you were talking about the dialogue with the board being, you need to get the spin and new Baxter, if you would, off on the right foot, and you wanted to see that through. But it sounds like now what you're saying is, it's more likely that a new CEO is on board at some point in 2016. Just want to make sure we're hearing that correctly. Thanks.
Robert L. Parkinson, Jr.:
Well, I said it was possible that a new CEO could be on board in 2016. The reality is, I think there has been benefit and will continue to be benefit by my continued involvement post-spin for a lot of different reasons. But the reality is, the progress we're making, I think that the focus and the momentum and the alignment behind what we need to do is really good. And I'm going to be 65 in January, and I've been around almost 111/2 years and so inevitably this has to be dealt with. So I think actually the stage is set very nicely for the board now to do what they have a primary responsibility of doing, is to revisit the issue of succession now that the spin has been successfully executed and transition and succession has been defined for Baxalta, now to focus on the Baxter piece. So I think that we can achieve the objective of stability post-spin. I intentionally didn't define a specific date, but I did respond to Bob's question in the fashion that you reiterated, and I think that's fair. So I think it's a good plan where all objectives can be effectively met.
Michael J. Weinstein:
And then Jay.
James K. Saccaro:
Mike, yeah, on your gross margin hedge question, we did have the benefit of $25 million of hedges in the second quarter on the gross margin line.
Michael J. Weinstein:
Wow. Okay. And then maybe just one follow-up. And this is, Jay, probably for you. One of the discussions coming out of the analyst meeting on new Baxter is the spread or disconnect, if you would, between the net income and free cash flow. I think you guys guided to basically what amounted to about $1.40 in cash earnings, depending on what the share count is next year, and the timing of some of what you do with Baxalta. And that compares to free cash flow of $400 million, which would be about $0.75, $0.80. And so, can you just talk a little bit about that quote-unquote "disconnect" or that spread, and then how you think about that narrowing, if you would, over the next several years? Thanks.
James K. Saccaro:
Great. So the primary driver of the spread between operating income or cash earnings and free cash flow relates to, in the short term, CapEx. As you know, Mike, our business is capital intensive. A lot of that has to do with the fact that we're in the IV and PD business, and those have a higher capital burn. In addition to that, in the near term, we've announced a number of important capacity expansion projects that start to benefit sales in 2016. The three major projects that we have ongoing that we'll complete in 2016, we have a China PD expansion, we have a Thai PD expansion and we have the Opelika dialyzer capacity expansion. All of these are revenue generating. All of these generate positive economics for Baxter, but they do have the impact in the near term of depressing free cash flow relative to operating income. Over time, as we migrate and improve the operating margin of the business, we will hold CapEx flat or even as I said in the Investor Conference, we'll see a decline in CapEx, and so the relationship between free cash flow and operating income becomes much more normalized. Mike, but having said all of this, I want to emphasize that the entire management team is very much focused on free cash flow generation, and while we have a plan on CapEx, we are extremely focused on every single capital project to ensure that those dollars are dollars that create economic value for the company. So that's a little background color and some further information for you.
Michael J. Weinstein:
That's good. Thank you, Jay.
Operator:
Our next question comes from Danielle Antalffy with Leerink Partners. Your line is open.
Danielle J. Antalffy:
Hi. Good afternoon, guys. Thanks so much for taking the question. Bob, just a follow-up on a question from earlier regarding the sales outlook. I mean this was obviously a very strong sales growth quarter, so I was hoping you could help me better understand – I guess, I should say very strong, better than expected. So I was hoping you could help me better understand the sort of near to medium term. I mean, actually let me ask it medium to longer term headwinds that make you think that you can't grow faster than that sort of long term 4% sales growth target that you put out at the analyst meeting.
Robert L. Parkinson, Jr.:
Well, actually – thanks for the question, Danielle. I mean, we need to pick up the pace a little bit right now to get to the 4%. We were at 3% for the quarter. So we know the primary driver for that will be with the capacity expansions in renal, both dialyzers and PD capacity, as well as momentum with the SIGMA Spectrum relaunch and the other new products. To get ahead of ourselves, first of all, if you adjust – if you go back to the 4% CAGR that we talked about over the LRP at the Investor Conference, adjusting for cyclophosphamide, that's actually closer to 5%. So that means you're really growing from a current run rate of 3% up to 5%. And the other point that I would reiterate is as part of our margin improvement program and really addressing the product portfolio, we are going to aggressively evaluate certain product categories in certain geographies which may result in us exiting those product lines in certain geographies which obviously has a depressing effect on the top line as well. So we do have some momentum implicit in our long-term projections. But we wanted to also reflect the fact that we are going to be proactively addressing portfolio in a way that may result to some decreases in revenue, not unlike the tender position we took in the first quarter on hemodialysis monitors. So I think overall it's balanced. I think our long range sales projection in the LRP is very achievable. Adjusting for cyclophosphamide, I think it's pretty stable and fairly predictable and again of course it doesn't reflect anything and therefore, not only M&A obviously, but any further business development as well. So I think, Danielle, it's a pretty balanced forecast both for the rest of the year, 2016 and throughout the LRP.
Danielle J. Antalffy:
Okay. That's helpful. And then just to follow up on your comment on business development, M&A, given the fact that the board is actively now searching for your successor, is it fair to assume that nothing major will happen on the business development side until a new CEO is in place? Or are you still actively looking to do things for the rest of your tenure?
Robert L. Parkinson, Jr.:
Look, we're continuously looking at deals. Our, kind of other than Gambro, our historical MO of doing kind of bolt-on deals and so on, we certainly, we conceivably can do over the next 12 months. But as a practical matter, we have financial constraints. So the notion of a transformational deal is interesting and we can talk about it in a hypothetical context, but as a practical matter in the short term, we don't have the financial wherewithal to do anything in the short-term. And if that's the case, then to speculate one way or the other, telegraph intent ahead of time doesn't seem to serve any stakeholder's interest effectively. The Gambro deal I think represents the fact that we're willing to think bigger if the value is there. And whether it's me or a successor, I think there's an open-mindedness to that, but again right now today, it's not a practical option just due to constraints, right, financial constraints. Not to mention, I would say organizationally we're still completing the Gambro integration. This company has been consumed over the last 12 months as a result of the spinoff, which has been the number one priority, and appropriately so, because I believe we'll look back and realize that that decision will have generated significant value for all stakeholders and all shareholders for both companies. Now that that's done, we refocus our attention on other priorities. And, but I think a transformational deal in the next, say, 12 months or something, it just isn't in the offing because we don't have the financial latitude to do it.
Danielle J. Antalffy:
Okay. Thanks so much
Clare Trachtman:
Stephanie, this is Clare. We have time for two more questions.
Operator:
Thank you. Our next question comes from Kristen Stewart with Deutsche Bank. Your line is open.
Kristen M. Stewart:
Hey. Thanks for taking the question. I just wanted to go back to Gambro, and just better understanding on what's changed on the sales growth forecast, because it seems like you're hitting the metrics from a cost synergies perspective, but the sales growth outlook seems to be very different. It was one that was, at least at the time of acquisition, supposed to accelerate the overall growth profile of Baxter as a whole. And obviously with them there, the Medical Products business and here we are talking about the HD business only growing 2% to 3% over the long range plan. That was certainly not something that was my impression that was going to be the growth forecast for Gambro at the time of the deal. So what's really changed about that business or the market that's really leading that Gambro, or maybe just the market, to be a lot slower now versus just only a couple years ago? Bob or Jay.
Robert L. Parkinson, Jr.:
Okay, Kristin, thanks for the questions. So let me start at a high level, okay. I'm really glad that we did the Gambro deal. Things always change in big acquisitions, but looking back now a year-and-a-half on or thereabouts, almost two years on now, I'm really glad we did the deal. Things always turn out differently than what you anticipate. And you're absolutely right. The core – and it's really a follow-on to commentary I made earlier. I don't know if it was David Lewis or David Roman's question, I can't recall, in terms of the traditional in-center hemo business, okay. Because that has fallen behind what our expectations are, so your commentary in that regard is spot on. I would agree with that. But if you take a step back and look at the total deal, first of all, much of the value of the deal, more so than typically in acquisitions, was based upon the cost reduction. And as we've commented today, we're well on track to achieve – frankly it's not – slightly exceed that $300 million target, so that's really positive. In terms of the higher growth higher margin business, the in-center CRRT, that's moving along totally in accordance with our expectation. The other thing that has been favorable, and I think going forward increasingly you have to look at our renal performance in aggregate. Part of the rationale was to complete the full product line, thereby enabling us to participate in commercial opportunities where previously perhaps we didn't, because we didn't have all the clubs in our bag so to speak in the traditional in-center piece. And so the commercial synergies that we're getting, particularly on PD and so on, have certainly achieved if not exceeded our expectation. The piece that has been slower is the traditional in-center piece. Part of it is market driven and part of it is organizationally driven. I think the integration of the commercial organizations has been more challenging than what we anticipated bringing the Gambro and the Baxter pieces together, including change out of leader – most of this business as you know is outside the U.S., so it's a byproduct of 50 general managers around the world and making sure the right leaders are in the right place in each market. And so the sorting out process in that regard has been somewhat more challenging than we had anticipated in the modeling. And secondarily, as we've converted from distributors to going direct, which is our mode of doing business as you know, while we fully anticipated that as a result of the due diligence, there have been some challenges associated with converting from distributors largely in emerging developing markets in ways that we didn't anticipate (58:35). So it's been slower than we anticipated. That was operationally related. Then in terms of the marketplace, frankly in terms of the pricing, it's performing pretty much in accordance with what we modeled. We anticipate in the acquisition analysis that this was and would continue to be pricing competitive. We didn't anticipate perhaps some of the austerity measures. I cited just one recently in France. And then the other piece of it is we have been consistent with our overall priority at new BAX going forward, more discerning and more demanding in terms of returns through our new mindset of new Baxter, and that's had an impact in terms of some of the profitability. So I touched on a lot of it, but I really – maybe I'll just end where I started, Kristen, which is I'm very pleased that we did the deal for a lot of different reasons and confident that the value clearly is going to be generated over the long term.
Kristen M. Stewart:
Great. And there's no update on the home hemodialysis timelines for the U.S. relative to the -
Robert L. Parkinson, Jr.:
I had – Clare, make sure I don't misspeak.
Clare Trachtman:
Obviously we announced, we said that we've filed. The FDA accepted the investigational device exemption so that allows us to start the U.S. trial which we continue to expect that will begin before the end of the year with filing likely sometime in the 2017 timeframe and a launch in 2018 consistent with what we shared at the Investor Conference in May.
Kristen M. Stewart:
Okay. And then for Jay, just in terms of the Baxalta stakes, sorry if I missed this. Can you comment on just how the split will be in terms of how much will go towards the U.S. pension? I think it was about $1 billion. And how much will go towards paying down debt or how much will just go towards acquisitions and whatnot or just will become cash on the balance sheet? And I think there was something in one of the filings that mentioned a potential stock exchange as well.
James K. Saccaro:
Yes. So, Kristen, there's really three uses for the retained stake, pension, a stock for stock exchange or split off as it's termed and a stock for debt exchange which essentially amounts to a secondary offering coupled with a debt buyback. So those are the three vehicles that we're currently evaluating, each of them to the extent that we pursue them within an 18 month window, are tax-free uses of the stake. So what we've said is we expect a 50 basis point benefit from contributions to the pension which would imply approximately a $600 million contribution to the pension. But frankly, the sizing of that ultimate contribution will very much depend upon the prevailing interest rate environment. We don't want to go well north of 100% funded status. As we sit today, we're at roughly 80%, and so this would close a portion of that gap but it wouldn't close all the gap. To the extent that interest rates rise between now and year-end when we would contemplate a transaction of this nature, we're going to watch that very carefully.
Kristen M. Stewart:
Okay.
James K. Saccaro:
As it relates to the other two pieces, it really is going to depend upon our ability to execute those transactions with the least amount of cost. Because to the extent that we over delever, we always have the opportunity to lever back up to buy shares or to pursue M&A. The important thing is we want to use the retained stake with the limited, the least amount of economic loss to Baxter, so that we're going to be very thoughtful about transaction costs and premiums and things of that nature.
Kristen M. Stewart:
Yes. Okay. Thank you.
Robert L. Parkinson, Jr.:
Thank you.
Operator:
Our final question comes from Josh Jennings with Cowen & Company. Your line is open.
Joshua T. Jennings:
Hi. Good evening. Thanks a lot. Just wanted a quick question on the operating margin front. Can you talk about the operating margin baseline and trajectories for the four business units relative to the corporate margins? Or is there one or two units that has more depressed margins where you can give us some more specifics or granularity on how the margin turnaround can be achieved?
James K. Saccaro:
We really haven't disclosed margins by segment or area except to say that there are certain businesses that carry a higher margin than the Baxter average, and those businesses include the CRRT business, our surgical care business, our nutrition business within integrated pharmacy systems. Those are a few of the businesses which carry a higher margin than the corporate average. In the case of those businesses, our full expectation is to grow them as fast as we can with promotional investments to support that. By doing that, we expect to see a positive benefit on the margin. There are other categories of businesses which we would characterize as having lower margins. And what we've said is, it's really not a global question to ask, but it's more specific than that. In certain products in certain geographies we have margins that are below our corporate target. With respect to those businesses, our expectations are we're either going to fix, shrink or exit those businesses over time. So we have a very disciplined framework in place, but it's a more fine-tuned methodology than a global methodology with businesses that have lower margins or higher margins. Because frankly in some businesses that may have a lower margin in one market, that margin may be dramatically different in another market depending on the nature of the dynamic.
Joshua T. Jennings:
Great. And just on that portfolio optimization point that you brought up, can you talk about the pace of product pruning or exiting suboptimal geographies? You've already started in renal. It sounds like you do have strategic plans in place, but is this going to depend on balancing this portfolio optimization and then loss of revenues and how that flows down to the bottom line?
James K. Saccaro:
Yeah, so we've completed the portfolio analysis. We have clear line of sight to the fully loaded profitability and the economic returns of our businesses. But before we exit a business, our first expectation is that our general managers will attempt to fix it, and that takes some time in certain instances. So the pace at which we do this will really be gated by how successful we are in turning around some of these businesses or not. And to the extent that we're not, we will make very clear and definitive decisions about exit, but only after we've given the opportunity to the operations team to actually fix that business. Bob, I don't know if you want to add anything to that?
Robert L. Parkinson, Jr.:
All I would say is, but that's not going to be a protracted period of time.
James K. Saccaro:
Yeah.
Robert L. Parkinson, Jr.:
There will be a sense of urgency on this. But there is a disciplined process, as Jay described, Josh.
Joshua T. Jennings:
Excellent. Thank you very much.
Robert L. Parkinson, Jr.:
Sure.
Operator:
Ladies and gentlemen, this concludes today's conference call with Baxter International. Thank you for participating. You may now disconnect.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's First Quarter 2015 Earnings Conference Call. Your lines will remain in a listen-only mode until the question-and-answer segment of today's call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Corporate Vice President, Investor Relations at Baxter International. Ms. Ladone, you may begin.
Mary Kay Ladone:
Thank you and good morning, everyone, and welcome to our Q1 2015 earnings conference call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International; Ludwig Hantson, President, BioScience; and Bob Hombach, Chief Financial Officer. As previously announced Bob Hombach will be transitioning into his new role as Chief Financial and Operations Officer for Baxalta Incorporated upon completion of the Baxalta spin and Jay Saccaro, who is also with us today will be assuming the role of Chief Financial Officer for Baxter International. On the call this morning, we'll be discussing Baxter's first quarter financial results and outlook for the second quarter before taking your questions. I would like to take a moment to highlight that we'll be hosting separate investor conferences in New York City on the afternoon of May 18 for Baxter International and the morning of May 19 for Baxalta Incorporated. At these conferences we will introduce you to the new Senior Management Teams and provide investors with more information regarding the strategies, growth prospects, capital structure and financial outlook for each company including guidance for the second half of 2015 and longer term projections. I encourage you to visit the Investor Relations page of the Baxter website to register for the event. In addition, we'll also engage in a comprehensive Investor Relations effort including Investor road shows for both companies with the respective Senior Management teams, several weeks before the spinoff is completed. So with that, let me start our prepared remarks this morning by reminding you that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters, contain forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, in today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I'd like to turn the call over to Bob Parkinson.
Bob Parkinson:
Thanks, Mary Kay. Good morning. Thank you all for calling in. As you saw in the press release that was issued this morning, Baxter reported financial results for the first quarter with adjusted earnings of $1 per diluted share, exceeding guidance of $0.85 to $0.90 per share. Worldwide sales excluding currency increased 4% also exceeding guidance. We continue to successfully deliver on a wide range of strategic and operational objectives as we're extending our global reach, launching innovative and differentiated products and therapies, advancing our new product pipeline and investing to drive future growth and position the two companies for sustained success. Our new product pipeline is focused on a number of programs that improve the quality of care and address key high potential areas of unmet medical need. Some recent highlights include CE marking in Europe for HOMECHOICE CLARIA an automated peritoneal dialysis system integrated with the SHARESOURCE web-based connectivity platform. This system is designed with user friendly features and secure two way connectivity. So healthcare providers can monitor their patient's home PD treatments and adjust prescriptions as necessary. We expect to initiate the commercial launch of the system in select European and Asian countries beginning in the second quarter of this year. We also received FDA approval and orphan drug designation of PHOXILLUM Renal Replacement Solutions for use in continuous renal replacement therapy, or CRRT, to correct electrolyte and acid-base imbalances and we plan to introduce these solutions in the United States in the coming weeks. In BioScience we submitted a new drug application to Japan’s Ministry of Health for the approval of BAX 855, our investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE. In addition, we've also completed enrollment in the BAX 855 pediatric study, which will support post-approval label expansion in the U.S. for previously treated pediatric patients and European regulatory submission in 2016. We announced positive results from the Phase III study of BAX 817 for patients with hemophilia A or B who develop inhibitors. The trial met its endpoint of successful resolution of acute bleeding episodes with an overall success rate of 92%. No patients developed inhibitors or binding antibodies during the study and none discontinued treatment due to adverse events. We expect to initiate regulatory submissions in the next several years aligned with the prioritization of other pipeline assets and manufacturing expansions currently underway. Our partner CTI BioPharma announced positive top-line results from PERSIST-1, a randomized, controlled Phase III registration clinical trial examining pacritinib, a next generation oral JAK2/FLT3 inhibitor for the treatment of patients with primary or secondary myelofibrosis. The trial met its primary endpoint of reduction of spleen volume and the safety profile was consistent with previous studies. Data will be highlighted in a late-breaking oral presentation at the American Society of Clinical Oncology Meeting in Chicago next month. Under our collaboration with Momenta Pharmaceuticals we initiated a pharmacokinetic trial in Europe for BAX 923 a biosimilar version of HUMIRA. As you know HUMIRA is a therapy for patients with autoimmune and inflammatory diseases. And finally, we presented interim data from the Phase I/II study of BAX 335, an investigational factor IX gene therapy treatment for hemophilia B. The trial is assessing the safety of ascending doses of BAX 335 in up to 16 adult patients to determine the optimal single dose. At the end of 2014, a total of six patients from three dosing cohorts had been treated, with evidence of a dose-related response. In the two highest dose cohorts, Factor IX activity levels in 10% or above were observed in two patients with no bleeding episodes. In addition, no patients developed Factor IX inhibitors. We expect to disclose additional data at the upcoming ISTH Congress in Toronto in June. In addition to internal innovations, strategic acquisitions and partnerships remain essential for both businesses as we continue to enhance and bolster our portfolio. During the first quarter, we acquired SuppreMol, a privately held biopharmaceutical company based in Germany developing treatment options for autoimmune and allergic diseases. The acquisition includes SuppreMol's early stage development portfolio of novel biologic immunoregulatory therapeutics for the treatment of autoimmune diseases and IgE-mediated allergic diseases. The technology focuses on the modulation of FC receptors signaling pathways and immune target that could have broad applications of diseases like Lupus, a disorder in which the immune system attacks healthy tissue. And we signed an exclusive global licensing and distribution agreement with Laboratoire Aguettant SAS for trace elements, which are essential micronutrients used in parenteral nutrition therapy. This collaboration augment Baxter’s leading parenteral nutritional portfolio and the companies will work together to pursue a broad range of regulatory approvals including United States. In summary, our core portfolio remains strong. We continue to benefit from the focus on life saving therapies and we’re pursuing new avenues to enhance the value of our products for patients in healthcare providers. Innovation is the life blood of Baxter’s success and our increased investment and recent achievements point the way to even greater success in the future. Before I turn the call over to Bob, I highlight as you know that we’re quickly nearing a transformational milestone in Baxter’s history with the creation of two leading healthcare companies. One focused on developing and marketing innovative biopharmaceuticals and the other on life saving medical products. This will present a remarkable opportunity for growth and success in two new companies with unique and compelling investment identities prospects and strategies while each continues to extend their legacy of pioneering science and enhancing shareholder value. Our employees around the world have been fully engaged in separation activity since the announcement last March. And we remain on track toward a mid-2015 completion as a result of their dedication and commitment. And while the separation will occur during a period of transitions our passion for saving and sustaining lives will be enduring. As always I’ll be happy to take any questions on this or other topics during the Q&A. And with that, let me now turn the call over to Bob Hombach for discussion of our first quarter financial results and outlook. Bob?
Bob Hombach:
Thanks Bob, and good morning, everyone. Adjusted earnings in the first quarter of $1 per diluted share exceeded our previously issued guidance range of $0.85 to $0.90 per share. These results included $74 million of unplanned other income or $0.11 per diluted share, primarily associated with the impact of foreign currency and balance sheet positions. As we mentioned in the press release, GAAP earnings of $0.78 per diluted share included net after tax special items totaling $120 million or $0.22 per diluted share primarily for intangible asset amortization and cost associated with the company’s plan separation and the integration of its Gambro AB acquisition. These charges were partially offset by a benefit related to the reversal of certain business optimization reserves. Now let me briefly walk you through the P&L by line item before turning to the financial outlook for the second quarter of 2015. Starting with sales. Worldwide sales of approximately $3.8 billion declined 2% on a reported basis. On a constant currency basis, sales increased 4% which favorably compares to our guidance for the quarter of 2 to 3%. Medical Product sales were in line with our expectations, while strong growth across the BioScience portfolio contributed to the over achievement. Sales in the U.S. increased 4% and international sales on a constant currency basis increased 5%. Emerging markets continue to be a key growth driver across the Medical Products and BioScience portfolios as evidenced by mid-teens growth in the BRIC markets during the first quarter. In terms of individual business performance, global BioScience sales totaled approximately 1.4 billion in the quarter and increased 2% on a reported basis. On a constant currency basis, BioScience sales advanced by more than 8% comparable to the full year growth generated last year with continued positive momentum across the portfolio. Our hematology business which includes hemophilia and inhibitor therapies generated global sales of $807 million, which declined 2% on a reported basis. On a constant currency basis, hematology sales grew 5%. Within the hematology product categories, hemophilia sales in the first quarter of $641 million declined 5% on a reported basis and on a constant currency basis, global sales increased 2%. Strong global demand for recombinant therapies including ADVATE and RIXUBIS was offset by the impact related to our reimbursement assistance program which was recently implemented for patients in the U.S. and the timing of tender sales in Eastern Europe. Excluding these impacts, hemophilia sales in the quarter increased 6%. In the U.S., sales in the hemophilia category were up 5% after adjusting for the impact of new reimbursement program. We continue to be pleased with the overall growth of recombinant factor A therapies despite the competitive environment and modest patient losses. We continue to estimate our cumulative recombinant factor A share loss at approximately 2%. Sales in the inhibitor category which includes FEIBA and OBIZUR of $166 million advanced 9% on a reported basis. On a constant currency basis, inhibitor sales advanced 18%. This was primarily driven by demand and price improvements for FEIBA as we continue to promote a prophylaxis indication and a modest contribution from the recent launch of OBIZUR for patients with acquired hemophilia. You may recall only 15% to 20% of inhibitor patients globally are treated prophylactically presenting a significant long term growth opportunity for a hematology business. Turning to the immunology business, which includes immunoglobulin therapies such as HYQVIA and GAMMAGARD LIQUID as well as biotherapeutics, sales totaled $554 million in advanced 10% on a reported basis. On a constant currency basis, immunology sales grew 14% versus the prior year. Immunoglobulin sales of $420 million increased 6% on a reported basis or 9% on a constant currency basis. This was a result of robust demand particularly in chronic primary immunodeficiency market, strong international growth driven by our improved supply and the contribution of HYQVIA. As you may recall, we launched HYQVIA in the U.S. during the fourth quarter last year. This is a transformational therapy within attractive value proposition for patients, physicians and payers. We are very pleased with the uptick and continue to experience a favorable reception in the U.S. marketplace based on its differentiation. Of the 15,000 adult PI subQ patients, we now have approximately 1,500 patients on HYQVIA with majority converting from competitive therapies. Lastly, in the biotherapeutics category which primarily includes albumin and our alpha-1 therapies, we recorded sales of $134 million which increased 29% on a reported basis. On a constant currency basis, sales increased 36% driven by an easier comparison to last year favorable pricing and increased demand for albumin particularly in China. In Medical Products, global sales were approximately $2.4 billion declined 5% and on a constant currency basis sales increased 2%. Adjusting both periods for the impact of new generic competition in the U.S. for cyclophosphamide, Medical Product sales rose 4% on a constant currency basis. Within the product categories renal sales totaled $913 million reflecting a decline of 8% on a reported basis. On a constant currency basis sales increased 1%. PD growth of mid to high single digits which was driven primarily by solid PD patient gains in Asia was offset by the selective loss of certain lower margin HD monitor and dialyzer sale along with our objective of optimizing margins. Within the fluid systems category, sales of $493 million declining 2% and on a constant currency basis sales grew 3%. Performances driven by favorable pricing and demand for IV therapies and infusion systems in the U.S. Sales in the integrated pharmacy solutions business totaled $564 million and declined 5%. On a constant currency basis sales increased 1% as strong growth of nutritional therapies and compounding services revenues were offset by lower cyclophosphamide sales in the U.S. Excluding this impact, sales in the category advanced 10%. A new competitor entered the U.S. market for cyclophosphamide during the fourth quarter last year and we continue to expect additional competitors. As a reference, full year 2014 U.S. cyclophosphamide sales totaled approximately $450 million and sales in the first quarter of 2015 totaled approximately $60 million. Revenues in surgical care which includes our inhaled anesthetics in BioSurgery products were $322 million in the quarter and comparable to last year. Sales rose 5% on a constant currency basis as double digit growth in anesthesia reflecting increased global penetration with someone offset by lower sales of select BioSurgery products. Finally, sales in the BioPharma Solutions and other category, which is our former partnering business, totaled $111 million increasing 1% on a reported basis or 6% on a constant currency basis. Performance can be attributive primarily to increased demand from our contract manufacturing partners. Turning to the rest of P&L, gross margin in the quarter was 49% compared to 50.4% last year. Positive mix, select pricing improvements and foreign currency hedge gains were more than offset by the expected cyclophosphamide and manufacturing impacts. SG&A totaled $887 million and declined 1%. On a constant currency basis, SG&A increased 6%. This growth reflects bad debt expense driven by adjustments in several emerging markets and BioScience’s investments to support international operations and marketing initiatives related to new product launches. R&D spending in the quarter of $298 million increased 7% driven primarily by an increasing in BioScience which was offset by foreign currency. In BioScience, we continue to invest in various programs across the disease areas of hematology, immunology and oncology while advancing technology platforms such as gene therapy and biosimilars. Interest expense was $30 million in the first quarter compared to $43 million last year as we benefitted from recent debt maturities, higher capitalized interest and income generated from the change in the mix of floating versus fixed interest rates. Other income totaled $74 million and -- including gains related to the impact of foreign currency on balance sheet positions driven by the significant decline in the Euro during the quarter. The tax rate was 21.8% for the quarter in line with our expectations and as previously mentioned adjusted earnings of $1 per diluted share exceeded our guidance range. Finally, let me conclude my comments this morning by providing an update on our full year sales guidance and outlook for the second quarter. Beginning with the new Baxter franchises, on a constant currency basis, we continue to expect sales for the full year 2015 to be comparable to 2014, primarily due to the impact of generics cyclophosphamide. Excluding cyclophosphamide in both years, underlying growth would be approximately 3%. We now expect sales in our renal franchise to grow approximately 3%. This is somewhat lower than our original expectations as we remain committed to servicing our patients while all folks focusing on enhancing profitability. As such, we made proactive decision to forgo lower margin sales opportunities. For fluid systems, we continue to expect sales to grow in the 2 to 3% range. We continue to expect sales of our surgical care franchise to grow in the 4 to 5% range. We now expect the integrated pharmacy solutions, sales to decline high single digits. This category includes cyclophosphamide and the impact of generic competition. For 2015, we estimate U.S. cyclophosphamide sales of approximately $150 million and growth for the category after adjusting for cyclo is expected to be in mid-single digits. And finally, we expect the other category to decline approximately 15% which will be impacted by major customer electing to self-manufacture products previously manufactured by Baxter. For Baxalta, we now project sales growth on a constant currency basis of approximately 4%. Our outlook includes growth in the hemophilia franchise of 0% to 2% which will be fueled by new product launches and strong international demand which will be somewhat offset by anticipated high single digit share loss for a recombinant factor A therapies in the U.S. due to competition. We now expect growth in the inhibitors category to exceed 8% driven by strong performance in the first quarter further penetration in growth of FEIBA for the treatment of inhibitors and the launch of OBIZUR of acquired hemophilia patients. For immunoglobulin therapies, we continue to expect growth of 6% to 8% driven by strong market demand and contribution from HYQVIA. And finally for BioTherapeutics which includes plasma based therapies like albumin and treatments for alpha-1 deficiencies, we continue to expect growth in the 2% to 4% range. As we previously highlighted, given the complexities of a mid-year spend, we are not in a position today to provide full year P&L guidance for Baxter and Baxalta. We are however, providing guidance for the second quarter as Baxter will be publishing earnings result for the combined business at the end of July. As stated in our press release for the combined business, we expect adjusted earnings excluding special items of $0.92 to $0.96 per diluted share. This guidance does not reflect any material incremental standup cost for the separation as expenses will begin to be layered in toward the end of the quarter. Our outlook by P&L line item, we expect second quarter sales growth excluding the impact of foreign currency to increase approximately 1%. At current foreign exchange rates we expect reported sales to decline 9% to 10%. By business on a constant currency basis we expect medical product sales to be comparable to last year and BioScience sales to grow approximately 4%. We expect the gross margin for the company to decline by more than 150 basis points versus the second quarter margin last year of 50.3%. We expect SG&A to decline in high single digits and R&D to decline in mid single digits. On a constant currency basis SG&A growth is expected to be in low single digits and R&D growth is expected to be in mid to high single digits. And finally for the second quarter, we expect interest expense to total approximately $35 million and other income of approximately $50 million. This does not include any impact of foreign currency on balance sheet positions as our outlook assumes current foreign exchange rates remain constant. We expect a tax rate of approximately 22% and an average share count of approximately 547 million shares. I would like to conclude my prepared remarks this morning by saying that we recognize investors and analysts need more information to help model both companies separately. So we look forward to providing you with an overview of the businesses at our upcoming investor conferences on May 18, 2015 and May 19, 2015, in New York. At this point, our estimate of initial incremental stand-up cost to create two independent companies remains approximately 2% of total Baxter sales or slightly more than $300 million. About half of these costs will be reflected in operating results beginning in the second half of 2015. Going forward both companies will take steps to reduce a meaningful portion of these costs over the next several years post spin. Finally as we're finalizing the capital allocation strategies of each business, I would emphasize that both businesses will have strong balance sheets, generate significant cash flow and have flexibility to follow a disciplined capital allocation approach, which balances reinvestment in the business with returning value to shareholders. This concludes my prepared remarks this morning. We look forward to providing more financial information to you in May. Now, let we open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. [Operator Instructions] I'd like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International's website for 30 days at www.baxter.com. Our first question comes from Josh Jennings of Cowen and Company. Your question please.
Josh Jennings:
Hi good morning. Thanks for taking the question. I guess first just on the renal business, I was hoping to get a little bit more color on not only the decrease in projection there for that business, but also just specifically on Gambro the performance in the quarter and the outlook going forward and then update on the cost synergies.
Bob Parkinson:
Sure Josh, Bob Parkinson. I may ask Jay Saccaro to add his comments as well. Relative to the renal performance, clearly the growth in first quarter was -- actually the business was fairly flat as we pointed out in the script, largely due conscious decision to walk away from a couple of tenders that frankly weren’t generating the kind of returns that we expect. One of the things that we've talked about before and you'll hear more about when we were in New York a few weeks is our increased focus on portfolio and particularly in areas that the returns in certain businesses in certain countries are not generating accept those kind of returns and so that was really what contributed mostly to the softness in the first quarter of the overall renal business. Going forward we're looking at mid single digit growth for the remainder of the year that’s really led by faster growth in the acute area. But overall, we're projecting about mid single digit growth as I said for the last nine months of the year. So in some ways the first quarter was a bit of an anomaly. Relative to your question more specifically about Gambro, the decisions we made to walk away from tenders and so were in fact in the chronic space the hemodialysis space that would be associated with the Gambro business. The PD business continues to -- underlying demand continues to be strong globally, I would say that we continue to work through the integration issues with Gambro as we face that on a global basis. Again the numbers right now are tracking a little bit behind the model that we pull together when we did the acquisition, but we continue to be very positive about the decision to make the acquisition and the prospects of the business going forward. Jay, you want to talk about maybe the second part of the question, Baxter question.
Jay Saccaro:
Yes, I believe the second part was in relation to overall cost synergies and how that's tracking. As we think about that component, we've previously commented $300 million in annual savings achieved by 2017. As we sit here today we're confident that we're much on track in terms of achieving the milestones necessary to achieve that level of cost savings by 2017.
Bob Parkinson:
Josh, one thing I would add coming back to my comments, the specific focus on Gambro, obviously one of the rationales behind the deal was to be able to bring forward a broad based product offering and in addition to the cost synergies that Jay just commented on is the opportunity for commercial synergies that we're all starting to release. So as we move forward, really the way to value this business or evaluate the business is to look at it in total. While the chronic business was softer in the first quarter for the reasons that I mentioned, we're seeing synergies already in terms of increased demand in the PD segment as a result of being able to bring a broad product offering to the marketplace, particularly participating in certain tenders and so on where we have as I say a complete product offering. So I think going forward the way to look at this business is really an aggregate because you're going to see the various components certainly in the chronic space where there is traditional in-center or PD in the home begin to melt together somewhat.
Josh Jennings:
Great, thanks for that and just a quick follow-up. I know you're going to give more details at the Investor Day, but you have called out that the new Baxter is going to hold a 20% stake in Baxalta. Can you just give us some details around the rationale behind that strategy? Any timelines in terms of the ultimate sale of that stake and deployment of that capital, thanks a lot.
Bob Parkinson:
Again we'll be more specific on that in a couple of weeks, but Bob maybe you might just want to make couple of comments about that.
Bob Hombach:
Well certainly, yes. Josh, I think first and foremost this is a clear indication of confidence in the future prospects of Baxalta and I think it provides a significant amount of flexibility in terms of capital structure really for both businesses as we approach this significant separation and try to set up the two entities for sustainable success going forward. Again very confident in the ability to generate significant cash for both and want to ensure we position both that in a very competitive environment to be ready and able to continue to pursue their strategies, which include reinvesting in the business and potentially bolt-on acquisitions as well. And as Bob mentioned, I think we will get into much more detail on that as we get into the Investor Conference in May.
Operator:
Thank you. David Roman of Goldman Sachs is on the line with a question. Your question please.
David Roman:
Thank you, good morning, everybody. Hey Bob. I wanted just to start with hemophilia. I think in your prepared remarks you referenced 2% cumulative share loss for now three quarters into the Biogen launch. Are we at a point now where you feel confident in sort of your original substance about the pace of share loss and if that is the case why not a more optimistic outlook than the 0% to 2% guidance that you're providing for the balance of 2015.
Bob Parkinson:
All right. I'll turn this to the expert Ludwig.
Ludwig Hantson:
Well, thanks for the question David. So as you said, we continue to see growth in our recombinant Factor VIII demands in the U.S. In addition to that, as you saw we have very strong FEIBA growth. I can tell you we have a very strong team and ADVATE has a very strong brand equity. And the bar is high and the bar is high on efficacy and tolerability. So with respect to guidance that we gave you already last year, high single digit market share loss between the launch and the launch of ELOCTATE and the launch of 855. We still stick to that guidance for now. The 2% market share we're doing better as expected. We're going to see what we're going to do in the next couple of quarters. You should also note that we will get additional competition within the Factor VIII space in U.S. So we will keep you posted on how we're doing and we will adjust our sales guidance accordingly.
David Roman:
And if I could just clarify something just before I go to my second question. You said the high single digit share loss between ELOCTATE and 855, so I think about the total Baxter franchise, ADVATE, plus 855 the share loss will be lower than high single digits.
Bob Parkinson:
Well I think the expectation is we would get approval very late in 2015 and then launch 855. So from midyear last year launch of ELOCTATE till that point at the end of this year before we launch 855 that that’s the single digit share loss that we're referring to.
Ludwig Hantson:
So as we think it's about in 18 months period.
David Roman:
Got it. Okay. And then secondly just on margins, Bob in your comments around renal, you made the point that you did walk away from some lower margin business and I think one of the potential opportunities around the medical products is the relative profitability compared to peers. Can you just may be give some sense on the dissynergies. How easy is it just to cut out those incremental $300 million, it sounds like you're adding the cost than in terms of pulling it back out. You have commitment to ranch it that down, but how long does something like that take and what are the steps needed to get there.
Bob Parkinson:
First of all the entire $300 million is in new BAX that's partly absorbed by Baxalta as well. But nonetheless it’s a meaningful number. I would say our intent would be to offset the negative impact of dissynergies and stranded costs if you will probably within a two-year timeframe, but frankly that’s just part of a broader initiative to evaluate opportunity to pull out structural cost, which is a significant opportunity going forward. This is the story that you're going to hear in a few weeks in New York is our belief strongly is that there is an opportunity to meaningfully improve margins over time whether it’s the Gambro synergies that we continue to track well on as Jay commented earlier focus on structural cost improvement in manufacturing efficiencies and costs going forward because we have absorbed some incremental costs. As you know in our facilities particularly in manufacturing IV solutions and PD solutions as a result of looking for ways to enhance our operational and quality performance in those businesses, the re-launch of CIGMA spectrum portfolio as I talked about in terms of a more proactive management of that and then increased focus on higher margin, higher growth product. So in aggregate, this provides a very exciting opportunity to meaningfully increase margins over time, but you're right. Back to your question David, as you benchmark versus peers and so on, as you'll see we're at the lower end. Now part of that frankly to some degree is the nature of the businesses that we're in. Not only IV solutions, but PD solutions, we incur significant distribution cost as associated would be in those businesses that typically are unique to those kinds of businesses compared to other companies you might want to benchmark again. So in some ways the real litmus test here is in those businesses are we generating returns that are sufficiently in excess of our cost of capital. In many ways this gets back to the whole notion of focusing on portfolio. So again I'll stop there. Jay I could talk a lot of this, but you'll hear more on this in few weeks David.
Operator:
Thank you. David Lewis of Morgan Stanley is on the line with a question. Please take you question.
David Lewis:
Good morning. Just a couple of quick ones here. Just into the second quarter Bob, the earnings was a little lower than you were expecting, but some of the factors you discussed weren’t materially different than we were expecting. So does that simple reflect conservatism or simply incremental cycle of pressure with a little bit of currency? So what is specifically driving some of the pressure sequentially?
Bob Parkinson:
Well yes first and foremost, I would say the second quarter very much aligns with our outlook of the full year. So there is a calendarization impact at work here as well just in terms of timing of tenders and so on. But clearly the cycle impact will accelerate in the second quarter relative to the first quarter fairly meaningfully as that first competitor is much more entrenched in the marketplace. And FX will continue to be a headwind as we've talked about the rate at which we've been able to hedge key currencies like the Euro or much in the first half of the year than they are in the back half of the year. So that's certainly a contributor to the near term. But again I would emphasize this is all very much in line with our expectations as we look at 2015 initially.
David Lewis:
Very, very clear. And then Ludwig just with the commentary I guess that Bob had made, but on inhibitors the volume growth is actually very impressive. The other comment that was interesting though, I think there was a comment about stronger pricing in the inhibitor segment. I am trying to figure out where exactly that stronger pricing is coming from? Is this simply mix or are you, just given the strength of the portfolio using this as an opportunity to take up price in either these or obviously this new or FEIBA.
Ludwig Hantson:
Well FEIBA is the number one driver within that segment. So we're just launching OBIZUR and the patient response is very positive on OBIZUR. So we're still building that business. On FEIBA we see different dimensions here. The first one continued growth -- demand growth because of very strong rollout of the [profile] [ph] indication and in addition to that, we've been able to take a little bit of price on FEIBA.
David Lewis:
Okay. And then just one quick one and I'll jump back in queue. For Bob Parkinson, Bob you talked about renal cost cutting and then sort of renal growth being a little slower. In terms of capacity that was a big driver of the Gambro transaction. Are we going to ramp capacity at certain plants? Is there any concern that if growth is slower on renal, that's going to put some pressure on some of the gross margin objectives or are you still comfortable with those gross margin objectives or simply feel that there are more SG&A cost opportunities at Gambro that make you very confident that you still get to those cost targets even with a little lower growth rate. Thank you.
Bob Parkinson:
Yes, well the synergies that Jay commented on earlier largely associated with structural cost and global manufacturing footprint and things of that nature -- very operational in nature. In terms of our gross margins, we're confident that we're on track with what we model in that regard. I think clearly the -- and we modeled this in. I think the traditional in center hemo market will always be very, very price competitive and so I think we've been very realistic in how we forecasted pricing and margins going forward and that business I think the acute segment and frankly the PD segment in certain markets around the world can be more blank in terms of pricing and selling. But net, net for the broad renal business including the Gambro component, I think our outlook in terms of pricing, market dynamics and how that manifests itself in gross margins is pretty realistic.
Jay Saccaro:
Yeah and maybe just adding one comment back to the second quarter and our outlook, I would also emphasize, we had given a somewhat wider range for two reasons. One is the volatility in FX, but the second one is during the course of the second quarter, likely we will execute our financing to establish the capital structure for Baxalta and have to adjust the existing debt portfolio potentially for Baxter. And as a result, there is some uncertainly around both timing and impact on interest expense. So we've built some conservatism into the outlook to account for that eventuality.
Operator:
Thank you. Our next question comes from Kristen Stewart of Deutsche Bank. Your question please.
Kristen Stewart:
Question and guess this will be our last call together as old Baxter, so I had a couple of questions just throw them out there. On the -- on the I guess the recombinant hemophilia side, you had mentioned new patient reimbursement programs. I was wondering if you could just comment on that. Is that part of a strategy to kind of keep people locked in with ADVATE? Just wanted to get an update on the Georgia plant and how things are going? Whether or not that is tracking on schedule from a completion perspective and Sanquin and then lastly just gross margins. You had guided to being down 250 to 300 basis points. Came in a little bit better than that. Just curious on what drove the favorability, thanks.
Ludwig Hantson:
Yes, this is Ludwig. Kristen, thanks for your question. With respect to hemophilia, these new patient reimbursement programs, we do this for access reasons. Want to make sure that people have access to all products. With respect to the Georgia plant, it is on schedule. As for supplies concerns, we will grow faster than the market including the Sanquin opportunity. You mentioned Sanquin is still on track to have the first product by the end of this year and we will be focused on European product.
Kristen Stewart:
Okay.
Bob Hombach:
And Kristen as it relates to gross margin yes, the gross margin did come in from a percentage base is a bit better than we expected in the quarter. That certainly is driven by mix. You saw BioScience grew very strongly. Some modest price contribution as well as a bit than we expected, but also on a reported basis, we did have hedge gains as I mentioned and so those hedge gains while they do impact the gross margin, they’re simply offsetting the underlying weakness in the currency that’s driving down the natural sales and gross margins that would otherwise be reported by the business. So the mechanics here with the lower reported sales, but the gross profit dollars being preserved by the hedges, result in a higher reported gross margin and that contributed somewhere between 60 and 70 basis points to the reported gross margin percentage benefit in the quarter. Just maybe a moment more on those hedges, again I would emphasize that these hedge preserve value, they do not in and of themselves create incremental value. They are there to hedge underlying exposures. By definition if the currencies are weak and those underlying exposures are worsening and the hedges again preserve value back to our original expectation. But as it relates to year-over-year comparisons as we think to the back half of 2015 and then into 2016, the hedge rates we have in place in the first half of 2015 are very attractive particularly for the Euro, north of $1.30, $1.30 per euro which clearly we put in a place a long time ago. But the hedge rates we have in place for the back half of ’15 are less than that and certainly for 2016 are nowhere near that. So while they do not create incremental value necessarily in 2015 for Baxter, in 2016 if rates stay where they're at, sales will continue to be depressed but our hedge rate will imply a gross margin percentage and value that will be less than what we're seeing now. We estimate at current rate that, that would be $70 million to $80 million of incremental headwind if you will in 2016 for the combined company, which equates to about $0.10 to $0.12. So at current rates we would see that in 2016, but again I just want to emphasize the hedge gains improve reported gross margin percentage but in and of themselves are not necessarily added to the bottom line because they’re there to hedge underlying exposure.
Kristen Stewart:
And can you update just for 2015, where we stand now with the total Baxter impacts from a foreign exchange perspective?
Robert Parkinson:
Yeah, it’s still very much where we expected, excluding this anomaly in other income here in the quarter operationally in margins and of margin it's still very much where we had previously projected with again most of the negative impact, somewhere in the order of two-thirds of the negative impact of the approximately $0.40 that we projected for the year we're going to experience in the back half of ‘15?
Kristen Stewart:
So $0.40 in the back half of ’15 in total?
Robert Parkinson:
$0.40 is our full year expectation, so excluding the anomaly of the other income in Q1 we're very much in that range still for 2015, but about two-thirds of that will impact us in the back half of the year for the reasons I mentioned the hedge rates are at less attractive levels for us and frankly the Euro has deteriorated from when initially gave guidance as well.
Kristen Stewart:
Got it, okay. Thank you very much guys.
Ludwig Hantson:
Thank you, Kristen.
Operator:
Bruce Nudell of Credit Suisse is online with the question. Please state your question.
Bruce Nudell:
Thanks for taking my question. I have a couple for Ludwig. Ludwig most of these net expense worked pretty well and the stock appears to have been handcuffed prior to the spend largely due to kind of perceived essential for us hemophilia specifically Factor VIII and FEIBA, there SubQ approaches that are out there in the development stage that are potentially once a month they work in the presence of inhibitors potentially Baxter 826 may be better than once per week dosing, but it’s not humans yet. Just schematically what’s the company’s view broadly speaking as to whether or not we should view Factor VIII and FEIBA as a kind of midterm grower or a decliner and if it’s a decliner are there enough offsets of it really should matter for the new Baxalta.
Ludwig Hantson:
This is a great question and you're going to feel the details on May 19. So I hope you'll be able to join us. But overall we believe that this business will continued to be a growth driver for us in all the different segments inhibitors as well as hemophilia. What we're doing is we're building both breadth and depth in our portfolio. The depth as you mentioned with 855 hopefully launched by the end of this year, 826 and then moving to gene therapy. Everything is related to factor replacement, which is an advantage because the clinical, the regulatory piece, the manufacturing piece is very well understood. So that’s the path that we’re on. The breadth is that we’re going outside of hemophilia and you know that we have different opportunities in development. So overall this will continue to be a growth driver for us, but we’re going to give you much more details on May 19.
Bruce Nudell:
Thanks so much for that and just your commentary on HYQVIA is very interesting. I think you said 1500 of the 15,000 patient equivalents in USPID are sub-QPID are now captured. So like what’s the sealing for that and what are the plans for extending that to non-PID applications?
Bob Parkinson:
Well we’re very pleased and we’re pleased in the first place, because the feedback from the patient is very strong. But it also gives value to the payer as well. Overall, we believe let’s say a decrease in total cost of therapy even though we were able to take a price premium, because of the equivalents of the bioavailability of HYQVIA. So I believe it’s a winner. We’re in a position over the long-term to make this a leading product within PI. The opportunities that we have on the development side is to go outside of PI, that PI is about 20% to 25% of the total business. So we’re starting Phase III program in CIBP as well as we continue to look at extending the label with NPI. At this moment we’ll restrict it to adults. So we’re very, very pleased with the uptake six months in and we have 1500 patients out of 15,000.
Bruce Nudell:
Thanks so much.
Mary Ladone:
Hey Stephanie, we have time for two more questions.
Operator:
Thank you. Mike Weinstein of JPMorgan is on the line with the questions. Please state your questions.
Mike Weinstein:
Thanks I just want to clarify as starting point just the FX impact commentary in the second quarter. So the $0.11 Bob as you called out for this quarter that would be offset in the $0.40 so the actual on a reported basis I guess the FX impact for the year is more like $0.30 this year and then another $0.20 to $0.22 next year is that how we should think about it?
Bob Hombach:
Yeah, I would definitely separate the anomalous situation that occurred here in Q1 in other income from the operational FX we expect to incur, which again we continue to think is approximately $0.40 and at the op income line. As it relates to 2016, my comments were specifically about the year-over-year potential for headwind related FX gains. The overall FX picture is clearly going to be defined by how currency rates move between now and in the end of 2015, which they have been fairly volatile. And plus we’ll have different impacts by business as well. So I don’t want to get too far ahead of myself here as it relates to overall expectations on FX impact in 2016 other than to say we’ve hedged gains here are clearly going to be an issue at the current level of exchange rates and the current level of hedge rates we’ve been able to achieve thus far in 2016 and again I peg that at about $0.10 to $0.12 on a year-over-year basis.
Mike Weinstein:
Okay and then just to think about the $0.92 to $0.96 for the second quarter, so if we’re analyzing that, which I realize is a problem doing that but it’s all we've got to do with right now. The incremental impact from there is the $0.40 of dyssynergies from the split and the net incremental FX impact as well was the whatever remaining erosion there is in cyclophosphamide is that fair?
Bob Parkinson:
Well just to be clear when you say $0.40 of these synergies that’s an annual number.
Mike Weinstein:
Right.
Bob Parkinson:
That’s not going to incur in the back half of ‘15, but that’s our current estimate of the annual impact. Initial dyssynergies from a run rate perspective I would tell you we’ll get into this more in May, but both businesses are going to begin to do what we can to mitigate some of those dyssynergies even starting in 2016. So that will be part of what we get into at the Investor Meeting here in a few weeks. But from a run rate perspective in the back half of ’15, the $0.40 roughly well as I said approximately, $300 million or so in overall dyssynergies. So it’s a bit more than $0.40.
Mike Weinstein:
Right, okay, just a couple of quick product clarification, you said in the prepared comments Bob considering that 817 that even though everything has gone well there, you said regulatory submissions over the next several year. So I was hoping you could clarify that because I think we’re assuming that you submit that product later this year and then 855 Ludwig, if you could just comment on the dialogue with the FDA in the confidence and an approval later this year that would be great. That’s all, thanks.
Ludwig Hantson:
817, recombinant VII, so positive Phase 3 data, we have to power test we have a long list of products within hemophilia. We have to prioritize from a manufacturing perspective, 817 is lower in the ranks and that’s the reason why, we will not be submitting later this year. With respect to 855 the regulatory review is ongoing. No red flags at this moment and we believe that we still have the chance to get approval before yearend.
Mary Kay Ladone:
And Stephanie our last question?
Operator:
Our final question comes from Bob Hopkins of Bank of America. Your question please.
Bob Hopkins:
Thanks very much for taking the question. So the first question I have is previously you guys suggested that fully loaded operating margin for Baxter medical products at the time of the spin would be in the low double digit range. And I was wondering in light of all the comments today about that business, is that still a good number to think about in terms of the operating margin from the start or is that now a little more?
Robert Parkinson:
Yeah, Bob we haven’t been quite that specific. What we simply said, it would be at the very low end of the peers that for a number of reasons and frankly as we work through all of the details here on the separation including things like the pension that we currently have in the U.S. which generates simply the amount of expense and how that gets a portion between the two companies and so on. Again we lay all this out at the Investor Meeting, but I just want to clarify, we haven’t specified a start point if you will from an operating income margin perspective.
Bob Hopkins:
Well then maybe another way to asking the question is in terms of what’s happened at the business since the last call on Q4, you’ve talked a lot about currency, I think we’ve got that straight, there has been cost like they're the same. Renal sounds a little worse, is there any other major moving parts you want to comment on here like is pension different than it was at the beginning of the year in terms of some of the big buckets we should be thinking about that might have changed again since the last conference call.
Robert Parkinson:
Yeah, the only thing I would say about pension is due to the fact that we are going to be have to split the pension, that triggers a gap requirement for a re-measurement. This is the process that normally happens at the end of the year where you rebase, where you discount rate is, your asset return assumption etcetera, your mortality table the whole mind yards. So there is a possibility that pension expense could be different. I think directionally interest rates are slightly lower now than they were at the end of the year. So there may be some impact. I don’t think it's going to be super material. Other than that and the factors that you've mentioned, I don’t think there is anything else in the business we’ve talked about that has changed.
Bob Hopkins:
And then lastly really quickly, are you guys going to address dividend policy at the upcoming meetings. Obviously there is given the decline in earnings there has been a lot of discussion about the dividend. Is that something you would lay out in detail at this meeting and just wondering how confident you are that you can maintain the total payout relative to what you’re currently paying?
Robert Parkinson:
Yes, as we said all along we're going to lay out the full financial outlook. The sales, the operating margins, the cash flow generation capabilities of two businesses as well as capital structure in terms of bed allocation and capital allocation policies including dividend policy, that will all be part of our discussions with investors on the 18 and 19 of May in New York.
Bob Hopkins:
Great, thank you.
Robert Parkinson:
Thanks Bob.
Operator:
Thank you ladies and gentlemen. That does conclude today’s Q&A session and today’s conference call of Baxter International. Thank you for participating. You may all disconnect and everyone have a great day.
Operator:
Good morning, ladies and gentlemen, and welcome to Baxter International's Fourth Quarter Earnings Conference Call. [Operator Instructions] As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter's permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Corporate Vice President, Investor Relations at Baxter International. Ms. Ladone, you may begin.
Mary Kay Ladone:
Thanks, Sam. Good morning, everyone, and welcome to our Q4 2014 earnings conference call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International; Ludwig Hantson, President, BioScience; and Bob Hombach, Chief Financial Officer. Before we get started, let me remind you that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters, contain forward-looking statements that involve risks and uncertainties, and of course, our actual results could differ materially from our current expectations. Please refer to today's press release and our SEC filings for more detail concerning factors that could cause actual results to differ materially. In addition, in today's call, non-GAAP financial measures will be used to help investors understand Baxter's ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I'd like to turn the call over to Bob Parkinson.
Robert L. Parkinson:
Thanks, Mary Kay. Good morning, and thank you all for calling in. 2014 was a great year for our company and I'm very pleased with our achievements and progress we've made from a financial, operational, scientific and strategic perspective. First, we were successful in meeting or exceeding our financial objectives with accelerated growth in sales, solid earnings and significant cash flow. And we've consistently executed a disciplined capital allocation strategy that balances reinvestment in the business with returning value to shareholders in the form of increased dividends and share repurchases. Positive momentum continues to build across the commercial franchises as we extend our global reach with the core portfolio, enhance care with the introduction of several new products and position both businesses for sustained success. We're balancing this with investments in commercial and operational excellence as well as manufacturing capacity to improve our competitive position and support the solid underlying fundamentals in future demand that we foresee for Baxter's products and therapies across the globe. We're also transforming innovation and advancing the pipeline with the achievement of significant clinical and regulatory milestones, while expanding the portfolio through acquisitions and collaborations. And most notably, in 2014, we reached a significant milestone in Baxter's history as we remain committed to driving long-term value for shareholders with the creation of 2 independent publicly traded companies in mid-2015, providing investors with 2 unique and compelling investment opportunities. Before turning the call over to Bob Hombach for a discussion of the financial results and future outlook, let me take just a few minutes to reflect on a number of the achievements from the past year. First, strong sales performance reflects our strategic focus on improving access and treatment standards, broadening our global presence while investing to support future growth. Baxter's worldwide revenues totaled $16.7 billion in 2014, advancing 11% or 5%, excluding Gambro and foreign exchange. International sales, representing nearly 60% of Baxter's total revenues, were augmented by significant growth in emerging markets with sales in the BRIC countries advancing by more than 15%. Continued emerging market penetration represents a significant opportunity for both businesses going forward as many products and therapies remain underpenetrated, diagnosed or treated. For example, in Medical Products, we continue to drive global penetration for higher-margin specialty products, including those from BioSurgery and nutrition franchises, with the expanded launches of FLOSEAL in Japan, HEMOPATCH in Europe and our proprietary triple-chamber nutritional containers in several new markets like China, Brazil, Australia and France. To address strong demand across our hospital products and renal portfolio, we announced plans to invest approximately $600 million to expand capacity and enhance production capabilities in several key markets and product areas, representing some of the greatest opportunities for future growth. These include investments in Asia and at our North Carolina facility to support production of peritoneal dialysis and intravenous solutions. We're also executing on expansion plans at our state-of-the-art manufacturing facility in Opelika, Alabama to meet the growing global demand for dialyzers. In addition, we've successfully executed on the integration of Gambro, achieving the commercial and cost benefits that we anticipated and further extending our global reach with a comprehensive renal therapies portfolio. In BioScience, we're building upon our global leadership position in hemophilia, as evidenced by our strong double-digit revenue growth for 2014. Highlights for this franchise include
Robert J. Hombach:
Thanks, Bob, and good morning, everyone. Adjusted earnings per diluted share from continuing operations increased 2% in the fourth quarter to $1.34, which exceeded our previously issued guidance range of $1.30 to $1.33 per share. These results reflect strong revenue growth across several key franchises and continued investments in operations and research and development. As we mentioned in the press release, GAAP earnings of $1.74 per diluted share reflects both earnings and an after-tax gain from the recently divested vaccines franchise totaling $429 million or $0.78 per diluted share. In addition, our GAAP results reflect after-tax special items totaling $209 million or $0.38 per diluted share for intangible amortization costs associated with business development and contingent milestone payments, integration of the company's acquisition of Gambro AB and Baxter's planned separation. Now let me briefly walk you through the P&L by line item before turning to the financial outlook for 2015. Starting with sales. Worldwide sales of approximately $4.5 billion advanced 3% on a reported basis. On a constant currency basis, sales increased 7%, reflecting a sequential improvement in growth over the last 4 quarters from an organic perspective. This growth also favorably compares to our guidance for the quarter of approximately 3%. Each product category contributed to the overachievement with particular strength coming from the hemophilia franchise, driven by ADVATE and FEIBA, and strong U.S. performance across the Medical Products portfolio. Sales in the U.S. increased 6% and international sales, excluding foreign currency, increased 7%. As Bob mentioned, sales in emerging markets were strong, advancing by more than 15% in the quarter with robust growth in the BRIC markets, driven by hemophilia sales in Brazil and the timing of tenders as expected. For the full year, worldwide sales of nearly $16.7 billion advanced 11% on a reported basis or 13% on a constant currency basis. Baxter's sales for the full year increased 5% on a constant currency basis when excluding Gambro revenues from both periods. Gambro sales were $1.6 billion in 2014 compared to $513 million in 2013. In terms of individual business performance, global BioScience sales totaled approximately $1.9 billion in the quarter and advanced 9% on a reported basis. On a constant currency basis, BioScience sales increased 12%, reflecting the highest quarterly growth in the last 5 years. For the full year, global BioScience sales advanced 7% to $6.7 billion. After adjusting for foreign currency, sales grew 8%, significantly exceeding our original expectation of sales growth in the 3% to 4% range for 2014. Within the product category, hemophilia sales in the fourth quarter of approximately $1.1 billion increased 9% on a reported basis, and excluding foreign currency, sales advanced 13%. While sales in the U.S. were strong, up 8%, international sales grew 16% on a constant currency basis. As mentioned in Bob's opening remarks, international penetration remains a significant opportunity for our company as hemophilia is a disease that remains tremendously underdiagnosed and undertreated around the world. As the established global leader, Baxter today derives approximately 60% of total hemophilia sales from outside the U.S. in more than 60 countries worldwide. In addition, in the quarter, we achieved a record level of ADVATE sales with a fifth consecutive quarter of double-digit growth. This was the result of strong global demand, prophy conversions, benefits from recent tender wins in the U.K. and Australia and conversion to recombinant therapy in Brazil. For the year, sales in Brazil totaled more than $100 million, in line with our expectations, and to date, we have converted approximately 40% of the estimated 10,000 hemophilia A patients in the country. In the U.S., where we face new competition, our recombinant Factor VIII sales outpaced market growth. In fact, for 2014, we've enhanced our overall Factor VIII unit share position despite a more competitive environment and modest patient losses. We were also pleased that growth in our hemophilia franchise was further augmented by the launch of several new products and indications, including double-digit growth of FEIBA for the treatment of hemophilia patients with inhibitors as well as contribution from RIXUBIS, a Factor IX treatment for hemophilia B patients, and the recent launch of OBIZUR for acquired hemophilia. In BioTherapeutics, sales of $628 million increased 11% on a reported basis. Sales increased 14% on a constant currency basis, driven by robust demand, particularly for immunoglobulin therapies and albumin. Throughout 2014, we enhanced our overall supply of plasma therapies as we successfully executed to increase capacity across our manufacturing network. We are now in a position to support ongoing growth in demand of at least 8% going forward. A significant achievement in the fourth quarter was the launch of HYQVIA in the U.S. This is a transformational therapy with an attractive value proposition for patients, physicians and payers. For 2014, Baxter successfully increased global subQ penetration, including U.S. HYQVIA sales in the fourth quarter of $35 million, which primarily reflects the impact of initial stocking orders by customers and the favorable reception of the product in the marketplace. In BioSurgery, sales of $197 million grew 2%. On a constant currency basis, sales rose 4%, driven by increased penetration of surgical sealants despite modest growth in surgical procedures and some competitive pricing pressures. As you may recall, the BioSurgery business will be reported in the Medical Products business going forward. In Medical Products, global sales of approximately $2.6 billion were comparable to the prior year, and on a constant currency basis, sales increased 3%. For the full year, Medical Products sales rose 15% to approximately $10 million, and on a constant currency basis, the sales growth was 16%. After adjusting for Gambro in both periods, Medical Products sales in 2014 increased 4% on a constant currency basis. Within the product categories, Renal sales in the quarter were approximately $1.1 billion, reflecting a decline of 2% on a reported basis. Excluding foreign currency, sales grew 3%, driven by solid PD patient gains in the U.S. and emerging markets and improved performance from the Gambro HD business. For the year, Gambro sales were in line with our expectations and exceeded $1.6 billion, an increase of approximately 2% on an organic basis. While sales in the first half of 2014 were comparable to the prior year, we are encouraged with the acceleration of sales to mid-single digits in the second half of 2014, driven primarily by mid-teens growth of the acute care business and improved dialyzer sales. Within the Fluid Systems category, sales of $822 million were comparable to the prior year period, and on a constant currency basis, sales grew 2%. Performance was driven by favorable demand for IV therapies as well as increased sales of cyclophosphamide, which collectively more than offset lower sales of infusion pumps. As you may know, a new competitor recently entered the U.S. market for cyclophosphamide, and we continue to expect additional competitors in the coming months. For your reference, full year 2014 U.S. cyclophosphamide sales totaled approximately $450 million. Specialty Pharmaceuticals, which includes our inhaled anesthetics and nutritional therapies, posted sales of $417 million in the quarter, reflecting an increase of 2%. Sales rose 6% on a constant currency basis as we continue to penetrate international markets with our higher-margin anesthesia portfolio and achieve strong growth in our U.S. nutrition business with improved sales of vitamins and lipids, which were constrained last year. Finally, sales in BioPharma Solutions, which is our pharma partnering business, totaled $271 million, increasing 1% on a reported basis or 4% on a constant currency basis. Performance can be attributed primarily to increased demand from our contract manufacturing partners and strong hospital pharmacy compounding revenues. Turning to the rest of the P&L. Gross margin in the quarter was 50.3% compared to 50.4% last year. Positive mix in BioScience and select pricing improvements across the portfolio were more than offset by the impact of foreign currency as well as expedited freight for PD solutions, ongoing manufacturing inefficiencies and investments we are making to enhance operational capabilities and advance our quality systems and processes. For the full year, the gross margin of 50.4% was in line with our guidance. SG&A totaled $970 million and increased 4%, driven by planned investments and promotional and marketing initiatives for new product launches in BioScience and incremental customer freight and logistical expenses to support the strong demand for IV solutions. R&D spending in the quarter of $305 million increased 6% versus the prior year, driven by the addition of new R&D programs in BioScience through acquisitions, the acceleration of other programs in the areas of hematology, oncology and immunology and investments in renal therapies aimed at improving patient outcomes across the continuum of care. Interest expense was $29 million in the fourth quarter compared to $41 million last year as we benefited from recent debt maturities and income generated from a change in the mix of floating versus fixed interest rates. Other expense totaled $25 million and was driven by the negative impact of foreign exchange on balance sheet positions. The tax rate was 20.5% for the quarter, bringing the full year tax rate to 21.7% in line with our expectations. And as previously mentioned, adjusted earnings per diluted share from continuing operations increased 2% to $1.34, and for the full year 2014, earnings per diluted share of $4.90 exceeded our guidance range. Turning to cash flow. For 2014, cash flow from operations was very strong and totaled more than $3.2 billion. Excluding cash costs associated with the spinoff of the biopharmaceutical business, we generated $3.3 billion in cash flow from operations. Capital expenditures totaled $1.9 billion for the year, reflecting investments in manufacturing capacity to support future demand and growth across the portfolio. DSO ended the quarter at 52 days, and excluding Gambro, Baxter's DSO was 50 days, lower than the prior year by more than 2 days. Inventory turns of 2.4 are lower than the prior year period by 0.3 days, driven by the impact of new product launches and enhanced inventories in our plasma business. And lastly, in 2014, the company repurchased approximately 7.8 million shares for $550 million, or on a net basis, 1.3 million shares for $206 million. Finally, let me conclude my comments this morning by providing some information on the financial outlook and assumptions affecting our performance in 2015. As I've previously mentioned, given the complexities of a midyear spend, we are not in a position today to provide full year guidance for Baxter and Baxalta. As we move into the second quarter of 2015, Baxter will likely begin reporting Baxalta as a discontinued operation, and at our investor conferences in May, each company will provide additional information on their financial profile and outlook. Today, we will provide investors with some relevant information on several key discrete challenges we expect to face in 2015. First, given significant volatility in foreign currency rates, particularly in emerging markets and more recently the euro, we expect a full year impact of approximately $0.40 per diluted share related to foreign exchange. Given the timing of currency movements, the impact of our hedging strategy and our geographic mix, the majority of this impact is expected to occur in the second half of 2015. Second, with interest rates much lower as we exited 2014, pension expense will be a headwind of approximately $0.10 per diluted share for the year. Third, given the assumption that we will experience additional competition for cyclophosphamide throughout 2015, we are assuming a full year impact of approximately $0.40 per diluted share. And lastly, as previously mentioned, we are incurring additional costs that reflect manufacturing inefficiencies and investments to enhance operational capabilities, creating an additional headwind in the first quarter of approximately $0.10 per diluted share. As we move into the second half of 2015, we expect these costs to stabilize as we begin to anniversary these impacts. Let me take a few moments to provide full year sales guidance for the 2 businesses and the major product categories for 2015. Recall that given the spin, we have taken the opportunity to step back and look at our organizational structure to ensure that we're best positioned to successfully operate 2 standalone companies. Therefore, we are moving to a new reporting configuration that is aligned with the respected internal organizations and are providing guidance in this new format this morning. For your convenience, we posted the historical restated sales, including 2014 by quarter, to the Investor Relations section of our website. Beginning with the new Baxter franchises, on a constant currency basis, we expect sales to be comparable to 2014. Excluding cyclophosphamide in both years, underlying growth will be approximately 3%. Specifically, we expect sales in our Renal franchise, which includes our leading peritoneal and hemodialysis products, to grow in the 4% to 5% range. We expect Fluid Systems sales to grow in the 2% to 3% range. This franchise includes our IV therapies, infusion pumps and associated disposables. We expect sales of our Surgical Care franchise to grow in the 4% to 5% range. This franchise includes anesthesia and BioSurgery products. We expect the Integrated Pharmacy Solutions sales to decline approximately 10%. This franchise includes injectable drugs like cyclophosphamide as well as our nutritional therapies and hospital pharmacy compounding business. Excluding the impact of cyclophosphamide of approximately $300 million, growth is expected to be in the low single digits. And finally, we expect the other category to decline approximately 15%. This category primarily includes our third-party manufacturing business, which will be impacted by a major customer electing to self-manufacture products previously manufactured by Baxter. For Baxalta, we project sales growth, excluding foreign currency, of approximately 3% to 4%. Our outlook includes growth in the hemophilia franchise of 0% to 2%. This includes sales of our recombinant and plasma-derived hemophilia therapies, including ADVATE, RIXUBIS and other treatments for Factor VIII and Factor IX deficiencies. Growth will be fueled by new product launches and strong international demand, which will be somewhat offset by anticipated high single-digit share loss in the U.S. due to increased competition. We expect growth in the inhibitors category to be in the 6% to 8% range, driven by further penetration and growth of FEIBA for the treatment of inhibitors and the launch of OBIZUR for the treatment of acquired hemophilia. For immunoglobulin therapies, which includes our antibody replacement treatments, we expect growth of 6% to 8%, driven by strong market demand and the contribution from HYQVIA. And finally, for BioTherapeutics, which includes plasma-derived therapies like albumin and treatments for alpha-1 deficiencies among others, we expect to grow in the 2% to 4% range. Now turning to the first quarter. We expect adjusted earnings, excluding special items, of $0.85 to $0.90 per diluted share, reflecting the headwinds just mentioned. It is important to note, however, that this guidance does not reflect any incremental cost or dis-synergies associated with the spinoff of the biopharmaceutical business as these costs will begin to be layered in throughout the second quarter. Now in terms of the P&L by line item, we expect first quarter sales growth, excluding the impact of foreign currency, of 2% to 3%. At current foreign exchange rates, we expect reported sales to decline 3% to 4%. By business, on a constant currency basis, we expect Medical Products sales growth of 1% to 2% and BioScience sales to grow 4% to 5%. In the first quarter, we expect gross margin for the company to decline by approximately 250 to 300 basis points versus the fourth quarter of last year of 50.4%. This reflects the impact of increased manufacturing costs, which are most pronounced in the first quarter, as well as the impact of cyclophosphamide and pension expense. We expect SG&A to decline by approximately 5% versus the prior year and R&D to be flat on a reported basis. Excluding foreign currency impacts, both SG&A and R&D are expected to grow in low single digits. And finally, for the first quarter, we expect interest expense to total approximately $35 million, no impact from other income versus gains we recorded in the prior year, and we expect a tax rate of approximately 22% with an average share count of approximately 547 million shares. This concludes my prepared remarks this morning. We look forward to providing more financial information to you in the near future. In the meantime, I'd now like to turn the call over to Bob for his closing comments.
Robert L. Parkinson:
Thanks, Bob. Let me end our prepared comments this morning with a brief update on the anticipated spinoff of our biopharmaceuticals business. Our organization has been fully engaged in separation activity since the announcement that we made last March, and we're energized by the prospects of separating Baxter into 2 leading global health care companies, one focused on developing and marketing innovative biopharmaceuticals and the other on life-saving medical products. This decision supports Baxter's evolution and underscores our commitment to ensuring long-term strategic priorities remain aligned with shareholders' best interest, while creating value for patients, health care providers and other key stakeholders. The 2 businesses operate in distinct markets with corresponding underlying fundamentals and each possesses unique and compelling growth prospects, investment requirements and risk profiles. The spinoff will create 2 well-capitalized, independent companies with strong balance sheets, investment-grade profiles and disciplined approaches to capital allocation. The spin will also provide greater management focus, the ability to more effectively commercialize new and existing product offerings to drive innovation and enhance our flexibility to pursue respective growth and investment strategies. This will result in revenue acceleration, improved profitability and enhanced returns for shareholders. During 2014, we named our senior leadership teams for both companies, established the international and commercial structures for both organizations, formally unveiled Baxalta Incorporated as the name of the new publicly traded biopharmaceutical company and filed a preliminary Form-10 with the SEC for Baxalta. While we continue to work through the complexities, this process is unfolding in line with our expectations, and we continue on track toward a mid-2015 completion. We recently announced that we'll be hosting an investor conference in New York City on the afternoon of May 18 for Baxter International and on the morning of May 19 for Baxalta Incorporated. At these conferences, we'll introduce you to the new senior management teams and provide investors with more information regarding the strategies, growth prospects, capital structure and financial outlooks for each company. We'll also engage in a comprehensive Investor Relations effort, including investor road shows for both companies with their respective senior management teams several weeks before the spinoff is completed. In closing, while 2015 will be a challenging year, momentum in the core business is building and we remain excited about our future prospects, and we're poised for improved performance in 2016 and beyond. As we chart distinct and unique paths forward as separate global health care leaders, we look forward to unlocking value for shareholders, partners, employees and the patients and health care providers that we serve. As always, I'll be happy to take any questions on these or other topics during the Q&A. So with that, I'd now like to open up the call to your questions, if we might.
Operator:
[Operator Instructions] I'd like to remind participants that this call is being recorded and a digital replay will be available on the Baxter International's website for 30 days at www.baxter.com. Our first question comes from Kristen Stewart of Deutsche Bank.
Brittany Henderson:
This is Brittany Henderson in for Kristen. I just wanted to kind of get more clarity as we think about 2015. How should we just think about the incremental standalone costs versus kind of the stranded costs associated with the Baxalta spin?
Robert J. Hombach:
Okay. Well, we're still working -- as we mentioned, we're still working through the details around that. We've talked about initial dis-synergies of approximately $300 million or approximately 2% of Baxter's current sales. Interestingly enough, almost half of that is going to relate to IT-related costs, and we will be working towards separating the IT infrastructure over time, but that is one of the longer lead time items. So that is actually a difficult thing to break out at this point. Our initial estimate was a little bit heavier towards Baxalta in terms of dis-synergies, but a fair amount of stranded cost for new Baxter given, again, some of this IT overlap for some period of time. But at this point, I'm still working through those details. That's part of what we look to address in the May investor conferences where each of the 2 companies will lay out the financial outlooks.
Brittany Henderson:
Okay. And just a quick follow-up. How should we think about Suprane in 2015? What are the assumptions for competition there?
Robert L. Parkinson:
This is Bob Parkinson, Brittany. We anticipate Suprane is going to continue to grow in 2015. Having said that, we also anticipate that we may get generic competition in various markets around the world, although as we sit here today, it's not evident when or if or who that will be. I will tell you that there continues -- it continues to be promotionally sensitive in many markets around the world. So longer term, we view the anesthesia contract -- franchise with Suprane as kind of a foundation product as a growth vehicle, not only in '15, but, frankly, over our LRP.
Operator:
Our next question comes from David Lewis of Morgan Stanley.
James Francescone:
This is actually James in for David. Just wanted to get a quick sense from you. The first quarter earnings guidance of $0.85 to $0.90, how representative do you think that is of where the business stands from a profitability or earnings power basis today? On the one hand, obviously, you've got some idiosyncratic headwinds from quality spending that are going to fade through the year. But on the other hand, it seems as if FX and any potential ADVATE competitive impact would get greater through the year. So is 1Q kind of a reasonable representation where the business stands today? Or is it wrong?
Robert J. Hombach:
As we've looked at the situation, there are clearly some things in Q1 that are more pronounced. The $0.10 in manufacturing, clearly, is something that is very much front-end loaded. Overall manufacturing, just to give you a sense, is definitely a meaningful headwind in the first half of the year but a slight tailwind in the back half of the year, and so that clearly is not representative of what the ongoing situation is with the company. FX and cyclo are clearly meaningful headwinds here, both around $0.40. They will be somewhat back-end loaded, particularly FX. We're very well hedged in the first half of the year on the euro and a few other key currencies. But again, as we've been highlighting for 6 months, the emerging market depreciation in currencies that happened in the back half of 2014 is still very much there, and we're much more exposed as well. So Q1, I would say, is definitely not representative. And as a general matter from a seasonality standpoint, it's usually, by far, our lowest quarter from an earnings perspective in any given year.
James Francescone:
Okay, that's helpful. And then just second, any help that you could give us on hemophilia guidance? Obviously, you've done very well in that business, strong double digits -- or double digits at a minimum for the past several quarters, decelerating to 0% to 2% next year. Clearly, there's some competitive impact there. But how do you think about balancing the U.S. competitive impact versus the continued strength internationally?
Ludwig N. Hantson:
Well, this is Ludwig, James. First of all, the hemophilia team is doing a great job, as you see from the numbers. We will continue to grow ADVATE faster than market internationally. So internationally, we'll see positive growth. In the U.S., as Bob was alluding to, our guidance of high single-digit market share loss between -- from the Biogen launch to 855's launch is still a guidance. This will result in a negative growth in the U.S. With respect to our sales guidance, as we said, hemophilia, this is the base business only. It's 0% to 2% for the year. We have a separate sales guidance for the inhibitor market. Our business will continue to grow 6% to 8%. So overall, when you take the 2 together, we're talking about those single digits market, low single-digit growth.
Operator:
Our next question comes from David Roman of Goldman Sachs.
David H. Roman:
I wanted just to start on HYQVIA, which, Bob, you gave some disclosure in your prepared remarks. I think you said that there are 400 prescribers as of now. Could you maybe just go into a little bit more detail on the launch? Was that a U.S. or a global number? And how are things going thus far domestically?
Robert L. Parkinson:
Yes, David, I'll let Ludwig address that. Go ahead, Ludwig.
Ludwig N. Hantson:
Yes, thanks. So we're very pleased with the launch in the U.S. The 400 number that we gave you is the U.S. number only. So the interest is very high. We have a value proposition for the patient as well as for the payer. The value proposition for the patient, clearly, it's a subQ once a month with one needle. From a payer perspective, although we take a price premium of about 30%, we -- overall, the cost of the treatment is still a favorable number. Overall cost, we think, about 10% less because of the higher viability that we have with HYQVIA versus subQ. So overall, it's a very strong proposition for all of our key stakeholders. Our objective is that HYQVIA is become -- will become a leadership brand within the PI market long term. With respect to our 2015 guidance, you saw 6% to 8% for IG. We think that HYQVIA will be about $100 million for 2015.
David H. Roman:
That's very helpful. And then maybe secondly, just broadly on the U.S. businesses. I think this was one of the better quarters you've had domestically in quite some time, particularly in some of the more volume exposed or Medical Products businesses. Can you maybe just talk through some of the underlying dynamics in the U.S., what really drove -- got better this quarter? And your guidance doesn't -- does not seem to suggest that that's sustainable, but why would that be the case?
Ludwig N. Hantson:
With respect to hemophilia, when I think about ADVATE, 2014 as well as the fourth quarter, we've seen an impact of 1 to 2 market share points from the Biogen launch over the last 6 months. However, when you take all the different pieces of the puzzle together here, the positive contribution of the prophy conversions, and we have more than 650 patients that converted to -- as a prophy, so that's positive contribution. In addition to the weight gain contribution, more than offset the share loss. So that's the dynamic that we have, and that's the reason why we are growing faster than the market. Then our projection for 2015, we will continue -- as we said, we're on track for a high single-digit market share loss for the year, but we will not only have a Biogen competition, our assumption is that we will also have new entries in the short-acting Factor VIII market segment.
Robert J. Hombach:
Yes. And David, I would just add that given the momentum we've seen the last couple of quarters, we are sticking with our original assumption here of the high single-digit market share loss, but that may prove to be conservative.
David H. Roman:
Understood. I guess, I was asking more broadly about your U.S. franchises across the board. I think if I look at the BioSurgery business, that did better. You had nice momentum in things like the specialty areas. Is that -- why wouldn't that continue in 2015?
Robert L. Parkinson:
I think -- Bob Parkinson here, David. Yes, I think, in many of those areas, it will continue in '15. I think we're seeing a little more stability in the market in terms of hospital procedures and hospital activity compared to what it was earlier, which is encouraging. We're also managing out of our -- some of the supply constraints that we incurred earlier in the year and got in a much better position in the fourth quarter on both IV solutions and PD solutions, and we're bringing some more capacity online in '15. So I think the underlying fundamentals, whether it's the IV Fluid Systems business, whether it's parenteral nutrition, BioSurgery as you mentioned, anesthesia. And again, we'll expand on this when we get together at the investor conference and so on, but I think each of these product segments, these are not -- these are never going to be double-digit growers, but they're going to be solid single-digit growers. And we'll provide some more color on that when we get together in May.
Mary Kay Ladone:
Yes, David, I think that -- yes, just to add -- it's Mary Kay. I will just say the decline in cyclo and in the other category are really predominantly what's driving the U.S. performance to where it is in 2015.
Robert L. Parkinson:
And offsetting the strength in the other areas that I commented on. So you get some pretty large netting effects there, as you know.
Mary Kay Ladone:
Correct. That's correct.
Operator:
Our next question comes from Mike Weinstein of JPMorgan.
Michael N. Weinstein:
Let me just -- I want to circle back to the first quarter guidance because that's what I'm getting the most questions on. So the $0.10 that you're calling out that's kind of the manufacturing impact, the quality upgrade, how much of that do you want us to think is ongoing versus onetime?
Robert J. Hombach:
Well, as I mentioned, we will see, on a year-over-year basis, a meaningful improvement in the back half of the year. The nature of these are partly due to capacity expansion and the timing of that, which will come online in the first half of 2015. So that will certainly alleviate the need for some of the expedited freight and incremental logistical costs that we've been incurring. Other aspects of the process modifications that we're working through will take a little bit more time to work down as we work down the cost curve on that. These are well-established processes that we've been manufacturing PD and IV solutions for, for decades, so we'll take a little bit of time. So I would say a meaningful portion in the back half, some will linger into 2016.
Michael N. Weinstein:
Okay. So if we think about just the $0.85 to $0.90 starting point and recognizing the first quarter's historically like 22% to 23% of the year's earnings so it's not a best representation, but you still have in front of you the full impact of generic cyclos. It sounds like you're assuming the front-end part, but not the whole part, so there's still a little bit of a tail there. And then, obviously, you've got that, call it, $0.45 of dis-synergies from the split of the 2 companies. Is that the right way to think about it in terms of what's still in front of you in terms of the EPS headwinds that we won't see in the first quarter, but we'll still see at some later date?
Robert J. Hombach:
Well, as it relates to cyclophosphamide, we do anticipate a pretty meaningful impact here in the first quarter. It won't be 1/4 of the year, but it will be meaningful, and certainly, even the first -- excuse me, in the first quarter, we expect a meaningful impact. And in the first half, almost half of the full year impact we expect to see. As you know, when generics come in, the pricing volume dynamics start to play out pretty quickly. So that is fairly representative of what the full year is going to look like. As it relates to the dis-synergies estimate, again, we won't really see those in the P&L in any meaningful way until the back half of 2015. The initial estimate is around $300 million, but both of the 2 companies are going to get busy as quickly as possible post spin to start working those down. So how that plays into what our full year 2016 is going to look like, I don't anticipate that's going to be $300 million. I think it's going to be lower, and that will be part of what we lay out in the May time frame.
Operator:
Our next question comes from Larry Keusch of Raymond James.
Lawrence S. Keusch:
Bob, I'm wondering if you could talk a little bit about the outlook for Brazil in 2015. You obviously did as you anticipated for this year and achieved over $100 million in sales. But talk a little bit about what has to continue to happen on the conversions and where you think you are as you go towards that, I think, $200 million-ish target.
Robert L. Parkinson:
Why don't you take that?
Ludwig N. Hantson:
Yes. So we gave you a target of $200 million. Clearly, we're on track to achieve that over time. As far as the market is concerned, there are about 10,000 hemophilia A patients in Brazil. We have now converted more than 4,000 patients. As we convert from plasma to recombinant, we also convert those patients from on-demand to prophy, and our penetration of prophy in those patients is about closer to 70%. So we still have a long way to go, and that's where the additional $100 million opportunity is coming from. 2015 will be the next step in the journey that is going to take longer than 2 years to get to the 100% conversion.
Lawrence S. Keusch:
Okay, that's helpful. And then, I guess, for Bob Parkinson, one thing that you've talked about is potential opportunities to establish other public-private relationships such as the Brazil hemophilia agreement. Could you provide any thoughts on -- do you think that's still viable in other either geographies or other product categories and when we may see something transpiring?
Robert L. Parkinson:
Yes. I think it's -- Larry, I think it's going to be an increasing opportunity actually for both companies in both businesses because I think governments are going to be thrust in a position to kind of embrace new paradigms in terms of how they manage health care cost. And I think inevitably, it's going to involve collaborations with suppliers, certainly, leading suppliers in ways of doing business going forward that are different. So obviously, the Hemobrás collaboration in Brazil on hemophilia has been well discussed and everybody understands that. But I mean, we're building a new solutions plant in Thailand to manufacture PD solutions, which was the direct result of us working with the Thai government to establish from a policy point of view peritoneal dialysis as the therapy of choice, not hemodialysis, largely because it's lower cost. It saves the government money, and in the process, we're making investments. We're creating jobs in Thailand. China is another good example where we've had a program that we'd refer to or describe internally as the Flying Angels project, which has really been another example of a great collaboration that's driving adoption of PD therapy. And I know Ludwig and his team continue to have discussions on various fronts as does new BAX. So I just think this is going to be a new way of doing business going forward, and I would anticipate in the coming years both companies will do more of these kinds of collaborations.
Operator:
Our next question comes from Derrick Sung of Sanford Bernstein.
Derrick Sung:
I wanted to ask a little bit about if you could help us think about the capital structure of the 2 split businesses moving forward. Can you give us a sense for how we should think about, will debt be split evenly amongst the companies? And in terms of the dividend, how should we think about high level kind of dividend profile of the 2 businesses?
Robert J. Hombach:
Derrick, this is Bob Hombach. As we've been saying, we're going to give the whole financial picture for both organizations, the financial outlook for sales, for earnings, CapEx spend and capital structure, including capital allocation assumptions, in the May time frame. A lot to work through as we work through the separation here and that act is obviously a very key aspect of this. We do believe both companies are going to generate significant cash flow going forward, and we'll have a significant amount of flexibility to be disciplined about capital allocation and to think about returning significant value to shareholders as we've been doing in the past, but also continue to reinvest in the businesses to support future growth. So we'll lay all that out in the May time frame.
Derrick Sung:
Okay. Well, maybe then focusing a bit on the Baxter, the Medical Products business, for, I guess, either of the Bobs. You've talked a bit about the potential for a margin expansion opportunity coming out with a relatively lower margin relative to your peers. Could you help us think a little bit more about kind of -- does that margin expansion come primarily from mix shift? Is it -- we understand the Gambro piece to it. But beyond Gambro, where does that primarily come from and kind of how do we get there?
Robert L. Parkinson:
Yes, Derrick, Bob Parkinson here. Let me spend a couple of minutes responding to that. First of all, the comment about our returns being lower than peers, I think everybody understands one of the reasons for that is we are in very logistics-intensive businesses. Shipping IV solutions and PD solutions is expensive, so we have a freight distribution line on our P&L, which is inherent in those businesses as opposed to, let's say, traditional medical device or hospital supply businesses. Now having said that, what we will show you at the investor conference in May is a steady improvement over the LRP and operating margins that are very achievable and I think will be significant as well. And they really emanate from a series of things, and I'll just touch on a few in the interest of time. We clearly are going to increase our focus and investment in what I'll call higher-margin, higher-growth product categories, things like anesthesia, BioSurgery, parenteral nutrition, the acute -- the CRRT business in the hospital setting. These are all businesses today that range between $0.5 billion to $1 billion that are promotionally sensitive, have prospects for higher growth and are higher margin, so would represent a mix upgrade. Also, we're very excited about the engagement, if you will, in the infusion pump business with the approval of the SIGMA Spectrum Version 8. We'll be rolling that out in 2015 in the U.S. We effectively have been out of the infusion pump business for a number of years, and there's been a lot of margin that's been lost attendant [ph] with share loss with -- starting with the colleague, things and so on. So we're on the cusp of being able to get that back. Also, our new product low in new BAX and again, we'll get into this in detail in May, but VIVIA home hemodialysis, AMIA, the next-generation home PD solution, Prismaflex [ph], which is our next-generation CRRT. We have a program called Project Carrera [ph] internally, which is an array of premixed drugs that we'll be developing and bringing to the market in our proprietary GALAXY technology. These are all very exciting growth opportunities and new product opportunities, but all of which represent margins. In some cases, that are meaningfully higher than the overall margin percentage of the business. Clearly, we still have a lot of synergy to capture from Gambro going forward. It's tracking very well. We've achieved a lot of that, but there's still meaningful opportunity consistent with our original projections on Gambro synergies, both cost and commercial synergies. I think you'll see us managing portfolio very aggressively, both from a product and geography point of view. And to be very frankly -- to be very frank, I think the split off of the company provides a better line of sight to really focus on overhead infrastructure costs and so on, and you can anticipate that we're going to do some things in that regard to be proactive. So I'll stop there and will expand on each of these in detail in May. But each of the things I mentioned are meaningful, and that's why we're pretty confident about our ability to drive meaningful improvement over the long-range plan and beyond.
Operator:
Our next question comes from Bruce Nudell of Crédit Suisse.
Bruce M. Nudell:
Ludwig, could you just parse in the U.S. hemophilia guidance for next year, how much of the high single digits kind of ELOCTATE versus more standard competitive or recombinant Factor VIII? And just comment more generally on -- basically, all the surveys, everybody did, on the sell-side indicated that ELOCTATE would be much more impactful than it's proving to be. Does that -- and given the changes in hemophilia that are likely to occur over the next 5 years or so, does it speak at all to Baxter's competitive advantage in that space because of the intimacy you have with patients and caregivers? Just any general comments in that regard.
Ludwig N. Hantson:
Well, it's a good question, thank you. With respect to the surveys, I think my answer would be we'll post the surveys. We have now 6 months of data. So at this point, the surveys are very qualitative, but the quantitative piece comes from the actual data. So that will be my answer to the survey question. With respect to the market itself, it's a very sticky market. We've seen this. We see this in Factor VIII. Now when you look at the market dynamics in IX, it's not much different with the new entrants including RIXUBIS. So the market, I believe, will continue to look for the standard treatment because we raised the bar, and the bar is very high. The bar is 0 blips. And when you look at the clinical data, 0 to 1 is where the SA data comes out, and that's a very high bar. So irrespective of the new technology, we're talking about an efficacy target, which is very high. We do believe that we have a very strong strategy in place, starting from the gold standard ADVATE moving to 855, which is ADVATE in a PEGylated form to known technologies, moving to 826, which is ADVATE in a PSA technology, and then leapfrogging maybe those technology with potentially gene therapy. In gene therapy, as you know, we'll post proof of clinical concept in hemophilia B. We're going to show that data in a couple of weeks in Helsinki. But overall, we believe that we are in a position of strength to continue to grow this franchise moving forward.
Bruce M. Nudell:
And Bob, just talk -- could you give us some general comments about your assessment of the progress of Gambro? I know that PD is growing high single digits, low double digits thereabouts and your guidance for renal, 4% to 5%, in '15. How does Gambro figure into that? Is it tracking as you hoped in terms of revenue growth?
Robert L. Parkinson:
Yes. First of all, relative to synergies, we're tracking very much on target, okay? And so the numbers that we laid out at the outset will be achieved, both in total and the time frame attendant with that, so we're pleased with that. In terms of commercial performance, frankly, we got off to a little bit of a slow start that we've really picked up steam. I think if you look at the first half, second half comps, '14 versus '13, you saw the momentum build in the second half, and I think that's a by-product of the natural challenges of integrating organizationally and getting the alignment leadership established and so on. But I think we are very much on a pace to generate revenue growth commensurate with what we messaged at the time of the acquisition. And of course, we look forward to being able to expand dialyzer capacity in 2016 and beyond, which is going to be very helpful to meet more demand. The other thing I would say, the commercial synergy component of this, now having the full product line, gives us a lot of flexibility. I mentioned in response to one of the earlier questions about public-private partnerships and so on, managing the cost of providing access to treatment of end-stage renal disease, dialysis is a very -- that's a big ticket item on every health care budget for every country around the world, and this is an area where naturally they're going to look for collaborations and how to partner to manage that. Given our full product offering, I think we're in the best position to partner with governments to do that, as evidenced by the example I gave with the PD First program in Thailand. So I'm very pleased with the acquisition. There's always fits and starts when you do something of this size and complexity, but I'm really glad we did the deal, and it's going to be a big part of our growth going forward. Bob?
Robert J. Hombach:
Yes, maybe just a clarification, Bruce. We have talked about patient double-digit patient growth in the U.S. as a result of change in reimbursement. Recall U.S. is less than 20% of global PD sales. So if we look at our guidance for 2015, kind of mid-single digits for the overall renal business. In fact, PD and the legacy Gambro business are both expected to grow in that mid single-digit range. So it's comparable.
Operator:
Our final question comes from Chris Hamblett of Cowen.
Christopher Hamblett:
Just one follow-up on hemophilia. As you kind of position gene therapy as the next major potential breakthrough for the longer competitive dynamics in that market, what do you think you'll need to show in terms of long-term durability and safety to address potential regulatory concerns there with the gene therapy? And then second, what exactly are you going to show in terms of new clinical data for BAX 335 in February? And when might the Factor VIII gene therapy be ready for the clinic? I believe you said later this year, but I wanted to make sure that was correct.
Ludwig N. Hantson:
Okay. With respect to the gene therapy, as I mentioned, we'll post proof of concept on hemophilia B. So the data that we're going to present in 2 weeks from now will be individual patient data where we will be showing -- and I've shared that before, we see sustained levels of Factor VIII expression elevated versus current treatments. With respect to what is the target level, there is some data with respect to target level, depends on activity of the patient. When you're talking about patients that are active, it might be 20%-plus and yet we are able to achieve those levels with hemophilia B. Then with respect to your question on regulatory pathway, that is still a work in progress. My assumption at this moment is that for every new technology that comes into hemophilia, that it might be a little bit different than the way that we've developed ADVATE 855 because there's always going to be more questions with respect to efficacy, sustainability and long-term probability. But we'll keep you posted as soon as we got the regulatory input. And with respect to the timing of gene therapy for hemophilia A, we're planning to start our clinical program in the next year. So hemophilia B, we'll post proof of concept; hemophilia A, we're going to take the same technology into the clinic in about a year from now.
Operator:
Thank you. Ladies and gentlemen, this does conclude today's conference call with Baxter International. Thank you for participating. Everyone, have a wonderful day.
Operator:
Good morning ladies and gentlemen and welcome to the Baxter International’s, third quarter earnings conference call. Your lines will remain in a listen-only mode until the question-and-answer segment of today’s call (Operator Instructions). As a reminder this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter’s permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Corporate Vice President, Investor Relations at Baxter International. Ms. Ladone, you may begin.
Mary Kay Ladone:
Thanks Pam. Good morning everyone and welcome to our Q3, 2014 earnings conference call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International; Ludwig Hantson, President, BioScience; and Bob Hombach, Chief Financial Officer. Before we get started, let me remind you that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters contain forward-looking statements that involve risks and uncertainties and of course our actual results could differ materially from our current expectations. Please refer to today’s press release and our SEC filings for more detailed concerning factors that could cause actual results to differ materially. In addition, in today’s call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I’d like to turn the call over to Bob Parkinson.
Robert L. Parkinson:
Thanks Mary Kay. Good morning and thank you all for calling in. As you saw in this morning’s press release Baxter reported strong financial results for the third quarter, which exceeded expectations. Relative to our guidance which included vaccines adjusted earnings increased 9% to $1.35 per diluted share and worldwide sales advanced 13%. Excluding foreign currency and Gambro, from both periods, global sales increase 6%. I am very pleased with overall organic sales performance from ongoing operations as the third quarter represents the highest quarterly growth of this year. This affords us the opportunity to increase investments and research and development and further enhance manufacturing and quality and operational excellence as we position our company for sustained success. In recent months we’ve continued to make progress in strengthening the portfolio with new collaborations advancing the new product pipeline through the achievement of meaningful milestones and the organization remains engaged in working to separate Baxter into two leading global healthcare companies aimed at enhancing shareholder value over the long term. For example within BioScience we are building on the strategic decision to expand our presence in the area of oncology, leveraging the company’s heritage of success in developing new therapies that treat unmet medical needs for patients with rare diseases. Not only has living Ludwig been building an experienced team of oncology leaders including senior clinical development, business development and proven commercial executives but we also continue to see partnership opportunities to expand the pipeline. You may recall that last month we signed an exclusive license and collaboration agreement with Merrimack Pharmaceuticals for the development and commercialization of MM-398, an investigational drug candidate for the treatment of patients with metastatic pancreatic cancer, previously treated with the gemcitabine-based therapy. As you know pancreatic cancer is a rare and deadly disease that’s difficult to diagnose and has limited treatment options. Through this agreement BioScience gains exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan. MM-398 has demonstrated robust survival results in a global Phase 3 trial that will be the basis for regulatory submissions outside the U.S. beginning in 2015. BioScience now has four oncology assets; MM-398, [inaudible] and BAX-069 with the potential for numerous indications for patients with hematologic and solid malignancies. We look forward to discussing the progress of the oncology portfolio and advancement of the pipeline in the future. The bioscience organization also continues to enhance its focus on specific disease areas, centered on core areas of expertise in hematology, immunology and through technology platforms like gene therapy and biosimilars. It's for this reason that we elected to divest the commercial vaccines business, including the NeisVac-C and FSME vaccines and during the third quarter announced a definitive agreement with Pfizer. We're working to close this transaction in the fourth quarter and continue to explore strategic options, including the potential for partnering or divesting the R&D development programs focused on influenza and line disease. In addition we've also achieved an array of significant pipeline milestones including the FDA approval of HYQVIA is the first subcutaneous immune globulant, a transformational subcutaneous treatment for adult patients with primary immunodeficiency. HYQVIA is the first subcutaneous immune globulant treatment approved with the dosing regimen requiring only one infusion per month and one injection site per fusion to deliver it full therapeutic dose while maintaining the same efficacy safety and tolerability profile in its currently marketed products. Today many patients received IV infusions in a doctor’s office or infusion center and current subcutaneous treatments require weekly or bi-weekly treatment with multiple infusion sites per treatment. We expect to launch HYQVIA in the United States next week and are evaluating regulatory requirements and initiation of additional clinical trials for new indications. As a reminder the global market for primary immunodeficiency is approximately $2 billion and only approximately 35% of patients are treated subcutaneously, providing a unique opportunity for HYQVIA as a differentiated therapy. In addition in August Baxter released positive top line results from the Phase 3 pivotal clinical trial of BAX-855, an extended half-life recombinant Factor VIII treatment for hemophilia A based on ADVATE. BAX-855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and peri-operative management for patients who are 12 years or older with patients in a twice weekly prophylaxis arm experiencing a 95% reduction in median annualized bleeding rates as compared to those in the on-demand arm. In addition BAX-855 was also affected in treating bleeding episodes 96% of which were controlled with one or two infusions and approximately 40% of patients were bleed-free. No patients developed inhibitors to BAX-855 and no treatment related serious adverse events including hypersensitivity were reported. Our continuation and pediatric studies are progressing and we're planning to submit a biologics license application to the FDA before the end of 2014. Also during the quarter Baxter received FDA approval of RIXUBIS for routine prophylactic treatment controlled and prevention of bleeding episodes and peri-operative management in children with hemophilia B. We launched RIXUBIS in the U.S. late last year for the adult population and are very pleased with its market acceptance. Our application for adults and pediatric patients is currently under review in the European Union and we expect a regulatory decision later this year. Within the medical products business recent highlights include an exclusive agreement with Rockwell Medical to commercialize their leading hemodialysis concentrate product line in the United States and in select overseas markets. Hemodialysis concentrates help to clean a patient's blood and remove waste and extra fluid from the body. This agreement enhances Baxter's comprehensive range of therapeutic options across home, in center and hospital settings for patients with end stage renal disease. And finally we recently announced the expansion plans at our state of the art manufacturing facility in OPELIKA, Alabama to help address the growing global demand for dialyzers. Baxter will invest nearly $300 million in the OPELIKA site and we expect to begin commercial production in 2016 augmenting several other recent capacity expansions for dialyzers across our footprint. In addition to delivering solid financial results and accelerating innovation the organization is fully engaged in the process of separating Baxter into two leading global healthcare companies; one, focused on developing and marketing innovative biopharmaceuticals and the other on life-saving medical products. During the quarter, as you know we formally unveiled Baxalta Incorporated as the name of the new publically traded biopharmaceutical company. The name Baxalta celebrates and sustains our heritages as an innovator and legacy of leadership by incorporating the Baxter name and coupling it with Alta which derives from opus which is Latin for high or profound. Upon completion of the separation Baxalta Inc. will trade at the New York stock exchange under the symbol BXLP and Baxter International will continue trading on the New York stock exchange under the symbol BAX. While the corporate headquarters of both companies will be located in Northern Illinois, we recently announced that Baxalta is forming a new global innovation and research and development center in Cambridge, Massachusetts. This will position the new company to optimize R&D productivity, accelerate innovation by building on its robust pipeline in core areas of expertise, strengthen and increase R&D collaborations with partners in new and emerging biotech areas and enhanced patient care globally. As many of you know we’ve now named our senior leadership teams for both companies and have established the international and commercial structures for both organizations. We have elevated several senior leaders into new roles and have complemented our strong commercial and operational teams with some new talent including experienced professionals from leading biotech pharmaceutical and medical device companies. Many of you have also asked about appointments within Investor Relations and today I am pleased to announce that Mary Kay Ladone after a 26 year career at Baxter will become Corporate Vice President of Investor Relations for Baxalta upon completion of the spin. In the interim Mary Kay will continue in her current role and will be responsible for the ongoing Investor Relations efforts at Baxter. In conjunction with Mary Kay’s appointment I am pleased to announce that Scott Bohaboy, a senior level Finance Executive with eight years of experience at our company will become Baxter’s Vice President of Investor Relations and Treasurer. During his tenure Scott has held several senior financial roles with Baxter including in corporate planning, the U.S. hospital business, our Asia Pacific region and he currently serves as Vice President, Finance for our international operations. Scott also has previous experience in Investor Relations at two other companies earlier in his career. In addition Clare Trachtman, who many of you already know will be named Vice President Investor Relations for Baxter and will report directly to Scott. Both Scott and Clare will continue in their current roles for the near future and will work closely with Mary Kay and her IR team as we transition into two separate companies in mid-2015. In closing, Baxter has an established history of executing successful spin-offs and we believe this separation provides two unique and compelling investment opportunities for shareholders. Our decision underscores our commitment to ensuring our long-term strategic priorities remain aligned with shareholders’ best interest while we seek to improve our competitive position and performance, enhance operational commercial and scientific effectiveness and create long-term value for patients’, heathcare providers’ and other key stakeholders. As always I’d be happy to address any questions you may have with regards to the spin-off or other topics during the Q&A and so with that I’ll now turn call over to Bob Hombach. Bob please.
Robert J. Hombach:
Thanks Bob, and good morning everyone. As Bob mentioned, adjusted earnings per diluted share in the third quarter advanced 9% to $1.35, which exceeded our previously issued guidance range of $1.28 to $1.32 per share. This performance reflects strong sales growth as well as continued investments in research and development, unplanned gains from equity investments totaling $0.03 per diluted share which will be reinvested in the business and adjusted income from discontinued operations of $26 million or $0.04 per diluted share. As we mentioned in the press release GAAP earnings of $0.86 per diluted share, includes income from discontinued operations of $21 million, or $0.04 per diluted share and after-tax special items totaling $273 million, or $0.49 per diluted share, primarily for intangible amortization and costs associated with upfront product development and milestone payments, integration of the company’s acquisition of Gambro AB and Baxter’s planned separation. Now let me briefly walk you through the P&L by line item before turning to the financial outlook for 2014. Please note that with a few exceptions for purposes of today’s discussion I will focus my comments on the adjusted P&L line items as seen on page 10 of the press release which shows the reconciliation of adjusted and GAAP earnings and reflects the Vaccine franchise as a discontinued operation. For reference we disclosed historical financial information for the vaccines franchise last week and have also posted the schedules to the Investor Relations page of Baxter’s website. Starting with sales, worldwide sales of approximately $4.2 billion advanced 13% on both a reported and constant currency basis. Excluding Gambro from both periods Baxter sales rose 5% on a reported basis or 6% on a constant currency basis reflecting an acceleration of organic growth versus the first half of the year. You may recall that our sales guidance for the quarter included vaccine revenues, which were expected to decline given the receipt of lower milestone payments versus last year. When including vaccine revenues Baxter global sales grew 5% on a constant currency basis which is at the high end of our previously issued guidance range. Sales in the U.S. increased 7% and international sales excluding Gambro and foreign currency also increased 7%. Sales from emerging markets, which now represent almost 25% of total Baxter sales, advanced nearly 20% given very strong performance in the BRIC markets driven by the timing of tenders. In terms of individual business performance global BioScience sales totaled approximately $1.7 billion and advanced 8% on both a reported and constant currency basis. And despite a difficult comparison the U.S. bio therapeutics franchise BioScience reported the highest quarterly growth in almost two years. Within the product categories hemophilia sales of $942 million increased 11% on both reported and constant currency basis. This is the fourth consecutive quarter of double-digit ADVATE growth which continues to be driven by strong global demand as well as benefits from recent tender wins in the UK and Australia and conversion to recombinant therapy in Brazil where to-date we have converted approximately 40% of the estimated 10,000 hemophilia A patients and continue to expect to generate sales of more than $100 million in 2014. In the U.S. ADVATE growth was high single-digits supported by continued conversion to prophylactic treatment and very minimal loss of share to a new competitive entrant. We are also benefiting from the launch of new products and indications. RIXUBIS, our treatment for hemophilia B patients was launched in the U.S. late last year and we continue to be pleased with its uptake. Our hemophilia performance also reflects robust demand and double-digit growth in FEIBA for the treatment of hemophilia patients with inhibitors. As you may recall only 15% to 20% of inhibitor patients globally are treated prophylactically and with approvals of this new indication across multiple large geographies like the U.S., Canada, Australia and Japan. We expect this to represent a significant growth opportunity for our hemophilia franchise over the long-term. In biotherapeutics sales of $546 million improved sequentially due to enhanced product availability and we continue to see robust demand and stable market growth for our immunoglobulin and albumin therapies globally. Sales growth for this product category was 3% in the quarter on a reported basis and grew 4% on a constant currency basis. As mentioned on our last earnings call we expected an acceleration in international growth this quarter as we are building on our position in many foothold markets. And we also expect the growth in the U.S. to moderate due to tough comparisons created by supply availability and the easing of constraints beginning in the third quarter last year. In addition we are being prudent in managing our global supply and inventory levels as we prepare for the upcoming HYQVIA launch which is expected next week. And given the renewal of albumin licenses in China we are once again optimizing our geographic mix with albumin shipments into that large and growing market. In BioSurgery sales totaled $185 million and increased 7%. On a constant currency basis sales rose 6% driven by increased penetration for surgical sealants like TISSEEL and FLOSEAL. In medical products global sales of more than $2.5 billion increased 17% on a reported basis and were up 18% on a constant currency basis. Excluding Gambro medical product sales grew 4% on both reported and constant currency basis. Within the product categories renal sales were approximately $1.1 billion which includes a contribution from Gambro of $391 million. Recall that we closed the Gambro acquisition in September last year and recorded sales of $100 million. Excluding Gambro from both periods renal sales of $664 million increased 3% or 4% on a constant currency basis. Strong global PD growth of 7% was somewhat offset by the impact of the CRRT divestiture. As mentioned last quarter PD patient gains remain strong particularly in the U.S. where PD sales increased 12% for the quarter and the 13% year-to-date. Given this very strong demand we are experiencing back orders and are expediting shipments as we remain committed to ensuring patients have interrupted access to their therapy. We continue to produce PD solutions at maximum capacity, are working to expand capacity to meet the growing demand and are beginning to source product from our facility in Castlebar, Ireland through the much appreciated support of the FDA which granted a temporary import license. Going forward we will continue to work with customers to carefully manage inventory and maintain continuity of care for our patients. We are very appreciative of the close collaboration and great support we received from the agency in this regard. Going forward we will continue to work with customers to carefully manage inventory and maintain continuity of care. Within the fluid systems category sales of $827 million increased 4% on a reported basis and 5% on a constant currency basis. Performance is driven by favorable demand and pricing for IV therapies. As you may know to date we have not experienced any new competition for cyclophosphamide and we're updating our guidance for this new assumption. For your reference sales of U.S. cyclophosphamide in the third quarter were approximately $120 million and were lower than the prior year and sales on a year-to-date basis now total $345 million. Specialty pharmaceuticals, which includes our inhaled anesthetics and nutritional therapies posted sales of $386 million reflecting an increase of 4%. Sales rose 3% on a constant currency basis, driven primarily by mid-single digit growth of our anesthesia portfolio where we are increasing international penetration and low single digit growth for nutritional therapies. Finally sales in bio pharma solutions which is our pharma partnering business totaled $256 million and increased 5% on reported basis or 3% on a constant currency basis. Performance can be attributed primarily to strong pharmacy compounding revenues. Turning to the rest of the P&L gross margin in the quarter was 50.5% compared to 52.7% last year. Positive mix from franchises within bioscience was primarily offset by the impact of foreign exchange and Gambro which collectively reduced the rate by approximately 130 basis points. In addition the gross margin was impacted by product mix within medical products, expedited freight for PD solutions and lower than expected production volumes as we continue to make investments to enhance our quality systems, processes and operational excellence to meet evolving regulatory requirements. SG&A totaled $921 million, and increased 13% with the Gambro acquisition accounting for the vast majority of the growth. Excluding Gambro SG&A increased 2% as leverage was derived from benefits associated with our business optimization initiatives. This was partially offset by select investments in promotional and marketing initiatives for new product launches in bioscience and incremental customer freight and logistical expenses to support the strong demand for IV solutions. R&D spending in the quarter of $292 million increased 16% versus the prior year. Excluding Gambro R&D rose 8% driven by the addition of new R&D programs in bioscience through acquisitions, the acceleration of other programs in the areas of hematology, oncology and immunology and investments in renal therapies aimed at improving patient outcomes across the continuum of care. The operating margin in the quarter of 21.6% is lower than last year's operating margin of 23.8%. Excluding Gambro the operating margin was 23.4% reflecting the impact of foreign exchange and incremental investments referenced earlier. Interest expense was $31 million in the third quarter compared to $45 million last year. As expected we benefited from debt maturities and a favorable change related to the mix of floating versus fixed interest rates. Other income totaled $39 million and was driven primarily by the favorable foreign exchange impact on balance sheet positions and approximately $20 million or $0.03 per diluted share in unplanned equity gains related to investments in the Baxter Ventures fund. The tax rate was 21.8% for the quarter, in line with our expectations and as previously mentioned adjusted earnings per diluted share advanced 9% to $1.35. Turning to cash flow on a year-to-date basis, cash flow from operations totaled approximately $2.1 billion. DSO ended the quarter at 55.9 days and excluding Gambro Baxter's DSO was 53 days lower than the prior year by more than two days. Inventory turns of 2.2 are modestly higher than the prior period and lastly to-date we repurchased approximately 7 million shares for $500 million on a net basis, 1.5 million shares for $200 million. Finally let me conclude my comments this morning by providing our updated financial outlook. For the full year we expect adjusted earnings from continuing operations of $4.86 to $4.89 per diluted share. After adding the expected earnings contribution from the vaccine franchise of approximately $0.27 per diluted share this guidance is in line with our previously issued and disclosed range of $5.10 to $5.20 per diluted share. In addition we have updated our assumptions for cyclophosphamide and do not expect any new competition before the end of the year. While this has resulted in a transitory benefit it is offsetting incremental headwinds associated with foreign currency in the fourth quarter of approximately $0.04 per diluted share and other investments to enhance quality and operational effectiveness in the medical products business and additional investments in SG&A and R&D in BioScience. Specifically by line item of the P&L and starting with sales, we now expect sales growth excluding the impact of foreign currency of approximately 11% to 12%, which includes annual sales of more than $1.6 billion for Gambro. At current foreign exchange rates we expect reported sales growth of approximately 10% to 11%. Excluding Gambro we expect Baxter’s organic sales to grow approximately 4% on a constant currency basis. For the full year we continue to expect gross margins for the company of approximately 50.5%. This compares to the prior year gross margin of 51.7%. In terms of expenses we now expect R&D and SG&A to grow in low to mid-teens for the full year. We expect interest expense to total approximately $150 million and other income to total approximately $90 million for the full year. We expect the tax rate of approximately 22%, slightly higher than our original expectations as the vaccine franchise carry a very low tax rate and we expect a full year average share count of approximately 547 million shares which assumes approximately 300 million in net share repurchases. From a cash flow perspective we continue expect to generate cash flow from operations of approximately $3.5 billion which excludes the cash cost associated with the spin-off of the biopharmaceuticals business. We now expect capital expenditures of $1.8 billion to $1.9 billion which excludes pre-spin capital expenditures primarily in the area of information technologies. Let me move to sales and expand on our assumptions for the two businesses in the major product categories. Beginning with medical products on a constant currency basis, including the contribution of Gambro we now expect sales growth of approximately 15% and excluding Gambro we expect sales for medical products to grow approximately 3%. Specifically we continue to expect renal sales to grow approximately 40%, we now expect Fluid Systems sales to grow approximately 4%, as we assume no material impact from cyclophosphamide competition this year. We continue to expect specialty pharmaceutical sales, which includes our nutritional therapies and inhaled anesthetics to grow in the 3% to 5% range and we expect our biopharma solution sales to be flat for the full year. For BioScience we are once again raising our guidance and now project sales growth, excluding foreign currency of approximately 6%. Our outlook includes strong growth in our global hemophilia franchise of approximately 8% fueled by underlying global demand for ADVATE, conversion to recombinant therapy in Brazil, new tender wins and continued benefits from new product launches including RIXUBIS and fiber prophylaxis. For the biotherapeutics franchise we continue to expect growth of approximately 4% driven by increased demand and the contribution from the HYQVIA launch. And finally for our BioSurgery business we continue to expect growth in low to mid-single digits. As mentioned in our press release for the fourth quarter we expect earnings per diluted share from continuing operations, excluding special items of $1.30 to $1.33, we expect sales growth excluding the impact of foreign currency of approximately 3% and we expect reported sales to be flat to the prior year. Before I open up the call for Q&A let me take a moment to update you on some of the financial aspects of the spin. First we expect to file our initial Form 10 for Baxalta before the end of this year, which will include historical financial results on a GAAP basis for the years 2010 through 2013 and year-to-date results for 2014. These financial statements will be prepared as if on a standalone basis and derive from Baxter’s consolidated financials and will include allocations of various costs previously held at Baxter corporate level. I would highlight that these financial statements are inherently limited as costs associated with corporate overhead, income taxes, support services and interest expenses may not be indicative of future costs associated with running Baxalta as an independent standalone corporation. We expect to file amendments to the Form-10 in 2015 results which will include 2014 and year-to-date 2015 financial results for Baxalta, in addition, to pro forma adjustments to reflect the impact of expected debt and interest expense and other associated agreements and transactions. As we previously disclosed we are in the process of designing the two new organizations and at this point our rough estimate of initial dis-synergies including [stranded] cost is approximately 2% of total Baxter sales or more than $300 million. About half of these costs will be incurred beginning in the second-half of 2015 and both companies will have the opportunity to reduce a meaningful portion of these costs over the next several years post spin. In addition, spin related costs incurred in the first-half of 2015 will be considered special items and will be excluded from our adjusted earnings. Also, as we continue to work through the details of our IT ownership and manufacturing footprint we have not uncovered any substantial issues from a tax perspective. While we will finalizing the capital allocation strategies of each of the businesses in the coming months we expect that both will have strong balance sheet, generate significant cash flow and have the flexibility to follow a disciplined capital allocation approach which balances reinvestment of business in CapEx, R&D and M&A with returning value to shareholders in the form of dividend and share repurchases. We look forward to sharing more information with you as we get closer to completing the spin. While we continue to work through the complexity this process is unfolding in line with our expectations and we continue on track toward a mid-2015 completion. This assumes the Form-10 registration statement is declared effective by the SEC and final approvals have been obtained including from our Board of Directors. As we proceed towards the separation date we plan to host an investor conference in the second quarter of 2015 to introduce you to the new senior management teams and provide investors with more information regarding the strategies, growth prospects and financial outlooks for each company. We recognize that investors and analysts would like more information to help them model both companies separately and the intent of the conference is to help you establish a base line as each company will have a different financial profile after the separation. We will also engage in a comprehensive Investor Relations effort, including investor road shows for both companies with the respective senior management teams several weeks before the spin-off is completed. Thanks. And now I’d like to open-up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. (Operator Instructions). I would like to remind participants that this call is being recorded and a digital replay will be available on Baxter International’s website for 30 days at www.baxter.com. Our first question comes from David Roman of Goldman Sachs. Your line is now open.
David Roman:
I want to start with the hemophilia franchise and just taking a step back for a second, at the last time you provided your long range plan, I think you had talked about hemophilia as a 3 to 4% grower and you have caveated in there the potential for new competition which we are now starting to see. Can you maybe just help us put into context the year-to-date growth that you have seen and the 8% guidance that you provided, how much of that is a reflection of some benefits you are seeing this year versus the potential to see a substantially higher growth rate in that franchise than what you had initially targeted?
Robert L. Parkinson:
Well I’ll make a couple of comments and then maybe I’ll turn over to Ludwig to give you some more perspective on the dynamics we see in the hemophilia market. You know the guidance we gave several years ago, what was over a five year period and 3% to 4% growth clearly pre-competition we expected to grow faster than that and then with the impact of competition it would moderate over the timeframe. You know clearly we have had a very strong 2014 to-date and given how things have played as we’ve discussed previously the overall competitive landscape has played out largely as we expected, if not slightly better in terms of what others have been able to achieve with on label indication for an enhanced extended half-life product and so I think going forward we have the opportunity to certainly achieve that if not potentially exceed that long-term guidance, but maybe I will turn over to Ludwig to add some color here on market dynamics.
Ludwig N. Hantson:
Yes, thanks for the question, David. So at this moment we are not changing our five year sales CAGR of 3% to 4% but as Bob was saying there is a probability for us to go beyond these numbers. The numbers that I gave you or that we gave you couple of years ago clearly were probabilized for R&D milestones. As we are hitting our R&D milestones it means that the likelihood that we are going to over achieve those numbers it’s greater and we do expect that in addition to ADVATE and continuous fiber growth and continued growth in emerging growth countries that our new product launches such as RIXUBIS, [inaudible, 855, recombinant [inaudible] will have an impact here on the five year plan.
David Roman:
Okay. And maybe just to follow-up on the emerging markets more broadly, the 20% FX neutral number that you gave, I know you said there is strength in BRIC and timing of tenders, so maybe you could just help us frame up those markets a little bit more broadly. We’ve seen some disruption across the healthcare landscape there the past several quarters, how confident are you on being able to sustain call the mid-teens type growth rate in those franchises on a go-forward basis?
Ludwig N. Hantson:
Well the big one for us is clearly Brazil. I think we have a strong plan in place, the strategy is there. As Bob was saying we have converted 4,000 out of the 10,000 hemophilia A patients so far. Just to remind you, this was a plasma market. In addition to that it was an on-demand market. So we are moving from plasma to recombinant. In addition to that we are moving a lot of those patients from on-demand to pre-feed. So we feel pretty good with the strategy that we have in Brazil. So this is our biggest one. But in addition to that we have opportunities in China where we’ve launched. In addition to that we got approval for ADVATE in Russia as well as in Turkey where we are launching and outside of these emerging growth markets clearly the UK tender as well as the Australian tender will continue to help us moving forward.
Robert L. Parkinson:
And David across the entire business between medical products and BioScience, as we said medical products about 25% of sales already in emerging markets, very strong presence and with the renal franchise and the broad portfolio great opportunity to continue to grow there. BioScience has only penetrated about 15% of sales in emerging markets and that’s really the opportunity here to continue to accelerate growth as Ludwig has laid out. So we feel very good about our positioning in emerging markets and the ability there to sustain double-digit growth going forward.
David Roman:
Got it, thank you.
Operator:
Thank you. Our next question comes from David Lewis of Morgan Stanley. Your line is now open.
David Lewis:
Good morning. There has been a lot of new job promotions and opportunities for people in the room so congratulations to all involved, but just two quick questions. The first one Bob Hombach, for next year and I appreciate you gave us some good details relating to step up cost and but I wonder if you could help us understand a couple of things. Is there sense of what the impact of FX could be for ‘15 given that cyclo competition has not happen yet this year, how you are thinking about cyclo for next year or any other important dynamics we should be thinking about for ‘15 numbers? And then what do we actually going to hear from an investment perspective in January Bob? And then a quick follow-up.
Robert J. Hombach:
Sure, so starting with FX, clearly very volatile timeframe here just within the last couple of weeks. As we indicated we expect an incremental headwind of about $0.04 here in the fourth quarter and given where rates have been throughout the course of the year where -- there was a timeframe where things looked like they might be getting slightly better. I think the fourth quarter, I think would be fairly indicative of what we are likely to see if rates stay where they are at today on a run rate basis. So yeah, we are probably in the ‘15 there $0.20 range of a headwind if rates stay where they are at today for 2015, but again lot of volatility here and we’ll see where things are at as we get to January and give guidance. For cyclophosphamide we continue with a very robust competitive intelligence effort to understand where things are at, again we know there are seven or eight players who are awaiting approval. We continue to hear that it’s likely to be in the not too distant future. But you know again the specificity around that just isn’t great. So I think as you get to January we will have a better sense but again we framed that it’s a $0.50 contributor to profit for Baxter and overtime we expect numerous entrants and the vast majority of that to go away with likely producing an impact in 2015. But at this point no further clarity that we have got to give. So and as it relates to what you are going to hear in January you know we continue to work through a number of things here. But I think key assumptions like sales guidance I think we will be in very good position as we always give sales guidance for the franchises in the two businesses and in the process of doing that I think we will make very clear what our assumptions are on key value drivers like the hemophilia franchise like cyclophosphamide which will clearly have a very meaningful impact. We will also be able to give you a sense of FX and pension and so on. So while it may be a challenge to give a full P&L level of detail we normally do for the full year given the mid-year split I think we will be able to give you a lot information to give you a good sense of where the profitability trends are heading for each of the two businesses but very clearly be able to give you sales guidance.
David Lewis:
Okay, very helpful. And maybe a quick one for Bob Parkinson. You know Bob one of the key catalysts that coming out as we think about the Baxter business, the medical products business for next year and the year after is this dynamic of cost opportunity and some of the things you may be able to get after. It’s not clear to us whether there is a true cost opportunity like an SG&A opportunity in medical products or the opportunity you see is more from portfolio reshaping which could be very positive for gross margins over time. So I think this is kind of shaping up as a kind of key investment debate. So maybe help us understand how do you see the cost opportunity broadly defined in medical products?
Robert L. Parkinson:
Sure David. So obviously as we get closer to the spin we will be in a position to be actually quite specific in terms of what are the elements that we believe are going to drive earnings for the new Bax if you will at a, I believe, meaningfully faster rate than top line revenue growth. Cost structure is very much part of that but let me just take a minute, maybe to comment on the other aspects or the other dimensions that we believe can drive margin improvement over time, first and foremost we have been very specific in terms of the future synergies associated with Gambro, both the margin drop through on commercial synergies as well as cost structure synergies, which I will tell we are tracking very well through 2014 and that’s a material improvement overtime which will make a large contribution to the earnings growth of new Baxter, if you will, going forward. Focus on mix shift of products so you know the re-launch of CIGMA, if you will with the recent approval provides great opportunity to recapture margin. I think I commented on this specifically in the last quarterly call but that’s a big opportunity to regain market share in the infusion pump business, intensifying focus in areas that continue to be undeveloped markets on a global basis like biosurgery, like parenteral nutrition, and then of course the anesthesia franchise. So there is mix shift effect toward higher growth, higher margin products which also will contribute to accelerated bottom line growth. Portfolio, you mentioned that in your question David, is also a big part of it and I tell you we will be very aggressive in evaluating the existing portfolio, not only from a business and product point of view but from a geographic point of view. There may be businesses that we want to stay in, in certain markets but exit in other market and obviously to do that will provide fuel for adding to that portfolio through bolt-on acquisitions and so on. And then cost structure clearly is an element, I think once we are able to spit up the two new companies and we through that process obviously integrate all the corporate support functions in the two businesses and get a better line of sight I will tell you I think there is significant opportunity to fundamentally take up cost structure. And then lastly, new product introductions like [inaudible] or next generation CRRT Systems, second generation infusion pump platform. So that kind of frames the various dimensions that will continue to margin enhancement and growth again at a faster rate than revenue and as we get close to the spin we will be in a position to be much more specific including the aspect of cost structure on all those elements okay.
David Lewis:
Right, thank you very much.
Operator:
Thank you. Our next question comes from Matt Miksic from Piper Jaffray. Your line is now open.
Matt Miksic:
Hi, everybody thanks for taking the questions. A couple of follow-ups, just to drill down a little bit in to hemophilia U.S. versus OUS, I mean you obviously have very strong worldwide number and driven by -- but in the U.S. just to understand how you're looking at the rest of the year. I guess what are you assuming in terms of the ADVATE launch, haven't seen much competition yet but are you still dialing in pressure in the back half that would be helpful color and one more follow-up?
Ludwig N. Hantson:
Well thanks for question, Matt. First of all we continue to expect solid growth across the hemophilia franchise, both on the U.S. side as well as the international side. As far as the ADVATE U.S. market share is concerned we gave you guidance that we expect a decline of high single digits in between the Biogen launch and the 855 launch. So 855 continues to be on track, you have seen the Phase 3 data. We continue to move towards a BLA submission before the end of this year and as you saw Q3 sales data in the U.S. ADVATE remained strong. We grew by 8% and year-to-date we have a net patient gain versus previous year and this is on top of our continued prophy conversions. So we believe that since the launch date approval about four months ago we have seen a very minimal share loss and we're also aware that several patients switched back to ADVATE over the last weeks. And we realize that this data is still early but so far it’s aligned with our expectations.
Matt Miksic:
And then one more, same subject, we talked about this before, there in our checks I guess and conversations indicate increasing interest in sort of fine tuning the dosing for patients and aligned with your PK analysis and data that you put out of couple of years ago, [My PK Fit] reaching the U.S., can you walk through maybe the timeline and how much of a factor is that going to be as you look at the competitive landscape over the next year.
Ludwig N. Hantson:
So one of our strategies is to continue to strengthen the ADVATE label. So as you know we just launched the [BAXA 3] device, [My PK Fit] is another opportunity for us to strengthen the label. We got approval in Europe and we are launching in selective countries as we speak for U.S., this is under regulatory review. It’s a 510(k) submission. The impact of that will be very limited this year. This will be more a 2015 event.
Matt Miksic:
Thanks so much.
Operator:
Thank you. Our next question comes from Bob Hopkins of Bank of America Merrill Lynch. Your line is now opened.
Robert Hopkins:
Great thanks. Can you hear me okay?
Robert L. Parkinson:
Yeah we can Bob, go ahead.
Robert Hopkins:
Great, thanks. Just a follow up on that ADVATE comment about anecdotally hearing that some patients are switching back, can you just kind of develop that little bit more what are the circumstances behind that, what's happened that they switched back and then I was just wondering if you could comment if your guidance that you gave last call, that you don’t expect ADVATE share loss in the U.S. of more than single digits, if that still holds given what you are seeing.
Ludwig N. Hantson:
Yes. As I mentioned -- so thanks for the question Bob as I mentioned we expect that the ADVATE U.S. market share will decline high single digits between the launch and the 855 launch so to be more specific on the 855 launch, so submission before the end of this year. So 855 hitting the market by the end of next year. So that’s the timeframe. Yes, we have anecdotes, we know of several patients who switched back for different reasons. I am not going to talk more about why those patients switched back but we're really pleased with the fact that ADVATE is the gold standard and remains the gold standard in hemophilia.
Robert Hopkins:
So no change to that guidance?
Ludwig N. Hantson:
No change in the guidance.
Robert Hopkins:
Okay. And then last question for me just very quickly on the back on the U.S. plasma side I know you walked through the U.S. result this quarter pretty fairly but I am just wondering was that number for the U.S. business about as you expected or was that a little bit weaker?
Ludwig N. Hantson:
Well, I think the most important thing here is that U.S. demand for IG remains strong and is growing with the market which is double digit. So that is the critical piece here and then Bob was talking about we had a major event last year as well as we are gearing up for the HYQVIA launch, we want to make sure that space in the inventory for HYQVIA which we will be shipping next week.
Mary Kay Ladone:
And Bob the major event that Lu is referring is the fact that we were able to enhance our capacity situation and in Q3 begin shipments at an increased level, so we had a difficult comp here in the third quarter.
Robert Hopkins:
Great, that’s very helpful. Thank you.
Operator:
Thank you. Our next question comes from Mike Weinstein of JPMorgan. Your line is now open.
Mike Weinstein:
Thank you. Just a couple of follow-ups to some of the earlier questions. So one will we see the full data set on 855 at ASH, that’s going to…?
Ludwig N. Hantson:
Well we have submitted to ASH the design and now we are submitting at the late breaking news so we don’t have a full yes yet, so we will keep you posted. Having said that I think we have disclosed the most critical information on the 855 study with all of you and again to repeat what the key messages were. First of all we had great control of bleeding 95% of the bleeds were reduced; 40% of the patients were bleed free. No inhibitors, no cases of hypersensitivity and with the PK profile extension of 40% to 50% versus ADVATE. So these were the key messages. We will keep you posted if it will be an ASH event.
Mike Weinstein:
Okay, and Ludwig, while I’ve got you here on 826 can you just give us an update on when you think you will be in the humans with that?
Ludwig N. Hantson:
Our objective is by the end of next year that we will be in studies.
Mike Weinstein:
Okay. Want to clarify just the commentary Bob Hombach on 2015 and expectations or set expectations around guidance, so in January you’ll guide for revenues and you’ll gave some other items but you don’t actually gave EPS guidance for 2015 is that correct?
Robert J. Hombach:
Well, we certainly will for the first half of the year, but for the full year it becomes very tricky with the mid-year separation at the investor conference in early Q2 would be the timeframe I think when we would lay out the full year picture in more detail for both companies.
Mike Weinstein:
And that first half guidance you are saying you will exclude the dis-synergies that you will start to incur in the first half, you’ll actually back those out?
Robert J. Hombach:
Well we do expect that to be fairly minor because we will time the adding the resources that creates a duplicative corporate overhead as and when we need to in order to be prepared and appropriately prepared on July 1. So there will be some cost there but we don’t expect that aspect of it will be overly significant but we will call that out separately yes.
Mike Weinstein:
Okay, last question for you and I will drop. You reiterate your cash flow guidance for the year but I was looking at the cash flow statement, looks like you are down 2% for the year, your guidance is $3.5 billion which is close to up 10%. So is that, you are confident in the big fourth quarter in your cash flows?
Robert J. Hombach:
Yes if we look at things, working capital was a bit below, a bigger drain on cash flow here in the third quarter than last year, receivables and payables in particular, some of that just have to do with the timing of a strong sales quarter and when that occurred and when we are likely to collect that. So yes there is a big fourth quarter here driven primarily by the timing on some of these working capital items.
Mike Weinstein:
Great, thank you guys.
Operator:
Thank you. Our next question comes from Lawrence Keusch of Raymond James. Your line is now open.
Lawrence S. Keusch:
To circle back on HYQVIA, and I just want to get some further thoughts on the ability to line up the patients the care givers and the payers as you launch that product as well as see if you are willing to talk at all about price? And then for Bob Parkinson, I am wondering if you can talk a little bit about the environment that you are seeing both in the U.S. and overseas in the med products business J&J obviously indicated that there was some slightly improvements in utilization just want to see what you guys are seeing?
Ludwig N. Hantson:
So with respect to HYQVIA we are really pleased with the approval and we’re gearing up as was mentioned. We are planning to ship product next week and that’s on target. When our goal for HYQVIA is to be the preferred and leading subcu treatment for PID and that should be supported by differentiation and we plan to expand HYQVIA into neurological indications in the coming year, so beyond PID. At this moment there is a broad market awareness, there is high interest from physicians patients on HYQVIA and we are expecting accelerated sales in Q4. Which respect to pricing we’re introducing HYQVIA to the PBMs and the payers as we speak. Our pricing strategy is consistent with HYQVIA’s differentiated and unique value which is to provide subcu IG treatment that can be administered once a month. A dose is equivalent to that of IV IG. So with respect to the price consistent with Europe we will be launching at a price premium.
Lawrence S. Keusch:
I understand. Can you say how much that might be?
Robert L. Parkinson:
At this point Larry you know until we get things finalized and get some traction in the market place I think it’s premature to talk about that.
Robert J. Hombach:
Okay.
Robert L. Parkinson:
Larry, Bob Parkinson here in terms of hospital utilization I did see J&J’s comments, I guess our view would be pretty much in line with that. Clearly hospital activity in developed markets around the world is not as dormant as it was a year ago. So I would say there is a slight improvement there but falling far short of being robust. I think I would distinguish that however, from the emerging markets and allow the general economies of the emerging markets have been softer than anticipated. In terms of dollar spin on healthcare these markets continue to dedicate more of their national budgets to healthcare. So you got so many therapies and procedures that previously there was no access or limited access in undeveloped market. So we do see a more robust growth underlying demand in emerging markets.
Lawrence S. Keusch:
Okay, great. Thank you.
Operator:
Thank you. Our next question comes from Kristen Stewart of Deutsche Bank. Your line is now open.
Kristen Stewart:
Hi, thanks for taking the question. I just wanted to get a little bit better sense of exactly where some of the investment spending is taking place and to what extent, just talking there I guess the underlying net income growth of the company, if you were to take out the Gambro accretion for the share, because it looks like next year, just adding up some of the things that you had referenced with $0.50 for cyclo, you have got separation added dis-synergy cost FX, I assume pension may actually be a headwind next year. It just seems that next year’s shaping up to be a challenging year, potentially more of the decline in overall performance, [inaudible] to the underlying business.
Robert J. Hombach:
Sure, sure. Well again I think we are pleased with the strong organic top line growth of the underlying business that we’ve seen across some of the key franchise this year and good strong momentum there that we expect that to carry forward in to next year. As we look at some of these high leverage variables it’s a little difficult sitting here in October to have a clear sense of where some of these are going to go. As we mentioned cyclo but the longer this goes, the more likely it is that not just one but multiple players will get approval in fairly short order which means that the market dynamic could change pretty dynamically and the impact could be accelerated. So again we are looking at $0.50. I don’t have a sense of how much of that would impact 2015 at this point but that will be a very high leverage variable depending upon when that occurs. As I mentioned earlier FX at current rates would be around $0.15 to $0.20 headwind incrementally but again a lot of volatility there, pension interest rates have moved dramatically in the last two or three weeks. That has certainly become more of a potential headwind, as we have gauged it previous, every 25 basis points change in the discount rate amounts to about $20 million impact to the P&L. So we have seen about 75 basis points move here relative to where it was last year. There are other factors that play into that including asset returns and so on, so that’s not necessarily a one for one but thinking about that at the moment in the $50 million to $60 million potential headwind at this point at current interest rates would be where we will be at, at the moment. So stripping a lot of that out and if you look at Baxter today ex-FX in 2014 we are talking about operating income growth in high single digits here. So I think the operating performance has been very good. We are cautiously making incremental investment though in SG&A to support multiple new product launches in BioScience that have already occurred and could occur going forward. We have ramped up R&D expense a bit as well through some of business development activity that we have done within bio that will continue into 2015 as well. We did talk about some of the operational challenges, largely driven by very strong demand in PD and IV solutions as well that are causing us some incremental headwinds here and some of that is likely to continue into next year. I will gauge that in the fourth quarter as approximately a $0.03 headwind or around $20 million to $25 million of incremental impact that we are likely to see operationally within medical products. So a lot of moving pieces here and a lot of volatility around a few of these factors. So again a bit early to look at the picture for 2015 but I think the underlying business is actually performing pretty well.
Kristen Stewart:
What is the underlying business ex the contribution from Gambro from an earnings perspective?
Robert J. Hombach:
We talked about a 4% top-line growth and with some leverage in the P&L. So I would gauge it in the mid to high single digits today.
Kristen Stewart:
Okay. And then just in terms of the cost you guys had mentioned with business optimization cost that offset spending on quality, how should we just think about the quality spend and can you just remind me if you have any outstanding FDA warning letters or notable 483s?
Robert L. Parkinson:
Yes Kristen, Bob Parks, maybe let me take that because most of that activity would be in the new vacs domain. One of the challenges that we are managing through right now is a combination of one hand, expanding capacity on both IVs and PD where we are experiencing unprecedented growth on PD in the United States and pretty robust demand for IVs while concurrently managing through some existing warning letters and ensuring that we continue to enhance our production standards. I mean we are focusing on areas like particular container integrity and some of these areas that as we expand capacity we have to make sure that we maintain the focus on these other quality issues, particularly in facilities that are older and facilities in most notably North Carolina, where we have an outstanding warning letter. So we want to balance expansion of capacity on one hand, yet be very vigilant to ensure that we have acceptable -- meet acceptable quality standards and that’s really the area that we are investing. And so we have added headcount there, investment in terms of process modifications and so on while we are also expanding capacity. In fact we are bringing on a new line in [North Co] to produce more PD solutions to assist us in managing through some of the short-term product shortages that we have that hopefully we will be able to manage through that, through I would say the first quarter of 2015. But we are sensitive to the existing warning letters and make sure we can bring those to a close at a time when we are expanding capacity. I will tell you we have very constructive dialog going with the agency. We actually had a regulatory meeting with them last week to talk about how we balance achieving systemic or systematic improvements really in quality and ensure that the supply issue is addressed. You may recall a year ago the U.S. market was in very short supply on IV solutions, and here we are approaching flu season and we read about Ebola and all these other things. So the agency is very sensitive as they should be as are we to supply. It’s why we are encouraged that they stepped in and provided the kind of support they did to approve PD product to be manufactured in Castlebar, Ireland to ship to the U.S. to help address our issue. So those are the things we are balancing and Bob kind of quantified the financial impact of that, that will continue for a while but I think at a certain point we will certainly manage down those costs and get back to a more normalized level.
Kristen Stewart:
Okay.
Mary Kay Ladone:
Thank you. We have time for two more questions.
Operator:
Thank you. Our next question comes from Bruce Nudell of Credit Suisse. Your line is now open.
Bruce Nudell:
Thanks for taking my question. Ludwig there is just kind of a general anxiousness about the pace of change in the hemophilia A treatment optionality as it were. The [two] molecule the bio specific antibody mimics the co factor behavior factor A could be subcu, could be relatively long lasting good in inhibitor patients and relative low immunogenicity. Could you just comment on molecules such as this and your long-term positioning of the company and give some assurance that Baxter has the options covered is it were?
Ludwig N. Hantson:
Yeah, so, well thanks for the Bruce. We believe that we have a solid short-term and long-term strategy for our hemophilia franchise. As you know we are building breadth and depth in our hemophilia portfolio and I think it’s also fair to say that we are doing better at hitting the R&D milestones. We continue to monitor the competitive landscape and we are aware of the technologies that you were mentioning, the [inaudible] opportunity well the company is still in early clinical development and the clinical data is limited. As a matter of fact one of our exploratory programs is in subcu technology and a couple of years we moved the subcu treatment into the clinic. However we have to stop the program because of the lack of efficacy. To go back to our strategy we believe we have a strong strategy. First of all we continue to strengthen the ADVATE label we talked about [My PK Fits] as well as well as Baxter-3 we have strong Phase 3 data for 855, which we will be submitting by the end of this year. We plan to bring 826 as well as our gene therapy program for hemophilia A into the clinic into the next 12 to 18 months and all of these are the programs that we have. So 855, 826 and gene therapy we believe are programs that are post proof-of-concept. When you think about the ultimate goal of hemophilia treatment it is to have sustainable higher level of factor expression without peaks and troughs because you will induce -- you would see dramatic or spontaneous bleeds and the protection should be there irrespective of the patients activity level and we believe that gene therapy could be a true game changer. And with respect to our progress in the technology we are really pleased with early clinical date in our hemophilia B program. We see factor level expression in our patients that is sustained over a longer period of time and as I mentioned we are planning to bring this to the clinic in about a year from now.
Bruce Nudell:
And Bob my follow-up pertains to the U.S. dialyzer opportunity you know there was a press release this quarter about enhancing your manufacturing capability. Could you just scale that opportunity for us because I know Baxter is a little bit light on the share side, how big is it, is it something that should be considered as a major initiative for the new Baxter?
Robert L. Parkinson:
Yeah, well that’s Bruce, Bob Parkinson here, so clearly expansion of dialyzer capacity is one of multiple drivers to the renal growth long-term, as I think you know even before the acquisition Gambro was constrained on capacity on dialyzer. Our share on dialyzers today is obviously disproportionately low so I think there is a significant opportunity there long-term. We are encouraged by the recent performance of the Gambro business in the third quarter. Our sales were up mid-single digits and we are starting to I think get focused and aligned after the integration. So that will represent a step function in growth when that capacity comes on in 2016 but in the mean time we have done some other things with third party suppliers and so on which will allow us to increase the supply. So right now the demand is exceeding our ability to supply. We have some smaller interim expansions that should help that out in the short-term but it won’t be as material until the OPELIKA capacity comes on. So that’s a significant opportunity and a significant driver for long-term renal growth for us.
Bruce Nudell:
And how big is the U.S. market for dialyzers?
Robert L. Parkinson:
In terms of, in dollars?
Bruce Nudell:
Yeah.
Ludwig N. Hantson:
Yeah, so just defining the Gambro businesses we acquired it the dialyzers represented about $500 million in sales for Gambro on a global basis but as Bob mentioned very underrepresented in the U.S. market and through this OPELIKA expansion and the others that Bob mentioned we expect that over three to four years to increase capacity by 50%. And so as we grow into that capacity this represents an opportunity to grow and grow share and grow up 50% off the $500 million base that we have got in the coming years. So a fairly meaningful opportunity here but clearly given the very low monitor placements that Gambro had historically in the U.S. and overall capacity constraints again very, very small player at the moment.
Robert L. Parkinson:
Mary Kay can get back to you Bruce with the exact specific answer to your question. I don’t know for the U.S. market. The reality is the production at OPELIKA will source global markets not just the U.S. and the largest opportunity is outside the U.S. for a number of reasons including obviously the concentration with Fresenius given their centers that they run and where they utilize their own dialyzers and so that’s a major segment of the U.S. market that largely is off the table even when we get expanded capacity. So this is really more of a global opportunity but we will get back to you with the specifics on that.
Bruce Nudell:
Thanks so much.
Mary Kay Ladone:
And our last question please.
Operator:
Our last question comes from Glenn Novarro of RBC Capital Markets. Your line is now open.
Glenn Novarro:
Hi, good morning guys. Two questions, one for Ludwig and one for Bob Parkinson. Ludwig outside the U.S. the hemophilia franchise did very well and you called out Brazil and you called out some tenders. I am curious about the tenders; I think those tenders are UK and Australia. When you start on a new tender, is there a channel fill and are the sales you see there one time or are these just remain sustainable at current levels into the fourth quarter of next year is there any way you can quantify what the tenders gave you in the third quarter? And then for Bob Parkinson, some of the companies that have reported so far have talked about some softness in Europe. I am wondering if you can comment on what you are seeing on the supply side of the business in Europe? Thank you.
Robert J. Hombach:
Yes, Glenn it’s Bob Hombach, let me answer the financial aspects of the tenders and maybe Ludwig can make some comments about our somewhat unique position particularly in Australia. So the UK and Australia represent very good opportunity for us. We had very little share in the UK from the last tender and we are completely out of the Australian market. And so I would frame these as about $50 million in incremental sales opportunity combined between the two. We will realize about $20 million of that $50 million here in the back half of 2014, less than $10 million contribution in the third quarter ramping up a bit in the fourth and the other $30 million of that $50 million we’ll get in 2015 as we get up to scale. I guess but the one thing I would add about Australia is our preferred position there in the tender gives us an opportunity to perhaps get disproportionate share of the overall Australian market which may allow us to go a bit above the $50 million overall that I mentioned.
Robert L. Parkinson:
Glenn repeat your question on the supply side Europe, I wasn’t sure what you are getting out there if you could just maybe rephrase that?
Glenn Novarro:
So if you look at some other companies that have reported so far this week they have talked about some softness in Europe so I was wondering what you are seeing if you can provide any commentary in Europe. I know in 3Q you always getting to see some softness due to seasonality but I wonder if there is anything from an economic point of view that or whatever you are seeing that would create any softness in Europe at this point?
Robert L. Parkinson:
Yes well I commented earlier on just hospital activity of developed markets versus emerging markets and distinguishing the two. I would say Europe clearly Western Europe is the softest area globally and I think to a large degree that is directly correlated with the general economic condition Glenn. So we see less robust demand in Europe for example than we do in the United States and I would project that given the broader macroeconomic environment that’s likely to continue. So it’s really about market share to drive growth and so on as opposed to depend upon robust underlying hospital activity if you will.
Glenn Novarro:
Okay, thank you.
Robert L. Parkinson:
Yes.
Operator:
Thank you. Ladies and gentlemen this does conclude today’s conference call with Baxter International. Thank you for participating and everyone have a wonderful day.
Operator:
Good morning ladies and gentlemen and welcome to Baxter International’s, second quarter earnings conference call. Your lines will remain in a listen-only mode until the question-and-answer segment of today’s call (Operator Instructions). As a reminder, this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter’s permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Corporate Vice President, Investor Relations at Baxter International. Ms. Ladone, you may begin.
Mary Kay Ladone:
Thanks Pam. Good morning everyone and welcome to our Q2, 2014 earnings conference call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International; Ludwig Hantson, President, BioScience; and Bob Hombach, Chief Financial Officer. Before we get started, let me remind you that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters contain forward-looking statements that involve risks and uncertainties and of course our actual results could differ materially from our current expectations. Please refer to today’s press release and our SEC filings for more detailed concerning factors that could cause actual results to differ materially. In addition, in today’s call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today, to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I’d like to turn the call over to Bob Parkinson.
Bob Parkinson:
Thanks Mary Kay. Good morning. Thank you all for calling in. As you all saw in the press release issued earlier this morning, Baxter reported strong financial results for the second quarter, which exceeded expectations and we’ve confirmed our full year 2014 outlook. Adjusted earnings increased 5% to $1.26 per diluted share and worldwide sales advanced 16%. Excluding Gambro and foreign currency, Baxter’s sales rose 5%, driven by solid growth across our global franchises. Positive momentum continues to build and Baxter is off to a strong start in 2014. We’re driving solid performance across our entire business portfolio in advancing care in both developed and emerging markets. This provides a strong foundation to build upon as we improve our competitive position, enhance operational, commercial and scientific effectiveness, continue to meet challenges posed by the global marketplace and regulatory environment and create value for patients, healthcare providers and other key stakeholders. I continue to be confident in our prospects for the long term and believe we are well positioned for sustained performance and success. Our strong results reflect our strategic focus on improving access to care, as we broaden our global presence and advance the new product pipeline through both internal development and collaborations. During the quarter we announced an array of pipeline achievements and approvals; advanced R&D collaborations with our partners and made progress towards the separation into two leading healthcare companies. First within the bioscience business, we continue to build upon our global leadership position in Hemophilia that is evidenced by a number of recent achievements, including European regulatory approval of a new manufacturing facility in Singapore for the production of recombinant proteins including ADVATE and BAX 855 upon regulatory approval. Baxter was granted multi-year awards for ADVATE in the U.K. and in Australia, where ADVATE was named the preferred recombinant factor VIII treatment. Baxter recently received regulatory approvals for ADVATE in Turkey and Russia, supporting efforts to increase access to recombinant treatments in emerging markets. With these approvals, ADVATE is now approved in 62 countries worldwide. In addition the FDA granted approval for the BAXJECT III reconstitution system, which reduces the number of steps in the reconstitution process for patients and caregivers and we recently received European approval for myPKFiT, which is a new web-based individualized dosing device for prophylactic treatment. This device allows physicians to calculate personalized ADVATE treatment regiments based on patient information and individual pharmacokinetic profiles. Lastly, we’ve now completed dosing for all patients in the Phase III clinical trial for BAX 855. To-date we have no reports of inhibitors or drug related serious adverse events. We look forward to sharing the top line data in the third quarter and continue to expect to file in the U.S. before the end of the year. In addition to our internal R&D accomplishments, we are collaborating with partners on advancing R&D programs in new disease areas with high unmet medical needs, which capitalize on our core technical capabilities, expertise and global channels. Progress to highlight includes first, initiation of two Phase III trials for an investigational etanercept biosimilar in rheumatoid arthritis and chronic plaque psoriasis by our partner Coherus BioSciences. As you know, Baxter has obtained exclusive commercial rights for Europe, Canada, Brazil and certain other markets. Second, the announcement by our partners CTI BioPharma, on the completion of enrollment in its PERSIST-1 pivotal trial of pacritinib, a novel oral JAK2/FLT3 inhibitor for patients with myelofibrosis, a chronic malignant bone marrow disorder. This is the first of two Phase III trials required to support regulatory approval. PERSIST-2 began earlier this year and is evaluating patients with low platelet counts for whom no viable treatment exists today. CTI and Baxter will jointly commercialize pacritinib in the U.S. and Baxter has been granted exclusive rights for all indications outside the U.S. And finally, we continue to augment our portfolio with acquisitions like Chatham Therapeutics, which we announced last quarter, and AesRx which we announced just last week. AesRx is a private U.S. biopharmaceutical company, focusing on sickle cell disease with its development program Aes-103. This investigational oral prophylactic treatment has clearly been evaluated in a Phase II clinical trial and has the potential to address an extremely high unmet clinical need in a community with inadequate treatment options and no recent major clinical advancements. Moving on to medical products business, the recent highlights include the presentation of data at a European Renal conference supporting the safely and efficacy of the VIVIA hemodialysis system. As you know, the VIVIA system completed CE marking in Europe late last year, and is currently being introduced on a limited basis in 2014. In the U.S. we continue to engage in productive dialog with the FDA regarding the design of our final clinical trial supporting a nocturnal indication and we are working towards initiating this trial before the end of the year. In addition Baxter received 510-K clearance from the FDA for our next generation SIGMA Spectrum Infusion Pump, offering an option for wireless connectivity and integration of data into hospitals electronic medical record. Before I turn the call over to Bob to review our financial results and outlook for the remainder of the year, I’d like to take a moment to outline the progress we are making to create two separate independent global healthcare companies. First as you know, we’ve named Bob Hombach, Chief Financial Officer of the new biopharmaceutical company and Jay Saccaro, Chief Financial Officer of Baxter International, following completion of the transaction. I’ve had the pleasure of working directly with Bob and Jay for many years and I’m confident that both businesses are positioned for future success given their deep knowledge of these businesses, financial expertise and their leadership qualities. In addition, last week we announced the appointment of Dr. John Orloff as Vice President and Global Head of R&D for Baxter BioScience. Dr. Orloff will be responsible for advancing the late stage bioscience pipeline, enhancing the current R&D operating model and pursuing additional innovative opportunities for the business. Dr. Orloff joins Bioscience from Merck Serono Pharmaceuticals, where he served as Global Head of Clinical Development. We continue to work diligently to prepare the organization for the spinoff and expect to announce additional senior leadership appointments in the coming months. In addition we are currently targeting the filing of a preliminary Form-10 with the SEC before the end of the year. We’re planning to host an Investor Conference in New York in the second quarter of 2015 to provide details on both companies, and we expect to finalize the transaction by mid 2015. As always, I’d be happy to address questions on this or any topic during the Q&A this morning, but with that I’ll now turn the call over to Bob.
Bob Hombach:
Thanks Bob, and good morning everyone. As Bob mentioned, adjusted earnings per diluted share in the second quarter advanced 5% to $1.26, which exceeded our previously issued guidance range of $1.18 to $1.22 per share. This over achievement can primarily be attributed to strong sales across several franchises, including cyclophosphamide in the absence of any new competition and the favorable timing of a large (inaudible) shipment originally scheduled for the third quarter. These items each drove favorability versus our guidance of approximately $0.02 per diluted share respectively. As we mentioned in the press release, GAAP earnings of $0.95 per diluted share included net special items totaling $172 million or $0.31 per diluted share, primarily for intangible amortization and costs associated with contingent revenue and product development milestone payments, remediation efforts related to the in-progress SPECTRUM Infusion Pump recall, integration of the company’s acquisition of Gambro, and Baxter’s planned separation into two independent healthcare companies. These charges were partially offset by the reversal of certain business optimization and litigation reserves. Now let me briefly walk you through the P&L by line item before turning to the financial outlook for 2014. Starting with sales, worldwide sales of approximately $4.3 billion advanced 16% on both a reported and constant currency basis, driven by solid growth across our global franchises. This performance exceeded our sales growth guidance range of 12% to 13%. Excluding Gambro revenues of $408 million, Baxter sales rose 5% on a constant currency basis. In terms of individual business performance, Global Bioscience sales exceeded $1.7 billion and advanced 7% in the second quarter. On a constant currency basis sales increased 6%. Within the product categories, haemophilia sales of $904 million increased 6% on both the reported and constant currency basis. We continue to capitalize on our global leadership position and brand differentiation. New product launches including the new fiber prophylactic indication and Rixubis for the treatment of Haemophilia B, and increased penetration of recombinant therapies, particularly in emerging markets. Specifically global demand for ADVATE remains very strong, resulting in double digit growth for the quarter and year-to-date. This reflects the positive patient experience with our brands and ongoing benefits derived from our prophylactic label expansion, augmented by shipments to Brazil as part of our ongoing collaboration with Hemobras to advance access to recombinant factor VIII therapy. To-date we have converted more than 35% of the 10,000 Haemophilia A patients in Brazil and continue to expect to generate sales of more than $100 million in 2014. In addition, global demand for fiber remains robust. We are benefiting from the new prophylactic indication in the U.S., where we generated double digit growth this quarter and we recently received approval in Canada, Australia and Japan. As you may recall, only 15% to 20% of inhibitor patients globally are treated prophylactically, presenting a significant long term growth opportunity for our Haemophilia franchise. In biotherapeutics, sales of $548 million increased 7% on a reported basis and increased 6% on a constant currency basis. This reflects sequential improvement driven by enhanced product availability and growth of immunoglobulin therapies, albumin and alpha-1 treatments. Consistent with last quarter, the U.S. sales increased 7%, while international sales were up 4%.International growth was marked by improved growth for immunoglobulin therapies and albumin, as we’ve resumed albumin shipments to China. While the U.S. growth may moderate in the second half of the year due to tough comparisons, we expect international growth to accelerate on a sequential basis in the third and fourth quarters. In BioSurgery, sales totaled $189 million and increased 6%. On a constant currency basis sales rose 5%, driven by increased penetration for surgical sealants like TISSEEL and FLOSEAL, particularly outside the U.S. As you know, growth of these products is tied directly to grow in surgical procedures, which remains very modest. Finally, vaccine revenues totaled $110 million and increased 12%. Sales grew 6% on a constant currency basis, driven primarily by strong sales of the FSME vaccine, which was partially offset by lower milestone payments related to government collaborations for the development of influenza vaccines. In medical products, global sales of more than $2.5 billion increased 24% on both a reported and constant currency basis. Excluding Gambro, medical product sales grew 4% on a constant currency basis. Within the product categories, renal sales totaled $1 billion, which includes the contribution from Gambro of $408 million. Excluding Gambro, renal sales of $636 million declined 3% or 1% on a constant currency basis as expected. PD patient gains in the U.S. have never been stronger, driving U.S. PD growth of 15%. However this was more than offset by lower international sales, which were impacted by the timing of certain tenders which we discussed last quarter, and the divestiture of the CRRT business. Excluding these items which totaled approximately $40 million, global renal sales increased approximately 4%. Sales in the fluid system category of $816 million increased 8% on a reported and constant currency basis. Performance continues to be driven by favorable demand and pricing for IV solutions and other injectables, particularly for cyclophosphamide. As you may know, to-date we have not experienced any new competition for cyclo and we’ve updated our full year guidance to reflect our new assumption. On the year-to-date basis, the U.S. cyclophosphamide sales totaled approximately $225 million. Specialty pharmaceuticals, which includes our inhaled anesthetics and nutritional therapies posted sales of $404 million, reflecting an increase of 10%. Sales rose 9% on a constant currency basis, driven primarily by increased penetration of Suprane in markets outside the U.S. and high single digit growth of our global nutrition franchise. Finally, sales in BioPharma Solutions, which is our pharma partnering business totaled $249 million and declined 3% on a reported basis or 4% on a constant currency basis. Performance can be attributed primarily to the timing of shipments and lower third party demand, which was partially offset by strong pharmacy compounding revenues. Turning to the rest of the P&L, gross margin in the quarter was 50.7% compared to 53.0% last year. Margin expansion in the base Baxter business resulting from mixed benefits was more than offset by the impact of the lower margin Gambro business and foreign currency, which collectably reduced the rate by approximately 250 basis points. SG&A totaled $961 million and increased 18% with the Gambro acquisition accounting for the vast majority of the growth. Excluding Gambro SG&A increased 4%, as leverage close to arise from benefits associated with our business optimization initiatives. This was partially offset by select investments and promotional end marketing initiatives for new product launches and with the international market to enhance our global presence, and the incremental expedited freight charges to support the strong demand we are seeing in the U.S. medical products business. R&D spending in the quarter of $292 million increased 15% versus the prior year. Excluding Gambro R&D spending rose 2%. We continue to advance the new product pipeline and accelerate investments in a number of areas, including programs in our leading hemophilia franchise, those leveraging our expertise in the therapeutic areas of hematology, oncology and immunology and investments in renal therapies aimed at improving patient outcomes across the continuum of care. The operating margin in the quarter of 20.3% is lower than last year’s operating margin of 23.8%. Excluding Gambro, the operating margin with 23.5% as positive mix was offset by foreign currency and investments in SG&A and R&D. Interest expense was $42 million in the second quarter, which reflects debt issuances to fund both the Gambro acquisition and the Covington plasma manufacturing site. Other income totaled $70 million, driven primarily by the favorable foreign exchange impact on balance sheet positions. The tax rate was 21.8% for the quarter, in line with our expectations and as previously mentioned adjusted earnings per diluted share advanced 5% to $1.26. For the first half of 2014, cash flow from operations was strong and totaled approximately $1.2 billion, reflecting an improvement versus last year. DSO ended the quarter as 56.7 days and excluding Gambro, Baxter’s DSO was 53 days, slightly lower than the prior year. Inventory turns of 2.2 are comparable to the prior year period and lastly in the first half of the year we repurchased approximately 6.4 million shares for $450 million dollars or on a net basis, 2 million shares for $218 million, in line with our full year objective. Finally, let me conclude my comments this morning by providing our financial outlook for the third quarter and full year 2014. For the full year, we now expect adjusted earnings of $5.10 to $5.20 per diluted share. We continue to provide a wider guidance range than our historical practice, as the number of factors and assumptions impact the outlook in the second half for the year, particularly potential headwinds related to cyclophosphamide competition in foreign currency. As mentioned earlier, we have updated our assumptions for cyclophosphamide competition. While this has resulted in a transitory benefit, it also provides the opportunity to accelerate investments that will better position both BioScience and the medical products businesses for sustained success going forward. For the full year the cyclo benefit is currently estimated to be more than $0.20 per diluted share. This benefit will largely be offset by incremental investments we are making across the portfolio, and by absorbing a foreign currency impact of almost $0.25 per diluted share in 2014, which is approximately $0.10 per share higher than our original expectations. Specifically by line under the P&L, starting with sales, we now expect sales growth, excluding the impact of foreign currency of approximately 10% to 11%, which includes annual sales of more than $1.6 billion for Gambro. At current foreign exchange rates, we expect reported sales growth of approximately 9% to 10%. Excluding Gambro, we expect the base Baxter business to grow approximately 3% on a constant currency basis. For the full year we continue to expect gross margin for the company to decline by approximately 150 basis points from the 2013 margin of 52%. Positive sales mix in the base Baxter business is more than offset by Gambro and the full year foreign currency impact of approximately 100 basis points. In terms of expenses, we continue to invest and support the elevated level of sales reflected in our guidance, as well as accelerated spending in sales and marketing to support new product launches and R&D investments, primarily related to recent business development activity within BioScience, while making incremental investments in our medical products operations to enhance our operational effectiveness. As a result, we now expect R&D and SG&A to grow in high single digits for the full year, representing an increase of approximately $200 million versus our original 2014 expectations. This includes an incremental impact from foreign currency of approximately $50 million dollars. We expect interest expense to total approximately $160 million, and we now expect other income of approximately $70 million for the full year, the vast majority of which has already been recognized in the first half of the year. We expect a tax rate of approximately 21.5% and we expect a full year average share count of approximately 547 million shares, which assumes approximately 300 million in net share repurchases. From a cash flow perspective, we continue to expect to generate cash flow from operations of approximately $3.5 billion, which excludes the cash cost associated with the spin-off of the biopharmaceuticals business. We expect capital expenditures of approximately $1.8 billion, which includes Gambro and the investments we are making to enhance our plasma manufacturing footprint in Covington, Georgia. Let me move to sales and expand on our assumptions for the two businesses and the major product categories. Beginning with medical products, on a constant currency basis, including the contribution of Gambro, we now expect sales growth of approximately 14% to 15%. Excluding Gambro, we expect sales for medical products to grow 1% to 2%. Specifically we expect renal sales to grow approximately 40%, including the benefit of continued PD penetration, and the incremental revenue contribution from Gambro. We now expect Fluid Systems sales to be flat to up 2%, reflecting a benefit of approximately $150 million relative to our original guidance. We are now assuming that we experience competition for cyclophosphamide later this year, reducing sales by approximately $50 million to $75 million compared to sales in the second half of 2013. We continue to expect specialty pharmaceutical sales, which includes our nutritional therapies and inhaled anesthetics to grow in the 3% to 5% range and we expect our BioPharma solution sales to be flat for the full year. For BioScience, we are also raising our guidance and now project sales growth excluding foreign currency of 4% to 5%. Our outlook includes sales growth in our global hemophilia franchise of 5% to 6%. While we continue to expect increased competition for recombinant factor VIII therapies in the second half of this year, performance will be fueled by underlying global demand for ADVATE, convergent to recombinant therapy in Brazil, new tender awards and continued benefits from new product launches, including RIXUBIS and FEIBA prophylaxis. For the BioTherapeutics franchise, we continue to expect growth of approximately 4%, with sales of immunoglobulin therapies and albumin in China ramping up in the second half of the year. And finally for our BioSurgery and vaccine businesses, we now expect growth in the low to mid single-digits. As mentioned in our press release, for the third quarter we expect earnings per diluted share excluding special items of $1.28 to $1.32. We expect sales growth excluding the impact of foreign currency of 12% to 13%. Excluding Gambro, we expect the base Baxter sales at constant currency rates to grow approximately 4% to 5%. Thanks. I’ll now open up the call for Q&A.
Operator:
Thank you. (Operator Instructions). I would like to remind participants that this call is being recorded and a digital replay will be available on Baxter International’s website for 30 days at www.baxter.com. Our first question comes from Derrick Sung of Sanford Bernstein. Your line is now opened.
Derrick Sung:
Hi, Good morning. Thank you for taking my questions and congratulations on a strong quarter. I wanted to get right to kind of the key [controversies] [ph] surrounding the stock right now, which is the sustainability of your hemophilia franchise. You’ve raised hemophilia guidance for the back half of this year. At the same time you are starting to see the competition now coming from the longer acting factor VIII. Just wondering if you could kind of comment on, is that hemophilia guidance raise coming from kind of the confidence in sustainability of your ADVATE franchise in the face of competition or is it coming more from some of these other growth drivers that you mentioned. Just give us a little bit more color on how you’re thinking about that business moving forward? Thank you.
Bob Parkinson:
Bob and Ludwig, you want to respond to Derrick’s questions.
Ludwig Hantson:
Sure. Hi Derrick, this is Ludwig. So overall we are very pleased with our hemophilia performance. As Bob was saying, we are increasing our sales guidance. I think the confidence is coming from different angles. First of all we feel that our ADVATE gold standard position is a strong position and that we believe that we will be able to continue to grow our ADVATE position through different factors. In addition to that we have new products coming in, we have RIXUBIS. In addition to that the fiber prophy indication is also a strong growth driver. In addition to that we have geographical expansion playing a role. So overall we feel good about the guidance that we gave you and we believe it’s coming from different angles here.
Derrick Sung:
Could you perhaps give us, quantify a little bit more for us the opportunity from the recent OUS tender wins and the launches in Russia and Turkey of ADVATE, as well as maybe Bob, if you can give us a sense for how much Brazil is contributing this quarter?
Bob Parkinson:
Sure Derrick. The tender wins in Australia and the U.K., we really will start ramping up activity here in the back half of 2014. So relative to our expectations and we did have a good line of sight on one of those two to begin with, so relative to our expectations, not much of an incremental contribution here in 2014. But as we move into ‘15 and beyond, these are multi-year tender awards and I think position us to significantly increase our market share in the U.K. where it had gotten down to below 10% at one point here and as you know we were completely out of the Australian market and now we have the preferred position. So we’ve not specifically quantified that opportunity at this point, but for both of them, it will be a meaningful opportunity to grow internationally and a key franchise for us. As it relates to Brazil, as I’ve mentioned before, we are going to experience some lumpiness here as we continue to ramp-up conversion and continue to open up the opportunity for different segments within Brazil, and so again we are projecting more than $100 million of sales here. The contribution in the second quarter was fairly modest. We do expect that to ramp up throughout the course of the back-half of this year, so more than half of that $100 million is going to happen in the back-half.
Derrick Sung:
May be one final follow-up to Ludwig’s comments. Ludwig can you may be just give us a little bit more detail now that the Biogen longer acting is in the market and that you’ve seen the label. Could you just may be give us a little bit more detail on sort of your expectations for the impact from that versus what you were thinking before as you’ve seen the label and any additional color on the early progress of their launch and how you’re specifically detailing against that competition? Thank you.
Ludwig Hantson:
Yes Derrick, I think that their label is not much differentiated from the ADVATE label. If you look at the ADVATE label, it has very strong annual bleed rate data in there which is unsurpassed, and which is still from a patient perspective the most important thing. We also have individualized PK in our label. We have every three day dosing in the label and when you look at the use of ADVATE, our ADVATE prophy patients are on an every three day or longer dosing regimen already. And so the data that we’ve shared with all of you are survey data that comes from patients and healthcare providers, tells us that yes the interest of the community is there for a longer acting. The definition of a longer acting for hemophilia A is one per week or longer dosing regimen. So our expectation is the same as the guidance that we gave you and that is we expect a single digit impact on our ADVATE to market share till 855 comes on board. Bob talked about the fact that we’ve completed the enrollment, we completed all the assessments, we are on track to share 855 data with you third quarter and we are still on track for a submission by the end of this year.
Operator:
Thank you. Our next question comes from Larry Keusch of Raymond James. Your line is now open.
Larry Keusch:
Yes hi, good morning. For Bob Hombach and then I have one for Bob Parkinson. Just again, I just want to want to make sure I’m understanding the cyclo updated guidance. So are you saying now that you obviously haven’t seen any competition yet and now you’re thinking later in this year and on top of that I think you had been initially anticipating about a $0.25 impact. Are you now saying it’s $0.20? Again, I just want to make sure I’m getting that all correct.
Bob Hombach:
We are now expecting competition to enter late Q3 to early Q4. We had previously guided to a potential negative impact of $0.20 to $0.30 that we baked into our initial guidance and from that initial guidance we are saying that’s going to get a little bit more than $0.20 better. So we are going to have improvements relative to our expectation around cyclo. Our original expectation is a little more than $0.20.
Larry Keusch:
Okay, and then you mentioned the investments that you’re going to make against that, so how do we sort of think about the net impact of all of this.
Bob Hombach:
Well, the net impact is as you know we didn’t change our overall guidance. So I talked a little bit about a pretty significant ongoing currency head-wind that we’re incurring here of an incremental $0.10 to our expectation as well, so that’s largely half of it. The rest of it relates to incremental investments that we’re making and as you know, we did a couple of business development deals here recently in gene therapy for haemophilia A, as well as an acquisition for sickle cell anemia treatment. Those are going to come with R&D burns with them and so that is going to ramp up our R&D spend. That and a few other things, about $50 million for the rest of this year and then we’re making internal investments to support numerous new product launches, primarily in BioScience and SG&A. Those two make up the bulk of the difference between the $0.20 benefit from cyclo and the $0.10 downside related to FX.
Larry Keusch:
Got you. And then I guess for Bob and may be for Ludwig, obviously post the Medtronic and Covidien deal and some of these other ones that are getting announced, clearly scale is something that seems to be dramatic out there. You guys obviously are going to innately get smaller with the spin off. So, I’m wonder if you could sort of discuss a little bit about how you guys think in the individual businesses, the needs to get better and to get bigger and sort of perhaps the strategy behind that.
Bob Parkinson:
Let me make some, may be some general comments for both businesses and then more specifically regarding new BAX and if Ludwig wants to comment on new bio going forward. Stating the obvious, we are consumed right now with activities associated with the spin. So it’s not about -- at this stage thinking about getting bigger, it’s about really moving forward to executive effectively the spin. Of course one of the strategic motivations behind the decision itself was to increase the focus in both businesses. I can tell you from the new BAX perspective if you will, we feel there is significant opportunities to grow earnings at a faster rate than sales as a result of a number of things, but one of which is to your question, I think aggressively managing portfolio, whether that’s business product, geographic portfolio and so on and I think you can anticipate post-spin activity in that regards. That also sets the stage then, I think to be proactive in term the acquisitions and so on to kind of reshape if you will the portfolio that comprises the new Baxter going forward. But again, those are the things we’re evaluating right now, but not spending a lot of time on given the focus of the energy slurries is really on the spin. Ludwig, I don’t know, from a new bio perspective if you want to add anything to that. I think probably it describes the intention of your organization right now as well.
Ludwig Hantson:
Correct. I think the question is not, how do we bigger here. I think the question is finding the right opportunity within the disease area that we are focusing on, which is immunology and hematology, oncology. And I think the question, can we make the difference in the patients’ life and how can we bring value.
Bob Parkinson:
Yes, I think that’s a great summary, in fact. I think you said it’s not about getting bigger at this stages, it’s about getting better and the spin, and its heart was really about intensifying the focus in each of the businesses so that we can be better, both from an innovation point of view, as well as how we launch and commercialize our products and manage the portfolios in both business. So the question of getting bigger is something we always think about, but I would tell you right now, it’s not really front burner.
Operator:
Thank you. Our next question comes from David Lewis of Morgan Stanley. Your line is now open
David Lewis:
Good morning. Bob Hombach, I just want to come back to the margins here for a second. I understand the discretionary spending in the back half of the year, but it’s released the second quarter. Were some of these discretionary spending items present in the second quarter, because obviously we would expect a little more up-side here in the second quarter, relative to our expectations, given the very strong revenue. And then Bob, some of the things you described are discretionary in nature in the back half of the year. How much do those carry forward into next year, because some of these you described are more base line spending on some of the new JV initiatives and some I imagine you can modulate pretty good heading into ’15. So if you can give us a sense of whether these items are kind of ’14 discretionary or linger into ’15 and then I have a quick follow-up.
Bob Hombach:
Okay. Yes, as it relates to second quarter, there was a fairly significant impact of gross margins. We did see some incremental SG&A, not so much in R&D yet. As I mentioned the two new acquisitions really are just going to start impacting BioScience from our R&D run rate perspective in the second half of this year. But from a gross margin perspective, the impact was pretty significant in the second quarter, primarily from FX, and the driver there really is the euro and as you know, as we’ve talked about in the past, given our global footprint, we have significant sales in Europe in the base Baxter business. Gambro had more than 50% of their sales in Western Europe as well. So that actually increased our exposure on the sales line, which is a good thing. But on the cost side, historically we’ve been able to mute most of Euro fluctuations at the gross margin line through a combination of our manufacturing footprint and financial hedging that we do. But as we’ve added Gambro into the mix, Gambro actually has a disproportionate amount of their manufacturing footprint in Europe and so their cost relative to revenue was much higher in Europe. So in fact the very strong Euro that we saw in the second quarter was a pretty meaningful negative to gross margin, because sales were higher related to the FX translation. But costs were even higher and so there’s pretty meaningful gross margin impact as we mentioned between that and Gambro, a 250 basis point negative on gross margin. So the lack of drop during the second quarter more is related to gross margin, primarily FX and less to do with these incremental investments, which again are primarily back half. And then as it relates to discretionary, clearly the R&D run rate for those two acquisitions is going to be their going forward. The SG&A and new product launches, those certainly can be modulated and that’s what we are doing now. We do have a platter of new products to position in the market over the next six to 12 months and we are going to make sure we make the right investment there, but we do have a bit more flexibility on that.
David Lewis:
Okay, helpful, thanks Bob. And then Bob Parkinson, just as you think about the spin heading into next year, obviously one of the biggest drivers of the medical products business will still be Gambro and then the broader Renal franchise. So maybe you can give us an update here over the last six months. Where do you think you stand as it relates to the organic growth profile you expected at Gambro? There’s capacity coming back on line and some of the cost opportunities that you saw. How would you give us sort of a summation of where Gambro sits across some of those metrics? Thank You.
Bon Parkinson:
Sure Dave. I would say first of all, at a high level we are tracking very well with the original expectations. More specifically in terms of the cost synergies, again tracking just may be a little bit behind in the short term, but longer term we feel that the target we communicated to you is more than achievable. Encouraging earlier returns, I think on commercial synergies. So when you look at the size of the business, in terms of revenue what’s becoming increasingly evident is the way to really monitor and this business is more broadly what we call Baxter Gambro Renal now, because we are seeing in the market place the expectation that the full complement of products would lever the legacy Baxter businesses, Peritoneal Dialysis and obviously home haemo going forward. In fact, if you look at our total Renal business revenue growth continues to perform very well and so in that sense, in terms of the revenue line, we continue to be very optimistic that we will achieve, if not exceed the original expectations. Having said that, on the legacy Gambro business, we continue to focus on ramping up capacity specifically in the dialyzer area, which is going to continue to be a challenge over the next year or two. Simply stated there’s more demand right now than our ability to deliver. You know some of the historical issues that the previous owners of Gambro were dealing with in that regard and so on. But we are moving forward to expand capacity. Our two primary dialyzer facilities in Hessiga, Germany and Opelika, Alabama, and it’s just a matter of time before we get that capacity ramped up, so that we can accelerate the growth of the dialyzer business. The acute business in the hospital is growing very nicely and the monitor business, we are pleased with how the monitor business is performing, specifically some of the reliability improvements and so on. So without getting more granular, I would say again back where I stated at a high level, things are tracking very nicely with our expectations.
Operator:
Thank You. Our next question comes from David Roman of Goldman Sachs. Your line is now opened.
David Roman:
Thank You. Good Morning everybody. I wanted to start with, I think the announcement was, it was yesterday and you highlighted it today on the call, the initiation to the Phase III trials in an Etanercept. May be you could just talk a little bit more about what you see the U.S. regulatory pathway being for your biosimilar program and how we should sort of expect that to unfold over the next couple of years.
Ludwig Hantson:
Hi David, it’s Ludwig. I think as you said, its evolving and I don’t think everybody has the answers here. But for us it’s critical that this is an opportunity to create access to these molecules. We are building a portfolio. We believe that a portfolio approach for us is critical, so we are building this portfolio and at this moment we have three molecules; one vertigo here and then there’s two with Momenta. I think there is an opportunity within the regulatory pathway to go for interchangeability. Of course that’s going to depend on finalizing those regulations, as well as what are the product characteristics. So we believe that we are in a strong situation, at least with one of the approaches that we have to shoot for interchangeability. I think you’ve seen that some of those, at least one of molecules is in Phase III. The other molecules continue to advance in the development. So stay tuned, we’ll know more as we move forward here.
Mary Kay Ladone:
And David, specifically related to Etanercept, remember we have OUS rights in Europe and several markets outside the U.S., so it’s not a product that we will have the rights for in the U.S.
David Roman:
Got it, thank you. And then just a follow-up may be to Bob Parkinson’s comment. I think in response to one of the earlier questions about leverage in the business and you did reference the potential for the remaining Baxter International to generate revenue growth and earning with earning growth pacing at a faster rate. Could you maybe just talk about the opportunity set there, because one of the things that stands out to us, at least when I look at your quarterly or annual filings, is the extent its current medical product margin sits below peers and I assume we’ll see more in the From 10. But maybe you sort of just preview for us some of the opportunities that exist there to close the gap in your mid products margin versus peers that has the potential to drive the outsized earnings growth for some period of time.
Bob Parkinson:
Sure David. Well first of all, kind of at a high level, everybody focuses on the creating of the BioScience spin off at the new public company, but I will tell you, our mindset is we are creating two new companies here. The spinoff of BioScience provides the legacy Baxter business, which as you know I will run going forward. I think an opportunity to reevaluate anything and everything that we do and I think that’s really healthy and that’s the mindset that we are embracing. First of all, I think intensifying focus on higher margin growth areas, product categories like anesthesia, parenteral nutrition, certainly the BioSurgery business, which while we’ve developed that market very nicely in the U.S., it continuous to be very undeveloped in many markets outside the U.S. Also infusion pumps. With the approval of the SIGMA Spectrum a month or so ago and the anticipated launch later this year with that, it’s going to put us in a position to play offence in infusion pumps for the first time really in many years. If you look at the margin accretion opportunity over the next five years or so in the infusion pump business for us to regain the share that we lost over the years in the U.S. due to the calling situation, and then be able to expand outside the U.S. there’s probably $0.30, $0.35 of EPS equivalent associated with margin accretion opportunities just in the infusion pump area. So anesthesia, nutrition, infusion pump, BioSurgery, all higher margin areas will benefit from intensified focus and as I mentioned, infusion pumps benefiting from now the ability to play offense with the recent approval. I commented earlier then on the opportunities in terms of portfolio and I think that there is significant opportunities to evaluate. As an example, core businesses like IV’s. In certain markets the IV business where we can bundle with the contract that includes the disposable sets, the infusion pumps, the secondary, the mini bags, the pre-mixes and so on, continues to be a very attractive business from a return on investment. In certain markets in IV’s where we’re contracting separately for IV’s, these are largely international markets, I think we really need to be more aggressive in terms of evaluating what is the sustainable value of these businesses, and so that’s the kind of example from a portfolio, geographic in that sense. The kind of things that I think we will be much more proactive in. I also think in terms of this new mindset and I’m challenging the organization to evaluative, really new paradigms in a lot of different areas. This recent IV shortage in the U.S. I think has sensitized a lot of people to the value of these products; products that largely have been taken for granted historically, which are essential to saving and sustaining lives and I described it as always the best deal in healthcare, to be able of pay for half a liter or a liter of IV at lower price than a bottle of water at Seven-Eleven, that kind of puts it in perspective and I think there’s opportunity there in terms of taking prices up and really getting value commensurate with the value that those products serve clinically and so on. So I’ll stop there. I would just tell you, I’m very excited to really lead this new organization and I think focus on those areas for margin accretion that exists. So this will be a subject we’ll talk a lot about in the coming months and certainly post-spin as we crystallize more specifically, but there’s fertile ground here I believe, to support my earlier comment about being able to drive earnings growth at a much faster rate than revenue growth in this new business.
Operator:
Thank you. Our next question comes from Mike Weinstein of JPMorgan. Your line is now opened.
Mike Weinstein:
Thank you for taking the questions. First one, Bob Hombach, when you had the late March call to announce the separation, it sounded like you still had a fair amount of work to do to put some numbers behind the separation costs. Have you had any additional work done on what you think the dilution from the spin will be; meaning really, for you guys will be all the incremental overhead that will have to be created, and I think you said at that time you didn't expect any tax leakage. So has there been any change there? Thanks.
Bob Hombach:
Yes, and no change on the view on tax leakage as I mentioned. I think transactionally we as create legal entities and move assets and people in various countries around the world, there may be small amount which will call out as separate special items, but in terms of ongoing tax rate for the two businesses, no change in prior view. Nothing significant we see for either business here at this stage. As it relates to synergy, we’re certainly working diligently internally to estimate what gross synergies are going to be and then how we’re going to go about mitigating them, how much before the spin occurs and how we will be able to get out the cost position over the first year or two. Again, we’re not seeing anything significant or different than what our consultants would say the benchmarks look like, so nothing has popped up and no red flags from what I said before that I think we are largely going to be in line with the type of operational, this synergy you’ve seen from other spin-offs. I would say though that our international footprint, which represents 60% of our sales on an annual basis, we are very integrated, it will be very complicated to separate the two businesses, but I think as we create a new biopharmaceutical company in an international framework, we’ll be able to do that in a fairly streamlined way. So again, there may be a little bit of extra dilution on day one related to international, but nothing significant.
Mike Weinstein:
Okay. And then can you give us an update on maybe – well, it maybe two items. One, you haven't talked about recently the plans for the vaccine business. Has there been any progress there? And then two, we've got the [IQVU] (ph) panel coming up at the end of the month. Can you set expectations for what we'll see that will be new in the panel pack, and how you expect the language from the FDA to read in the panel pack? Thanks.
Bob Parkinson:
Bob, you want to handle the vaccines and…
Bob Hombach:
Yes, certainly. As we mentioned earlier this year, we did take the strategic decision to look at, first a couple of development programs within R&D, particularly flu and our line program and see if those would be better served to be partnered or divested and we also were open potentially to our two inline vaccines to divesting those as well, depending on the preference of the partner. So we’ve gone through a process, talked to a lot of different interested parties and that process is ongoing, so not appropriate to comment further now. We are very focused on optimizing the value of the overall vaccine portfolio and as we make progress, we’ll certainly share that as appropriate, so still working on it, but nothing to update at the moment.
Ludwig Hantson:
With respect to the [IQVU] (ph) panel scheduled for July 31, the team is getting ready for the interaction, the dialogue. No new questions. It’s still the same as we discussed, the four questions or the questions related to long term safety of the antibodies related to a pH20 and specifically neuronal development in fertility, so nothing new there. I’m very pleased that you will be able to see all our data and we believe that our data is clean and that we have a positive benefit risk, but as you will be there most likely, we’ll have a great dialogue with the FDA.
Mike Weinstein:
Thank you Ludwig.
Operator:
Thank you. Our next question comes from Rick Wise of Stifel Nicolaus. Your line is now opened.
Rick Wise:
Good morning Bob, how are you doing?
Bob Parkinson:
Hi.
Rick Wise:
Bigger picture first. You're clearly investing heavily on the biosciences side pre-spin, seemingly on the surface a little less though in medical devices, although obviously Gambro is a big investment that you're integrating. So definitely you're actively supplementing biopharma ahead of the spin. Should we expect that Medical Product business development opportunities could come before the spin too or are you going to focus on that post-spin? And maybe just as part of that, as long as I'm laying it all out here, it sounds like you're interested in M&A. What areas are you likely to be thinking about? Something directly related to the existing business or broadening the scope of the post-spin med device company? Thanks.
Bob Parkinson:
Okay Rick, thanks for the questions, several things. Yes, I mean obviously when Gambro is the largest acquisition in the history of the company, so that really expresses an investment I guess in the new batch, but I think may be what is under appreciated is much is in the R&D area. The nature of the investments have been really in new systems; home hemodialysis, the VIVIA system, which we’re really excited about has been a five year investment. Likewise the AMIA system which is our next generation home choice and so on. So those don’t jump out in the way that our bio pharmaceutical investments do, but we have been making meaningful investments in internal R&A, those being just a couple of examples. Relative to business development activity going forward, I mean we continue to be open to that, despite as you say, and we all know our primary focus is the spin. I’m not suggesting we won’t do anything, but if we do, it will be of the smaller nature. Longer term, look we think there continue to be opportunities within the two core areas, which are the treatment of end stage renal disease, as well as the hospital channel. With the movement of the BioSurgery business over to the new Baxter going forward, very few companies can represent the breadth and diversity of products that are sold in the acute care hospital and so from an acquisition business development point of view going forward, that will continue to be I think a major area of focus to further solidify the channel. I’m not sure what percent of all healthcare dollars are either spent or driven through the acute care channel, but it’s a very high percentage and as I say, very few companies have a strong over presence in platform from a channel perspective there as we do. So I think it’s fair to say, at a very high level that will drive our business development, including acquisition efforts going forward.
Ludwig Hantson:
And Rick, I would just point out that I did mention in my prepared comments that in addition to the SG&A and R&D investments, we are making investments in operations within medical products. We’re seeing very strong demand, particularly in the U.S. for IV’s and PD and we’re seeing the regulatory environment raising the bar on everything from production through logistics, so there are incremental investments going in to that as well.
Rick Wise:
Right, and just to follow up quickly on renal, Bob Hombach as you said, PD gains are very strong in the quarter, up 15% in the U.S. Is that kind of growth sustainable? May be help us understand that and help us understand a little bit more about the timing issues OUS. I mean, do they swing back positive in the second half? It didn’t happen in the second quarter, but now they have happened. I’m not sure I fully understood what was going on there. Thank you.
Bob Parkinson:
Well, let me, Rick I’ll comment on kind of what I’ll call the market trends and then if Bob wants to add some color in terms of specifically the financial flow and so on, he can do that. It’s fair to say that globally, not just the U.S. but globally there is a movement in tumor treatment in the home, okay, whether that’s peritoneal dialysis or over time home hemodialysis and you see a number of countries, Thailand being one, Taiwan being another. In the case of Thailand, what they called PD first, which says, look as we provide access to treatment of in-stage renal disease, the government policy is going to drive treatment in home. There is this general feeling that its lower cost, it certainly is greater convenience for patients and in some cases and we believe very strongly in terms of home hemodialysis we are going to be able to demonstrate advancing clinical outcomes in a terms in a meaning full way, such as life expectancy and so on. So when you see the same dynamics going on in the U.S. and so in response to the first part of question Rick, yes I think the strength that we’re seeing in the U.S. market for PD, clearly is going to continue. I think it’s driven by kind of a rebalancing of the reimbursements, so now there are economic incentives for the providers to be in PD and ways in the past there were not and then of course with our launch over time of a home hemodialysis, I think it further accelerated to grow. So simply stated in the U.S., I think the strength you’re seeing is not a transient effect. I think it’s a representation of some more longer-term environmental trends and give us confidence that that kind of growth is sustainable. Bob you want to comment maybe more specifically on the numbers part of it.
Bob Hombach:
Yes, so as it relates to PD patients in the U.S., I mean we’ve seen a pretty consistent trend over the last five or six quarters of high single digit, low double digit PD patient growth. So that demand is there with the harmonization around reimbursement. We are certainly seeing a very strong move in the U.S. in particular. So I don’t think 15% necessarily is sustainable, but certainly high single digit, low double digit PD patient growth here in the near term is certainly a possibility. And OUS, given the mix of revenue that we get per patient in different markets, whatever the renal sales number we are reporting, you can be assured that the patient growth is probably a little faster for all the reasons that Bob just mentioned. So we are globally seeing very strong PD patient growth, but particularly in the U.S.
Bob Parkinson:
The other think that I would mentioned again from a macro perspective is that in many emerging markets and developing markets you have a lot of patients that aren’t even being treated today. So it’s one of the reasons we made the investment in Gambro that we did. This is a large market, it’s going to continue to growth. By virtue of the Gambro acquisition we have established a leadership position in this market, augmented by the existing launch system, new products such as VIVIA in the home and I think it’s a good bet that we made long term.
Bob Hombach:
Yes, last think I’ll add, the second quarter is somewhat depressed because of the timing of our tender as we talked about in Q1 related to renal, so I’d really look at year-to-date sales as being more indicative of the trend.
Bob Parkinson:
Yes good point.
Mary Kay Ladone:
Sam, we have time for two more questions.
Operator:
Certainly. Our next question comes from Kristen Stewart of Deutsche Bank. Your line is now open.
Kristen Stewart:
Hi, thanks for taking the question. I just wanted to check, just with the respect to the spin-off, at the time of the announcement, you guys had commented that you do not anticipate being able to redomicile the BioScience businesses. Is that still the case or have your thoughts changed at all?
Bob Parkinson:
No change. I mean certainly just as a function of a spin out. That is not an opportunity to do a tax-free redomiciling. So that’s not on the radar.
Kristen Stewart:
Okay. And then just on the IG business, can you comment just a little bit about what you’re seeing in terms of the dynamic between price and then the supply in the marketplace, because it sounds like price has been a little less favorable than what it has been historically, particularly within the U.S.
Bob Parkinson:
Yes, I would say we’ve had very modest expectations on price in the U.S. over the last couple of years and our longer range outlook assume that as well. So I think that remains largely consistent. We are looking forward to having enhanced supply here as we go forward. We are able to support market growth here in ‘14 and ’15 with our current footprint and we continue to work with Sanguine to bring flexible capacity online, which we expect in 2015, to be able to provide not only for the U.S. potentially, but certainly for Europe and other markets. So we are pleased with where we are at from a capacity standpoint and the flexibility we are going to have going forward and again, from a price perspective, I think largely in-line with our expectations.
Operator:
Thank you. And our final question comes from Bruce Nudell of Credit Suisse. Your line is now opened.
Bruce Nudell:
Good morning. Thanks for taking the question. Ludwig, one question for you. Just to clarify, you kind of framed the (inaudible) impact as kind of high single digits in the U.S. I guess just to clarify, is that high single-digit market share in the second half or is that average over the whole year or is that actually in fact a worldwide impact?
Ludwig Hantson:
The single digit market share impact is for the U.S. and that is between now and the launch of 855.
Bruce Nudell:
Perfect, that's great. And Bob, one of the things, that just looking at the numbers and it's not a very insightful observation, but when you look at the renal business, it is so heavily ex-US. So could you just broadly speak about the opportunities in the U.S., now that Gambro is part of the fold?
Bob Parkinson:
Yes. Bruce, some of this is consistent with my response earlier. It was to Rick Wise’s question. For the first time over the last year or so, largely as a result of reimbursement changes and so on, we are seeing really a boost to our PD business. We look forward to that being augmented by the home HD launch, but there is a lot of things that now for the first time in the U.S. are actually driving consideration of treatment in the home, whether that is PD or HD, which is very exciting, because frankly the U.S. business as you know for us has been pretty lack luster over the last number of years, but as has been demonstrated, I think Bob Hombach cited some of the growth numbers for PD patients. We are really seeing that business get re-energized and again as I commented in my response earlier to Rick, we think that’s going to be sustainable.
Bruce Nudell:
Thanks so much
Operator:
Thank you. Ladies and gentlemen, this concludes today’s conference call with Baxter International. Thank you for participating and have a wonderful day.
Operator:
Good morning ladies and gentlemen and welcome to the Baxter International’s First Quarter Earnings Conference Call. Your line will remain in a listen-only mode until the question-and-answer segment of today’s call. (Operator Instructions) As a reminder this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter’s permission. If you have any objections, please disconnect at this time. I would now like to turn the call over to Ms. Mary Kay Ladone, Corporate Vice President, Investor Relations at Baxter International. Ms. Ladone, you may begin.
Mary Kay Ladone:
Good morning, everyone and welcome to our Q1 2014 Earnings Conference Call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International; Ludwig Hantson, President of BioScience; and Bob Hombach, Chief Financial Officer. Before we get started, let me remind you that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters, contain forward-looking statements that involve risks and uncertainties, and, of course, our actual results could differ materially from our current expectations. Please refer to today’s press release and our SEC filings for more details concerning factors that could cause actual results to differ materially. In addition, in today’s call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website. Now I’d like to turn the call over to Bob Parkinson.
Bob Parkinson:
Thanks Mary Kay. Good morning. Thank you all for calling in. As you read in the press release issued earlier this morning Baxter reported strong financial results for the first quarter which exceeded expectations and we’ve also confirmed our full year 2014 guidance. Adjusted earnings increased 9% to $1.19 per diluted share and worldwide sales excluding currency increased 16%. Excluding Gambro and foreign currency, Baxter’s sales advanced 5%. Positive momentum is building and Baxter is off to a strong start in 2014. I’m pleased that we delivered strong financial results continued to enhance our flexibility to invest for future growth and position the company for sustained performance and success. Our new product pipeline is focused on a number of programs that improve the quality of care and address key high potential areas of unmet medical needs. Some recent highlights in the quarter include FDA approval of a label change allowing for a shorter total infusion time for GLASSIA, a chronic augmentation and maintenance therapy for hereditary emphysema and under diagnosed condition characterized by a low level of alpha-1 protein in the blood. This change enhances convenience and allows for less overall time for the entire infusion process from preparation to administration. Also success in meeting the primary efficacy endpoint in the phase III study of BAX 111. The first stand-alone recombinant treatment in clinical development for von Willebrand Disease for a on-demand bleeding events. We expect to file for regulatory approval in the United States before the end of 2014. We also intend to pursue a study for a prophylaxis indication. Baxter also presented interim data that the European association for Haemophilia and Allied Disorders from our first year observation from the ADVATE HaEmophilia A Database study, a four year outcomes registry of Hemophilia A patients. A total of 562 patients have been enrolled to-date. And the data supports the clinical experience of prophylaxis treatment with ADVATE, showing 51% experienced no bleeds during the one year of treatment. Also in the quarter, we executed a new exclusive agreement with Xenetic Biosciences for the development of BAX 826, a recombinant Factor VIII therapy for hemophilia A utilizing Xenetic’s proprietary polysialic acid technology. BAX 826 is currently in preclinical development as a treatment that maybe administered less frequently potentially at once weekly intervals without compromising efficacy. At lastly during the quarter, the company acquired Chatham Therapeutics including their developmental Gene Therapy preclinical hemophilia A and ongoing hemophilia B programs and the potential application for additional hemophilia treatments. As you may recall Baxter and Chatham are currently in a phase I, II trial evaluating Chatham’s Biological Nano Particle platform as the potential treatment for hemophilia B. The vector-based technology which provides a mechanism for the patients on liver to begin producing Factor IX following a single dose of the genetically engineered treatment as the potential to redefine the concept of longer acting therapy. And finally in the first quarter as you all know we reached a significant milestone in our company’s history with the announcement of our plans to create two separate independent global healthcare companies, one focused on developing and marketing innovative biopharmaceuticals and the other on life saving medical products. This decision supports Baxter’s evolution and underscores our commitment to ensuring our long-term strategic priorities remain lined with shareholders best interest, while creating value for patients, healthcare providers and other key stakeholders. The two businesses operate in distinct markets with the corresponding underlying fundamentals and each possess unique and compelling growth prospects, investment requirements and risk profiles. The spin-off will create two well capitalized independent companies with strong balance sheets, investment grade profiles and disciplined approaches to capital allocation. And other benefits of this include one greater management focus on the distinct businesses of biopharmaceuticals and medical products, the ability to more effectively commercialize new and existing product offerings. The ability to drive innovation across the franchises and allocate necessary resources to the areas presenting the highest growth potential and the flexibility to pursue respective growth and investment strategies resulting in revenue acceleration, improved profitability and enhanced returns. We look forward to closing this transaction by mid-2015 and preparations are already been made to affect in efficient and orderly transition to position both companies to capitalize on the exciting opportunities that the future holds. So with that, I would like to ask Bob at this point review financial results for the first quarter and also discuss our guidance for the remainder of 2014. Bob?
Bob Hombach:
Thanks Bob and good morning everyone. As Bob mentioned adjusted earnings per diluted per share in the first quarter advanced 9% to $1.19, which exceeded our previously issued guidance range of $1.06 to $1.09 per share. These financial results include an after tax gain of $35 million or $0.06 per share associated with the sale of certain equity investments, which will largely be reinvested in the business over the balance of the year. As we mentioned in the press release GAAP earnings of $1.01 per diluted share included after tax special items totaling $96 million or $0.18 per share for intangible asset amortization and cost associated with the integration of Gambro business development and business optimization initiatives. The business optimization initiatives include additional cost related to the decision to explore strategic options for the vaccines and cell therapies R&D programs. Now, let me briefly walk you through the P&L by line item before turning to the financial outlook for 2014. Starting with sales, worldwide sales were approximately $4 billion advanced 15%. On a constant currency basis sales rose 16% and exceeded our guidance range primarily due to strong demand for hemophilia products as well as the accelerated timing of vaccine milestone payments and a renal PD tender. Excluding Gambro revenues of $400 million which were in line with expectations Baxter sales rose 5% on a constant currency basis. In terms of individual business performance, Global BioScience sales of more than $1.6 billion advanced 5% in the first quarter. On the constant currency basis sales increased 6%. Within the product categories, hemophilia sales of $827 million increased 8% or 9% on a constant currency basis. This is the result of capitalizing on our global leadership position and brand differentiation broadening our portfolio with new product launches like RIXUBIS for the treatment of Hemophilia B and expanding access to care particularly in emerging markets. Specifically global demand for ADVATE remain strong as we continue to benefit from our label expansion improved prophylaxis penetration and shipments to Brazil as part of our ongoing collaboration with Hemobrás to enhance access to Recombinant factor A therapy. We have now converted more than 30% of the total patients in Brazil and we expect to generate sales of more than $100 million in 2014. In addition, global demand for FEIBA also remained robust resulting in double digit sales growth in the quarter. In BioTherapeutics sales of $502 million declined 1% on both a reported and constant currency basis. Growth in the U.S. of 7% was a result of improved cost availability and growth of the Immune Globulin therapies albumin and alpha-1 treatments. This strength was more than offset by lower sales in international markets as a result of lower albumin sales in China and decisions to exit certain markets due to previous supply constraints. Sales in BioSurgery of $176 million increased 2%, on a constant currency basis sales rose 3% driven by demand for surgical sealants like TISSEL and COSEAL. As you know both of these products is tied directly to growth in surgical procedures. Finally, vaccines revenue totaled $103 million and increased 23%. Sales advanced 25% on a constant currency basis driven primarily by accelerated milestone payments of approximately $40 million related to ongoing government collaborations for the development of influenza vaccines. In medical products global sales exceeded $2.3 billion and increased 22%. On a constant currency basis sales advanced 24%. Excluding Gambro and foreign currencies medical product sales grew 4%. Within the product categories, renal sales totaled $991 million including Gambro sales of $400 million. Excluding Gambro and foreign currency renal sales increased 4%. This was a result of strong PD growth of 9% supported by strong patient gain in the U.S. and emerging markets that also benefit from the timing of certain tender sales of more than $15 million. This momentum was partially offset by the divestiture of the CRRT business. Sales in the fluid system category of $757 million increased 2% or 3% on a constant currency basis. Performance continued to be driven by price improvements for the injectable oncology drug cyclophosphamide which more than offset lower sales of drug delivery systems. Especially pharmaceuticals which includes our inhaled anesthetics and nutritional therapies posted sales of $367 million reflecting an increase of 1%. Sales rose 2% on the constant currency basis as strong global anesthesia growth offset lower sales of certain nutritional therapies resulting from ongoing supplier shortages. Finally sales in BioPharma solutions which is our pharma partner business totaled $228 million with close to 1% on a reported basis or 4% on a constant basis. This performance attributed primarily to the easing of supply constraints which impacted orders and shipments in the first quarter of last year. Turning to the rest of the P&L, gross margin in the quarter was 51.0% compared to 51.7% last year. Margin expansion in the base Baxter business was more than offset by the impact of lower margin Gambro business and in foreign currency. SG&A totaled $903 million and increased 16% with the Gambro acquisition accounting for the vast majority of the growth. Excluding Gambro SG&A increased 2% as leverage close to arise and benefits associated with our business optimization initiatives. This was partially offset by select investments and promotional and marketing initiatives for new product launches and with the international market to enhance our global presence. R&D spending in the quarter of $282 million increased 15% versus the prior year. Excluding Gambro R&D rose 2% and continuous to be driven by investments we are making to advance a number of programs in our pipeline, including those in our leading hemophilia franchise, programs to leverage our expertise in the therapeutic areas of hematology, oncology and immunology and investments in renal therapies aimed and improving patient outcomes across the continuum of care. The operating margin in the quarter of 21% is lower than last year’s operating margin of 22%. However, excluding Gambro, leverage in the base Baxter business was also been an operating margin improvement of 80 basis points to 22.8% versus the prior year. Interest expense was $43 million which reflects recent debt issuances to fund both the Covington plasma manufacturing site and the Gambro acquisition. Other income totaled $41 million compared to income of $30 million last year. This includes $44 million of pre-tax gains associated with the sale of certain equity investments. As referenced earlier on an after tax basis, this equates to benefit of $35 million or $0.06 per share with largely reinvested in the business over the balance of the year. The tax rate was 21.4% for the quarter in line with our expectations and as previously mentioned adjusted earnings per diluted share advanced 9% to $1.19. For the first quarter, cash flow from operations was very strong and totaled $559 million. This reflects an improvement versus last year of approximately $175 million. DSO ended the quarter at 53.6 days and excluding Gambro, Baxter’s DSO was 49.9 days lower than the prior year by 3.7 days. Inventory turns of 2.0 or lower than 2.2 turns in the prior year period due to increased plasma inventories to support strong demand and future growth. Lastly, in the first three months of this year, we repurchased approximately 3.7 million shares for $250 million or on a net basis 1.2 million shares for $123 million in line with our full year objective. Finally, let me conclude my comments this morning by providing our financial outlook for the second quarter and full year 2014. For the full year, we continued to expect adjusted earnings of $5.05 to $5.25 per diluted share. As we know that last quarter, we are providing a lighter range, it’s been our historical practice as a number of factors and assumptions impact the outlook particularly headwinds created by cyclophosphamide competition in emerging market FX volatility. Specifically by line item of the P&L and starting with sales, we continue to expect sales growth excluding the impact of foreign currency of approximately 9% to 10%, which includes annual sales of more than $1.6 billion for Gambro. At current foreign exchange rates, we expect reported sales growth of approximately 8% to 9%. Excluding Gambro, we expect the base Baxter sales to grow approximately 2% on a constant currency basis. For the full year, we continued to expect gross margin for the company to decline by approximately 150 basis points in the 2013 margin of 52%. Given the strong first quarter, we expect the first half margin to be approximately 40 to 50 basis points higher than the gross margin in the second half which includes the impact of new competitive entrants. In terms of expenses, as mentioned earlier our first quarter performance enhances our flexibility to invest in the business to drive future growth. Therefore, we now expect R&D to grow in mid-single digits and SG&A to grow in mid-to-high single digits. We expect interest expense to total approximately $160 million and we now expect other income of approximately $40 million for the year. We expect the tax rate of approximately 21.5% and we expect a full year average share count of approximately 547 million shares, which assumes approximately 300 million in net share repurchases. From a cash flow perspective, we continue to expect to generate cash flow from operations of approximately $3.5 billion. We expect capital expenditures of approximately $1.8 billion, which includes Gambro and the investments we are making to enhance our plasma manufacturing footprint in Covington, Georgia. Let me move to sales and expand our assumptions for the two businesses and the major product categories which are very consistent with our original guidance. Beginning with medical products on a constant currency basis including the contribution of Gambro, we expect sales growth of approximately 13% to 14%. Excluding Gambro, we expect sales from medical products to grow 0% to 1%. Specifically, we expect renal sales to grow approximately 40% including the benefit of continued PD penetration, the incremental revenue contribution from Gambro as well as commercial synergies. We expect fluid system sales to decline 3% to 5% reflecting the impact of lower cyclophosphamide sales. As we mentioned, if we have two competitors by mid-year, the sales and pre-tax impact would equate to $150 million to $200 million. We expect specialty pharmaceutical sales, which includes our nutritional therapies and inhaled anesthetics, to grow in the 3% to 5% range. And we now expect our BioPharma Solutions sales to be flat for the full year. For BioScience, we project sales growth excluding foreign currency at 3% to 4%. Our outlook includes growth of 4% to 5% in our hemophilia franchise. Well we continue to expect to increase competition for recombinant factor VIII therapies in the second half of this year, performance will be fueled by underlying global demand for ADVATE, convergent to recombinant therapy in Brazil, new tender awards, as well as the benefit from new product launches, including RIXUBIS, OBI-1 and FEIBA prophylaxis. For the BioTherapeutics franchise, we continue to expect growth of approximately 4% with sales of albumin in China and immunoglobulin therapies ramping up particularly in the second half of the year. In BioSurgery, we expect growth in the 5% to 7% range. And finally, given the first quarter performance, we now expect our vaccine sales to decline in low single-digits. As mentioned in our press release, for the second quarter, we expect earnings per diluted share excluding special items of $1.18 to $1.22, which reflects the timing benefits that were accelerated and recorded in the first quarter. We expect sales growth, excluding the impact of foreign currency, of 12% to 13%. Excluding Gambro, we expect the base Baxter sales at constant currency rates to grow approximately 2%. Thanks. I’ll now open up the call for Q&A.
Operator:
Thank you. We will now begin the question-and-answer session. (Operator Instructions) I would like to remind participants that this call is being recorded and a digital replay will be available on Baxter International’s website for 30 days at www.baxter.com. Our first question comes from David Lewis of Morgan Stanley. Your question please.
David Lewis:
Good morning.
Bob Parkinson:
Good morning.
David Lewis:
Bob, simply start off on the financial guidance for the second quarter, obviously a very nice start to the first quarter year on earnings, some of that was the gain but just the underlying business was stronger and margins are good. Can you talk us about what factors change here in the second quarter, because that earnings number is little lower and you would have expect to get assuming the strength in the first quarter?
Bob Parkinson:
Certainly, David. Yes, there are definitely an unusual number of timing impacts here that have benefited the first quarter to the determent of the second quarter. And I would gage that in a $0.05 to $0.06 range. And, so let me walk you through those, it’s really two main things. We have a collaboration on the vaccine side to do a tech transfer related to our Vero cell technology, we expected milestones to occur later in the year and including in the second quarter. The good news is, those were completed a bit early and fully recognized in the first quarter, but that does create about $0.03 of upside in the first quarter at the expense of the second quarter. And then secondly, again along the lines of revenue recognition in terms of timing of when tender sales occur, we have a large tender in the PD franchise that we expected in the second that occurred in the first. The combination of those two and a couple other things really is what drove the strong performance in the first quarter. I would also mention that as you know the gains in the first quarter that we highlighted there of $0.06 related to the two minority investments that were sold. We also incurred incremental FX in the first quarter that dampened the impact of some of these timing benefits primarily related to Argentina, and other emerging market impacts including related to the Gambro business. So, a lot going on between the first and second quarter, I think if you look at the two of them combined it will give you a better sense of where we’re at and that’s largely why if we looked at the full year, we’d maintain our full year guidance, again a lot of volatility potentially we have ahead of us with cyclo and FX but operationally a very, very solid start.
David Lewis:
Okay.
Mary Kay Ladone:
And David, I would also add that in plasma, we have some plasma tender timing as well that impacts the second quarter versus the prior year. Those tenders are going to occur more in the third and fourth quarter this year versus some of the major tenders that occurred in the second quarter last year.
David Lewis:
Thanks, Mary Kay. Very helpful. And then, maybe just a follow-up. The key strength where we’ve seen in the last couple of quarters has been but still and I imagine that’s a surprise for certain investors. So, if we think about that strength, in the last two quarters, obviously it’s coming out of the U.S. markets. And there is really two factors going on this quarter, it feels like one is Brazil and there maybe some of the early product launches like RIXUBIS, but you talked about Brazil being about $100 million in 2014. Frankly, based on the trend-line out of 2013 in the first quarter result, $100 million just seems low. So, is there anything going on in terms of the timing of Brazil or maybe you can give us the mix of the factors contributing to U.S. in the affiliate strength during the first quarter. Just seems that, that $100 million number could go a lot higher in 2014?
Bob Parkinson:
Yes, it could go somewhat higher David. I would tell you in the first quarter, though the contribution from Brazil was not outside in the sense of what the trend would need to be in order for us to deliver something just north of $100 million. So, we’re very pleased with the progress we’re making. And so, that certainly is a contributor, but frankly ADVATE continues to do well in many other international markets including markets like Japan where we’ve had very strong growth over the last couple of years.
David Lewis:
Okay. Thank you, very much.
Operator:
Thank you. Mike Weinstein of JPMorgan is on the line with the questions. Please state your questions.
Mike Weinstein:
Thanks. Question on clarifications on the guidance. So, the – it looks like you took another price increase about 30% on cyclophosphamide in January. Can you just maybe clarify what you’re assuming in the second quarter relative to competition, I haven’t seen anybody announcing it then. Just want to clarify what you’re assuming? And then second, look at guidance for the year, I assume you weren’t assuming the $0.06 gain in the original guidance. So, why should we move up number by $0.06 given the gain here this quarter? Thanks.
Bob Parkinson:
Okay. Couple of things, so on cyclo, I’d like to first point out, we in our Q1 guidance did not assume any competition nor do we see any competition and results in the first quarter were basically as expected. So, cyclo was not a contributor to our performance in the first quarter relative to our guidance. At this point, we’re not expecting competitive entrants though very late in the second quarter, so not much impact in the second quarter either but certainly in the back-half then depending on when the second and or third enters in, that will determine how that plays out for the remainder of the year, but for the second quarter again not expecting significant competitive impact on cyclo. As to the price increase, we did take a price increase, obviously there are different channels and different customer relationships, I wouldn’t say with across the board at the same level, but we did take a price increase in the first quarter.
Mary Kay Ladone:
And then the gain Bob.
Bob Parkinson:
As it relates to the gain, yes. And so, as I mentioned there are some aspects here as well in the first quarter FX being 1. But, as we look at the balance of the year in some of the areas that we want to ensure reposition ourselves to generate the best success. We are looking at R&D and SG&A reinvestment here that over the balance of the year, we’re not going to be taking that gain to the bottom-line.
Mary Kay Ladone:
And we did change our guidance...
Mike Weinstein:
I have a question for Bob Parkinson. And I really want to focus on strategy for the medical product side of the business close within. Can you just talk little bit about what drives that business and I’m really thinking not only about the top-line but about margins obviously it’s going to be a big regions that the next pertaining two months with Cyclophosphamide going away. But once that’s done, what drives there when your top-line, but what drives margins there and what periods kind of the story beyond this be currently underlying growth we’re seeing right now? Thanks.
Bob Parkinson:
Yes. Okay, Mike. So, let me not be too lengthy in my response because there is not a simple response. So let me start with the Gambro acquisition. Which as we discussed before, it allows us to participate in a leadership role in a large global markets that we believe will grow in the 5% to 6% range long-term. And so, the acquisition of Gambro, the expansion of our presence augmenting our PD business to address treatment of end-stage renal disease a significant long-term growth platform for the newly defined medical products business, but I think you all understand that. Within the traditional medication delivery business if you will, again our plans are to intensify focus in those product categories that are higher growth than higher margins. So, anesthesia would be one parenteral nutrition would be another. Also, there continue to be opportunities to improve margins in our core global IV business in terms of manufacturing efficiencies, productivity, supply chain productivity in the like. So, again there is not a simple answer to that. I think there is a lot of levers might that can be pulled to enhance margin over the long-term in the newly defined Baxter if you will going forward. And I would also say that as we’ve accelerated business development activity over the last couple of years, certainly it is our plan to continue that as we go forward with the new company. So, I think the – I think the – with increased focus which is one of the primary rationales behind the decision to spin-off the Biopharmaceuticals business with an increased focus globally frankly I think will allow us to address a number of margin improvement opportunities over time.
Mike Weinstein:
Great. Thank you, Bob.
Bob Parkinson:
Thank you.
Operator:
Thank you. Our next question comes from Bruce Nudell of Credit Suisse. Your line is now open.
Bob Parkinson:
Bruce, are you there?
Operator:
Please check your mute button sir. And we’ll move on to our next question. Our next question comes from Larry Keusch of Raymond James. Your line is now open.
Larry Keusch:
Hi, good morning. Just to perhaps for Bob Hombach. Bob you obviously mentioned in your prepared comments that the underlying Baxter gross margin has been improving, I believe you said up 80 basis points year-over-year. So, I just want to dig into that and fully understand what is driving those improvements there because that’s pretty impressive? And then, secondly if we could just get an update on where you guys stand with the large volume infusion pumps?
Bob Hombach:
Sure. So, yeah the comment was around operating margin and there is obviously a number of factors there in the base Baxter business FX, calling FX to the side which has tended to be more of a headwind in the last couple of quarters. Mix, certainly placed in ADVATE strong hemophilia sales here for the quarter. The business optimization efforts that we put into not only this year but last year as well are certainly playing into that. The vaccine milestones come with fairly high margins as well. So, those being recognized here in the first quarter were beneficial as well. And we are starting to see the benefits of the Gambro synergies starting to come into the -I know we’re talking about the base Baxter business but overall that is something that’s going to drive our margins throughout the rest of the year.
Larry Keusch:
Okay, great. And then on the pump side, where do we stand there?
Bob Hombach:
So, update on the pumps, as we had filed the necessary documents and are waiting for the review to be complete and we expect to hear something about in middle of this year, so I don’t think there is really any other update at this point.
Larry Keusch:
Okay, great. Thanks very much.
Operator:
Thank you. Our next question comes from Matt Miksic of Piper Jaffray.
Matt Miksic:
Hey, thanks. Good morning. Wanted to ask just Bob if I could, Bob Hombach on the gain and the FX loss you mentioned the FX, the incremental FX kind of offsetting the gain. I guess we were looking for about a dime of FX impact this year. Did this push you closer to $0.15 or can you give us anymore color on to just how that offsets that number? And then I have a couple of quick follow-ups.
Bob Hombach:
Yes. So, Matt actually we characterize them more like a $0.15 at the time we gave guidance for the full year, we had FX at about $0.15 headwind. And in fact it’s going to be a little bit higher than that given the Argentina situation as well as how things are playing out. I think I would note about FX is historically a stronger euro would be beneficial to Baxter given the size of our business there and a overall global manufacturing footprint. As we bring Gambro into the fold though, the vast majority of their manufacturing a lot of their cost base is in euro. And so, we’re actually like we benefit less from a stronger euro in the near-term, but it did increase our exposure to all other currencies outside the U.S. given the footprint they have. And so as emerging market currencies have continued to struggle a bit, our current set up here with Gambro given the stronger euro and the weaker emerging market currencies actually creates incremental FX downsides in that original $0.15 assumption.
Matt Miksic:
That’s helpful. And then the other comment, I think that Bob or one of your mate here in the beginning of the call was around sort of synergies or sort of the broad portfolio of hemophilia products of course FEIBA launching in the quarter, appropriate FEIBA and OUS strength. I guess, can you tell us little bit about anything that any sort of -any sort of synergy effects of launching these multiple therapies into this general category whether it’s for hemophilia B, hemophilia A or the treatment of inhibitors as in FEIBA that you’re seeing develop in the market either in the U.S. or international? And then I have just one last quick one.
Bob Hombach:
So a couple of things, I want to come back to the comment that was made on the strong demand x U.S. for the hemophilia. I must add to that that we also continue to see strong demand for ADVATE and FEIBA in the U.S. And although it’s not reflecting the sales numbers still there were some inventory adjustments versus first quarter of last quarter. So, we stick to our full guidance and believe that the U.S. is also showing a very strong demand. As far as the launches is concerned, the launches are staggered geographically RIXUBIS at this moment a U.S. launch company as you know we still needed the application end of last year both in Europe as well as Japan and so we expect to launch RIXUBIS ex-U.S. by the beginning of 2015. As far as the launch is -are concerned, so as this prophy is on track, we launched this in 2012, we’ve had more than 500 patients on ADVATE, FEIBA prophy is on track. We launched this in the beginning of this year and it is ahead of expectations and it’s also reflected in our numbers, and the RIXUBIS launch as I said in the U.S. is on track. We’ve converted quite some patients, so we really pleased with the launches in our hemophilia franchise.
Matt Miksic:
Great, and then Ludwig the last one actually is for you. Just if you – we’re all looking at competition – to throw the competition in the back-half in hemophilia and of course also to some top-line indication of the 855 data hopefully on mid-year or third quarter. And I’m just wondering, you’ve said us before that if you did receive anti-inhibitor in that data, that you would announce it as you receive data shortly thereafter. If you could help us understand was the trial fully enrolled in say November or wherever it was, is how far along here do we need to be to feel like or can we feel like there is any sort of comfort level that okay, we’ve gotten this far in with anti-inhibitor, inhibitors usually happen in whatever the early part of that therapy. Any color you could provide us is to whether we should be feeling more comfortable as we get to May or June or July or what’s the timing would be very helpful? Thanks.
Ludwig Hantson:
Yeah so I’m not going to speculate on the outcome of the study, but as far as timing is concerned yes we did enrolled less patients in this study end of last year, it is a six month study so that will give you some idea of when the last patient, last assessment will be and correct we have not seen anti-inhibitors. We planned to release the data third quarter of this year with a submission before the end of this year.
Matt Miksic:
Thank you so much.
Operator:
Thank you. Our next question comes from David Roman of Goldman Sachs.
David Roman:
Thank you and good morning everyone. First question was on the Biotherapeutics business just on the ramp in the back-half of the year. Can you maybe just enumerate some of the details that are supporting that I presume on albumin its obtaining the licenses in China, but you maybe update us on the Sanquin as well in that question?
Bob Hombach:
With respect BioT if you did see a negative growth for international in the first quarter, we believe that this is going to change moving forward with particular guidance that we give for the full year for BioT which is plus 4%. So you will see an uptake in growth in the next quarters. There is an impact of albumin especially on the China, IG International will pick up also in the next quarters, so that’s what where we are.
Bob Parkinson:
Yeah and we do expect to start meaningful shipments to China and albumin in the second quarter David, we already have one of the two licenses renewed and so, at this rate we expect to sell almost as much albumin in China this year as we did last year.
David Roman:
And then the ramp in IG is that coming from the contribution from IQ or ramp up in production somewhere else?
Bob Hombach:
It will primarily come from the IG business and the substitute business not from IQ, as we said the ramp up for this for IQ, ex-U.S. as well as U.S. will be minimal, but there will be some contribution, with respect to your question on Sanquin – Sanquin will not have an impact on the 2014 numbers.
David Roman:
Okay great. And…
Mary Kay Ladone:
I would just add David; we didn’t expect Sanquin to impact 2014 as the capacity won’t come on until early next year.
David Roman:
Got it, okay. And then on the renal business, I think you said 4% organic growth that included the tender win, but I know its early in the Gambro integration process, but can you give us some sense as to what the magnitude of commercial sort of clinical revenue synergies you might be able to realize in that deal going forward and can that business get to sort of a sustainably ex these had a one-time tenders of 4% to 6% growth rate over time?
Bob Parkinson:
Yeah David, Bob Parkinson here. First of all yes is the answer to your – the last part of your question that clearly is our expectation. It’s a little bit early in the game to quantify commercial synergies although I would say, the first quarter for Gambro and revenue came in virtually spot on our model and of course the rest of the renal business, the legacy renal business was even stronger than our forecast. And we’re beginning to see early stages of synergies, one example, would be certain tenders where our ability to bid more broadly with product offerings and all the categories allow us to compete were previously we’ve been able to -unable to do that. So, we anticipate that we’re going to be able to experience more things like that as we go forward. But certainly the long-term projection the growth of Baxter’s renal business broadly defined both the legacy business and Gambro is going to be very much in line with what I said.
David Roman:
Okay, thank you very much.
Operator:
Thank you. Our next question comes from Josh Jennings of Cowen and Company.
Josh Jennings:
Hi good morning, thanks for taking the questions. Just a follow-up on David’s question, is with the Gambro acquisition I think Bob you said $400 million this quarter and PD growth of 9%. Are you seeing some early cannibalization of your historic hemodialysis business and is there any qualification there?
Bob Parkinson:
Well our historic hemodialysis business is, very modest, so I don’t think there is any cannibalization that we’re seeing that at all, Bob I don’t know if you have any.
Bob Hombach:
Yeah of course, well two things I would say, we did mention that the CRT divestiture that was about a $55 million business that we had to divest as part of the closing the deal. So that will be throughout 2014 from a growth rate perspective. And while there are some modest impacts, because largely our HT business previously was through was self acting as the distributor for other parties and now that we’ve acquired Gambro that will – that will tail-off overtime, but in 2014 no significant impacts that we’re expecting on those relations.
Bob Parkinson:
Josh I think it’s important for you and everyone to understand to that you raised a question of cannibalization, in terms of our legacy home presence with PD and of course our aspirations to launch our new home hemodialysis systems. We really believe that our broader position resulting from the Gambro acquisition will actually enhance our ability to penetrate the market on both our traditional PD business as well as support the home HT launches as those cascade out overtime. So, we see that as a positive synergistic effect.
Josh Jennings:
All right, great thanks for that. And then just one for Ludwig, just on the BAX 111 approval, can you just help us frame the global von Willebrand factor market and I’ll stop there. Thanks a lot.
Ludwig Hantson:
Thanks Josh and maybe I should correct you, we didn’t get approval. Your question is 111?
Josh Jennings:
Yes.
Ludwig Hantson:
So, we got the phase III results and we released those early this week, so we’re really pleased with the results, the products a couple of things on the product it could be the first recombinant von Willebrand and we received orphan status in U.S. and Europe. It’s a pure von Willebrand molecule with a ratio of 100:1. The phase III study was very positive since the 100% of the patients had positive response on the efficacy rating scale, which we read on with the FDA. As far as the market is concerned currently it says $300 million to $400 million, it’s a 100% plasma. But I do see, taking this opportunity to grow this market to increase diagnosis – diagnosis rates are really low as well as prophy used, since the prophy used is really is about 5% in total and when you look at the type III severe patients it’s only a 20%. So, we look at this market as a potential market where we continue to make difference in those patients life and increase the value.
Operator:
Thank you. Our next question comes from Kristen Stewart of Deutsche Bank. Your line is now opened.
Kristen Stewart:
Hi, thanks for taking the question. Just to clarify back on Mike’s original question. Was the gain on the sale of the investment contemplated in your guidance that you issued back in January?
Bob Hombach:
No, not.
Kristen Stewart:
Okay. And then just on…
Mary Kay Ladone:
Kristen, can I just add to that as well because, I think Mike’s question, I try to jump in but we did increase the guidance in terms of our R&D spend. We did have an acquisition in the quarter Chatham which is going to increase some R&D on this as well as some other things that are planned as we accelerate some program. So, guidance there went up as well as guidance in SG&A.
Kristen Stewart:
Okay. And these investments, have you disclosed or is there any filing to share which what exactly you sold and why sold them. I know you guys have had a portfolio of investments.
Bob Parkinson:
Well, actually these were much more -much older investments going back 12 to 15 years, there were minority positions we had the underlying companies made an independent decision to sell. And so, we really had no impact on the timing and they both happen to happen in the first quarter and they were sold to private firms. One of them was GHX which is an EDI platform that a number of large healthcare companies got together to form a contortion again 10, 15 years ago and so that was recently sold to again to a private firm. So, that’s really the extend of it.
Kristen Stewart:
Right, the gain was nothing in your control in terms of the timing, it was just simply these underlying companies were sold to you?
Bob Hombach:
Yes, they own less than 10%, I think both, we had a very little say on timing.
Kristen Stewart:
Okay, great. And then you’d also mentioned, I guess Bob you had mentioned kind of the parenteral nutrition business and your interest there. How do you just think about, I guess expanding that business, would you consider to run acquisitions kind bolster up your nutritional franchise. And does I guess the split off I guess in general just make it a little bit more challenging to do M&A over the next year or so?
Bob Parkinson:
I mean this certainly in terms of -in terms of the financial strength, clearly we have the ability to continue the kinds of acquisitions that we’ve done in the recent past. I actually think in some ways Kristen after the split, we might have been have more latitude and flexibility to pursue some things given the nature of the new Baxter without the biopharmaceutical business that would be more aligned with expectations of shareholders. So, clearly business development acquisitions are very much part of our strategy at the new Baxter going forward. And the area parenteral nutrition, specifically I think is a significantly under penetrated market globally. And I think the opportunity there is really more internal investment to cultivate the growth of that market whereas you know we’re a leader in that market today. Whether specifically there are acquisition candidates within parenteral nutrition not really going to comment it is an evident to me that there are, but the key thing is the underdeveloped nature of that market, I think with the increased focus and associated investment and opportunity to accelerate the growth of that product category.
Operator:
Thank you. Our next question comes from Bruce Nudell of Credit Suisse. Your line is now open.
Bruce Nudell:
Good morning. Thanks for bearing with me, phone problems here. Ludwig, it’s been very hard to get an extension of the half-life refractory. And the zoonotics thing, it sounds like it is the departure from that and could you basically explain why you think it might work and likely to success?
Ludwig Hantson:
Well, first of all this is early stage, this is still pre-clinical. And the PSA I think we will extend for the pioneer of highly tested about the same. Maybe the difference here is that it’s biodegradable in our pre-clinical studies with the monkeys, we showed a prolongation by a factor of more than two compared to ADVATE. We’ve been wanting to see what it means in the clinic and what is the chances that you will go all the way, I think you know the signs of biopharmaceuticals in the pre-clinical we believe that it has a lot of value but puts us in the studying in of clinical studies will show we can repeat the execute. They went from back to maybe what is the most important thing here it is for us it is a belief towards and it’s not about extending the half-life, it is about making sure that we have zero bleeds and you get zero bleed spot extra levels that are high enough, constantly not from the peak and is from that perspective that our approach on gene therapy in hemophilia, we believe could be disruptive and that’s why we want to be a leader in the technology as well.
Bruce Nudell:
Great. So, and my follow-up is just very tactical with regard to saying when I know there were regulatory issues that were out there, how are they looking, is it likely that this will be coming on line in 2015 kind of in a seamless way as planed?
Bob Hombach:
Well, we are working with Sanquin on the question, as much as we can. As we also said, the Sanquin volumes are not reflected in our 2014 numbers. And we believe that the guidance that we gave on our ability to grow with the market 6% to 8% that will not be affected for the next couple of years irrespective of the ultimate Sanquin. But we believe that we should be able to work with Sanquin to those questions in our next year most likely have that inputs.
Bruce Nudell:
Thanks so much.
Mary Kay Ladone:
And we have time for one more question.
Operator:
Yes, ma’am. And our final question comes from Derrick Sung of Sanford Bernstein.
Derrick Sung:
Hi, good morning. Thanks for fitting me in. Just starting with a quick question here, I wanted to – have you remind us of your expectations for SUPRANE generic competition and what is factored in your guidance for this year for that?
Bob Hombach:
Bob, you want to take?
Bob Parkinson:
Yeah, we had a modest competitive impact put into our original guidance and given the latest information that we have, we don’t expect much of an impact here. So, it’s largely competitive and out of our guidance here for Suprane. But the delta between our original guidance and where we’re at today is around $10 million or so, if not significant.
Derrick Sung:
Okay great that’s very helpful. And then, my follow-up is for Ludwig on – on the long acting recombinant factor VIII market, two things there, one we’ve seen now phase III data from a number of the other competitors Nova as well as Bayer in addition talk to Biogens product. Somewhat if you kind of get your reaction that we’ve seen more phase III data come in on just kind of what you think of the long acting competition maybe how that might relate to your product? And then secondly there, one of the big questions, I mean that’s out there is how pricing in the market might change with the entering of new competitors, particularly competitors who currently don’t have a presence in the market and wanted to get your thoughts on that as well?
Ludwig Hantson:
I’ll respond with the pricing question which is going to be a short answer, so I have no comments on that, so no comments here. With respect to your question on LA maybe a couple of observations. The first one is we call them long acting factor VIII products mentioned it several times that we believe that these are not long acting, these are extended half-life products. The half-life is still shorter than one day shorter than RIXUBIS half-life, and I would not call RIXUBIS a long acting product. So that’s number one. Number two is, the – what the data shows consistently is that when we’re pushing to dosing regimen towards 5 or 7 days that the data consistently shows that ABRs the annual bleed rate increases. And then we should ask ourself the question, are we doing the right thing for the patient here. Again this is a bleeding disorder with the objective of zero bleed and is not infusion disorder. So, my answer is that, I do believe that we are on track with what we’re doing with 855 that it is based on the ADVATE molecule that is proven that is shown to be preventive, that is shown to have consistent factor level data irrespective of the ADVATE that is being used. And I believe that we have a very strong platform to work from. So I really feel comfortable with 855 approach in addition to that as I mentioned, I believe that gene therapy could be disruptive, we are of course proof-of-concept in hemophilia B. And with the new acquisition, we are on the lead from the gene therapy perspective across the board broader than we. So, I’m really comfortable with our strategy, the data as I said for 855 will get this done in second quarter.
Derrick Sung:
Ludwig do you expect to this class of extended half-life products to expand prophylaxis used in hemophilia A and how much did that expand market growth?
Ludwig Hantson:
I would say that prophy penetration will increase irrespective of the extended half-life products. We’ve seen this; we’ve seen a significant uptake since we launched ADVATE prophy. We should know that all label shows up to three ADVATE 3 days, and more than 50% of our patients are on 3 days or longer dosing regimen so irrespective of the entry extended half-life products I do believe that the prophy segments will increase over time.
Derrick Sung:
Okay thank you very much.
Operator:
Thank you. Ladies and gentlemen, this concludes today’s conference call with Baxter International. Thank you for participating. Everyone have a wonderful day.